US20060259118A1 - Delivery system and devices for the rapid insertion of self-expanding devices - Google Patents
Delivery system and devices for the rapid insertion of self-expanding devices Download PDFInfo
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- US20060259118A1 US20060259118A1 US11/408,121 US40812106A US2006259118A1 US 20060259118 A1 US20060259118 A1 US 20060259118A1 US 40812106 A US40812106 A US 40812106A US 2006259118 A1 US2006259118 A1 US 2006259118A1
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- guide channel
- channel member
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- stent
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
- A61M25/0053—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
Abstract
Delivery systems for self-expanding devices are provided having a system proximal portion with a handle, an elongate middle section delivery device with an outer sheath and inner compression member, and a system distal portion including an outer guide channel member with first and second end portions defining a guide channel that slidably receives an inner guide channel member having a guide channel, the guide channels being substantially aligned. A mounting region for self-expanding devices is disposed radially between the inner and outer guide channel members. The outer guide channel member has a stepped profile from a first outer diameter to a second smaller outer diameter located near a transition region having a breech position opening for passage of a wire guide, catheter, or other medical instrument. The outer member is axially slideable relative to the inner member to deploy a self-expanding device. Methods of using and manufacturing are also provided.
Description
- The present patent document claims the benefit of the filing date under 35 U.S.C. §119(e) of United States Provisional Patent Application filed on Apr. 20, 2005 entitled, “Delivery System and Devices for the Rapid Insertion of Self-Expanding Devices,” and having an application Ser. No. 60/673,199, the disclosure of which is hereby incorporated by reference in its entirety.
- The present invention relates to medical devices generally used percutaneously or through a delivery apparatus (such as an endoscope) for the delivery of self-expanding devices, as well as methods of making and using such devices.
- This invention relates generally to medical devices and, in particular, to a delivery system that employs a catheter device for use with self-expanding devices such as stents, prosthetic valve devices, and other implantable articles at a selected location inside a patient's body. More particularly, the device includes a flexible, kink-resistant middle section having an outer sheath and inner compression member and having a distal end comprising an inner guide channel member and an outer guide channel member, the inner and outer guide channel members being configured to facilitate rapid insertion of a wire guide and delivery of self-expanding devices.
- Self-Expanding Devices
- Medical delivery and placement systems and tools have grown out of the need for implanting medical devices in endovascular and other body lumens of a patient. The present invention relates to new and useful medical devices generally used percutaneously or through an apparatus such as an endoscope for delivering a particular type of implantable medical devices: self-expanding devices. Types of self-expanding devices include various medical devices, such as stents, prosthetic valve devices, and other implantable articles for placement inside a patient's body. Although use of the present invention is not limited to stents, a discussion of stent technology provides a general and beneficial introduction into the variety of self-expanding devices that the present invention delivers and places in endovascular and other body lumens.
- Minimally invasive surgical stent technology has become popular since the introduction of stents to the medical device market in the United States in the early 1990s. For more than a decade, stents have proven to provide an excellent means for maintaining vessel patency, and have become widely accepted in the medical field.
- By way of background, stents are configured to be implanted into body vessels having a passageway in order to reinforce, support, repair, or otherwise enhance the performance of the passageway. The term “passageway” is understood to be any lumen, channel, flow passage, duct, chamber, opening, bore, orifice, or cavity for the conveyance, regulation, flow, or movement of bodily fluids and/or gases of an animal. As an example, stents have been used in the passageways of an aorta, artery, bile duct, blood vessel, bronchiole, capillary, esophagus, fallopian tube, heart, intestine, trachea, ureter, urethra, vein, and other locations in a body (collectively, “vessel”) to name a few.
- Depending on the vessel in which it is to be implanted, a stent may come in a variety of different configurations. In general, a stent may comprise a ring, or stack of rings, each ring being formed of struts and apices connecting the struts, whereby the stent defines an approximately tube-like configuration. Furthermore, the stent perimeter, when viewing the stent end-on, may define a structure roughly, but not exactly, resembling a round cylinder if the struts are straight, because the struts follow a straight line from the apex on one end of the strut to the apex on the other end of the strut.
- In addition to their having a variety of configurations, stents also come in different types as defined by the way they expand. For instance, various types of expandable stents have been described that are self-expanding, balloon-expandable, or a combination thereof where the stent is partially self-expanding and partially balloon-expandable. Expandable stents are normally evaluated, more or less, with respect to four performance criteria: the radially outward expansile force that the stent exerts in the vessel passageway on an interior surface of the vessel; the small diameter to which the stent is capable of being compressed for the insertion procedure; the ability of the stent to traverse curved passageways; and the stability of the stent in being resistant to migrating from its originally implanted position.
- A balloon-expandable stent is generally mounted on an expandable member, such as a balloon, provided on the distal end of a delivery system, such as a catheter or tubular delivery device, to be discussed more fully below. In operation, a physician or other healthcare professional (collectively, “physician”) inserts the catheter into and navigates the catheter through a vessel passageway by advancing the catheter to a desired location adjacent the target site within the vessel passageway of a patient. In a subsequent step, the physician pulls back a sheath or other covering member to withdraw from and releasably expose the stent for deployment. In another step, the physician inflates the balloon to plastically deform the stent into a substantially permanent expanded condition. The physician then deflates the balloon and removes the catheter or delivery device from the patient's body.
- For a self-expanding stent, the stent is resiliently compressed into a collapsed first, smaller diameter, carried by the delivery system, and due to its construction and material properties, the stent expands to its second, larger diameter upon deployment. In its expanded configuration, the stent exhibits sufficient stiffness so that it will remain substantially expanded and exert a radially outward force in the vessel passageway on an interior surface of the vessel.
- One particularly useful self-expanding stent is the Z-stent, introduced by Cook Incorporated, due to its ease of manufacturing, high radial force, and self-expanding properties. Examples of the Z-stent are found in U.S. Pat. Nos. 4,580,568; 5,035,706; 5,282,824; 5,507,771; and 5,720,776, the disclosures of which are incorporated in their entirety. The Zilver stent, introduced by Cook Incorporated, is another particularly useful self-expanding stent due to its nitinol platform and use of the Z-stent design properties. Examples of the Zilver stent are found in U.S. Pat. Nos. 6,743,252 and 6,299,635, the disclosures of which are incorporated in their entirety. By way of example only, one or more of these designs have been utilized in stents for applications involving the bronchioles, trachea, thoracic aortic aneurysms (stent-graft), abdominal aortic aneurysms (stent-graft), intestines, biliary tract, and prosthetic venous valve devices. The Z-stent and Zilver stent are capable of being compressed, inserted into a catheter or delivery device, pushed out into the passageway of a vessel, and then self-expanded to help keep the vessel passageway in an open state. A few of the embodiments of devices using one of these stents are the Zilver® 518 biliary self-expanding stent and the Zenith® AAA Endovascular Graft for the endovascular treatment of an abdominal aortic aneurysm.
- A stent of the self-expanding type, like the balloon-expandable type, may assume a collapsed tubular configuration having a smaller diameter and an expanded tubular configuration having a larger diameter. In its collapsed smaller diameter configuration, the stent can be constrained by a delivery system in order to be positioned in the vessel passageway where desired. The stent is then deployed by the delivery system and expanded.
- In both the self-expanding and balloon-expandable types of stents (and combinations thereof), a delivery system for percutaneous positioning of the stents in the vessel passageway may use a wire guide. The physician uses the wire guide to maneuver a portion of the delivery system through the vessel passageway and to the desired position therein.
- Wire Guide
- A wire guide can be used to place a delivery system, such as a catheter or tubular delivery device, into a vessel passageway percutaneously. A physician may use a cannula or a needle as a way of introducing the wire guide. For instance, the physician may create an incision in the patient and then position the cannula in the incision for the insertion of the wire guide. The typical wire guide has proximal and distal ends. A physician inserts the distal end into the proximal end of the cannula or needle and then out a distal end of the cannula or needle, and thus into the vessel passageway. Once inside the vessel, the wire guide may be advanced and manipulated until the distal end of the wire guide reaches its destination. Alternatively, the physician may place the cannula or needle into any one of a variety of vessels, such as an artery, bile duct, brachial vein, cephalic vein, or other vessel as described above, and then may introduce the wire guide through the needle into the vessel. In subsequent steps, the physician may withdraw the needle over the wire guide and introduce a guide catheter over the wire guide and into the patient.
- Regardless of how the physician places the wire guide into a vessel passageway for use with a traditional delivery system, the physician must ensure that the catheter or other medical device has the right length relative to the length of the wire guide. Consequently, the catheter or other medical device will be inserted over the wire guide to a precise length inside the patient so that a distal end of the catheter or other medical device is positioned at or near the distal end of the wire guide in proximity to a target site for treatment, diagnosis, or medical intervention. However, a long, straightened portion of the wire guide will remain outside of the patient's body and may get caught on outside objects and disturb the placement of the catheter.
- Additional procedures that involve wire guides often require exchanging of catheters or medical devices. For example, a catheter may be used for the delivery of a self-expanding device such as a stent. In that case, the stent may be deployed, the catheter withdrawn and reloaded with an additional stent or replaced with a separate catheter carrying another stent, or even exchanged for a different medical device. This procedure may prove cumbersome and time consuming, because as explained below, the overall length of a wire guide in an over-the-wire delivery system needs to be substantially longer than the length of the delivery catheter (e.g., the wire guide may need to be twice as long as the catheter). Furthermore, the proximal portion of the wire guide outside the patient's body must remain a sterile field, but as explained below, when the wire guide needs removing or the catheter exchanging for another catheter or other medical device, then an additional person in the operating room needs to hold onto the proximal end of the wire guide to keep the wire guide straight and to prevent unintended proximal or distal movement of the wire guide.
- Catheter
- Many delivery systems employ a catheter, sheath, cannula, introducer, or other medical delivery device or tube-like structure, which must “slide over” the wire guide yet fit “within” a guide catheter or a working channel of an endoscope or an external accessory channel device used with an endoscope (individually and collectively, “catheter”). The catheter comprises a lumen for the wire guide. Generally stated, these delivery systems may fall within two categories. The first category of delivery systems to have been used, and consequently the first to be discussed below, is commonly referred to as an “over-the-wire” catheter system. The other category of delivery systems is sometimes referred to as a “rapid exchange” catheter system. In either system, a wire guide is used to position the delivery system within a vessel passageway. The typical wire guide has proximal and distal ends. A physician inserts the distal end into the vessel passageway, advances, and maneuvers the wire guide until the distal end reaches its desired position within the vessel passageway.
- In the “over-the-wire” catheter delivery system, a physician places the catheter over the wire guide, with the wire guide being received into a lumen that extends substantially through the entire length of the catheter. In this over-the-wire type of delivery system, the wire guide may be back-loaded or front-loaded into the catheter. In front-loading an over-the-wire catheter delivery system, the physician inserts the distal end of the wire guide into the catheter's lumen at or near the catheter's proximal end. In back-loading an over-the-wire catheter delivery system, the physician inserts a distal portion of the catheter over the proximal end of the wire guide. The back-loading technique is more common when the physician has already placed the wire guide into the patient, which is typically the case today. In either case of back-loading or front-loading an over-the-wire catheter delivery system, the proximal and distal portions of the catheter will generally envelop the length of the wire guide that lies between the catheter first and second ends. While the wire guide is held stationary, the physician may maneuver the catheter through the vessel passageway to a target site at which the physician is performing or intends to perform a treatment, diagnostic, or other medical procedure.
- Because this delivery system fits over the wire guide, the replacement or exchange of catheters or medical devices requires that the portion of the wire guide protruding from the patient's body be longer than the replacement or exchanged catheter or medical device. For instance, if 60 centimeters (cm) of the catheter is to be inserted into the patient, then a wire guide will need to be slightly longer than approximately 120 cm, because the physician will need to hold or secure the proximal portion of the wire guide (i.e., the portion extending out of the body) as the delivery catheter is being back-loaded onto the wire guide. Consequently, the overall length of the wire guide may need to be at least more than 120 cm. Likewise, replacement or exchange of a catheter or medical device requires that a physician secure the proximal end of this lengthy wire guide while the catheter is withdrawn from the patient until the distal end of the catheter is then slipped off of the proximal end of the wire guide. This procedure requires a considerable operational time when the catheter is initially placed over the wire guide for insertion into the patient and is withdrawn from the wire guide for exchange or replacement. Furthermore, the extra wire guide length makes control and manipulation of the wire guide difficult, cumbersome, and usually requires an extra person in the sterile field of the procedure to help control and protect the proximal end of the wire guide.
- Therefore, there is a need for an apparatus that enables a user to quickly and easily advance a catheter over a wire guide. The present invention solves these and other problems.
- Another problem with conventional over-the-wire delivery systems is tendency for the stent-carrying inner catheter to kink during stent deploment. It should be understood in conceptual terms how self-expanding devices (such as stents, prosthetic valve devices, and other implantable articles) are generally deployed from the delivery system. Using a self-expanding stent as an example, inner and outer catheters are utilized for delivering the implantable stent to a deployment site well within the vessel passageway of the patient. The stent is releasably positioned on a platform located at the distal end of a stent-carrying inner catheter. On the platform, the stent is seated axially intermediate optional distal and proximal radiopaque restraint markers and sandwiched transversely (i.e., compressed) between the outer catheter and the inner catheter.
- Typically (using the self-expanding stent for illustration), the stent-constraining outer catheter is withdrawn proximally over the stent. As is conventional, “distal” means away from the physician when the device is inserted into a patient, while “proximal” means closest to or toward the physician when the device is inserted into a patient. The outer catheter and inner catheter must be flexible enough to navigate a vessel passageway. In particular, the inner catheter may be susceptible to kinking when the stent-constraining outer catheter is withdrawn to deploy the self-expanding device, because the self-expanding device exerts friction and drag on the interior surface of the stent-constraining outer catheter, owing to the self-expanding device's radially outward expansile force property as discussed above. Thus, the self-expanding device and the stent-carrying inner catheter will be prone to withdraw together with the stent-constraining outer catheter. As a result, the inner catheter may be prone to kink upon withdrawal of the outer catheter.
- Therefore, there is a need for an apparatus that enables the user to withdraw the stent-constraining outer catheter proximally over the stent without causing the stent-carrying inner catheter to move proximally or to kink. The present invention solves these and other problems.
- The present invention has enough flexibility to navigate through the vessel passageway with an outer catheter, and an inner compression member has sufficient stiffness to “push” the stent in order to counter the urge for the stent (or a stent-carrying catheter) to prolapse proximally with the withdrawing of the outer guide channel member. As will be understood, “pushing” on the inner compression member will keep a stent-carrying inner catheter (and therefore the stent) from translating as a result of an outer catheter being pulled over the stent; thereby “pushing” holds the stent in place at the desired deployment site within the patient's body.
- Another aspect of the present invention is to design the inner compression member so that it optionally has a dual functionality. For instance, in addition to being a flexible and sufficiently stiff member to resist kinking during stent deployment, the inner compression member in one embodiment also carries and removes fluids, where the term “fluid” is understood as including but not limited to gases, air, water, contrast fluid, oil, saline solution, blood sample, flushing solution, medication, drug eluting therapeutic substance, or other liquid, gas, fluid, or medium that is biocompatible or capable of being made biocompatible.
- Turning now to a delivery system that is sometimes referred to as a “rapid exchange delivery system,” the traditional rapid exchange delivery system may be prone to the same susceptibility of kinking as discussed above and, additionally, may be prone to kink the wire guide as explained below. Like the over-the-wire delivery system, the conventional rapid-exchange system utilizes an outer catheter and an inner catheter, which are substantially co-axial. The conventional rapid-exchange delivery system further comprises a distal segment with a stent-carrying inner member. Unlike the over-the-wire system where the wire guide is received into the lumen of the inner catheter and extends the entire length of the inner catheter, in the rapid exchange delivery system the wire guide occupies a catheter lumen extending only through the distal segment of the outer catheter.
- With respect to the distal segment of the outer catheter in a traditional rapid exchange delivery system, the wire guide enters a distal section and, in particular, a lumen of a stent-carrying inner catheter at a distal opening and exits the stent-carrying inner catheter at a side opening proximal to the distal opening. The wire guide in the conventional rapid exchange system bends substantially and diverges significantly away from the longitudinal axis of the stent-carrying inner catheter as it converges toward an exit side port located in an outer wall of a stent-constraining outer catheter. Thus, the wire guide enters the delivery system at the distal portion of the inner catheter, exits the side opening in the inner catheter and the side port of the outer catheter, and then runs proximally along the outside surface of the outer catheter wall and is substantially parallel with or “side-by-side” with the inner catheter.
- The bend that the wire guide goes through, in the traditional rapid exchange system, as it passes from the lumen of a stent-carrying inner catheter to the exit side port in the outer wall of the stent-constraining outer catheter proximately causes and contributes to added resistance (compared to a wire guide experiencing substantially no or considerably reduced bending). For instance, the wire guide turns significantly away from the longitudinal axis of the lumen of the stent-carrying inner catheter when the physician withdraws the outer catheter proximally to remove, replace, or exchange the delivery system with a new catheter containing another self-expanding stent or a different medical device. As a result of its bending, the wire guide tends to kink. A kink in the wire guide may cause difficulty during a later step where, after the stent is deployed, the outer catheter during withdrawal catches on the wire guide kink and pulls the distal end of the wire guide away from the deployment site. Also, after the delivery system is withdrawn from the proximal end of the wire guide, the inner catheter may need to be reloaded onto the wire guide (e.g., with an additional stent, or replaced with a catheter carrying a different medical device) and will then encounter the wire guide kink as the inner catheter moves distally.
- Buckling and bowing, as two forms of kinking, of the distal segment of the device may occur with a traditional design of a rapid exchange delivery system in the vicinity where the wire guide exits the inner catheter side opening and turns substantially transverse to the inner catheter in order to leave the side exit port of the relatively juxtaposed proximal opening in the stent-carrying member and the side port in the outer wall of the stent-constraining outer catheter. Owing to the transverse position of the side opening in the outer wall of the stent-carrying inner catheter and the transverse side exit port in the outer wall of the stent-constraining outer sheath, there is an open cutout profile in the traditional device that may have a tendency to buckle or bow at the cutout when traversing within the narrow confines of the vessel passageway. The tendency to buckle or bow may decrease with a closure of the cutout by elongating the exit side port in the outer wall of the stent-constraining outer catheter, but this may cause weakness in pull strength or bending properties of the outer catheter. Indeed, the outer catheter and the stent-carrying inner catheter are basically of thin-wall construction: while increasing the thickness of the walls at the location of the inner catheter side opening and the outer catheter exit side port minimally improves the level of resistance to buckling or bowing, this level is still often considered unacceptable. In addition, increasing the thickness of the walls is generally considered undesirable because it necessitates the use of a larger delivery device or entry hole in the patient than would otherwise be required (owing to the increased profile of the catheter). Furthermore, the larger catheter profile may also cause unnecessary irritation of the patient's vessel, as well as limiting the size of the vessel in which the delivery system may operate.
- The present invention solves these and other problems by providing a breech position opening.
- Another challenge with the traditional design of a rapid exchange delivery system is proper alignment of the stent-carrying inner catheter side opening and the exit side port of the stent-constraining outer catheter. Misalignment may occur during several steps. For instance, the stent-carrying inner catheter and the stent-constraining outer catheter may rotate or their relative axial positions may shift during navigation and positioning of the delivery system through the vessel passageway. Another example where misalignment may occur is during the withdrawal of the stent-constraining outer catheter. As the outer catheter retracts proximally from the relative position of the stent-carrying inner catheter to expose and to deploy the stent from the stent-carrying platform, misalignment may result. Increasing the size of the exit side port of the stent-constraining outer catheter alleviates some of the alignment challenges but further increases the problems of kinking, buckling, bending, and bowing as discussed above.
- Thus, during positioning, operation, repeated use, or patient movement, the stent-constraining outer catheter may be bent or shifted axially or rotationally, thereby resulting in a kink in the sheath or misalignment of the side opening of the stent-carrying inner catheter and the side exit port of the outer catheter's outer wall. A kinked or misaligned catheter may become unusable and, even if useable may be difficult to straighten while positioned in the body of a patient. Consequently, the sheath must be manipulated within the patient's vessel passageway, giving rise to an increased duration in the medical procedure. Alternatively, the delivery system may need to be removed, leaving an enlarged, bleeding opening which typically cannot be reused. Vascular access must then be re-attempted at an alternative site, and the procedure restarted. This can cause an unnecessary delay of time and, during emergency procedures, may be life threatening. In addition, in some cases, an acceptable alternative site is not available for introducing another delivery device.
- The present invention solves these and other problems by providing a transition region for an inner guide channel member and an outer guide channel member.
- Therefore, it would be desirable to have a medical device delivery system for self-expanding devices such as stents, prosthetic valve devices, and other implantable articles inside a patient's body, whereby a flexible, kink-resistant middle section delivery device has an outer sheath and an inner compression member, and a distal end of the device comprises an outer guide channel member and inner guide channel member that comprise a cooperatively kink-resistant wire guide lumen configured to facilitate rapid insertion of a wire guide and delivery of a self-expanding device. Consequently, it is desirable to have medical systems and rapid insertion delivery devices for the delivery of self-expanding devices as taught herein, and methods of making and using such devices.
- The present invention provides medical device delivery systems for the rapid insertion of medical devices.
- In one embodiment, an inner guide channel member has a first end portion having an entry port and a second end portion having an exit port and a guide channel therebetween and having an outer surface for a stent platform intermediate the first and second end portions. A proximal stent restraint is disposed about and operatively coupled to the inner guide channel member intermediate the inner guide channel member first and second end portions, and the stent platform distal the proximal stent restraint and proximal the inner guide channel member entry port. An outer guide channel member has first and second end portions defining a channel therebetween for receiving the inner guide channel member second portion, wherein the guide channels are substantially aligned.
- In another embodiment, an inner guide channel member has a first end portion with an entry port and a second end portion with an exit port and defining a channel therebetween and having a stent platform intermediate the ports. An outer guide channel member has first and second portions defining a channel sized to slidably receive the inner guide channel member second end portion. The outer guide channel member has a stent constraining surface disposed about the inner guide channel member stent platform, and has a stepped profile with a first outer diameter intermediate the outer guide channel member first and second end portions, and a second smaller outer diameter near the outer guide channel member exit port. The exit ports are in fluid communication.
- In still another embodiment, the delivery apparatus includes a system proximal portion having a handle and stylet. A middle section delivery device has an elongate outer sheath operatively coupled to the handle, and an elongate inner compression member having a proximal end and a distal mating end portion, the inner compression member proximal end being operatively coupled to the stylet. A system distal portion has an inner guide channel member with a first and second end portion defining a channel, an outer guide channel member axially slidably receiving the inner guide channel member second end portion. The outer guide channel member has an entry port and an exit port defining a guide channel therebetween, and a stepped profile having a first outer diameter intermediate the outer guide channel member first and second end portions and a second smaller outer diameter located at or near the outer guide channel member second end portion. The system distal portion and middle section delivery device are operatively coupled.
- In still another embodiment, methods of using a delivery apparatus for the rapid insertion of medical devices for intracorporeal procedures are provided. A delivery system is provided having a system proximal portion having a handle and a stylet and intended to remain outside a patient, a middle section delivery device having an outer sheath and an inner compression, and a system distal portion having an inner guide channel member and an outer guide channel member having a stepped profile, the system distal portion further comprising a self-expanding deployment device mounting region, a transition region, and a proximal breech opening. A self-expanding device is loaded into a radially compressed state at the stent mounting region. The system distal portion is slide over a previously positioned guiding device. The outer guide channel member is retracted proximally relative to the inner member so as to deploy the self-expanding device.
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FIG. 1 is a schematic view, broken away, of a medical device system according to one embodiment of the invention. -
FIG. 2 is an exploded side view, broken away, of a proximal portion of a medical device according to one embodiment of the invention. -
FIG. 2A shows longitudinally sectioned exploded side views of a handle first connector and a handle second connector according to one embodiment of the invention. -
FIG. 2B shows a longitudinally sectioned side view of operatively coupled first and second connectors according toFIG. 2A . -
FIG. 2C shows a longitudinally sectioned side view of a handle first connector and a handle second connector according toFIG. 2B operatively coupling a strain relief member and/or an outer sheath according to one embodiment of the invention. -
FIG. 3 is a longitudinally sectioned view along a partial length of an embodiment of a catheter used for an outer sheath of a middle section delivery device and/or for an outer guide channel member of a distal portion of a medical device according to the invention. -
FIGS. 4A and 4B are longitudinal sectional perspective side views, broken away, of embodiments of an outer sheath for a middle section delivery device comprising multifilar material. -
FIG. 4C is an alternative embodiment of an outer sheath, broken away, for a middle section delivery device comprising a wrapped round coil. -
FIG. 4D is an alternative embodiment of an outer sheath, broken away, for a middle section delivery device comprising a cable tubing or spiral cut cannula. -
FIG. 4E is an alternative embodiment of an outer sheath, broken away, for a middle section delivery device comprising a cable tubing connected to spiral cut cannula. -
FIG. 4F is an alternative embodiment of an outer sheath, broken away, for a middle section delivery device comprising a round braid. -
FIG. 4G is an alternative embodiment of an outer sheath, broken away, for a middle section delivery device comprising a flat braid. -
FIG. 5 is a schematic sectional side view, broken away, of an integral outer sheath of a middle section delivery device and an outer guide channel member of a distal portion of a medical device according to the invention. -
FIG. 5A provides a longitudinally sectioned schematic side view, broken away, of a brace device for use in a middle section delivery device and/or for bridging the middle section delivery device and a distal portion of a medical device according to the invention. -
FIG. 5B shows a cross sectional view ofFIG. 5A taken along thelines 5B-5B. -
FIGS. 5C through 5G show alternative perspective views of a bridge associating a partial schematic middle section delivery device and a partial schematic distal portion of a medical device according to the invention, the bridge comprising a span. -
FIGS. 5H through 5K show perspective schematic views of an alternative embodiment of a bridge comprising a plurality of spans. -
FIG. 5L shows an insert having a flared end. -
FIG. 5M shows an alternative embodiment of an insert. -
FIG. 5N shows an embodiment of an insert having perforations. -
FIG. 5O shows an embodiment of an insert having slots. -
FIG. 5P shows a schematic sectional side views, broken away, of an outer sheath and an outer guide channel member bridged by interfacing distal and middle inserts. -
FIG. 5P shows a schematic sectional side views, broken away, of an outer sheath and an outer guide channel member. -
FIG. 5Q shows a schematic sectional side views, broken away, of an outer sheath and an outer guide channel member bridged by interfacing distal and middle inserts. -
FIG. 5R illustrates a sectional side view, broken away, of an embodiment of an insert according toFIG. 5O secured to one of the outer sheath of the middle section delivery device or second end of the outer guide channel member according to the invention. -
FIG. 5S illustrates a sectional side view, broken away, of an embodiment of an insert according toFIG. 5N secured to one of the outer sheath of the middle section delivery device or second end of the outer guide channel member according to the invention. -
FIG. 5T illustrates a sectional side view, broken away, of an embodiment of a bridging insert according toFIG. 5L secured to one of the outer sheath of the middle section delivery device or second end of the outer guide channel member according to the invention. -
FIG. 6 is a longitudinally sectioned view, broken away, of a distal portion of medical device delivery system according to one embodiment of the invention. -
FIGS. 6A and 6B schematically represent cross sectional views of melt bonding according to one embodiment of the invention, whereFIG. 6A shows components before melt bonding whileFIG. 6B shows the components after melt bonding. -
FIG. 7 is a longitudinally sectioned view, broken away, of an alternative embodiment of a distal portion of a medical device delivery system according to one embodiment of the invention. -
FIG. 8 is a longitudinally sectioned view of an embodiment of a distal portion according to the invention, shown having a portion of a wire guide. -
FIG. 9 is a longitudinally sectioned view, broken away, of another embodiment of a distal portion of a medical device delivery system according to one embodiment of the invention. -
FIGS. 9A, 9B , and 9C show cross sectional views ofFIG. 9 taken along thelines 9A-9A, 9B-9B, and 9C-9C, respectively. -
FIG. 10 is a longitudinal sectional side view of an alternative embodiment of a distal portion of a device for the rapid insertion of self-expanding stents according to the invention shown in an un-deployed delivery state. -
FIG. 11 is a view ofFIG. 10 shown in one illustrative deployed delivery state. -
FIG. 12 is a cross sectional view ofFIG. 10 taken along the line 12-12. -
FIGS. 13A, 13B , and 13C are alternative embodiments of cross sectional views ofFIGS. 10 and 11 taken along the line 13-13. -
FIGS. 14A, 14B , 14C, 14D, 14E, and 14F are alternative embodiments of cross sectional views ofFIGS. 10 and 11 taken along the line 14-14. -
FIG. 15 is one embodiment of a cross sectional view ofFIGS. 10 and 11 taken along the line 15-15. -
FIG. 16 is a longitudinal schematic sectional side view, broken away, of a portion of an embodiment of an outer guide channel member according toFIG. 10 . -
FIG. 17 is a longitudinal schematic sectional side view, broken away, of a portion of an embodiment of an inner compression member and an inner guide channel member according toFIG. 10 . -
FIG. 18 is longitudinal sectional side view of an alternative embodiment of a distal portion of a device for the rapid insertion of self-expanding stents according to the invention shown in an illustrative deployed delivery state, and shown with a wire guide. -
FIG. 19 is an alternative view ofFIG. 18 shown in an un-deployed delivery state, and shown with a wire guide. -
FIG. 20 is a view of a portion of an embodiment of an outer guide channel member depicted inFIG. 18 . -
FIG. 21 is a longitudinal schematic sectional side view, broken away, of a portion of an embodiment of an inner compression member and an inner guide channel member according toFIG. 18 . -
FIG. 22 is a longitudinal sectional side view of an alternative embodiment of a distal portion of a medical device according to the invention. -
FIG. 23A is a cross sectional view of one embodiment ofFIG. 22 taken along the line A-A. -
FIG. 23B is a cross sectional view of one embodiment ofFIG. 22 taken along the line B-B. -
FIG. 24 shows a schematic side view of an inner compression member according to an embodiment of the invention. -
FIGS. 24A, 24B , and 24C show cross sectional views ofFIG. 24 taken along the lines A-A, B-B, and C-C, respectively. -
FIGS. 25A through 25C are longitudinal schematic sectional views, broken away, of alternative embodiments of a distal portion of a medical device according to the invention. -
FIG. 26 is a block diagram illustrating a method of providing a delivery system configured for rapid insertion delivery of self-expanding devices. -
FIG. 27 is a block diagram illustrating a method of manufacturing an outer sheath, outer guide channel member, and/or inner guide channel member for use with a delivery system configured for rapid insertion delivery of self-expanding devices. -
FIG. 28 is a block diagram illustrating an alternative method of manufacturing an outer sheath, outer guide channel member, and/or inner guide channel member for use with a delivery system configured for rapid insertion delivery of self-expanding devices. -
FIG. 29 is a block diagram illustrating a method of assembling a middle section delivery device and distal portion for use with a delivery system configured for rapid insertion delivery of self-expanding devices. - The present invention relates to medical devices, and in particular to a delivery system configured for rapid insertion delivery of self-expanding devices such as stents, prosthetic valve devices, and other implantable articles inside a patient's body. For conciseness and ease of description of the embodiments of the invention, the term “stent” and its variations shall refer individually and collectively (without limiting the invention) to all self-expanding devices used with the invention, such as stents, prosthetic valve devices, and other implantable articles inside a patient's body. For the purposes of promoting an understanding of the principles of the invention, the following provides a detailed description of embodiments of the invention as illustrated by the drawings as well as the language used herein to describe the aspects of the invention. The description is not intended to limit the invention in any manner, but rather serves to enable those skilled in the art to make and use the invention. As used herein the terms comprise(s), include(s), having, has, with, contain(s) and the variants thereof are intended to be open ended transitional phrases, terms, or words that do not preclude the possibility of additional steps or structure.
- In
FIG. 1 , an illustrative embodiment of adelivery system 10 having a host of uses, including for the rapid insertion of self-expanding stents, is provided. Thedelivery system 10 comprises a systemproximal portion 12, a middlesection delivery device 14, and a systemdistal portion 13 shown in a partially deploying position. -
System Proximal Portion 12 - In the embodiment shown in
FIG. 1 , theproximal portion 12 remains outside of the patient's body. Theproximal portion 12 comprises ahandle 30 and anoptional pusher stylet 20. -
FIG. 1 depicts a schematic representation of thehandle 30 and theoptional pusher stylet 20 shown more particularly inFIG. 2 . In general, ahandle 30 retracts an outer guide channel member (discussed below) of thedistal portion 13 of thedelivery system 10 to deploy an implantable prosthesis such as self-expanding, balloon expandable, or non-expanding stents, prosthetic valve devices, and other implantable articles (individually and collectively, “stent,” “stents,” “implantable prosthesis,” and “implantable prostheses”) at a selected location inside a patient's body. Thehandle 30 may comprise any mechanical, electromechanical, pneumatic, or hydraulic handle configured in communication with—directly or indirectly through intervening parts—the distal portion's outer guide channel member. Communication would include, by way of illustration and not by way of limitation, ahandle 30 that uses or is otherwise associated with, directly or indirectly, an elongated mechanical wire, rod, shaft, cable, sheath, pneumatic tube, or hydraulic pistons, cylinders and/or flow paths configured for moving the outer guide channel member proximally in order to deploy a stent. -
FIG. 2 provides a schematic view, broken away, of adelivery system 10 for rapid insertion of self-expanding stents, but could be used with other implantable prostheses described above. Thedelivery system 10 shown inFIG. 2 is one embodiment of theproximal portion 12, middlesection delivery device 14, anddistal portion 13 shown in a partially deploying position. The middlesection delivery device 14 extends distally from theproximal portion 12, and adistal portion 13 extends to a position that is distal the middlesection delivery device 14. More particularly,FIG. 2 shows an exploded view of theproximal portion 12 of thedelivery system 10 according to one embodiment of the invention, with an emphasis on thehandle 30 and theoptional stylet 20. Features of one embodiment of ahandle 30 andpusher stylet 20 are discussed below. - The
handle 30 comprises any tubular structure having adistal aperture 30″ and aproximal aperture 30′, the apertures defining achamber 31 therebetween. In general, thehandle 30 is a component, instrument, mechanism, tool, device, apparatus, or machine configured for directly or indirectly retracting an outer guide channel member (discussed below) of thedistal portion 13 of the device to expose and, ultimately, to deploy a stent at a selected location inside a patient's body. - The
handle 30 is axially slideable relative to an elongate (long)inner compression member 41 that comprises aproximal end 40 and amiddle section 40′. As discussed more fully below, theinner compression member 41 helps to keep the stent from moving proximally with proximal movement of thehandle 30, which handle movement causes the outer guide channel member to withdraw proximally over the stent in order to expose and thereby to deploy the stent. Thus, the inner compression member helps to “push” the stent or stent carrying inner guide channel member in order to counter the urge for the stent or stent carrying member to prolapse proximally with the withdrawing of the outer guide channel member. As will be understood, “pushing” on the inner compression member will keep the stent carrying inner guide channel member (and therefore the stent) from translating as a result of an outer sheath or outer guide channel member being pulled over the stent; thereby “pushing” holds the stent in place at the desired deployment site within the patient's body. In one embodiment, thehandle 30 is a unidirectional handle that is axially slideable relative to theinner compression member 41 and/or theoptional pusher stylet 20 in order to deploy a stent. In one embodiment, theinner compression member 41 is secured to apusher stylet 20. - As shown in
FIG. 2 , one embodiment of apusher stylet 20 comprises aproximal end 20′, adistal end 20″, and acannula 23 intermediate the proximal anddistal ends 20′, 20″, respectively, and areceptacle 22. Thecannula 23, as should be understood, comprises any suitable hollow plastic or metal tube. As a hollow tube, thecannula 23 optionally allows theinner compression member 41 to pass proximally through thecannula 23 and to theproximal end 20′ so that the inner compression member proximal end 40 (such as a flared proximal end 40) may secure to aplug 21 that fits within thereceptacle 22, whereinFIG. 2 shows theproximal end 20′, plug 21, and anoptional securing material 28 are shown in an exploded view relative to thereceptacle 22 into which they may be secured. Furthermore, thecannula 23 assists with keeping that portion of the inner compression member substantially straight. - The
stylet 20 is optional, because in an alternative embodiment the physician may hold the inner compression memberproximal end 40′ directly in order to “push” (e.g., hold substantially stationary) the stent carrying inner guide channel member (and therefore the stent). This controls the stent carrying inner guide channel member and stent from translating as a result of an outer sheath or outer guide channel member being pulled over the stent, so that the stent remains at the desired deployment site within the patient's body. Alternatively, thestylet 20 is any stationary handle secured to theinner compression member 41 for achieving the “pushing” (e.g., hold substantially stationary) of the stent or stent carrying inner guide channel member while the outer sheath or outer guide channel member are moved proximally. - The stylet
distal end 20″ is housed within thehandle chamber 31 and is flared or otherwise flanged sufficiently to be larger than the handleproximal aperture 30′ so as not to pull out of thechamber 31. In one embodiment, the styletdistal end 20″ is secured to the distal portion of thestylet cannula 23, while in another embodiment the styletdistal end 20″ is formed integral with the distal portion of thestylet cannula 23. Consequently, the styletdistal end 20″ functions as a proximal stop that prevents thestylet cannula 23 from backing all the way out the handle while being axially slideable within thehandle chamber 31. Thus, thestylet 20 will not slide off thehandle 30, if so desired. The styletdistal end 20″ may also, in one embodiment, function as a distal stop against arestraint 33 formed in thehandle chamber 31 intermediate the handle proximal anddistal apertures 30′, 30″, respectively, where intermediate should be understood to be any position between, and not necessarily equidistant to, thehandle apertures 30′, 30″. As a result of the styletdistal end 20″, thehandle 30 may slide axially the distance separating thehandle restraint 33 and the styletdistal end 20″, which has a maximum distance of when the styletdistal end 20″ is abutting the handleproximal aperture 30′. - A threaded tapered
plug 21 and threaded taperedreceptacle 22 optionally secure the inner compression memberproximal end 40. In one embodiment, the inner compression memberproximal end 40 is flared. Securingmaterial 28, such as glue, adhesives, resins, welding, soldering, brazing, chemical bonding materials or combinations thereof and the like (collectively and individually, “glue”) may be used to keep the threaded taperedplug 21 from backing out of the threaded taperedreceptacle 22. A portion of thecannula 23 and styletdistal end 20″ are received within thehandle chamber 31 distal to the handleproximal aperture 30′ as previously explained. - By optionally placing the inner compression member
proximal end 40 in mechanical communication with theplug 21 andreceptacle 22, the gripping and “pushing” (e.g., hold substantially stationary) on the stylet 20 (e.g., the receptacle 22) thereby helps to keep theinner compression member 41 from moving away from thedistal portion 13 and, accordingly, counters the tendency for a stent or stent carrying member to move proximally during withdrawal of the outer guide channel member as will be explained below. Of course, the inner compression member may be secured elsewhere by thestylet 20, such as at or near the styletdistal end 20″ or intermediate the stylet proximal anddistal ends 20′, 20″, respectively, and the styletdistal end 20″ may extend to a position at or near thedistal end aperture 30″ of thehandle 30. -
FIG. 2 shows amiddle section 40′ that extends distally from theproximal end 40 of theinner compression member 41. In one embodiment, themiddle section 40′ passes through the handle 30 (and may pass through thecannula 23 and/or bushings housed within thehandle chamber 31 or other portions of the proximal portion 12). In one embodiment, themiddle section 40′ is elongate (at least 50.0 cm or longer as described below) and extends to a distance distally of thehandle 30 and to a position at or near the medical system delivery devicedistal portion 13. It should be understood that, by describing themiddle section 40′ as passing through thehandle 30, themiddle section 40′ does not necessarily need to pass proximally through the entire length of thehandle 30, such as in an embodiment (by way of example and not by way of limitation) where theproximal end 40 of theinner compression member 41 is secured to a distal portion of thecannula 23 and/or the styletdistal end 20″ extending within thehandle chamber 31 to a position at or near thehandle restraint 33. - In addition to holding a threaded tapered
plug 21 and optionally theproximal end 40 of theinner compression member 41, the threaded taperedreceptacle 22 may secure the proximal portion of theoptional cannula 23.Glue 28′ may be used at or near an interface of thecannula 23 and distal aperture of the threaded taperedreceptacle 22. Theglue 28′ serves many functions, such as to keep dust from settling within the threaded taperedreceptacle 22, to make thecannula 23 easier to clean, and to give aesthetics and a smooth feel to the device. - The
handle 30 slidably receives the distal portion of thecannula 23 within thehandle aperture 30′ and handlechamber 31. As a result, thehandle 30 is slidable relative to the stylet 20 (e.g., slidable relative to the threaded taperedplug 21, threaded taperedreceptacle 22, and the cannula 23). In use, the physician grips thehandle 30 in one hand and grips the stylet 20 (e.g., the receptacle 22) in the other hand. The physician holds thestylet 20 relatively stationary, which prevents the inner compression member and inner guide channel member and its stent carrying portion from moving proximally, and then withdraws thehandle 30 proximally relative to thestationary stylet 20 andinner compression member 41. As a result, the physician is thereby retracting an outer guide channel member (discussed below) of thedistal portion 13 of thedelivery system 10 to expose and, ultimately, to deploy a stent locatable at thedistal portion 13 of thedelivery system 10. Thehandle 30 is in communication with—directly or indirectly through intervening parts—the outer guide channel member at thedistal portion 13. - As shown in
FIG. 2 , some of those optional parts may include the following: afirst bushing 36 having an optionalfirst bushing flange 35; asecond bushing 36′ having an optionalsecond bushing flange 35′; anintermediate seal 37 intermediate the first andsecond bushing flanges second seal 37′ intermediate thesecond bushing flange 35′ and acheck flow body 38; and adetachable cap 39, such a Luer cap by way of example but not by way of limitation. In one embodiment, one or both of theintermediate seal 37 and thesecond seal 37′ is from a class such as an O-ring. In another embodiment, one or both of theintermediate seal 37 and thesecond seal 37′ is a cylinder or disk with a center aperture, and may be made from material that comprises an O-ring. Thebushings handle 30 so that the inner compression member has less room to buckle. Fully assembled in one embodiment, thefirst bushing 36 is inserted within thecannula 23 and thefirst bushing flange 35 is distal to and abutting thehandle restraint 33, which is sized to interfere with thebushing flange 35 to prevent thebushing flange 35 from moving proximal to thehandle restraint 33. Thesecond bushing flange 35′ is distal to and optionally abutting thebushing flange 35 so to prevent it from moving proximal thefirst bushing flange 35, and thesecond bushing 36′ is inserted within anopening 139 of thecheck flow body 38. Theintermediate seal 37 and thesecond seal 37′ help to prevent fluids that could be used with the device (discussed below) from entering thehandle chamber 31, which directs fluids distally, which fluids may be conveyed through anouter sheath 50 of the middlesection delivery device 14 and systemdistal portion 13. In one embodiment, thehandle restraint 33 is from a class such as a counterbore wherein therestraint 33 comprises, by way of example only and not by way of limitation, a flat-bottomed cylindrical enlargement of thehandle chamber 31 sized for receiving afirst bushing flange 35, anintermediate seal 37, asecond bushing flange 35′, and/or a check flow bodyproximal mating end 38″ intermediate therestraint 33 and the handledistal aperture 30″. - The
handle 30 andcheck flow body 38 operatively couple with the handledistal aperture 30″ receiving a check flow bodyproximal mating end 38″ and being secured together by any suitable means, including but not limited to a crimp, friction fit, press fit, wedge, threading engagement, glue, adhesives, resins, welding (laser, spot, etc.), soldering, brazing, adhesives, chemical bonding materials, or combinations thereof. In one embodiment, thehandle 30 comprises acoupling member 32 and the check flow bodyproximal mating end 38″ comprises acoupling member 32′, thecoupling members handle 30 and check flow bodyproximal mating end 38″ together. In one embodiment, thecoupling members coupling members coupling members handle 30 and check flow bodyproximal mating end 38″ may be put together and taken apart for servicing, in which case thecoupling members handle 30 and check flow bodyproximal mating end 38″ according to these embodiments may be fixed such that they do not rotate relative to each other, or may rotate while preventing undesired axial separation. - During use, the
detachable cap 39 may be detached or opened and the device flushed with saline to remove air in order to help keep air out of the patient. Theintermediate seal 37 and thesecond seal 37′ ensure that any flushed fluid moves distally in the device and does not back up into thehandle 30, such as between thehandle restraint 33 and thefirst bushing 36, into thehandle chamber 31, or out the handleproximal aperture 30′. The detachable cap 39 (such as a Luer cap) keeps saline from backing out of thecheck flow body 38, air from flowing into thecheck flow body 38, and blood from rushing out during periods of high blood pressure inside the patient. - The medical
device delivery systems 10 may be used to deploy an implantable prosthesis that is a balloon expandable or self-expanding stent, prosthetic valve device, or other implantable articles provided on the distal portion of a delivery system. In operation, a physician inserts the distal portion and at least a portion of the middle section delivery device into a vessel passageway, and advances them through the vessel passageway to the desired location adjacent the target site within the vessel passageway of a patient. In a subsequent step, the physician moves the handle proximally, which withdraws the outer sheath and/or the outer guide channel member and releasably exposes the stent for deployment. In another step, the physician inflates the expandable member, such as a balloon, positioned under the stent inner surface to plastically deform the stent into a substantially permanent expanded condition. The physician may inflate the expandable member by injecting fluid such as saline from a syringe into theinner compression member 41, viapusher stylet 20, through a Luer fitting at theproximal end 20′. Therefore, the fluid is directed distally to the expandable member, filling the expandable member chamber and expanding the stent. The physician then deflates the balloon and removes the catheter or delivery device from the patient's body. - In one embodiment as shown in
FIG. 2 , thehandle 30 further comprises a check flow bodydistal mating end 38′ and aconnector cap 39′ (optionally detachable) secured to the check flow bodydistal mating end 38′, and astrain relief 29. In one embodiment, theconnector cap 39′ is from a class of fasteners such as nuts, and in one embodiment is a flare nut. Theconnector cap 39′ functions to hold (or assist in holding in combination with the check flow bodydistal mating end 38′) a flared proximal portion of anouter sheath 50 and/or a flaredstrain relief 29 disposed about (and optionally extending proximally from) that held portion of theouter sheath 50. Thestrain relief member 29 provides a kink resistant point where theouter sheath 50 connects to theconnector cap 39′ and/or the check flow bodydistal mating end 38′. - The check flow body
distal mating end 38′ andconnector cap 39′ may be operatively coupled mechanically, chemically, and/or chemical-mechanically. In one embodiment, theconnector cap 39′ is crimped, friction fitted, press fitted, and/or wedged into engagement onto the check flow bodydistal mating end 38′. In another embodiment for example, the check flow bodydistal mating end 38′ andconnector cap 39′ are operatively coupled by glue, adhesives, resins, welding (laser, spot, etc.), soldering, brazing, adhesives, chemical bonding materials, or combinations thereof. - According to
FIG. 2A , yet another embodiment of theconnector cap 39′ comprises a handlefirst connector 130 and the check flow bodydistal mating end 38′ comprises a handlesecond connector 132. According toFIG. 2A , the handle first andsecond connectors strain relief member 29 operatively coupled to the proximal portion of the outer sheath 50 (discussed below). In one embodiment, the handlefirst connector 130 is from a class of fasteners such as nuts, and in one embodiment is a flare nut. Optionally, the distal portion of thesecond bushing 36′ is sized (but for thesecond bushing flange 35′) to be received within a check flow bodyproximal opening 139 in communication with thesecond connector 132. -
FIG. 2A shows an exploded longitudinally sectioned side view of one embodiment of a portion of the handle comprising afirst connector 130 and asecond connector 132. The handlefirst connector 130 further comprises aproximal portion 134 and adistal portion 136. Anopening 138 at theproximal portion 134 and anopening 140 at thedistal portion 136 and define alumen 133 therebetween. There is anengaging surface 142 at or near thedistal portion 136. A threadedfirst piece 146 is disposed within thelumen 133 and intermediate the handle first connectordistal end opening 140 andproximal end opening 138. The handlesecond connector 132 further comprises aproximal portion 135 and adistal portion 137. Anopening 141 at thedistal portion 137 and check flow body proximal opening 139 (e.g.,FIG. 2 ) at theproximal portion 135 define alumen 131 therebetween. There is anengaging surface 143 at or near thedistal portion 137. A threadedsecond piece 145 is disposed on the outside surface and intermediate the handle second connectordistal end opening 141 and the check flow bodyproximal opening 139. - According to one embodiment shown in
FIGS. 2A and 2B , the second connectordistal portion 137 is received within the first connectorproximal end opening 138. Thefirst connector 130 andsecond connector 132 are operatively coupled by a threading engagement between the first connector threadedfirst piece 146 and the second connector threadedsecond piece 145. Alternatively, thefirst connector 130 andsecond connector 132 are operatively coupled mechanically, chemically, and/or chemical-mechanically. In one embodiment for example, thefirst connector 130 andsecond connector 132 are crimped, friction fit, press fit, and/or wedged into engagement. In another embodiment for example, thefirst connector 130 andsecond connector 132 are operatively coupled by glue, adhesives, resins, welding (laser, spot, etc.), soldering, brazing, adhesives, chemical bonding materials, or combinations thereof. -
FIG. 2B shows the second connector threadedsecond piece 145 operatively coupled to the first connector threadedfirst piece 146 such that the second connectorproximal portion 135 is proximal to the first connectorproximal portion 134 and the second connectordistal portion 137 is located at or near the first connectordistal portion 136. As shown inFIG. 2B , the secondconnector engaging surface 143 is spaced proximal to the firstconnector engaging surface 142 for receiving and compressing a strain relief member second end portion therebetween. -
FIG. 2C shows one embodiment of an optionalstrain relief member 29 comprising a tubularfirst end portion 118 and a flared second end portion 117. According toFIG. 2C , the medical device delivery system includes an elongate outer sheath 50 (e.g.,FIGS. 2, 2C , 3, 4A-4G, 5M, 5R-5T, 6, 7, 8, 9, 10-11, 18-19, 25A-25D). Like elements from the previous drawings, embodiments, and description from above are labeled the same. The term elongate is used, not lexicographically but instead, to describe embodiments according to the embodiment that measures at least about 50.0 cm or measures within one of the ranges of lengths exceeding 50.0 cm and as more fully discussed above. - More particularly,
FIG. 2C shows that theouter sheath 50 comprises a proximal end portion 57 and adistal end portion 58. Thedistal end portion 58 comprises anopening 52 and the proximal end portion 57 comprises an opening 53; the openings define apassageway 59 therebetween. In one exemplary embodiment according toFIG. 2C , the strain relief member tubular first andsecond end portions 118, 117, respectively, are disposed about and operatively coupled to the outer sheath proximal end portion 157. In another embodiment, the tubular firstend portion portion 118 disposes about the outer sheath proximal end portion 157 while the flared second end portion portion 117 extends proximally from outer sheath proximal end portion 157. In addition, the strain relief member second end portion portion 117 and/or outer sheath proximal end portion 57 comprise an opening 123 in fluid communication with theouter sheath passageway 59. - By way of example only and not by way of limitation, the terms “operatively coupling,” “operatively coupled,” “coupling,” “coupled,” and variants thereof are not used lexicographically but instead are used to describe embodiments of the invention having a point, position, region, section, area, volume, or configuration at which two or more things are mechanically, chemically, and/or chemical-mechanically bonded, joined, adjoined, connected, associated, united, mated, interlocked, conjoined, fastened, held together, clamped, crimped, friction fit, pinched, press fit tight, nested, wedged, and/or otherwise associated by a joint, a junction, a juncture, a seam, a union, a socket, a melt bond, glue, adhesives, resins, welding (laser, spot, etc.), soldering, brazing, adhesives, chemical bonding materials, implanted arrangement, or combinations thereof.
-
FIG. 2C shows the strain relief member second end portion 117 and/or outer sheath proximal end portion 57 being operatively coupled between thefirst connector 130 and thesecond connector 132, and thesecond connector lumen 131 being in fluid communication with theouter sheath passageway 59. In one embodiment, the strain relief member second end portion portion 117 and/or outer sheath proximal end portion 57 comprises a first opposingsurface 124 and a second opposing surface 125. The firstconnector engaging surface 142 is disposed against the first opposingsurface 124 and the secondconnector engaging surface 143 is disposed against the second opposing surface 125, whereby the strain relief member second end portion 117 and/or outer sheath proximal end portion 57 becomes operatively coupled between the first and secondconnector engaging surfaces connector engaging surfaces - Thus, the
check flow body 38 provides an optional three way connector. The check flow bodyproximal mating end 38″ and handlecoupling member 32 are operatively coupled. The side port is controlled by thedetachable connector cap 39. The bodydistal mating end 38′ is operatively coupled to asecond connector cap 39′, or optionally the handlesecond connector 132 is received within and operatively coupled to a handlesecond connector cap 130. - The foregoing description of a
proximal portion 12 of a medicaldevice delivery system 10 according to one embodiment of the invention may be one assembly during shipping, or may include a two-part assembly or more. Otherwise stated, thestylet 20 and handle 30 may be sold already combined or may be combined after purchase by inserting thestylet cannula 23 into the handle at the hospital via the threaded taperedplug 21 and threaded taperedreceptacle 22. Anoptional safety lock 34 helps to ensure against unintentional actuation by preventing distal movement of the styletdistal end 20″ by extending inwardly within thehandle chamber 30 through a slot in the handle outer wall distal to the handleproximal aperture 30′. Consequently, theoptional safety lock 34 thereby maintains thehandle 30 in an undeployed position until the physician is ready to deploy an implantable prosthesis (e.g., a self-expanding, balloon expandable, or non-expanding stent; prosthetic valve devices, and other implantable articles) at a selected location inside a patient's body. - Middle
Section Delivery Device 14 - A
delivery system 10 as shown inFIGS. 1 and 2 comprises a middlesection delivery device 14. According to the invention, the middlesection delivery device 14 is intermediate the proximal portion 12 (FIGS. 1, 2 ) and the distal portion 13 (FIGS. 1, 2 ) of thedelivery system 10. The term “intermediate” is intended to describe embodiments of the invention whereby the middlesection delivery device 14 is intermediary, intervening, lying or occurring between two extremes, or spatially in a middle position, state, or nature—though not necessarily equidistant—between the distal tip of thedistal portion 13 and the proximal tip of theproximal portion 12. Furthermore, the middlesection delivery device 14 may overlap or be partially inserted into a portion of thedistal portion 13 and/or theproximal portion 12. In another embodiment, a portion of the middle section delivery device 14 (such as thesheath 50 explained below) and the distal portion outer guide channel member 80 (e.g.,FIGS. 5M, 6 , 7, 8, 9, 10-11, 16, 18-20, 22, 25A-25D) may be an elongate tubular catheter or Flexor® sheath of integral construction. - According to the invention, a middle
section delivery device 14 is a flexible, elongate (long, at least about 50.0 centimeters (“cm”)) tubular assembly. In one embodiment, the middlesection delivery device 14 is from approximately 100.0 centimeters (“cm”) to approximately 125.0 cm for use when placing adistal portion 13 of the invention within a patient's body, although it may be sized longer or shorter as needed depending on the depth of the target site within the patient's body for delivering the stent. The term “tubular” in describing this embodiment includes any tube-like, cylindrical, elongated, shaft-like, rounded, oblong, or other elongated longitudinal shaft extending between theproximal portion 12 and thedistal portion 13 and defining a longitudinal axis. As used herein and throughout to describe embodiments of the invention, the term “longitudinal axis” should be considered to be an approximate lengthwise axis, which may be straight or may at times even be curved because the middlesection delivery device 14, for instance, is flexible and thedistal portion 13 also may be substantially or partially flexible. - A middle
section delivery device 14 comprises an outer sheath 50 (e.g.,FIGS. 2, 2C , 3, 4A-4G, 5M, 5R-5T, 6, 7, 8, 9, 10-11, 18-19, 25A-25D).FIG. 2C shows that theouter sheath 50 is generally tubular and comprises a proximal end portion 57 and adistal end portion 58 and defining apassageway 59 therebetween (e.g.,FIG. 2C ). In one embodiment, thedistal end portion 58 comprises anopening 52 and the proximal end portion 57 comprises an opening 53, which openings define thepassageway 59. The middlesection delivery device 14 further comprises an elongate inner compression member 41 (e.g.,FIGS. 2, 2C , 6, 7, 8, 9, 9A-9C, 10, 11, 17-19, 20, 22, 24-24B). Theouter sheath passageway 59 is configured for slidably receiving theinner compression member 41, a catheter, or other medical device. -
FIG. 3 depicts an enlarged, longitudinally sectioned view along a partial length of one embodiment of anouter sheath 50 for use as the middlesection delivery device 14, with the delivery system's proximal anddistal portions outer sheath 50 comprises three layers: aninner layer 44 comprising Teflon material; a middle layer comprising a stainless steelcircumferential spiral coil 43; and anouter layer 42 comprising a nylon, a polyether block amide (“PEBA”), and/or other melt bonding material discussed below. Theouter layer 42 andinner layer 44 optionally may comprise a lubricious material, one example of which includes a fluorocarbon such as polytetrafluoroethylene (PTFE), to present a slideable surface to allow easier inserting and retracting the middlesection delivery device 14 for deploying a self-expanding stent, as will be explained later. - The wall of the
inner layer 44 of theouter sheath 50 has sufficient radial rigidity to decrease any tendency of bulging, kinking, and the like under an internal radial expansile force. In other words, theinner layer 44 resists an inner object from protruding or becoming embedded into theinner layer 44, which is beneficial to the slideability of anouter sheath 50. Thecoil 43 may be compression fitted or wound around theinner layer 44. Thecoil 43 includes a plurality of turns, and preferably includesuniform spacings 43′ between the turns of thecoil 43. Thecoil 43 may be formed of any suitable material that will provide appropriate structural reinforcement, such as stainless steel flat wire or biologically compatible metals, polymers, plastics, alloys (including super-elastic alloys), or composite materials that are either biocompatible or capable of being made biocompatible. - Although the embodiment in
FIG. 3 shows a flat ribbon shapedwire coil 43, coils of other cross-sectional dimensions, such as round wire, may also be used. When flat wire stainless steel is used, thecoil 43 is optionally formed from wire that is about 0.003 inches thick by about 0.012 inches wide. In one embodiment, the turns ofcoil 43 are uniformly spaced 43′ apart by approximately 0.0118 inches. WhileFIG. 3 shows an embodiment that uses coils 43 having uniformly spaced turns and a constant pitch, this is not required and coils 43 may be spaced 43′ by non-uniform distances or at varying distances. In one embodiment, the ends ofcoil 43 are positioned approximately 0.197 inches proximal to thedistal portion 13 and approximately 0.591 inches distal to theproximal portion 12. - The
outer sheath 50 for use with the middlesection delivery device 14, and the outer guide channel member 80 (e.g.,FIGS. 5M, 6 , 7, 8, 9, 10-11, 16, 18-20, 22, 25A-25D) and/or the inner guide channel member 70 (e.g.,FIGS. 6, 7 , 8, 9, 10-11, 17-19, 21, 22, 25A-25D) for use with thedistal portion 13, are available for purchase from Cook Incorporated, of Bloomington, Ind. under the trade name of “Flexor®.” Examples of the Flexor® sheath devices, materials, and methods of manufacturing them are found in U.S. Pat. Nos. 5,700,253 and 5,380,304, the contents of which are incorporated herein by reference. The Flexor® sheath is particularly suited for theouter sheath 50 of the middlesection delivery device 14 and/or the outerguide channel member 80 of the distalsecond end portion 13 due to its thin PTFE liner on the inside wall of theinner layer 44, thinflat wire coil 43, and Nylon and/orPEBA overcoat 42 that captures thecoil 43 andPTFE liner 44 and binds the structure together. The PTFEinner layer 44 of the Flexor® sheath resists an expansile inner object from protruding or becoming embedded into theinner layer 44 and, thereby, provides a slick, smooth surface that slides (e.g., across the surface of a stent if the Flexor® sheath is used with thedistal portion 13 or across the surface of aninner compression member 41 if the Flexor® sheath is used with the middle section delivery device 14) relatively easily when retracted to expose, release, and deploy the stent or allow theouter sheath 50 to move relative to theinner compression member 41, and the outerguide channel member 80 to move relative to the innerguide channel member 70, during deployment of the stent. - As an alternative to purchasing the
outer sheath 50 for use with the middlesection delivery device 14 and the outerguide channel member 80 for use with thedistal portion 13 from Cook Incorporated, one may manufacture the outer sheath and outer guide channel member from various component parts. For instance, one may purchase a tubularinner layer 44 comprising a lubricious material comprising a fluorocarbon such as polytetrafluoroethylene (PTFE or Teflon) from Zeus, Inc. in Orangeburg, S.C., and dispose thatinner layer 44 over a mandrel. Alternatively, a sheet of material comprising Teflon may be positioned on a mandrel and formed into a tubular body for theinner layer 44 by any suitable means known to one skilled in the art. - The tubular inner layer 44 (whether formed from a sheet on a mandrel or purchased as a tube and slid onto a mandrel) may be slightly longer than the desired length described above for the
outer sheath 50 and/or outerguide channel member 80, and slightly longer than the mandrel. In one embodiment, the tubularinner layer 44 may extend about 5.0 cm from each mandrel end. As explained below, the “loose” ends of the tubularinner layer 44 help during manufacturing of the device. - The mandrel-tubular
inner layer 44 assembly is prepared for a middle layer comprising a stainless steelcircumferential spiral coil 43 as described above and available for purchase from Cook Incorporated or Sabin Corporation in Bloomington, Ind. As purchased, thecoil 43 comes in a long, pre-coiled configuration and will be cut by hand or machine to the desired length either before or after winding the coil about theinner layer 44 to the desired length. As an alternative, one may manufacture the coil from raw material available from Fort Wayne Medical in Fort Wayne, Ind., and process it into aspiral coil 43 shape. - The operator may apply the
spiral coil 43 about the mandrel-tubularinner layer 44 assembly by hand or machine. If by hand, then an end of thespiral coil 43 may be started onto the tubularinner layer 44 by any suitable means, for example, such as hooking and winding (e.g., wrapping) thecoil 43 around the tubularinner layer 44 in a pigtailed manner at an initial position a desired distance (e.g., 5.0 cm or more) from a first end of the tubularinner layer 44 and to a terminating position that is a desired distance (e.g., 5.0 cm or more) from a second end of the tubularinner layer 44, and then cutting thecoil 43 at the terminating position before or after hooking thecoil 43 onto theinner layer 44. If by machine, then chucks, for instance, may hold the opposing ends of the mandrel-tubularinner layer 44 assembly while thespiral coil 43 is threaded through an arm on a machine and started onto the tubularinner layer 44 at the initial position as described above. As the chucks rotate, theinner layer 44 rotates, and the arm moves axially down the length of theinner layer 44, thereby applying thecoil 43 in a spiral configuration about theinner layer 44. The machine arm moves to a terminating position where the machine or operator cuts the coil before or after hooking thecoil 43 onto theinner layer 44. - An operator then applies an
outer layer 42 about the coil-inner layer-mandrel assembly. Theouter layer 42 may comprise a polyether block amide, nylon, and/or a nylon natural tubing (individually and collectively, “PEBA” and/or “nylon”). Theouter layer 42 preferably has a tubular configuration that disposes about (e.g., enveloping, surrounding, wrapping around, covering, overlaying, superposed over, encasing, ensheathing, and the like) a length of the coil-inner layer-mandrel assembly. - Heat shrink tubing, available from many suppliers, including Zeus, Inc. in Orangeburg, S.C. for instance and also Cobalt Polymers in Cloverdale, Calif., may be disposed about the outer layer-coil-inner layer-mandrel assembly. Heating the assembly causes the
outer layer 42 to melt. The inner surface of theouter layer 42 thereby seeps throughspaces 43′ in or between middle layer coils 43 and bonds to both the outer surface of theinner layer 44 and thecoils 43. In one embodiment, the inner surface of theouter layer 42 forms a melt bond 47 (explained below) to the outer surface of theinner layer 44. Upon cooling, a solid-state bond results such that the assembly comprises the three layers discussed above. The operator removes the shrink wrap (e.g., by cutting) and withdraws the mandrel. The operator may cut the Flexor® sheath to a desired length for anouter sheath 50 and/or outerguide channel member 80. - The temperature, total rise time, and dwell time for the heat shrink-outer layer-coil-inner layer-mandrel assembly will vary depending on many factors including, for instance, the actual melt bonding material that the
outer layer 42 comprises, and also the diameter of the desired Flexor® sheath. For example, the baking parameters for a 2.5 French Flexor® sheath may be approximately 380 degrees Fahrenheit for about five minutes, while the baking parameters for a 4 French Flexor® sheath may be approximately 380 degrees Fahrenheit for about six minutes. - In addition to the
outer sheath 50, the middlesection delivery device 14 further comprises aninner compression member 41. The delivery device 14 (and, thus, theouter sheath 50 and inner compression member 41) may be constructed to have any diameter and length required to fulfill its intended purposes. - The
outer sheath 50, for instance, may be available in a variety of lengths, outer diameters, and inner diameters. In one embodiment, theouter sheath 50 may have a substantially uniform outer diameter in the range from approximately 2 French to approximately 7 French, and in one embodiment the diameter is from approximately 4 French to approximately 5 French in diameter. Otherwise stated, theouter sheath 50 may range from about 0.010 inches to about 0.090 inches in diameter, and in one embodiment the diameter is approximately 0.050 inches. Likewise, thepassageway 59 may be available in a variety of diameters. In one embodiment, the inner diameter ranges from about 0.032 inches to about 0.040 inches, and in a preferred embodiment thepassageway 59 is approximately 0.032 inches. The diameter may be more or less than these examples, however, depending on the intended vessel passageway for the device. For instance, a larger vessel passageway (e.g., greater expandable inner diameter) may tolerate a bigger device with anouter sheath 50 having a correspondingly greater diameter. Conversely, a narrower vessel passageway may require a thinnerouter sheath 50. Likewise, the overall length may vary. In one embodiment, theouter sheath 50 will have a length from about 50.0 cm (or about 19.685 inches) to about 125.0 cm (or about 49.213 inches), and more particularly between about 70.0 cm (or about 27.559 inches) and about 105.0 cm (or about 41.339 inches), and in yet another embodiment the length is approximately 100.0 cm (or about 39.370 inches). - The
inner compression member 41 comprises an elongated pusher bar, stiffening member, or stiff polymer that helps to “push” the stent by pushing the stent carrying inner guide channel member at or near thedistal portion 13 in order to counter the urge for the stent or stent carrying member to move as a result of an outer sheath or outer guide channel member being pulled over the stent; thereby “pushing” holds the stent in place at the desired deployment site within the patient's body. Theinner compression member 41 “pushes” the stent by helping to prevent or minimize the inner guide channel member from prolapsing, recoiling, kinking, buckling, or moving; thereby keeping the inner guide channel member's stent platform on which the stent is disposed (discussed later) substantially stationary, for the most part, relative to the proximal retraction of the distal outer guide channel member (discussed below) that exposes and, thus, deploys the stent. The phrase “at or near” as used herein to describe an embodiment of the invention includes a location that is at, within, or a short distance such as about 0.1 cm to about 15.0 cm, although other ranges may apply, for instance from about 0.5 cm to about 10.0 cm. - The overall length of the
inner compression member 41 may vary, as desired. In one embodiment theinner compression member 41 has a length from about 50.0 cm to about 175.0 cm, and more particularly between about 75.0 cm and 150.0 cm, and in one embodiment the length is approximately 125.0 cm to about 140.0 cm. A portion of the inner compression member 41 (e.g., theproximal end 40 and/ormiddle section 40′) may be contained within thehandle 30 and thestylet 20, as explained above (FIG. 2 ). - Likewise, the diameter or width of the
inner compression member 41 may vary. In one embodiment, theinner compression member 41 has a diameter or width ranging from about 0.010 inches to about 0.030 inches, by way of example only and not by way of limitation. In one embodiment, theinner compression member 41 has a diameter or width that is approximately 0.016 inches. The diameter or width may be more or less than these illustrative ranges. For example, a deeper target site within a patient may require a thickerinner compression member 41 for greater push-ability, but may tolerate lesser flexibility. In addition, the material that theinner compression member 41 comprises determines whether a smaller and more flexibleinner compression member 41 will give suitable flexibility, and also determines whether a widerinner compression member 41 may have the flexibility of a thinnerinner compression member 41 made of different material. Furthermore, theinner compression member 41 may have a curved transverse cross-section, such as, for example, a circular cross-section, or it may have a polygonal cross-section, such as, for example, a rectangular cross-section. Alternatively, the transverse cross-section of the inner compression member may include both curved and straight portions. According to one embodiment, theinner compression member 41 may have a nonuniform diameter or width along its length. These various diameters, widths, and cross-sections may occur at the inner compression memberproximal end 40, the inner compression membermiddle section 40′, and/or the inner compression member distalmating end portion 48. It should be understood that the diameter, width, and/or cross-section of theinner compression member 41 may taper. - Also, an
inner compression member 41 may have an outer surface comprising a lubricious PTFE material and/or aninner surface 44 of theouter sheath 50 may comprise a lubricious PTFE material against theinner compression member 41, in order to allow easy retraction of theouter sheath 50, which is in communication with a distal outer guide channel member to deploy a self-expanding stent, as will be explained later. - Generally, the
inner compression member 41 andouter sheath 50 may optionally be approximately the same in length, and the axial length ofcoil 43 will be less than the length of the inner compression member and outer sheath. In one embodiment, however, theinner compression member 41 comprises aproximal end 40 that extends proximal relative to the outer sheath. In yet another embodiment, the inner compression member extends to a position that is distal the outer sheath. In still another embodiment, theinner compression member 41 stops short of extending all the way to the distal tip of thedelivery system 10, and may stop generally from 10 to 40 cm short of the distal tip of thedelivery system 10, and in one embodiment it stops approximately 20 to 25 cm short of the distal tip of thedelivery system 10, where the distal end portion of theinner compression member 41 is operatively coupled to a proximal portion of an inner guide channel member. - As an alternative to a Flexor® sheath discussed above, the
outer sheath 50 may have a construction comprising multifilar material, round wire, cable tubing, spiral cut cannula, cable tubing connected to spiral cut cannula, round wire braid, flat braid, and any equivalents thereto and/or combinations thereof.FIGS. 4A through 4G are schematic views of alternative embodiments of anouter sheath 50 for use as the middlesection delivery device 14, with the delivery system's proximal anddistal portions - In particular,
FIGS. 4A and 4B illustrate alternative embodiments of anouter sheath 50 comprising a construction of multifilar material. The multifilar material is illustrated as tubular but could also be other shapes, such as plastic or metal cables or wires that are flat, rectangular, and the like. Such multifilar material or tubing may be obtained, for example, from Asahi-Intec USA, Inc. (Newport Beach, Calif.). Materials and methods of manufacturing a suitable multifilar tubing are described in Published U.S. Patent Application 2004/0116833 (Koto et al.) having an application Ser. No. 10/611,664 and entitled, “Wire-Stranded Hollow Coil Body, A Medical Equipment Made Therefrom and a Method of Making the Same,” the contents of which are incorporated herein by reference. Use of multifilar tubing in a vascular catheter device, for instance, is described in U.S. Pat. No. 6,589,227 (Sonderskov Klint, et al.; Assigned to Cook Incorporated of Bloomington, Ind. and William Cook Europe of Bjaeverskov, Denmark), which is also incorporated by reference. - The middle
section delivery device 14 ofFIGS. 3 and 4 A-4G may taper distally to enhance flexibility in several ways. For example, flexibility increases by decreasing the outer diameter of theouter sheath 50. The portion of theouter sheath 50 having a smaller diameter is more flexible than the portion having a larger diameter. Such tapering also decreases the thickness of the outer sheath wall. A grinding process or other suitable process is used to reduce the outer diameter, as shown inFIG. 4B . Alternatively, tapering may be used within the internal diameter of theouter sheath 50, enhancing flexibility by decreasing wall thickness without altering the outer diameter. A milling process or other suitable process is used to reduce the wall thickness without altering the outer diameter. The steepness and location of the tapering is determined by the desired application of thedelivery system 10. For example, use of the device in coronary arteries will typically benefit from a smaller outer diameter, compared to use of the device in a bile duct, both for gross size and flexibility. -
FIGS. 4C through 4E show alternative constructions of theouter sheath 50. While the multifilar materials ofFIGS. 4A-4B are side-by-side and extend approximately longitudinally,FIG. 4C shows anouter sheath 50 that is a wrapped round coil of an approximate perpendicular pitch relative to the longitudinal axisouter sheath 50.FIG. 4D shows anouter sheath 50 that is a wrapped cable tubing or spiral cut cannula wherein the coil, compared toFIG. 4C , has a more acute pitch relative to the longitudinal axis of theouter sheath 50.FIG. 4E shows that various constructions can be combined for anouter sheath 50, such as one section constructed of the wrapped round coil ofFIG. 4C and one section constructed of the cable tubing/spiral cut cannula ofFIG. 4D . Other embodiments of anouter sheath 50 comprise a plurality of round wire braids (e.g., strands) of suitable material weaved as inFIG. 4F or a flat braided construction as in as inFIG. 4G . The term “plurality,” as used herein and throughout to describe embodiments of the invention, means “two or more.” - According to the embodiments of the
outer sheath 50 shown inFIGS. 3, 4A , 4B, 4C, 4D, 4E, 4F, and/or 4G may comprise a drug eluting coating. This coating may comprise a therapeutic agent. Types of agents may be active, such as a medicine utilized in the medical procedure to, for example, assist with the healing process, assist with reducing bacterial count, and otherwise assist with delivering medication. Other types of agents may comprise inactive coatings, such as AQ® hydrophilic. Still other agents may comprise biodegradable polymers that are active, inactive, or polymeric. - Operatively Coupling the Middle
Section Delivery Device 14 and theDistal Portion 13 - Against the foregoing description of embodiments of the
proximal portion 12 and middlesection delivery device 14 and before discussing embodiments of thedistal portion 13 of the delivery system, the invention further comprises associating thedistal portion 13 and the middlesection delivery device 14. These ways of operatively coupling the middlesection delivery device 14 anddistal portion 13 allow the outerguide channel member 80 of thedistal portion 13 to move relative to the innerguide channel member 70 of thedistal portion 13. In particular, theouter sheath 50 of the middlesection delivery device 14 may be operatively coupled with the outerguide channel member 80 of thedistal portion 13. Also, theinner compression member 41 of the middlesection delivery device 14 may be operatively coupled with the innerguide channel member 70 of thedistal portion 13. Therefore, the ways of constructing or joining the middlesection delivery device 14 anddistal portion 13 as described below are merely illustrations of non-limiting embodiments only. - In one embodiment, outer
guide channel member 80 of thedistal portion 13 and theouter sheath 50 of the middlesection delivery device 14 may be constructed as comprising an integral unit. In other words, the sameouter body sheath 50 construction shown and described in connection withFIGS. 4A-4G may comprise theouter sheath 50 of the middlesection delivery device 14 as labeled, but it may also comprise an integral construction with the outer guide channel member of the distal portion. -
FIG. 5 shows an alternative embodiment of an integral construction of theouter sheath 50 of the middle section delivery device and the outerguide channel member 80. In one embodiment, theouter sheath 50 and the outerguide channel member 80 comprise a Flexor® sheath or equivalent device shown inFIG. 3 and described above. WhileFIG. 5 shows an outer sheath and outerguide channel member coil 43, however, these outer bodies could use any other construction shown inFIGS. 4A-4G or combination thereof. - Moreover, where coil, multifilar material, weave, or braid (as described in the context of
FIGS. 4A through 4G ) is used in combination or individually, each may be continuous along the length of theouter sheath 50 of the middlesection delivery device 14 andouter guide channel 80 of thedistal portion 13 in one embodiment. In an alternative embodiment, a plurality of coils, multifilar materials, weaves, or braids may be joined end-to-end by a lap joint, brace, or other suitable means along the length of theouter sheath 50 of the middlesection delivery device 14 andouter guide channel 80 of thedistal portion 13. In a further alternative embodiment, a plurality of coil, multifilar material, weave, or braid may comprise a plurality of segments as where each segment is joined end-to-end by a lap joint, brace, or other suitable means along the length of theouter sheath 50 of the middlesection delivery device 14 andouter guide channel 80 of thedistal portion 13. - Another embodiment may be used for constructing or joining the middle
section delivery device 14 anddistal portion 13 in a way that permits the outerguide channel member 80 of thedistal portion 13 to move relative to the innerguide channel member 70 of thedistal portion 13. In this embodiment, theouter sheath 50 of the middlesection delivery device 14 and the outerguide channel member 80 of thedistal portion 13 comprise a plurality of units. Each unit may comprise the construction shown and described above in connection with the discussion relating toFIGS. 4A through 4G and/orFIG. 5 . Moreover, the plurality of units, such as thedistal portion 13 and the middlesection delivery device 14, may be assembled or joined together in various ways described next. - In one assembly, the
distal portion 13 and the middlesection delivery device 14 may be put together by any suitable connector. By way of example, the middlesection delivery device 14 anddistal portion 13 may be put together with a lap joint or a brace. -
FIG. 5A provides a longitudinally sectioned schematic side view, broken away, of abrace section 240 for use in associating the middle section delivery device and a distal portion of a medical device according to the invention.FIG. 5B shows a cross sectional view ofFIG. 5A taken along thelines 5B-5B. - According to
FIGS. 5A and 5B , thebrace section 240 comprises apuller 54 that can be used to connect or fasten two structures. For instance, thepuller 54 may be used to operatively couple the middlesection delivery device 14 and thedistal portion 13. In general, thepuller 54 represents any bridged reinforcement piece of suitable material, such as stainless steel wire or other alloy, with a proximal flattened end and a distal flattened end, wherein the proximal flattened is placed between a Tefloninner layer 242 and/orcoil 243 and a nylonouter layer 244 of anouter sheath 50 and wherein the distal flattened end is placed between a Tefloninner layer 242 and/orcoil 243 and a nylonouter layer 244 of an outer guide channel member. Thepuller 54 may be heat bonded between the Tefloninner layer 242 and the nylonouter layer 244, or it may be adhesively bonded to the Tefloninner layer 242 and the nylonouter layer 244, or it may be welded, soldered, glued, or lap jointed to thecoil 243. - Also, the
puller 54 may join a plurality of coils, multifilar materials, weaves, or braids end-to-end. Furthermore, thepuller 54 may join a plurality of segments comprising a coil, multifilar material, weave, or braid. Moreover, thepuller 54, when used with a “Flexor®” sheath as anouter sheath 50 of a middlesection delivery device 14 as previously described, provides additional strength anywhere support is needed to provide structural integrity, such as when there is a gap between the bridged components, or a reduced cross sectional area of a component compromises that component's structural integrity. -
FIGS. 5A and 5B show thebrace section 240 comprising three layers: aninner layer 242, amiddle layer 243, and anouter layer 244. Theinner layer 242 may comprise Teflon; theouter layer 244 may comprise nylon and/or PEBA; and themiddle layer 243 may comprise stainless steel circumferential coil. Heating thebrace section 240 to an appropriate temperature reduces the outer layerinner surface 249 to a liquid state. Treating, mechanical or chemical etching, sandblasting, or otherwise preparing the inner layerouter surface 241 improves the bonding properties of the inner layerouter surface 249. Consequently, the melted outer layerinner surface 249 seeps through spaces in or between middle layer coils 243 and bonds to both the inner layerouter surface 241 and to thecoils 243. -
FIG. 9B shows that thebrace section 240 may further comprise one ormore pullers 54. Thepullers 54 may include, for example, stainless steel flat wire. Optionally, apuller 54 may overlap, weave, or braid with the middle layer coils 243. The surface of thepuller 54 may be treated, mechanical or chemical etched, sandblasted, or otherwise prepared and the outer layerinner surface 249 melted to bond the threelayers puller 54 anywhere two structures need connecting or fastening, or simply anywhere additional support is needed. - In one embodiment, the
puller 54 is generally rectangular, polygonal, or irregular in shape or cross section and is positioned approximately parallel to alongitudinal axis 246 of thebrace section 240. Alternatively, thedistal portion 13 and the middlesection delivery device 14 may be attached, adjoined, joined, or combined by abrace section 240, wherein thepuller 54 is a mechanical connector selected from the group consisting of a wire, inward protrusion, nuts and bolts, pins, clamp, pincher, hook, fastener, joint, ring, sheath, ball and socket, full or partial bearing, shaft, thread, cable, rod, bar, ball or hemispherical ball, fulcrum, support, linkage, or other crimping, clutching, gripping, joining, or holding mechanical holding materials, to name a few illustrative examples of mechanical connectors for operatively coupling the middlesection delivery device 14 and thedistal portion 13 in accordance with an embodiment of the invention. Other examples of apuller 54 include glue, adhesives, resins, welding, soldering, brazing, adhesives, or chemical bonding materials or combinations thereof. By way of further illustration, thedistal portion 13 and middlesection delivery device 14 may be attached by apuller 54 that is a stainless steel coil. -
FIGS. 5C through 5K show thedistal portion 13 and middlesection delivery device 14 are operatively coupled by abridging device 100 as inFIGS. 5C through 5K . For clarity, thedistal portion 13 and middlesection delivery device 14 having adelivery device 40 with anouter sheath 50 andinner compression member 41 are not shown in full inFIGS. 5C through 5K , and instead they are only represented schematically as a truncated tubulardistal portion 13 and a truncated tubular middlesection delivery device 14. - A
bridging device 100 has a low profile and may vary in length, thickness, and width. For example, the length may be from 1 cm to about 10 cm or more, and in one embodiment from about 2 cm to about 6 cm, or it may correspond to the approximate length of the self-expanding device in a compressed state or the approximate length that the outer guide channel member may need to slide relative to the inner guide channel member to deploy the self-expanding device. Moreover, the low profile of thebridging device 100—relative to thedistal portion 13 or middlesection delivery device 14—facilitates the exiting of a wire guide from a breech position opening 65 located at or near the rear, back, or proximal part of thedistal portion 13. The low profile and length allow the physician to grab the exiting wire guide as needed. The physician may desire to feed the exiting wire guide into another instrument, into a passageway of the middle section, or through one or more eyelets attached to maintain the wire guide the middle section to substantially parallel with or side-by-side with the middlesection delivery device 14. - The
bridging device 100 further comprises alink member 101′ joining the bridge to thedistal portion 13 and alink member 101 joining the bridge to the middlesection delivery device 14. Thelink members section delivery device 14 anddistal portion 13, where thepuller 54 is a connector selected from the group consisting of mechanical structures, chemical bonding materials (resins, glue, adhesives, and the like), and welding (soldering, brazing, and the like) materials or combinations. Certain additional non-limiting examples oflink members link member bridging device 100 to an outer surface or an inside surface of the middlesection delivery device 14 ordistal portion 13. - The
bridging device 100 may comprise a single span construction or a plurality of spans.FIGS. 5C-5G show various views of an embodiment of abridging device 100 comprising aspan 102 andlink members FIGS. 5H-5K , thebridging device 100 comprises afirst span 104 joined to the middlesection delivery device 14 by alink member 101, and asecond span 106 joined to thedistal portion 13 by alink member 101′. Thefirst span 104 andsecond span 106 are joined together by anarticulation member 105. - The
bridging device 100 may be made of any suitable material used for the middlesection delivery device 14 as described above or used for thedistal portion 13 as described below. The material is resilient with sufficient column strength to be kink resistant. Optionally, thebridging device 100 may be pliable, elastic, twistable, and flexible. For illustration, onlyFIGS. 5F, 5I , and 5J are shown flexing, but thebridging device 100 ofFIGS. 5C-5K may all be made flexible (if desired).FIG. 5F shows the embodiment flexing.FIG. 51 shows the embodiment with both first andsecond spans FIG. 5J shows the embodiment with thesecond span 106 flexing torsionally. The flexibility of thebridging device 100 may be varied by the materials used to construct thebridging device 100, depending on the degree of flexibility desired. - Optionally, the
span 102,first span 104, andsecond span 106 may articulate aboutlink members FIGS. 5C-5G , and thearticulation member 105 shown inFIGS. 5H-5K . When articulation is desired, thelink members articulation member 105 preferably comprise mechanical structures, such as a nut, bolt, screw, thread, suture, cotter and pin, spring, full or partial bearing, bearing surface, rivet, pin, shaft, thread, joint, or other linkage or securing mechanism that allows articulation. Furthermore, articulation may be controlled by limiting the range of motion from a range within about 1 degree to approximately 15 degrees. - Articulation, as used here, means that one or more of the following pieces is moveable relative to one or more of the other pieces: middle
section delivery device 14, spans (102, 104, 106), anddistal portion 13. Articulation may include one or more degrees of translational displacements and/or rotations. For instance, the articulation may be axial, longitudinal, forward, backward, orthogonal, lateral, transverse, rotational, pivotable, sloping incline or decline, swinging, torsional, revolving, and other forms of translation and/or rotation in an x, y, and/or z coordinate system. - According to
FIGS. 5L through 5O , adistal insert 220 andproximal insert 230 may be used as an alternative embodiment of abridging device 100. The embodiments forFIGS. 5L through 5O may be used for either or both thedistal insert 220 andproximal insert 230, so alternative reference numerals are used, but are explained separately below. -
FIGS. 5L through 5O show examples of adistal insert 220 having anopening 283″ at amating portion 222, anexit port 283′ at aninterfacing portion 224, and theopenings 283′, 283″ defining a guide channel 281. Similarly,FIGS. 5L through 5O may represent examples of aproximal insert 230 having anopening 233′ at a mating portion 232, anexit port 233 at aninterfacing portion 234, and theopenings 233′, 233 defining a guide channel 231. Theinserts -
FIG. 5L shows an example of aninsert opening 283″, 233′ at a flaredmating portion 222, 232 for securing to the outside of the outer sheath distal end and outer guide channel membersecond end mating portions 222, 232 of the otherFIGS. 5M through 5O also may secure, however, either to the outer sheath distal end or outer guide channel membersecond end inserts section delivery device 14 or later described as making up thedistal portion 13. In one embodiment, theinserts - The lengths of the
inserts openings 283′, 233 may be at an angle between a range of zero to about 90 degrees relative to an axis of theinsert -
FIGS. 5N and 5O , in addition to having anopening 283″, 233′ at amating portion 222, 232, and aport 283′, 233 at aninterfacing portion perforations 208 and/orslots 209 intermediate themating portion 222, 232 and the interfacingportion slots slots 209 ofFIG. 5O increase the flexibility of theinserts slots inserts mating portions 222, 232 are dispose between aninner layer 44 andouter layer 42 of the outer guide channel member orouter sheath outer layers mating portions 222, 232 between the inner and outer layers, as shown inFIGS. 5R and 5S . -
FIG. 5P represents sectional side schematic views, broken away, of an outer guide channel member 80 (discussed below) and anouter sheath 50. The outerguide channel member 80 comprises asecond end portion 87 with anexit port 83 and aguide channel 81. Theouter sheath 50 comprises adistal end 58 with adistal opening 52 and having apassageway 59. - A
distal insert 220 has an outermember mating portion 222 secured to an outerguide channel member 80, while aproximal insert 230 has an outer sheath mating portion 232 bonded to the outer sheathdistal end 58. In one embodiment, the outermember mating portion 222 of the distal insert may be secured to aninner layer 44 within the outermember guide channel 81, while the outer sheath mating portion 232 of theproximal insert 230 may be secured to aninner layer 44 within theouter sheath passageway 59. In an alternative embodiment, themating portions 222, 232 of thedistal insert 220 andproximal insert 230 may be received by and secure to theouter layer 42 of the outerguide channel member 80 and theouter sheath 50, respectively. - As shown in
FIG. 5Q , another embodiment comprises themating portions 22, 232 of thedistal insert 220 andproximal insert 230 being disposed between aninner layer 44 and anouter layer 42 of the outerguide channel member 80 and theouter sheath 50, respectively, wherein the mating portion 232 is optionally located distal to theouter sheath coil 43 and wherein themating portions 222 is optionally located proximal to thecoil 43 of the innerguide channel member 80. Optionally, aninner layer 44 comprises Teflon material and anouter layer 42 optionally comprises a nylon and/or PEBA material. Also, themating portions 222, 232 optionally replace a middle layer, such as acoil 43, of the outer sheathdistal end 58 and outer guide channel membersecond end portion 87, respectively. In one embodiment, themating portions 222, 232 are secured to the outer sheath distal end 58 (between the inner andouter layers outer layers distal end 58 and outer membersecond end portion 87. Alternatively, post construction of thedistal end 58 and the outer guide channel membersecond end portion 87, themating portions 222, 232 may be secured between the inner andouter layers distal end 58 and outer guide channel membersecond end portion 87, respectively, by heat-bonding, for example. -
FIG. 5Q further shows an interfacingportion 224 of thedistal insert 220 and aninterfacing portion 234 of theproximal insert 230. The insert interfacing ends 224, 234 are brought together and operatively coupled by any suitable connection selected from the group consisting of glue, adhesive, resin, welding, fusing, soldering, brazing, wire, crimping, link member, interlocking member, or other mechanical or chemical bonding materials or combinations thereof. One example of welding includes laser welding. In addition, the insert interfacing ends 224, 234 may be operatively coupled by a solid-state bond resulting from heat-bonding, such as the melting and solidifying (fusing) of material of the interfacing ends 224, 234, which allows the joining of similar and dissimilar metals according to materials science. -
FIG. 5R shows a sectional side view, broken away, of a device havingmating portions 222, 232 of aninsert FIG. 5O secured to thesecond end portion 87 of the outerguide channel member 80 or thedistal end 58 of theouter sheath 50, respectively. Themating portions 222, 232 are disposed between aninner layer 44 and anouter layer 42 of the outerguide channel member 80 andouter sheath 50, respectively. Aconnector 209′ is formed through theslot 209 via a solid-state bond resulting from heat-bonding, such as the melting and solidifying (fusing) of the material of the outer andinner layers -
FIG. 5S shows a sectional side view, broken away, of adevice having openings 283″, 233′ atmating portions 222, 232 of a distal insert andproximal insert FIG. 5N secured to thesecond end portion 87 of the outerguide channel member 80 or thedistal end 58 of theouter sheath 50, respectively. Themating portions 222, 232 are disposed between aninner layer 44 and anouter layer 42 of the outerguide channel member 80 andouter sheath 50, respectively. Aconnector 208′ is formed through theperforation 208 via a solid-state bond resulting from heat-bonding, such as the melting and solidifying (fusing) of the material of the outer andinner layers -
FIG. 5T shows a section side view, broken away, of an example of aninsert FIG. 5L . Themating portion 222 is flared for securing around thesecond end portion 87 of an outerguide channel member 80. Alternatively, the flared mating portion 232 is configured to secure arounddistal end 58 of theouter sheath 50. In both of these and like embodiments, themating portion 222, 232 may also secure around theouter layer 42 or theinner layer 44 of the outerguide channel member 80 orouter sheath 50. - Optionally, the inner compression member
distal mating end 48 may be secured to aproximal insert 230 and an inner guide channel membersecond end portion 77 may be secured to adistal insert 220. The insert interfacing ends 224, 234 are brought together and operatively coupled by any suitable connection discussed above. Alternatively, theproximal insert 230 may be omitted, and the distalinsert interfacing end 224 may be operatively coupled directly to the inner compression memberdistal mating end 48 by glue, adhesive, resin, welding, fusing, soldering, brazing, melt bonding, crimping, or other mechanical or chemical bonding materials or combinations thereof. -
System Distal Portion 13 - Now turning to embodiments of a
distal portion 13 of medical device delivery systems according to the invention,FIGS. 6, 7 , 8, and 9 show thedistal portion 13 to be a relatively tubular body. Given the configuration of vessels, vessel passageways, a working channel of an endoscope, or an external accessory channel device used with an endoscope to be navigated, a mostly tubular distal end with a distal tapered, rounded, chamfered, or arrowhead shape may be better tolerated by the patient. Further, in certain embodiments, the distal portion of thedistal portion 13 may be soft, rounded, and flexible so as to provide further protection for and care to the patient. -
FIG. 6 illustrates an embodiment of thedistal end 13 of a delivery system for the rapid insertion of self-expanding stents (for example) comprising an innerguide channel member 70, an outerguide channel member 80 axially slideable relative to the innerguide channel member 70, a self-expanding deployment device mounting region 90 (e.g., a stent mounting region), and atransition region 60. As used in connection with describing embodiments of the inner and outerguide channel members FIG. 8 ) or another component of the distal end (e.g., an innerguide channel member 70 relative to the outer member channel 81). - The
distal end 13, according to thedelivery system 10 and shown inFIGS. 6, 7 , 8, and 9, may be made of any suitable material (natural, synthetic, plastic, rubber, metal, or combination thereof) that is rigid, strong, and resilient, although it should be understood that the material may also be pliable, elastic, and flexible. By way of illustration only and not by way of limitation, the distal end may comprise one or a combination of the following materials: metals and alloys such as nickel-titanium alloy (“nitinol”) or medical grade stainless steel, and/or plastic and polymers such as polyether ether-ketone (“PEEK”), polytetrafluoroethylene (PTFE), nylon and/or a polyether block amide (“PEBA”), polyimide, polyurethane, cellulose acetate, cellulose nitrate, silicone, polyethylene terephthalate (“PET”), polyamide, polyester, polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, or mixtures or copolymers thereof, polylactic acid, polyglycolic acid or copolymers thereof, polycaprolactone, polyhydroxyalkanoate, polyhydroxy-butyrate valerate, polyhydroxy-butyrate valerate, or another polymer or suitable material. Where it will not contact the patient (e.g., it is contained within a sheath, working channel of an endoscope, or an external accessory channel device used with an endoscope), the middlesection delivery device 14 anddistal end 13 do not need to be biocompatible. In contrast, where there is the possibility of patient contact, the material may need to be biocompatible or capable of being made biocompatible, such as by coating, chemical treatment, or the like. - The inner and outer
guide channel members distal end 13. In one embodiment, the innerguide channel member 70 and the outerguide channel member 80 comprise PEEK material, which has the advantage of softening under heat before burning or degrading. PEEK tubing may be purchased from many suppliers, such as Zeus, Inc. in Orangeburg, S.C. for instance. - Beginning with the inner
guide channel member 70, a description will follow relating to features common to embodiments of adistal end 13 of adelivery system 10 for the rapid insertion of “stents” according to the invention. The innerguide channel member 70 is generally tubular and comprises afirst end portion 78 and asecond end portion 77 defining awire guide channel 71 therebetween. Optionally, the innerguide channel member 70 is configured to be slidably nested, fitted, secured, or otherwise positioned within the outerguide channel member 80 such that at least one of the inner guide channel member first orsecond end portions first end portion 88 and an outer guide channel membersecond end portion 87. - The
first end portion 78 of the innerguide channel member 70 further comprises a wireguide entry port 72, and thesecond end portion 77 has a wireguide exit port 73. The entry andexit ports wire guide channel 71. A port, in describing an embodiment of an innerguide channel member 70 and an outerguide channel member 80 according to the invention, includes any structure that functions as an entry or exit aperture, cutout, gap, hole, opening, orifice, passage, passageway, port, or portal. The inner guide channelmember entry port 72 is sized to receive a wire guide into the innermember guide channel 71, and the innerguide channel member 70 is configured so that the wire guide may exit proximally out the inner guide channelmember exit port 73. Optionally, theexit port 73 is located at or near thetransition region 60. In one embodiment of the present invention, the innerguide channel member 70 is a cannula (or catheter) having anentry port 72 and anexit port 73 as previously described and defining aguide channel 71 therebetween. - The inner
guide channel member 70 further comprises an outer self-expanding deployment device mounting region 90 (e.g., an outer stent mounting region) positioned intermediate the inner guide channel member entry andexit ports guide channel member 70 of any of the embodiments of the present invention may vary generally from about 10.0 to about 40.0 cm. In one alternative embodiment, the length of the innerguide channel member 70 is approximately 15.0 to approximately 25.0 cm. In another embodiment, the length of the innerguide channel member 70 is approximately 20.0 cm. Also, the length of the innerguide channel member 70 may depend on the intended stent, and in another embodiment the length of the innerguide channel member 70 is approximately 15.0 cm for an 8.0 cm stent. - The inner
guide channel member 70 further comprises inner and outer diameters. In one embodiment, both diameters are substantially uniform over the entire length of the innerguide channel member 70. By way of example, aninternal diameter 74 might measure approximately 0.0205 inches at or near the inner guide channel member proximalsecond end portion 77, at or near the inner guide channel member distalfirst end portion 78, and intermediate the first andsecond end portions guide channel member 70 might have anouter diameter 75 that measures approximately 0.0430 inches. Thus, theouter diameter 75 might measure approximately 0.0430 inches at or near the inner guide channel member proximalsecond end portion 77, at or near the inner guide channel member distalfirst end portion 78, and intermediate the first andsecond end portions - In an alternative embodiment to an inner
guide channel member 70 having a substantially uniformouter diameter 75 along its length from about thesecond end portion 77 to about thefirst end portion 78, the inner guide channel member may also comprise a taperedouter diameter 76. In one embodiment, the inner guide channel member tapers distally to a secondouter diameter 76′ at or near the inner guide channel memberfirst end portion 78 or intermediate the inner guide channel member first andsecond end portions taper 76 has a decreased cross section, diameter, width, height, area, volume, thickness, and/or other configuration, shape, form, profile, structure, external outline, and/or contour relative to theouter diameter 75. In other words, the inner guide channel member secondouter diameter 76′ is smaller in cross section, diameter, width, height, area, volume, thickness, and/or other configuration, shape, form, profile, structure, external outline, and/or contour than theouter diameter 75. -
FIG. 6 further shows an optionalatraumatic tip 170 coupled to the inner guide channel memberfirst end portion 78. Extending distally from the inner guide channel memberfirst end portion 78, theatraumatic tip 170 is tapered, rounded, chamfered, or arrowhead shape to be better tolerated by the patient. Theatraumatic tip 170 comprises a distalfirst end portion 178 with a wireguide entry port 172 and a proximalsecond end portion 177 with a wireguide exit port 173, whereby the entry and exit ports define an atraumatictip guide channel 171. Theports channel 171 are sized to slidably receive a wire guide. - The atraumatic tip
second end portion 177, as shown inFIG. 4 , may abut the outer guide channel memberdistal end portion 88 and, thereby, extend entirely distally beyond adistal opening 89 of the outer guide channel memberfirst end portion 88. Optionally, the outer guide channel memberdistal opening 89 is spaced from theatraumatic tip 170 sufficient to allow delivery system to be flushed with saline that exits the distal end to remove air in order to help keep air out of the patient, as explained above. In the alternative and as shown inFIG. 5 , theatraumatic tip 170 may be configured to have asecond end portion 177 that is beveled such that the atraumatic tipsecond end 172 is partially positioned within the outermember guide channel 81 and partially proximal to the outer guide channel memberdistal opening 89. The beveled design of the atraumatic tipsecond end portion 177 forms a proximal stop against the outer guide channel memberdistal opening 89 while permitting the atraumatic tipsecond end portion 177 to be partially slidably nested, fitted, secured, or otherwise positioned within the outer guide channel memberfirst end portion 88 so that the outer guide channel memberfirst end portion 88 overlaps theatraumatic tip 170 to form a suitable seal that substantially occludes passage of a wire guide between theatraumatic tip 170 and thedistal opening 89 of the outer member first end portion 88 (FIG. 7 ). Furthermore, the atraumatic tipsecond end portion 177 comprises a stentdistal restraint 93′ as explained below. - In
FIG. 6 , the outerguide channel member 80 also is generally tubular and comprises afirst end portion 88 and asecond end portion 87. The outerguide channel member 80 further comprises a wireguide entry port 82 proximal to thefirst end portion 88 and a proximal wireguide exit port 83 located at or near thesecond end portion 87. The entry and exit ports, 82, 83, respectively, define aguide channel 81 of the outerguide channel member 80, wherein theports channel 81 are sized to slidably receive a wire guide. Theentry port 82 is configured to receive a wire guide into the outermember guide channel 81, and in one embodiment, theentry port 82 is defined by the inner guide channelmember exit port 73. In that embodiment, the wire guide moves proximally through the innermember guide channel 71 and egresses from the inner guide channelmember exit port 73, wherein the proximal passage of the inner guide channelmember exit port 73 is designated as the outer guide channel member wireguide entry port 82. The outer guide channel member proximal wireguide exit port 83 is configured so that a wire guide may egress proximally out the outermember exit port 83. In one embodiment, the outer guide channel memberdistal opening 89 andexit port 83 define theguide channel 81 therebetween. - In one embodiment, the Flexor® sheath, manufactured and sold by Cook Incorporated of Bloomington, Ind., may be adapted for use with the
distal end 13 and/or the middlesection delivery device 14. Otherwise stated, the Flexor® sheath, as shown inFIG. 3 and described above, may be provided for thedistal end 13 and/or the middlesection delivery device 14. For instance, thedistal end 13 may be constructed as comprising an integral Flexor® sheath tube with the middlesection delivery device 14. Alternatively, a Flexor® tubing may be used for either the middlesection delivery device 14 or thedistal end 13, or both. Then, the separable middlesection delivery device 14 anddistal end 13 may be attached, adjoined, joined, or combined as taught herein above. - The Flexor® sheath has a PTFE
inner lining 44 that provides a slick, smooth surface for sliding theouter sheath 50 and/or the outerguide channel member 80 proximally. With regard to thedistal end 13, the outerguide channel member 80 slides relative to the innerguide channel member 70, and a stent constraininginner surface 92 of the outerguide channel member 80 would be theinner layer 44 described above, thereby resulting in minimal friction to astent 17 on thestent platform 91. The slidableinner surface 92 of the Flexor® sheath exhibits a second benefit of minimizing damage or misalignment to the stent. Indeed, because self-expanding stents continuously exert an expanding force against theinside surface 92 of the outerguide channel member 80, any substantial friction or drag between the stent and theinner surface 92 of the outerguide channel member 80 as the outerguide channel member 80 withdraws may damage the stent or cause the stent to be deployed slightly off of the target site. - The thin flat
wire reinforcing coil 43 of the Flexor® sheath provides the outerguide channel member 80 with the necessary radial strength to constrain the stent over long periods of storage time. In contrast, where the a stent constraininginner surface 92 of an outerguide channel member 80 does not comprise the Flexor® sheathinner layer 44 or equivalent, the stent over time may tend to become imbedded in theinner surface 92 and, as a result, interfere with retraction of the outerguide channel member 80 at the time of deployment. In an outerguide channel member 80 that comprises a Flexor® sheath, in addition to theinner layer 44 and the reinforcingcoil 43, the outerguide channel member 80 has a Flexor® sheathouter layer 42. Theouter layer 42 comprises nylon and/or PEBA to provide the necessary stiffness for pushability, retraction, and control of the outerguide channel member 80 to facilitate proper deployment of the constrained self-expanding stent. Therefore, the Flexor® sheath is one non-limiting example of an embodiment of anouter sheath 50 and/or an outerguide channel member 80. - While
FIG. 6 shows an outerguide channel member 80 having theexit port 83 proximal to theentry port 82 in one embodiment of the outerguide channel member 80, the relative axial distances between the entry andexit ports guide channel member 80 is in a non-deployed state versus a deployed state, because the outerguide channel member 80 moves axially relative to the innerguide channel member 70. Otherwise stated,FIG. 6 shows an embodiment where theexit port 83 is proximal to theentry port 82 in either a non-deployed stent position or in a deployed stent position. In a non-deployed stent position of another embodiment, however, theexit port 83 may be substantially co-planar to or aligned with theentry port 82. In the fully deployed stent position, theexit port 83 may likewise be proximal, co-planar, or aligned with theentry port 82. Optionally, theentry port 82 andexit port 83 are located at or near thetransition region 60 to be discussed below. - Furthermore, the outer
guide channel member 80 has a stepped 84, 85 profile, whereby the outerguide channel member 80 comprises a firstouter diameter 84 intermediate the outer guide channel member first andsecond end portions outer diameter 85 located at or near the outer guide channel membersecond end portion 87 in the vicinity of thetransition region 60 and thebreech position opening 65. The stepped 84, 85 profile includes an embodiment where the outerguide channel member 80 transitions to thedistal end portion 58 of theouter sheath 50 of the middlesection delivery device 14. In describing embodiments of the invention, however, the stepped 84, 85 profile shall be discussed in reference to the outerguide channel member 80 in particular, but it should be understood as including a stepped 84, 85 profile in reference to thetransition region 60 of thedistal end 13 relative to the middlesection delivery device 14 where the middlesection delivery device 14 anddistal end 13 are formed from separate units such as, by way of example only and not by way of limitation, separate “Flexor®” sheaths where one comprises a firstouter diameter 84 and the other comprises a second smallerouter diameter 85. - As shown in
FIG. 6 , the second smallerouter diameter 85 of the outerguide channel member 80 is located proximal to the larger firstouter diameter 84 and, thereby, comprises a stepped 84, 85 profile. Having a second smallerouter diameter 85 reduces the profile of the outerguide channel member 80 and/or the outerguide channel member 80 transition to the middlesection delivery device 14, which is advantageous in procedures involving narrow vessel passageways, endoscope working channels, or accessory channels for use with endoscopes. The difference in thefirst diameter 84 and thesecond diameter 85 may vary. By way of illustration, thesecond diameter 85 may be approximately one-fourth to approximately nine-tenths that of thefirst diameter 84. In another embodiment, thesecond diameter 85 may be about one-half that of thefirst diameter 84. In another embodiment, thefirst diameter 84 is roughly 5 French while thesecond diameter 85 is roughly 4 French. - In one embodiment of the stepped 84, 85 profile of the outer
guide channel member 80, the second smallerouter diameter 85 is located at or near the outer guide channel membersecond end portion 87. Thesecond end portion 87 may decrease precipitously from the firstouter diameter 84 to the secondsmaller diameter 85. In a precipitous step, the change from the diameters occurs over a short length along the longitudinal axis of thedistal end 13. In a further example of a precipitous step, the plane formed by theexit port 83 may be substantially perpendicular to the longitudinal axis of the outerguide channel member 80. In an alternative embodiment, thesecond end portion 87 may decrease gradually from the firstouter diameter 84 to the secondsmaller diameter 85. In a gradual step, the change from the two diameters occurs over a length of more than 1.0 millimeter (“mm”) along the longitudinal axis of thedistal end 13 at or near thetransition region 60 and breech position opening 65, and in one instance this change occurs over a length from about 1.0 mm to about 10.0 mm. In a further example of a gradual step, the plane formed by theexit port 83 may be at an angle other than 90 degrees relative to the longitudinal axis of thedistal end 13. -
FIG. 6 also shows a breech position opening 65 located at or near thesecond end portion 87 of the outerguide channel member 80 comprising the wireguide exit port 83. In other words, rather than theexit port 83 being an aperture in a lateral sidewall of the outerguide channel member 80 intermediate the first andsecond end portions exit port 83 is at the rear, back, or proximal part of thedistal end 13 at or near the outer membersecond end portion 87 and the stepped 84, 85 profile such that it opens in the direction of the outer surface of theouter sheath 50. - The breech position opening 65 may be used for front-loading and the more common procedure of back-loading a wire guide (or catheter, for instance). In a back-loading procedure for a delivery system having a breech position opening 65, the wire guide may pass proximally through the
guide channel 71 of the innerguide channel member 70, proximally through theguide channel 81 of the outerguide channel member 80, and leave theexit port 83 of thesecond end portion 87 of the outerguide channel member 80 from a breech position opening 65 in a rear, back, or proximal part of thedistal end 13. Conversely, in a front-loading procedure for a delivery system having a breech position opening 65, the physician may feed the wire guide distally into a breech position opening 65 at the rear, back, or proximal part of thedistal end 13 by entering theexit port 83 of thesecond end portion 87 and theguide channel 81 of the outerguide channel member 80 and through theguide channel 71 of the innerguide channel member 70, where the wire guide may exit from the wireguide entry port 72 of the innerguide channel member 70 and/or wireguide entry port 172 of theatraumatic tip 170. - In a
distal portion 13 having a breech position opening 65 that comprises anexit port 83 located at a breech position of thetransition region 60 according to the invention, the wire guide does not need to make any sharp turns away from the longitudinal axis of theguide channel 71 of the innerguide channel member 70 and/or thedistal portion 13 generally that may result in kinking of the wire guide. In one embodiment, theexit port 83 is spaced proximally of the inner guide channel membersecond end portion 77 and is substantially (e.g., less than 30 degrees and preferably less than 15 degrees) along the longitudinal axis of the innerguide channel member 70 such that the longitudinal axis of the innerguide channel member 70 intersects theexit port 83, runs through theexit port 83, or theexit port 83 otherwise lies along the plane of the longitudinal axis of the innerguide channel member 70. In another embodiment, theexit port 83 is within the plan form by the side walls of the outerguide channel member 80, as opposed to a sideport that is within the sidewall of the outerguide channel member 80, wherein the wire guide needs to may a sharp turn away from the longitudinal axis of theguide channel 71. In another embodiment, the breech position opening 65 comprises anexit port 83 according to embodiments of the invention, as those shown inFIGS. 6, 7 , 8, and 9 (by way of example and not by way of limitation) is located proximal to the inner guide channel membersecond end portion 77 and may be transverse or angled relative to the longitudinal axis of the tubular innerguide channel member 70 and/or thedistal portion 13. In one embodiment, the wireguide exit port 83 may be positioned at or near a breech position opening 65 of thedistal portion 13, wherein theexit port 83 is located at or near the rear, back, or proximal part of the outerguide channel member 80 and/orsecond end portion 87; in other words, not positioned exclusively on the side (e.g., outer circumferential cylinder wall) or substantially a length of the side of the outerguide channel member 80. - In
FIG. 6 , the breech position opening 65 comprises anexit port 83 that is illustrated as being oblique, although other configurations of the exit port may be utilized to aid the wire guide in exiting the rear of the outer member. In one example, theexit port 83 may form a plane substantially perpendicular to the longitudinal axis of the outer guide channel membersecond end portion 87. In another example, the plane formed by theexit port 83 may be at an angle other than 90 degrees relative to the longitudinal axis of thedistal end 13. Optionally, theoblique exit port 83 of a breech position opening 65 haslateral walls section delivery device 14 and to run along the outside of theouter sheath 50. - The overall axial length of the
exit port 83 of the breech position opening 65 may vary. In one embodiment, the length is approximately from about 1.0 mm to about 10.0 mm. Another embodiment has a length of approximately 5.0 mm. The overall width of theexit port 83 may also vary. In one example, the width of the exit port is approximately 1 French. In yet another instance, the width of theexit port 83 ranges from about 1 French to about 4 French. In another example, the width of theexit port 83 may be the approximate difference between the firstouter diameter 84 and the secondouter diameter 85 of the outerguide channel member 80. In yet another embodiment, theexit port 83 comprises a diameter defined as being substantially equal to the difference between the outer guide channel member firstouter diameter 84 and the outer guide channel member second smallerouter diameter 85. - At the
transition region 60, theexit port 73 of the innerguide channel member 70 is in communication with the outerguide channel member 80 wireguide entry port 82, while thesecond end portion 77 is operatively coupled to thedistal mating end 48 of the innerguide channel member 70 as explained below. The length of thetransition region 60 may vary. For instance, thetransition region 60 may be approximately from about 0.5 cm to about 10.0 cm. In another embodiment, thetransition region 60 has the approximate length of about 5.0 cm. Furthermore, the length of thetransition region 60 is variable: from a shorter axial length when the outerguide channel member 80 is in a non-deployed axial position; to a greater axial length when the outerguide channel member 80 retracts proximally to deploy the stent. Likewise, the overall length of thetransition region 60 varies in the embodiment where theexit port 83 is distal to theentry port 82 when the outerguide channel member 80 is in a non-deployed stent position, compared to the initial length of thetransition region 60 in an embodiment where theexit port 83 is proximal to theentry port 82 when the outerguide channel member 80 is in a non-deployed stent position. - In one use of the
transition region 60 according to an embodiment of the invention, the outer guide channelmember entry port 82 receives a wire guide from the inner guide channelmember exit port 73 and the wire guide thereby is received in the outermember guide channel 81. At thetransition region 60, the innermember guide channel 71 and outermember guide channel 81 are approximately aligned relatively coaxially in one embodiment. Approximate alignment of theguide channels member guide channel 71 to the outermember guide channel 81. - Several factors individually or collectively may further ensure that the inner
member guide channel 71 and outermember guide channel 81 are approximately aligned relatively coaxially so that the wire guide may find its way out thedistal portion 13. The breech position opening 65 is located in a longitudinally optimal location at the rear, back rear, back, or proximal part of thedistal portion 13. Also, the breech position opening 65 is large enough to provide an easy exit; if too large it compromises the structural integrity of the outerguide channel member 80 and/or thetransition region 60, and apuller 54 as taught herein may be needed. Furthermore, the inside shape of the breech position opening 65 is conducive to receiving the wire guide and directing it out, as with the [lateral walls section delivery device 14 and to run along the outside of theouter sheath 50, and/or with the overall axial length of theexit port 83 of the breech position opening 65 from about 1.0 mm to about 10.0 mm and alternatively approximately 5.0 mm, and/or the overall width of theexit port 83 of approximately from about 1 French to about 4 French or the difference in the firstouter diameter 84 and the secondouter diameter 85. Furthermore,outer sheath 50 has a passageway that is only large enough for theinner compression member 41 to pass through but not large enough to provide a receptacle for the wire guide as it is being fed through thedistal portion 13. - Moreover, as the delivery system is being assembled, a pseudo-wire guide may be threaded through the breech position opening “backward” from normal. The pseudo-wire guide is then threaded backward through the inner
guide channel member 70. As the outerguide channel member 80 and innerguide channel member 70 are slid together longitudinally, the pseudo-wire guide ensures that the inner guide channelmember exit port 73 and the outer guide channelmember exit port 83 are rotationally aligned. Because the outerguide channel member 80 is operatively coupled to theouter sheath 50 and the innerguide channel member 70 is operatively to theinner compression member 41, by connected the outer sheath proximal end 57 and the inner compression memberproximal end 40 at the systemproximal portion 12 as described above, this locks the inner guide channelmember exit port 73 and the outer guide channelmember exit port 83 into a properly aligned relationship. Then, the pseudo-wire guide can be removed, or left to function as a shipping fixture that is removed by the end user. - As shown in
FIG. 6 , thedistal end 13 also comprises a self-expanding deploymentdevice mounting region 90. This mountingregion 90 may be used for implantable prosthesis such as expandable (self-expanding, balloon expandable, or otherwise expanding) and nonexpanding stents, prosthetic valve devices, and other implantable articles for placement inside a patient's body (the implantable prostheses being referred to individually and collectively as “stents” without limiting the invention) and therefore may be referred to as a stent mounting region to include the foregoing implantable prostheses. - The
stent mounting region 90 comprises astent platform 91 on an outside surface of the innerguide channel member 70 located at or near the inner guide channel membersecond end portion 78. In describing embodiments of the invention, theplatform 91 “at or near” the inner guide channel membersecond end portion 78 includes a region intermediate the inner guide channelmember entry port 72 and the inner guide channelmember exit port 73. Theplatform 91 may be any stent mounting surface, including but not limited to the outside surface of the innerguide channel member 70, a recess, or an indentation located at or near thefirst end portion 78 of the innerguide channel member 70. In a non-deployed state, a self-expanding stent for example (not shown) compresses against thestent platform 91 and disposes around the outside of the innerguide channel member 70. - The
stent mounting region 90 controls the lateral movement (e.g., transverse expansion away from the inner guide channel member longitudinal axis) to avoid premature deployment of the stent. In order to control the lateral movement of the stent, the stent is sandwiched between theplatform 91 on the inner surface of the stent and the stent constraininginner surface 92 of the outerguide channel member 80 to keep the stent in a compressed state. Because the stent is bound from above by theinner surface 92 of the outerguide channel member 80 and bound from below by theplatform 91 of the innerguide channel member 70, thestent mounting region 90 maintains the stent in a substantially compressed state and controls premature deployment of the stent. - In addition to controlling a stent's lateral movement, the
stent mounting region 90 restrains the axial movement of a stent to control the stent movement away from the target site. Aproximal restraint 93 controls proximal axial movement of the stent. In one embodiment, theproximal restraint 93 is sized to be large enough to make sufficient contact with the loaded proximal end of the stent without making frictional contact with theinner surface 92 of the outerguide channel member 80. In addition to helping to stop the stent's proximal movement in the non-deployed state, thisrestraint 93 assists with “pushing” the stent out of thedistal end 13 by helping to prevent the innerguide channel member 70 and/or the stent disposed on thestent mounting region 90 from migrating proximally when the outerguide channel member 80 retracts proximally relative to the stationary innerguide channel member 70 in order to expose and deploy the stent. Optionally, therestraint 93 may be radiopaque so as to aid in stent positioning within the vessel passageway at or near the target site within a patient. In one embodiment, an optionaldistal restraint 93′ is large enough to make sufficient contact with the loaded distal end of the stent to control axially distal movement of the stent. Similarly, in another embodiment the proximalsecond end portion 177 of an optionalatraumatic tip 170 controls the stent's distal axial movement. Indeed, because the medical device delivery system may be used for deploying an implantable prosthesis that comprises balloon expandable or non-expanding stents, prosthetic valve devices, and other implantable articles at a selected location inside a patient's body, theproximal restraint 93 anddistal restraint 93′ control the axial distal movement of the implantable prosthesis. Optionally, thedistal restraint 93′ and/oratraumatic tip 170 may comprise radiopaque materials so as to aid in stent positioning within the vessel passageway at or near the target site within a patient. -
FIG. 6 also illustrates that theinner compression member 41 and inner guide channel membersecond end portion 77 may be operatively coupled by any suitable means. In one embodiment, a melt bond 47 (described below) operatively couples an inner compression member distal mating end 48 (“mating end 48”) and thesecond end portion 77 of the innerguide channel member 70. Amelt bond 47 provides surface-to-surface contact between an outer engagingsurface 48′ of themating end 48 and the inner guide channelsecond end portion 77, thereby forming a more solid connection between theinner compression member 41 and the innerguide channel member 70. - In one embodiment, the inner compression member outer engaging
surface 48′ may form amelt bond 47 to aninner surface 101 of the inner guide channel membersecond end portion 77. Alternatively, the inner compression member outer engagingsurface 48′ may form amelt bond 47 to theouter surface 102 of the inner guide channelsecond end portion 77. In yet another embodiment, thedistal mating end 48 of a solidinner compression member 41 as shown inFIG. 6 is implanted 49 between (and/or melt bonded 47 between) inner andouter surfaces second end portion 77. In still another embodiment, an insert body operatively couples theinner compression member 41 and the second end innerguide channel member 70. - As used to describe an embodiment of the invention, melt bonding 47 (for shorthand purposes in describing embodiments according to the invention, melt
bonding 47 includes implanting 49) comprises any suitable means for melting, liquefying, making semi-molten, making molten, softening, making tacky, fusing, or making malleable, pliant, supple, moldable, ductile, or otherwise penetrable by another component or fused to melt bonding material comprising the other element. For instance, meltbonding 47 involves bringing two components together at an interface, wherein one (or preferably both) of the component interfaces are in the melted state. Strictly speaking,true melt bonding 47 requires that both of the components be melted at the interface and that they may be sufficiently chemically and physically compatible such that they fuse together upon cooling. - The melt bonding materials comprising the two components may be the same or substantially same materials. In the alternative, the melt bonding materials may be different, so long as they have substantially similar melting points at standard atmospheric pressure such that the materials soften (or liquefy) under heat and thereby fuse together in a solid
state melt bond 47 joining the first and second melt bonding materials of the components. If the materials had melting points that were too different, then one material may degrade or burn and the like before the second material begins to melt. -
Melt bonding 47 may be single layer interface whereby one component interface/surface mates to a second component interface/surface, or may be multi-layer interface whereby one component is implanted 49 into a second component and then surrounded by the second component. The chemical compatibility can best be expressed in terms of having similar values for surface energy and/or solubility parameter. In simple terms, similar materials tend to have a mutual affinity and a greater propensity to adhere to one another than do dissimilar materials. Melt bonding includes bonding whereby one component is melted while the other component is at or above its melting point. - Melt bonding materials may have different “melt bonding” temperatures at which they soften and become almost tacky without substantial degradation. Melt bonding materials are available from vendors, including Zeus, Inc. in Orangeburg, S.C. for instance; Cobalt Polymers in Cloverdale, Calif.; and under the trade name of Pebax® PEBA from the Arkema Group. The melt bonding materials may include one or a combination of a class of suitable materials comprising nylon, nylon natural tubing, polyether block amide, polyetheretherketone, thermoplastic, acrylonitrile-butadiene-styrene copolymer, polypropylene, polyamide, ionomer, polycarbonate, polyphenylene oxide, polyphenylene sulphide, acrylic, liquid crystal polymer, polyolefin, polyethylene acrylate acid, polyvinylidene fluoride, polyvinyl, and polyvinyl chloride.
- In one embodiment, PEEK material is used for the melt bonding material. PEEK melts at about 633° F., so the material may be heated from about 628° F. to about 638° F. For instance, a radiofrequency loop heater may be used for heating the melt bonding materials. Such a machine is available from Magnaforce, Incorporated and sold under the name and model Heatstation 1500. Another such machine is available from Cath-Tip, Inc. and is sold under the model and name Cath-Tip II. There is a rise dwell and cool down time for the process. The total rise time is approximately 20 seconds and dwell time is approximately 10 seconds. During the dwell time the temperature is approximately 600° F. In one embodiment where nylon or PEBA are used, heating is at about 400° F., with dwell time of about 10 seconds.
-
FIGS. 6A and 6B present a schematic representation of across section 105 of components before and after melt bonding according to one embodiment of the invention. Thecross section 105 ofFIG. 6A , for example, represents aninner component 106, amiddle component 107, and anouter component 108. While all components are shown having interfaces in abutting physical contact, they need only be close enough to form a melt bond therebetween. Indeed, as previously explained in connection with the Flexor® sheath'souter layer 42 andinner layer 44, there may even be a middle layer comprising acoil 43 havingspacings 43′ through which the melt bonding material of theouter layer 42 may move to be into contact with theinner layer 44. - In the example represented in
FIG. 6A , the middle andouter components middle component 107 comprises a firstmelt bonding material 109 while theouter component 108 comprises a secondmelt bonding material 109′, which may be the same material or may be separate materials that have similar melting points at atmospheric pressure. -
FIG. 6B shows some of the firstmelt bonding material 109 of themiddle component 107 moving into some of the secondmelt bonding material 109′ of theouter component 108. Likewise, some of the secondmelt bonding material 109′ of theouter component 108 moves into some of the firstmelt bonding material 109 of themiddle component 107. It should be noted that both of the first andsecond materials second materials outer layer 42 may melt to the middle layer coil 43 (which has not melted) and bond to the outer surface of theinner layer 44 with or without the outer surface of theinner layer 44 melting into theouter layer 42. -
FIG. 6B further shows that the first and secondmelt bonding materials middle component 107 and theouter component 108 or other components that have been melt bonded, upon cooling to solid state will form amelt bond 47 operatively coupling the components and/or the melt bonding materials that comprise the components. This results in additional strength and helps to form a more solid connection to the melt bonded components, because a solid-state bond results from using a suitable form of heat for melting and solidifying (e.g., fusing and/or cross-linking bonds formed at the melt bonded material interfaces). -
FIG. 7 illustrates a schematic view showing an alternative embodiment of adistal portion 13 of a delivery system for the rapid insertion of stents comprising an innerguide channel member 70, an outerguide channel member 80 axially slideable relative to the innerguide channel member 70, a deployment device mounting region 90 (e.g., a stent mounting region), and atransition region 60. Like elements from the previous drawings, embodiments, and description from above are labeled the same. In this embodiment, theinner compression member 41 optionally comprises a passageway 45 (e.g., hollow, having a lumen) that facilitates the conveyance, ventilation, flow, movement, blockage, evacuation, or regulation of medication and/or fluids or accommodates the insertion of a diagnostic, monitoring, scope, or other instrument. - The tubular
inner compression member 41 may have a uniform inside diameter ranging from about 0.0527 to about 0.132 inches. The wall thickness of the tubularinner compression member 41 is approximately 0.0015 inch. These dimensions are illustrative only, and the inner diameter and wall thickness may be constructed to be of any size necessary to accomplish the purposes for which the delivery system is to be employed (i.e., limited by the vessel passageway or working channel in which the device is to be used). - In addition, this
inner compression member 41 has an optional distal one-way valve 61. Thus, thevalve 61 may serve a dual function. First, a one-way valve is relatively resistant to contamination from bodily fluids entering the innercompression member passageway 45. Second, it allows the movement of medication and/or fluids to exit distally theinner compression member 41passageway 45 at or near thetransition region 60 and may direct medication and/or fluids into the innermember guide channel 71 and/or the outermember guide channel 81. - Indeed, the inner
compression member passageway 45 may facilitate using the medical device delivery system for deploying an implantable prosthesis that comprise balloon expandable stents, prosthetic valve devices, and other implantable articles (individually and collectively, “stent”) at a selected location inside a patient's body. The stent is disposed at the deploymentdevice mounting region 90 intermediate theproximal restraint 93 anddistal restraint 93′ to control the axial distal movement of the implantable prosthesis. - In one embodiment for using the delivery system with a balloon expandable implantable prosthesis, the inner compression member distal mating end
portion engaging surface 48′ operatively couples to the inner guide channel member outer surface 102 (or is welded to an outer surface of a metal cannula that has the inner guide channel membersecond end portion 77 glued within the cannula lumen), and an inflation member (e.g., a balloon) extends distally from the inner compression member distal mating end portion and is disposed over theproximal restraint 93 and distally about theplatform 91 of thestent mounting region 90 such that the balloon is located under the stent. The stent is positioned within the vessel passageway at or near the target site within a patient, wherein theouter sheath 50 and outerguide channel member 80 is axially slideable relative to theinner compression member 41 and innerguide channel member 70 upon corresponding axial slideable movement of thehandle 30, thereby exposing and, ultimately, deploying the stent from thestent mounting region 90. Thestylet 20 may be adapted to receive a syringe for allowing inflation fluid, such as saline, to travel from and through theproximal end 40 of theinner compression member 41 and out thevalve 61 at thedistal end portion 48 in order to fill the inflation chamber of the balloon. Therefore, balloon expands under the stent and, as a result, the stent expands radially to plastically deform the stent into a substantially permanent expanded condition. The physician then deflates the balloon and removes the innerguide channel member 70 and remainder of the delivery system from the patient's body. This description of using the delivery system for balloon expandable implantable prosthesis is given by way of example and not by way of limitation. Alternatively, a tubular inflation fluid carrying device is in theouter sheath passageway 59 and extends from the systemproximal portion 12 to the systemdistal portion 13 and operatively couples to an inflation member disposed under the stent. - In one embodiment of the
distal portion 13 of a delivery system illustrated inFIG. 7 , an internal joint 46 comprises amelt bond 47 that operatively couples the inner guide channel member distalmating end portion 48 and thesecond end portion 77 of the innerguide channel member 70. For example, the inner compression member outer engagingsurface 48′ may form amelt bond 47 to the inner surface 101 (or alternatively to the outer surface 102) of the inner guide channel membersecond end portion 77, as taught above. - The embodiment shown in
FIG. 7 also illustrates that theexit ports FIG. 4 they slope over a longer overall axial length to aid the wire guide in exiting the inner member and outer member, respectively. Furthermore, theexit port 83 thereby has longer axiallateral walls middle section 14 and to run along the outside of theouter sheath 50. - Moving to the
atraumatic tip 170 as illustrated inFIG. 7 , this is a little less arrowhead-shaped compared to theatraumatic tip 170 shown inFIG. 6 . Instead, the atraumatic tip inFIG. 7 has asecond end portion 177 that comprises a right cylindrical tubular configuration. Furthermore, the sides of the atraumatic tipsecond end portion 177 are more uniformly parallel and do not form a proximal stop against the outer guide channel memberdistal opening 89 as in a beveled embodiment of the atraumatic tipsecond end portion 177 as illustrated inFIG. 6 . The atraumatic tipsecond end portion 177 optionally comprises a stentdistal restraint 93′ for controlling distal axial movement of the implantable prosthesis when the medical device delivery system is used for deploying balloon expandable or non-expanding stents, prosthetic valve devices, and other implantable articles at a selected location inside a patient's body. - Turning now to
FIG. 8 , that figure shows a partially sectioneddistal portion 13 in accordance with an embodiment of the device according toFIG. 7 with awire guide 16 inserted therein. In a back-loading procedure, thewire guide 16 enters theguide channel 171 of theatraumatic tip 170 and travels proximally toward the innerguide channel member 70. Thewire guide 16 then enters the innermember guide channel 71 and travels proximally toward the outerguide channel member 80 via theentry port 82 and enters the outermember guide channel 81 and out theexit port 83. The less common front-loading procedure could be described as above but conversely stated. - In
FIG. 8 , the inner andouter guide channels distal portion 13. Because thechannels wire guide 16 moves through the innermember guide channel 71 to the outermember guide channel 81 and out the outer guide channelmember exit port 83 at or near the breech position opening 65 with relatively little kinking, bending, buckling, or bowing. It should be noted that for the ease of showing thewire guide 16, thewire guide 16 proximal to theexit port 83 is shown slightly offset fromouter sheath 50, though thewire guide 16 may actually run along the outside of theouter sheath 50 or in a groove (not shown) in theouter sheath 50. -
FIG. 9 illustrates a longitudinally sectioned side view showing an alternative embodiment of adistal portion 13 of a delivery system for the rapid insertion of stents comprising an innerguide channel member 70, an outerguide channel member 80 axially slideable relative to the innerguide channel member 70, a deployment device mounting region 90 (e.g., a stent mounting region), and atransition region 60. Like elements from the previous drawings, embodiments, and description from above are labeled the same. This embodiment represents an alternative embodiment of a joint 46 for operatively coupling theinner compression member 41 and innerguide channel member 70 with acannula 95. - In one embodiment, the
cannula 95 is a hollow, rigid tube, cylinder, ring, cannula (with or without a trocar), or other coupling device comprising metal such as medical grade stainless steel or super-elastic alloys (e.g., nitinol) to name but a few non-limiting examples. In one embodiment, thecannula 95 comprises a generally right cylindrical configuration or is elliptical, hyperbolic, parabolic, curved, polygonal, rectangular, or irregular in shape or cross section. Thecannula 95 is sized for receiving the inner guide channelsecond end portion 77 and/or the inner guide channel second end portionouter diameter 75. Theouter surface 102 of the inner guide channelsecond end portion 77 is operatively coupled to an inner engaging surface of the securingbody 95 by glue, adhesives, resins, chemical bonding materials or combinations thereof and the like (collectively and individually, “glue”). By way of example only, the glue may be Loctite 4061 instant adhesive, formulated to polymerise rapidly in thin films between two surfaces to form rigid thermoplastics. Loctite 4061 instant adhesive is a medical device adhesive particularly suitable for a wide variety of substrates such as rubber, plastics, and metals, ant it is available from the Loctite Corporation. - In addition to securing the
outer surface 102 of the inner guide channel membersecond end portion 77 to an inner engaging surface of thecannula 95, thecannula 95 also operatively couples the inner guide channel member distalmating end portion 48. An outer engagingsurface 48′ of themating end portion 48 is in an abutting relationship (e.g., touching, in contact directly or by intervening parts, or adjacent) to an outer engaging surface of thecannula 95, and themating end portion 48 andcannula 95 are operatively coupled by any suitable means, including but not limiting to welding, soldering, brazing, or fusing. Soldering and brazing are used if a semi-permanent connection between the distalmating end portion 48 and thecannula 95 is desired, because solder or braze metals have a lower melting point than the metals that are joined. Thus, when sufficient heat is applied to melt the solder or braze metal, they form an alloy with the surfaces of themating end portion 48 and thecannula 95 and, upon solidification, thus form a joint that can be unfastened during manufacturing (e.g., to redo in the event of a poor connection) by reheating without destroying the parts that have been joined. In contrast, welding involves melting the outer engagingsurface 48′ of themating end portion 48 and an outer engaging surface of thecannula 95 at the interface, or involves combining temperature and pressure so as to cause localized coalescence. Consequently, in most instances higher temperatures are involved than for soldering, and the union is permanent. - Where the inner compression member distal
mating end portion 48 and thecannula 95 are connected, an optional tube may be disposed about the joint 46. The tubing has the advantage of minimizing some of the sharp edges created by a welded, soldered, or fused joint. In one embodiment, the tube is a melt bonding tube disposed about and melt bonded to the joint 46. WhereasFIG. 9 shows the distal most tip of the distalmating end portion 48 flush with (e.g., substantially co-planar) the distal end portion of thecannula 95, it may alternatively be set back approximately 0.5 mm proximally from the distal end portion of thecannula 95. The set back arrangement allows solder, weld, or fusion to form a smooth transition and fill the space between that distal end tip and thecannula 95. This would also minimize the profile compared to placing more of a circumferential solder, weld, or fusion about the joint. - According to
FIGS. 9, 9A , 9B, and 9C, the distalmating end portion 48 comprises a contouredconfiguration 48″ that is complementary to an outer engagingsurface 95′ of thecannula 95. Thus, in an embodiment comprising acannula 95 that is curved or otherwise circular in cross-section, thenFIG. 9A shows that the contouredconfiguration 48″ is fluted so that the outer engagingsurface 48′ is capable of being in an abutting relationship (e.g., touching, in contact directly or by intervening parts, or adjacent) relative to a curved or circular outer engagingsurface 95′ of thecannula 95. A fluted contouredconfiguration 48″ comprises any curved, shoehorn shape, celery shape, semicircular shape, crescent shape, wishbone shape, saddle shape, C-shaped, V-shaped, U-shaped, or other arcuate configuration. In another embodiment, an outer engagingsurface 95′ of thecannula 95 could have a flat portion, andFIG. 9B shows that the contouredconfiguration 48″ is likewise flat so that the outer engagingsurface 48′ is capable of being in an abutting relationship (e.g., touching, in contact directly or by intervening parts, or adjacent) relative to the flat portion of the outer engaging surface of thecannula 95. Even when the outer engagingsurface 95′ of thecannula 95 is curved or circular in cross section, however,FIG. 9C shows that the inner compression member contouredconfiguration 48″ could be flat, because the soldering, brazing, or fusing may fill in the space between the outer engagingsurface 48′ and a tangent that theflat configuration 48″ forms to the curved portion of theouter surface 95′ of thecannula 95. Similarly, if welding 96 is used, then theflat configuration 48″ will form to a curved or circular outer engagingsurface 95′ of thecannula 95. - In addition, the contoured
configuration 48″ maintains low profile, high-strength, and flexibility of the connection between the inner compression member distalmating end portion 48 and thecannula 95. The contouredconfiguration 48″ is in contrast to a rounded inner compression member distalmating end portion 48, which would have a greater diameter at the connection between the inner compression member distalmating end portion 48 and thecannula 95. - In order to create the contoured
configuration 48″, the inner compression member distalmating end portion 48 may be formed, sheared, casted, or molded. By way of example only, forming can be done both hot and cold (except for stamping, which is always done cold) in order to modify the shape and/or physical properties of the material comprising the inner compression member distalmating end portion 48. Common forming processes include rolling the distal mating end portion 48 (between one or two rollers), stretching, forging, straight bending, and stamping. -
FIGS. 10 and 11 illustrate an alternate embodiment of adistal portion 13 of a delivery system for the rapid insertion of self-expanding stents during deployment of a stent. InFIG. 8 , thedistal portion 13 is in an un-deployed position, whileFIG. 9 depicts thedistal portion 13 in a deployed position after proximal retraction of an outerguide channel member 80 relative to the innerguide channel member 70. In other words, thewire guide 16 both enters thedistal portion 13 and exits thedistal portion 13 of the delivery system at a substantially straight path so as to minimize kinking of the wire guide, and then runs proximally along the outside surface of theouter sheath 50. The outerguide channel member 80 has a stepped profile comprising a first outer diameter and a proximal second smaller outer diameter in order to maintain a low profile at the transition region, as has been previously describe in detail in relation toFIGS. 6, 7 , 8, and 9. Moreover, aguide 51 helps to align the wire guide as it exits thedistal portion 13. For example, theguide 51 may comprise a U-shaped recess or an eyelet for aligning and guiding the wire guide. Furthermore, anoptional groove 52 on the outside surface of theouter sheath 50 helps support the wire guide as it runs alongside the outside of the outer sheath. -
FIGS. 12, 13A through 13C, and 14A through 14F show embodiments (by way of illustration and not by way of limitation) of several partial schematic cross sectional views ofFIGS. 10 and 11 .FIG. 12 is a cross sectional schematic view of thestent mounting region 90 taken along lines 12-12 ofFIG. 10 .FIG. 12 shows aguide wire 16 along a longitudinal axis (in the plane of the paper) of the tubularstent mounting region 90 and within the innerguide channel member 70. Astent 17 surrounds the innerguide channel member 70, and in turn an outerguide channel member 80 covers thestent 17. -
FIGS. 13A through 13C are cross sectional schematic views taken along lines 13-13 ofFIGS. 10 and 11 .FIG. 13A shows aninner compression member 41, which comprises an elongated pusher bar, stiffening member, or stiff polymer that helps to “push” the stent out at or near thedistal portion 13 by preventing prolapse, recoil, kinking, or movement (collectively, “prolapse”) of the innerguide channel member 70 relative to the outerguide channel member 80 during proximal retraction of the outer member to deploy self-expanding stent. While theinner compression member 41 is depicted at about 6 o'clock, that position is only illustrative, and can be located elsewhere within the boundary defined by the outerguide channel member 80. Theinner compression member 41 may also have other configurations. By way of illustration, those configures include a winged-shapedinner compression member 41 as inFIG. 13B , or a “D-shaped”inner compression member 41 as inFIG. 11C for bonding and for an increased lumen area for higher flow with injecting fluids (the characteristics of which are described below in more detail). -
FIGS. 14A through 14F are alternate illustrative embodiments of cross sectional schematic views taken along lines 14-14 ofFIGS. 10 and 11 . These figures show various embodiments of several features, including additional embodiments of theinner compression member 41, anoptional guide 51, and various embodiments of theguide channels outer members inner compression member 41 embodiments. - By way of illustration and not by way of limitation,
FIGS. 14A through 14F depict aninner compression member 41, such as a pusher bar, of different configurations. InFIGS. 14A, 14B , and 14E, for instance, theinner compression member 41 is a pusher bar represented as a rod-like structure having a generally circular cross section. However, theinner compression member 41 may also assume other configurations, such as a semicircular shape (FIG. 14C ), an arcuate shape (FIG. 14D ), a crescent shape (FIG. 14F ), or the winged-shape or “D-shaped” previously discussed in connection withFIGS. 13B and 13C , respectively, to name a few examples of alternate configurations. These configurations help to provide aninner compression member 41 with increased column strength guarding against prolapse and having a low profile. - More specifically,
FIG. 14A depicts anoptional guide 51, which can take on numerous configurations so as to achieve the function of aligning the wire guide as it exits proximally thedistal portion 13, such as a saddle or a shelf shape (FIG. 14A ) or a butterfly or dog bone shape (FIG. 14B ) to name a few. Additionally, it should be understood inFIG. 14A that the saddle groove of theguide 51 could abut the inner compression member 41 (e.g., pusher bar) and allow limited passage of thewire guide 16. - Likewise, the
guide channel 71 of the innerguide channel member 70 and theguide channel 81 of the outerguide channel member 80 may assume numerous configurations to ensure a low profile at the distal end, and to guide thewire guide 16. These configurations include but are not limited to spherical, elliptical, crescent, saddle, slit, or wishbone shapes, such as by way of illustration theco-axial channels FIG. 14C , agroove guide channel 71 leading to the interior lumen ofchannel 81 as shown inFIG. 14D , or thechannels FIG. 14E . Additionally, the diameters ofchannels -
FIG. 15 is an alternate illustrative embodiment of a cross sectional schematic view taken along lines 15-15 ofFIGS. 10 and 11 (absent the wire guide 16). This figure shows aninner compression member 41 and anouter sheath 50. Furthermore,FIG. 15 illustrates anoptional groove 52 on the outside surface of theouter sheath 50 to help the wire guide run proximally alongside the outside of the outer sheath. -
FIG. 16 is an alternative embodiment of an outerguide channel member 80 used in a delivery system for the rapid insertion of self-expanding stents during deployment of a stent. The outerguide channel member 80 is tubular and includes a wireguide entry port 82 and a breech position opening 65 comprising a proximal wireguide exit port 83, the entry and exit ports defining aguide channel 81 of the outerguide channel member 80. Theexit port 83 in this embodiment is slanted. The outerguide channel member 80 has a stepped 84, 85 profile comprising a firstouter diameter 84 and a second smallerouter diameter 85 located proximal to the larger firstouter diameter 84. The second smallerouter diameter 85 offsets the added diameter of the wire guide as it leaves theexit port 83 and runs proximally alongside the outside of the outer sheath, thereby maintaining a negligible dimension to the profile, which is a particular advantage in procedures involving narrow vessel passageways. -
FIG. 17 is an alternative embodiment of an innerguide channel member 70 used in a delivery system for the rapid insertion of self-expanding stents during deployment of a stent. The innerguide channel member 70 in this embodiment is tubular and has adistal arrowhead tip 70′ that is rounded and chamfered to be better tolerated by the patient. Formed from a suitable material (discussed above), thedistal tip 70′ is soft, rounded, and flexible so as to provide further safety to the patient. The innerguide channel member 70 has a wireguide entry port 72 and a proximal wireguide exit port 73 that define aguide channel 71. Theexit port 73 in this embodiment is transverse to aninner compression member 41 and attached thereto by any suitable means, such as welding, brazening, adhesives, wires, chemical cross-linking, heat source, light source, radiofrequency, lasering, or other energy source for attaching the innerguide channel member 70 to theinner compression member 41. -
FIG. 18 shows a schematic sectional side view of an alternative embodiment of adistal portion 13 of a delivery system for the rapid insertion of self-expanding stents. This embodiment further comprises apuller 54. Furthermore, this embodiment comprises an innerguide channel member 70, an outerguide channel member 80 axially slideable relative to the innerguide channel member 70, and astent mounting region 90 sandwiched between the inner and outerguide channel members member guide channels wire guide 16 moves through theguide channel 71 to the outermember guide channel 81 and out the outermember exit port 83, and thereby egresses the breech position opening 65 (e.g., rear, back, or proximal part of the distal portion 13) with relatively little kinking, bending, buckling, or bowing. The breech position opening 65 is oversized to facilitate thewire guide 16 exiting thedistal portion 13 with relatively little kinking, bending, buckling, or bowing. - The
puller 54 of the embodiment of thedistal portion 13 ofFIG. 16 has a low profile relative to the firstouter diameter 84 and a second smallerouter diameter 85 sufficient to provide a stiffening element, a tension element, and an occlusion element. Optionally, thepuller 54 is sandwiched between anouter surface 47 of theinner compression member 41 and an inner surface 57 of theouter sheath 50. Also, thepuller 54 may be unattached but wedged nearly immovably between the compression memberouter surface 47 and the outer sheath inner surface 57, or it may be attached by mechanical structures, chemical bonding materials, and welding materials or combinations as described above in connection with thebridge 100. Optionally, thepuller 54 is tubular and surrounds a portion of theinner compression member 41, in which case thepuller 54 may have a plurality of thicknesses sufficient to lift theinner compression member 41 and occlude thewire guide 16 from entering apassageway 45 of theinner compression member 41 or a gap 55 (as described below). Furthermore, thepuller 54 may be a cutout ring, with the cutout located on the portion of the puller closest to theexit port 83. In yet another embodiment, thepuller 54 comprises a protuberance that lifts theinner compression member 41 and thereby occludes thewire guide 16 from theinner compression member 41passageway 45 or a gap 55 between the outer sheath inner surface 57 and the compression memberouter surface 47. - The
puller 54 may vary in length and height. The length may vary from about 1 to 10 cm, from about 2 to 6 cm, and in one embodiment has a length of approximately 5 cm. Optionally, the puller could run approximately the length of the middlesection delivery device 14, or about 125 cm, so long as the puller height increases at or near the proximal wireguide exit port 83 of the outerguide channel member 80 to lift theinner compression member 41 and occlude thewire guide 16. The overall height, as measured from a longitudinal axis of thedistal portion 13 at or near theexit port 83, also may vary. In one embodiment, the height approximately equals or slightly exceeds the absolute difference between theouter diameter 84 and theinner diameter 85. In another embodiment, the height is from about 0.2 French to about 2.0 French, and in another the height approximates 1 French. - As a stiffening element, the
puller 54 reduces the flexing, buckling, kinking, or bending of the distal end at or near theexit port 83. Moreover, thepuller 54 may be used where structural integrity is compromised, as in a case where theexit port 83 is a large longitudinal gap and reduced material, low profile, and circumference at the breech position opening 65 as shown inFIG. 20 . Optionally, the construction of abridge 100, as already explained, may be modified for apuller 54, which may comprise any suitable material used for a bridge. - As an optional occlusion element, the
puller 54 may lift the inner compression member or thewire guide 16 in order to ensure that thewire guide 16 does not enter a passageway 45 (e.g.,FIG. 7 ) of an inner compression member and/or the passageway 59 (e.g.,FIGS. 6, 7 , 8, 9) of theouter sheath 50. In other words, thewire guide 16 may unintentionally enter that inner compression member passageway 45 (e.g.,FIG. 7 ) or outer sheath passageway 59 (e.g.,FIGS. 6, 7 , 8, 9) as the wire guide exits proximally from the proximal wireguide exit port 83 of the outerguide channel member 80. By lifting the inner compression member and occluding the wire guide, thewire guide 16 exits thedistal portion 13 in a position exterior to theouter sheath 50. -
FIGS. 18 and 19 illustrate deployment of an embodiment of adistal portion 13 having apuller 54. InFIG. 19 , thedistal portion 13 is in an un-deployed position, whileFIG. 18 depicts thedistal portion 13 in a deployed position after proximal retraction of an outerguide channel member 80 relative to the innerguide channel member 70. Thewire guide 16 enters thedistal portion 13 and then exits from a breech position opening 65 of the delivery system at a substantially straight path so as to minimize kinking of the wire guide, and then runs proximally along the outside surface of theouter sheath 50. At or near theexit port 83, thepuller 54 produces a lift that causes thewire guide 16 to be guided toward theexit port 83 and leave theouter guide channel 80. -
FIG. 20 shows an embodiment of an outerguide channel member 80 used in adistal portion 13 havingpuller 54. The outerguide channel member 80 comprises a wireguide entry port 82 and a proximal wireguide exit port 83 defining aguide channel 81. The outerguide channel member 80 has a firstouter diameter 84 and a proximal second smallerouter diameter 85 at or near thebreech position opening 65. Theexit port 83 in this embodiment is sloped in this embodiment, although any of the previously discussed configurations would be suitable. Thepuller 54 is positioned at or near theexit port 83 and extends proximal thereto a length as previously described. -
FIG. 21 shows an embodiment of an innerguide channel member 70 used in adistal portion 13 having apuller 54 according toFIGS. 18-20 and aninner compression member 41. The puller lifts the distal end of theinner compression member 41 at anoptional ramp 61 of a slight angle or grade in atransition region 60. This lift helps to ensure that theguide channel 71 of the innerguide channel member 70 is approximately aligned and substantially coaxial with the outermember guide channel 81 and/or the exit port 83 (FIGS. 18-20 ). Alignment helps to facilitate transition of the wire guide and to direct the wire guide from the outer member wireguide entry port 82, through theguide channel 81, and toward the breech position opening 65 located at or near the rear, back, or the proximal part of the outer membersecond end portion 87 as illustrated inFIGS. 18, 19 , and 20. -
FIG. 22 shows still another embodiment of a delivery system having a breech position opening 65 for the rapid insertion of self-expanding stents. This embodiment has several features that add to the utility and ease of aspirating thestent mounting region 90 where a stent is positioned about astent platform 91 on the outside surface located at or near the distal end of the innerguide channel member 70 intermediate distal tip of the inner member and aproximal restraint 93, and is sandwiched between theplatform 91 and theinner surface 92 of the outerguide channel member 80, which controls premature deployment of the stent. - In this embodiment, the
distal portion 13 of the device comprises a venting structure. A flushingport 94 is positioned at the distal portion of thestent mounting region 90 to aspirate air out from inside the delivery system and from around the outerguide channel member 80, thereby reducing the chance of air embolisms. In addition, there may be a flushingpathway 74 in theouter diameter 75 of the inner member between thestent platform 91 and the proximal wireguide exit port 73, thereby improving flow of air out of the system in the area of the stent during air aspiration. Also, the flushingport 94 may be formed in the outerguide channel member 80 intermediate thestent mounting region 90 and theexit port 83. Furthermore, the outer guide channelmember exit port 83 may comprise aslit 186 for the wire guide to exit thedistal portion 13. In one embodiment, the distal end of theinner compression member 41passageway 45 may comprise avalve 61 such as a simple flap or diaphragm type valve as previously explained for purging air from the interior of the delivery system in the area of the stent, and in a closed position may also act as an optional guide to direct the wire guide toward theslit 186. It should be understood that these venting structures are optional, and that the device may include one or more of these structures. -
FIGS. 23A and 23B are cross sectional schematic views taken along lines A-A and B-B, respectively, ofFIG. 22 .FIG. 23A shows an outerguide channel member 80, an innerguide channel member 70 having achannel 71, and alongitudinal groove vent 74 in the outer diameter of the innerguide channel member 70.FIG. 23B shows a cross sectional view of theinner compression member 41 defining apassageway 45, the outerguide channel member 80 having aguide channel 81, and aslit 186 formed in the outerguide channel member 80. The structures ofFIGS. 23A and 23B are illustrative, and alternative structures consistent with the venting feature ofFIG. 22 are contemplated as being within this description. -
FIG. 24 is a schematic side view of an alternative embodiment of an elongateinner compression member 41 at or near a distal portion of a delivery system having a breech position opening for the rapid insertion of self-expanding stents. The distal end of theinner compression member 41 has an increasing degree of flattening at or near theexit port 83 so as to allow bending and room for the wire guide to pass. - The
inner compression member 41 may have the dimensions (diameter, length) a previously described. Similarly, theinner compression member 41 may comprise the materials as previously described. In one embodiment, theinner compression member 41 comprises aproximal end 40, amiddle section 40′, and adistal mating end 48 having an outer engagingsurface 48′. Like elements from the previous drawings, embodiments, and description from above are labeled the same. - The overall length of the
distal mating end 48 may vary. In one embodiment, it is from about 1.0 mm to about 10.0 mm. In another embodiment, thedistal mating end 48 is approximately 3.0 mm. Furthermore, thedistal mating end 48 optionally comprises a decreasing height 148 (FIGS. 24, 24B ) discussed below. The decreasingheight 148 may extend along the length of thedistal mating end 48 to the distal mating end outer engagingsurface 48′ and/or to a contouredconfiguration 48″ that is described below. In one embodiment, the decreasingheight 148 occurs along a length of about 3.0 mm, while in another embodiment the decreasingheight 148 occurs over a much shorter length, such as approximately 0.5 mm. The contouredconfiguration 48″ and outer engagingsurface 48′ may occur along the entire length of thedistal mating end 48 or the decreasingheight 148. Alternatively, thedistal mating end 48 has a decreasingheight 148 down to the contouredconfiguration 48″ and outer engagingsurface 48′, and in one embodiment the decreasingheight 148 is about 0.5 mm in length while the contouredconfiguration 48″ and outer engagingsurface 48′ may extend distally from the decreasingheight 148 and measure approximately 2.5 mm in length, for adistal mating end 48 that is approximately 3.0 mm in overall length. -
FIGS. 24A and 24B show cross sectional views ofFIG. 24 taken along thelines 24A-24A and 24B-24B, whereby theinner compression member 41 inFIG. 24A has an approximate height (e.g., outer diameter or thickness) of approximately 0.024 inches andFIG. 24B shows an embodiment of a decreasingheight 148 from less than about 0.24 inches to greater than about 0.08 inches, and in one embodiment the decreasingheight 148 is approximately 0.016 inches from top 148′ tobottom 148″. The term “decreasing height” and variations thereof describe embodiments of the invention, rather than any lexicographic definition. For instance, the inner compression memberdistal mating end 48 may gradually decrease from top 148′ tobottom 148″ over the length of themating end 48 in a variety of ways. In other words, thedistal mating end 48 may have a portion that becomes gradually lesser in height (FIG. 24B )—relative to the inner compression member 41 (FIG. 24A )—in the distal direction. A decreasingheight 148 may result from or be measured in a height, thickness, cross-section, diameter, width, and/or other configuration, shape, form, profile, structure, external outline, and/or contour that is lesser in height from the top 148′, from the bottom 148″, or as shown inFIG. 24B from both the top 148′ and the bottom 148″. It should be understood that the top 148′ and bottom 148″ may be relative, and the inventions includes without limitation an embodiment where top 148′ and bottom 148″ are viewed end-on, a side view, or any view along the x-axis and y-axis from 0 to 2π (e.g., including the top 148′ designated from 0 radians and bottom might be π radians). In one embodiment, the top 148′ is the portion facing the outer engaging surface 164 of the base securing section 154. - While the decreasing
height 148 may have a gradually smaller cross sectional area when compared to the cross sectional area at the inner compression member 41 (FIGS. 24, 24A ) that is proximal to thedistal mating end 48, the cross sectional area need not decrease. For example, the width might increase inversely proportional to the decrease in height as shown inFIG. 24B , although if desired the increased width could be cut away, machined, trimmed, chipped, planed, and the like. Also, this is not to say that thedistal mating end 48 may only decrease in height. Indeed, the decreasingheight 148 might extend to a position at or near the contouredconfiguration 48″, which might increase in height, such as with an upward curve or other configuration that reverses to form a fluted embodiment, a flare, or upward protrusion. Furthermore, thedistal mating end 48 may comprise more than one portion having a decreasing height, whereby thedistal mating end 48 decreases in height from top 148′ tobottom 148″, then increases in height from top 148′ tobottom 148″, only to decrease again along the length of thedistal mating end 48. - According to the invention, the inner compression member
distal mating end 48 and/or outer engagingsurface 48′ further comprise a contouredconfiguration 48″ that is generally complementary to the cannula 95 (e.g.,FIGS. 9, 9A , 9B, 9C) and/or the second end of the inner guide channel member (e.g.,FIGS. 6, 7 , 8, 9) as previously described.FIG. 24C , by way of example and not by way of limitation, an embodiment of a contouredconfiguration 48″ and an outer engagingsurface 48′ taken along theline 24C-24C. InFIG. 24C , the contouredconfiguration 48″ and outer engagingsurface 48′ are both flat. While the contouredconfiguration 48″ has decreased in height relative to theinner compression member 41 shown in the background with a circular cross section, the contouredconfiguration 48″ inFIG. 24C has an increased width. - The decreasing
height 148 and the contouredconfiguration 48″ may be achieved by swaging, stamping, forging, or rolling between two rollers. For example, rolling the shaft between rollers of a mill will help to prevent any lessening of strength (i.e., fatigue strength) that could result if the decreasingheight 148 and/or the contouredconfiguration 48″ were machined. It should be understood that the shape of theinner compression member 41 can be chosen depending on the shape of thecannula 95, the outerguide channel member 80, and/or the innerguide channel member 70, and the decreasingheight 148 and/or the contouredconfiguration 48″ (or other configurations) may vary along the longitudinal axis of theinner compression member 41. Furthermore, the degree of flatness of aninner compression member 41 can determine the flexibility in a certain direction. -
FIGS. 25A through 25C are schematic alternative embodiments of adistal portion 13 of a delivery system having a breech position opening 65 for the rapid insertion of self-expanding stents according to the invention. In these embodiments, thedistal portion 13 has a stepped 84, 85 profile comprising a firstouter diameter 84 and a second smallerouter diameter 85. Thedistal portion 13 further comprises an innerguide channel member 70, an outerguide channel member 80 axially slideable relative to the innerguide channel member 70, astent mounting region 90, and atransition region 60. -
FIGS. 25A and 25C show a two-piece embodiment of anouter sheath 50 and an outerguide channel member 80 joined by any suitable means as previously described. At or near thetransition region 60, the innerguide channel member 70 has aninner sheath flange 176 that engages the outer sheathouter edge 152 on the outside surface of theouter sheath 50 at an overlapping engagement region 160. Because theflange 176 andouter sheath edge 152 overlap at the overlapping engagement region 160, this arrangement facilitates awire guide 16 to run along the outside of the outer sheath instead of entering a lumen of the outer sheath or inner compression member lumen (not shown) of the outer sheath. During deployment, the length of the overlapping engagement region 160 will diminish as the outer guide channel member withdraws proximally. In the non-deployed state, the overlapping engagement region 160 ofFIG. 25A has a lesser length than that region 160 ofFIG. 259B . Therefore, thedistal portion 13 ofFIG. 25A should have a reduced length relative to thedistal portion 13 ofFIG. 25B . -
FIG. 25C shows an integralouter sheath 50 and outerguide channel member 80 formed from a continuous tube with a firstouter diameter 84 and a second smallerouter diameter 85. LikeFIGS. 25A and 25B , at or near thetransition region 60, the innerguide channel member 70 has aninner sheath flange 176 that engages the outer sheathouter edge 152 on the outside surface of theouter sheath 50 at an overlapping engagement region 160. - Methods
- Methods of manufacturing and of providing a medical device for delivering a self-expanding stent are also provided.
-
FIG. 26 shows a block diagram illustrating amethod 300 of providing (step 302) adelivery system 10 for the rapid insertion of self-expanding stents comprising a systemproximal portion 12; a middlesection delivery device 14; and a systemdistal portion 13 having an innerguide channel member 70 with aguide channel 71, an outerguide channel member 80 axially slideable relative to the innerguide channel member 70 and having aguide channel 81 arranged relative to the innermember guide channel 71 to reduce any bending of the wire guide as the wire guide moves proximally from the innermember guide channel 71 to the outermember guide channel 81, and a stepped 84, 85 profile; and wherein the systemdistal portion 13 further comprises a self-expanding deployment device mounting region 90 (e.g., a stent mounting region), atransition region 60, and aproximal breech opening 65 located at or near the rear, back, orproximal part 87 of thedistal portion 13. A self-expandingdevice 17 is loaded (step 304) into a radially compressed state at thestent mounting region 90. Thedistal portion 13 is slid over (step 306) a guiding device such as a wire guide, catheter, and the like either by back-loading or front-loading. The outerguide channel member 80 is retracted (step 308) proximally relative to the inner member so as to deploy thestent 17. -
FIG. 27 is a block diagram illustrating amethod 400 of manufacturing the invention as an alternative to purchasing the inner and outerguide channel members outer sheath 50 from Cook Incorporated. A first rectangular sheet 401 and a second rectangular sheet 401′ of inner andouter member guide channel member 70 having anentry port 72 at afirst end portion 78 and anexit port 73 at asecond end portion 77, theports guide channel 71, and a self-expanding deployment device mounting region 90 (e.g., a stent mounting region) intermediate the first andsecond end portions guide channel member 80 having anentry port 82 at a first end portion 88 (side D) andexit port 83 at a second end portion 87 (side C), theports guide channel 81, with the outer member having a stepped 84, 85 profile, whereby the outer member comprises a greater firstouter diameter 84 at thefirst end portion 88 and a second smallerouter diameter 85 located at or near the outer membersecond end portion 87. Alternatively, when joining opposing sides of a rectangular sheet, features such asentry ports exit ports channels member exit port 83, may be stamped or cut away from the sheet after joining the edges (e.g., sides) of the sheet. The inner member is slidably joined (step 408) within the secondmember guide channel 81. In all of these manufacturing methods, the inner andouter members -
FIG. 28 is a block diagram illustrating amethod 500 of manufacturing a sheath for use with the middlesection delivery device 14 and/ordistal portion 13, as another alternative to purchasing theouter sheath 50 or the inner and outerguide channel members section delivery device 14 ordistal portion 13 from a sheet of material (such as a material comprising Teflon) consistent with theouter sheath 50 or one of themembers inner layer 44 may be formed into a tubular body on a mandrel and then heated in an oven while inside a shrink tube. (Step 502). After cooling, the shrink tube is peeled off and, if the tubular bodyinner layer 44 is to be used as aninner compression member 41 or an innerguide channel member 70, the mandril is removed. For assembling the outer sheath or the outerguide channel member 80, the tubular bodyinner layer 44 is left on the mandril while acoil 43 is wrapped around the tubular bodyinner layer 44. (Step 504). A sheet of material for theouter layer 42 is then formed around thecoil 43 layer of the tubular bodyinner layer 44, and the mandril pulled out. (Step 506). In order to assemble an outerguide channel member 80 with an eccentric stepped 84, 85 profile (i.e., a reduction in outer diameter) in the area of the proximal wire guide exit hole (e.g., the exit port 83), the outerguide channel member 80 is formed from material ofinner layer 44 on a mandril having alarger diameter 85 for afirst end portion 88 and a second mandril having a smaller diameter 84 (or one mandril of thesediameters 85, 84) according to theSteps 502 and 504 (thecoil 43 step). Then, anouter layer 42 of material, such as a Nylon and/or PEBA overcoat, is extended across the mandrel outer diameter and across a step down diameter (i.e., the second smallerouter diameter 85 relative to the first outer diameter 84) at the proximal end of the mandrel, the assembly is heated and shrunk together and, once cooled, the mandril pulled out, and thesecond end portion 87 cut, machined, or milled in order to provide the outer member wireguide exit port 83 and the optionallateral walls guide channel member 80 that has the advantages of a reinforced type of restraining sheath in the area of the stent. Thus, outer guide channel member permits the wire guide to exit without adding to the diameter of the outer member and, in fact, presenting a lower profile at or near theexit port 83 of the outer member. -
FIG. 29 is a block diagram illustrating amethod 600 of manufacturing a delivery apparatus for the rapid insertion of self-expanding devices. A middlesection delivery device 14 having aninner compression member 41 andouter sheath 50 and apassageway 59 and having aninsert 130 comprising an outersheath mating portion 132 secured at or near an outer sheathdistal end 50′ and having an interfacingportion 134 and guide channel 133 (as described above and shown in the figures) is provided (step 602). Adistal portion 13 has an outerguide channel member 80 with asecond end portion 87 and an insert 120 comprising a distal insert mating portion 122 secured at or near an outer membersecond end portion 87 and having an interfacingportion 124 and guidechannel 81′ (as described above and shown in the figures) is provided (step 604), thedistal portion 13 further having an innerguide channel member 70 with anguide channel 71; the outerguide channel member 80 axially slideable relative to the innerguide channel member 70 and having aguide channel 81 and a stepped 84, 85 profile; a self-expanding deployment device mounting region 90 (e.g., a stent mounting region); atransition region 60; and aproximal breech opening 65 located at or near the rear, back, orsecond end portion 87 of thedistal portion 13. - Materials and methods of manufacturing a suitable middle
section delivery device 14 anddistal portion 13 are described in Published U.S. Patent Application 2004/0116833 (Koto et al.) and in U.S. Pat. No. 6,589,227 (Sonderskov Klint, et al.; Assigned to Cook Incorporated of Bloomington, Ind. and William Cook Europe of Bjaeverskov, Denmark). The contents of the patent and patent application are incorporated herein by reference. Examples further include a multifilar embodiment and a “Flexor® sheath” as described above and shown in the figures, or other component. Furthermore, the “Flexor® sheath,” manufactured and sold by Cook Incorporated of Bloomington, Ind., may be adapted for use with thedistal portion 13 and/or the middlesection delivery device 14. The Flexor® sheath, as previously described and shown in the figures above, may be provided for thedistal portion 13 and/or the middlesection delivery device 14. Instep 606, the insert interfacing ends 124, 134 are brought together (step 606). The interfacing ends 124, 134 are secured by a connector 110 (step 608). - A method of manufacturing and of providing a medical device for delivering a self-expanding stent need not be performed sequentially. For instance, in
method 300, a self-expandingdevice 17 may be loaded (step 304) before thedelivery system 10 is provided (step 302). Inmethod 400, the adjacent corners of side C of the second sheet 401′ may be cut and the opposing sides A and B joined (step 406) to form an outerguide channel member 80 before the inner member is formed by joining opposing sides A and B of the first sheet 401 (step 404). Inmethod 600, thedistal portion 13 may be provided (step 604) before providing the middle section delivery device 14 (step 602). - It is intended that the foregoing detailed description of the delivery system and devices for the rapid insertion of self-expanding stents be regarded as illustrative rather than limiting, and that it be understood that it is the following claims, including all equivalents, that are intended to define the spirit and scope of this invention. Terms are to be given their reasonable plain and ordinary meaning. Also, the embodiment of any figure and features thereof may be combined with the embodiments depicted in other figures. Other features known in the art and not inconsistent with the structure and function of the present invention may be added to the embodiments.
- While particular elements, embodiments and applications of the present invention have been shown and described, it will be understood, of course, that the invention is not limited thereto since modifications may be made by those skilled in the art, particularly in light of the foregoing teachings. Therefore, it is therefore contemplated by the appended claims to cover such modifications as incorporate those features which come within the spirit and scope of the invention.
Claims (25)
1. A delivery apparatus for the rapid insertion of medical devices, comprising:
a tubular inner guide channel member comprising a distal first end portion having an entry port and a proximal second end portion having an exit port and defining a guide channel therebetween that is sized to slidably receive a wire guide, a proximal stent restraint is disposed about and operatively coupled to the inner guide channel member intermediate the inner guide channel member first and second end portions, and a stent platform is disposed about the inner guide channel member distal the proximal stent restraint and proximal the inner guide channel member entry port; and
an outer guide channel member comprising a distal first end portion having a distal opening and proximal second end portion having an exit port and defining a guide channel therebetween, the inner guide channel member second end portion, the proximal stent restraint, and the inner guide channel member stent platform being positioned within the guide channel of the outer guide channel member intermediate the outer guide channel member distal opening and exit port, and the outer guide channel member being axially slideable relative to the inner guide channel member,
wherein the guide channel of the inner guide channel member and the guide channel of the outer guide channel member are substantially coaxially aligned,
wherein the outer guide channel member exit port is in fluid communication with the inner guide channel member exit port.
2. The device of claim 1 further comprising an atraumatic tip comprising a distal first end portion having an entry port and a proximal second end portion having an exit port and defining a guide channel therebetween, the atraumatic tip second end portion being operatively coupled to the inner guide channel member first end portion.
3. The device of claim 2 wherein the atraumatic tip guide channel is in fluid communication with the guide channel of the inner guide channel member
4. The device of claim 2 wherein the atraumatic tip second end portion forms a distal stent restraint of the inner guide channel member stent platform,
5. The device of claim 4 wherein the atraumatic tip first end extends distally relative to the outer guide channel member distal end.
6. The device of claim 5 wherein the outer guide channel member distal opening is spaced from the atraumatic tip sufficient to allow flushing.
7. The device of claim 1 wherein the outer guide channel member exit port comprises a substantially breech position opening.
8. The device of claim 7 wherein the outer guide channel member exit port is spaced proximally of the inner guide channel member second end portion.
9. The device of claim 7 wherein the outer guide channel member exit port is substantially aligned with a longitudinal axis of the inner guide channel member.
10. A delivery apparatus for the rapid insertion of medical devices, comprising:
an inner guide channel member comprising a distal first end portion having an entry port and a proximal second end portion having an exit port and defining a guide channel therebetween, and a stent platform disposed about the inner guide channel member intermediate the entry port and the exit port;
an outer guide channel member comprising a distal first end portion having a distal opening and proximal second end portion having an exit port and defining a guide channel therebetween and sized to slidably receive the inner guide channel member second end portion and stent platform, the outer guide channel member comprising a stent constraining inner surface intermediate the outer guide channel member distal opening and exit port, the stent constraining inner surface being located at or near the inner guide channel member stent platform and being circumferentially spaced radially from the inner guide channel member stent platform, and the outer guide channel member comprising a stepped profile having a first outer diameter intermediate the outer guide channel member first and second end portions and a second smaller outer diameter proximal to the outer guide channel member exit port,
wherein outer guide channel member is substantially coaxially slideable relative to the inner guide channel member second end portion, and
wherein the outer guide channel member exit port is in fluid communication with the inner guide channel member exit port.
11. The device of claim 10 wherein the outer guide channel member exit port comprises a diameter substantially equal to the difference between the outer guide channel member first outer diameter and second smaller outer diameter.
12. The device of claim 10 wherein the outer guide channel member further comprises a flushing port at or near the first end portion.
13. The device of claim 10 wherein the outer guide channel member comprises an inner layer, a coil forming a plurality of turns positioned longitudinally around the inner layer with spacings between the turns, and an outer layer comprising melt bonding material positioned longitudinally around the coil and melt bonded to the inner layer through the coil spacings.
14. A delivery apparatus for the rapid insertion of medical devices, comprising:
a system proximal portion comprising a handle and a stylet slidably disposed therethrough;
a middle section delivery device comprising an elongate outer sheath and an elongate inner compression member, the outer sheath comprising a proximal end portion having an opening and a distal end portion having an opening and defining a passageway therebetween, the outer sheath proximal end portion being operatively coupled to the handle, and the inner compression member having a proximal end operatively coupled to the stylet, a middle section extending through the outer sheath passageway, and a distal mating end portion; and
a system distal portion comprising an inner guide channel member and an outer guide channel member, the inner guide channel member including a distal first end portion having an entry port and a proximal second end portion having an exit port and defining a guide channel therebetween, the outer guide channel member axially slidably receiving the inner guide channel member second end portion and further comprising a distal first end portion and a proximal second end portion, an entry port and an exit port defining a guide channel therebetween, and a stepped profile having a first outer diameter intermediate the outer guide channel member first and second end portions and a second smaller outer diameter located at or near the outer guide channel member second end portion;
wherein the system distal portion and middle section delivery device are operatively coupled.
15. The device of claim 14 further comprising a self-expanding deployment device mounting region disposed within the outer guide channel member and comprising a proximal stent restraint, an inner guide channel member stent platform, and an outer guide channel member stent constraining inner surface.
16. The device of claim 15 further comprising a transition region proximal to the self-expanding deployment device mounting region, wherein the inner guide channel member exit port is in communication with the outer guide channel member exit port and comprising a breech position opening located proximal to the inner member exit port.
17. The device of claim 14 wherein the guide channel of the inner guide channel member and the guide channel of the outer guide channel member are substantially coaxially aligned.
18. The device of claim 14 wherein the inner guide channel member is tubular and comprises a longitudinal axis, and the outer guide channel member exit port is substantially aligned with the inner guide channel member longitudinal axis.
19. The device of claim 18 such that the inner guide channel member longitudinal axis intersects the outer guide channel member exit port without the inner guide channel member second end portion bending more than about 15 degrees.
20. The device of claim 14 wherein the system distal portion and middle section delivery device are operatively coupled by operatively coupling the outer guide channel member second end portion and the outer sheath distal end portion.
21. The device of claim 14 wherein the system distal portion and middle section delivery device are operatively coupled by operatively coupling the inner guide channel member second end portion and the inner compression member distal mating end portion.
22. The device of claim 14 wherein the system distal portion and middle section delivery device are operatively coupled by a bridging device.
23. The device of claim 14 wherein the system distal portion and middle section delivery device are operatively coupled by an insert.
24. The device of claim 14 wherein the system distal portion and middle section delivery device are operatively coupled by an integrally formed outer sheath and outer guide channel member.
25. A method of using a delivery apparatus for the rapid insertion of medical devices for intracorporeal procedures, comprising the steps of:
providing a delivery system comprising a system proximal portion having a handle and a stylet and intended to remain outside a patient, a middle section delivery device having an outer sheath with a passageway and an inner compression slidably received within the outer sheath passageway, and a system distal portion having an inner guide channel member with a guide channel, an outer guide channel member axially slideable relative to the inner guide channel member and having a guide channel substantially aligned with the guide channel of the inner guide channel member and having a stepped profile, the system distal portion further comprising a self-expanding deployment device mounting region, a transition region, and a proximal breech opening;
loading a self-expanding device in a radially compressed state into the stent mounting region;
sliding the system distal portion over a previously positioned guiding device;
retracting the outer guide channel member proximally relative to the inner member so as to deploy the self-expanding device.
Priority Applications (1)
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US11/408,121 US20060259118A1 (en) | 2005-04-20 | 2006-04-20 | Delivery system and devices for the rapid insertion of self-expanding devices |
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US67319905P | 2005-04-20 | 2005-04-20 | |
US11/408,121 US20060259118A1 (en) | 2005-04-20 | 2006-04-20 | Delivery system and devices for the rapid insertion of self-expanding devices |
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US11/408,259 Abandoned US20060247661A1 (en) | 2005-04-20 | 2006-04-20 | Joint for operatively coupling a contoured inner compression member and an inner guide channel member for medical device delivery systems |
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US11/408,259 Abandoned US20060247661A1 (en) | 2005-04-20 | 2006-04-20 | Joint for operatively coupling a contoured inner compression member and an inner guide channel member for medical device delivery systems |
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EP (2) | EP1871310B1 (en) |
JP (2) | JP2008536652A (en) |
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Also Published As
Publication number | Publication date |
---|---|
WO2006113913A3 (en) | 2007-07-19 |
US20060282041A1 (en) | 2006-12-14 |
AU2006236229A1 (en) | 2006-10-26 |
AU2006236272A1 (en) | 2006-10-26 |
EP1871310B1 (en) | 2016-07-27 |
US20060247661A1 (en) | 2006-11-02 |
KR20080005433A (en) | 2008-01-11 |
KR20080002984A (en) | 2008-01-04 |
AU2006236229B2 (en) | 2011-03-17 |
WO2006113863A2 (en) | 2006-10-26 |
AU2006236272B2 (en) | 2011-05-19 |
EP1871311B1 (en) | 2014-11-26 |
JP2008536652A (en) | 2008-09-11 |
JP2008536639A (en) | 2008-09-11 |
WO2006113863A3 (en) | 2007-09-27 |
WO2006113913A2 (en) | 2006-10-26 |
EP1871310A2 (en) | 2008-01-02 |
US7892215B2 (en) | 2011-02-22 |
EP1871311A2 (en) | 2008-01-02 |
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