CA2397263A1 - Stabilization of implantable bioprosthetic tissue - Google Patents

Stabilization of implantable bioprosthetic tissue Download PDF

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Publication number
CA2397263A1
CA2397263A1 CA002397263A CA2397263A CA2397263A1 CA 2397263 A1 CA2397263 A1 CA 2397263A1 CA 002397263 A CA002397263 A CA 002397263A CA 2397263 A CA2397263 A CA 2397263A CA 2397263 A1 CA2397263 A1 CA 2397263A1
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CA
Canada
Prior art keywords
bioprosthesis
implantable
implantable bioprosthesis
linked
tissue
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
CA002397263A
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French (fr)
Other versions
CA2397263C (en
Inventor
Narendra Vyavahare
Ivan Alferiev
Robert J. Levy
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Childrens Hospital of Philadelphia CHOP
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Individual
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Publication of CA2397263A1 publication Critical patent/CA2397263A1/en
Application granted granted Critical
Publication of CA2397263C publication Critical patent/CA2397263C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials 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
    • A61L27/3683—Materials 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 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
    • A61L27/3687—Materials 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 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials 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
    • A61L27/3641—Materials 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 site of application in the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/507—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial blood vessels

Abstract

The invention relates to implantable bioprostheses (e.g. implantable biological tissues) and to compositions and methods for stabilizing them.
Implantable bioprostheses stabilized as described herein exhibit improved mechanical properties and reduced post-implantation calcification. The implantable bioprosthesis is made by contacting a bioprosthesis (e.g. a tissue obtained from an animal or an article comprising a tissue and a synthetic material) with a polyepoxy amine compound.

Claims (29)

1. An implantable bioprosthesis comprising proteins cross-linked with a poly-(2-hydroxyorgano)amino moiety.
2. The implantable bioprosthesis of claim 1, wherein a methylthio group of the bioprosthesis is linked with the poly-(2-hydroxyorgano)amino moiety.
3. The implantable bioprosthesis of claim 1, wherein an amine group of the bioprosthesis is linked with the poly-(2-hydroxyorgano)amino moiety.
4. The implantable bioprosthesis of claim 1, wherein a phenolic hydroxyl group of the bioprosthesis is linked with the poly-(2-hydroxyorgano)amino moiety.
5. The implantable bioprosthesis of claim 1, wherein a phosphate group of the bioprosthesis is linked with the poly-(2-hydroxyorgano)amino moiety.
6. The implantable bioprosthesis of claim 1, wherein a carboxyl group of the bioprosthesis is linked with the poly-(2-hydroxyorgano)amino moiety.
7. The implantable bioprosthesis of claim 1, wherein substantially all epoxy-reactive groups of the bioprosthesis are linked with the poly-(2-hydroxyorgano)amino moiety.
8. The implantable bioprosthesis of claim 1, wherein the implantable bioprosthesis is selected from the group consisting of an artificial heart, a heart valve prosthesis, an annuloplasty ring, a dermal graft, a vascular graft, a vascular stent, a structural stent, a vascular shunt, a cardiovascular shunt, a dura mater graft, a cartilage graft, a cartilage implant, a pericardium graft, a ligament prosthesis, a tendon prosthesis, a urinary bladder prosthesis, a pledget, a suture, a permanently in-dwelling percutaneous device, a surgical patch, a vascular stent, a cardiovascular stent, a structural stent, a coated stent, a vascular shunt, a cardiovascular shunt, and a coated catheter.
9. The implantable bioprosthesis of claim 8, wherein the implantable bioprosthesis is a heart valve prosthesis.
10. The implantable bioprosthesis of claim 1, wherein the implantable bioprosthesis comprises a biological tissue.
11. The implantable bioprosthesis of claim 10, wherein the tissue is selected from the group consisting of a heart, a heart valve, an aortic root, an aortic wall, an aortic leaflet, a pericardial tissue, a connective tissue, dura mater, a bypass graft, a tendon, a ligament, a dermal tissue, a blood vessel, an umbilical tissue, a bone tissue, a fascia, and a submucosal tissue.
12. The implantable bioprosthesis of claim 10, wherein the tissue is harvested from an animal.
13. The implantable bioprosthesis of claim 12, wherein the animal is selected from the group consisting of a human, a cow, a pig, a dog, a seal, and a kangaroo.
14. The implantable bioprosthesis of claim 1, wherein the implantable bioprosthesis comprises a synthetic analog of a bioprosthetic tissue.
15. The implantable bioprosthesis of claim 1, wherein the poly-(2-hydroxyorgano)amino moiety is a poly-(2-hydroxypropyl)amino moiety.
16. An implantable bioprosthesis comprising proteins cross-linked by contacting the bioprosthesis with a polyepoxy amine compound
17. The implantable bioprosthesis of claim 16, wherein the bioprosthesis is contacted with the polyepoxy amine compound in an aqueous liquid having a pH
of about 6 to 10.
18. The implantable bioprosthesis of claim 16, wherein the proteins are cross-linked by contacting the bioprosthesis with the polyepoxy amine compound in an aqueous liquid having a pH of about 7 to 10.
19. The implantable bioprosthesis of claim 16, wherein the proteins are cross-linked by contacting the bioprosthesis with the polyepoxy amine compound in an aqueous liquid having a pH of about 7.0 to 7.4.
20. The implantable bioprosthesis of claim 16, wherein the polyepoxy amine compound is triglycidyl amine.
21. The implantable bioprosthesis of claim 16, wherein the proteins are cross-linked by contacting the polyepoxy amine compound with moieties of the proteins which are independently selected from the group consisting of a methylthio moiety, a primary amine moiety, a phenolic hydroxyl moiety, a phosphate moiety, and a carboxyl moiety.
22. The implantable bioprosthesis of claim 16, wherein the implantable bioprosthesis is treated with a second stabilization reagent.
23. The implantable bioprosthesis of claim 22, wherein the second stabilization reagent is a cross-linking reagent.
24. The implantable bioprosthesis of claim 22, wherein the second stabilization reagent is a calcification inhibitor.
25. The implantable bioprosthesis of claim 24, wherein the calcification inhibitor is aluminum chloride.
26. The implantable bioprosthesis of claim 22, wherein the second stabilization reagent is a glycosaminoglycan-stabilizing reagent.
27. The implantable bioprosthesis of claim 26, wherein the glycosaminoglycan-stabilizing reagent is a carbodiimide.
28. A method of stabilizing an implantable bioprosthesis, the method comprising contacting the bioprosthesis and a polyepoxy amine compound, whereby the bioprosthesis is stabilized.
29. A composition for stabilizing an implantable bioprosthesis, the composition comprising a polyepoxy amine compound and at least one of a calcification inhibitor, a glycosaminoglycan-stabilizing reagent, and a second cross-linking reagent.
CA2397263A 2000-02-09 2001-02-02 Stabilization of implantable bioprosthetic tissue Expired - Fee Related CA2397263C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/501,331 2000-02-09
US09/501,331 US6391538B1 (en) 2000-02-09 2000-02-09 Stabilization of implantable bioprosthetic tissue
PCT/US2001/003509 WO2001058503A1 (en) 2000-02-09 2001-02-02 Stabilization of implantable bioprosthetic tissue

Publications (2)

Publication Number Publication Date
CA2397263A1 true CA2397263A1 (en) 2001-08-16
CA2397263C CA2397263C (en) 2011-01-25

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2397263A Expired - Fee Related CA2397263C (en) 2000-02-09 2001-02-02 Stabilization of implantable bioprosthetic tissue

Country Status (7)

Country Link
US (2) US6391538B1 (en)
EP (1) EP1257305B1 (en)
JP (1) JP4841097B2 (en)
AT (1) ATE302622T1 (en)
CA (1) CA2397263C (en)
DE (1) DE60112897T2 (en)
WO (1) WO2001058503A1 (en)

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Also Published As

Publication number Publication date
DE60112897D1 (en) 2005-09-29
ATE302622T1 (en) 2005-09-15
US20020172706A1 (en) 2002-11-21
EP1257305A1 (en) 2002-11-20
US6824970B2 (en) 2004-11-30
CA2397263C (en) 2011-01-25
JP4841097B2 (en) 2011-12-21
EP1257305B1 (en) 2005-08-24
US6391538B1 (en) 2002-05-21
DE60112897T2 (en) 2006-06-08
JP2003522001A (en) 2003-07-22
WO2001058503A1 (en) 2001-08-16

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