WO2000007521A1 - Assembly for collecting emboli and method of use - Google Patents

Assembly for collecting emboli and method of use Download PDF

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Publication number
WO2000007521A1
WO2000007521A1 PCT/US1999/017685 US9917685W WO0007521A1 WO 2000007521 A1 WO2000007521 A1 WO 2000007521A1 US 9917685 W US9917685 W US 9917685W WO 0007521 A1 WO0007521 A1 WO 0007521A1
Authority
WO
WIPO (PCT)
Prior art keywords
restraining sheath
stent
sheath
filter
proximal end
Prior art date
Application number
PCT/US1999/017685
Other languages
French (fr)
Inventor
Andrew J. Fitz
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 AU54655/99A priority Critical patent/AU5465599A/en
Publication of WO2000007521A1 publication Critical patent/WO2000007521A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/0105—Open ended, i.e. legs gathered only at one side
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/011—Instruments for their placement or removal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/016—Filters implantable into blood vessels made from wire-like elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/005—Rosette-shaped, e.g. star-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0073—Quadric-shaped
    • A61F2230/0078—Quadric-shaped hyperboloidal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0073—Quadric-shaped
    • A61F2230/008—Quadric-shaped paraboloidal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0093—Umbrella-shaped, e.g. mushroom-shaped

Definitions

  • the present invention relates generally to the field of surgical instruments. Specifically, the present invention relates to an emboli-capture device for treating cerebral blood vessels such as carotid arteries.
  • Stenting and angioplasty in stenosed cerebral vessels pose risks of dislodging thrombus or friable plaque.
  • the thrombus or plaque can become lodged in the brain or arteries and cause serious injury such as a stroke. If such embolic material is dislodged during a stenting procedure, it is necessary to collect the material before it migrates and causes injury.
  • U.S. Patent No. 4,921,478, "Cerebral Balloon Angioplasty System," Solano et al. employs an occlusion catheter carrying a relatively large inflatable occlusion balloon to repair vessels.
  • the balloon is capable of being formed into a funnel while simultaneously sealing a vessel and establishing retrograde blood flow.
  • the balloon is bulky and difficult to refold and withdraw from lesions within the vessels. The withdrawal is prone to causing extensive tissue damage and dislodging more emboli.
  • the balloon-type system will not work effectively without a complete and perfect seal between the balloon and the vessel wall.
  • Solano et al. contemplates no occlusion in conjunction with the deployment of a self-expanding stent. Further, although the prior art filtered the blood, sometimes excess emboli remained when the device was removed from blood vessels.
  • the present invention is directed to an apparatus and method for treating stenosed cerebral blood vessels such as carotid arteries.
  • the system generally includes an apparatus and method for safely and easily deploying a self-expanding stent in a vessel while preventing embolic migration.
  • a system for percutaneously delivering a stent within a vessel while preventing embolic migration includes: a restraining sheath that is capable of both expanding and retracting whereby minimal friction is created between the restraining sheath and the stent during deployment of the stent; a filter for trapping and retaining embolic material, the filter being located relative to the restraining sheath such that the filter will trap any embolic material flowing into the restraining sheath; a stent delivery catheter having a proximal end open to atmospheric pressure and a distal end connected to a proximal end of the restraining sheath; and a stent that initially is in a collapsed state and positioned within the restraining sheath.
  • the filter may consist of one of many devices already in use, e.g., a strainer device comprised of a plurality of wires.
  • the expansion of the restraining sheath may be accomplished by mechanically pushing a composite sheath using a design similar to that of an umbrella.
  • expansion of the filter may be accomplished by using a wedge and spine mechanism to open the restraining sheath from a closed position.
  • the expansion of the filter may be accomplished by releasing a plurality of bent wires that are restrained in a straightened position.
  • the sheath design provides optimal deployment of the self-expanding stent because the sheath both expands in a radial direction and retracts in a proximal direction simultaneously. Therefore, due to the angle of incidence created between the sheath and the stent during deployment there is a low coefficient of friction between the sheath and the stent. This is an ideal configuration for recapturing a partially deployed stent because contact is constantly maintained between the sheath and the undeployed part of the stent.
  • a desired site within a vessel is first accessed with the system.
  • the restraining sheath then is deployed while being moved proximally.
  • the restraining sheath forms an occlusive conical member or catch basin at a proximal end of the stent.
  • the stent being self-expanding, is automatically deployed as the restraining sheath expands.
  • a temporary seal is created between the stent and the restraining sheath.
  • An outer edge of a distal end of the restraining sheath may include a material taken from the group of materials consisting of soft plastic, rubber, and a gel, in order to ensure a proper seal between the sheath and the stent. Therefore, unlike the situation where a balloon exerts pressure on a vessel wall to cause a seal, in the present invention vessel damage is minimized.
  • the filter is located within the restraining sheath at the occlusion site in another embodiment.
  • the filter may be located within the stent delivery catheter.
  • the filter may be located outside of the patient's body.
  • a pressure differential is created between the more distal arteries (pressurized at blood pressure plus atmospheric pressure) and a lumen of the stent delivery catheter (pressurized at atmospheric pressure). Therefore, retrograde blood flow is induced and blood and embolic particles are flushed into the filter where the embolic particles are captured.
  • a vacuum apparatus may be included in the system if the occlusion is not adequate to induce sufficient retrograde blood flow or to ensure that the maximum number of embolic particles are aspirated into the filter. The restraining sheath is then collapsed to its original size, thereby trapping any remaining embolic material. The system is then removed from the patient.
  • FIGURE 1 is a perspective view of one embodiment, depicting in a closed position an apparatus of a composite design similar to that of an umbrella for expanding a restraining sheath wherein expansion is accomplished by mechanically pushing the sheath.
  • FIG. 2 is a perspective view of the apparatus of FIG. 1 depicted in an open position.
  • FIG. 3 is a perspective view of another embodiment depicting an apparatus in a closed position for expanding the restraining sheath wherein expansion is accomplished by using a wedge and spine mechanism to open the restraining sheath from a closed position.
  • FIG. 4 is a perspective view of the apparatus of FIG. 3 in a partially expanded position.
  • FIG. 5 is a perspective view of the apparatus of FIG. 3 in a fully expanded position.
  • FIG. 6 is a perspective view of another preferred embodiment depicting an apparatus in a closed position for expanding the restraining sheath wherein expansion is accomplished by releasing bent wires that are restrained in a straightened position.
  • FIG. 7 is a perspective view of the apparatus of FIG. 6 in a fully expanded position.
  • FIG. 8 is a cross-sectional view of a restraining sheath in a closed position.
  • FIG. 9 is a perspective view of a restraining sheath that has been partially expanded by the apparatus of FIG. 3.
  • FIG. 10 is a perspective view of a restraining sheath that has been partially expanded by the apparatus of FIG. 6.
  • FIG. 11 is an elevational view of the present invention, partially in cross- section, after advancement to a desired vessel site and just prior to commencement of stent deployment.
  • FIG. 12 is an elevational view, partially in cross-section, depicting the present invention during stent deployment.
  • FIG. 13 is an elevational view, partially in cross-section, depicting the present invention after the stent has been fully deployed.
  • FIG. 14 is an elevational view, partially in cross-section, depicting the present invention after the stent has been fully deployed, including an optional vacuum apparatus.
  • FIG. 1 depicting one preferred embodiment, an apparatus 10 of a composite design similar to that of an umbrella for expanding a restraining sheath is shown.
  • the restraining sheath is omitted for clarity.
  • a stent delivery catheter 12 is coaxially positioned within the apparatus 10. Expansion of the restraining sheath is accomplished by mechanically pushing the sheath via expansion of an expandable cage 14.
  • the cage 14 consists of spines 16 each of which have bends 18.
  • the spines 16 are secured by a fixed support ring 20 at the proximal end of spines 16.
  • a distal end of a control wire 22 is fixed to a collar 24 that is slidably mounted about the delivery catheter.
  • the cage is expanded by pulling the collar proximally via the control wire which causes secondary spines 26 (see FIG. 2) to press against the larger spines 16.
  • One end of each secondary spine 26 is pivotally secured to the collar 24.
  • the opposing end of each secondary spine is pivotally secured to larger spine 26.
  • the proximal end of each larger spine 16 is pivotally secured to the fixed control ring 20.
  • an apparatus 30 provides expansion for the sheath membrane (omitted for clarity), as shown in FIG. 3.
  • a plurality of spines 32 project distally and function to support the sheath.
  • the spines 32 are pivotally secured at their proximal ends to the stent delivery catheter 12.
  • a wedge 34 is slidably mounted on the stent delivery catheter and may be moved axially relative to the catheter and the spines 32 by a control wire (omitted for clarity) or other means.
  • FIG. 4 when the wedge 34 is moved proximally relative to the spines, the wedge forces the spines to protrude outwardly in a radial direction.
  • FIG. 5 depicts the spines in a fully expanded position. The wedge has been moved as far as possible in a proximal direction.
  • an apparatus 40 for expanding the sheath membrane provides yet another preferred embodiment.
  • a plurality of bent wires 42 are restrained in a straightened position by a fixed restraint ring 44 at a proximal end of the apparatus 40 and slidably mounted restraint ring 46 at a distal end of the apparatus.
  • the slidably mounted restraint ring is initially positioned at the distal ends of the wires 42.
  • a catheter 12 is coaxially positioned within the wires 42 and the rings 44,46.
  • a second control wire 48 is attached to the slidably mounted restraint ring. Referring to FIG. 7, the slidably mounted restraint ring 46 has been moved proximally via the second control wire.
  • the wires 42 have thus been released and have sprung into their resting bent positions. This action serves to fully expand a restraining sheath.
  • a restraining sheath 50 is depicted and is supported by spines 52, or alternatively wires.
  • the restraining sheath in a closed position may consist of folds 54.
  • An alternative to providing folds 54 is to construct a restraining sheath of a material that is capable of being stretched in a radial direction. This alternative would require less material but would require more force to expand the material in a radial direction than would be required if folds were implemented.
  • a restraining sheath may be formed from a material selected from the group of materials consisting of polyethylene, polyester, and polyamide. The material, which has a low coefficient of friction, may be obtained in varying grades of softness.
  • the restraining sheath 56 may be expanded by the apparatus 30 of FIG. 3 such that the diameter at the distal end is larger than the diameter at the proximal end.
  • the restraining sheath 58 may be expanded by the apparatus of FIG. 6 such that the diameter at the distal end is larger than the diameter at the proximal end.
  • the sheath design provides optimal deployment of the self-expanding stent because the sheath both expands in a radial direction and retracts in a proximal direction simultaneously. Therefore, due to the angle of incidence created between the sheath and the stent during deployment, there is a low coefficient of friction between the sheath and the stent. This is an ideal configuration for recapturing a partially deployed stent because contact is constantly maintained between the sheath and the undeployed part of the stent.
  • a desired site within vessel 60 is first accessed with the system, via a percutaneous technique.
  • a stent delivery catheter 62 has its proximal end open to atmospheric pressure and its distal end running into the proximal end of restraining sheath 64.
  • a self-expanding stent 66 is initially in a collapsed state and partially disposed within the restraining sheath. The restraining sheath then is deployed, and as it expands, the restraining sheath forms an occlusive conical member 68 or a catch basin at the proximal end of the stent.
  • the stent being of the self- expanding type, is automatically deployed as the restraining sheath expands.
  • a temporary seal is created between the stent and the restraining sheath.
  • the outer edge of the distal end of restraining sheath 64 may include a material consisting of soft plastic, rubber, or a gel, in order to ensure a proper seal between the sheath and the stent. Therefore, unlike the situation where a balloon exerts pressure on a vessel wall to cause a seal, in the present invention vessel damage is minimized.
  • a filter 70 for trapping and retaining embolic material or particles 72 is located relative to the restraining sheath 64 such that the filter will trap any embolic material flowing into the restraining sheath.
  • Such filters are known in the art and may include a strainer device comprised of a plurality of wires.
  • the filter may be located within the restraining sheath at the occlusion site one embodiment.
  • the filter 70 may be located within the stent delivery catheter 62, as shown in phantom in FIG. 13.
  • the filter may be located outside of the patient's body (not shown).
  • an aspiration system consisting of a vacuum device 74 with an optional valve 76 may be included in the system if the occlusion is not adequate to induce sufficient retrograde blood flow or to ensure that the maximum number of embolic particles 72 is aspirated into the filter 70.
  • an aspiration system consisting of a luer lock (not shown) capable of accepting a syringe may be used.
  • the restraining sheath 64 then is collapsed to its original size, thereby trapping any remaining embolic material or particles 72.
  • the system is then removed from the patient.
  • a self-expanding stent is deployed safely and easily without the risk of embolic migration. While the invention has been illustrated and described herein in terms of its use as a safe and easy-to-use apparatus and method for treating blood vessels while minimizing the risk of embolic migration, it will be apparent to those skilled in the art that the invention can be used in other instances. Other modifications and improvements may be made without departing from the scope of the invention.

Abstract

The present invention is directed to an apparatus and method for treating cerebral blood vessels such as carotid arteries. The system generally includes an apparatus and method for safely and easily deploying a self-expanding stent in a vessel while preventing embolic migration using a filter.

Description

ASSEMBLY FOR COLLECTING EMBOLI AND METHOD OF USE
BACKGROUND OF THE INVENTION
The present invention relates generally to the field of surgical instruments. Specifically, the present invention relates to an emboli-capture device for treating cerebral blood vessels such as carotid arteries.
Stenting and angioplasty in stenosed cerebral vessels (e.g., carotid arteries) pose risks of dislodging thrombus or friable plaque. The thrombus or plaque can become lodged in the brain or arteries and cause serious injury such as a stroke. If such embolic material is dislodged during a stenting procedure, it is necessary to collect the material before it migrates and causes injury. A previous invention, U.S. Patent No. 4,921,478, "Cerebral Balloon Angioplasty System," Solano et al., employs an occlusion catheter carrying a relatively large inflatable occlusion balloon to repair vessels. The balloon is capable of being formed into a funnel while simultaneously sealing a vessel and establishing retrograde blood flow. The balloon is bulky and difficult to refold and withdraw from lesions within the vessels. The withdrawal is prone to causing extensive tissue damage and dislodging more emboli. Moreover, the balloon-type system will not work effectively without a complete and perfect seal between the balloon and the vessel wall. Moreover, Solano et al. contemplates no occlusion in conjunction with the deployment of a self-expanding stent. Further, although the prior art filtered the blood, sometimes excess emboli remained when the device was removed from blood vessels. What has been needed and heretofore unavailable is a means to deliver and implant a stent in conjunction with a safe and easy-to-use device and method of use for stenting blood vessels while minimizing the risk of embolic migration. The present invention satisfies this need. SUMMARY OF THE INVENTION
The present invention is directed to an apparatus and method for treating stenosed cerebral blood vessels such as carotid arteries. The system generally includes an apparatus and method for safely and easily deploying a self-expanding stent in a vessel while preventing embolic migration.
In a preferred embodiment, a system for percutaneously delivering a stent within a vessel while preventing embolic migration includes: a restraining sheath that is capable of both expanding and retracting whereby minimal friction is created between the restraining sheath and the stent during deployment of the stent; a filter for trapping and retaining embolic material, the filter being located relative to the restraining sheath such that the filter will trap any embolic material flowing into the restraining sheath; a stent delivery catheter having a proximal end open to atmospheric pressure and a distal end connected to a proximal end of the restraining sheath; and a stent that initially is in a collapsed state and positioned within the restraining sheath.
The filter may consist of one of many devices already in use, e.g., a strainer device comprised of a plurality of wires. The expansion of the restraining sheath may be accomplished by mechanically pushing a composite sheath using a design similar to that of an umbrella. In another preferred embodiment, expansion of the filter may be accomplished by using a wedge and spine mechanism to open the restraining sheath from a closed position.
In another preferred embodiment, the expansion of the filter may be accomplished by releasing a plurality of bent wires that are restrained in a straightened position.
The sheath design provides optimal deployment of the self-expanding stent because the sheath both expands in a radial direction and retracts in a proximal direction simultaneously. Therefore, due to the angle of incidence created between the sheath and the stent during deployment there is a low coefficient of friction between the sheath and the stent. This is an ideal configuration for recapturing a partially deployed stent because contact is constantly maintained between the sheath and the undeployed part of the stent.
A desired site within a vessel is first accessed with the system. The restraining sheath then is deployed while being moved proximally. The restraining sheath, as it expands, forms an occlusive conical member or catch basin at a proximal end of the stent. The stent, being self-expanding, is automatically deployed as the restraining sheath expands. A temporary seal is created between the stent and the restraining sheath. An outer edge of a distal end of the restraining sheath may include a material taken from the group of materials consisting of soft plastic, rubber, and a gel, in order to ensure a proper seal between the sheath and the stent. Therefore, unlike the situation where a balloon exerts pressure on a vessel wall to cause a seal, in the present invention vessel damage is minimized.
The filter is located within the restraining sheath at the occlusion site in another embodiment.
In yet another preferred embodiment, the filter may be located within the stent delivery catheter. Alternatively, the filter may be located outside of the patient's body.
Due to the occlusion of the vessel at the proximal end of the stent, a pressure differential is created between the more distal arteries (pressurized at blood pressure plus atmospheric pressure) and a lumen of the stent delivery catheter (pressurized at atmospheric pressure). Therefore, retrograde blood flow is induced and blood and embolic particles are flushed into the filter where the embolic particles are captured. In another preferred embodiment, a vacuum apparatus may be included in the system if the occlusion is not adequate to induce sufficient retrograde blood flow or to ensure that the maximum number of embolic particles are aspirated into the filter. The restraining sheath is then collapsed to its original size, thereby trapping any remaining embolic material. The system is then removed from the patient.
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 one embodiment, depicting in a closed position an apparatus of a composite design similar to that of an umbrella for expanding a restraining sheath wherein expansion is accomplished by mechanically pushing the sheath.
FIG. 2 is a perspective view of the apparatus of FIG. 1 depicted in an open position.
FIG. 3 is a perspective view of another embodiment depicting an apparatus in a closed position for expanding the restraining sheath wherein expansion is accomplished by using a wedge and spine mechanism to open the restraining sheath from a closed position.
FIG. 4 is a perspective view of the apparatus of FIG. 3 in a partially expanded position.
FIG. 5 is a perspective view of the apparatus of FIG. 3 in a fully expanded position. FIG. 6 is a perspective view of another preferred embodiment depicting an apparatus in a closed position for expanding the restraining sheath wherein expansion is accomplished by releasing bent wires that are restrained in a straightened position.
FIG. 7 is a perspective view of the apparatus of FIG. 6 in a fully expanded position.
FIG. 8 is a cross-sectional view of a restraining sheath in a closed position.
FIG. 9 is a perspective view of a restraining sheath that has been partially expanded by the apparatus of FIG. 3.
FIG. 10 is a perspective view of a restraining sheath that has been partially expanded by the apparatus of FIG. 6.
FIG. 11 is an elevational view of the present invention, partially in cross- section, after advancement to a desired vessel site and just prior to commencement of stent deployment.
FIG. 12 is an elevational view, partially in cross-section, depicting the present invention during stent deployment.
FIG. 13 is an elevational view, partially in cross-section, depicting the present invention after the stent has been fully deployed. FIG. 14 is an elevational view, partially in cross-section, depicting the present invention after the stent has been fully deployed, including an optional vacuum apparatus.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
As shown in the exemplary drawings, the present invention may be embodied in various ways. Where common elements occur in more than one embodiment, the same reference numerals will be used. Referring to FIG. 1, depicting one preferred embodiment, an apparatus 10 of a composite design similar to that of an umbrella for expanding a restraining sheath is shown. The restraining sheath is omitted for clarity. A stent delivery catheter 12 is coaxially positioned within the apparatus 10. Expansion of the restraining sheath is accomplished by mechanically pushing the sheath via expansion of an expandable cage 14. The cage 14 consists of spines 16 each of which have bends 18. The spines 16 are secured by a fixed support ring 20 at the proximal end of spines 16. A distal end of a control wire 22 is fixed to a collar 24 that is slidably mounted about the delivery catheter. The cage is expanded by pulling the collar proximally via the control wire which causes secondary spines 26 (see FIG. 2) to press against the larger spines 16. One end of each secondary spine 26 is pivotally secured to the collar 24. The opposing end of each secondary spine is pivotally secured to larger spine 26. Likewise, the proximal end of each larger spine 16 is pivotally secured to the fixed control ring 20. As a result, the cage 14 pushes outwardly on the sheath membrane and the sheath thus expands at a distal end and forms a catch basin.
In another preferred embodiment, an apparatus 30 provides expansion for the sheath membrane (omitted for clarity), as shown in FIG. 3. A plurality of spines 32 project distally and function to support the sheath. The spines 32 are pivotally secured at their proximal ends to the stent delivery catheter 12. A wedge 34 is slidably mounted on the stent delivery catheter and may be moved axially relative to the catheter and the spines 32 by a control wire (omitted for clarity) or other means. As shown in FIG. 4, when the wedge 34 is moved proximally relative to the spines, the wedge forces the spines to protrude outwardly in a radial direction. FIG. 5 depicts the spines in a fully expanded position. The wedge has been moved as far as possible in a proximal direction.
As shown in FIG. 6, an apparatus 40 for expanding the sheath membrane (omitted for clarity) provides yet another preferred embodiment. A plurality of bent wires 42 are restrained in a straightened position by a fixed restraint ring 44 at a proximal end of the apparatus 40 and slidably mounted restraint ring 46 at a distal end of the apparatus. The slidably mounted restraint ring is initially positioned at the distal ends of the wires 42. A catheter 12 is coaxially positioned within the wires 42 and the rings 44,46. A second control wire 48 is attached to the slidably mounted restraint ring. Referring to FIG. 7, the slidably mounted restraint ring 46 has been moved proximally via the second control wire. The wires 42 have thus been released and have sprung into their resting bent positions. This action serves to fully expand a restraining sheath.
Turning to FIG. 8, a restraining sheath 50 is depicted and is supported by spines 52, or alternatively wires. The restraining sheath in a closed position may consist of folds 54. An alternative to providing folds 54 is to construct a restraining sheath of a material that is capable of being stretched in a radial direction. This alternative would require less material but would require more force to expand the material in a radial direction than would be required if folds were implemented. A restraining sheath may be formed from a material selected from the group of materials consisting of polyethylene, polyester, and polyamide. The material, which has a low coefficient of friction, may be obtained in varying grades of softness. As shown in FIG. 9, the restraining sheath 56 may be expanded by the apparatus 30 of FIG. 3 such that the diameter at the distal end is larger than the diameter at the proximal end.
Turning to FIG. 10, the restraining sheath 58 may be expanded by the apparatus of FIG. 6 such that the diameter at the distal end is larger than the diameter at the proximal end.
The sheath design provides optimal deployment of the self-expanding stent because the sheath both expands in a radial direction and retracts in a proximal direction simultaneously. Therefore, due to the angle of incidence created between the sheath and the stent during deployment, there is a low coefficient of friction between the sheath and the stent. This is an ideal configuration for recapturing a partially deployed stent because contact is constantly maintained between the sheath and the undeployed part of the stent.
Turning to FIGS. 11-13, in a preferred method, a desired site within vessel 60 is first accessed with the system, via a percutaneous technique. A stent delivery catheter 62 has its proximal end open to atmospheric pressure and its distal end running into the proximal end of restraining sheath 64. A self-expanding stent 66 is initially in a collapsed state and partially disposed within the restraining sheath. The restraining sheath then is deployed, and as it expands, the restraining sheath forms an occlusive conical member 68 or a catch basin at the proximal end of the stent. The stent, being of the self- expanding type, is automatically deployed as the restraining sheath expands. A temporary seal is created between the stent and the restraining sheath. The outer edge of the distal end of restraining sheath 64 may include a material consisting of soft plastic, rubber, or a gel, in order to ensure a proper seal between the sheath and the stent. Therefore, unlike the situation where a balloon exerts pressure on a vessel wall to cause a seal, in the present invention vessel damage is minimized. A filter 70 for trapping and retaining embolic material or particles 72 is located relative to the restraining sheath 64 such that the filter will trap any embolic material flowing into the restraining sheath. Such filters are known in the art and may include a strainer device comprised of a plurality of wires. The filter may be located within the restraining sheath at the occlusion site one embodiment. In another embodiment, the filter 70 may be located within the stent delivery catheter 62, as shown in phantom in FIG. 13. In yet another preferred embodiment, the filter may be located outside of the patient's body (not shown).
Due to the occlusion of the vessel 60 at the proximal end of the stent 66, a pressure differential is created between the more distal arteries (pressurized at blood pressure plus atmospheric pressure) and a lumen of the stent delivery catheter (pressurized at atmospheric pressure). Therefore, retrograde blood flow is induced and blood and embolic particles are flushed into the filter 70 where the embolic particles are collected. Turning to FIG. 14, in another preferred embodiment an aspiration system consisting of a vacuum device 74 with an optional valve 76 may be included in the system if the occlusion is not adequate to induce sufficient retrograde blood flow or to ensure that the maximum number of embolic particles 72 is aspirated into the filter 70. Alternatively, in another embodiment, an aspiration system consisting of a luer lock (not shown) capable of accepting a syringe may be used.
The restraining sheath 64 then is collapsed to its original size, thereby trapping any remaining embolic material or particles 72. The system is then removed from the patient. Thus, a self-expanding stent is deployed safely and easily without the risk of embolic migration. While the invention has been illustrated and described herein in terms of its use as a safe and easy-to-use apparatus and method for treating blood vessels while minimizing the risk of embolic migration, it will be apparent to those skilled in the art that the invention can be used in other instances. Other modifications and improvements may be made without departing from the scope of the invention.

Claims

WHAT IS CLAIMED IS:
1. A system for delivering a stent within a vessel while preventing embolization, comprising: a restraining sheath adapted for expanding and retracting whereby minimal friction exists between the restraining sheath and the stent during deployment of the stent; a filter for collecting and retaining embolic material, the filter being located relative to the restraining sheath so that the filter collects any embolic material flowing into the restraining sheath; and a stent delivery catheter having a proximal end open to atmospheric pressure and a distal end running into a proximal end of the restraining sheath; whereby the stent initially is in a low-profile, collapsed state and positioned within the restraining sheath.
2. The system of claim 1, wherein the restraining sheath is formed from a material that has a low coefficient of friction.
3. The system of claim 1, wherein the restraining sheath is formed from a material selected from the group of materials consisting of polyethylene, polyester, poly amide, peba, silicone, rubber, nylon and elastomers.
4. The system of claim 1 , wherein the restraining sheath is formed from a material that may be obtained in varying grades of softness.
5. The system of claim 2, wherein the restraining sheath expands to form a catch basin.
6. The system of claim 2, wherein an outer edge of a distal end of the restraining sheath includes a material taken from the group of materials consisting of soft plastic, rubber, and a gel, thereby ensuring a seal between the sheath and the stent.
7. The system of claim 2, wherein the restraining sheath includes a plurality of folds for expanding from a closed position to an open position.
8. The system of claim 2, wherein the restraining sheath is formed from an elastic material so that the restraining sheath can be stretched from a closed to an open position.
9. The system of claim 2, wherein expansion of the restraining sheath may be accomplished by an apparatus including an expandable cage having a plurality of first spines, each of the first spines including a bend and being pivotally secured by a fixed support ring at a proximal end, the apparatus further including a plurality of secondary spines, each of the secondary spines being pivotally secured at a proximal end to one of each of the first spines and being pivotally secured at a distal end to a slidably mounted collar, the cage pushing outwardly on the sheath when the collar is moved proximally.
10. The system of claim 2, wherein a wedge and a spine mechanism move the restraining sheath from a closed position to an open position.
11. The system of claim 2, wherein one or more restrained spring elements are provided to expand the restraining sheath.
12. The system of claim 11, wherein a plurality of bent wires being associated with the restraining sheath, the bent wires being restrained in a straightened position and when released expand the restraining sheath.
13. The system of claim 12, further including a restraint ring for retaining the bent wires in a straightened position.
14. The system of claim 13, further including a fixed support ring for supporting the bent wires at a proximal end.
15. The system of claim 1, wherein the filter is located within the restraining sheath.
16. The system of claim 1, wherein the filter is located within the stent delivery catheter.
17. The system of claim 1 , wherein the filter is located outside of the body of a patient.
18. The system of claim 1, further including an aspiration system for aspirating embolic material into the stent delivery catheter.
19. The system of claim 18, wherein the aspiration system attaches the stent delivery catheter by a luer lock fitting.
20. The system of claim 19, wherein the luer lock is capable of accepting a syringe for facilitating the aspiration of embolic material into the stent delivery catheter.
21. The system of claim 18, wherein the aspiration system includes a vacuum apparatus for inducing retrograde blood flow.
22. The system of claim 21, wherein the vacuum apparatus includes a valve for facilitating rapid activation of the vacuum apparatus.
23. The system of claim 1 , wherein the stent is self-expanding.
24. A method for deploying a self-expanding stent within a vessel while simultaneously preventing the migration of embolic material, using a system including a restraining sheath, a filter, a stent delivery catheter having a proximal end open to atmospheric pressure and a distal end running into a proximal end of the restraining sheath, and a self-expanding stent, comprising the steps of: accessing a desired site within the vessel with the system; deploying the restraining sheath while moving the sheath proximally, thereby forming a catch basin and simultaneously deploying and implanting the self-expanding stent, the catch basin occluding the vessel at a proximal end of the stent, thereby inducing retrograde blood flow through the filter; collapsing the restraining sheath and collecting any remaining embolic material; and removing the system from the patient.
25. A method for deploying a self-expanding stent within a vessel while simultaneously capturing a resultant emboli, using a system including a restraining sheath, a filter, a stent delivery catheter having a proximal end open to atmospheric pressure and a distal end running into a proximal end of the restraining sheath, a vacuum apparatus, and a self-expanding stent, comprising the steps of: accessing a desired site within the vessel with the system; deploying the restraining sheath while moving the sheath proximally, thus causing the formation of a catch basin and the automatic deployment of the stent, the catch basin occluding the vessel at a proximal end of the stent, thereby inducing retrograde blood flow through the filter; activating the vacuum apparatus to maximize the aspiration of embolic material into the filter; collapsing the restraining sheath to its original size, thus collecting any remaining embolic material; and removing the system from the patient.
26. A method of creating a pressure differential in a vessel to collect embolic material by creating a substantially atraumatic seal across a lesion within the vessel while preventing embolization.
27. The method of claim 26, further including activating a vacuum apparatus to maximize the amount of embolic material that is aspirated into a filter.
PCT/US1999/017685 1998-08-04 1999-08-04 Assembly for collecting emboli and method of use WO2000007521A1 (en)

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