WO2011011482A4 - Variable density tissue graft composition and methods of making and using the same - Google Patents

Variable density tissue graft composition and methods of making and using the same Download PDF

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Publication number
WO2011011482A4
WO2011011482A4 PCT/US2010/042698 US2010042698W WO2011011482A4 WO 2011011482 A4 WO2011011482 A4 WO 2011011482A4 US 2010042698 W US2010042698 W US 2010042698W WO 2011011482 A4 WO2011011482 A4 WO 2011011482A4
Authority
WO
WIPO (PCT)
Prior art keywords
layer
composition
layers
tissue graft
perforations
Prior art date
Application number
PCT/US2010/042698
Other languages
French (fr)
Other versions
WO2011011482A2 (en
WO2011011482A3 (en
Inventor
Rodney W. Bosley, Jr.
Clay Fette
Original Assignee
Acell, 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 Acell, Inc. filed Critical Acell, Inc.
Publication of WO2011011482A2 publication Critical patent/WO2011011482A2/en
Publication of WO2011011482A3 publication Critical patent/WO2011011482A3/en
Publication of WO2011011482A4 publication Critical patent/WO2011011482A4/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
    • A61L27/3604Materials 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
    • A61L27/3633Extracellular matrix [ECM]
    • 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
    • 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
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • 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
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/34Materials or treatment for tissue regeneration for soft tissue reconstruction
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T156/00Adhesive bonding and miscellaneous chemical manufacture
    • Y10T156/10Methods of surface bonding and/or assembly therefor

Abstract

Disclosed are tissue graft compositions made of materials having different densities, methods of making, and methods of treatment for restoring tissues in a patient.

Claims

AMENDED CLAIMS received by the International Bureau on 5th May 2011 (05.05.11)
1. A tissue graft composition, comprising:
at least two layers, at least one layer comprising an ECM having a density that differs from at least one of the other layers, each of the layers having a first planar surface and a second planar surface and each of the layers at least partially overlapping an adjacent layer.
2. The tissue graft composition of claim 1, wherein a first layer comprises raised elements and a second layer comprises depressions, said raised element of the first layer mated with said depression of the second layer to join said first and said second layers together.
3. The tissue graft composition of claim 1, wherein said at least one layer comprising a density that differs from at least one other layer is in the range of about 400% to 125% more dense than said other layer.
4. The tissue graft composition of claim 1, wherein said at least one of said layers comprises epithelial basement membrane.
5. The tissue graft composition of claim 1, wherein at least one of said two layers comprises aponeurosis.
6. The tissue graft composition of claim 1 , wherein said at least one layer is an intermediate layer positioned between two outer layers, said two outer layers devoid of perforations, said intermediate layer comprising a plurality of perforations that extend from a first planar surface of said intermediate layer to a second planar surface of said intermediate layer thereby forming a lumen in said intermediate layer that is substantially perpendicular to the first and the second planar surface of said intermediate layer.
7. A method for manufacturing a tissue graft composition, comprising:
providing a first layer of planar biological material having a first density;
providing a second layer of planar biological material comprising a second density that is less than the density of the first layer of material; and
joining the first layer to the second layer.
8. The method according to claim 7, further comprising:
introducing perforations into the first layer of material;
introducing columns into the second layer of material and compressing the first layer and the second layer of material together wherein the columns of the second layer of material are introduced into the perforations of the first layer of material to join the first layer to the second layer of material.
9. The method according to claim 8, further comprising a third layer of material, perforating said third layer of material, positioning said third layer of material between said first and said second layers of material, and introducing said columns in said second layer of material through said perforations in said third layer of material to join the first layer, the second layer and the third layers of material.
10. The method according to claim 7, further comprising perforating said first and said second layers.
11. The method according to claim 7, further comprising:
introducing raised members into the first layer of material;
introducing depressed members complementary to the raised members into the second layer of material; and
compressing the first layer and the second layer of material together wherein the raised members of the first layer of material intercalates with the depressed members of the second layer of material thereby joining the first layer to the second layer.
12. The method according to claim 11, further comprising stretching said material over a template to introduce said raised member or said depressed member into the first or the second layer of material.
13. The method according to claim 11, further comprising compressing said first or said second layer of material on a template to introduce said raised member or said depressed member into said material.
14. The method according to claim 11, wherein said first material and said second material are hydratcd materials when said first and said second materials are compressed together.
15. A method for restoring tissue damage of a joint, skin, an abdominal body wall, a thoracic body wall, a tendon, a ligament, or a hernia comprising:
providing a composition comprising a first layer and a second layer of extracellular matrix wherein the second layer has a density at least 125% of the density of the first layer; and
applying said composition to said joint, skin, abdominal body wall, thoracic body wall, tendon, ligament, or hernia.
16. The method of claim 15, wherein said first layer of said composition comprises aponeurosis.
17. The method according to claim 15, wherein said first layer comprises a plurality of perforations, each of said perforations comprising a lumen and said second layer is non- perforated, said lumen of the perforations of said first layer enclosing a portion of said second layer whereby said perforated first layer is joined to said non-perforated second layer.
18. The method of claim 15, wherein said first layer comprises epithelial basement membrane.
19. The method according to claim 18, wherein said composition is implanted in the abdominal wall of a patient and said epithelial basement membrane is positioned on the peritoneal surface of the abdominal wall.
20. A method for restoring an epithelial tissue at an anatomic site of a patient, comprising: providing a composition comprising UBM comprising epithelial basement membrane, and an ECM comprising a devitalized portion of site-specific ECM derived from said anatomic site from a mammal, wherein said epithelial basement membrane is located on a surface of said composition; and
implanting said composition at the anatomic site of the patient wherein said epithelial basement membrane is located on the epithelial side of said anatomic site.
21. The tissue graft composition of claim 1 wherein said first layer comprises a first ECM and said second layer comprises a second ECM.
22. The tissue graft composition of claim 1 wherein said ECM comprises a plurality of naturally associated components of a native ECM.
22
PCT/US2010/042698 2009-07-22 2010-07-21 Variable density tissue graft composition and methods of making and using the same WO2011011482A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12/507,338 US8298586B2 (en) 2009-07-22 2009-07-22 Variable density tissue graft composition
US12/507,338 2009-07-22

Publications (3)

Publication Number Publication Date
WO2011011482A2 WO2011011482A2 (en) 2011-01-27
WO2011011482A3 WO2011011482A3 (en) 2011-04-28
WO2011011482A4 true WO2011011482A4 (en) 2011-06-30

Family

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Family Applications (1)

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PCT/US2010/042698 WO2011011482A2 (en) 2009-07-22 2010-07-21 Variable density tissue graft composition and methods of making and using the same

Country Status (2)

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US (6) US8298586B2 (en)
WO (1) WO2011011482A2 (en)

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Also Published As

Publication number Publication date
US8962035B2 (en) 2015-02-24
US20110020420A1 (en) 2011-01-27
US20130035768A1 (en) 2013-02-07
US20150196381A1 (en) 2015-07-16
US10517994B2 (en) 2019-12-31
US20170165401A1 (en) 2017-06-15
US20140018937A1 (en) 2014-01-16
US8298586B2 (en) 2012-10-30
WO2011011482A2 (en) 2011-01-27
US8541032B2 (en) 2013-09-24
WO2011011482A3 (en) 2011-04-28
US20200129666A1 (en) 2020-04-30
US9579183B2 (en) 2017-02-28

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