US20130204356A1 - Transcatheter Valve Delivery Systems and Methods - Google Patents
Transcatheter Valve Delivery Systems and Methods Download PDFInfo
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- US20130204356A1 US20130204356A1 US13/792,777 US201313792777A US2013204356A1 US 20130204356 A1 US20130204356 A1 US 20130204356A1 US 201313792777 A US201313792777 A US 201313792777A US 2013204356 A1 US2013204356 A1 US 2013204356A1
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Classifications
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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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
Delivery devices and methods for percutaneously delivering a prosthetic valve to the heart of a patient. These prosthetic valves may be configured to provide complimentary features that promote optimal placement of the prosthetic valve in a native heart valve, such as the aortic valve, mitral valve, pulmonic valve, and/or tricuspid valve. The delivery device includes a release sheath assembly housed within an outer delivery sheath. A release sheath component of the assembly captures a portion of the prosthetic valve to the delivery device, and effectuates complete release of the prosthetic valve with retraction of the outer sheath.
Description
- This application claims priority under 35 U.S.C. §119(e)(1) to U.S. Provisional Patent Application Ser. No. 61/237,373, filed Aug. 27, 2009, entitled “Transcatheter Valve Delivery Systems and Methods”, and bearing Attorney Docket No. P0035291.00; and the entire teachings of which are incorporated herein by reference.
- The present disclosure relates to delivery systems for implanting transcatheter valves. More particularly, it relates to delivery systems and methods of percutaneously implanting prosthetic heart valves.
- Diseased or otherwise deficient heart valves can be repaired or replaced using a variety of different types of heart valve surgeries. One general type of heart valve surgery involves an open-heart surgical procedure that is conducted under general anesthesia, during which the heart is stopped and blood flow is controlled by a heart-lung bypass machine. This type of valve surgery is highly invasive and exposes the patient to a number of potential risks, such as infection, stroke, renal failure, and adverse effects associated with use of the heart-lung machine, for example.
- Due to the drawbacks of open-heart surgical procedures, there has been an increased interest in minimally invasive and percutaneous replacement of cardiac valves. Such surgical techniques involve making a relatively small opening in the skin of the patient into which a valve assembly is inserted and delivered into the heart via a delivery device similar to a catheter. This technique is often preferable to more invasive forms of surgery, such as the open-heart surgical procedure described above.
- Various types and configurations of prosthetic heart valves are used in percutaneous valve procedures to replace diseased natural human heart valves. The actual shape and configuration of any particular prosthetic heart valve is dependent to some extent upon the valve being replaced (i.e., mitral valve, tricuspid valve, aortic valve, or pulmonary valve). In general, prosthetic heart valve designs attempt to replicate the function of the valve being replaced and thus will include valve leaflet-like structures used with either bioprostheses or mechanical heart valve prostheses. If bioprostheses are selected, the replacement valves may include a valved vein segment that is mounted in some manner within an expandable stent frame to make a valved stent. In order to prepare such a valve for percutaneous implantation, one type of valved stent can be initially provided in an expanded or uncrimped condition, then crimped or compressed around a balloon portion of a catheter until it is as close to the diameter of the catheter as possible. In other percutaneous implantation systems, the stent frame of the valved stent can be made of a self-expanding material. With these systems, the valved stent is crimped down to a desired size and held in that compressed state with a sheath, for example. Retracting the sheath from this valved stent allows the stent to expand to a larger diameter, such as when the valved stent is in a desired position within a patient. With either of these types of percutaneous stent delivery systems, conventional sewing of the prosthetic heart valve to the patient's native tissue is typically not necessary.
- Although there have been advances in percutaneous valve replacement techniques and devices, there is a continued desire to provide different delivery systems for delivering cardiac valves to an implantation site in a minimally invasive and percutaneous manner. There is also a continued desired to be able to reposition and/or retract the valves once they have been deployed or partially deployed in order to ensure optimal placement of the valves within the patient. In addition, there is a desire to provide a valve and corresponding delivery system that provide for easy loading of the valve onto the delivery system and allow for positive release of the valve when it is in its desired position in the patient.
- The delivery devices of the disclosure can be used to deliver replacement valves to the heart of a patient. These replacement heart valves may be configured to provide complimentary features that promote optimal placement of the replacement heart valve in a native heart valve, such as the aortic valve, mitral valve, pulmonic valve, and/or tricuspid valve. In some embodiments, the replacement heart valves of the disclosure are highly amenable to transvascular delivery using a retrograde transarterial approach (either with or without rapid pacing). The methodology associated with the present disclosure can be repeated multiple times, such that several prosthetic heart valves of the present disclosure can be mounted on top of, adjacent to, or within one another, if necessary or desired.
- Methods for insertion of the replacement heart valves of the disclosure include delivery devices that can maintain the stent structures in their compressed state during their insertion and allow or cause the stent structures to expand once they are in their desired location. In addition, delivery methods of the disclosure can include features that allow the stents to be retrieved for removal or relocation thereof after they have been at least partially deployed from the stent delivery devices. The methods may include implantation of the stent structures using either an antegrade or retrograde approach. Further, in many of the delivery approaches of the disclosure, the stent structure is rotatable in vivo to allow the stent structure to be adjusted to a desired orientation within the patient.
- Some aspects in accordance with principles of the present disclosure relate to a delivery device for percutaneously deploying a stented prosthetic heart valve otherwise including a stent frame to which a valve structure is attached. The delivery device includes a delivery sheath assembly, an inner shaft, a hub, and a release sheath assembly. The delivery sheath assembly terminates at a distal end and defines a lumen. The inner shaft is slidably disposed within the lumen. The hub projects from the inner shaft and is configured to releasably receive a portion of a prosthetic heart valve stent frame, such as one or more posts formed by the stent frame. The release sheath assembly is disposed along the delivery sheath assembly and the inner shaft. In this regard, the release sheath assembly includes a release sheath slidably disposed about the inner shaft. With this construction, the delivery device is configured to provide a loaded state and a deployment state. In the loaded state, the delivery sheath assembly maintains a stented prosthetic heart valve over the inner shaft. Further, the stented prosthetic heart valve is coupled to the hub via the release sheath. In the deployment state, the distal end of the delivery sheath assembly is withdrawn from the prosthetic heart valve, as is the release sheath. In the deployment state, then, the prosthetic heart valve is permitted to release from the hub. In some embodiments, the release sheath assembly is configured to self-retract the release sheath relative to the hub with proximal retraction of the delivery sheath assembly. In other embodiments, the release sheath assembly further includes a mounting base connected to the release sheath by at least one biasing member that can be a leaf spring-like body. With these constructions, the mounting base is fixed to the inner shaft proximal the hub; when the biasing member is constrained with the delivery sheath assembly's lumen, the biasing member is forced to a deflected state, directing the release sheath over the hub. When the biasing member is released from the confines of the delivery sheath assembly, the biasing member self-transitions to a normal state, thereby retracting the release sheath.
- Yet other aspects in accordance with principles of the present disclosure relate to a system for replacing a defective heart valve of a patient. The system includes a prosthetic heart valve and the delivery device as described above. The prosthetic heart valve includes a stent frame and a valve structure attached thereto. The stent frame defines a distal region and a proximal region, with the proximal region forming at least one post. In a loaded condition of the system, the post is captured between the release sheath and the hub. Upon retraction of the delivery sheath assembly's distal end proximally beyond the release sheath, the release sheath assembly self-retracts the release sheath, thereby permitting the post to release from the hub.
- Yet other aspects in accordance with principles of the present disclosure relates to methods of percutaneously deploying a stented prosthetic heart valve to an implantation site of a patient. A delivery device loaded with a radially expandable prosthetic heart valve having a stent frame and a valve structure is received. The delivery device includes a delivery sheath assembly containing the prosthetic heart valve in a compressed arrangement over an inner shaft in a loaded state of the device. The delivery device further includes a hub projecting from the inner shaft, and a release sheath assembly including a release sheath slidably capturing a post of the stent frame to the hub. The prosthetic heart valve is delivered, in the compressed arrangement, through a bodily lumen of a patient and to the implantation site via the delivery device in the loaded state. The delivery sheath assembly is proximally retracted from the prosthetic heart valve. Finally, the post is permitted to release from the hub in effectuating full deployment, including the release sheath assembly self-retracting the release sheath relative to the hub.
- The present disclosure will be further explained with reference to the appended figures, wherein like structures is referred to by like numerals throughout the several views, and wherein:
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FIG. 1A is a side view of a stented prosthetic heart valve useful with systems and methods of the present disclosure and in a normal, expanded arrangement; -
FIG. 1B is a side view of the prosthetic heart valve ofFIG. 1A in a compressed arrangement; -
FIG. 2A is an exploded perspective view of a stented prosthetic heart valve delivery device in accordance with principles of the present disclosure; -
FIG. 2B is a side view of the delivery device ofFIG. 2A upon final assembly; -
FIG. 3A is a side view of a hub component useful with the delivery device ofFIG. 2A ; -
FIG. 3B is an end view of the hub ofFIG. 3A ; -
FIG. 3C is a cross-sectional view of the hub ofFIG. 3A ; -
FIG. 4 is a side view of another embodiment hub useful with the delivery device ofFIG. 2A ; -
FIG. 5 is a perspective view of a portion of a release sheath assembly component of the delivery device ofFIG. 2A ; -
FIG. 6A is a side view of the release sheath assembly component of the delivery device ofFIG. 2A and in a normal state; -
FIG. 6B is a side view of the release sheath assembly ofFIG. 6A and in a compressed or deflected state; -
FIG. 7 is a cross-sectional view of a portion of a heart valve replacement system in accordance with the present disclosure, including the delivery device ofFIG. 2A loaded with the prosthetic heart valve ofFIG. 1B ; -
FIG. 8A is a side view of a distal portion of the system ofFIG. 7 in a partially deployed state; -
FIG. 8B illustrates delivery of the system ofFIG. 8A within a patient's anatomy, including partial deployment of the stented prosthetic heart valve; -
FIG. 9A is a simplified perspective view of the delivery device ofFIG. 2A in a sequentially further stage of deployment; -
FIG. 9B is a side view of the system ofFIG. 7 in a sequentially further state of partial deployment; -
FIGS. 10A and 10B are simplified perspective views of the delivery device ofFIG. 2A in various stages of transitioning to a deployment state; -
FIG. 11A is a side view of a portion of the system ofFIG. 7 in a deployment state; and -
FIG. 11B illustrates, in simplified form, a location of the system ofFIG. 7 relative to a patient's anatomy, including full deployment of the prosthetic heart valve from the delivery device and implantation to the native valve. - As referred to herein, stented transcatheter prosthetic heart valves useful with and/or as part of the various systems, devices, and methods of the present disclosure may assume a wide variety of different configurations, such as a bioprosthetic heart valve having tissue leaflets or a synthetic heart valve having polymeric, metallic, or tissue-engineered leaflets, and can be specifically configured for replacing any heart valve. Thus, the stented prosthetic heart valve useful with the systems, devices, and methods of the present disclosure can be generally used for replacement of a native aortic, mitral, pulmonic, or tricuspid valve, for use as a venous valve, or to replace a failed bioprosthesis, such as in the area of an aortic valve or mitral valve, for example.
- In general terms, the stented prosthetic heart valves of the present disclosure include a stent or stent frame maintaining a valve structure (tissue or synthetic), with the stent having a normal, expanded arrangement and collapsible to a compressed arrangement for loading within a delivery device. The stent is normally constructed to self-deploy or self-expand when released from the delivery device. For example, the stented prosthetic heart valve useful with the present disclosure can be a prosthetic valve sold under the trade name CoreValve® available from Medtronic CoreValve, LLC. Other non-limiting examples of transcatheter heart valve prostheses useful with systems, devices, and methods of the present disclosure are described in U.S. Publication Nos. 2006/0265056; 2007/0239266; and 2007/0239269, the teachings of each which are incorporated herein by reference. The stents or stent frames are support structures that comprise a number of struts or wire portions arranged relative to each other to provide a desired compressibility and strength to the prosthetic heart valve. In general terms, the stents or stent frames of the present disclosure are generally tubular support structures having an internal area in which valve structure leaflets will be secured. The leaflets can be formed from a variety of materials, such as autologous tissue, xenograph material, or synthetics as are known in the art. The leaflets may be provided as a homogenous, biological valve structure, such as porcine, bovine, or equine valves. Alternatively, the leaflets can be provided independent of one another (e.g., bovine or equine pericardial leaflets) and subsequently assembled to the support structure of the stent frame. In another alternative, the stent frame and leaflets can be fabricated at the same time, such as may be accomplished using high-strength nano-manufactured NiTi films produced at Advance BioProsthetic Surfaces (ABPS), for example. The stent frame support structures are generally configured to accommodate at least two (typically three) leaflets; however, stented prosthetic heart valves of the types described herein can incorporate more or less than three leaflets.
- Some embodiments of the stent frames can be a series of wires or wire segments arranged such that they are capable of self-transitioning from the compressed or collapsed arrangement to the normal, radially expanded arrangement. In some constructions, a number of individual wires comprising the stent frame support structure can be formed of a metal or other material. These wires are arranged in such a way that the stent frame support structure allows for folding or compressing or crimping to the compressed arrangement in which the internal diameter is smaller than the internal diameter when in the normal, expanded arrangement. In the compressed arrangement, such a stent frame support structure with attached valve leaflets can be mounted onto a delivery device. The stent frame support structures are configured so that they can be changed to their normal, expanded arrangement when desired, such as by the relative movement of one or more outer sheaths relative to a length of the stent frame.
- The wires of these stent frame support structures in embodiments of the present disclosure can be formed from a shape memory material such as a nickel titanium alloy (e.g., Nitinol™) With this material, the support structure is self-expandable from the compressed arrangement to the normal, expanded arrangement, such as by the application of heat, energy, and the like, or by the removal of external forces (e.g., compressive forces). This stent frame support structure can also be compressed and re-expanded multiple times without damaging the structure of the stent frame. In addition, the stent frame support structure of such an embodiment may be laser-cut from a single piece of material or may be assembled from a number of different components. For these types of stent frame structures, one example of a delivery device that can be used includes a catheter with a retractable sheath that covers the stent frame until it is to be deployed, at which point the sheath can be retracted to allow the stent frame to self-expand. Further details of such embodiments are discussed below.
- With the above understanding in mind, one non-limiting example of a stented
prosthetic heart valve 30 useful with systems, devices, and methods of the present disclosure is illustrated inFIG. 1A . As a point of reference, theprosthetic heart valve 30 is shown in a normal or expanded arrangement in the view ofFIG. 1A ;FIG. 1B illustrates theprosthetic heart valve 30 in a compressed arrangement (e.g., when compressively retained within an outer catheter or sheath). Theprosthetic heart valve 30 includes a stent orstent frame 32 and avalve structure 34. Thestent frame 32 can assume any of the forms described above, and is generally constructed so as to be self-expandable from the compressed arrangement (FIG. 1B ) to the normal, expanded arrangement (FIG. 1A ). In other embodiments, thestent frame 32 is expandable to the expanded arrangement by a separate device (e.g., a balloon internally located within the stent frame 32). Thevalve structure 34 is assembled to thestent frame 32 and provides two or more (typically three)leaflets 36. Thevalve structure 34 can assume any of the forms described above, and can be assembled to thestent frame 32 in various manners, such as by sewing thevalve structure 34 to one or more of the wire segments defined by thestent frame 32. - With the but one acceptable construction of
FIGS. 1A and 1B , theprosthetic heart valve 30 is configured for replacing or repairing an aortic valve. Alternatively, other shapes are also envisioned, adapted to the specific anatomy of the valve to be repaired (e.g., stented prosthetic heart valves in accordance with the present disclosure can be shaped and/or sized for replacing a native mitral, pulmonic, or tricuspid valve). With the one construction ofFIGS. 1A and 1B , thevalve structure 34 extends less than the entire length of thestent frame 32, but in other embodiments can extend along an entirety, or a near entirety, of a length of thestent frame 32. A wide variety of other constructions are also acceptable and within the scope of the present disclosure. For example, thestent frame 32 can have a more cylindrical shape in the normal, expanded arrangement. - With the above understanding of the stented
prosthetic heart valve 30 in mind, one embodiment of adelivery device 50 for percutaneously delivering theprosthesis 30 is shown inFIGS. 2A and 2B . Although thedevice 50 can be loaded with a stented valve for delivery thereof, such a stented valve is not shown inFIGS. 2A and 2B in order to more clearly illustrate the components of thedelivery device 50. Thedelivery device 50 includes adelivery sheath assembly 52, aninner shaft assembly 54, a retention body orhub 56, arelease sheath assembly 58, and ahandle 60. Details on the various components are provided below. In general terms, however, thedelivery device 50 combines with a stented prosthetic heart valve (not shown) to form a system for repairing a defective heart valve of a patient. Thedelivery device 50 provides a loaded state in which a stented prosthetic heart valve is coupled to theinner shaft assembly 54 via thehub 56, and compressively retained within acapsule 62 of thedelivery sheath assembly 52. Thedelivery sheath assembly 52 can be manipulated to withdraw thecapsule 62 proximally from the prosthetic heart valve via operation of thehandle 60, permitting the prosthesis to self-expand and release from theinner shaft assembly 54. Therelease sheath assembly 58 operates to effectuate this release. Further, thehandle 60 can be operated to maneuver thecapsule 62 to effectuate a partial deployment state in which a distal region of the prosthetic heart valve is permitted to self-expand, whereas a proximal region of the prosthesis remains coupled to thehub 56. - Various features of the components 52-60 reflected in
FIGS. 2A and 2B and described below can be modified or replaced with differing structures and/or mechanisms. Thus, the present disclosure is in no way limited to thedelivery sheath assembly 52, theinner shaft assembly 54, thehub 56, thehandle 60, etc., as shown and described below. More generally, delivery devices in accordance with the present disclosure provide features capable of compressively retaining a self-deploying, stented prosthetic heart valve (e.g., thecapsule 62 in combination with thehub 56/release sheath assembly 58), and a mechanism capable of effectuating partial and full release or deployment of the prosthesis (e.g., retracting thecapsule 62 in combination with the release sheath assembly 58). - In some embodiments, the
delivery sheath assembly 52 includes thecapsule 62 and ashaft 70, and defines proximal and distal ends 72, 74. Alumen 76 is formed by thedelivery sheath assembly 52, extending from thedistal end 74 through thecapsule 62 and at least a portion of theshaft 70. Thelumen 76 can be open at theproximal end 72. Thecapsule 62 extends distally from theshaft 70, and in some embodiments has a more stiffened construction (as compared to a stiffness of the shaft 70) that exhibits sufficient radial or circumferential rigidity to overtly resist the expected expansive forces of the stented prosthetic heart valve (not shown) when compressed within thecapsule 62. For example, theshaft 70 can be a polymer tube embedded with a metal braiding, whereas thecapsule 62 includes a laser-cut metal tube that is optionally embedded within a polymer covering. Alternatively, thecapsule 62 and theshaft 70 can have a more uniform construction (e.g., a continuous polymer tube). Regardless, thecapsule 62 is constructed to compressively retain the stented prosthetic heart valve at a predetermined diameter when loaded within thecapsule 62, and theshaft 70 serves to connect thecapsule 62 with thehandle 60. The shaft 70 (as well as the capsule 62) is constructed to be sufficiently flexible for passage through a patient's vasculature, yet exhibits sufficient longitudinal rigidity to effectuate desired axial movement of thecapsule 62. In other words, proximal retraction of theshaft 70 is directly transferred to thecapsule 62 and causes a corresponding proximal retraction of thecapsule 62. In other embodiments, theshaft 70 is further configured to transmit a rotational force or movement onto thecapsule 62. - The
inner shaft assembly 54 can have various constructions appropriate for supporting a stented prosthetic heart valve within thecapsule 62. In some embodiments, theinner shaft assembly 54 include aninner support shaft 80 and atip 82. Theinner support shaft 80 is sized to be slidably received within thelumen 76 of thedelivery sheath assembly 52, and is configured for mounting of thehub 56 and therelease sheath assembly 58. Theinner support shaft 80 can include a distal segment 84 and aproximal segment 86. The distal segment 84 connects thetip 82 to theproximal segment 86, with theproximal segment 86, in turn, coupling theinner shaft assembly 54 with thehandle 58. The components 80-86 can combine to define a continuous lumen 88 (referenced generally) sized to slidably receive an auxiliary component such as a guide wire (not shown). - The distal segment 84 can be a flexible polymer tube embedded with a metal braid. Other constructions are also acceptable so long as the distal segment 84 exhibits sufficient structural integrity to support a loaded, compressed stented prosthetic heart valve (not shown), as well as the
hub 56 and therelease sheath assembly 58 mounted thereto. Theproximal segment 86 can include, in some constructions, a leading portion 90 and a trailingportion 92. The leading portion 90 serves as a transition between the distal andproximal segments 84, 86, and thus in some embodiments is a flexible polymer tubing (e.g., PEEK) having an outer diameter slightly less than that of the distal segment 84. The trailingportion 92 has a more rigid construction (e.g., a metal hypotube), adapted for robust assembly with thehandle 60. Other materials and constructions are also envisioned. For example, in alternative embodiments, the distal andproximal segments 84, 86 are integrally formed as a single, homogenous tube or solid shaft. - The
tip 82 forms or defines a nose cone having a distally tapering outer surface adapted to promote atraumatic contact with bodily tissue. Thetip 82 can be fixed or slidable relative to theinner support shaft 80. - The
hub 56 serves to selectively couple corresponding features of the stented prosthetic heart valve (not shown) relative to theinner shaft assembly 54, and can be configured for assembly over theinner support shaft 80. One embodiment of thehub 56 is shown in greater detail inFIGS. 3A-3C . Thehub 56 can be used for securing a stent frame to thedelivery device 50 until it is desired to release the stent frame within a patient. Thehub 56 includes a basecylindrical portion 102 and aflange 104 at one end of thecylindrical portion 102. Theflange 104 is at least slightly larger in diameter than the diameter of thecylindrical portion 102. Thecylindrical portion 102 includesmultiple indentations 106 around its outer periphery. Theindentations 106 can be hemispherical or semi-hemispherical, for example, or can have another concave shape. Theindentations 106 are recessed areas shaped to engage with outward protrusions of corresponding stent frame wires to aid in securing the stent frame to the delivery device. That is, protrusions can be provided on the end (or posts) of a certain number of stent frame wires, where these protrusions are designed to fit into or engage with theindentations 106 and can also be hemispherical or semi-hemispherical in shape. The number of protrusions that extend from stent frame wires is preferably the same as the number ofindentations 106 on thecylindrical portion 102 of thehub 56; however, the number of protrusions provided on a particular stent frame may be different than the number of indentations on the corresponding collar. - The shape of each of the
indentations 106 can be the same or similar in shape and size to other indentations of a particular hub. The shape and size of each of the protrusions on the stent frame wires of a stent frame that will engage with the indentations can exactly or closely match the indentation with which it will be engaged. However, the protrusions can be at least slightly smaller and/or differently shaped than the corresponding indentation in which it will be positioned. In any case, each of the protrusions should be able to seat securely within a corresponding indentation for positive engagement between the components. The thickness of each of the stent frame wires that extend from the shaped protrusions can be the same as the rest of the wires of the stent frame, or the thickness can be different. However, in one embodiment, the thickness of the wires will be small enough that when their protrusions are positioned in theindentations 106, the wires do not extend beyond the outer periphery of theflange 104 of thehub 56. In addition, it is contemplated that the protrusions from the stent frame can extend from crowns or other area of a stent wire arrangement, additional wires with protrusions can be provided to extend from an existing stent structure, or other structures can be provided with such protrusions. - Another embodiment of a
hub 56′ useful with the transcatheter stented prosthetic heart valve delivery devices of the present disclosure is shown inFIG. 4 . Thehub 56′ is a generally cylindrical element that includes aradial groove 108 extending around its perimeter. Although thegroove 108 of this embodiment extends around an entire perimeter of thehub 56′, thehub 56′ can instead include multiple grooves spaced from each other. - Returning to
FIG. 2A , thehub 56 can assume a wide variety of other forms differing from the above descriptions. For example, thehub 56 can incorporate slots, springs, etc., configured to interface with corresponding feature(s) of the stented prosthetic heart valve 30 (FIG. 1B ) (e.g., posts or wire extensions formed by the stent frame 32). - The
release sheath assembly 58 is generally constructed to selectively capture the prosthetic heart valve 30 (FIG. 1B ) to thehub 56. With this in mind, therelease sheath assembly 58 includes a mounting collar orbase 150, one ormore biasing members 152, and arelease sheath 154. In general terms, the mountingbase 150 couples therelease sheath assembly 58 to theinner support shaft 80. Therelease sheath 154 is sized to be slidably disposed over thehub 56, with the biasingmembers 152 serving to bias therelease sheath 154 to a longitudinal position relative to the mountingbase 150, and thus relative to thehub 56, as described below. - The mounting
base 150 can assume various configurations appropriate for non-moveable, fixed mounting to theinner support shaft 80. For example, the mountingbase 150 can be a ring or collar that is bonded to theinner support shaft 80. Other structures appropriate for establishing a fixed location relative to theinner support shaft 80 as well as resisting forces generated in or by the biasing member(s) 152 are also envisioned. For example, in other embodiments, the mountingbase 150 can be omitted and an end of each of the biasing member(s) 152 opposite therelease sheath 154 directly attached to theinner support shaft 80. - The biasing
members 152 are leaf spring-like bodies or arms, and are spaced from one another about a periphery of therelease sheath 154. In some constructions, therelease sheath assembly 58 will include at least two of the biasingmembers 152, which may be positioned at generally opposite sides of therelease sheath 154, if desired, although it is possible that they are positioned different relative to each other. In other constructions, only one of the biasingmembers 152 is provided. In yet other embodiments, therelease sheath assembly 58 includes three ormore biasing members 152, and each of the biasingmembers 152 may be configured the same or differently than the other biasingmembers 152. Regardless, and as described in greater detail below, the biasing member(s) 152 can have a shape memory attribute, normally or naturally assuming the outwardly curved shape reflected inFIG. 2A , and can be externally forced to deflect to a more straightened shape. Upon removal of the external force, the biasing member(s) 152 self-revert back toward the normal curved shape. Other spring-related shapes or structures are also acceptable. - The
release sheath 154 is a tubular body sized to be slidably received over thehub 56, including theflange 104. Therelease sheath 154 is designed to move freely over thehub 56 due to a gap clearance (e.g., on the order of 0.001 inch or greater) that is provided between therelease sheath 154 and the maximum outer diameter of basecylindrical portion 102 and theflange 104. In some constructions, and as best shown inFIG. 5 (that otherwise illustrates therelease sheath 154 assembled over theflange 104 of analternative embodiment hub 56″ incorporatinglongitudinal slots 158 in the base portion 102), therelease sheath 154 forms or defines at least onelongitudinal notch 160 extending from, and open relative to, adistal end 162 thereof. Therelease sheath 154 can include a plurality of thenotches 160 corresponding with the number of thelongitudinal slots 158 provided with thehub 56. Thenotches 160 can be identical and are arranged relative to a circumference of therelease sheath 154 such that each of thenotches 160 is longitudinally aligned with a corresponding one of theslots 158 upon assembly of therelease sheath 154 over theflange 104. With embodiments in which therelease sheath 154 forms two (or more) of thenotches 160, two (or more)fingers 164 are formed by or between adjacent ones of thenotches 160. For example, a first finger 164 a is defined between the first andsecond notches notches 160 can have a relatively uniform circumferential width, an increased circumferential width is optionally defined immediately adjacent thedistal end 162. Alternatively, thenotches 160 can have other shapes, and in yet other embodiments are omitted. - Returning to
FIG. 2A , therelease sheath assembly 58, including the biasingmembers 152 and/or therelease sheath 154, can be made of one of more materials such as metal or polymers (e.g., Nitinol™, stainless steel, Delrin™, and the like). The material(s) have a thickness on the order of 0.002-0.007 inch, for example, although the thickness can be lower or higher than this size range. Therelease sheath assembly 58 can have a length on the order of 5-15 mm, for example, in order to provide both flexibility and spring-radial strength to the components. The material(s) can have either a closed cell or an open-cell design. - Operation of the
release sheath assembly 58 in facilitating partial and full deployment of a prosthetic heart valve is based upon a longitudinal position of therelease sheath 154 as dictated by biasingmembers 152. As mentioned above, the biasingmembers 152 are formed to normally assume the curved shape generally reflected inFIG. 2A . A diameter collectively defined by the biasing members 152 (in their normal state) is greater than a diameter of the deliverysheath assembly lumen 76. Thus, when therelease sheath assembly 58 is disposed within the capsule 62 (or within the delivery sheath shaft 70), the biasingmembers 152 are forced to deflect radially inwardly, effectuating an increase in a longitudinal spacing between the mountingbase 150 and therelease sheath 154. Upon removal of this external force, the biasingmembers 152 self-revert back to the natural condition reflected inFIG. 2A , thereby biasing therelease sheath 154 to an original longitudinal spacing relative to the mountingbase 150.FIGS. 6A and 6B illustrate this relationship in simplified form.FIG. 6A reflects a normal state of the biasingmembers 152 that establishes a first longitudinal spacing L1 between the mountingbase 150 and therelease sheath 154. When subjected to a compressive force (e.g., upon insertion within the delivery sheath assembly 52 (FIG. 2A)), the biasingmembers 152 deflect inwardly as shown inFIG. 6B . Because the mountingbase 150 is spatially fixed (i.e., attached to the inner support shaft 80 (FIG. 2A)), the deflected biasingmembers 152 force therelease sheath 154 away from the mountingbase 150, to a second longitudinal spacing L2 that is greater than the first longitudinal spacing L1. When the compressive force is removed, the biasingmembers 152 self-revert back to the arrangement ofFIG. 6A , thereby pulling therelease sheath 154 back toward the mountingbase 150. - Returning the
FIG. 2A , thehandle 60 generally includes ahousing 170 and an actuator mechanism 172 (referenced generally). Thehousing 170 maintains theactuator mechanism 172, with theactuator mechanism 172 configured to facilitate sliding movement of thedelivery sheath assembly 52 relative to theinner shaft assembly 54. Thehousing 170 can have any shape or size appropriate for convenient handling by a user. In one simplified construction, theactuator mechanism 172 includes a user interface oractuator 174 slidably retained by thehousing 170 and coupled to asheath connector body 176. Theproximal end 72 of thedelivery sheath assembly 52 is coupled to the sheath connector body 176 (e.g., via an optional mountingboss 178 in some embodiments). Theinner shaft assembly 54, and in particular theproximal tube 86, is slidably received within apassage 180 of thesheath connector body 176, and is rigidly coupled to thehousing 170. Sliding of theactuator 174 relative to thehousing 170 thus causes thedelivery sheath assembly 52 to move or slide relative to theinner shaft assembly 54, for example to effectuate deployment of a prosthesis from theinner shaft assembly 54 as described below. Alternatively, theactuator mechanism 172 can assume a variety of other forms differing from those implicated by the illustration ofFIG. 2A . Similarly, thehandle 60 can incorporated other features, such as acap 182 and/or afluid port assembly 184. -
FIG. 7 illustrates a portion of asystem 200 in accordance with the present disclosure for replacing (or repairing) a defective heart valve of a patient and including the stentedprosthetic heart valve 30 within thedelivery device 50. In the loaded state of thedelivery device 50 inFIG. 7 , theprosthetic heart valve 30 is crimped over theinner shaft assembly 54, with thedelivery sheath assembly 52 located such that thecapsule 62 surrounds and compressively retains theprosthetic heart valve 30 in the compressed arrangement shown thereby defining a loaded condition of therepair system 200. Thehub 56 and the release sheath assembly 58 (referenced generally) are mounted to theinner support shaft 80, with therelease sheath 154 being slidably directed over thecylindrical base 102 via deflection of the biasing members 152 (shown partially) in response to placement within thedelivery sheath shaft 70. Therelease sheath 154 can be slidably supported along theflange 104 to better ensure desired positioning relative tocylindrical base 102. With this arrangement, then, a portion of the prosthetic heart valve stent frame 32 (e.g., posts 202) is captured to thehub 56 via therelease sheath 154. - The loaded
delivery device 50 can then be used to percutaneously deliver theprosthetic heart valve 30 to an implantation site, such as a defective heart valve. For example, thedelivery device 50 is manipulated to advance the compressedprosthetic heart valve 30 toward the implantation site in a retrograde manner through a cut-down to the femoral artery, into the patient's descending aorta, over the aortic arch, through the ascending aorta, and approximately midway across the defective aortic valve (for an aortic valve repair procedure). Theprosthetic heart valve 30 can then be partially or fully deployed from thedelivery device 50. With either procedure, the capsule 62 (FIG. 2A ) is proximally retracted or withdrawn from over theprosthetic heart valve 30. As generally reflected inFIG. 8A , at an initial stage of proximal retraction of thecapsule 62, thedistal end 74 is located approximately mid-length along the stentedprosthetic heart valve 30. Adistal region 210 of theprosthetic heart valve 30 is thus “exposed” relative to thedistal end 74 of thecapsule 62, and is allowed to self-expand. However, because thedistal end 74 is distal the release sheath assembly 58 (hidden inFIG. 8A ), a proximal region of theprosthetic valve 30 remains secured to thedelivery device 50.FIG. 8B illustrates thesystem 200 percutaneously directed to a native valve and thedelivery device 50 in a partially related state; as shown, theprosthetic heart valve 30 is partially deployed or expanded, yet remains connected to thedelivery device 50. - The delivery process continues by further retracting the
delivery sheath assembly 52. As shown inFIG. 9A (in which the stentedprosthetic heart valve 30 is omitted for purposes of clarity), proximal retraction has located thedistal end 74 approximately over thehub 56 and therelease sheath 154. Because the biasing members 152 (FIG. 6B ) remains within the confines of thedelivery sheath assembly 52, and thus in the deflected state, therelease sheath 154 is held over thehub 56, thereby maintaining a secured connection of the stentedprosthetic heart valve 30 to thedelivery device 50.FIG. 9B illustrates an even further sequential retraction of thedelivery sheath assembly 52, locating thedistal end 74 immediately proximal therelease sheath 154. However, because the biasingmembers 152 are still acted upon or constrained by thedelivery sheath assembly 52, the stentedprosthetic heart valve 30 remains secured between therelease sheath 154 and thehub 56. As shown, in this partial deployment state, a substantial portion (e.g., 90%) of the stentedprosthetic heart valve 30 has self-expanded toward the expanded condition. - In the stage of partial deployment of
FIG. 9B (or in any other sequentially prior stage of partial deployment), the clinician can perform desired evaluations of the partially deployedprosthetic heart valve 30 relative to the implantation site. Notably, a substantial majority of theprosthetic heart valve 30 is in an expanded arrangement, including, for example, the inflow region and at least a portion of the outflow region. Thus, the valve replacement systems and delivery devices and methods of the present disclosure afford the clinician the ability to make an accurate estimate of the position of theprosthetic heart valve 30 relative to the implantation site. Under circumstances where the clinician determines that theprosthetic heart valve 30 should be repositioned, thecapsule 62 can, in some constructions, be distally advanced back over theprosthetic heart valve 30, thereby resheathing or recapturing theprosthetic heart valve 30 and returning to the compressed arrangement. Alternatively, thedelivery device 50 can incorporate other features to effectuate recapturing of theprosthetic heart valve 30. - When full deployment of the
prosthetic heart valve 30 from thedelivery device 50 is desired, thecapsule 62 is further proximally retracted over the biasingmembers 152. As shown inFIGS. 10A and 10B (the prosthesis 30 (FIG. 1A ) being omitted from the views ofFIGS. 10A and 10B for ease of explanation), as the biasingmembers 152 are sequentially released from the confines of thecapsule 62, the biasingmembers 152 self-revert toward their natural state. This action, in turn, causes the biasingmembers 152 to proximally retract therelease sheath 154 from the hub 56 (or at least the cylindrical base 102) as reflected by a comparison of the arrangement ofFIG. 10A with that ofFIG. 10B . - Retraction of the
release sheath 154 relative to thehub 56 permits thestent frame 32 to fully release from thehub 56 as shown inFIGS. 11A and 11B . Once therelease sheath 154 has self-retracted proximally beyond thestent frame 32, theprosthetic heart valve 30 fully releases from the delivery device 50 (e.g., due to self-expansion of the stent frame 32).FIG. 11B reflects that the releasedprosthetic heart valve 30 is now implanted to the native valve. Thedelivery device 50 can then be removed from the patient. - The
delivery device 50 is configured so that thestent frame 32 of theprosthetic valve 30 will release from thedelivery device 50 at a pre-designed step of the delivery sequence. Thisdelivery device 50 thereby advantageously allows the user to entirely move an outer sheath from a valved stent prior to release of the stent from thedelivery device 50. In addition, thedevice 50 allows the out flow portion of the valved stent to open or release so that the valve function can be determined prior to final release of the valved stent. Should the valve function be less than optimal and/or if it is desired to reposition the valve stent before it is completely released from thedelivery device 50, the process steps described above can be performed in reverse order until the valve stent is sufficiently compressed within the sheath(s) that it can be moved to a different location or removed from the patient. - The delivery devices of the present disclosure provide for placement of a stent for replacement of an aortic valve, for example. Alternatively, the systems and devices of the present disclosure can be used for replacement of other valves and/or in other portions of the body in which a stent is to be implanted. When delivering a valved stent to replace an aortic valve, the delivery devices of the disclosure can be used with a retrograde delivery approach, for example, although it is contemplated that an antegrade delivery approach can be used, with certain modifications to the delivery device. With the systems described herein, full or partial blood flow through the valve can advantageously be maintained during the period when the valved stent is being deployed into the patient but is not yet released from its delivery device. This feature can help to prevent complications that may occur when blood flow is stopped or blocked during prosthetic valve implantation with some other known delivery devices. In addition, it is possible for the clinician to thereby evaluate the opening and closing of leaflets, examine for any paravalvular leakage and evaluate coronary flow and proper positioning of the valve within the target anatomy before final release of the valved stent.
- Because it is often desirable to minimize the diameter of the system for percutaneous delivery of valved stents, the number of stent wires and corresponding extending elements can be designed or chosen to optimize the quality of the attachment between the stent frame and the delivery device, while providing a stent that has certain desirable characteristics when implanted in a patient.
- The delivery devices shown and described herein can be modified for delivery of balloon-expandable stents, within the scope of the present disclosure. That is delivering balloon-expandable stents to an implantation location can be performed percutaneously using modified versions of the delivery devices of the disclosure. In general terms, this includes providing a transcatheter assembly which may include release sheaths and/or additional sheaths and/or collars including indentations and/or grooves, as described above. These devices can further include a delivery catheter, a balloon catheter, and/or a guide wire. A delivery catheter used in this type of device defines a lumen within which the guide wire is slidably disposed. Further, the balloon catheter includes a balloon that is fluidly connected to an inflation source. It is noted that if the stent being implanted is the self-expanding type of stent, the balloon would not be needed and a sheath or other retraining means would be used for maintaining the stent in its compressed state until deployment of the stent, as described herein. In any case, for a balloon-expandable stent, the transcatheter assembly is appropriately sized for a desired percutaneous approach to the implantation location. For example, the transcatheter assembly can be sized for delivery to the heart valve via an opening at a carotid artery, a jugular vein, a sub-clavian vein, femoral artery or vein, or the like. Essentially, any percutaneous intercostals penetration can be made to facilitate use of transcatheter assembly.
- With the stent mounted to the balloon, the transcatheter assembly is delivered through a percutaneous opening (not shown) in the patient via the delivery catheter. The implantation location is located by inserting the guide wire into the patient, which guide wire extends from a distal end of the delivery catheter, with the balloon catheter otherwise retracted within the delivery catheter. The balloon catheter is then advanced distally from the delivery catheter along the guide wire, with the balloon and stent positioned relative to the implantation location. In an alternative embodiment, the stent is delivered to an implantation location via a minimally invasive surgical incision (i.e., non-percutaneously). In another alternative embodiment, the stent is delivered via open heart/chest surgery. In one embodiment of the stents of the disclosure, the stent includes a radiopaque, echogenic, or MRI visible material to facilitate visual confirmation of proper placement of the stent. Alternatively, other known surgical visual aids can be incorporated into the stent. The techniques described relative to placement of the stent within the heart can be used both to monitor and correct the placement of the stent in a longitudinal direction relative to the length of the anatomical structure in which it is positioned. Once the stent is properly positioned, the balloon catheter is operated to inflate the balloon, thus transitioning the stent to an expanded condition.
- The present disclosure has now been described with reference to several embodiments thereof. The foregoing detailed description and examples have been given for clarity of understanding only. No unnecessary limitations are to be understood therefrom. It will be apparent to those skilled in the art that many changes can be made in the embodiments described without departing from the scope of the disclosure. Thus, the scope of the present disclosure should not be limited to the structures described herein.
Claims (13)
1-10. (canceled)
11. A system for replacing a defective heart valve of a patient, the system comprising:
a prosthetic heart valve having a stent frame and a valve structure attached to the stent frame, the stent frame defining a distal region and a proximal region, the proximal region forming at least one post; and
a delivery device comprising:
a delivery sheath assembly terminating at a distal end and defining a lumen,
an inner shaft slidably disposed within the lumen,
a hub projecting from the inner shaft and configured to releasably receive the at least one post,
a release sheath assembly disposed between the delivery sheath assembly and the inner shaft, the release sheath assembly including a release sheath slidably disposed about the inner shaft;
wherein the system is configured to provide a loaded condition in which the prosthetic heart valve is retained between the delivery sheath assembly and the inner shaft, including the at least one post captured between the release sheath and the hub.
12. The system of claim 11 , wherein the release sheath assembly is configured to proximally retract the release sheath relative to the hub with proximal retraction of the delivery sheath distal end from the release sheath.
13. The system of claim 11 , wherein the release sheath assembly further includes a mounting base connected to the release sheath by at least one biasing member.
14. The system of claim 13 , wherein the at least one biasing member is a leaf spring-like body.
15. The system of claim 13 , wherein the mounting base is fixed to the inner shaft proximal the hub.
16. The system of claim 15 , wherein the release sheath assembly is self-transitionable from a deflected state to a normal state, and further wherein a longitudinal spacing between the release sheath and the mounting base in the deflected state is greater than a spacing in the normal state.
17. The system of claim 16 , wherein the release sheath assembly includes two biasing members interconnecting the release sheath and the base.
18. The system of claim 17 , wherein an outer diameter collectively defined by the biasing member in the normal state is greater than a diameter of the lumen of the delivery sheath assembly.
19. A method of percutaneously deploying a stented prosthetic heart valve to an implantation site of a patient, the method comprising:
receiving a delivery device loaded with a radially expandable prosthetic heart valve having a stent frame to which a valve structure is attached, the delivery device including a delivery sheath assembly containing the prosthetic heart valve in a compressed arrangement over an inner shaft in a loaded state of the device, a hub projecting from the inner shaft, and a release sheath assembly including a release sheath slidably capturing a post of the stent frame to the hub;
delivering the prosthetic heart valve in the compressed arrangement through a bodily lumen of the patient and to the implantation site via the delivery device in the loaded state;
proximally retracting the delivery sheath assembly from the prosthetic heart valve; and
permitting the post to release from the hub, including the release sheath assembly self-retracting the release sheath relative to the hub.
20. The method of claim 19 , wherein proximally retracting the delivery sheath assembly includes locating a distal end of the delivery sheath assembly longitudinally between a distal end of the prosthetic heart valve and the release sheath in a partially deployed state such that a distal portion of the prosthetic heart valve is exposed, and further wherein the partially deployed state includes the exposed distal portion self-expanding from a compressed arrangement toward a normal arrangement, and a proximal portion of the prosthetic heart valve remains secured to the delivery device via capturing of the at least one post between the release sheath and the hub.
21. The method of claim 19 , wherein the release sheath assembly further includes at least one biasing member connecting the release sheath with a mounting base.
22. The method of claim 21 , wherein the mounting base is fixed to the inner shaft proximal the release sheath, and further wherein proximally retracting the delivery sheath assembly includes locating the distal end of the delivery sheath assembly proximal the release sheath such that the biasing member self-transitions toward a normal state and retracts the release sheath from the hub.
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Also Published As
Publication number | Publication date |
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JP2013503009A (en) | 2013-01-31 |
CN102573703A (en) | 2012-07-11 |
US20110098805A1 (en) | 2011-04-28 |
CN102573703B (en) | 2014-12-10 |
US8414645B2 (en) | 2013-04-09 |
EP2470119B1 (en) | 2017-05-10 |
EP2470119A1 (en) | 2012-07-04 |
JP5744028B2 (en) | 2015-07-01 |
AU2010286587B2 (en) | 2013-10-17 |
AU2010286587A1 (en) | 2012-03-15 |
WO2011025945A1 (en) | 2011-03-03 |
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