WO2002034111A3 - In situ bioprosthetic filler and methods, particularly for the in situ formation of vertebral disc bioprosthetics - Google Patents

In situ bioprosthetic filler and methods, particularly for the in situ formation of vertebral disc bioprosthetics Download PDF

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Publication number
WO2002034111A3
WO2002034111A3 PCT/US2001/032632 US0132632W WO0234111A3 WO 2002034111 A3 WO2002034111 A3 WO 2002034111A3 US 0132632 W US0132632 W US 0132632W WO 0234111 A3 WO0234111 A3 WO 0234111A3
Authority
WO
WIPO (PCT)
Prior art keywords
cavity
bioprosthetic
situ
biopolymer
vertebral disc
Prior art date
Application number
PCT/US2001/032632
Other languages
French (fr)
Other versions
WO2002034111A2 (en
Inventor
K Umit Yuksel
Steven P Walsh
Kirby S Black
Original Assignee
Cryolife Inc
K Umit Yuksel
Steven P Walsh
Kirby S Black
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 Cryolife Inc, K Umit Yuksel, Steven P Walsh, Kirby S Black filed Critical Cryolife Inc
Priority to CA002422884A priority Critical patent/CA2422884C/en
Priority to AT01984004T priority patent/ATE494014T1/en
Priority to AU1538702A priority patent/AU1538702A/en
Priority to DE60143804T priority patent/DE60143804D1/en
Priority to EP01984004A priority patent/EP1328220B1/en
Priority to JP2002537171A priority patent/JP4202749B2/en
Priority to AU2002215387A priority patent/AU2002215387B2/en
Publication of WO2002034111A2 publication Critical patent/WO2002034111A2/en
Publication of WO2002034111A3 publication Critical patent/WO2002034111A3/en

Links

Classifications

    • 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
    • A61L27/3683Materials 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
    • A61L27/3691Materials 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 physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
    • 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
    • A61L27/18Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L27/22Polypeptides or derivatives thereof, e.g. degradation products
    • 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
    • A61L27/22Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/227Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
    • 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
    • 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
    • A61L27/3641Materials 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
    • A61L27/3645Connective tissue
    • A61L27/3654Cartilage, e.g. meniscus
    • A61L27/3658Intervertebral discs
    • 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
    • A61L27/40Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • 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
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • A61F2002/4445Means for culturing intervertebral disc tissue
    • 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
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • A61F2002/445Intervertebral disc tissue harvest sites

Abstract

Bioprosthetic devices (10) include an exterior biological tissue member (10-1) which at least partly defines a cavity, and a proteinaceous biopolymer (10-2) which fills the cavity, and intercalates and is chemically bound (fixed) to the tissue of the surrounding biological tissue member. In preferred forms, the bioprosthetic device (10) is a bioprosthetic vertebral disc, having a fibrillar outer annulus which surrounds and defines an interior cavity and is formed by removal of at least a substantial portion of the natural gelatinous core therefrom. The cavity defined by the fibrillar outer annulus may then be filled with a flowable proteinaceous biopolymer (10-2). Preferably, the proteinaceous biopolymer (10-2) is a liquid mixture comprised of human or animal-derived protein material and a di- or polyaldehyde, which are allowed to react in situ to form a cross-linked biopolymer within the cavity. The liquid mixture may be formed in advance of being introduced into the cavity, or may be formed simultaneously during introduction into the cavity.
PCT/US2001/032632 2000-10-24 2001-10-24 In situ bioprosthetic filler and methods, particularly for the in situ formation of vertebral disc bioprosthetics WO2002034111A2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
CA002422884A CA2422884C (en) 2000-10-24 2001-10-24 In situ bioprosthetic filler and methods, particularly for the in situ formation of vertebral disc bioprosthetics
AT01984004T ATE494014T1 (en) 2000-10-24 2001-10-24 BIOPROSTHETIC FILLERS AND METHODS, IN PARTICULAR FOR THE FORMATION OF INTERVERTAL DISC BIOPROStheses IN SITU
AU1538702A AU1538702A (en) 2000-10-24 2001-10-24 In situ bioprosthetic filler and methods, particularly for the in situ formationof vertebral disc bioprosthetics
DE60143804T DE60143804D1 (en) 2000-10-24 2001-10-24 BIOPROTHETIC FILLER AND METHODS, ESPECIALLY FOR THE FORMATION OF BANCH BIOPROTHESIS IN SITU
EP01984004A EP1328220B1 (en) 2000-10-24 2001-10-24 Bioprosthetic filler and methods, particularly for the in situ formation of vertebral disc bioprosthetics
JP2002537171A JP4202749B2 (en) 2000-10-24 2001-10-24 In-situ bioartificial filler and method for in-situ formation of bioartificial intervertebral disc in particular
AU2002215387A AU2002215387B2 (en) 2000-10-24 2001-10-24 In situ bioprosthetic filler and methods, particularly for the in situ formation of vertebral disc bioprosthetics

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US24245700P 2000-10-24 2000-10-24
US60/242,457 2000-10-24

Publications (2)

Publication Number Publication Date
WO2002034111A2 WO2002034111A2 (en) 2002-05-02
WO2002034111A3 true WO2002034111A3 (en) 2003-01-16

Family

ID=22914850

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/032632 WO2002034111A2 (en) 2000-10-24 2001-10-24 In situ bioprosthetic filler and methods, particularly for the in situ formation of vertebral disc bioprosthetics

Country Status (9)

Country Link
US (4) US20020049498A1 (en)
EP (1) EP1328220B1 (en)
JP (1) JP4202749B2 (en)
AT (1) ATE494014T1 (en)
AU (2) AU1538702A (en)
CA (1) CA2422884C (en)
DE (1) DE60143804D1 (en)
ES (1) ES2358498T3 (en)
WO (1) WO2002034111A2 (en)

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