WO2003002035A2 - Delivery and recovery sheaths for medical devices - Google Patents

Delivery and recovery sheaths for medical devices Download PDF

Info

Publication number
WO2003002035A2
WO2003002035A2 PCT/US2002/018504 US0218504W WO03002035A2 WO 2003002035 A2 WO2003002035 A2 WO 2003002035A2 US 0218504 W US0218504 W US 0218504W WO 03002035 A2 WO03002035 A2 WO 03002035A2
Authority
WO
WIPO (PCT)
Prior art keywords
recovery
housing portion
sheath
restraining device
expandable
Prior art date
Application number
PCT/US2002/018504
Other languages
French (fr)
Other versions
WO2003002035A3 (en
Inventor
William J. Boyle
Andy E. Denison
Benjamin C. Huter
Scott J. Huter
John E. Papp
Charles R. Peterson
Kent C. B. Stalker
Original Assignee
Advanced Cardiovascular Systems, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Advanced Cardiovascular Systems, Inc. filed Critical Advanced Cardiovascular Systems, Inc.
Priority to AU2002315046A priority Critical patent/AU2002315046A1/en
Publication of WO2003002035A2 publication Critical patent/WO2003002035A2/en
Publication of WO2003002035A3 publication Critical patent/WO2003002035A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/01Filters implantable into blood vessels
    • A61F2/011Instruments for their placement or removal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/01Filters implantable into blood vessels
    • A61F2002/018Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0006Rounded shapes, e.g. with rounded corners circular
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0073Quadric-shaped
    • A61F2230/008Quadric-shaped paraboloidal

Definitions

  • the present invention relates generally to delivery and recovery devices for use in conjunction with specialized medical devices, such as embolic filter used when an interventional procedure is being performed in a stenosed or occluded region of a body vessel to capture embolic material that may be created and released into the vessel during the procedure.
  • specialized medical devices such as embolic filter used when an interventional procedure is being performed in a stenosed or occluded region of a body vessel to capture embolic material that may be created and released into the vessel during the procedure.
  • the present invention also can be used to deliver other self-expanding medical devices, such as a self-expanding stent, within a patient's vasculature.
  • the balloon is then deflated to a small profile so that the dilatation catheter can be withdrawn from the patient's vasculature.
  • Enhanced blood flow should now resume in the dilated artery.
  • abrupt reclosure may occur or restenosis of the artery may develop over time, which may require another angioplasty procedure, a surgical bypass operation, or some other method of repairing or strengthening the injured area.
  • a physician can implant an intravascular prosthesis for maintaining vascular patency, commonly known as a stent, inside the artery across the lesion.
  • the stent can be crimped onto the balloon portion of the catheter and transported in its delivery diameter through the patient's vasculature. At the deployment site, the stent is expanded to a larger diameter, often by inflating the balloon portion of the catheter.
  • stent designs have been developed and include self- expanding stents insertable and deliverable through the patient's vasculature in a compressed state for deployment in a body.
  • self- expanding stents are made from materials which are self-expanding in order to move between a compressed or collapsed position to an expanded, implanted position.
  • Stent delivery catheters used for implanting self-expanding stents usually include an inner member upon which the compressed or collapsed stent is mounted and an outer restraining sheath placed over the stent to maintain it in its compressed state prior to deployment.
  • the outer restraining sheath When the stent is to be deployed in the body vessel, the outer restraining sheath is retracted in relation to the inner member to uncover the compressed stent, allowing the stent to move into its expanded condition for implantation in the patient.
  • These non-surgical interventional procedures when successful, avoid the necessity of major surgical operations.
  • there is one common problem associated with these procedures namely, the potential release of embolic debris into the bloodstream that can occlude distal vasculature and cause significant health problems to the patient.
  • the metal struts of the stent it is possible for the metal struts of the stent to cut into the stenosis and shear off pieces of plaque which become embolic debris that can travel downstream and lodge somewhere in the patient's vascular system.
  • Pieces of plaque material can sometimes dislodge from the stenosis during a balloon angioplasty procedure and become released into the bloodstream.
  • Angioplastic procedures which are performed in occluded saphenous vein grafts, implanted as a result of an open heart surgical procedure, pose a particularly difficult problem to the physician since a large amount of embolic debris is usually generated during the angioplasty procedure.
  • Medical devices have been developed to attempt to deal with the problem created when debris or fragments enter the circulatory system during vessel treatment.
  • One technique which has had some limited success include the placement of a filter or trap downstream from the treatment site to capture embolic debris before it reaches the smaller blood vessels downstream.
  • the placement of a filter in the patient' s vasculature during treatment of the vascular lesion can reduce the presence of the embolic debris in the bloodstream.
  • Some prior art expandable filters are attached to the distal end of a guide wire or guide wire-like member that allows the filtering device to be placed in the patient's vasculature. The guide wire allows the physician to steer the filter to a downstream location from the area of treatment.
  • the embolic filter can be deployed to capture embolic debris.
  • embolic filtering devices usually utilize a restraining sheath to maintain the expandable filter in its collapsed position. Once the proximal end of the restraining sheath is retracted by the physician, the expandable filter will move into its fully expanded position. The restraining sheath can then be removed from the guide wire allowing the guide wire to be used by the physician to deliver interventional devices, such as a balloon angioplasty catheter or a stent delivery catheter, into the area of treatment.
  • interventional devices such as a balloon angioplasty catheter or a stent delivery catheter
  • a recovery sheath can be delivered over the guide wire using over-the-wire techniques to collapse the expanded filter (with the trapped embolic debris) for removal from the patient's vasculature.
  • Both the delivery sheath and recovery sheath should be relatively flexible to track over the guide wire and to avoid straightening the body vessel once in place. While a filter can be effective in capturing embolic material, the filter still needs to be collapsed and removed from the vessel. During this step, there is a possibility that trapped embolic debris can backflow through the inlet opening of the filter and enter the bloodstream as the filtering system is being collapsed and removed from the patient.
  • the guide wire be rotatable so that the physician can steer it downstream of the area of treatment using techniques well known in the art.
  • the guide wire is usually "torqued" by the physician to point or steer the distal end of the guide wire into the desired body vessel.
  • a restraining sheath it can be difficult to properly turn the composite device to deliver the filter through the tortuous anatomy of the patient.
  • the restraining sheath remain positioned over the collapsed filter, otherwise the filter could be deployed prematurely in an undesired location in the patient's anatomy. This occurrence can cause trauma to the walls of the patient's vasculature and would require the physician to re-sheath the expanded filter in order to further advance the filter into the desired area.
  • the length of the sheath can sometimes be problematic to the physician as well.
  • a full-length restraining sheath i.e., a tubular sheath extending from the area of treatment to an area outside of the patient
  • the guide wire utilized must have an extended length to allow the sheath to be removed and advanced along the guide wire.
  • additional medical personnel may be required to hold the guide wire in place when the restraining sheath is being removed to allow the interventional devices to be advanced over the guide wire.
  • a full-length recovery sheath is being used to collapse the expanded filter for removal from the patient's vasculature. Morever, when full-length sheaths are used for other delivery or recovery, more time is usually needed to remove or advance the sheath along the guide wire.
  • the present invention provides delivery and recovery sheaths for use with expandable embolic filtering devices and other medical devices which deliver self- expanding components, such as self-expanding stents and vascular grafts, for implantation in a patient's vasculature.
  • the present invention can be used with an embolic filtering device that generally includes a guide wire having a distal end, a self- expanding filter basket attached to the guide wire near its distal end, and a restraining sheath that maintains the self-expanding filter basket in a collapsed position until it is ready to be deployed in the patient.
  • the present invention eliminates the need for a full-length restraining sheath which have been previously used to deploy and retrieve the filter basket.
  • the present invention provides the physician with a rapid exchange delivery and recovery sheath which can eliminate the need to use long exchange wires when delivering or recovering the expandable filtering device and may reduce the time needed to perform the same.
  • the delivery sheath of the present invention can be used not only to deliver the filter to the target location in the patient's anatomy, but can also be used to collapse and retrieve the filtering device once the interventional procedure has been completed.
  • the present invention eliminates the need for two separate sheaths to be supplied with a single filtering device since one sheath can perform both delivery and recovery functions.
  • the delivery sheath includes an expandable housing portion adapted to collapse and hold the filter basket until the basket is ready to be deployed within the patient.
  • the sheath itself can be attached to a mandrel or guide wire which extends proximally from the sheath. The proximal end of the mandrel extends outside of the patient and is utilized by the physician to manipulate and move the sheath along the guide wire of the filtering device to retract the expandable housing portion from the filter basket.
  • the sheath also includes a lumen which extends from the housing portion and serves as a rapid exchange port for receiving the guide wire of the embolic filtering device.
  • the expandable housing portion of the sheath can be made from a number of different materials and configurations, as will be described herein, to maintain the filter basket in its collapsed position while the filter basket is being advanced or removed from the patient's anatomy.
  • the delivery sheath can be used to deliver a self-expanding stent or vascular graft within the patient's anatomy.
  • the sheath is used with a delivery catheter which includes a member for mounting the stent or graft. Like the filtering device, this delivery catheter is attached to a guide wire or guide wire-like member to allow the physician to steer the self-expanding device into the area of treatment.
  • the expandable housing portion of the sheath is stretchable and elastic to allow the sheath to hold the filter basket in place and prevent premature deployment.
  • the housing portion of the sheath acts to "encapsulate" the filter basket, thus preventing it from being released from the sheath until the physician is ready to do so.
  • the sheath is elastic and stretchable, it can achieve a number of different diameters and sizes when recovering or delivering the filtering device. For example, when the present invention is utilized as a recovery sheath, the housing portion will initially contract to its smaller diameter as it tracks along the guide wire of the embolic filtering device.
  • the possibility that the tip of the sheath could scrape the walls of the body vessel causing a "snowplow" effect as the device is being advanced over the guide wire is reduced.
  • the distal tip of the housing portion After the distal tip of the housing portion starts to contact the filter basket, it will begin to expand radially to draw the basket into the housing portion. Once the distal tip starts to expand, the remainder of the sheath begins to expand somewhat allowing the filter basket to be drawn into the remainder of the housing portion.
  • the housing portion has sufficient strength to impart an inward radial force that compresses the filter basket to its smaller diameter permitting the filter device to be subsequently removed from the patient.
  • the basket Once the basket is drawn into the housing portion of the sheath, it will be “encapsulated” to prevent emboli trapped in the filter basket from “back washing” into the body vessel, thus preventing the re-release of potentially damaging emboli into the patient's vasculature.
  • the expandable housing portion of the sheath can be made in a number of different ways.
  • the sheath portion of the device is made from a highly elastic material with a distal tip that expands to collapse the filter basket.
  • An expandable and retractable member such as self-expanding nitinol wire made from a material such as nickle-titanium (NiTi) would be embedded within the elastic tip material. The wire would be biased to normally contract, but would be radially expandable when subjected to an outward radial force.
  • the expandable housing portion would be made from a relatively stiff tubular material which has interspersed therein elastic material that creates expansion members or joints that provide the necessary elasticity to allow the housing portion to expand and contract.
  • the tubular portion of the housing provides column strength needed to maintain the embolic basket in its collapsed position and to prevent buckling of the sheath as it is advanced along the guide wire.
  • the highly elastic material forming the expansion members can take on numerous shapes and sizes and can be fitted into spaces cut into the tubular member or molded therein.
  • the expandable housing portion could be formed from a tubular member which is highly elastic and includes reinforcing members that provide the column strength needed when advancing the sheath along the guide wire but do not interfere with the radial expansion of the housing.
  • the present invention is also directed to a recovery sheath having an inner recovery tip which extends out of the distal tip of the recovery sheath and tracks along the guide wire of the embolic filtering device to prevent a "snowplowing" effect from occurring.
  • the inner recovery tip and the outer recovery sheath are positioned such that a frictional fit between the inner recovery tip and outer recovery sheath is created to maintain the inner tip at the distal end of the recovery sheath as the two components are advanced simultaneously along the guide wire.
  • the frictional fit can be enhanced by a frictional mechanism, such as overlapping ribs located on the surfaces of the recovery sheath and inner tip.
  • the frictional fit is overcome allowing the inner tip to slide back into the outer recovery sheath.
  • the distal tip of the recovery sheath will now come in contact with the filter basket in order to collapse the basket.
  • the inner recovery tip continues to slide proximally back into the outer recovery sheath until the entire embolic filter device is completely recovered.
  • FIGURE 1 is a perspective view of a rapid exchange delivery sheath embodying features of the present invention.
  • FIG. 2 is an elevational view, partially in cross section, of the distal end of the rapid exchange delivery sheath of FIG. 1, with an embolic filtering device housed therein.
  • FIG. 3 is an elevational view, partially in cross section, of the distal end of the rapid exchange delivery sheath of FIG. 1, with a self-expanding stent housed therein.
  • FIG. 4 is a perspective view of one embodiment of an expandable housing portion of a delivery and recovery sheath embodying features of the present invention in its contracted position.
  • FIG. 5 is a perspective view of the expandable housing portion of FIG.4 in an expanded position.
  • FIG. 6 is a perspective view of another embodiment of an expandable housing portion of a delivery and recovery sheath embodying features of the present invention in its contracted position.
  • FIG .7 is a perspective view, partially in cross-section, of the expandable housing shown in FIG. 6 as it is placed in an expanded position.
  • FIG. 8 is a perspective view of another embodiment of an expandable housing portion of a delivery and recovery sheath embodying features of the present invention in its contracted position.
  • FIG. 9 is a perspective view of the housing portion of FIG. 8 in an expanded position.
  • FIG. 10 is a perspective view of another embodiment of an expandable housing portion of a delivery and recovery sheath embodying features of the present invention.
  • FIG. 11 is a perspective view of the housing portion of FIG. 10 in an expanded position.
  • FIG. 12 is a perspective view of another embodiment of an expandable housing portion of a delivery and recovery sheath embodying features of the present invention.
  • FIG. 13 is a perspective view of the housing portion of FIG. 12 in an expanded position.
  • FIG. 14 is a side elevational view showing an expandable housing portion made in accordance with the present invention as it approaches an expandable filter basket for recovery purposes.
  • FIG. 15 is a side elevational view of the expandable housing portion of FIG. 14 as it begins to collapse the filter basket of the embolic filtering device.
  • FIG. 16 is a side elevational view of the expandable housing portion of FIG. 14 as it completely recovers the filter basket of the embolic filtering device.
  • FIG. 17 is a side elevational view of a recovery sheath with an inner recovery tip embodying features of the present invention as it approaches the proximal end of a filter basket of an embolic filtering device.
  • FIG. 18 is a side elevational view of the outer recovery sheath and inner recovery tip of FIG. 17 as the inner recovery tip retracts back into the outer recovery sheath as the outer recovery sheath is advanced to collapse the filter basket.
  • FIG. 19 is a side elevational view showing the inner recovery tip retracted further into the outer recovery sheath as the filter basket is retrieved by the outer recovery sheath.
  • FIG.20 is a side elevational view, in cross-section, showing the frictional mechanism which enhances the frictional contact between the recovery sheath and inner recovery tip shown in FIG. 17.
  • FIG. 21 is a side elevational view, in' cross-section, of another embodiment of a frictional mechanism which enhances the frictional contact between the outer recovery sheath and inner recovery tip of FIG. 17.
  • FIGS. 1 and 2 illustrate a restraining device 20 incorporating features of the present invention.
  • This restraining device is adapted for use with a medical device, such as an expandable embolic filtering device designed to capture embolic debris which may be created and released into a body vessel during an interventional procedure.
  • the restraining device 20 can be used both as a delivery sheath of placing the filtering device into the target area and a recovery sheath for retrieving the device from the patient.
  • FIGS. 1 and 2 show a particular embodiment of a restraining device 20 incorporating features of the present invention which includes a sheath 22 having a distal tip 24 and expandable housing portion 26.
  • the sheath 22 is a tube-like member which has a lumen 28 extending proximally from the expandable housing portion 26 to receive the distal end of a mandrel 30.
  • the sheath 22 also has a second lumen 32 which extends proximally from the housing portion 26 to form a channel for receiving a guide wire 38 of an embolic filter device 34, such as the one shown in FIG. 2.
  • the lumen 32 has an opening 36 through which the guide wire 38 can extend therethrough.
  • the mandrel 30 has a proximal end 40 and a torquing handle 42 which is manipulated by the physician when positioning the restraining device 20 and embolic filtering device 34 in the patient's vasculature.
  • the embolic filtering device 34 includes an expandable filter basket 44 having a plurality of self-expanding struts 46 which are attached to a filtering element 48.
  • the embolic filter device 34 also includes an obturator 50 affixed to the distal end of the filter basket 44 to prevent possible "snowplowing" of the embolic filtering device during delivery to the vasculature.
  • This obturator can be made from a soft polymeric material, such as PEBAX D 40, and has a smooth surface which creates a substantially smooth outer surface when placed adjacent to the sheath 22.
  • the guide wire 38 of the embolic filtering device 34 extends through the lumen 32 of the sheath 22 and extends proximally outside of the patient.
  • the physician can manipulate the proximal end (not shown) of the guide wire 38 with a torque handle to steer the distal guid wire tip 39 and restraining device 20 into the desired location in the patient's vasculature.
  • the filter basket 44 should be rotatably affixed to the guide wire 38 to allow the guide wire to be rotated freely as the filter basket 44 is held in place by the housing portion 26 of the sheath 22. As can be further seen in FIG.
  • the mandrel 30 has a tapered distal tip 52 which creates a bit more flexibility to the device near its distal end where flexibility is required when the physician steers through the sometimes tortuous anatomy of the patient.
  • a marker band 54 located proximal to the opening 36 of the rapid exchange lumen 32 would be used both as a marker to help the physician in locating the device when using flouroscopic instruments and would also be able to keep the opening 36 inside the guiding catheter or sheath 45 at all times. This helps to prevent these components from damaging the system.
  • the mandrel can be coated with a polymeric coating, or PTFE (Teflon ® ) in order to provide a lubricious coating which helps when advancing the device through the guide catheter (not shown).
  • the overall length of the restraining device 20 would be approximately 75 to 190 centimeters.
  • the overall length of the device will depend, of course, upon the type of medical component being delivered by restraining device 20, along with the location of the intended area of treatment and the area of access. These figures can change accordingly.
  • the sheath 22 would be approximately 70 to 185 centimeters in length with the expandable housing portion 26 being approximately 3 centimeters in length in order to properly hold the embolic filtering device 34. It should be appreciated that the size of the expandable housing portion 26 can vary in accordance with the size and length of the self-expanding medical component which it is restraining.
  • different medical devices can be used in conjunction with the present invention which may have a larger or smaller overall length that would change the size needed for the housing portion 26.
  • the majority of the sheath 22 is dedicated to the lumen 28 which holds the mandrel and the rapid exchange lumen 32 that receives the guide wire of the embolic filtering device. It should be appreciated that this length can also vary depending upon any given application, although other lengths are particularly suited since the sheath 22 is intended to extend out of the guide catheter (see FIGS. 2 and 3) while the mandrel 30 is usually housed within the sheath 22 itself. It should be noted that although a mandrel 30 is shown, this particular elongated member can be any one of a number of different structures including a guide wire or other guide wire-like devices.
  • the versatility of the present invention is shown as the restraining device 20 is utilized in delivering a self-expanding medical component, namely a stent 56, within the patient's vasculature.
  • a self-expanding medical component namely a stent 56
  • the stent 56 is mounted onto a delivery device 58 that includes a mounting region 60 upon which the collapsed stent is placed during delivery.
  • the delivery device 58 also includes a guide wire 38 which extends from the mounting region 60 to provide the physician with an end that can be manipulated to steer the device into the area of treatment.
  • This particular delivery device may also include a obturator 50 which also forms a smooth transition surface to the outer surface with the sheath 22 to prevent possible "snowplowing" when the device is being steered through the patient's vasculature.
  • the delivery device 58 depicted herein is just one example of numerous different delivery devices which can be utilized in accordance with the present invention.
  • the delivery device 58 includes a mounting region and a steerable guide wire which allows the physician to manipulate the device into the target area.
  • a stent is shown on this particular delivery device, it also possible to mount another medical device, such as a vascular graft having self-expanding rings which can be deployed within a patient' s vasculature as well.
  • the mouting region may be longer in length to accommodate the vascular graft.
  • the housing portion 26 of the sheath 22 may have to be longer in length to accommodate the larger medical component.
  • the size, shape and length of the restraining device 20 can be varied in order to accommodate the particular medical component that it is delivering to the target location.
  • the embolic filtering device 34 would be delivered within a body vessel of the patient, such as an artery.
  • the filter basket 44 would be placed downstream from an area of treatment where an interventional procedure is to be performed.
  • the area of treatment might be an artherosclerotic stenosis in which plaque has built up against the inside wall of the artery.
  • the therapeutic interventional procedure may comprise the implantation of a stent to increase the diameter of the occluded artery and increase the blood flow therethrough.
  • the present invention can be used in other body vessels, such as the coronary arteries, carotid arteries, renal arteries, saphenous veins and other peripheral arteries. Additionally, the present invention can be utilized to deploy an embolic filtering device when a physician performs any one of a number of interventional procedures, such as balloon angioplasty, laser angioplasty or atherectomy, which requires the need for a filtering device to be located downstream from the area of treatment.
  • interventional procedures such as balloon angioplasty, laser angioplasty or atherectomy
  • the sheath 64 is made from two different materials which provide the elasticity and flexibility needed to preform the functions of the recovery sheath.
  • the sheath 64 includes highly elastic expansion members 66 which are interspaced between sections 68 of low expansive material that provides column strength and axial stiffness to the housing portion 62.
  • the expansion members 66 extend lengthwise across the housing portion 62 and function in such a manner as to provide elasticity to cause the normal diameter C of the housing portion 62 (FIG. 4) to expand to the larger diameter X as shown in FIG. 5.
  • the low expansion section 68 can be made from, for example, a soft material loaded with radiopaque materials to provide additional radiopacity to the sheath 64.
  • the material for the section 68 could be PEBAX 40 D loaded with known radiopaque materials.
  • Other suitable materials include polymeric materials such as cross-linked HDPE, polyolefin and polyamide.
  • the expansive members 66 couldbe highly elastic materials which include biocompatible polyurethane, silicone, polyisoprene and lower durometer PEBAX. As can be seen in FIG. 5, once an outer expansive force is placed on the inside surface 70 of the housing portion 62, the expansion member 66 will expand causing an increase in the inner diameter as is shown.
  • the low expansion sections 68 remain relatively unchanged although it should be appreciated that some expansion could possibly take place depending upon the materials which are utilized for this particular portion of the housing 62.
  • the particular embodiment shown in FIGS. 4 and 5 utilize three expansion members 66 which extend longitudinally along the length of the housing portion 62, it should be appreciated that the number of expansion members which is utilized can vary depending upon the particular properties which are to be achieved. For example, more or less expansion members can be utilized as needed. Additionally, the elasticity of the material used for the expansion members could also dictate the number, size and location of expansion members which can be interspersed onto the housing portion 62. Additionally, although the expansion members are shown substantially as longitudinal strips which extend longitudinally along the housing, a variety of different shapes and sizes could be utilized without departing from the spirit and scope of the present invention.
  • each end of the expansive member 66 can include a circular shape 72 which allows the low expansion sections 68 to expand without tearing.
  • this particular sheath 64 includes a proximal end 73 which tapers to a tubular member 74 that extends proximally to an outside location from the patient.
  • the expandable housing portion 62 can be part of a elongated tubular member which creates a full-length sheath.
  • the tubular member 74 would have an internal lumen formed therein which receives the guide wire of the medical device, such as the embolic filtering device, which would be restrained within the housing portion 62.
  • the sheath 64 could be made with two lumens forming a rapid exchange lumen and a lumen for receiving a mandrel to create the rapid exchange-type restraining device as shown in FIGS. 1-3.
  • the sheath 78 includes reinforcing members 80 disposed within a tubular member 82, made from highly elastic material.
  • This highly elastic tubular member 82 is adapted to expand up and over the filter basket as has been described herein and is shown in greater detail in FIGS. 14-16.
  • the sheath 78 is primarily formed from the elastic tubular member 82 with the reinforcing members 80 being disposed to provide column strength to the housing portion 76. As is shown in FIG.
  • the elastic tubular portion 82 is expandable to a larger diameter X to extend over the filter basket when the device is to be retrieved from the patient's vasculature.
  • the reenforcing members 80 do not expand with the tubular portion 82 but provide reenforcing characteristics to prevent the housing portion 78 from buckling as it is being advanced along a guide wire.
  • These reenforcing members 80 are disposed along the tubular member 82 such that they will not interfere with the radial expansion of the tubular member 82.
  • the reenforcing member can be loaded with a material having high radiopacity to increase the ability to visualize the sheath within the patient using a fluoroscope, or other visualization equipment.
  • FIGS. 4 and 5 can be made by selecting a cylindrical or tubular member made from a low elastic material, such as the PEBAX 40 D, as described above. Slots which correspond to the size, shape and location of the expandable expansion members 66 can then be cut into the tubular member creating voids into which the material forming the expansion members 66 can be placed. For example, slots could be cut into the material by a laser or by mechanical means. A coated mandrel could then be inserted into the inner diameter of the tubular member to provide rigidity to the sheath as the expansion members are being formed. The highly elastic material to be used for the expansion member 66 could then be dissolved in volatile solution which would be applied at the cut or lased areas to create the highly elastic expansion members .
  • a low elastic material such as the PEBAX 40 D
  • the elastic material can then cure within the cut or lased pattern to create the expansion members 66. While this is just one method for manufacturing this sheath, it should be appreciated that the expansion members could be cut from an elastic material and physically bonded within the slots formed on the tubular member, as well. Still other ways of manufacturing the composite unit can be utilized.
  • the housing portion 78 of the sheath 78 shown in FIGS. 6 and 7 could be made in much the same way.
  • a tubular member having high elasticity can be selected and stiffer reenforcing members 80 can be physically applied to the member.
  • stiffer reenforcing members 80 can be physically applied to the member.
  • slots can be cut into the member with reenforcing members 80 bonded or otherwise affixed within the slots to form a composite unit.
  • the reenforcing members 80 are shown as being embedded into the tubular member 82, they could also be fromed from thinner strips which are applied to the inner surface 84 or outer surface 86 of the sheath 76.
  • the number, location and size of the reenforcing members 80 can vary depending upon the application and the particular materials which are being utilized to create the sheath 78.
  • This particular sheath 78 can be incorporated into a rapid exchange-type sheath as shown in FIGS. 1-3, or alternatively, could be incorporated into a full-length sheath as shown in the design of FIGS. 4 and 5.
  • the materials which can be utilized for the reenforcing members include stainless steel, polymers and nickel-titanium alloys such as nitinol.
  • the sheath 92 includes a coil spring 94 embedded into the sheath 92 to provide the elasticity needed to expand the housing portion 90 when needed.
  • the coil spring 94 can be permanently set into the material forming the sheath 92 or it could be attached to the outside or inside surface of the sheath as well. In use, the coil spring 94 is normally biased to the smaller collapsed diameter C, as shown in FIG. 8. Thereafter, when a outward radial force is applied to the inner surface 96 of the housing portion 90, the coil spring expands outwardly allowing the housing portion to expand as needed to capture the filter basket.
  • the coil spring 94 can be made from a material such as nickel titanium, spring steel or a plastic material having high flexibility.
  • the sheath 92 can be made from a soft material with high elongation or elasticity, such as silicone, polyurethane or other stretchable material.
  • FIGS. 10 and 11 show another embodiment of the expandable housing portion 100 is shown as it is affixed to a sheath 102.
  • an expandable ring member 104 is utilized near the distal end 106 of the housing portion 100.
  • This particular ring member can be made from material such as nickel titanium or spring steel.
  • the ring member 104 has undulations which allow the ring member to expand radially outward as shown in FIG. 11 to increase the diameter of the housing portion 100.
  • the ring member 104 is normally biased to the collapsed diameter C, as shown in FIG. 10.
  • the ring member 104 can be either attached to the outside surface or inside surface of the sheath 102 or can be formed directly into the sheath 102 using molds and other known techniques well-known in the art. Again, the sheath 102 should be made from an elastic material such as silicone, polyurethane or other highly stretchable material.
  • the housing portion 110 includes a distal tip portion 114 which includes a ring member 116, similar to the one shown in FIGS. 10 and 11.
  • the distal tip portion 114 can be made from a material which is different from the remaining portion of the sheath 112.
  • the tip material can be made from a material which is even more elastic than the portion 118 which forms the remainder of the sheath 112.
  • the tip of the sheath will be highly elastic yet will have a biasing member which contracts the tip once the tip extends over the component to be restrained, such as the filter basket of an embolic filtering device.
  • the tip portion 114 can be adhesively bonded to the remaining portion 118 of the sheath 112 using adhesives, or other bonding or molding techniques.
  • the ring member 116 can be either embedded into the material forming the tip portion 114 itself, or can be applied to the outer surface or inner surface of this portion of the sheath as well.
  • FIGS . 14-16 show the use of a restraining device 20 which incorporates the features of the present invention is shown as it is retrieving an embolic filtering device 34, similar to the one shown in FIG. 2.
  • the expandable housing portion 26 is shown as it is approaching the proximal end of the filtering device 34.
  • the distal tip 120 of this expandable housing portion 26 is shown conforming close to the diameter of the guide wire to closely track to the guide wire as it is being advanced into the patient's vasculature, thus avoiding a possible "snowplowing" effect on the vascular walls of the patient.
  • the housing portion 26 encapsulates the filter basket for removal from the patient without the fear of releasing captured embolic material.
  • This particular sequence is typical of the manner in which all of the embodiments disclosed and described herein would functions during usage. This is irregardless of whether the housing portion is formed as a rapid exchange-type sheath or is incorporated into a full-length sheath.
  • the recovery sheath 120 includes an inner recovery tip 122 located within the recovery sheath 120.
  • This recovery sheath 120 has a lumen 124 through which a guide wire 38 extends.
  • the recovery sheath 120 and inner recovery tip 122 are designed to collapse and retrieve a device, such as an embolic filter device, as shown in FIGS. 17- 19.
  • the recovery sheath 120 includes a tip portion 126 designed to come in contact with a shoulder portion 128 formed on the recovery tip 122. In this manner, the recovery tip 122 will not be removable past the distal tip 126 of the recovery sheath.
  • the recovery tip 122 and recovery sheath 120 are in frictional contact with each other and will remain in contact until a sufficient external force is applied to the recovery tip to causes it to slide back into the lumen 124 of the recovery sheath 120. As is shown in FIG. 18, this inner recovery tip 122 retracts back into the recovery sheath 120 when an external force is placed at the distal end 130 of the inner tip 122. As the recovery tip 122 contacts the proximal fitting 129 of the filter basket 44, a sufficient force will cause the recovery tip 122 to retract back inside of the restraining sheath 120. Thereafter, as shown in FIG.
  • the recovery tip 122 will retract even further back into the sheath to allow the filter basket to be retrieved for removal from the patient. In this manner, the recovery tip 122 permits the recovery sheath 120 to be advanced along the guide wire to patient's vasculature without causing a "snowplowing" effect. Thereafter, once the recovery tip reaches the filter basket, it can be retracted backwards into the sheath to allow for the recovery of the filter basket.
  • the frictional fit which is created between the inner recovery tip 122 and recovery sheath 120 can be enhanced by a mechanism for increasing the frictional force between these two components.
  • the surface 131 of the restraining sheath 120 includes a number of outwardly projecting ribs 132 which are formed within the lumen 124.
  • the inner recovery tip 122 likewise includes a number of outwardly projecting ribs 134 designed to be placed between the ribs 132 of the recovery sheath 120. In this manner, the two sets of ribs 132 and 134 intermesh to help increase the frictional force between the recovery sheath 120 and the inner recovery tip 122.
  • the recovery sheath 120 includes a single rib 132 which extends outwardly from the surface 131.
  • the surface of the inner recovery tip 122 includes a number of rib-like channels 136 which are adapted to receive the rib 132 formed on the recovery sheath 120.
  • these channels 136 help to increase the frictional contact between these two components since a certain amount of force must first be applied to move the rib 132 into the second and third channels 136 located on the inner recovery tip. Additional channels can be added if additional resistive force is to be maintained.
  • the inner recovery tip 122 will then retract fully into the lumen 124 of the recovery sheath 120. Again, this is just one of a number of different simple frictional mechanisms which can be utilized in accordance with these components to increase the amount of force needed to retract the inner recovery tip 122 into the recovery sheath 120.
  • Friction between the restraining sheath and medical component can be reduced by applying a coat of silicone lubricant, such as Microglide®, to the inside surface of the restraining sheath before the sheath is placed over the medical component.
  • silicone lubricant such as Microglide®
  • the devices of the present invention substantially enhance the safety and efficiency of delivering and recovering embolic protection devices, and other medical devices, in a patient's vasculature. Further modifications and improvements may additionally be made to the system and method disclosed herein without departing from the scope of the present invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.

Abstract

A deployment control system (20) provides controlled deployment of an embolic protection device which may include a guide wire (38), an expandable filter (34) attached to the guide wire (38) near its distal end, and a restraining sheath (22, 26) that maintains the expanded filter in a collapsed position. The deployment control system (20) includes a torque control device which allows the physician to torque the guide wire (38) into the patient's anatomy and a mechanism for preventing the guide wire (38) form buckling as the restraining sheath (22, 26) is being retracted to deploy the expandable filter (38). A recovery control system for recovering the embolic protection device (44) includes an inner catheter (122) which extends within a lumen of an outer recovery sheath (120) in a coaxial arrangement. A distal portion of the inner catheter (122) extends beyond another recovery sheath during advancement of the recovery system into the vasculature. The recovery sheath (120) can be advanced over the inner catheter (122) to collapse the expandable filter. The proximal ends of the inner catheter and recovery sheath include handle portions having snap mechanisms which hold the components together as the recovery system is being advanced into the patient's vasculature.

Description

DELIVERY AND RECOVERY SHEATHS FOR MEDICAL DEVICES
BACKGROUND OF THE INVENTION The present invention relates generally to delivery and recovery devices for use in conjunction with specialized medical devices, such as embolic filter used when an interventional procedure is being performed in a stenosed or occluded region of a body vessel to capture embolic material that may be created and released into the vessel during the procedure. The present invention also can be used to deliver other self-expanding medical devices, such as a self-expanding stent, within a patient's vasculature.
Numerous procedures have been developed for treating occluded blood vessels to allow blood to flow without significant obstruction. Such procedures usually ' involve the percutaneous introduction of an interventional device into the lumen of the artery, usually through a catheter. One widely known and medically accepted procedure is balloon angioplasty in which an inflatable balloon is introduced within the stenosed region of the blood vessel to dilate the occluded vessel. The balloon catheter is initially inserted into the patient's arterial system and is advanced and manipulated into the area of stenosis in the artery. The balloon is inflated to compress the plaque and press the vessel wall radially outward to increase the diameter of the vessel, resulting in increased blood flow. The balloon is then deflated to a small profile so that the dilatation catheter can be withdrawn from the patient's vasculature. Enhanced blood flow should now resume in the dilated artery. As should be appreciated by those skilled in the art, while the above-described procedure is typical, it is not the only method used in angioplasty.
In the procedure of the kind referenced above, abrupt reclosure may occur or restenosis of the artery may develop over time, which may require another angioplasty procedure, a surgical bypass operation, or some other method of repairing or strengthening the injured area. To reduce the likelihood of the occurrence of abrupt reclosure and to strengthen the area, a physician can implant an intravascular prosthesis for maintaining vascular patency, commonly known as a stent, inside the artery across the lesion. The stent can be crimped onto the balloon portion of the catheter and transported in its delivery diameter through the patient's vasculature. At the deployment site, the stent is expanded to a larger diameter, often by inflating the balloon portion of the catheter.
A variety of stent designs have been developed and include self- expanding stents insertable and deliverable through the patient's vasculature in a compressed state for deployment in a body. Unlike balloon expandable stents which rely on an external radial force to expand the stent at the area of treatment, self- expanding stents are made from materials which are self-expanding in order to move between a compressed or collapsed position to an expanded, implanted position. Stent delivery catheters used for implanting self-expanding stents usually include an inner member upon which the compressed or collapsed stent is mounted and an outer restraining sheath placed over the stent to maintain it in its compressed state prior to deployment. When the stent is to be deployed in the body vessel, the outer restraining sheath is retracted in relation to the inner member to uncover the compressed stent, allowing the stent to move into its expanded condition for implantation in the patient. These non-surgical interventional procedures, when successful, avoid the necessity of major surgical operations. However, there is one common problem associated with these procedures, namely, the potential release of embolic debris into the bloodstream that can occlude distal vasculature and cause significant health problems to the patient. For example, during deployment of a stent, it is possible for the metal struts of the stent to cut into the stenosis and shear off pieces of plaque which become embolic debris that can travel downstream and lodge somewhere in the patient's vascular system. Pieces of plaque material can sometimes dislodge from the stenosis during a balloon angioplasty procedure and become released into the bloodstream. Angioplastic procedures which are performed in occluded saphenous vein grafts, implanted as a result of an open heart surgical procedure, pose a particularly difficult problem to the physician since a large amount of embolic debris is usually generated during the angioplasty procedure.
When any of the above-describedprocedures are performed in the carotid arteries, the release of emboli into the circulatory system can be extremely dangerous and sometimes fatal to the patient. Debris that is carried by the bloodstream to distal vessels of the brain can cause these cerebral vessels to occlude, resulting in a stroke, and in some cases, death. Therefore, although cerebral percutaneous transluminal angioplasty has been performed in the past, the number of procedures performed has been limited due to the justifiable fear of causing an embolic stroke should embolic debris enter the bloodstream and block vital downstream blood passages.
Medical devices have been developed to attempt to deal with the problem created when debris or fragments enter the circulatory system during vessel treatment. One technique which has had some limited success include the placement of a filter or trap downstream from the treatment site to capture embolic debris before it reaches the smaller blood vessels downstream. The placement of a filter in the patient' s vasculature during treatment of the vascular lesion can reduce the presence of the embolic debris in the bloodstream. Some prior art expandable filters are attached to the distal end of a guide wire or guide wire-like member that allows the filtering device to be placed in the patient's vasculature. The guide wire allows the physician to steer the filter to a downstream location from the area of treatment. Once the guide wire is in proper position in the vasculature, the embolic filter can be deployed to capture embolic debris. These embolic filtering devices usually utilize a restraining sheath to maintain the expandable filter in its collapsed position. Once the proximal end of the restraining sheath is retracted by the physician, the expandable filter will move into its fully expanded position. The restraining sheath can then be removed from the guide wire allowing the guide wire to be used by the physician to deliver interventional devices, such as a balloon angioplasty catheter or a stent delivery catheter, into the area of treatment. After the interventional procedure is completed, a recovery sheath can be delivered over the guide wire using over-the-wire techniques to collapse the expanded filter (with the trapped embolic debris) for removal from the patient's vasculature. Both the delivery sheath and recovery sheath should be relatively flexible to track over the guide wire and to avoid straightening the body vessel once in place. While a filter can be effective in capturing embolic material, the filter still needs to be collapsed and removed from the vessel. During this step, there is a possibility that trapped embolic debris can backflow through the inlet opening of the filter and enter the bloodstream as the filtering system is being collapsed and removed from the patient. Therefore, it is important that any captured embolic debris remain trapped within this filter so that particles are not released back into the body vessel. When a combination of an expandable filter and guide wire is utilized, it is important that the guide wire be rotatable so that the physician can steer it downstream of the area of treatment using techniques well known in the art. In this regard, the guide wire is usually "torqued" by the physician to point or steer the distal end of the guide wire into the desired body vessel. Often, when a restraining sheath is utilized, it can be difficult to properly turn the composite device to deliver the filter through the tortuous anatomy of the patient. Moreover, during delivery, it is imperative that the restraining sheath remain positioned over the collapsed filter, otherwise the filter could be deployed prematurely in an undesired location in the patient's anatomy. This occurrence can cause trauma to the walls of the patient's vasculature and would require the physician to re-sheath the expanded filter in order to further advance the filter into the desired area. When a restraining sheath is utilized to deliver or recover an expandable filter in the patient' s vasculature, the length of the sheath can sometimes be problematic to the physician as well. For example, when a full-length restraining sheath is used (i.e., a tubular sheath extending from the area of treatment to an area outside of the patient), the guide wire utilized must have an extended length to allow the sheath to be removed and advanced along the guide wire. As a result, additional medical personnel may be required to hold the guide wire in place when the restraining sheath is being removed to allow the interventional devices to be advanced over the guide wire. The same would be true when a full-length recovery sheath is being used to collapse the expanded filter for removal from the patient's vasculature. Morever, when full-length sheaths are used for other delivery or recovery, more time is usually needed to remove or advance the sheath along the guide wire.
What has been needed are reliable delivery and recovery sheath which can be used with embolic filtering devices that minimize the above-mentioned incidents from ever occurring. These devices should be relatively easy for a physician to use and should provide an effective means for deploying the embolic filtering device into the desired area of the body vessel and retrieving the same device without releasing any captured embolic debris into the body vessel. Moreover, it would be advantageous if sheaths can be advanced and removed from the guide wire in relatively quick fashion. The inventions disclosed herein satisfy these and other needs.
SUMMARY OF THE INVENTION
The present invention provides delivery and recovery sheaths for use with expandable embolic filtering devices and other medical devices which deliver self- expanding components, such as self-expanding stents and vascular grafts, for implantation in a patient's vasculature. The present invention can be used with an embolic filtering device that generally includes a guide wire having a distal end, a self- expanding filter basket attached to the guide wire near its distal end, and a restraining sheath that maintains the self-expanding filter basket in a collapsed position until it is ready to be deployed in the patient. The present invention eliminates the need for a full-length restraining sheath which have been previously used to deploy and retrieve the filter basket. The present invention provides the physician with a rapid exchange delivery and recovery sheath which can eliminate the need to use long exchange wires when delivering or recovering the expandable filtering device and may reduce the time needed to perform the same. Moreover, the delivery sheath of the present invention can be used not only to deliver the filter to the target location in the patient's anatomy, but can also be used to collapse and retrieve the filtering device once the interventional procedure has been completed. As a result, the present invention eliminates the need for two separate sheaths to be supplied with a single filtering device since one sheath can perform both delivery and recovery functions.
In one aspect of the present invention, the delivery sheath includes an expandable housing portion adapted to collapse and hold the filter basket until the basket is ready to be deployed within the patient. The sheath itself can be attached to a mandrel or guide wire which extends proximally from the sheath. The proximal end of the mandrel extends outside of the patient and is utilized by the physician to manipulate and move the sheath along the guide wire of the filtering device to retract the expandable housing portion from the filter basket. The sheath also includes a lumen which extends from the housing portion and serves as a rapid exchange port for receiving the guide wire of the embolic filtering device. The expandable housing portion of the sheath can be made from a number of different materials and configurations, as will be described herein, to maintain the filter basket in its collapsed position while the filter basket is being advanced or removed from the patient's anatomy. In one aspect of the present invention, the delivery sheath can be used to deliver a self-expanding stent or vascular graft within the patient's anatomy. In this particular aspect of the invention, the sheath is used with a delivery catheter which includes a member for mounting the stent or graft. Like the filtering device, this delivery catheter is attached to a guide wire or guide wire-like member to allow the physician to steer the self-expanding device into the area of treatment.
In another aspect of the present invention, the expandable housing portion of the sheath is stretchable and elastic to allow the sheath to hold the filter basket in place and prevent premature deployment. In this fashion, the housing portion of the sheath acts to "encapsulate" the filter basket, thus preventing it from being released from the sheath until the physician is ready to do so. Since the sheath is elastic and stretchable, it can achieve a number of different diameters and sizes when recovering or delivering the filtering device. For example, when the present invention is utilized as a recovery sheath, the housing portion will initially contract to its smaller diameter as it tracks along the guide wire of the embolic filtering device. As a result, the possibility that the tip of the sheath could scrape the walls of the body vessel causing a "snowplow" effect as the device is being advanced over the guide wire is reduced. After the distal tip of the housing portion starts to contact the filter basket, it will begin to expand radially to draw the basket into the housing portion. Once the distal tip starts to expand, the remainder of the sheath begins to expand somewhat allowing the filter basket to be drawn into the remainder of the housing portion. The housing portion has sufficient strength to impart an inward radial force that compresses the filter basket to its smaller diameter permitting the filter device to be subsequently removed from the patient. Once the basket is drawn into the housing portion of the sheath, it will be "encapsulated" to prevent emboli trapped in the filter basket from "back washing" into the body vessel, thus preventing the re-release of potentially damaging emboli into the patient's vasculature.
The expandable housing portion of the sheath can be made in a number of different ways. In one aspect of the present invention, the sheath portion of the device is made from a highly elastic material with a distal tip that expands to collapse the filter basket. An expandable and retractable member, such as self-expanding nitinol wire made from a material such as nickle-titanium (NiTi) would be embedded within the elastic tip material. The wire would be biased to normally contract, but would be radially expandable when subjected to an outward radial force. This would enable the sheath to track closely to the guide wire of the embolic filtering device while still being be able to expand radially to collapse the filter basket when the distal tip contacts the struts of the filter basket. In another aspect of the present invention, the expandable housing portion would be made from a relatively stiff tubular material which has interspersed therein elastic material that creates expansion members or joints that provide the necessary elasticity to allow the housing portion to expand and contract. In this regard, the tubular portion of the housing provides column strength needed to maintain the embolic basket in its collapsed position and to prevent buckling of the sheath as it is advanced along the guide wire. The highly elastic material forming the expansion members can take on numerous shapes and sizes and can be fitted into spaces cut into the tubular member or molded therein. In still another aspect of the present invention, the expandable housing portion could be formed from a tubular member which is highly elastic and includes reinforcing members that provide the column strength needed when advancing the sheath along the guide wire but do not interfere with the radial expansion of the housing.
The present invention is also directed to a recovery sheath having an inner recovery tip which extends out of the distal tip of the recovery sheath and tracks along the guide wire of the embolic filtering device to prevent a "snowplowing" effect from occurring. The inner recovery tip and the outer recovery sheath are positioned such that a frictional fit between the inner recovery tip and outer recovery sheath is created to maintain the inner tip at the distal end of the recovery sheath as the two components are advanced simultaneously along the guide wire. The frictional fit can be enhanced by a frictional mechanism, such as overlapping ribs located on the surfaces of the recovery sheath and inner tip. Once the inner tip comes in contact with the proximal end of the filter basket and a sufficient amount of force is applied to the inner recovery tip, the frictional fit is overcome allowing the inner tip to slide back into the outer recovery sheath. The distal tip of the recovery sheath will now come in contact with the filter basket in order to collapse the basket. As the basket is retracted into the outer recovery sheath, the inner recovery tip continues to slide proximally back into the outer recovery sheath until the entire embolic filter device is completely recovered.
It is to be understood that the present invention is not limited by the embodiments described herein. Other features and advantages of the present invention will become more apparent from the following detailed description of the invention, when taken in conjunction with the accompanying exemplary drawings.
BRIEF DESCRIPTION OF THE DRAWINGS FIGURE 1 is a perspective view of a rapid exchange delivery sheath embodying features of the present invention. FIG. 2 is an elevational view, partially in cross section, of the distal end of the rapid exchange delivery sheath of FIG. 1, with an embolic filtering device housed therein.
FIG. 3 is an elevational view, partially in cross section, of the distal end of the rapid exchange delivery sheath of FIG. 1, with a self-expanding stent housed therein.
FIG. 4 is a perspective view of one embodiment of an expandable housing portion of a delivery and recovery sheath embodying features of the present invention in its contracted position.
FIG. 5 is a perspective view of the expandable housing portion of FIG.4 in an expanded position.
FIG. 6 is a perspective view of another embodiment of an expandable housing portion of a delivery and recovery sheath embodying features of the present invention in its contracted position.
FIG .7 is a perspective view, partially in cross-section, of the expandable housing shown in FIG. 6 as it is placed in an expanded position.
FIG. 8 is a perspective view of another embodiment of an expandable housing portion of a delivery and recovery sheath embodying features of the present invention in its contracted position.
FIG. 9 is a perspective view of the housing portion of FIG. 8 in an expanded position.
FIG. 10 is a perspective view of another embodiment of an expandable housing portion of a delivery and recovery sheath embodying features of the present invention.
FIG. 11 is a perspective view of the housing portion of FIG. 10 in an expanded position.
FIG. 12 is a perspective view of another embodiment of an expandable housing portion of a delivery and recovery sheath embodying features of the present invention.
FIG. 13 is a perspective view of the housing portion of FIG. 12 in an expanded position.
FIG. 14 is a side elevational view showing an expandable housing portion made in accordance with the present invention as it approaches an expandable filter basket for recovery purposes.
FIG. 15 is a side elevational view of the expandable housing portion of FIG. 14 as it begins to collapse the filter basket of the embolic filtering device.
FIG. 16 is a side elevational view of the expandable housing portion of FIG. 14 as it completely recovers the filter basket of the embolic filtering device.
FIG. 17 is a side elevational view of a recovery sheath with an inner recovery tip embodying features of the present invention as it approaches the proximal end of a filter basket of an embolic filtering device.
FIG. 18 is a side elevational view of the outer recovery sheath and inner recovery tip of FIG. 17 as the inner recovery tip retracts back into the outer recovery sheath as the outer recovery sheath is advanced to collapse the filter basket.
FIG. 19 is a side elevational view showing the inner recovery tip retracted further into the outer recovery sheath as the filter basket is retrieved by the outer recovery sheath. FIG.20 is a side elevational view, in cross-section, showing the frictional mechanism which enhances the frictional contact between the recovery sheath and inner recovery tip shown in FIG. 17.
FIG. 21 is a side elevational view, in' cross-section, of another embodiment of a frictional mechanism which enhances the frictional contact between the outer recovery sheath and inner recovery tip of FIG. 17.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Turning now to the drawings, in which like reference numerals represent like or corresponding elements in the drawings, FIGS. 1 and 2 illustrate a restraining device 20 incorporating features of the present invention. This restraining device is adapted for use with a medical device, such as an expandable embolic filtering device designed to capture embolic debris which may be created and released into a body vessel during an interventional procedure. The restraining device 20 can be used both as a delivery sheath of placing the filtering device into the target area and a recovery sheath for retrieving the device from the patient.
FIGS. 1 and 2 show a particular embodiment of a restraining device 20 incorporating features of the present invention which includes a sheath 22 having a distal tip 24 and expandable housing portion 26. The sheath 22 is a tube-like member which has a lumen 28 extending proximally from the expandable housing portion 26 to receive the distal end of a mandrel 30. The sheath 22 also has a second lumen 32 which extends proximally from the housing portion 26 to form a channel for receiving a guide wire 38 of an embolic filter device 34, such as the one shown in FIG. 2. The lumen 32 has an opening 36 through which the guide wire 38 can extend therethrough. The mandrel 30 has a proximal end 40 and a torquing handle 42 which is manipulated by the physician when positioning the restraining device 20 and embolic filtering device 34 in the patient's vasculature.
The embolic filtering device 34, as shown in FIG. 2, includes an expandable filter basket 44 having a plurality of self-expanding struts 46 which are attached to a filtering element 48. The embolic filter device 34 also includes an obturator 50 affixed to the distal end of the filter basket 44 to prevent possible "snowplowing" of the embolic filtering device during delivery to the vasculature. This obturator can be made from a soft polymeric material, such as PEBAX D 40, and has a smooth surface which creates a substantially smooth outer surface when placed adjacent to the sheath 22.
As is shown in FIG. 2, the guide wire 38 of the embolic filtering device 34 extends through the lumen 32 of the sheath 22 and extends proximally outside of the patient. The physician can manipulate the proximal end (not shown) of the guide wire 38 with a torque handle to steer the distal guid wire tip 39 and restraining device 20 into the desired location in the patient's vasculature. It should be appreciated to those skilled in the art that the filter basket 44 should be rotatably affixed to the guide wire 38 to allow the guide wire to be rotated freely as the filter basket 44 is held in place by the housing portion 26 of the sheath 22. As can be further seen in FIG. 2, the mandrel 30 has a tapered distal tip 52 which creates a bit more flexibility to the device near its distal end where flexibility is required when the physician steers through the sometimes tortuous anatomy of the patient. A marker band 54 located proximal to the opening 36 of the rapid exchange lumen 32 would be used both as a marker to help the physician in locating the device when using flouroscopic instruments and would also be able to keep the opening 36 inside the guiding catheter or sheath 45 at all times. This helps to prevent these components from damaging the system. Additionally, the mandrel can be coated with a polymeric coating, or PTFE (Teflon®) in order to provide a lubricious coating which helps when advancing the device through the guide catheter (not shown).
The overall length of the restraining device 20 would be approximately 75 to 190 centimeters. The overall length of the device will depend, of course, upon the type of medical component being delivered by restraining device 20, along with the location of the intended area of treatment and the area of access. These figures can change accordingly. The sheath 22 would be approximately 70 to 185 centimeters in length with the expandable housing portion 26 being approximately 3 centimeters in length in order to properly hold the embolic filtering device 34. It should be appreciated that the size of the expandable housing portion 26 can vary in accordance with the size and length of the self-expanding medical component which it is restraining. For example, as would be shown below, different medical devices can be used in conjunction with the present invention which may have a larger or smaller overall length that would change the size needed for the housing portion 26. The majority of the sheath 22 is dedicated to the lumen 28 which holds the mandrel and the rapid exchange lumen 32 that receives the guide wire of the embolic filtering device. It should be appreciated that this length can also vary depending upon any given application, although other lengths are particularly suited since the sheath 22 is intended to extend out of the guide catheter (see FIGS. 2 and 3) while the mandrel 30 is usually housed within the sheath 22 itself. It should be noted that although a mandrel 30 is shown, this particular elongated member can be any one of a number of different structures including a guide wire or other guide wire-like devices.
Referring now to FIG. 3, the versatility of the present invention is shown as the restraining device 20 is utilized in delivering a self-expanding medical component, namely a stent 56, within the patient's vasculature. In this particular figure, the stent 56 is mounted onto a delivery device 58 that includes a mounting region 60 upon which the collapsed stent is placed during delivery. The delivery device 58 also includes a guide wire 38 which extends from the mounting region 60 to provide the physician with an end that can be manipulated to steer the device into the area of treatment. This particular delivery device may also include a obturator 50 which also forms a smooth transition surface to the outer surface with the sheath 22 to prevent possible "snowplowing" when the device is being steered through the patient's vasculature. It should be appreciated that the delivery device 58 depicted herein is just one example of numerous different delivery devices which can be utilized in accordance with the present invention. Generally, the delivery device 58 includes a mounting region and a steerable guide wire which allows the physician to manipulate the device into the target area. Additionally, while a stent is shown on this particular delivery device, it also possible to mount another medical device, such as a vascular graft having self-expanding rings which can be deployed within a patient' s vasculature as well. In such a case, the mouting region may be longer in length to accommodate the vascular graft. Likewise, the housing portion 26 of the sheath 22 may have to be longer in length to accommodate the larger medical component. Again, the size, shape and length of the restraining device 20 can be varied in order to accommodate the particular medical component that it is delivering to the target location.
In use, the embolic filtering device 34 would be delivered within a body vessel of the patient, such as an artery. The filter basket 44 would be placed downstream from an area of treatment where an interventional procedure is to be performed. In this manner, the area of treatment might be an artherosclerotic stenosis in which plaque has built up against the inside wall of the artery. The therapeutic interventional procedure may comprise the implantation of a stent to increase the diameter of the occluded artery and increase the blood flow therethrough. It should be appreciated that the embodiments of the present invention are illustrated and described herein by way of example only and not by way of limitation. Also, those skilled in the art will appreciate that the present invention can be used in other body vessels, such as the coronary arteries, carotid arteries, renal arteries, saphenous veins and other peripheral arteries. Additionally, the present invention can be utilized to deploy an embolic filtering device when a physician performs any one of a number of interventional procedures, such as balloon angioplasty, laser angioplasty or atherectomy, which requires the need for a filtering device to be located downstream from the area of treatment.
Referring now to FIGS. 4 and 5, an expandable housing portion 62 incorporating features of the present invention is shown. In this particular embodiment, the sheath 64 is made from two different materials which provide the elasticity and flexibility needed to preform the functions of the recovery sheath. As is shown in FIGS. 4 and 5, the sheath 64 includes highly elastic expansion members 66 which are interspaced between sections 68 of low expansive material that provides column strength and axial stiffness to the housing portion 62. The expansion members 66 extend lengthwise across the housing portion 62 and function in such a manner as to provide elasticity to cause the normal diameter C of the housing portion 62 (FIG. 4) to expand to the larger diameter X as shown in FIG. 5. The low expansion section 68 can be made from, for example, a soft material loaded with radiopaque materials to provide additional radiopacity to the sheath 64. For example, the material for the section 68 could be PEBAX 40 D loaded with known radiopaque materials. Other suitable materials include polymeric materials such as cross-linked HDPE, polyolefin and polyamide. The expansive members 66 couldbe highly elastic materials which include biocompatible polyurethane, silicone, polyisoprene and lower durometer PEBAX. As can be seen in FIG. 5, once an outer expansive force is placed on the inside surface 70 of the housing portion 62, the expansion member 66 will expand causing an increase in the inner diameter as is shown. The low expansion sections 68 remain relatively unchanged although it should be appreciated that some expansion could possibly take place depending upon the materials which are utilized for this particular portion of the housing 62. Although the particular embodiment shown in FIGS. 4 and 5 utilize three expansion members 66 which extend longitudinally along the length of the housing portion 62, it should be appreciated that the number of expansion members which is utilized can vary depending upon the particular properties which are to be achieved. For example, more or less expansion members can be utilized as needed. Additionally, the elasticity of the material used for the expansion members could also dictate the number, size and location of expansion members which can be interspersed onto the housing portion 62. Additionally, although the expansion members are shown substantially as longitudinal strips which extend longitudinally along the housing, a variety of different shapes and sizes could be utilized without departing from the spirit and scope of the present invention. Additionally, each end of the expansive member 66 can include a circular shape 72 which allows the low expansion sections 68 to expand without tearing. As is shown in FIGS. 4 and 5, this particular sheath 64 includes a proximal end 73 which tapers to a tubular member 74 that extends proximally to an outside location from the patient. In this manner, the expandable housing portion 62 can be part of a elongated tubular member which creates a full-length sheath. In this manner, the tubular member 74 would have an internal lumen formed therein which receives the guide wire of the medical device, such as the embolic filtering device, which would be restrained within the housing portion 62. Alternatively, the sheath 64 could be made with two lumens forming a rapid exchange lumen and a lumen for receiving a mandrel to create the rapid exchange-type restraining device as shown in FIGS. 1-3.
Referring now to FIGS. 6 and 7, another embodiment of the expandable housing portion 76 of a sheath 78 is shown. In this particular embodiment, the sheath 78 includes reinforcing members 80 disposed within a tubular member 82, made from highly elastic material. This highly elastic tubular member 82 is adapted to expand up and over the filter basket as has been described herein and is shown in greater detail in FIGS. 14-16. In this particular embodiment, the sheath 78 is primarily formed from the elastic tubular member 82 with the reinforcing members 80 being disposed to provide column strength to the housing portion 76. As is shown in FIG. 7, the elastic tubular portion 82 is expandable to a larger diameter X to extend over the filter basket when the device is to be retrieved from the patient's vasculature. The reenforcing members 80, as shown in FIG. 7, do not expand with the tubular portion 82 but provide reenforcing characteristics to prevent the housing portion 78 from buckling as it is being advanced along a guide wire. These reenforcing members 80 are disposed along the tubular member 82 such that they will not interfere with the radial expansion of the tubular member 82. The reenforcing member can be loaded with a material having high radiopacity to increase the ability to visualize the sheath within the patient using a fluoroscope, or other visualization equipment.
The particular embodiment shown in FIGS. 4 and 5 can be made by selecting a cylindrical or tubular member made from a low elastic material, such as the PEBAX 40 D, as described above. Slots which correspond to the size, shape and location of the expandable expansion members 66 can then be cut into the tubular member creating voids into which the material forming the expansion members 66 can be placed. For example, slots could be cut into the material by a laser or by mechanical means. A coated mandrel could then be inserted into the inner diameter of the tubular member to provide rigidity to the sheath as the expansion members are being formed. The highly elastic material to be used for the expansion member 66 could then be dissolved in volatile solution which would be applied at the cut or lased areas to create the highly elastic expansion members . The elastic material can then cure within the cut or lased pattern to create the expansion members 66. While this is just one method for manufacturing this sheath, it should be appreciated that the expansion members could be cut from an elastic material and physically bonded within the slots formed on the tubular member, as well. Still other ways of manufacturing the composite unit can be utilized.
In a similar fashion, the housing portion 78 of the sheath 78 shown in FIGS. 6 and 7 could be made in much the same way. A tubular member having high elasticity can be selected and stiffer reenforcing members 80 can be physically applied to the member. For example, slots can be cut into the member with reenforcing members 80 bonded or otherwise affixed within the slots to form a composite unit. It should be appreciated that although the reenforcing members 80 are shown as being embedded into the tubular member 82, they could also be fromed from thinner strips which are applied to the inner surface 84 or outer surface 86 of the sheath 76. Again, the number, location and size of the reenforcing members 80 can vary depending upon the application and the particular materials which are being utilized to create the sheath 78. This particular sheath 78 can be incorporated into a rapid exchange-type sheath as shown in FIGS. 1-3, or alternatively, could be incorporated into a full-length sheath as shown in the design of FIGS. 4 and 5. The materials which can be utilized for the reenforcing members include stainless steel, polymers and nickel-titanium alloys such as nitinol.
Referring now to FIGS. 8 and 10, an alternative embodiment of an expandable housing portion 90 incorporating features of the present invention is shown. In this particular embodiment, the sheath 92 includes a coil spring 94 embedded into the sheath 92 to provide the elasticity needed to expand the housing portion 90 when needed. In this embodiment, the coil spring 94 can be permanently set into the material forming the sheath 92 or it could be attached to the outside or inside surface of the sheath as well. In use, the coil spring 94 is normally biased to the smaller collapsed diameter C, as shown in FIG. 8. Thereafter, when a outward radial force is applied to the inner surface 96 of the housing portion 90, the coil spring expands outwardly allowing the housing portion to expand as needed to capture the filter basket. The coil spring 94 can be made from a material such as nickel titanium, spring steel or a plastic material having high flexibility. The sheath 92 can be made from a soft material with high elongation or elasticity, such as silicone, polyurethane or other stretchable material.
FIGS. 10 and 11, show another embodiment of the expandable housing portion 100 is shown as it is affixed to a sheath 102. In this particular embodiment, an expandable ring member 104 is utilized near the distal end 106 of the housing portion 100. This particular ring member can be made from material such as nickel titanium or spring steel. As can be seen in FIGS. 10 and 11, the ring member 104 has undulations which allow the ring member to expand radially outward as shown in FIG. 11 to increase the diameter of the housing portion 100. The ring member 104 is normally biased to the collapsed diameter C, as shown in FIG. 10. The ring member 104 can be either attached to the outside surface or inside surface of the sheath 102 or can be formed directly into the sheath 102 using molds and other known techniques well-known in the art. Again, the sheath 102 should be made from an elastic material such as silicone, polyurethane or other highly stretchable material.
Referring now to FIGS . 12 and 13 , yet another example of an expandable housing portion 110 of a sheath 112 is shown. In this particular embodiment, the housing portion 110 includes a distal tip portion 114 which includes a ring member 116, similar to the one shown in FIGS. 10 and 11. In this particular embodiment, the distal tip portion 114 can be made from a material which is different from the remaining portion of the sheath 112. For example, the tip material can be made from a material which is even more elastic than the portion 118 which forms the remainder of the sheath 112. In this regard, the tip of the sheath will be highly elastic yet will have a biasing member which contracts the tip once the tip extends over the component to be restrained, such as the filter basket of an embolic filtering device. The tip portion 114 can be adhesively bonded to the remaining portion 118 of the sheath 112 using adhesives, or other bonding or molding techniques. Again, the ring member 116 can be either embedded into the material forming the tip portion 114 itself, or can be applied to the outer surface or inner surface of this portion of the sheath as well. FIGS . 14-16, show the use of a restraining device 20 which incorporates the features of the present invention is shown as it is retrieving an embolic filtering device 34, similar to the one shown in FIG. 2. Referring first to FIG. 14, the expandable housing portion 26 is shown as it is approaching the proximal end of the filtering device 34. The distal tip 120 of this expandable housing portion 26 is shown conforming close to the diameter of the guide wire to closely track to the guide wire as it is being advanced into the patient's vasculature, thus avoiding a possible "snowplowing" effect on the vascular walls of the patient. As the distal tip 120 of the expandable housing portion 26 contacts the struts 46 of the filter basket 44, it begins to expand somewhat since the outward radial force being produced by the expanded filter basket is greater than the contracting force. As is shown in FIG. 16, as the distal tip 120 extends over the filter basket 44 and contacts the obturator 50, the collapsing forces of the housing portion 26 take over to collapse the filter basket back to its collapsed position. In this fashion, the filter basket 44 is fully encapsulating to prevent any embolic debris that which may have been collected in the filter element 16 from backflowing into the body lumen. As a result, the housing portion 26 encapsulates the filter basket for removal from the patient without the fear of releasing captured embolic material. This particular sequence is typical of the manner in which all of the embodiments disclosed and described herein would functions during usage. This is irregardless of whether the housing portion is formed as a rapid exchange-type sheath or is incorporated into a full-length sheath.
Referrring now to FIGS. 17-21, another embodiment of a recovery sheath 120 made in accordance with the present invention is shown. As is seen in FIG. 17, the recovery sheath 120 includes an inner recovery tip 122 located within the recovery sheath 120. This recovery sheath 120 has a lumen 124 through which a guide wire 38 extends. The recovery sheath 120 and inner recovery tip 122 are designed to collapse and retrieve a device, such as an embolic filter device, as shown in FIGS. 17- 19. The recovery sheath 120 includes a tip portion 126 designed to come in contact with a shoulder portion 128 formed on the recovery tip 122. In this manner, the recovery tip 122 will not be removable past the distal tip 126 of the recovery sheath. The recovery tip 122 and recovery sheath 120 are in frictional contact with each other and will remain in contact until a sufficient external force is applied to the recovery tip to causes it to slide back into the lumen 124 of the recovery sheath 120. As is shown in FIG. 18, this inner recovery tip 122 retracts back into the recovery sheath 120 when an external force is placed at the distal end 130 of the inner tip 122. As the recovery tip 122 contacts the proximal fitting 129 of the filter basket 44, a sufficient force will cause the recovery tip 122 to retract back inside of the restraining sheath 120. Thereafter, as shown in FIG. 19, as an additional force is used to retract the filter basket 44 back into the recovery sheath 120, the recovery tip 122 will retract even further back into the sheath to allow the filter basket to be retrieved for removal from the patient. In this manner, the recovery tip 122 permits the recovery sheath 120 to be advanced along the guide wire to patient's vasculature without causing a "snowplowing" effect. Thereafter, once the recovery tip reaches the filter basket, it can be retracted backwards into the sheath to allow for the recovery of the filter basket.
Referring now specifically to FIGS.20 and 21 , the frictional fit which is created between the inner recovery tip 122 and recovery sheath 120 can be enhanced by a mechanism for increasing the frictional force between these two components. As can be seen in FIG.20, the surface 131 of the restraining sheath 120 includes a number of outwardly projecting ribs 132 which are formed within the lumen 124. The inner recovery tip 122 likewise includes a number of outwardly projecting ribs 134 designed to be placed between the ribs 132 of the recovery sheath 120. In this manner, the two sets of ribs 132 and 134 intermesh to help increase the frictional force between the recovery sheath 120 and the inner recovery tip 122. When a sufficient amount of axial force is applied to the inner recovery tip 122, as is shown in FIG. 18, the interconnection between the sets of ribs will be end, allowing the inner recovery tip 122 to slide back within the lumen 124 of the recovery sheath 120. This is just one example of simple mechanism which can be utilized to increase the frictional contact between these two members.
Referring now specifically to FIG. 21, an alternative frictional mechanism is illustrated. In this particular figure, the recovery sheath 120 includes a single rib 132 which extends outwardly from the surface 131. The surface of the inner recovery tip 122 includes a number of rib-like channels 136 which are adapted to receive the rib 132 formed on the recovery sheath 120. In a similar manner, these channels 136 help to increase the frictional contact between these two components since a certain amount of force must first be applied to move the rib 132 into the second and third channels 136 located on the inner recovery tip. Additional channels can be added if additional resistive force is to be maintained. After the force is sufficient to extend the rib past the last channel, the inner recovery tip 122 will then retract fully into the lumen 124 of the recovery sheath 120. Again, this is just one of a number of different simple frictional mechanisms which can be utilized in accordance with these components to increase the amount of force needed to retract the inner recovery tip 122 into the recovery sheath 120.
Friction between the restraining sheath and medical component can be reduced by applying a coat of silicone lubricant, such as Microglide®, to the inside surface of the restraining sheath before the sheath is placed over the medical component.
In view of the foregoing, it is apparent that the devices of the present invention substantially enhance the safety and efficiency of delivering and recovering embolic protection devices, and other medical devices, in a patient's vasculature. Further modifications and improvements may additionally be made to the system and method disclosed herein without departing from the scope of the present invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.

Claims

WHAT IS CLAIMED IS:
1. A restraining device for maintaining a self-expanding medical device on a delivery catheter, comprising: a restraining sheath having an expandable housing portion adapted to receive and maintain the self-expanding medical device in a collapsed condition on the delivery catheter.
2. The restraining device of claim 1, wherein: the expandable housing portion is adapted to expand between a contracted position and an expanded position, the housing portion having sufficient column strength to maintain the self-expanding medical device in its collapsed condition on its delivery catheter.
3. The restraining device of claim 2, wherein: the expandable housing portion is made primarily from an elastic material which is stretchable between the contracted position and expanded position and includes at least one reenforcing member associated therewith for providing additional column strength to the housing portion.
4. The restraining device of claim 3 , further including : a plurality of reenforcing members associated with the expandable housing portion to provide additional column strength to the housing portion.
5. The restraining device of claim 4, wherein: the reenforcing members extend substantially along the length of the expandable housing portion but do not interfere with the expansion of the elastic material.
6. The restraining device of claim 5, wherein: the reenforcing members are elongated bar-like members made from a material having high stiffness.
7. The restraining device of claim 3, wherein: the elastic material is selected from a group of materials which includes silicone, polyurethane, polyisoprene , and lower durometer PEBAX.
8. The restraining device of claim 4, wherein: the reenforcing member is made from a material selected from a group including stainless steel, polymeric material, and nitinol.
9. The restraining device of claim 8, wherein: the reenforcing members are loaded with a material having high radiopacity.
10. The restraining device of claim 1 , wherein: the expandable housing portion is made from a substantially tubular-shaped material which is highly elastic and includes a plurality of reenforcing members disposed within the tubular elastic material to provide additional column strength to the housing portion.
11. The restraining device of claim 4, wherein: the reenforcing members are disposed within the elastic material forming the expandable housing portion.
12. The restraining device of claim 4, wherein: the reenforcing members are attached to the surface of the expandable housing portion.
13. The restraining device of claim 4, wherein: each reenforcing member is disposed along the expandable housing portion to provide additional column strength to the housing portion but does not interfere with the expansion of the housing portion.
14. The restraining device of claim 2, further including: coil spring associated with the expandable housing portion which provides column strength to the housing portion and is expandable from the contracted position to the expanded position with the elastic material which forms the housing portion.
15. The restraining device of claim 14, wherein: the coils of the coil spring extend longitudinally along the length of the expandable housing portion.
16. The restraining device of claim 14, wherein: the coil spring is made from a material selected from a group including nickel-titanium, spring steel and highly flexible plastic.
17. The restraining device of claim 2, further including: a ring member disposed near the distal tip of the expandable housing portion.
18. The restraining device of claim 17, wherein: the ring member has a plurality of undulations and is expandable with the elastic material which forms the housing portion.
19. The restraining device of claim 18, wherein: the ring member is made from a material selected from a group including nickel-titanium, spring steel and highly flexible plastic.
20. The restraining device of claim 2, wherein: the expandable housing portion includes a low expansion section with at least one expansion member disposed within the low expansion section to provide the elasticity needed to move the housing portion between the contracted position and expanded position.
21. The restraining device of claim 2, wherein: the expandable housing portion includes a plurality of low expansion sections and a plurality of expansion members disposed between low expansion sections.
22. The restraining device of claim 21 , wherein: the low expansion sections are made from a material loaded with a material having high radiopacity.
23. The restraining device of claim 21 , wherein: the expansion members are made from an elastic material selected from a group which includes polyurethane, silicone, polyisoprene and lower durometer PEBAX.
24. The restraining device of claim 23, wherein: the low expansion sections are made from a material selected from a group including cross-linked HDPE, polyolefin and polyamide.
25. The restraining device of claim 21 , wherein: the expansion members extend longitudinally along the length of the expandable housing portion.
26. The restraining device of claim 25, wherein: the expansion members include means for preventing the low expansion sections from tearing as the expandable housing portion expands from the contracted position to the expanded position.
27. The restraining device of claim 2, wherein: the expandable housing portion includes a distal tip section made from highly elastic material which is expandable and contractable between a contracted position and expanded position.
28. The restraining device of claim 27, wherein: the distal tip section is made from a more elastic material than the remaining portion of the expandable housing portion.
29. The restraining device of claim 28, further including: an expandable ring member associated with the distal tip section which is expandable between the contracted position and expanded position and is normally biased to the contracted position.
30. The restraining device of claim 29, wherein: , the ring member is encapsulated within the material forming the distal tip section.
31. The restraining device of claim 29, wherein: the ring member is attached to the outer surface of the distal tip section.
32. The restraining device of claim 29, wherein: the ring member is made from materials selected from a group including nickel-titanium, stainless steel and highly elastic plastic.
33. A recovery device for retrieving from a body vessel a deployed embolic filtering device which includes an expandable filter basket mounted on a guide wire, the recovery device comprising: a recovery sheath having a lumen extending therethrough which is coaxially mounted on the guide wire of the filtering device, the recovery sheath having a distal end which is adapted to contact the filter basket to collapse the filter basket; and an inner recovery tip coaxially mounted on the guide wire, a portion of the inner recovery tip disposed within the lumen of the recovery sheath and a distal portion of the inner recovery tip extending distally from the distal tip of the recovery sheath as the recovery sheath and inner recovery tip move simultaneously along the guide wire.
34. The recovery device of claim 33, wherein: the inner recovery tip is slidable within the lumen of the recovery sheath after a certain amount of force is applied to the inner recovery tip.
35. The recovery device of claim 33 , wherein : the inner recovery tip engages the inner surface of the lumen of the recovery sheath to maintain a frictional fit therebetween which is overcome upon application of a certain external force to the inner recovery tip.
36. The recovery device of claim 33, wherein: the inner recovery tip is in contact with the recovery sheath to maintain a frictional fit therebetween.
37. The recovery device of claim 33 , wherein : the lumen of the recovery sheath defines a surface which contacts the surface of the inner recovery tip to maintain a frictional fit therebetween.
38. The recovery device of claim 37, further including: a mechanism for enhancing the frictional fit between the inner recovery tip and the recovery sheath.
39. The recovery device of claim 38 , wherein : the mechanism includes a plurality of rib-like proj ections disposed on the surface of the recovery sheath which contact a plurality of rib-like projections on the surface of the inner recovery tip.
40. The recovery device of claim 39, wherein: the ribs of the recovery sheath are maintained in an interconnected relationship with the ribs of the inner recovery tip until a certain amount of force is applied to the inner recovery tip which causes the inner recovery tip to move within the lumen of the recovery sheath.
PCT/US2002/018504 2001-06-29 2002-06-10 Delivery and recovery sheaths for medical devices WO2003002035A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002315046A AU2002315046A1 (en) 2001-06-29 2002-06-10 Delivery and recovery sheaths for medical devices

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/897,295 US7678128B2 (en) 2001-06-29 2001-06-29 Delivery and recovery sheaths for medical devices
US09/897,295 2001-06-29

Publications (2)

Publication Number Publication Date
WO2003002035A2 true WO2003002035A2 (en) 2003-01-09
WO2003002035A3 WO2003002035A3 (en) 2003-10-09

Family

ID=25407702

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/018504 WO2003002035A2 (en) 2001-06-29 2002-06-10 Delivery and recovery sheaths for medical devices

Country Status (3)

Country Link
US (2) US7678128B2 (en)
AU (1) AU2002315046A1 (en)
WO (1) WO2003002035A2 (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6793648B2 (en) 2000-08-03 2004-09-21 Ev3 Inc. Back-loading catheter
US7578830B2 (en) 1999-03-08 2009-08-25 Kusleika Richard S Minimally invasive medical device deployment and retrieval system
EP2388333A2 (en) 2003-06-19 2011-11-23 Evolva SA A method of producing a low molecular weight organic compound in a cell

Families Citing this family (173)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE382309T1 (en) * 1997-11-07 2008-01-15 Salviac Ltd EMBOLIC PROTECTION DEVICE
US7491216B2 (en) * 1997-11-07 2009-02-17 Salviac Limited Filter element with retractable guidewire tip
US7037320B2 (en) * 2001-12-21 2006-05-02 Salviac Limited Support frame for an embolic protection device
US6918921B2 (en) * 1999-05-07 2005-07-19 Salviac Limited Support frame for an embolic protection device
WO2000067666A1 (en) * 1999-05-07 2000-11-16 Salviac Limited Improved filter element for embolic protection device
US6964672B2 (en) * 1999-05-07 2005-11-15 Salviac Limited Support frame for an embolic protection device
AU4606400A (en) * 1999-05-07 2000-11-21 Salviac Limited Improved filter element for embolic protection device
US6660021B1 (en) * 1999-12-23 2003-12-09 Advanced Cardiovascular Systems, Inc. Intravascular device and system
US6402771B1 (en) 1999-12-23 2002-06-11 Guidant Endovascular Solutions Snare
US6575997B1 (en) * 1999-12-23 2003-06-10 Endovascular Technologies, Inc. Embolic basket
US6695813B1 (en) 1999-12-30 2004-02-24 Advanced Cardiovascular Systems, Inc. Embolic protection devices
US7918820B2 (en) * 1999-12-30 2011-04-05 Advanced Cardiovascular Systems, Inc. Device for, and method of, blocking emboli in vessels such as blood arteries
US6540722B1 (en) * 1999-12-30 2003-04-01 Advanced Cardiovascular Systems, Inc. Embolic protection devices
US20040167567A1 (en) * 2001-03-23 2004-08-26 Cano Gerald G. Method and apparatus for capturing objects beyond an operative site in medical procedures
GB2369575A (en) * 2000-04-20 2002-06-05 Salviac Ltd An embolic protection system
US6939362B2 (en) * 2001-11-27 2005-09-06 Advanced Cardiovascular Systems, Inc. Offset proximal cage for embolic filtering devices
US6964670B1 (en) * 2000-07-13 2005-11-15 Advanced Cardiovascular Systems, Inc. Embolic protection guide wire
US6537294B1 (en) * 2000-10-17 2003-03-25 Advanced Cardiovascular Systems, Inc. Delivery systems for embolic filter devices
US6893451B2 (en) * 2000-11-09 2005-05-17 Advanced Cardiovascular Systems, Inc. Apparatus for capturing objects beyond an operative site utilizing a capture device delivered on a medical guide wire
US6506203B1 (en) * 2000-12-19 2003-01-14 Advanced Cardiovascular Systems, Inc. Low profile sheathless embolic protection system
US6645223B2 (en) * 2001-04-30 2003-11-11 Advanced Cardiovascular Systems, Inc. Deployment and recovery control systems for embolic protection devices
US6929652B1 (en) * 2001-06-01 2005-08-16 Advanced Cardiovascular Systems, Inc. Delivery and recovery systems having steerability and rapid exchange operating modes for embolic protection systems
US7674245B2 (en) 2001-06-07 2010-03-09 Cardiac Pacemakers, Inc. Method and apparatus for an adjustable shape guide catheter
US6599307B1 (en) * 2001-06-29 2003-07-29 Advanced Cardiovascular Systems, Inc. Filter device for embolic protection systems
US7678128B2 (en) * 2001-06-29 2010-03-16 Advanced Cardiovascular Systems, Inc. Delivery and recovery sheaths for medical devices
US7338510B2 (en) 2001-06-29 2008-03-04 Advanced Cardiovascular Systems, Inc. Variable thickness embolic filtering devices and method of manufacturing the same
US6951570B2 (en) * 2001-07-02 2005-10-04 Rubicon Medical, Inc. Methods, systems, and devices for deploying a filter from a filter device
US20030032941A1 (en) * 2001-08-13 2003-02-13 Boyle William J. Convertible delivery systems for medical devices
US6638294B1 (en) 2001-08-30 2003-10-28 Advanced Cardiovascular Systems, Inc. Self furling umbrella frame for carotid filter
US6592606B2 (en) 2001-08-31 2003-07-15 Advanced Cardiovascular Systems, Inc. Hinged short cage for an embolic protection device
US8262689B2 (en) * 2001-09-28 2012-09-11 Advanced Cardiovascular Systems, Inc. Embolic filtering devices
US20030069597A1 (en) * 2001-10-10 2003-04-10 Scimed Life Systems, Inc. Loading tool
US7241304B2 (en) 2001-12-21 2007-07-10 Advanced Cardiovascular Systems, Inc. Flexible and conformable embolic filtering devices
US7717899B2 (en) 2002-01-28 2010-05-18 Cardiac Pacemakers, Inc. Inner and outer telescoping catheter delivery system
US7144408B2 (en) * 2002-03-05 2006-12-05 Salviac Limited Embolic protection system
US20070135832A1 (en) * 2002-03-12 2007-06-14 Wholey Michael H Vascular catheter with aspiration capabilities and expanded distal tip
AU2003237570A1 (en) * 2002-05-13 2003-11-11 Salviac Limited Catheter system with procedural catheter and embolic proctection system
US7717934B2 (en) * 2002-06-14 2010-05-18 Ev3 Inc. Rapid exchange catheters usable with embolic protection devices
US6887258B2 (en) * 2002-06-26 2005-05-03 Advanced Cardiovascular Systems, Inc. Embolic filtering devices for bifurcated vessels
US7172614B2 (en) * 2002-06-27 2007-02-06 Advanced Cardiovascular Systems, Inc. Support structures for embolic filtering devices
US20040039371A1 (en) * 2002-08-23 2004-02-26 Bruce Tockman Coronary vein navigator
US7331973B2 (en) 2002-09-30 2008-02-19 Avdanced Cardiovascular Systems, Inc. Guide wire with embolic filtering attachment
US7252675B2 (en) 2002-09-30 2007-08-07 Advanced Cardiovascular, Inc. Embolic filtering devices
US7998163B2 (en) * 2002-10-03 2011-08-16 Boston Scientific Scimed, Inc. Expandable retrieval device
US8468678B2 (en) * 2002-10-02 2013-06-25 Boston Scientific Scimed, Inc. Expandable retrieval device
US20040088000A1 (en) * 2002-10-31 2004-05-06 Muller Paul F. Single-wire expandable cages for embolic filtering devices
US8591540B2 (en) * 2003-02-27 2013-11-26 Abbott Cardiovascular Systems Inc. Embolic filtering devices
US20040172055A1 (en) * 2003-02-27 2004-09-02 Huter Scott J. Embolic filtering devices
US8801767B2 (en) * 2003-07-29 2014-08-12 Vipul Narain Roy Drug eluting stent and a guide catheter device assembly for implanting the same
US7892251B1 (en) 2003-11-12 2011-02-22 Advanced Cardiovascular Systems, Inc. Component for delivering and locking a medical device to a guide wire
US20050159773A1 (en) * 2004-01-20 2005-07-21 Scimed Life Systems, Inc. Expandable retrieval device with dilator tip
US20050159772A1 (en) * 2004-01-20 2005-07-21 Scimed Life Systems, Inc. Sheath for use with an embolic protection filtering device
US7678129B1 (en) 2004-03-19 2010-03-16 Advanced Cardiovascular Systems, Inc. Locking component for an embolic filter assembly
US7524250B2 (en) * 2004-05-12 2009-04-28 Acushnet Company Golf club head with top line insert
US8480506B2 (en) * 2004-05-12 2013-07-09 Cobra Gold Incorporated Golf club head with top line insert
US8795315B2 (en) * 2004-10-06 2014-08-05 Cook Medical Technologies Llc Emboli capturing device having a coil and method for capturing emboli
ATE539789T1 (en) 2005-02-18 2012-01-15 Tyco Healthcare QUICKLY REPLACEABLE CATHETER
US20060190024A1 (en) * 2005-02-24 2006-08-24 Bei Nianjiong Recovery catheter apparatus and method
US8945169B2 (en) 2005-03-15 2015-02-03 Cook Medical Technologies Llc Embolic protection device
US8221446B2 (en) 2005-03-15 2012-07-17 Cook Medical Technologies Embolic protection device
US9259305B2 (en) * 2005-03-31 2016-02-16 Abbott Cardiovascular Systems Inc. Guide wire locking mechanism for rapid exchange and other catheter systems
US20060259132A1 (en) * 2005-05-02 2006-11-16 Cook Incorporated Vascular stent for embolic protection
US20080004571A1 (en) * 2006-06-28 2008-01-03 Abbott Laboratories Expandable introducer sheath
US9168359B2 (en) * 2005-06-30 2015-10-27 Abbott Laboratories Modular introducer and exchange sheath
US8801744B2 (en) * 2006-06-28 2014-08-12 Abbott Laboratories Expandable introducer sheath to preserve guidewire access
US8440122B2 (en) * 2005-06-30 2013-05-14 Abbott Vascular Inc. Introducer sheath and methods of making
US8359723B2 (en) * 2005-06-30 2013-01-29 Abbott Vascular Inc. Introducer sheath and methods of making
US20100130937A1 (en) * 2005-06-30 2010-05-27 Abbott Vascular Inc. Introducer sheath and methods of making
US9352118B2 (en) * 2005-06-30 2016-05-31 Abbott Laboratories Modular introducer and exchange sheath
US9597063B2 (en) * 2006-06-28 2017-03-21 Abbott Laboratories Expandable introducer sheath to preserve guidewire access
US7674252B2 (en) * 2005-08-04 2010-03-09 Medtronic Vascular, Inc. Single operator sheath catheter
US8187298B2 (en) * 2005-08-04 2012-05-29 Cook Medical Technologies Llc Embolic protection device having inflatable frame
US20070043390A1 (en) * 2005-08-18 2007-02-22 Salviac Limited Delivery catheter
US8377092B2 (en) * 2005-09-16 2013-02-19 Cook Medical Technologies Llc Embolic protection device
US8632562B2 (en) * 2005-10-03 2014-01-21 Cook Medical Technologies Llc Embolic protection device
US8182508B2 (en) * 2005-10-04 2012-05-22 Cook Medical Technologies Llc Embolic protection device
US20070088382A1 (en) * 2005-10-13 2007-04-19 Bei Nianjiong J Embolic protection recovery catheter assembly
US8252017B2 (en) * 2005-10-18 2012-08-28 Cook Medical Technologies Llc Invertible filter for embolic protection
US8216269B2 (en) * 2005-11-02 2012-07-10 Cook Medical Technologies Llc Embolic protection device having reduced profile
US8152831B2 (en) * 2005-11-17 2012-04-10 Cook Medical Technologies Llc Foam embolic protection device
DE102005059670A1 (en) * 2005-12-12 2007-06-14 Phenox Gmbh Device for removing thrombi from blood vessels
US9889275B2 (en) 2006-06-28 2018-02-13 Abbott Laboratories Expandable introducer sheath to preserve guidewire access
US20100198160A1 (en) * 2006-06-28 2010-08-05 Abbott Vascular Inc. Expandable Introducer Sheaths and Methods for Manufacture and Use
US20080071307A1 (en) * 2006-09-19 2008-03-20 Cook Incorporated Apparatus and methods for in situ embolic protection
US9107736B2 (en) * 2006-12-06 2015-08-18 Abbott Cardiovascular Systems Inc. Highly trackable balloon catheter system and method for collapsing an expanded medical device
US20080140003A1 (en) * 2006-12-06 2008-06-12 Advanced Cardiovascular Systems, Inc. Balloon catheter having a regrooming sheath and method for collapsing an expanded medical device
US9901434B2 (en) 2007-02-27 2018-02-27 Cook Medical Technologies Llc Embolic protection device including a Z-stent waist band
US8216209B2 (en) 2007-05-31 2012-07-10 Abbott Cardiovascular Systems Inc. Method and apparatus for delivering an agent to a kidney
US7867273B2 (en) 2007-06-27 2011-01-11 Abbott Laboratories Endoprostheses for peripheral arteries and other body vessels
US8475478B2 (en) * 2007-07-05 2013-07-02 Cardiovascular Systems, Inc. Cleaning apparatus and method for high-speed rotational atherectomy devices
CA2697364C (en) 2007-08-23 2017-10-17 Direct Flow Medical, Inc. Translumenally implantable heart valve with formed in place support
US8252018B2 (en) * 2007-09-14 2012-08-28 Cook Medical Technologies Llc Helical embolic protection device
US8419748B2 (en) * 2007-09-14 2013-04-16 Cook Medical Technologies Llc Helical thrombus removal device
US9138307B2 (en) 2007-09-14 2015-09-22 Cook Medical Technologies Llc Expandable device for treatment of a stricture in a body vessel
US9597172B2 (en) * 2007-09-28 2017-03-21 W. L. Gore & Associates, Inc. Retrieval catheter
US8224417B2 (en) * 2007-10-17 2012-07-17 Neuronexus Technologies, Inc. Guide tube for an implantable device system
US20090138037A1 (en) * 2007-10-27 2009-05-28 Salviac Limited Strain limiting tether for a catheter
US8114116B2 (en) * 2008-01-18 2012-02-14 Cook Medical Technologies Llc Introduction catheter set for a self-expandable implant
US8790387B2 (en) 2008-10-10 2014-07-29 Edwards Lifesciences Corporation Expandable sheath for introducing an endovascular delivery device into a body
US8388644B2 (en) * 2008-12-29 2013-03-05 Cook Medical Technologies Llc Embolic protection device and method of use
US20100211094A1 (en) * 2009-02-18 2010-08-19 Cook Incorporated Umbrella distal embolic protection device
US20100234876A1 (en) * 2009-03-10 2010-09-16 Boston Scientific Scimed, Inc. Apparatus and methods for recapturing an ablation balloon
US20100274277A1 (en) * 2009-04-27 2010-10-28 Cook Incorporated Embolic protection device with maximized flow-through
US20110264133A1 (en) 2010-03-01 2011-10-27 Tyco Healthcare Group Lp Introducer sheaths, thrombus collection devices and associated methods
US9603708B2 (en) 2010-05-19 2017-03-28 Dfm, Llc Low crossing profile delivery catheter for cardiovascular prosthetic implant
CN103313750B (en) 2010-10-20 2015-08-19 斯瑞克公司 There is the stent delivery catheter of rapid exchange capability
WO2012054178A1 (en) * 2010-10-21 2012-04-26 Boston Scientific Scimed, Inc. Stent delivery system with a rolling membrane
CN102038565B (en) * 2010-12-17 2013-08-14 北京有色金属研究总院 Great vascular stent delivery system
US10112045B2 (en) 2010-12-29 2018-10-30 Medtronic, Inc. Implantable medical device fixation
US9775982B2 (en) 2010-12-29 2017-10-03 Medtronic, Inc. Implantable medical device fixation
US8831741B2 (en) 2011-03-14 2014-09-09 Medtronic Vascular, Inc. Catheter with deflectable cap
US9339384B2 (en) 2011-07-27 2016-05-17 Edwards Lifesciences Corporation Delivery systems for prosthetic heart valve
US9119639B2 (en) 2011-08-09 2015-09-01 DePuy Synthes Products, Inc. Articulated cavity creator
US11213318B2 (en) 2011-11-10 2022-01-04 Medtronic Vascular, Inc. Expandable introducer sheath and method
BR112014012352A2 (en) 2011-11-10 2017-07-18 Transaortic Medical Inc system for implanting a device at a distal location through a diseased vessel
US9220906B2 (en) 2012-03-26 2015-12-29 Medtronic, Inc. Tethered implantable medical device deployment
US10485435B2 (en) * 2012-03-26 2019-11-26 Medtronic, Inc. Pass-through implantable medical device delivery catheter with removeable distal tip
US9717421B2 (en) 2012-03-26 2017-08-01 Medtronic, Inc. Implantable medical device delivery catheter with tether
US9833625B2 (en) 2012-03-26 2017-12-05 Medtronic, Inc. Implantable medical device delivery with inner and outer sheaths
US9339197B2 (en) 2012-03-26 2016-05-17 Medtronic, Inc. Intravascular implantable medical device introduction
US9854982B2 (en) 2012-03-26 2018-01-02 Medtronic, Inc. Implantable medical device deployment within a vessel
EP2844163A4 (en) * 2012-04-30 2015-09-23 Bio2 Medical Inc Multi-lumen central access vena cava filter apparatus for clot management and method of using same
US9445897B2 (en) * 2012-05-01 2016-09-20 Direct Flow Medical, Inc. Prosthetic implant delivery device with introducer catheter
EP2869860A1 (en) * 2012-07-09 2015-05-13 Boston Scientific Scimed, Inc. Expandable guide extension catheter
US9241729B2 (en) 2012-12-14 2016-01-26 DePuy Synthes Products, Inc. Device to aid in the deployment of a shape memory instrument
US8945201B2 (en) * 2013-01-30 2015-02-03 Telesis Research, Llc Prosthesis delivery system
US9439693B2 (en) 2013-02-01 2016-09-13 DePuy Synthes Products, Inc. Steerable needle assembly for use in vertebral body augmentation
US20140236213A1 (en) * 2013-02-15 2014-08-21 BiO2 Medical, Inc. Temporary filter retrieval apparatus and method
US8679150B1 (en) 2013-03-15 2014-03-25 Insera Therapeutics, Inc. Shape-set textile structure based mechanical thrombectomy methods
WO2014150288A2 (en) 2013-03-15 2014-09-25 Insera Therapeutics, Inc. Vascular treatment devices and methods
US8715314B1 (en) 2013-03-15 2014-05-06 Insera Therapeutics, Inc. Vascular treatment measurement methods
US8715315B1 (en) 2013-03-15 2014-05-06 Insera Therapeutics, Inc. Vascular treatment systems
EP3964168A1 (en) * 2013-05-10 2022-03-09 Medtronic, Inc. System for deploying a device to a distal location across a diseased vessel
WO2014186414A1 (en) 2013-05-17 2014-11-20 Transaortic Medical, Inc. Expandable introducer sheath
US10071243B2 (en) 2013-07-31 2018-09-11 Medtronic, Inc. Fixation for implantable medical devices
US9492674B2 (en) 2013-08-16 2016-11-15 Cardiac Pacemakers, Inc. Leadless cardiac pacemaker with delivery and/or retrieval features
US9480850B2 (en) 2013-08-16 2016-11-01 Cardiac Pacemakers, Inc. Leadless cardiac pacemaker and retrieval device
WO2015023488A1 (en) 2013-08-16 2015-02-19 Cardiac Pacemakers, Inc. Leadless cardiac pacing devices
WO2015023474A1 (en) 2013-08-16 2015-02-19 Cardiac Pacemakers, Inc. Leadless cardiac pacemaker and retrieval device
US10842993B2 (en) 2013-08-16 2020-11-24 Cardiac Pacemakers, Inc. Leadless cardiac pacing devices
US10722723B2 (en) 2013-08-16 2020-07-28 Cardiac Pacemakers, Inc. Delivery devices and methods for leadless cardiac devices
ES2666373T3 (en) 2013-08-16 2018-05-04 Cardiac Pacemakers, Inc. Management devices for wireless heart devices
US9393427B2 (en) 2013-08-16 2016-07-19 Cardiac Pacemakers, Inc. Leadless cardiac pacemaker with delivery and/or retrieval features
CN106456968B (en) 2014-04-29 2018-11-30 心脏起搏器股份公司 With the leadless cardiac pacemaker for fetching feature
US10080887B2 (en) 2014-04-29 2018-09-25 Cardiac Pacemakers, Inc. Leadless cardiac pacing devices including tissue engagement verification
US20160135829A1 (en) * 2014-11-13 2016-05-19 Angiodynamics, Inc. Systems and methods for en bloc removal of undesirable material from passageways
US10327896B2 (en) * 2015-04-10 2019-06-25 Edwards Lifesciences Corporation Expandable sheath with elastomeric cross sectional portions
US10792471B2 (en) 2015-04-10 2020-10-06 Edwards Lifesciences Corporation Expandable sheath
US10099050B2 (en) 2016-01-21 2018-10-16 Medtronic, Inc. Interventional medical devices, device systems, and fixation components thereof
US10463853B2 (en) 2016-01-21 2019-11-05 Medtronic, Inc. Interventional medical systems
EP3416568A4 (en) 2016-02-16 2019-10-16 Insera Therapeutics, Inc. Aspiration devices and anchored flow diverting devices
JP7044374B2 (en) 2016-05-19 2022-03-30 メタモディクス インコーポレイテッド Extraction device
EP3528885B1 (en) 2016-10-18 2024-03-13 Boston Scientific Scimed Inc. Guide extension catheter
US10912919B2 (en) 2017-01-23 2021-02-09 Edwards Lifesciences Corporation Expandable sheath
US10799685B2 (en) 2017-03-09 2020-10-13 Edwards Lifesciences Corporation Expandable sheath with longitudinally extending reinforcing members
EP3412337A1 (en) * 2017-06-08 2018-12-12 BIOTRONIK SE & Co. KG Flexible band tine array, particularly for an implantable cardiac pacemaker
US11051939B2 (en) * 2017-08-31 2021-07-06 Edwards Lifesciences Corporation Active introducer sheath system
DE102017121251A1 (en) * 2017-09-13 2019-03-14 Universitätsmedizin Der Johannes Gutenberg-Universität Mainz catheter
US11344705B2 (en) 2017-12-27 2022-05-31 Argos Corporation Split sheath introducer and method of manufacturing a split sheath introducer
USD847864S1 (en) 2018-01-22 2019-05-07 Insera Therapeutics, Inc. Pump
WO2019161175A1 (en) 2018-02-15 2019-08-22 Boston Scientific Scimed, Inc. Introducer with expandable capabilities
JP2021520873A (en) 2018-04-09 2021-08-26 エドワーズ ライフサイエンシーズ コーポレイションEdwards Lifesciences Corporation Expandable sheath
US11786695B2 (en) 2018-07-25 2023-10-17 Edwards Lifesciences Corporation Methods of making an expandable sheath
US11857441B2 (en) 2018-09-04 2024-01-02 4C Medical Technologies, Inc. Stent loading device
AU2019343639B2 (en) 2018-09-20 2022-12-01 Three Peaks Medical Pty Ltd Adjustable sheath device
US10874850B2 (en) 2018-09-28 2020-12-29 Medtronic, Inc. Impedance-based verification for delivery of implantable medical devices
JP7362753B2 (en) * 2019-02-19 2023-10-17 テレフレックス ライフ サイエンシズ リミテッド guide extension catheter
US11759632B2 (en) 2019-03-28 2023-09-19 Medtronic, Inc. Fixation components for implantable medical devices
US11331475B2 (en) 2019-05-07 2022-05-17 Medtronic, Inc. Tether assemblies for medical device delivery systems
US20200375733A1 (en) * 2019-05-30 2020-12-03 4C Medical Technologies, Inc. Devices, systems and methods for collapsible and expandable implant loading, transseptal delivery, positioning deployment and repositioning deployment
US20210338425A1 (en) * 2020-04-30 2021-11-04 Cephea Valve Technologies, Inc. Catheter Lumen Lubricant
CN111938865B (en) * 2020-07-31 2024-03-08 李云松 Filter-related vein hyperplasia intima cutting catheter
CN115137536B (en) * 2022-09-05 2022-12-09 艾柯医疗器械(北京)股份有限公司 Bead string-shaped component, stent conveying system comprising same and stent system

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2200848A (en) * 1987-02-25 1988-08-17 Mo Med Inst Pirogova Intravenous filter, and apparatus and method for pre-operative preparation thereof
WO1998039053A1 (en) * 1997-03-06 1998-09-11 Scimed Life Systems, Inc. Distal protection device and method
US6039744A (en) * 1997-12-19 2000-03-21 B. Braun Celsa Assembly for positioning an implant in an internal passageway of a body
US6171327B1 (en) * 1999-02-24 2001-01-09 Scimed Life Systems, Inc. Intravascular filter and method

Family Cites Families (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5176659A (en) * 1991-02-28 1993-01-05 Mario Mancini Expandable intravenous catheter and method of using
US6123715A (en) * 1994-07-08 2000-09-26 Amplatz; Curtis Method of forming medical devices; intravascular occlusion devices
US5766203A (en) * 1995-07-20 1998-06-16 Intelliwire, Inc. Sheath with expandable distal extremity and balloon catheters and stents for use therewith and method
NL1003984C2 (en) * 1996-09-09 1998-03-10 Cordis Europ Catheter with internal stiffening bridges.
US5879342A (en) * 1996-10-21 1999-03-09 Kelley; Gregory S. Flexible and reinforced tubing
US5944691A (en) * 1996-11-04 1999-08-31 Cordis Corporation Catheter having an expandable shaft
EP1054634A4 (en) * 1998-02-10 2006-03-29 Artemis Medical Inc Entrapping apparatus and method for use
US6511492B1 (en) * 1998-05-01 2003-01-28 Microvention, Inc. Embolectomy catheters and methods for treating stroke and other small vessel thromboembolic disorders
US5974652A (en) * 1998-05-05 1999-11-02 Advanced Cardiovascular Systems, Inc. Method and apparatus for uniformly crimping a stent onto a catheter
WO2000067666A1 (en) * 1999-05-07 2000-11-16 Salviac Limited Improved filter element for embolic protection device
US6544279B1 (en) * 2000-08-09 2003-04-08 Incept, Llc Vascular device for emboli, thrombus and foreign body removal and methods of use
AU6464500A (en) * 1999-08-12 2001-03-13 Salviac Limited Retrieval device
US6290710B1 (en) * 1999-12-29 2001-09-18 Advanced Cardiovascular Systems, Inc. Embolic protection device
US6383206B1 (en) * 1999-12-30 2002-05-07 Advanced Cardiovascular Systems, Inc. Embolic protection system and method including filtering elements
US6679902B1 (en) * 2000-07-19 2004-01-20 Advanced Cardiovascular Systems, Inc. Reduced profile delivery sheath for use in interventional procedures
US6616651B1 (en) * 2000-11-17 2003-09-09 Robert C. Stevens Intravascular microcatheter with embedded helical coil reinforcement member and methods and apparatus for making same
US6663651B2 (en) * 2001-01-16 2003-12-16 Incept Llc Systems and methods for vascular filter retrieval
EP1379177A2 (en) * 2001-04-17 2004-01-14 Salviac Limited A retrieval catheter tip and catheter
US7678128B2 (en) * 2001-06-29 2010-03-16 Advanced Cardiovascular Systems, Inc. Delivery and recovery sheaths for medical devices
US6887258B2 (en) * 2002-06-26 2005-05-03 Advanced Cardiovascular Systems, Inc. Embolic filtering devices for bifurcated vessels
US7115138B2 (en) * 2002-09-04 2006-10-03 Boston Scientific Scimed, Inc. Sheath tip
JP5260936B2 (en) 2007-10-25 2013-08-14 トヨタ自動車株式会社 Electromagnetic shock absorber for vehicles

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2200848A (en) * 1987-02-25 1988-08-17 Mo Med Inst Pirogova Intravenous filter, and apparatus and method for pre-operative preparation thereof
WO1998039053A1 (en) * 1997-03-06 1998-09-11 Scimed Life Systems, Inc. Distal protection device and method
US6039744A (en) * 1997-12-19 2000-03-21 B. Braun Celsa Assembly for positioning an implant in an internal passageway of a body
US6171327B1 (en) * 1999-02-24 2001-01-09 Scimed Life Systems, Inc. Intravascular filter and method

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7578830B2 (en) 1999-03-08 2009-08-25 Kusleika Richard S Minimally invasive medical device deployment and retrieval system
US6793648B2 (en) 2000-08-03 2004-09-21 Ev3 Inc. Back-loading catheter
US7572271B2 (en) 2000-08-03 2009-08-11 Ev3 Inc. Back-loading catheter
EP2388333A2 (en) 2003-06-19 2011-11-23 Evolva SA A method of producing a low molecular weight organic compound in a cell

Also Published As

Publication number Publication date
US20030004537A1 (en) 2003-01-02
WO2003002035A3 (en) 2003-10-09
US20100174355A1 (en) 2010-07-08
US7678128B2 (en) 2010-03-16
US8672991B2 (en) 2014-03-18
AU2002315046A1 (en) 2003-03-03

Similar Documents

Publication Publication Date Title
US8672991B2 (en) Delivery and recovery sheaths for medical devices
US7252675B2 (en) Embolic filtering devices
US7172614B2 (en) Support structures for embolic filtering devices
US6592606B2 (en) Hinged short cage for an embolic protection device
US7344549B2 (en) Expandable cages for embolic filtering devices
US7241304B2 (en) Flexible and conformable embolic filtering devices
US8262689B2 (en) Embolic filtering devices
US7678131B2 (en) Single-wire expandable cages for embolic filtering devices
US6443979B1 (en) Expandable stent delivery sheath and method of use
US7425215B2 (en) Delivery systems for embolic filter devices
US6569184B2 (en) Recovery system for retrieving an embolic protection device
US6939362B2 (en) Offset proximal cage for embolic filtering devices
EP1399089B1 (en) Embolic protection device
US6575995B1 (en) Expandable cage embolic material filter system and method
US20100004673A1 (en) Embolic filtering devices for bifurcated vessels

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A2

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NO NZ OM PH PL PT RO RU SD SE SG SI SK SL TJ TM TN TR TT TZ UA UG UZ VN YU ZA ZM ZW

AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): GH GM KE LS MW MZ SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

122 Ep: pct application non-entry in european phase
NENP Non-entry into the national phase

Ref country code: JP

WWW Wipo information: withdrawn in national office

Country of ref document: JP