US20050165469A1 - Vascular prosthesis including torsional stabilizer and methods of use - Google Patents

Vascular prosthesis including torsional stabilizer and methods of use Download PDF

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Publication number
US20050165469A1
US20050165469A1 US10/723,565 US72356503A US2005165469A1 US 20050165469 A1 US20050165469 A1 US 20050165469A1 US 72356503 A US72356503 A US 72356503A US 2005165469 A1 US2005165469 A1 US 2005165469A1
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United States
Prior art keywords
vascular prosthesis
distal
torsional stabilizer
vessel
section
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Abandoned
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US10/723,565
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English (en)
Inventor
Michael Hogendijk
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NovoStent Corp
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Individual
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Publication date
Priority claimed from US10/342,427 external-priority patent/US7846198B2/en
Application filed by Individual filed Critical Individual
Priority to US10/723,565 priority Critical patent/US20050165469A1/en
Priority to AU2003300323A priority patent/AU2003300323A1/en
Priority to JP2005510057A priority patent/JP2006513010A/ja
Priority to EP03814356A priority patent/EP1581147A4/en
Priority to PCT/US2003/041122 priority patent/WO2004058100A2/en
Priority to CA002508247A priority patent/CA2508247A1/en
Priority to US10/746,668 priority patent/US7862608B2/en
Assigned to NOVOSTENT CORPORATION reassignment NOVOSTENT CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HOGENDIJK, MICHAEL
Publication of US20050165469A1 publication Critical patent/US20050165469A1/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • 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
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • A61F2/885—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
    • 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
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/068—Modifying the blood flow model, e.g. by diffuser or deflector
    • 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
    • A61F2002/828—Means for connecting a plurality of stents allowing flexibility of the whole structure
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • A61F2230/0054—V-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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir

Definitions

  • the present invention relates to an implantable vascular prosthesis configured for use in a wide range of applications, and more specifically, a ribbon-type prosthesis having a torsional stabilizer that increases frictional engagement with a vessel wall.
  • Balloon expandable and self-expanding stents are well known for restoring patency in a stenosed vessel, e.g., after an angioplasty procedure, and the use of coils and stents are known techniques for treating aneurysms.
  • Previously-known self-expanding stents generally are retained in a contracted delivery configuration using an outer sheath, then self-expand when the sheath is retracted.
  • Such stents commonly have several drawbacks, for example, the stents may experience large length changes during expansion (referred to as “foreshortening”) and may shift within the vessel prior to engaging the vessel wall, resulting in improper placement.
  • many self-expanding stents have relatively large delivery profiles because the configuration of their struts limits further compression of the stent. Accordingly, such stents may not be suitable for use in smaller vessels, such as cerebral vessels and coronary arteries.
  • PCT Publication WO 00/62711 to Rivelli describes a stent comprising a helical mesh coil having a plurality of turns and including a lattice having a multiplicity of pores.
  • the lattice is tapered along its length.
  • the plurality of turns are wound into a reduced diameter helical shape, then constrained within a delivery sheath.
  • the delivery sheath is retracted to expose the distal portion of the stent and anchor the distal end of the stent.
  • the subsequent individual turns of the stent unwind to conform to the diameter of the vessel wall.
  • the stent described in the foregoing publication has several drawbacks. For example, due to friction between the turns and the sheath, the individual turns of the stent may bunch up, or overlap with one another, when the delivery sheath is retracted. In addition, once the sheath is fully retracted, the turns may shift within the vessel prior to engaging the vessel wall, resulting in improper placement of the stent. Moreover, because the distal portion of the stent may provide insufficient engagement with the vessel wall during subsequent retraction of the remainder of the sheath, ambiguity concerning accuracy of the stent placement may arise.
  • the drug is disposed in the matrix of a bioabsorbable polymer coated on an exterior surface of the struts of the stents, and then gradually released into a vessel wall.
  • the quantity of the therapeutic agent provided by the stent generally is limited by the surface area of the struts. Increasing the surface area of the struts may enhance drug delivery capability, but may compromise the overall delivery profile of the stent. There therefore exists a need for a prosthesis having a reduced delivery profile and enhanced drug delivery capabilities.
  • an implantable vascular prosthesis comprising a ribbon-type stent having a torsional stabilizer, wherein the prosthesis is configured to be used in a wide range of applications including, but not limited to, treating aneurysms, maintaining patency in a vessel, and delivering drugs to a vessel.
  • vascular prosthesis comprising a ribbon-type stent having a torsional stabilizer that enhances frictional engagement with the vessel.
  • vascular prosthesis having a distal anchoring section that allows for controlled deployment of a ribbon-type stent at a desired location within a vessel.
  • an object of the present invention to provide apparatus and methods for an implantable vascular prosthesis comprising a ribbon-type stent having a torsional stabilizer, wherein the prosthesis is configured to be used in a wide range of applications including, but not limited to, treating aneurysms, maintaining patency in a vessel, and delivering drugs to a vessel.
  • a vascular prosthesis comprising a distal anchor section joined a helical mesh proximal section and including a torsional stabilizer, wherein the prosthesis is configured to engage a vessel wall and adapt to a natural curvature of the vessel wall.
  • the torsional stabilizer is an extension of the proximal section and enhances contact and friction with the vessel wall.
  • the vascular prosthesis may be used in a wide range of applications, such as treating aneurysms, maintaining patency in a vessel, e.g., after an angioplasty procedure, and other procedures requiring a controlled delivery of therapeutic drugs to a vessel.
  • the vascular prosthesis comprises a shape memory material, such as Nitinol, and includes a distal anchor section having a generally zig-zag or cell-like configuration coupled to a proximal helical section having a helical mesh configuration formed of a plurality of turns.
  • shape memory material such as Nitinol
  • the prosthesis is delivered to a target vessel in a contracted state, constrained within an outer sheath, in which radially inwardly directed compressive forces are applied by the outer sheath to the distal section.
  • the helical proximal section and torsional stabilizer are wound down to a smaller configuration, so that adjacent turns preferably partially overlap, and are constrained in the contracted state by the outer sheath.
  • the distal section, proximal section and torsional stabilizer are provided in their respective contracted states within the outer sheath and the prosthesis is fluoroscopically advanced into a selected vessel using techniques that are per se known in the art.
  • the proximal section then is positioned adjacent a target region of a vessel, such as an aneurysm or a stenosed region, with the distal section positioned distal of the target region.
  • the outer sheath then is retracted proximally to cause the distal section to self-deploy and engage an inner wall of the vessel distal of the target region.
  • a distal portion of the distal section may be biased radially outward, or provided with proximally-directed barbs, to facilitate secure anchoring of the distal section within the vessel.
  • the outer sheath further is retracted to cause the proximal section to self-deploy and engage the vessel wall at the target region.
  • each turn of the helical proximal section will unwind in a controlled manner as the outer sheath is retracted. This technique ensures that the prosthesis will not shift within the vessel during deployment.
  • the vascular prosthesis of the present invention is flexible enough to conform to the shape of a delicate vessel without substantially remodeling the vessel.
  • the zig-zag or cell-like configuration of the distal section may conform to a natural curvature of a vessel wall better than traditional stents having interconnected struts, which may be more rigid.
  • the helical mesh configuration of the proximal section conforms to vasculature of the target region since each of the plurality of turns is free to assume a curved configuration substantially independently of one another.
  • the proximal section of the vascular prosthesis has a ribbon-like structure, the proximal section may be wound down to a contracted state with a substantially reduced delivery profile, compared to slotted-tube stents. This feature makes the stent of the present invention especially useful for treating defects in smaller vessels, such as cerebral arteries.
  • the plurality of turns may comprise a substantially increased surface area relative to conventional stents that have a plurality of interconnected struts.
  • the increased surface area of the turns is particularly advantageous for localized drug delivery.
  • the turns may be coated with a drug-laden polymer coating or, alternatively, one or more dimples or through-holes may be disposed in a lateral surface of the turns to elute drugs over an extended period of time.
  • Methods of using the vascular prosthesis of the present invention for example, in the treatment of an aneurysm, also are provided.
  • FIGS. 1A-1B are, respectively, side and perspective views of a vascular prosthesis of the present invention.
  • FIG. 2 is a side view describing features of the junction of the prosthesis of FIG. 1 ;
  • FIG. 3 is a side view of a vascular prosthesis having a distal section that is biased radially outward;
  • FIG. 4 is an enlarged view of the distal end of the prosthesis of FIG. 3 ;
  • FIG. 5 is a side view illustrating different drug delivery modalities
  • FIG. 6 is a side sectional view of a delivery system that may be used in conjunction with the vascular prosthesis of FIG. 1 ;
  • FIGS. 7A-7C are side sectional views illustrating use of the vascular prosthesis of FIG. 1 in the treatment of an aneurysm;
  • FIGS. 8A-8B are, respectively, side and perspective views of an alternative embodiment of the vascular prosthesis of the present invention.
  • FIGS. 9A-9B are, respectively, side and perspective views of a vascular prosthesis including a torsional stabilizer according to the present invention.
  • FIG. 10 is a detailed side view of the torsional stabilizer portion of the vascular prosthesis of FIG. 9 ;
  • FIG. 11 is a side view of the torsional stabilizer portion of an alternative vascular prosthesis.
  • FIG. 12 is a side view of the torsional stabilizer portion of another alternative vascular prosthesis.
  • the present invention is directed to an implantable vascular prosthesis configured for use in a wide range of applications, such as treating aneurysms, maintaining patency in a vessel, and allowing for the controlled delivery of therapeutic agents to a vessel wall.
  • the prosthesis has a ribbon-type configuration that provides a substantially smaller delivery profile than other known devices, while having an increased surface area to allow for delivery of the therapeutic agents. Additionally, the prosthesis is configured to conform to a vessel wall without substantially remodeling the vessel, and further is configured to provide improved accuracy during deployment relative to previously known devices.
  • Vascular prosthesis 20 comprises proximal section 22 and distal section 24 , each capable of assuming contracted and deployed states.
  • proximal and distal sections 22 and 24 are each depicted in their respective deployed states.
  • Vascular prosthesis 20 preferably is formed from a solid tubular member comprising a shape memory material, such as nickel-titanium alloy (commonly known in the art as Nitinol).
  • the solid tubular member then is laser cut, using techniques that are per se known in the art, to a desired deployed configuration, as depicted in FIG. 1A .
  • An appropriate heat treatment per se known in the art, then may be applied to solid regions 33 of vascular prosthesis 20 while the device is held in the desired deployed configuration.
  • the treatment of the shape memory material allows vascular prosthesis 20 to self-deploy to the desired deployed configuration, depicted in FIGS. 1 , for purposes described hereinafter.
  • Distal section 24 preferably has a generally zig-zag configuration in the deployed state, as shown in FIG. 1A .
  • the zig-zag configuration preferably is formed by laser cutting a solid tube, as described hereinabove, to form a pattern comprising plurality of struts 31 disposed between plurality of bends 32 .
  • Proximal section 22 preferably comprises a helical mesh configuration in the deployed state, as depicted in FIGS. 1 .
  • the helical mesh configuration includes a plurality of substantially flat turns 26 .
  • Plurality of turns 26 may include a multiplicity of openings provided in different shapes and sizes, as illustrated by larger rectangular openings 25 , smaller rectangular openings 28 and small circular openings 29 .
  • the multiplicity of openings are disposed between solid regions 33 of the shape memory material used to form vascular prosthesis 20 .
  • turns 26 may comprise fully covered sections 39 , as depicted hereinbelow in FIG. 7C .
  • proximal section 22 depicted herein is merely for illustrative purposes. Any combination of covered sections 39 , circular openings 29 , large or small rectangular openings, or any other shape may be provided along portions of turns 26 , as desired. Plurality of turns 26 similarly may comprise exclusively one type of opening, such as small circular openings 29 . Alternatively, plurality of turns 26 may be completely solid, such that the openings are omitted altogether.
  • the combination of solid regions and openings may be selectively provided along the length of proximal section 22 , for example, to selectively increase surface area and drug delivery capabilities along proximal section 22 , or to influence flow dynamics within a vessel.
  • Proximal section 22 includes distal turn 34 that transitions into bend 32 of distal section 24 , thereby forming junction 23 .
  • Proximal turn 35 of proximal section 22 forms a free end that permits proximal section 22 to conform to a natural configuration of a patient's vessel, as described hereinbelow with respect to FIGS. 7 .
  • junction 23 is disposed between proximal and distal sections 22 and 24 of vascular prosthesis 20 .
  • Junction 23 preferably comprises extension strut 47 that is coupled to at least one bend 32 of distal section 24 .
  • Junction 23 extends in a proximal direction towards proximal section 22 and ultimately transitions into proximal wall 42 of distal turn 34 , as shown in FIG. 2 .
  • Junction 23 further preferably comprises substantially orthogonal segment 48 , i.e., a segment that is substantially orthogonal to a longitudinal axis of vascular prosthesis 20 .
  • Segment 48 transitions into extension strut 47 in the vicinity of bend 32 , and further transitions into distal wall 41 of distal turn 34 , as shown in FIG. 2 .
  • Junction 23 may comprise one or more radiopaque markers 44 , such as a radiopaque marker band or coating.
  • Radiopaque marker 44 facilitates positioning of junction 23 at a desired longitudinal position within a patient's vessel, and further facilitates alignment of vascular prosthesis 20 at a desired radial orientation within the vessel.
  • radiopaque marker 44 may be used to orient proximal section 22 so that a desired lateral surface of proximal section 22 , e.g., comprising covered sections 39 or small circular openings 29 , deploys to overlay the arc of a vessel in which an aneurysm is situated.
  • junction 32 may comprise other strut arrangements to connect distal section 24 to proximal section 22 .
  • more than one extension struts 47 may be coupled between bends 32 and distal turn 34 of proximal section 22 .
  • proximal and distal sections 22 and 24 may be manufactured as two distinct sections, then coupled together to form a junction.
  • the junction may be formed when distal turn 34 of proximal section 22 is coupled to one or more bends 32 situated at proximal end 37 of distal section 24 .
  • Distal turn 34 may be coupled to one or more bends 32 using a means for bonding, such as a solder, or the sections alternatively may be mechanically coupled together, for example, using a rivet or any other means, as will be apparent to one skilled in the art.
  • a means for bonding such as a solder
  • distal section 24 ′ has proximal end 37 and distal end 38 .
  • Distal end 38 is biased radially outward with respect to the longitudinal axis of vascular prosthesis 20 .
  • the deployed configuration of distal section 24 ′ may be established by heat treating a shape memory material, using techniques that are per se known in the art, as described above.
  • Distal section 24 ′ is configured to impose an increased radial outward force upon a patient's vessel and may further improve anchoring of the prosthesis within the vessel.
  • Distal end 38 of distal section 24 ′ further may comprise at least one barb 40 protruding from bend 32 and/or a distal portion of strut 31 , as depicted in FIG. 4 .
  • Barb 40 is configured to extend radially outward and in a proximal direction with respect to a longitudinal axis of vascular prosthesis 20 .
  • Each barb 40 may comprise sharpened tip 41 , which is configured to engage a patient's vessel when distal section 24 ′ is deployed in a vessel, as described in hereinbelow with respect to FIGS. 7 .
  • illustrative turn 26 ′ of proximal section 22 comprises multiplicity of openings 28 disposed between solid regions 33 , and further comprises at least one dimple 50 and/or through hole 52 disposed in solid regions 33 .
  • Each dimple 50 and through hole 52 may have therapeutic agent 54 disposed therein.
  • Therapeutic agent 54 may be disposed in the matrix of a bioabsorbable polymer, and the drug may be gradually released into a localized region of an arterial wall.
  • Dimples 50 may be selectively disposed on an interior surface of turn 26 ′, and/or disposed on an exterior surface of turn 26 ′, as depicted in FIG. 5 .
  • One or more turns 26 may be selectively coated with elastomeric polymer 56 , such as polyurethane.
  • Elastomeric polymer 56 may partially or fully cover selected regions of turns 26 .
  • elastomeric polymer 56 may be disposed on one arc of the circumference of proximal section 22 to overlay an aneurysm and reduce blood flow into a sac of the aneurysm.
  • therapeutic agent 54 may be disposed on elastomeric polymer 56 , which increases the working surface area of proximal section 22 .
  • the therapeutic agent may be disposed directly on solid region 33 , either with or without the use of elastomeric polymer 56 .
  • delivery system 60 is similar to that disclosed in U.S. Pat. No. 4,665,918 to Garza et al., and includes catheter 61 having central lumen 62 , nose cone 63 and outer sheath 64 .
  • catheter 61 includes recessed portion 65 that cooperates with outer sheath 64 to retain proximal and distal sections 22 and 24 of vascular prosthesis 20 in their respective contracted states for transluminal delivery.
  • Delivery system 60 also may comprise fluid delivery lumen 67 , which may be used to deliver chilled saline to vascular prosthesis 20 during delivery of the device.
  • Fluid delivery lumen 67 may be disposed within catheter 61 , as depicted in FIG. 6 , and one or more ports 68 may be formed in a distal lateral surface of catheter 61 to facilitate fluid communication between lumen 67 and recessed portion 65 .
  • vascular prosthesis 20 also may be used in general stenting procedures, for example, to maintain patency in a vessel after a carotid angioplasty procedure, or may be used as an intravascular drug delivery device, or may be used in other applications apparent to those skilled in the art.
  • vascular prosthesis 20 of FIG. 1 is provided in the fully contracted state disposed between recessed portion 65 of catheter 61 and outer sheath 64 of FIG. 6 .
  • distal section 24 is compressed to its contracted delivery state about recessed portion 65 of catheter 61
  • the plurality of turns of proximal section 22 are wound down to a contracted delivery state about recessed portion 65 , as shown in FIG. 7A .
  • Outer sheath 64 is disposed over proximal and distal sections 22 and 24 , as depicted, to retain both sections in their contracted states.
  • guide wire 70 is percutaneously and transluminally advanced through a patient's vasculature, using techniques that are per se known in the art, until a distal end of guide wire 70 is positioned distal of aneurysm A, which is situated in vessel V.
  • Delivery system 60 having vascular prosthesis 20 contracted therein, then is advanced over guide wire 70 via central lumen 62 of catheter 61 .
  • Nose cone 63 serves as an atraumatic bumper during advancement of delivery system 60 .
  • Delivery system 60 is advanced under fluoroscopic guidance until proximal section 22 is situated adjacent aneurysm A, as shown in FIG. 7A .
  • chilled saline preferably is delivered to vascular prosthesis 20 via fluid delivery lumen 67 and port 68 .
  • the chilled saline may be used to increase the flexibility of prosthesis 20 to facilitate advancement of delivery system 60 over guide wire 70 .
  • outer sheath 64 is retracted proximally to cause distal section 24 to self-deploy distal of aneurysm A, as shown in FIG. 7B .
  • Struts 31 of distal section 24 expand in a radial direction to engage an inner wall of vessel V.
  • Barbs 40 of FIG. 3 may engage vessel V, and/or the distal end of distal section 24 may be biased radially outward with respect to the proximal end (see FIG. 3 ) to enhance the engagement between distal section 24 and the vessel wall.
  • outer sheath 64 With distal section 24 anchored distal of aneurysm A, outer sheath 64 then is further retracted proximally to cause distal turn 34 of proximal section 22 to unwind and deploy to its predetermined shape, as shown in FIG. 7C . As the outer sheath is further retracted, each subsequent turn 26 unwinds one at a time and engages and conforms to an inner wall of vessel V in a controlled manner. When prosthesis system 20 is fully deployed, delivery system 60 then is proximally retracted over guide wire 70 and withdrawn from the patient's vessel, and guide wire 70 is removed.
  • deploying distal section 24 prior to deploying proximal section 22 allows distal section 24 to serve as an anchoring mechanism that allows for a controlled deployment of the helical turns of proximal section 22 .
  • turns 26 of proximal section 22 will be accurately deployed within vessel V, with substantially no proximal or distal shifting with respect to the vessel as outer sheath 64 is retracted.
  • distal section 24 by deploying distal section 24 prior to deploying proximal section 22 , drawbacks associated with the device described in the above-referenced publication to Rivelli may be overcome. Specifically, without a distal anchoring element, the multiplicity of turns of the stent described in the Rivelli publication may experience a tendency to “bunch up,” i.e., overlay one another, as the outer sheath is retracted due to friction between the turns and the outer sheath. In the present invention, distal section 24 serves as an anchoring mechanism prior to retraction of the outer sheath over the proximal section. Accordingly, such a distal anchoring mechanism overcomes potential friction and turns 26 will be less likely to bunch up.
  • vascular prosthesis 20 of the present invention is configured to be flexible enough to substantially conform to the shape of vessel V without causing the vessel to remodel.
  • the zig-zag configuration of distal section 24 and the helical configuration of proximal section 22 allow for increased flexibility of prosthesis 20 .
  • the pitch associated with plurality of turns 26 may be varied to vary the overall flexibility of proximal section 22 .
  • a lower pitch, whereby adjacent turns 26 are spaced relatively close together, may be employed to increase flexibility of proximal section 22 .
  • a lower pitch is desirable, for example, to treat cerebral aneurysms so that turns 26 may conform to the vasculature without causing remodeling of the vessel.
  • a higher pitch whereby adjacent turns 26 are spaced further apart, may be employed to increase the rigidity of proximal section 22 .
  • Such a design may be desirable for use in maintaining patency in a stenosed vessel by increasing rigidity of proximal section 22 .
  • the width of the coil may be tapered, as described in the Rivelli publication.
  • covered sections 39 may be positioned to overlay aneurysm A to significantly reduce blood flow into aneurysm A.
  • smaller rectangular openings 28 or small circular openings 29 may overlay aneurysm A to reduce blood flow into the sac of the aneurysm. Over time, the intima of vessel V will grow over plurality of turns 26 of proximal section 22 to completely exclude the aneurysm A from vessel V.
  • proximal section 22 depicted in FIG. 7C is merely for illustrative purposes. Any combination of covered sections 39 , circular openings 29 , large or small rectangular openings, or any other shape may be provided along turns 26 , as desired. Plurality of turns 26 similarly may exclusively comprise one type of opening, e.g., small circular openings 29 . Alternatively, plurality of turns 26 may be completely solid such that the openings are omitted altogether.
  • therapeutic agents may be delivered to expedite treatment of the aneurysm or prevent restenosis.
  • therapeutic agent 54 may be delivered to a desired location within vessel V, either using internal or external dimples 50 , through holes 52 , elastomeric polymer 56 and/or solid regions 33 of one or more turns 26 .
  • Therapeutic agent 54 may include, for example, antiplatelet drugs, anticoagulant drugs, agents used for purposes of providing gene therapy to a target region, or any other agent, and may be tailored for a particular application. Radiopaque markers (not shown) may be selectively disposed on turns 26 in the vicinity of the therapeutic agents to facilitate alignment of the therapeutic agents with a target site of a vessel wall.
  • Radiopaque markers may be selectively disposed on turns 26 in the vicinity of the therapeutic agents to facilitate alignment of the therapeutic agents with a target site of a vessel wall.
  • higher doses of such agents may be provided using vascular prosthesis 20 of the present invention, relative to previously known coils or stents having interconnected struts, due to the increased surface area associated with turns 26 .
  • Vascular prosthesis 120 comprises proximal section 122 and distal sections 124 .
  • Distal section 124 preferably is provided in accordance with distal section 24 of FIG. 1 and comprises a generally zig-zag configuration including struts 131 and bends 132 .
  • Proximal section 122 includes a plurality of individual helical turns 126 . Each turn has a distal end that is coupled to a respective bend 132 of distal section 124 at junctions 127 , as shown in FIGS. 8 . Individual helical turns 126 are aligned in a pattern such that each turn maintains its own helical curvature without overlapping with an adjacent turn, as depicted in FIG. 8 . Individual helical turns 126 of vascular prosthesis 120 may be heat treated to self-deploy to the configuration shown, and may be wound down to a small diameter in which turns 126 are constrained within delivery system 60 of FIG. 6 .
  • vascular prosthesis 120 The deployment of vascular prosthesis 120 is substantially similar to the deployment of prosthesis 20 , as described in detail hereinabove with respect to FIGS. 7 , and vascular prosthesis 120 encompasses many of the advantages noted hereinabove with respect to vascular prosthesis 20 .
  • vascular prosthesis 140 is described and includes torsional stabilizer 146 according to the principles present invention.
  • Vascular prosthesis 140 comprises a proximal section 142 , distal section 144 and torsional stabilizer 146 .
  • Proximal section 142 , distal section 144 and torsional stabilizer 146 are joined at junction 148 .
  • Each of the proximal section, distal section and torsional stabilizer are capable of assuming contracted and deployed states, and each are depicted in their respective deployed states in FIGS. 9A and 9B .
  • distal section 144 is configured to be deployed within a vessel before torsional stabilizer 146 , which is configured to be deployed before proximal section 142 .
  • Deploying distal section 144 first allows the distal section to serve as an anchor controls subsequent deployment of the helical turns of proximal section 142 .
  • Torsional stabilizer 146 provides further contact with the vessel wall, thereby providing an additional anchor that transmits torsional forces proximally during deployment of proximal section 142 .
  • Distal section 144 and torsional stabilizer 146 preferably work in conjunction to balance the torsional force of the proximal section and thus stabilize the vascular prosthesis. This action is expected to further reduce shifting with respect to the vessel wall during deployment of proximal section 142 .
  • the above-identified order of deployment alleviates drawbacks associated with the prior art such as the tendency of the turns of the proximal section to “bunch up” during deployment.
  • vascular prosthesis including distal section 144 , proximal section 142 and torsional stabilizer 146 , preferably is formed from a solid tubular member comprising a shape memory material, such as Nitinol, processed as described above with respect to the embodiment of FIGS. 1 .
  • torsional stabilizer 146 includes at least one dimple or through-hole disposed on a solid portion of the torsional stabilizer.
  • distal section 144 in the deployed state has a cell-like configuration comprising a pair zig-zags 144 a, 144 b joined by struts 144 c.
  • distal section 144 may include a single zig-zag configuration, such as described with respect to FIGS. 1 .
  • the cell configuration of FIGS. 9 is expected to be more rigid than the single zig-zag configuration, and hence is capable of applying, and withstanding, greater radial force.
  • Either configuration of distal section 144 may be formed by laser cutting a solid tube, as described hereinabove, to form the requisite pattern.
  • distal section 144 may have many other configurations without departing from the scope of the present invention.
  • Proximal section 142 preferably comprises a helical ribbon including plurality of turns 152 having multiplicity of openings 154 provided in varying shapes and sizes. The multiplicity of openings are disposed between solid regions 150 of the shape memory material used to form vascular prosthesis 140 .
  • Proximal section 142 alternatively may comprise the helical mesh configuration of FIGS. 1 or any other suitable pattern.
  • Proximal section 142 includes distal turn 156 that transitions into torsional stabilizer 146 .
  • Torsional stabilizer 146 comprises strut 158 that preferably remains substantially parallel to distal section 144 .
  • distal section 144 is coupled to proximal section 142 at junction 148 . More particularly, strut 144 b extends in a proximal direction forming neck 149 , which is attached to proximal section 142 at junction 148 . It will be apparent to those skilled in the art that other strut arrangements may be employed to connect distal section 144 to proximal section 142 . For example, more than one strut may be coupled between proximal section 142 and distal section 144 . Alternatively, proximal section 142 and distal section 144 may be manufactured as two distinct sections, then coupled together.
  • the X-axis is substantially parallel to a longitudinal axis of vascular prosthesis 140 and the Y-axis is substantially orthogonal to the longitudinal axis of vascular prosthesis 140 .
  • Torsional stabilizer 146 generally comprises the portion of the proximal section that extends past the plane of the X-axis junction 148 .
  • torsional stabilizer 146 is an extension of proximal section 142 and may comprise a continuation of the helical pattern of the proximal section.
  • Torsional stabilizer 146 optionally may be biased outwardly to provide increased frictional contact with the vessel wall. Torsional stabilizer 146 also may comprise one or more radiopaque markers 160 , such as a radiopaque marker band or coating. Radiopaque marker 160 facilitates positioning of torsional stabilizer 146 at a desired longitudinal position within a patient's vessel, and further facilitates alignment of vascular prosthesis 140 at a desired radial orientation within the vessel. For example, radiopaque marker 160 may be used to orient the prosthesis axially within the body vessel.
  • Torsional stabilizer 162 comprises loop 164 of material that extends past the plane of the X-axis. Loop 164 is shaped substantially triangularly and includes first segment 164 a disposed substantially parallel to the Y-axis, second segment 164 b coupled to the proximal section, and third segment 164 c. As would be appreciated by those of skill in the art, torsional stabilizer 162 may include other shapes and configurations without departing from the scope of the present invention. By way of example, torsional stabilizer 162 may comprise two or more interconnected curvilinear loops.
  • FIG. 12 further alternative vascular prosthesis 140 ′′ includes torsional stabilizer 168 .
  • Torsional stabilizer 168 comprises loop 170 of material that extends past the plane of both the X-axis and Y-axes, and illustratively includes semicircular portion 170 a.
  • torsional stabilizer 168 may include other shapes and configurations without departing from the scope of the present invention.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
US10/723,565 2002-12-24 2003-11-25 Vascular prosthesis including torsional stabilizer and methods of use Abandoned US20050165469A1 (en)

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US10/723,565 US20050165469A1 (en) 2002-12-24 2003-11-25 Vascular prosthesis including torsional stabilizer and methods of use
AU2003300323A AU2003300323A1 (en) 2002-12-24 2003-12-23 Vascular prosthesis and methods of use
JP2005510057A JP2006513010A (ja) 2002-12-24 2003-12-23 脈管プロテーゼおよび使用方法
EP03814356A EP1581147A4 (en) 2002-12-24 2003-12-23 VASCULAR PROSTHESIS AND METHODS OF USE
PCT/US2003/041122 WO2004058100A2 (en) 2002-12-24 2003-12-23 Vascular prosthesis and methods of use
CA002508247A CA2508247A1 (en) 2002-12-24 2003-12-23 Vascular prosthesis and methods of use
US10/746,668 US7862608B2 (en) 2002-12-24 2003-12-23 Vascular prosthesis and methods of use

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US10/342,427 US7846198B2 (en) 2002-12-24 2003-01-13 Vascular prosthesis and methods of use
US10/723,565 US20050165469A1 (en) 2002-12-24 2003-11-25 Vascular prosthesis including torsional stabilizer and methods of use

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US20040186556A1 (en) 2004-09-23
WO2004058100A2 (en) 2004-07-15
US7862608B2 (en) 2011-01-04
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AU2003300323A8 (en) 2004-07-22
EP1581147A4 (en) 2006-12-06

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