CA2523812A1 - Compliant venous graft - Google Patents

Compliant venous graft Download PDF

Info

Publication number
CA2523812A1
CA2523812A1 CA002523812A CA2523812A CA2523812A1 CA 2523812 A1 CA2523812 A1 CA 2523812A1 CA 002523812 A CA002523812 A CA 002523812A CA 2523812 A CA2523812 A CA 2523812A CA 2523812 A1 CA2523812 A1 CA 2523812A1
Authority
CA
Canada
Prior art keywords
support
tubular
venous graft
graft
vein segment
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
CA002523812A
Other languages
French (fr)
Other versions
CA2523812C (en
Inventor
Peter P. Zilla
Nasser Rafiee
Deon Bezuidenhout
Thomas Franz
Mark Yeoman
Hellmut Bowles
Nareak Douk
Michael F. Wolf
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kips Bay Medical Inc
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of CA2523812A1 publication Critical patent/CA2523812A1/en
Application granted granted Critical
Publication of CA2523812C publication Critical patent/CA2523812C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3625Vascular tissue, e.g. heart valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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

Abstract

A venous graft for replacement of a section of an artery and methods of making the graft. The graft comprises a flexible, resilient, generally tubular external support and a vein segment carried within and having an ablumenal surface in contact with and supported by the tubular support, the venous graft being capable of resilient radial expansion in a manner mimicking the radial compliance properties of an artery.

Claims (33)

1. A flexible, resilient, generally tubular external support within which may be supported a vein segment to form a venous graft mimicking the compliance properties of a healthy artery, the tubular support being capable of resilient radial expansion in a manner providing compliance in the range of 3 to 30%/100 mm Hg.
2. The tubular external support of claim 1 in which said support comprises a knit wire mesh.
3. The tubular external support of claim 1 in which said support comprises a braided wire mesh including an element for controlling the degree of axial extension of the support.
4. The tubular external support of claim 3 in which said element comprises a thread attached to and carried internally of the support.
5. The tubular external support of claim 1 including a vein segment carried within the support, the vein segment having an ablumenal surface in contact with, and supported by, said tubular support.
6. A venous graft for replacement of a section of an artery, the graft comprising a flexible, resilient, generally tubular external support and a vein segment carried within and having an ablumenal surface in contact with and supported by the tubular support, the venous graft being capable of resilient radial expansion in a manner mimicking the compliance properties of an artery.
7. The venous graft of claim 6 wherein said tubular support is capable of said resilient radial expansion without significant axial dimensional changes.
8. The venous graft of claim 6 wherein the compliance of the graft ranges from 3 to 30 %/100 mm Hg.
9. The venous graft of claim 6 wherein the external support comprises a generally tubular fiber mesh capable of expanding in diameter through resilient movement of wires of the mesh to accommodate radial expansion of the vein segment supported in it sufficient to provide the graft with said compliance.
10. The venous graft of claim 6 wherein said external support comprises a knit, tubular mesh capable of expanding radially to accommodate radial expansion of the vein segment supported in it within said compliance range.
11. The venous graft of claim 6 wherein said external support comprises a braided fiber mesh so configured as to exhibit radial expansion in said compliance range without significant reduction in the axial length of the support.
12. The venous graft of claim 11 wherein said fiber mesh is made of metal wire.
13. The venous graft of claim 12 wherein said metal wire is of stainless steel or of a cobalt chrome alloy.
14. The venous graft of claim 11 wherein said metal wire is a shape memory alloy.
15. The venous graft of claim 11 wherein said fiber mesh is polymeric.
16. The venous graft of claim 6 wherein the ablumenal surface of the vein segment is bonded to said tubular support.
17. The venous graft of claim 6 wherein the vein segment and the tubular support are axially coextensive.
18. The venous graft of claim 10 wherein said knitted tubular fiber mesh is made from crimped fibers.
19. The venous graft of claim 9 wherein said tubular fiber mesh is made from fibers that are crimped after having been formed into said tubular mesh.
20. A venous graft for replacement of a section of an artery, the graft comprising a flexible, resilient, knit wire mesh configured as a generally tubular external support and a vein segment carried within and having an ablumenal surface in contact with and supported by the tubular support, the support having resilient radial expansion and contraction characteristics that provide the venous graft with compliance properties mimicking those of an artery.
21. The venous graft of claim 1 wherein the compliance of the venous graft ranges from 3 to 30 %/100 mm Hg.
22. Method of producing a venous graft for use in replacing a section of an artery, comprising providing a segment of a vein and sheathing the segment in a generally tubular support in supportive contact with the ablumenal surface of the vein segment, the support being sufficiently flexible and radially resilient as to provide the graft with compliance properties mimicking the compliance properties of an artery.
23. The method of claim 22 including the step of cutting said venous graft from a longer section of vein sheathed in said tubular support, the ends of the vein and tubular support of the venous graft being coextensive.
24. The method of claim 22 including the step of supporting said generally tubular support upon an exterior surface of an applicator having an internal passage within which is positioned the vein segment, and removing the applicator to permit the tubular support to come into supportive contact with the ablumenal surface of the vein segment.
25. The method of claim 22 including the step of supporting said generally tubular support upon an exterior surface of an applicator having an internal passage, and, while passing the vein segment from within the applicator passage, drawing the tubular support onto the surface of the vein segment.
26. The method of claim 22 wherein said generally tubular support is chosen to be sufficiently radially resilient as to provide the venous graft with a compliance ranging from 3 to 30%/100 mm Hg.
27. The method of claim 24 wherein said tubular support is axially resilient, the method including the step of controlling axial dimension changes of the tubular support as the support comes into supportive contact with the vein segment to provide the venous graft with said compliance properties.
28. The method of claim 27 including the step of providing the tubular support with an axially extending, relatively inextensible element that restrains the tubular support from unwanted axial extension.
29. The method of claim 28 wherein said inextensible element comprises a flexible fiber positioned within the tubular support and between the tubular support and the ablumenal surface of the vein segment.
30. The method of claim 28 wherein the flexible fiber is a wire joined to the interior of the tubular support.
31. The method of claim 22 including the step of bonding the ablumenal surface of the vein segment to the tubular support.
32. The tubular external support of claim 1 in which said a knit wire mesh support comprises loops that alternate in size circumferentially of the support.
33. The method of claim 22 including forming said tubular support from a knit wire mesh, wherein said mesh is formed with loops that alternate in size circumferentially of the support.
CA2523812A 2003-04-28 2004-04-28 Compliant venous graft Expired - Fee Related CA2523812C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US46622603P 2003-04-28 2003-04-28
US60/466,226 2003-04-28
PCT/US2004/012973 WO2004096095A2 (en) 2003-04-28 2004-04-28 Compliant venous graft

Publications (2)

Publication Number Publication Date
CA2523812A1 true CA2523812A1 (en) 2004-11-11
CA2523812C CA2523812C (en) 2011-06-21

Family

ID=33418355

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2523812A Expired - Fee Related CA2523812C (en) 2003-04-28 2004-04-28 Compliant venous graft

Country Status (8)

Country Link
US (3) US8057537B2 (en)
EP (2) EP1626679B1 (en)
JP (1) JP4692902B2 (en)
AT (1) ATE531338T1 (en)
CA (1) CA2523812C (en)
ES (1) ES2375566T3 (en)
WO (1) WO2004096095A2 (en)
ZA (1) ZA200508920B (en)

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US20120116495A1 (en) 2012-05-10
CA2523812C (en) 2011-06-21
ATE531338T1 (en) 2011-11-15
EP2335648A1 (en) 2011-06-22
US20050070995A1 (en) 2005-03-31
US8057537B2 (en) 2011-11-15
US20090163987A1 (en) 2009-06-25
ZA200508920B (en) 2011-10-26
JP4692902B2 (en) 2011-06-01
EP1626679B1 (en) 2011-11-02
WO2004096095A3 (en) 2005-04-28
WO2004096095A2 (en) 2004-11-11
EP1626679A2 (en) 2006-02-22
ES2375566T3 (en) 2012-03-02
JP2006524556A (en) 2006-11-02
US8172746B2 (en) 2012-05-08

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