Materials for soft and hard tissue repair

Abstract

Biomaterials and methods and uses for repair or augmentation of tissues are provided. In particular, the invention provides a multi-layered, naturally occurring multi-axial oriented biomaterial comprising predominately type I collagen fibers. The invention further provides methods and uses for repair or augmentation of tissues using biomaterials of the invention.

1 . A multi-layered, naturally occurring multi-axial oriented biomaterial comprising predominately type I collagen fibers, wherein the biomaterial is suitable for tissue repair or augmentation. 
     
     
         2 . The biomaterial of  claim 1 , wherein the biomaterial is derived from a mammalian source. 
     
     
         3 . The biomaterial of  claim 1 , wherein the biomaterial is derived from a non-human source. 
     
     
         4 . The biomaterial of  claim 2  or  3 , wherein the mammalian or non-human source comprises a porcine, a bovine, an ovine, an equine or a hircine. 
     
     
         5 . The biomaterial of any of  claims 1  to  3 , wherein the biomaterial comprises multiple layers of tendinous, aponeurotic fibrous collagen, optionally wherein the type I collagen fibers are multi-axial oriented. 
     
     
         6 . The biomaterial of any of  claims 1  to  3 , wherein the biomaterial is derived from a dense fibrous, aponeurotic layer of a mammalian or non-human body or tissue source. 
     
     
         7 . The biomaterial of  claim 6 , wherein the mammalian or non-human body or tissue source mimics a connective tissue or abdominal wall of a mammal, human or non-human body. 
     
     
         8 . The biomaterial of  claim 6 , wherein the mammalian tissue source mimics the naturally oriented fibers of the anterior abdominal wall of a mammal, human or non-human body. 
     
     
         9 . The biomaterial of any of  claims 1  to  3 , wherein the biomaterial comprises a multi-density construct derived from one or more of dermis, rectus sheath fascia, shoulder, hind and/or forequarter tissues. 
     
     
         10 . The biomaterial of any of  claims 1  to  3 , wherein the biomaterial has been processed, modified or treated to reduce the amount of cells, fat, protein, nucleic acid, non-collagenous and/or antigenic components in the mammalian or non-human source from which the biomaterial was derived. 
     
     
         11 . The biomaterial of any of  claims 1  to  3 , wherein the biomaterial is substantially free of cells, nucelic acids, non-collagenous proteins, and/or antigenic components in the mammalian or non-human source from which the biomaterial was derived. 
     
     
         12 . The biomaterial of any of  claims 1  to  3 , wherein the biomaterial has been cleaned, decellularized, or de-fatted, or processed to remove non-collagenous proteins, cells, nucelic acids or antigenic components present in the mammalian or non-human source from which the biomaterial was derived. 
     
     
         13 . The biomaterial of any of  claims 1  to  3 , wherein the biomaterial has been purified or lyophilized. 
     
     
         14 . The biomaterial of any of  claims 1  to  3 , wherein the biomaterial is suitable for soft or hard tissue repair. 
     
     
         15 . The biomaterial of  claim 1 , wherein the biomaterial is perforated for improved tissue grafting or integration. 
     
     
         16 . The biomaterial of  claim 1 , wherein the biomaterial is cross-linked or not cross-linked. 
     
     
         17 . The biomaterial of  claim 1 , wherein the biomaterial is cross-linked by chemical modification. 
     
     
         18 . The biomaterial of  claim 16  or  17 , wherein the cross-linked biomaterial has increased resistance to tearing, degradation, creep and attenuation under functional loading. 
     
     
         19 . The biomaterial of any of  claims 1  to  3 , wherein the biomaterial comprises at least 2, 3, 4 or more layers. 
     
     
         20 . The biomaterial of  claim 1 , wherein the biomaterial comprises a soft or hard tissue repair, reinforcing or augmenting graft or implant. 
     
     
         21 . The biomaterial of any of  claims 1  to  3 , wherein the biomaterial comprises or is formed into a multi-component, or coated, fused or layered construct, with one or more second materials. 
     
     
         22 . The biomaterial of  claim 21 , wherein the second material comprises a synthetic or biologic hard, semi-soft or soft, flexible or rigid, mesh, implant, graft, or prosthesis. 
     
     
         23 . The biomaterial of  claim 22 , wherein the mesh comprises an absorbable polymer mesh. 
     
     
         24 . The biomaterial of  claim 21 , wherein the second material comprises a polymer material or an absorbable layer designed to limit, prevent, reduce or retard adhesion formation. 
     
     
         25 . The biomaterial of  claim 21 , wherein the polymer material comprises a polyglycolide, polydioxanone, polypropylene (PP), polyester, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), and/or polyetheylene-terephthalat (PET). 
     
     
         26 . The biomaterial of  claim 21 , wherein the second material comprises a material that provides the biomaterial with increased or additional strength. 
     
     
         27 . The biomaterial of  claim 21 , wherein the second material improves or increases integration, grafting, durability or stability of the biomaterial when integrated into or combined with tissue of a mammalian, human or non-human recipient. 
     
     
         28 . The biomaterial of  claim 21 , wherein the second material comprises mammalian cells that are autologous or are a xenograft with respect to the source of the biomaterial, or are autologous or are a xenograft with respect to the recipient of the biomaterial. 
     
     
         29 . The biomaterial of  claim 28 , wherein the cells comprises dermis cells, or stem cells, fibroblasts, myoblasts, myocytes, edothelial cells, immune cells (macrophages, monocytes), osteoblasts, or chondroblasts. 
     
     
         30 . The biomaterial of  claim 21 , wherein the second material comprises a scaffold or lattice. 
     
     
         31 . The biomaterial of  claim 21 , wherein the second material comprises an autologous or recombinant growth factor, chemokine or cytokine. 
     
     
         32 . The biomaterial of  claim 21 , wherein the second material comprises a bone morphogenic protein (BMP). 
     
     
         33 . The biomaterial of  claim 21 , wherein the second material comprises platelet derived growth factor (PDGF), epidermal growth factor (EGF), insulin like growth factor (IGF)-1, fibroblast growth factor (FGF), transforming grow factor (TGF)-beta, bone morphogenic protein (BMP)-2, BMP-3, BMP-4, or BMP-7. 
     
     
         34 . The biomaterial of  claim 1 , wherein the biomaterial is multilaminar. 
     
     
         35 . The biomaterial of  claim 1 , wherein the biomaterial is multidirectional with regard to fiber orientation of the collagen. 
     
     
         36 . The biomaterial in  claim 1 , wherein the biomaterial has a plurality of pores, wherein the pores aid in tissue grafting or integration or reducing or decreasing adhesion formation. 
     
     
         37 . The biomaterial of  claim 1 , wherein the biomaterial has a thickness of between 0.2 mm and approximately 5.0 mm. 
     
     
         38 . The biomaterial of  claim 1 , wherein the biomaterial has a suture retention strength from between 4-150 Newtons (N). 
     
     
         39 . The biomaterial of  claim 1 , wherein the biomaterial has a suture retention strength of at least 20 N. 
     
     
         40 . The biomaterial of  claim 1 , wherein the biomaterial has a tear resistance of between 5 to 100N. 
     
     
         41 . The biomaterial of  claim 1 , wherein the biomaterial has a uniaxial or a multiaxial tensile strength of at least 20 N. 
     
     
         42 . The biomaterial of  claim 1 , wherein the biomaterial has ball burst tensile strength of 25 to 1200 N/cm. 
     
     
         43 . The biomaterial of  claim 1 , wherein the biomaterial has ball burst tensile strength of greater than 50 N/cm. 
     
     
         44 . The biomaterial of  claim 1 , wherein the biomaterial ball burst strain (at a stress of 16N/cm) is in the range of 5% to 35%. 
     
     
         45 . The biomaterial of  claim 1 , wherein the biomaterial has a first rough side and an opposing second dense side. 
     
     
         46 . The biomaterial of  claim 1 , wherein the first rough side provides for cell ingrowth in a recipient. 
     
     
         47 . The biomaterial of  claim 1 , wherein the second dense side provides for reduced cell ingrowth or adhesion to viscera or bowel of a recipient. 
     
     
         48 . The biomaterial of  claim 1 , wherein the tissue comprises connective tissue. 
     
     
         49 . The biomaterial of  claim 1 , wherein the biomaterial may be cut, configured, formed or shaped without substantial loss of collagen fiber integrity, substantial disruption of collagen fiber orientation or substantial loss of strength. 
     
     
         50 . The biomaterial of  claim 1 , wherein the biomaterial comprises a quilted, stitched, sutured, or attached multi-layer construct, a predominantly flat, oval, circular, or rectangular, folded or rolled sheet. 
     
     
         51 . The biomaterial of  claim 50 , wherein the multi-layer construct is formed by welding, joining or gluing with an adhesive. 
     
     
         52 . The biomaterial of  claim 1 , wherein the biomaterial comprises a plurality of biomaterial elements stitched, sutured, joined or quilted together to increase size or thickness. 
     
     
         53 . The biomaterial of  claim 1 , wherein the biomaterial is cut, configured, formed or shaped for deployment as a hernia repair implant, for repair of a body cavity defect, or to strengthen, augment or reinforce weakened, attenuated tissues, or tissues damaged as a result of disease, trauma or surgery. 
     
     
         54 . A method for repair or augmentation of a tissue of a recipient mammalian subject in need of repair or augmentation, comprising attaching, joining or affixing thereto the biomaterial of any of  claims 1  to  53  to the tissue of the recipient mammlian subject in need of repair or augmentation. 
     
     
         55 . A method for closure or repair of a wound or cavity in a tissue of a recipient mammlian subject, comprising:
 a) providing a biomaterial of any of  claims 1  to  53 ;   b) contacting the wound with the biomaterial, or positioning, shaping or contouring the biomaterial over the cavity, or introducing the biomaterial into the cavity;   c) joining, attaching or affixing the biomaterial to the wound or cavity to secure said biomaterial; and   d) closing said cavity or repairing said wound in the tissue.   
     
     
         56 . A method of repairing a defect or augmenting a tissue of a recipient mammlian subject in need thereof, comprising:
 (a) positioning, shaping or contouring the biomaterial of any of  claims 1  to  53  to cover a defect or augment the tissue in need thereof; and   (b) securing the biomaterial in place.   
     
     
         57 . A method for tissue repair or augmentation comprising delivering to tissue of a recipient mammlian subject a biomaterial of any of  claims 1  to  53 , wherein the biomaterial serves to repair or augment the tissue. 
     
     
         58 . The method of any of  claims 54  to  57 , wherein the tissue repaired or augmented comprises a soft or hard tissue. 
     
     
         59 . The method of any of  claims 54  to  57 , wherein the tissue repaired or augmented comprises muscle or abdominal wall. 
     
     
         60 . The method of any of  claims 54  to  57 , wherein the recipient mammlian subject has an abdominal wall defect, trauma, damage, or weakness, a hernia, a fistula, or torn or damaged dura. 
     
     
         61 . The method of  claim 60 , wherein the hernia comprises a ventral incisional hernia; a umbilical, inguinal, femoral, spigelian, parastomal or hiatal hernia; a diaphragmatic hernia; or a lumbar triangle hernia. 
     
     
         62 . The method of any of  claims 54  to  57 , wherein the recipient mammlian subject is in need of pelvic floor reconstruction; in need of repair, reinforcement or augmentation of esophageal perforations or defects; in need of a protective barrier between vascular anastamosis and bowel; in need of a protective barrier between viscera following repair; in need of correction or surgery for rectal prolapse; in need of maxillofacial, periodontal or dental surgery: as a soft tissue augmentation material or in the repair of hard and/or soft tissue defects; in need of skeletal defect repair; in need of orthopedic surgery; in need of urologic surgery; in need of gynecologic surgery; in need of plastic surgery; or in need of neurosurgery. 
     
     
         63 . The method of any of  claims 54  to  57 , wherein the recipient mammlian subject is in need of a protective barrier between proximal aortic anastamosis and bowel, as encountered following aortic reconstruction utilizing prosthetic vascular grafts; in need of a protective barrier between viscera following repair of rectovaginal fistula, rectovesicle fistula; in need of skeletal defect repair in the craniomaxillofacial or axial skeleton; in need of orthopedic surgery for joint repair or replacement or in soft tissue repair or augmentation of joints or to reinforce, augment, replace weakened, injured, attenuated or diseased ligamentous or joint structures; in need of urologic surgery for stress urinary incontinence or organ prolapse; in need of gynecologic surgery to correct or reinforce for pelvic floor weakness, as in rectocele, cystocele, vaginal prolapse; in need of plastic surgery to support or reinforce, inhibit or limit migration of implanted prosthesis, reinforce or augment defects or areas of weakness created by mobilization of soft tissues used in various reconstructive procedures, or to create, alter or manipulate body contours; or in need of neurosurgery for dural replacement and/or patche of a dural defect. 
     
     
         64 . The method of any of  claims 54  to  57 , wherein the biomaterial is a xenograft with respect to the recipient mammalian subject. 
     
     
         65 . The method of any of  claims 54  to  57 , wherein the biomaterial further comprises cells or proteins that are autologous with respect to the recipient mammalian subject. 
     
     
         66 . A method for manufacture of a biomaterial suitable for tissue repair or augmentation comprising:
 (a) obtaining a multi-layered, naturally occurring multi-axial oriented biomaterial comprising predominately type I collagen fibers; and   (b) processing, modifying or treating the biomaterial to be suitable as a xenograft in human and non-human mammal tissue repair or augmentation.