WO1995025482A1 - Three-dimensional bioremodelable collagen fabrics - Google Patents

Three-dimensional bioremodelable collagen fabrics Download PDF

Info

Publication number
WO1995025482A1
WO1995025482A1 PCT/US1995/003455 US9503455W WO9525482A1 WO 1995025482 A1 WO1995025482 A1 WO 1995025482A1 US 9503455 W US9503455 W US 9503455W WO 9525482 A1 WO9525482 A1 WO 9525482A1
Authority
WO
WIPO (PCT)
Prior art keywords
fabric
collagen
dimensional
bioremodelable
dimensional bioremodelable
Prior art date
Application number
PCT/US1995/003455
Other languages
English (en)
French (fr)
Inventor
Paul D. Kemp
John F. Cavallaro
Original Assignee
Organogenesis, 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 Organogenesis, Inc. filed Critical Organogenesis, Inc.
Priority to MX9603990A priority Critical patent/MX9603990A/es
Priority to EP95914761A priority patent/EP0751751A4/en
Priority to JP52475295A priority patent/JPH09510639A/ja
Publication of WO1995025482A1 publication Critical patent/WO1995025482A1/en

Links

Classifications

    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04B—KNITTING
    • D04B21/00—Warp knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes
    • D04B21/20—Warp knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes specially adapted for knitting articles of particular configuration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/00051—Accessories for dressings
    • A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
    • 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
    • A61F2/28—Bones
    • 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
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/24—Collagen
    • 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
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • 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
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • 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
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30965—Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
    • 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
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A61F2/3872—Meniscus for implantation between the natural bone surfaces
    • 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
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
    • 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
    • A61F2002/041—Bile ducts
    • 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
    • A61F2002/043—Bronchi
    • 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
    • A61F2002/044—Oesophagi or esophagi or gullets
    • 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
    • A61F2002/046—Tracheae
    • 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
    • A61F2002/047—Urethrae
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30224—Three-dimensional shapes cylindrical
    • A61F2002/30235—Three-dimensional shapes cylindrical tubular, e.g. sleeves
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30677—Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00089—Wound bandages
    • A61F2013/00093—Wound bandages tubular
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00089—Wound bandages
    • A61F2013/00217—Wound bandages not adhering to the wound
    • A61F2013/00221—Wound bandages not adhering to the wound biodegradable, non-irritating
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00089—Wound bandages
    • A61F2013/00238—Wound bandages characterised by way of knitting or weaving
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/0054—Plasters use for deep wounds
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00902—Plasters containing means
    • A61F2013/0091—Plasters containing means with disinfecting or anaesthetics means, e.g. anti-mycrobic
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00902—Plasters containing means
    • A61F2013/00927—Plasters containing means with biological activity, e.g. enzymes for debriding wounds or others, collagen or growth factors
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • 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
    • A61F2230/0063—Three-dimensional shapes
    • 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
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity
    • 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
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00365—Proteins; Polypeptides; Degradation products thereof
    • D—TEXTILES; PAPER
    • D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2509/00—Medical; Hygiene

Definitions

  • the invention is in the field of tissue engineering implantable medical devices and is directed to three-dimensional bioremodelable fabrics made from collagen threads which are used to replace or repair tissue or organs.
  • a device made from an open collagen mesh through which three long collagen tapes were interwoven was used by Girgis and Veenema (1965).
  • Schonbauer and Fanta (1958) implanted a mesh made from chromic tanned catgut sutures into the abdominal and dorsal fascia of dogs. All these materials were single layers of collagen weave as can be seen in Figure 2 of Girgis and Veenema (1965) and Abb. 1 of Schonbauer and Fanta (1958).
  • Connective tissue derive their mechanical strength and physical character mainly from the three-dimensional assembly of long, intertwined crosslinked collagen fibrils and fibers formed from one or more of the 18 known distinct types of collagen; each of which has its own structure and properties.
  • the same type of collagens synthesized by different tissues organizes itself into different organizational structures.
  • collagen fibers form a structure whereby Type I collagen fibers are laid down at various acute angles in relation to the skin surface.
  • tendons and ligaments however, most of the Type I collagen fibers are arranged with their long axis parallel to the long axis of the tissue.
  • cornea the Type I collagen fibers are oriented in orthogonal layers.
  • the collagen fibers are laid down in a cross-ply arrangement with the two arrays of fibers running diagonally in a clockwise and anti-clockwise direction.
  • the large collagen fibers are arranged such that they best counter the loads imposed on the tissue.
  • Warp knitting with multiple re-reinforcing yarns can be used to produce a fabric that is multi-layered.
  • Braiding can also be used to produce highly complex, three-dimensional shapes.
  • the fabrics can be woven with a space between the layers (core fabrics) or woven as thick dense structures as seen in Figure 8 of Mohamed, supra.
  • the inventors have combined collagen's fibrillogenic capacity with textile technologies in order to bioengineer three-dimensional bioremodelable fabrics tailor-made to suit a wide variety of applications with varied porosity, elongation, and strength requirements based on the knowledge gained from biomimetic studies.
  • the bioremodelability of the collagen fabrics of this invention permits them to undergo biodegradation in a controlled fashion so that the production of endogenous structural collagen, vascularization, and epithelialization of the fabric by the ingrowth of host cells occurs at a rate faster than the loss of biomechanical strength of the implanted fabric due to biodegradation by host enzymes.
  • This invention provides for the production of three-dimensional bioremodelable collagen fabrics of various configurations. These fabrics are thus bioengineered implants and devices which serve the required physical function while facilitating remodeling of the replaced or repaired tissue or organ implant.
  • This invention is directed to three-dimensional bioremodelable fabrics formed from collagen threads.
  • This invention is directed to implantable medical devices which can be used to replace or repair tissue or organs. More particularly, this invention is directed to devices that can serve as in vivo scaffolds for the regeneration of new tissue.
  • three- dimensional fabrics achieve their greatest strength when the threads are intertwined, interlaced or intermeshed in the crosswise, lengthwise and thickness directions. These directions are also termed the X-, Y-, and Z-axes.
  • the three-dimensional bioremodelable fabrics of this invention are applications of textile techniques with knowledge of collagen's fibrillogenic capacity and ability to bioremodel.
  • the three-dimensional bioremodelable fabrics are made from collagen threads and, using textile techniques, are woven and/or knitted into the desired configurations to replace or repair organs and tissues.
  • the three-dimensional fabrics of this invention are meant to include collagen threads in multiaxial directions, as compared with two-dimensional fabrics, which only have width and length directions.
  • a two-dimensional fabric does, of course, have some depth based on the diameter of the threads used in the construction, but it is not a true multiaxial, three-dimensional fabric.
  • fabric means a structure used as the three- dimensional framework or scaffold for bioremodeling which can be formed into a number of patterns or shapes, as dictated by the biomimetics approach to tissue engineering.
  • a three-dimensional bioremodelable fabric can be shaped into a structure resembling a bone, with a hollow core.
  • the collagen threads can be formed into a solid configuration, such as a structure resembling a sling for hernia repair.
  • fabric is used because it describes a construct made from collagen threads using textile techniques.
  • the term is meant to include braids that can be made into a wide range of geometric shapes in which the braiding threads interlock the entire structure.
  • Biocompatible Devices are described in detail in co-pending application, U.S. serial number 08/216,527, filed concurrently herewith as "Biocompatible Devices,” the contents of which are incorporated herein by reference in its entirety.
  • the bioremodelable collagen fabric is designed not only to perform an immediate physical function, but equally importantly, to guide and encourage appropriate host tissue formation, dissolve, and gradually transfer the load to the newly formed collagen.
  • Bioremodelable means the ability of the implanted collagen fabric to function as a scaffold for new host tissue ingrowth by facilitating the production of endogenous structural collagen, vascularization, and epithelialization by the ingrowth of host cells at a rate faster than the loss of biomechanical strength of the implanted fabric due to biodegradation.
  • a three-dimensional fabric is a woven and /or knitted product which is multiaxial, with X-, Y-, and Z-axes.
  • the three-dimensional fabrics are continuously formed by intertwining a plurality of strands together, some of which are at an angle from the traditional flat fabric weaving plan.
  • An inherent disadvantage of fiber constructs made into two-dimensional fabric sheets is their limited strength. Two dimensional fabrics are anistropic, exhibiting unequal strength properties when measured along the X- and Y- axis. To extend the use and value of textile technology into bioremodelable collagen constructs, strength in more than two directions is required.
  • the three-dimensional fabrics of this invention can be constructed from collagen threads using textile techniques. Three-dimensional fabric formation in the textile industry has been used to produce a number of different articles. These techniques are described in detail in the following patents, which is not intended to be limiting: U.S. Patent Nos. 5,019,435; 4917,756; 4,863,660; 4,848,414; 4,834,144; 4,805,422; 4,805,421; 4,779,429; 4,346,741; 5,067,525; 4,936,186; 4,881,444; 4,800,796; 4,719,837; 4,615,256; 4,312,261, all of which are incorporated herein by reference.
  • the construction of three-dimensional bioremodelable fabrics can be accomplished using the textile techniques of weaving and knitting. Using these techniques, the three-dimensional bioremodelable fabrics of this invention can be made into any of a variety of shapes: (1) a solid weave; (2) an open weave; (3) a solid knit; and (4) an open knit. All of these fabrics can be made with the same size threads or with different size threads in the same construct. Further, the threads may first be plied, braided, or otherwise manipulated to increase the diameter or strength of the threads, such as by crosslinking, prior to using them in the construction of the bioremodelable fabrics. Additionally, a combination of knit construction and weave construction can be used in the same fabric construct. These collagen fabrics may be used for a wide variety of applications with varied porosity, elongation, and strength requirements.
  • a woven fabric is defined in textile terms as a cloth made by interlacing or intertwining warp strands with filling strands, the woof.
  • a warp is a series of strands extended lengthwise in a loom and crossed by the woof, the filling strands.
  • Multilayer woven fabrics are composed of several series of warp and filling strands that form distinct layers, one above the other.
  • the fabrics can be woven with a space between layers (core fabrics) or woven as thick, dense structures.
  • the layers can be bound together by interlacing warp ends in the structure with the filling of adjacent layers (angle interlock) or by having the ends interlace between the face and back layers (warp interlock).
  • the binding yarns may also interlace vertically between layers, producing an orthogonal weave.
  • Multilayer woven fabrics do not need not be interlaced throughout the fabric: the addition of vertical yarns interlaced with the top and bottom horizontal yarns provides the same kind of reinforcement in a three- dimensional structure that is provided by the over and under interlacing of yarns in flat weaving.
  • Multilayer structures can be given additional strength by inserting in each layer stuffing yarns, which remain straight and contribute their full strength in the direction in which they are oriented.
  • Yarns that interlace between layers as binding yarns contribute partially to the strength of their direction; in orthogonal woven fabrics, they contribute dramatically to the strength in the thickness direction. There are trade-offs that must be made, however, since only one yarn can occupy any position within the structure.
  • a key step in assuring the strength of the finished structure occurs each time the needles cross the warp.
  • a vertical needle, threaded with the yarn that will secure the selvage loops on the vertical edge is inserted from below the weaving area, coming up to catch the filling yarn that has just been brought across the warp.
  • This selvage needle holds a loop of each filling yarn at the edge of the warp as the filling needles return to their original positions.
  • the selvage needles retract for the next step, but the selvage yarn - which now holds the filling loops - is clasped and held in its vertical position by a knitting needle.
  • the loops of selvage yarns are knitted together as the process continues.
  • the step that is called "beat-up" in traditional weaving is used in three- dimensional weaving to position the vertical (z) yarns. These yarns are threaded through needles suspended from harness frames (similar to those used in the traditional loom) and are passed through the vertical openings in a reed at angles, crossing on the opposite side of the filling needles. Once every cycle, as the z yarns are suspended in diagonal position, the reed moves horizontally to push the filling against the already-woven length of textile. This action pushes the crossed z yarns into a vertical arrangement. The harnesses holding the z yarns then move up and down to reverse the positions of the yarns before the process begins again.
  • the fiber volume fraction can be varied in the vertical direction by using more than one warp yarn for every z yarn. This proportion may not be required for every application.
  • a knitted fabric is formed by interlacing yarn or thread in a series of connected loops.
  • the knit stitch is a basic knitting stitch usually made with yarn at the back of the work by inserting the right needle into the front part of the loop on the left needle from the left side, catching the yarn with the point of the right needle, and bringing it through the first loop to form a new loop.
  • the purl stitch a knitting stitch usually made with the yarn at the front of the work by inserting the right needle into the front of a loop on the left needle from the right, catching the yarn with the right needle, and bringing it through to form a new loop.
  • Knitting is a versatile technique for producing strong, porous structures and is the preferred method of making the three-dimensional bioremodelable collagen fabrics.
  • the main advantage of knitting over weaving is that knitting introduces closed loops at the yarn crossover points, allowing the product to hold sutures with very little bite, and without needing to fold the material at the suture line.
  • weaving interposes parallel yarns, resulting in a fabric more subject to fraying when cut.
  • knitting offers more options for varying the physical character of the final material than weaving does.
  • Weft knitting machines use only a single end of yarn and individual needles cast off stitches sequentially.
  • Warp knitting machines use many ends of yarn parallel-wound on a cylinder (the warp) and man needles (a "needle bar”) cast off stitches simultaneously to produce the fabric. Warp knitting, however, offers distinct advantages. Since weft knitted fabrics are formed from a single end, they can unravel if that end is pulled, or if the fabric is cut in the middle and the free end is pulled. Most warp knitted fabrics do not unravel when cut. Moreover, by simultaneously using additional warps and additional needle bars, complex fabrics can be designed in which a heavier weight, and more complex fabric with new mechanical properties results.
  • Raschel machines There are two main categories of warp knitting machines.
  • the Raschel type has a latched needle to hold the yarn.
  • the Tricot type holds the yarn with flexible bent tip, termed a "beard.”
  • Raschel machines offer a more versatile array of knitting patterns, but Tricot machines exert less stress on the fibers.
  • Both flat and tubular structures can be made on Raschel machines; Tricot machines are mainly used to produce flat structures.
  • Collagen fabrics can be made by both flat and tubular weft knitting, and both Raschel and Tricot warp knitting.
  • the variety of knitting designs runs the gamut from open elastic meshes, to dense stable fabrics, to tubular structures, using starting materials from individual or multiple monofilament threads to twisted or braided yarns.
  • Variations of knitting techniques can be used to manufacture three- dimensional constructs in cylindrical or conical shapes.
  • axial rods are placed to form the shape of the structure; after radial yarns are added, knitting needles catch the radial yarns and create chain stitches to loop these yarns around the axial rods, which are replaced with axial reinforcing fibers when the preform is pulled off the machine.
  • Braiding techniques have been developed to produce complex shapes (Florentine 1982). In essence, these are multilayered structures in which some braiding yarns traverse the inner layers to bind the two exterior layers together. Complex shapes can be formed by braiding over a removable mandrel whereby the contours of the final braid match those of the mandrel as can be seen in Figure 7 of Mohamed, supra.
  • the collagen that can be used in this invention can be formed from collagen parts derived from animals, or from collagen produced by cells in tissue culture. Collagen can be extracted in a number of ways from animal parts. Suitable sources of collagen include, but are not limited to, skin, tendons, bone, cartilage, ligaments, fascia, intestinal submucosa, placenta. Extraction methods that have been commercialized for the production of collagen preparations can be divided into the categories of dispersion, digestion, and dissolution.
  • Dispersion techniques generally involve swelling and comminution of connective tissue. This results in heterogeneous material with a high solids content formed from portions of collagen fibrils. Digestion utilizes proteolytic enzymes which cleave the telopeptides downstream of the crosslinks. This method produces a monomeric solution of partially degraded collagen which, although still contain intact triple helical regions, has now lost most or all of the telopeptide region. The dissolution of collagen relies on the acid labile nature of the newly formed covalent cross linkages. This technique, which employs low pH solutions, results in extraction of the intact, collagen molecule. Although yields are relatively low compared to the enzymatic digestion methods, there are major benefits to this technique due to the fact that the complete, native structure is maintained.
  • Collagen sutures are also included in the definition of collagen threads and can be used in this invention. Collagen sutures are described in U.S. Patent Nos. 3,114,593 and 3,114,591, incorporated herein by reference.
  • Thread size can be measured two ways.
  • the diameter can be measured microscopically (10X) using a measuring eyepiece, averaging the readings taken on at least five thread samples in at least five random locations.
  • Another way to measure diameter, which is more characteristic of textile fibers, is to measure thread mass per length, or denier (mass in grams per 9000 meters of length).
  • the denier can range from about 15 to about 300, typically about 80.
  • Thread strength can be determined by mounting a 50 mm sample lengths in a force gauge (Chatillon Corp., Agawam, Massachusetts) and pulling at 50% strain per minute until failure. Ultimate elongation and load at break can then be characterized.
  • Thread knitability may be evaluated by knitting a 5 mm diameter tubular fabric on a circular (weft) knitting machine (Lamb, Chicopee, MA).
  • Shrinkage temperature a measure of the stability of the collagen triple helix, can be measured by immersing a 5 to 7 loop of thread loaded with 2.5 g in 1.0 mM potassium phosphate monobasic, 11 mM sodium phosphate dibasic, and 150 mM NaCl at pH 7.30, and heating at 1°C per minute until shrinkage occurs. The temperature at which the sample shrinks by at least 10% is the shrinkage temperature.
  • Bioremodelable collagen constructs can be braided or bundled for use as load bearing orthopedic prostheses such as bone, cartilage, tendon or ligament replacements.
  • the collagen constructs can be shaped into a structure with a hollow core.
  • the bone prosthesis can be formed of (1) an outer, hollow tubular structure with the desired strength and biomechanical properties required to bear the load exerted on the particular bone being replaced and the necessary diameter required to achieve a suitable match at the site of implantation and (2) an inner matrix of collagen fabric of the desired porosity to permit it to be seeded with hematopoietic stem cells.
  • Collagen fabric knitted or woven into tubular form may also be used as a support for a vascular prosthesis, providing that a luminal smooth flow surface is also provided.
  • tubes of larger diameter could be woven for use as implants in the reconstructive-restorative surgery of tubular organs such as the larynx, trachea, bronchi, esophagus, urethra, intestine, colon or bile ducts.
  • Collagen fabric constructs may also be formed in the shape of a wedge for implantation in synovial joints to replace a damaged articular miniscus or in the shape of a disk to replace damaged intervertebral disks.
  • the implants will be bioremodeled with endogenous fibrocartilage to create a new miniscus or disk.
  • the collagen fabric constructs of this invention can also be sprayed or coated with antibiotics, antiviral agents, growth factors, thrombosis-resistant agents or the like before implantation to enhance remodeling or to prevent infection.
  • the collagen fabric could also be produced from collagen threads that have been formed from a mixture of collagen and one or more of the following:
  • Protepglycans or other extra-cellular matrix components such as fibronectin, laminin, tenascin;
  • Cytokines such as members of the transforming growth factor betas (TGFbs), platelet derived growth factor (PDGF), insulin like growth factors (IGFs), fibroblast growth factors (FGFs), bone morphogenic proteins (BMPs) or interleukin (IL) families. These factors could be uniformly incorporated within the collagen thread or coextruded such that a gradient of factor was formed from the center to the edge of the thread.
  • TGFbs transforming growth factor betas
  • PDGF platelet derived growth factor
  • IGFs insulin like growth factors
  • FGFs fibroblast growth factors
  • BMPs bone morphogenic proteins
  • IL interleukin
  • the collagen fabric could also be produced from non crosslinked collagen and implanted in this state.
  • the collagen fabric may also be crosslinked by any of the known crosslinking agents described in U.S. Patent No. 5,263,984, Column 3, lines 54-62.
  • the individual threads could be crosslinked prior to formation of the construct so that in order to control the biomechanical properties of and cell response to the construct the fabric could be made from mixtures of crosslinked and non crosslinked threads.
  • This fabric was manufactured first by producing a 2-ply collagen yarn.
  • Collagen threads were made by the process described in copending patent application, U.S. serial number 08/216,527, filed concurrently herewith, as "Biocompatible Devices.” Two monofilament strands of thread were each twisted at 1.5 twists-per-inch (tpi) in the Z-direction; then, they were twisted together at 2.5 tpi in the S-direction. The result was a 2-ply yarn which does not unravel or spring.
  • This yarn was then warped using a conventional single and warper (more convenient for trial quantities than a creel) onto an ordinary knitting beam.
  • the hernia repair fabric under investigation used three such beams on a 20-gauge Tricot sample knitting machine in a pattern designed for high bulk and low extensibility.
  • the stitch design is as follows: • Front bar (#1): 0-1/1-0///
  • This fabric was evaluated as an abdominal wall replacement in the rat model, using a full muscle layer defect measuring 2 cm by 2 cm. Before implantation, the fabric was cleaned with acetone, crosslinked with 50 mM EDC in 90% acetone at room temperature overnight, depyrogenated in 0.1 N NaOH at 4°C overnight, and cold chemical sterilized. The fabric could also be sterilized (dry) by gamma irradiation or ethylene oxide.
  • collagen fabric was examined for its ability to close a full- thickness abdominal excision in a rat model.
  • a 2 cm x 2 cm full-thickness abdominal wall defect was created in each of 5 Sprague-Dawley rats.
  • a 2.5 cm x 2.5 cm piece of collagen fabric was sutured over the defect using six 4-0 polypropylene, with a 0.25 cm overlap around the perimeter. Additional continuous sutures were placed around the fabric perimeter, through the fabric and muscle.
  • the animals were examined for herniation and mechanical stability of the implant. The implants, along with a margin of surrounding tissue, were then removed and fixed for histological processing as described below. The area of the repair was assessed by tracing the perimeter of the wound.
  • This fabric has high bulk and thickness with low extensibility, and would be useful for space-filling applications with moderate load-bearing requirements. Further, several layers of 3-dimensional fabric could be thus joined to provide compound fabric of any thickness desired.
  • EXAMPLE 2 Formation of a Menisci Repair Device for Knees
  • the menisci stretch to accommodate the movement.
  • the menisci may overstretch and tear.
  • the medial meniscus is especially vulnerable to tearing because it is anchored to the tibial collateral ligament, and so has less mobility than the lateral meniscus.
  • the lateral or medial meniscus can be repaired using the menisci repair device of this invention.
  • the knitted fabric described in Example 1 above is rolled by laying the fabric on a flat surface, and taking the length of one side of the fabric and rolling it end over end.
  • the fabric is rolled to approximate the overall length and diameter of meniscus to be repaired.
  • the rolled menisci repair device is then curled to conform to the original contours of the meniscus.
  • the rolled menisci repair device is then crosslinked with standard techniques using 50mM l-ethyl-3-(3-dimethylaminopropyl) carbodiimide hydrochloride (EDO for 8 hours in 90% acetone, then rinsing exhaustively with water.
  • EEO room temperature ethylene oxide
  • the device is implanted into the lateral or medial, or both, meniscus surrounding the kneecap.
  • Fabric constructs with hollow structures are also produced by direct tubular knitting.
  • the yarn described in Example 1 above is Raschel knitted with two needle bars into a tube using the following pattern: • Front bar: 1-0/1-2
  • a tubular fabric has its inner and outer diameter dimensions, mechanical strength and porosity determined by the specific knitting design employed. If necessary, nesting structures of progressively larger diameters may be joined to provide a hollow tube of any wall desired wall thickness.
  • the center of the cylinder may be filled with collagen in any form, for example, a parallel bundle of collagen threads formed as described above, a paste of homogenized collagen fibers, a collagen gel. Any of the elements of the structure may be coated with various agents such as bone morphogenic proteins to stimulate bone repair.
  • a knitted device may be attached over either end of non-union fracture in order to stimulate bone repair.
  • a tubular structure may be formed from more than one coaxial layer of braided collagen such that the outer diameter of the braid matched that of the bone to be repaired.
  • the braid may be hollow or completely filled with braided material. If a hollow braid was used, the center of the cylinder may be filled with collagen in any form, for example, with a parallel bundle of collagen threads formed as described above; a paste of homogenized collagen fibers; a collagen gel; and the like. Any of the elements of the structure may be coated with various agents, such as bone morphogenic proteins to stimulate bone repair.
  • a braided medical device formed in this fashion may be attached over either end of a non-union fracture to stimulate bone repair.
  • Collagen threads formed from any of the threads described above in the description may be used to weave the fabric.
  • Threads are woven by loading sets of bobbins with collagen thread. One set supplies the warp (lengthwise) yarns. These will be stationary during the weaving process. A harness suspends the vertical yarns at oblique angles (some from above and some from below). Two additional sets of yarns are used: "filling yarns" which are inserted from the side by two horizontal sets of needles and “selvage yarns” inserted from below by a pair of vertical needles. Two knitting needles are also positioned so that they can knit loops of selvage yarn together at the corners of the woven structure. To weave the structure the filling needles move between layers of warp and vertical yarns to inset the filling yarns in a crosswise direction.
  • the vertical selvage needles move up to catch the filling; a horizontal bar in turn catches the selvage yarns at the top.
  • the filling needles then retract and a pair of knitting needles clasps the selvage yarns to allow the cross bar to also retract.
  • the reed which is a comblike device positioned in front of the harness then moves horizontally to pack the yarns into their final configuration. While this occurs, the vertical yarns are pushed from their diagonal position into a vertical alignment.
  • the knitting needles pass the new loop of selvage yarn through the previous one and the harnesses switch to reverse the position of the vertical yarns for the next cycle.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Textile Engineering (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
PCT/US1995/003455 1994-03-22 1995-03-20 Three-dimensional bioremodelable collagen fabrics WO1995025482A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
MX9603990A MX9603990A (es) 1994-03-22 1995-03-20 Telas de colageno bioremodelables, tridimensionales.
EP95914761A EP0751751A4 (en) 1994-03-22 1995-03-20 THREE-DIMENSIONAL BIOREMODELABLE COLLAGEN
JP52475295A JPH09510639A (ja) 1994-03-22 1995-03-20 生体再形成コラーゲン立体織物

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US21576094A 1994-03-22 1994-03-22
US08/215,760 1994-03-22

Publications (1)

Publication Number Publication Date
WO1995025482A1 true WO1995025482A1 (en) 1995-09-28

Family

ID=22804272

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1995/003455 WO1995025482A1 (en) 1994-03-22 1995-03-20 Three-dimensional bioremodelable collagen fabrics

Country Status (5)

Country Link
EP (1) EP0751751A4 (es)
JP (1) JPH09510639A (es)
CA (1) CA2183962A1 (es)
MX (1) MX9603990A (es)
WO (1) WO1995025482A1 (es)

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0943345A1 (en) * 1996-11-20 1999-09-22 Tapic International Co., Ltd. Artificial esophagus
US6361551B1 (en) 1998-12-11 2002-03-26 C. R. Bard, Inc. Collagen hemostatic fibers
US6454787B1 (en) 1998-12-11 2002-09-24 C. R. Bard, Inc. Collagen hemostatic foam
DE10137414A1 (de) * 2001-07-31 2003-02-27 Aesculap Ag & Co Kg Ummantelung für Venen, Verfahren zu ihrer Herstellung und Verwendung in der Chirurgie
WO2004050133A2 (en) * 2002-12-05 2004-06-17 Cardio Incorporated Layered bioresorbable implant
WO2005077432A2 (en) * 2004-02-09 2005-08-25 Cook Incorporated Cast bioremodelable graft
WO2005115272A2 (en) * 2004-04-23 2005-12-08 Boston Scientific Limited Composite medical textile material and implantable devices made therefrom
WO2008060973A1 (en) * 2006-11-10 2008-05-22 Vance Products Incorporated D/B/A Cook Urological Incorporated Graft for hysterotomy closure
WO2009137829A2 (en) * 2008-05-09 2009-11-12 Wake Forest University Health Sciences Directed stem cell recruitment
WO2012121986A3 (en) * 2011-03-08 2012-12-06 Mimedx, Inc.. Collagen fiber ribbons with integrated fixation sutures and methods of making the same
WO2016203409A1 (en) * 2015-06-15 2016-12-22 University Of New South Wales Engineered materials and methods of forming
US20210228779A1 (en) * 2018-05-04 2021-07-29 Bioconix Pty Ltd. Smart composite textiles and methods of forming
WO2021224526A1 (es) * 2020-05-06 2021-11-11 Servicio Cántabro De Salud Apósito para terapias de presión negativa

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005141263A (ja) * 2001-08-08 2005-06-02 Tsuchiya Tsco Co Ltd 微細粉粒体のクリーニング材及びシール材
CN105653874B (zh) * 2016-01-18 2018-11-13 杭州越波生物科技有限公司 一种大鼠股骨内血管3d结构重建实验方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4880429A (en) * 1987-07-20 1989-11-14 Stone Kevin R Prosthetic meniscus
US5308889A (en) * 1988-11-21 1994-05-03 Collagen Corporation Dehydrated collagen-polymer strings

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4839215A (en) * 1986-06-09 1989-06-13 Ceramed Corporation Biocompatible particles and cloth-like article made therefrom
NL8700113A (nl) * 1987-01-19 1988-08-16 Groningen Science Park Entstuk, geschikt voor behandeling door reconstructieve chirurgie, met weefsel specifieke porositeit, alsmede werkwijze ter vervaardiging van het entstuk.
US5108438A (en) * 1989-03-02 1992-04-28 Regen Corporation Prosthetic intervertebral disc
EP0334045B1 (en) * 1988-03-22 1994-08-17 American Cyanamid Company Prosthetic article
US5378469A (en) * 1990-04-06 1995-01-03 Organogenesis, Inc. Collagen threads
EP0461791B1 (en) * 1990-06-11 1997-01-02 Hector D. Barone Aortic graft and apparatus for repairing an abdominal aortic aneurysm
US5236447A (en) * 1990-06-29 1993-08-17 Nissho Corporation Artificial tubular organ

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4880429A (en) * 1987-07-20 1989-11-14 Stone Kevin R Prosthetic meniscus
US5308889A (en) * 1988-11-21 1994-05-03 Collagen Corporation Dehydrated collagen-polymer strings

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP0751751A4 *

Cited By (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0943345A1 (en) * 1996-11-20 1999-09-22 Tapic International Co., Ltd. Artificial esophagus
EP0943345A4 (en) * 1996-11-20 2000-12-27 Tapic Int Co Ltd ARTIFICIAL EYES
US6361551B1 (en) 1998-12-11 2002-03-26 C. R. Bard, Inc. Collagen hemostatic fibers
US6454787B1 (en) 1998-12-11 2002-09-24 C. R. Bard, Inc. Collagen hemostatic foam
DE10137414B4 (de) * 2001-07-31 2005-12-29 Aesculap Ag & Co. Kg Ummantelung für Venen und Verwendung in der Chirurgie
US7691460B2 (en) 2001-07-31 2010-04-06 Aesculap Ag & Co. Kg Covering element for veins, method for the production and use thereof in surgery
DE10137414A1 (de) * 2001-07-31 2003-02-27 Aesculap Ag & Co Kg Ummantelung für Venen, Verfahren zu ihrer Herstellung und Verwendung in der Chirurgie
WO2004050133A2 (en) * 2002-12-05 2004-06-17 Cardio Incorporated Layered bioresorbable implant
WO2004050133A3 (en) * 2002-12-05 2004-08-12 Cardio Inc Layered bioresorbable implant
WO2005077432A2 (en) * 2004-02-09 2005-08-25 Cook Incorporated Cast bioremodelable graft
WO2005077432A3 (en) * 2004-02-09 2006-03-30 Cook Inc Cast bioremodelable graft
WO2005115272A2 (en) * 2004-04-23 2005-12-08 Boston Scientific Limited Composite medical textile material and implantable devices made therefrom
WO2005115272A3 (en) * 2004-04-23 2006-01-26 Boston Scient Scimed Inc Composite medical textile material and implantable devices made therefrom
US8343207B2 (en) 2004-04-23 2013-01-01 Ronald Rakos Composite medical textile material and implantable devices made therefrom
WO2008060973A1 (en) * 2006-11-10 2008-05-22 Vance Products Incorporated D/B/A Cook Urological Incorporated Graft for hysterotomy closure
US8790414B2 (en) 2006-11-10 2014-07-29 Cook Biotech Incorporated Graft for hysterotomy closure
WO2009137829A3 (en) * 2008-05-09 2010-04-08 Wake Forest University Health Sciences Directed stem cell recruitment
WO2009137829A2 (en) * 2008-05-09 2009-11-12 Wake Forest University Health Sciences Directed stem cell recruitment
US11786581B2 (en) 2008-05-09 2023-10-17 Wake Forest University Health Sciences Directed stem cell recruitment
WO2012121986A3 (en) * 2011-03-08 2012-12-06 Mimedx, Inc.. Collagen fiber ribbons with integrated fixation sutures and methods of making the same
US9636209B2 (en) 2011-03-08 2017-05-02 Mimedx Group, Inc. Collagen fiber ribbons with integrated fixation sutures and methods of making the same
US10653514B2 (en) 2011-03-08 2020-05-19 Mimedx Group, Inc. Collagen fiber ribbons with integrated fixation sutures and methods of making the same
WO2016203409A1 (en) * 2015-06-15 2016-12-22 University Of New South Wales Engineered materials and methods of forming
AU2021221909B2 (en) * 2015-06-15 2023-09-28 Bioconix Pty Ltd. Engineered materials and methods of forming
US11814757B2 (en) 2015-06-15 2023-11-14 Bioconix Pty Ltd. Engineered materials and methods of forming
US20210228779A1 (en) * 2018-05-04 2021-07-29 Bioconix Pty Ltd. Smart composite textiles and methods of forming
WO2021224526A1 (es) * 2020-05-06 2021-11-11 Servicio Cántabro De Salud Apósito para terapias de presión negativa

Also Published As

Publication number Publication date
CA2183962A1 (en) 1995-09-28
JPH09510639A (ja) 1997-10-28
EP0751751A1 (en) 1997-01-08
MX9603990A (es) 1997-12-31
EP0751751A4 (en) 1998-03-25

Similar Documents

Publication Publication Date Title
CN103590177B (zh) 制造用于假体装置的编织网的方法
US8177839B2 (en) Woven and/or braided fiber implants and methods of making same
EP1520552B1 (en) Implantable surgical mesh
US20220362004A1 (en) Composite scaffold for the repair, reconstruction, and regeneration of soft tissues
WO1995025482A1 (en) Three-dimensional bioremodelable collagen fabrics
CN103533910A (zh) 修复器械和其制造方法
US20210161645A1 (en) Composite scaffold for the repair, reconstruction, and regeneration of soft tissues
US20130317526A1 (en) Silk medical device
CA2829339A1 (en) Collagen fiber ribbons with integrated fixation sutures and methods of making the same
CN111345920B (zh) 一种促进腱骨愈合的移行结构化纺织基支架及其制备方法
WO2010046787A2 (en) Collagen-based tendon replacement implant
MXPA96003990A (es) Telas de colageno bioremodelables, tridimensiona
Irsale et al. Design and characterization of polymeric stents
Fernández-Colino et al. Textile-reinforced scaffolds for vascular tissue engineering
Gupta Shaped biotextiles for medical implants
CA3187896A1 (en) Composite scaffold for the repair, reconstruction, and regeneration of soft tissues
WO2016028797A1 (en) Pliable silk medical device
Sen et al. Nanofibrous Textile Scaffolds: A New Innovation in Nanotechnology for Tissue Engineering
Mankodi Application of textile materials in cardiovascular implants
AU2013358983A1 (en) Silk medical device
Out Application of textile materials in cardiovascular implants Written by: Hireni Mankodi Hireni Mankodi

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): CA JP MX

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): AT BE CH DE DK ES FR GB GR IE IT LU MC NL PT SE

121 Ep: the epo has been informed by wipo that ep was designated in this application
DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
WWE Wipo information: entry into national phase

Ref document number: 2183962

Country of ref document: CA

WWE Wipo information: entry into national phase

Ref document number: 1995914761

Country of ref document: EP

WWP Wipo information: published in national office

Ref document number: 1995914761

Country of ref document: EP

WWW Wipo information: withdrawn in national office

Ref document number: 1995914761

Country of ref document: EP