Abstract:
The present disclosure relates to bioprosthetics. For example, to the use of bioprosthetics for the repair and replacement of connective tissue.

Description:
TECHNICAL FIELD  
       [0001]     The present disclosure relates to bioprosthetics and particularly, for example, to the use of bioprosthetics for the repair and replacement of connective tissue.  
       BACKGROUND  
       [0002]     There are currently many ways in which various types of soft tissues, such as ligaments or tendons, for example, are reinforced and/or reconstructed. Suturing the tom or ruptured ends of the tissue is one method of attempting to restore function to the injured tissue. Sutures may also be reinforced through the use of synthetic non-bioabsorbable or bioabsorbable materials. Autografting, where tissue is taken from another site on the patient&#39;s body, is another means of soft tissue reconstruction. Yet another means of repair or reconstruction can be achieved through allograffing, where tissue from a donor of the same species is used. Still another means of repair or reconstruction of soft tissue is through xenografting in which tissue from a donor of a different species is used. Accordingly, devices and methods for the repair and replacement of connective tissue are desirable. For example, devices and methods for the repair, restoration, regeneration of spinal ligaments and spinal soft tissues are desirable.  
       SUMMARY  
       [0003]     A device or method in accordance with an illustrative embodiment of the present disclosure includes one or more of the following features or combinations thereof:  
         [0004]     The present disclosure provides a bioprosthetic device comprising an extracellular matrix layer (hereafter extracellular matrix is referred to as ECM) and a pair of wing members. In one illustrative embodiment, the ECM layer has a body portion having an outer surface and a thickness. Each wing member extends from the body portion and has an end, a length, a outwardly facing surface and an inwardly facing surface. In this embodiment the length of each wing member is greater than the thickness of the body portion. In addition, the outwardly facing surfaces of the wing members cooperate to form an outwardly facing attachment surface extending between the ends of the wing members. In addition, the wing members may cooperate to form a V-shaped structure extending from the body portion of the ECM layer. Furthermore, the bioprosthetic device may include a synthetic reinforcement component positioned in contact with the outwardly facing attachment surface.  
         [0005]     The device may also include at least one secondary ECM layer positioned in contact with the inwardly facing surface of a wing member and the outer surface of the body portion. The device may also include a synthetic reinforcement component positioned between the secondary ECM layer and the inwardly facing surface of a wing member. In addition, the synthetic reinforcement component may be positioned between the secondary ECM layer and the outer surface of the body portion.  
         [0006]     In another illustrative embodiment, a bioprosthetic device is provided that comprises an ECM layer positioned in contact with a synthetic mesh reinforcement component. The density of the synthetic mesh reinforcement weave pattern is not uniform. For example, the synthetic mesh reinforcement pattern has (i) a first area with a first weave pattern, (ii) a second area with a second weave pattern and (iii) the density of the first weave pattern is greater than the density of the second weave pattern.  
         [0007]     The bioprosthetic device may also include another synthetic mesh reinforcement component attached to the aforementioned synthetic mesh reinforcement component so that the ECM layer is interposed between both synthetic mesh reinforcement components. Each synthetic mesh reinforcement component may have a circular shape with a radius. The ECM layer may also have a circular shape with a radius. The radius of each synthetic mesh reinforcement component may be larger than the radius of ECM layer so that an outer rim portion of the each synthetic mesh reinforcement component extends beyond an edge of the ECM layer. The outer rim portion of each synthetic mesh reinforcement component can be attached so as to interpose the ECM layer.  
         [0008]     In another illustrative embodiment a bioprosthetic device is provided that comprises an ECM layer with a pair of length-wise edges, and a pair of width-wise edges. The bioprosthetic device also includes a synthetic mesh reinforcement component wrapped around the ECM layer. The synthetic mesh reinforcement component has a weave pattern such that any angle formed by the intersection point of two fibers of the synthetic mesh reinforcement component is either acute or obtuse. The synthetic mesh reinforcement component may include a number of cross fibers which extend between length wise edges of the ECM layer and are substantially parallel to a width wise edge of the ECM layer. In addition, the device may include a pair of lateral fibers which at least extend the length of the ECM layer and are orientated relative to the ECM layer so that these fibers are substantially parallel to the length wise edges of the ECM layer.  
         [0009]     In another illustrative embodiment of the present disclosure a bioprosthetic device is provided that includes an ECM member having a first ECM layer, a second ECM layer, a first end, and second end. A number of fibers are interposed between the first ECM layer and the second ECM layer. Each fiber has an inner portion positioned between the first and second ECM layers, and an outer portion extending outwardly from the first end or from both the first end and the second end. The inner portion inner portion of each fiber positioned between the first and second ECM layers intersects at least one other fiber so as to define either an obtuse or acute angle between the intersecting fibers.  
         [0010]     In yet another illustrative embodiment of the present disclosure there is provided a bioprosthetic device that includes an ECM layer having a surface, a length wise edge, and a width wise edge. The device also includes at least two fiber populations both in contact with the surface of the ECM layer. Each fiber in one population is separated by a first distance. In addition, each fiber in the other population of fibers is separated by a second distance. Furthermore, the fiber populations are separated by a third distance. The third distance is greater than either the first distance or the second distance. Each fiber in each population of fibers can be positioned relative to the ECM layer so that they are substantially parallel with the width wise edge or substantially parallel with the length wise edge.  
         [0011]     This device may also include another population of fibers placed in contact with the ECM surface. Each fiber of this population of fibers is positioned relative to the ECM layer so that they are substantially parallel with the length wise or width wise edge of the ECM layer. In addition, the fibers of this population of fibers intersects the fibers of the aforementioned populations so as to form an orthogonal angle at each intersection point.  
         [0012]     In another illustrative embodiment of the present disclosure a prosthetic device is provided which comprises an ECM member having two ECM layers, a width wise edge, a length wise edge, and two ends. The device also includes two populations of fibers interposed between the two ECM layers. The fibers of the first population of fibers is substantially parallel with the length wise edge. These fibers have an inner portion positioned between the ECM layers and have an outer portion extending outwardly from at least one end of the ECM member. The fibers of the second population of fibers are substantially parallel with the width wise edge. Moreover, a number of fibers of the second population intersect a number of fibers of the first population so as to define an orthogonal angle.  
         [0013]     The present disclosure also provides an illustrative embodiment of a prosthetic device which comprises an ECM member which includes a pair of ECM layers, a width wise edge, a length wise edge, and a pair of ends. The device also includes two populations of fibers interposed between the pair of ECM layers. One population is substantially parallel with the length wise edge, has an inner portion positioned between the ECM layers, and has at least one outer portion extending outwardly from an end of the ECM member. The other population of fibers is positioned between the ECM layers and are positioned relative to one another so as form a nonwoven mesh.  
         [0014]     Additional features of the present disclosure will become apparent to those skilled in the art upon consideration of the following detailed description of embodiments exemplifying the best mode of carrying out the subject matter of the disclosure. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0015]      FIG. 1  is an enlarged fragmental cross sectional view of an ECM layer prior to bifurcation;  
         [0016]      FIG. 2  is a bioprosthetic device having the ECM layer of  FIG. 1  (i) after bifurcation and (ii) having a synthetic reinforcement component placed in contact with an attachment surface;  
         [0017]      FIG. 3  an enlarged fragmental cross sectional view of an ECM layer similar to the one shown in  FIG. 2  but having multiple layers;  
         [0018]      FIG. 4  is a view similar to  FIG. 3  but having a synthetic reinforce component interposed each ECM layer;  
         [0019]      FIG. 5  is an exploded perspective view of a bioprosthetic device having an ECM layer interposed two synthetic reinforcement components;  
         [0020]      FIG. 5A  is an enlarge view of a portion of one of the synthetic reinforce components of  FIG. 5 ;  
         [0021]      FIG. 5B  is an enlarged view of another portion of the synthetic reinforce component of  FIG. 5A ;  
         [0022]      FIG. 6  is an elevafional view of the bioprosthetic device of  FIG. 5 , with the ECM layer positioned between the two synthetic reinforcement components;  
         [0023]      FIG. 7  is an elevational view of a bioprosthetic wrapped in a synthetic reinforcement component;  
         [0024]      FIG. 8  is an elevafional view of a bioprosthefic device having a number of fibers interposed two ECM layers;  
         [0025]      FIG. 9  is a cross sectional view of the bioprosthetic device of  FIG. 8  viewed in the direction indicated by arrows  9 - 9 ;  
         [0026]      FIG. 10  is an elevational view of a bioprosthetic device in contact with a number of fibers;  
         [0027]      FIG. 11  is an elevational view of a bioprosthetic device similar to the one shown in  FIG. 10  but having the fibers orientated in a different manner;  
         [0028]      FIG. 12  is an elevational view of a bioprosthetic device similar to the one shown in  FIG. 8  but having the fibers orentated in a different manner;  
         [0029]      FIG. 13  is a cross sectional view of the bioprosthetic device of  FIG. 12  viewed in the direction indicated by arrows  13 - 13 ;  
         [0030]      FIG. 14  is an elevational view of a bioprosthetic device similar to the one shown in  FIG. 12  but having the fibers orentated in a different manner;  
         [0031]      FIG. 15  is a cross sectional view of the bioprosthetic device of  FIG. 14  viewed in the direction indicated by arrows  15 - 15 ;  
         [0032]      FIG. 16  is an illustrative example of an embodiment of a bioprosthetic device of the present disclosure being used to repair tissue;  
         [0033]      FIG. 17  is an illustrative example of another embodiment of a bioprosthetic device of the present disclosure being used to repair tissue;  
         [0034]      FIG. 18  is a side view of  FIG. 17 ; and  
         [0035]      FIG. 19  is an illustrative example of yet another embodiment of a bioprosthetic device of the present disclosure being used to repair tissue.  
     
    
     DETAILED DESCRIPTION  
       [0036]     According to the present disclosure, a bioprosthetic device for soft tissue attachment with enhanced, reinforcement, remolding, and/or reconstruction capabilities is provided. In addition, a bioprosthetic device of the present disclosure has enhanced capabilities for the repair, restoration, regeneration of spinal ligaments and spinal soft tissues.  
         [0037]     The device includes a layer of a naturally occurring (ECM) and a synthetic reinforcement component. For the purposes of this disclosure, it is within the definition of a naturally occurring extracellular matrix (ECM) to clean, delaminate, and/or comminute the ECM, or to cross-link the collagen fibers within the ECM. The ECM may be dehydrated or not dehydrated. However, it is not within the definition of a naturally occurring ECM to extract and purify the natural fibers and refabricate a matrix material from purified natural fibers. Compare WO 00/16822 A1. However, any other appropriate well known method of preparing ECM may be utilized in constructing a bioprosthetic device of the present disclosure.  
         [0038]     With respect to comminuted ECM, it is contemplated that it may be positioned in contact with an ECM layer of any embodiment of a bioprosthetic device of the present disclosure. For example, comminuted ECM may be positioned between any two ECM layers of a bioprosthetic device of the present disclosure. Comminuted ECM enhances the attachment, reinforcement, remolding and/or reconstruction capabilities of the bioprosthetic device. In addition, one of ordinary skill in the art can recognize that certain embodiments of the bioprosthetic device of the present disclosure may require a biological glue between the ECM material and the synthetic reinforcement component. Comminuted ECM may also be utilized as a such a biological glue. In addition, it should be appreciated that fibrin glue or other biocompatible glues or bonding agents may also be used for this purpose.  
         [0039]     Examples of an ECM which can be utilized, include, but are not limited to, small intestinal submucosa (hereinafter referred to as SIS), lamina propria, stratum compactum or other naturally occurring (ECM). Further, other sources of ECMs from various tissues are known to be effective for tissue remodeling as well and can be utilized in the present disclosure. These sources include, but are not limited to, stomach, bladder, alimentary, respiratory, and genital submucosa. See, e.g., U.S. Pat. Nos. 6,171,344, 6,099,567, and 5,554,389, hereby incorporated by reference. Such submucosa-derived matrices comprise highly conserved collagens, glycoproteins, proteoglycans, and glycosaminoglycans. Any appropriate ECM, or combination of ECMs, may be utilized in a bioprosthetic device of the present disclosure. With respect to SIS, porcine is widely used. However, it will be appreciated that SIS may be obtained from other animal sources, including cattle, sheep, and other warm-blooded mammals. Furthermore, a single ECM may be utilized in a bioprosthetic device of the present invention or a combination of ECMs. For example, it should be understood that an ECM mentioned anywhere in this disclosure may be made entirely from SIS or include SIS, such as a combination of SIS and another ECM.  
         [0040]     As discussed above, the bioprosthetic device of the present disclosure may include a synthetic reinforcement component. Such a component enhances mechanical and handling properties of the bioprosthetic device. For example, a synthetic reinforcement component may function to support and maintain the desired shape of a bioprosthetic device of the present disclosure during a surgical procedure. The synthetic reinforcement component may also be utilized to, and thereby enhance, the attachment of the bioprosthetic device to a soft tissue. In addition, the synthetic reinforcement component enhances the ability of the bioprosthetic device to reinforce, reconstruct, and/or remodel a soft tissue.  
         [0041]     The synthetic reinforcement component may be made or derived from, for example, absorbable and/or non-absorbable biocompatible materials or any combination thereof. Examples of non-absorbable biocompatible materials include silk, polyester, polyamide, polypropylene, nylon, poly(ethylene terephtalate, poly(vinylidene fluoride), and poly(vinylidene fluoride-co-hexafluoropropylene), and similar compounds.  
         [0042]     Examples of bioresorbable materials include hydroxy acids, such as, lactic acids and glycolic acids; caprolactone; hydroxybutyrate; dioxanone; orthoesters; orthocarbonates; and aminocarbonates. Bioresorbable materials also include natural materials such as chitosan, collagen, cellulose, fibrin, hyaluronic acid; fibronectin. Additional examples of suitable biocompatible, bioabsorbable materials include, but are not limited to, aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyalkylenes oxalates, polyamides, tyrosine derived polycarbonates, poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, biomolecules (i.e., biopolymers such as collagen, elasfin, bioabsorbable starches, etc.) and blends thereof. Examples of aliphatic polyesters include, but are not limited to, homopolymers and copolymers of lactide (which includes lactic acid, D-,L- and meso lactide), glycolide (including glycolic acid), ε-caprolactone, p-dioxanone (1,4-dioxan-2-one), trimethylene carbonate (1,3-dioxan-2-one), alkyl derivatives of trimethylene carbonate, δ-valerolactone, β-butyrolactone, χ-butyrolactone, ε-decalactone, hydroxybutyrate, hydroxyvalerate, 1,4-dioxepan-2-one (including its dimer 1,5,8,12-tetraoxacyclotetradecane-7,14-dione), 1,5-dioxepan-2-one, 6,6-dimethyl-1,4-dioxan-2-one, 2,5-diketomorpholine, pivalolactone, χ,χ-diethylpropiolactone, ethylene carbonate, ethylene oxalate, 3-methyl-1,4-dioxane-2,5-dione, 3,3-diethyl-1,4-dioxan-2,5-dione, 6,8-dioxabicycloctane-7-one and polymer blends thereof. Poly(iminocarbonates), include those polymers described by Kemnitzer and Kohn, in the  Handbook of Biodegradable Polymers,  edited by Domb, et. al., Hardwood Academic Press, pp. 251-272 (1997) incorporated herein by reference. Copoly(ether-esters), include those copolyester-ethers as described in the Journal of Biomaterials Research, Vol. 22, pages 993-1009, 1988 by Cohn and Younes, and in Polymer Preprints (ACS Division of Polymer Chemistry), Vol. 30 (1), page 498, 1989 by Cohn (e.g. PEO/PLA) both incorporated herein by reference. Polyalkylene oxalates, include those described in U.S. Pat. Nos. 4,208,511; 4,141,087; 4,130,639; 4,140,678; 4,105,034; and 4,205,399 all of which are incorporated herein by reference. Polyphosphazenes, co-, ter- and higher order mixed monomer-based polymers made from L-lacfide, D,L-lactide, lactic acid, glycolide, glycolic acid, para-dioxanone, trimethylene carbonate and ε-caprolactone such as are described by Allcock in  The Encyclopedia of Polymer Science,  Vol. 13, pages 31-41, Wiley Intersciences, John Wiley &amp; Sons, 1988 and by Vandorpe, et al in the  Handbook of Biodegradable Polymers,  edited by Domb, et al, Hardwood Academic Press, pp. 161-182 (1997) all of which are incorporated herein by reference. Polyanhydrides include those derived from diacids of the form HOOC—C 6 H 4 —O—(CH 2 ) m —O—C 6 H 4 —COOH, where m is an integer in the range of from 2 to 8, and copolymers thereof with aliphatic alpha-omega diacids of up to 12 carbons. Polyoxaesters, polyoxaamides and polyoxaesters containing amines and/or amido groups are described in one or more of the following U.S. Pat. Nos. 5,464,929; 5,595,751; 5,597,579; 5,607,687; 5,618,552; 5,620,698; 5,645,850; 5,648,088; 5,698,213; 5,700,583; and 5,859,150 all of which are incorporated herein by reference. Polyorthoesters such as those described by Heller in  Handbook of Biodegradable Polymers,  edited by Domb, et al, Hardwood Academic Press, pp. 99-118 (1997) incorporated herein by reference.  
         [0043]     Examples of structural elements synthetic reinforcement components can be made of include, but are not limited to, fibers, such as, monofilaments, sutures, yarns, or threads. Any one, or any combination of, elements may be used to construct a synthetic reinforcement component. In addition, the synthetic reinforcement component may include or be organized into, for example, a group of fibers, a braided suture, a mesh structure (which includes knitted structures), bundles of fibers, or any combination thereof. The synthetic reinforcement component may include a woven and/or or nonwoven structure. In addition, the mechanical properties of the synthetic reinforcement component can be altered by changing its density or texture.  
         [0044]     In some embodiments, the bioprosthetic device of the present disclosure can be augmented with growth factors, peptides, amino acids, anti-microbials, analgesics, anti-inflammatory agents, anabolics, analgesics and antagonists, anaesthetics, anti-adrenergic agents, anti-asthmatics, anti-atherosclerotics, antibacterials, anticholesterolics, anti-coagulants, antidepressants, antidotes, anti-emetics, anti-epileptic drugs, anti-fibrinolytics, anti-inflammatory agents, antihypertensives, antimetabolites antimigraine agents, antimycotics, antinauseants, antineoplastics, anti-obesity agents, antiprotozoals, antipsychotics, antirheumatics, antiseptics, antivertigo agents, antivirals, appetite stimulants, bacterial vaccines, bioflavonoids, calcium channel blockers, capillary stabilizing agents, coagulants, corticosteroids, detoxifying agents for cytostatic treatment, diagnostic agents (like contrast media, radiopaque agents and radioisotopes), electrolytes, enzymes, enzyme inhibitors, ferments, ferment inhibitors, gangliosides and ganglioside derivatives, hemostatics, hormones, hormone antagonists, hypnotics, immunomodulators, immunostimulants, immunosuppressants, minerals, muscle relaxants, neuromodulators, neurotransmitters and nootropics, osmotic diuretics, parasympatholytics, para-sympathomimetics, peptides, proteins, psychostimulants, respiratory stimulants, sedatives, serum lipid reducing agents, smooth muscle relaxants, sympatholytics, sympathomimetics, vasodilators, vasoprotectives, vectors for gene therapy, viral vaccines, viruses, vitamins, oligonucleotides and derivatives, and any therapeutic agent capable of affecting the nervous system.  
         [0045]     As used herein, the term “growth factor” encompasses any cellular product that modulates the adhesion, migration, growth, or differentiation of other cells, particularly connective tissue progenitor cells. In addition, the term “growth factor” as used herein only includes substances purposefully disposed in contact with the bioprosthetic device (e.g. disposed in contact with the ECM component) and does not include naturally occurring substances already present in contact with the device (e.g. growth factors already present n contact with the ECM component) or present in the environment the device is surgically placed.  
         [0046]     The growth factors that may be used in accordance with the present invention include, but are not limited to, members of the fibroblast growth factor family, including acidic and basic fibroblast growth factor (FGF-1 and -2) and FGF-4, members of the platelet-derived growth factor (PDGF) family, including PDGF-AB, PDGF-BB and PDGF-AA; EGFs, members of the insulin-like growth factor (IGF) family, including IGF-I and -II; the TGF-β superfamily, including TGF-β1, 2 and 3 (including rhGDF-5), osteoid-inducing factor (OIF), angiogenin(s), endothelins, hepatocyte growth factor and keratinocyte growth factor; members of the bone morphogenetic proteins (BMP&#39;s) BMP-1, (BMP-3); BMP-2; OP-1; BMP-2A, -2B, and -7, BMP-14; HBGF-1 and -2; growth differentiation factors (GDF&#39;s), members of the hedgehog family of proteins, including indian, sonic and desert hedgehog; ADMP-1; members of the interleukin (IL) family, including IL-1 thru -6; rhGDF-5 and members of the colony-stimulating factor (CSF) family, including CSF-1, G-CSF, and GM-CSF; and isoforms thereof.  
         [0047]     Furthermore, all of the embodiments described below have are either a rectangular or circular shape. However, it should be appreciated that any embodiment of a bioprosthetic device of the present disclosure may have any shape which is appropriate for the procedure in which it is being used. For example, the ECM component and/or the synthetic reinforcement component may be shaped as a square, a triangle, or be irregularly shaped.  
         [0048]     Illustrative examples of the bioprosthetic device of the present disclosure are described below. Now turning to  FIGS. 1 and 2 .  FIG. 1  shows a layer of naturally occurring extracellular matrix  10 . The ECM layer  10  has a body portion  12 , an outer surface  16 , an outer surface  18 , an edge  14  interposed outer surfaces  16  and  18 , and a thickness T.  FIG. 1  illustrates a bifurcation axis  20  extending into ECM layer  10  through edge  14  and between outer surface  16  and  18 . As shown in  FIG. 1 , ECM layer  10  is split along bifurcation axis  20  to a distance D. Preferably, distance D is greater that thickness T. The bifurcation of ECM layer  10  along bifurcation axis  20  forms one embodiment of a bioprosthetic device of the present disclosure, i.e. bioprosthetic device  22  illustrated in  FIG. 2 .  
         [0049]     As shown in  FIG. 2 , bioprosthetic device  22  may include a pair of wing members  24  and  26  extending from body portion  12 . Wing member  24  includes an end  28 , a length L 1 , an outwardly facing surface  30  facing away from body portion  12 , and an inwardly facing surface  32  facing toward body portion  12 . Wing member  26  also includes an end  34 , a length L 2 , an outwardly facing surface  36  facing away from body portion  12 , and an inwardly facing surface  38  facing toward body portion  12 . Since bifurcation axis  20  is preferably greater than thickness T, the lengths L 1  and L 2  are greater than the thickness T. In the illustrative embodiment shown in  FIG. 2 , wing members  24  and  26  cooperate form a V-shaped structure  42  extending from body portion  12 . However, it should be understood that wing members  24  and  26  may cooperate to form other structures, for example, a T-shaped structure, or a structure where wing members  24  and  26  are pushed back to a degree so that each inwardly facing surface  32  and  38  is positioned in contact with outer surfaces  16  and  18 .  
         [0050]     In addition, as shown in  FIG. 2 , bifurcation of ECM layer  10  along bifurcation axis  20  results in outwardly facing surfaces  30  and  36  cooperating to form an outwardly facing attachment surface  40  extending between end  28  of wing member  24  and end  34  of wing member  26 . Accordingly, having an outwardly facing attachment surface  40  increases the surface area of edge  14  (see  FIG. 1 ) of ECM layer  10 . It should be appreciated that when the bioprosthetic device is utilized in a surgical procedure, the outwardly facing attachment surface  40  may be placed in contact with a soft tissue surface, sandwiching the tissue. The increased surface area of outwardly facing attachment surface  40  enhances the ability of ECM layer  10  to attach to the desired soft tissue. In addition, as shown in  FIG. 2 , if desired a synthetic reinforcement component  44  may be positioned in contact with, and attached to, outwardly facing attachment surface  40 . As discussed above, synthetic reinforcement component  44  may have any desired configuration as long as it performs the desired function.  
         [0051]     Now turning to  FIG. 3 , it should be appreciated that bioprosthetic device  22  may also include a number secondary ECM layers. As shown in  FIG. 3 , bioprosthetic device  22  includes a total of four secondary ECM layers  46 ,  48 ,  50 , and  52 . Each secondary layer  46 ,  48 ,  50 , and  52  has a pair of exterior surfaces, however, these are only pointed out in  FIG. 3  for secondary layers  48  and  50 . In particular, secondary ECM layer  48  has exterior surfaces  54  and  56 , and secondary ECM layer  50  has exterior surfaces  58  and  60 . Secondary ECM layer  48  is positioned relative to ECM layer  10  so that the exterior surface  54  of secondary ECM layer  48  is in contact with outer surface  16  and inwardly facing surface  32  of ECM layer  10 . In a similar manner, secondary ECM layer  50  is positioned relative to ECM layer  10  so that the exterior surface  60  of secondary ECM layer  50  is in contact with outer surface  18 , and inwardly facing surface  38  of ECM layer  10 . Still referring to  FIG. 3 , secondary ECM layer  46  is positioned in contact with exterior surface  56  of secondary ECM layer  48 . Secondary ECM layer  52  is positioned in contact with exterior surface  58  of secondary ECM layer  50 . As indicated above, comminuted ECM, may be placed between any two ECM layers of bioprosthetic device  22 .  
         [0052]     In a similar manner as shown in  FIG. 2 , the embodiment shown in  FIG. 3  may also include synthetic reinforcement components. For example, as shown in  FIG. 4  bioprosthetic device  22  may include a synthetic reinforcement component  64  positioned in contact with outwardly facing attachment surface  40  of ECM layer  10 . Still referring to  FIG. 4 , a number of synthetic reinforcement components may be interposed ECM layer  10  and secondary ECM layers  46 ,  48 ,  50 , and  52 . For example, a synthetic reinforcement component  62  may be positioned interposed (i) secondary ECM layers  46  and  48 , (ii) ECM layer  10  and secondary ECM layer  48 , (iii) ECM layer  10  and secondary ECM layer  50 , and (iv) secondary layer  50  and secondary ECM layer  52 . If desired, having synthetic reinforcement component  62  positioned in the above described manner results in the reinforcement component  62  being interposed a secondary ECM layer and an inwardly facing surface of a wing member. Furthermore, it may result in having a synthetic reinforcement component interposed a secondary ECM layer and an outer surface of body portion  12 .  
         [0053]      FIG. 5  illustrates another embodiment of a bioprosthetic device  66  of the present disclosure. Bioprosthetic device  66  may include synthetic mesh reinforcement components  68  and  70 . In  FIG. 5  both synthetic mesh reinforcement components  68  and  70  are circular in shape, however, as previously mentioned for any bioprosthetic device of the present disclosure, other shapes are contemplated, including but not limited to rectangular, square, triangle or any other geometric shape including irregular shaped components. The bioprosthetic device  66  may also include an ECM layer  72 . Since the embodiment of the bioprosthetic device  66  illustrated in  FIGS. 5 and 6  has a circular shape each synthetic mesh reinforcement component  68  and  70  has a radius  74  and  76 , respectively. Furthermore, ECM layer  72  also has a radius  78  which is smaller than the radius  74  and  76 . Synthetic mesh reinforcement component  68  includes an area  80  and an area  82 . An enlarged view of area  82  is shown in  FIG. 5A , while an enlarged view of area  80  is shown in  FIG. 5B . Area  80  has a weave pattern  84 , while area  82  has a weave pattern  86 . The density of weave patterns  84  and  86  may be different. For example, the density of weave pattern  84  may be grater than the density of weave pattern  86  as shown in  FIGS. 5A and 5B . In a similar manner, synthetic mesh reinforcement component  70  may also include two areas which have different weave densities.  
         [0054]     In  FIG. 5  one half of each synthetic mesh reinforcement component  68  and  70  has a weave density greater than the other half. However, it should be appreciated that any configuration of differing weave densities can be utilized as long as the weave density of the synthetic mesh reinforcement component is not uniform. Any mechanism for altering the weave density can be utilized. Examples of such mechanisms include, but are not limited to, (i) having the elements (e.g. fibers) of the synthetic mesh reinforcement component in one area closer to one another than the elements in another area, (ii) using larger elements (e.g. circumference of the fiber) in one area of the synthetic mesh reinforcement component as compared to another area, (iii) utilizing a different weave pattern in one area as compared to another area, or (iv) incorporating a different material in one area of the synthetic mesh reinforcement component as compared in another area, or any combination thereof.  
         [0055]     As shown in  FIGS. 5 and 6 , synthetic mesh reinforcement component  68  may be attached to synthetic mesh reinforcement component  70  so that the ECM layer  72  is interposed synthetic mesh reinforcement component  68  and synthetic mesh reinforcement component  70 . In addition, since radius  74  and  76  of synthetic mesh reinforcement components  68  and  70  may be greater than radius  78  of ECM layer  72  (i) an outer rim portion  88  of synthetic mesh reinforcement component  68  may extend beyond an edge  90  of ECM layer  72  and (ii) an outer rim portion  92  of synthetic mesh reinforcement component  70  may extend beyond edge  90  of ECM layer  72 , and (iii) outer rim portion  88  of synthetic mesh reinforcement component  68  and outer rim portion  92  of synthetic mesh reinforcement component  70  may be attached so as to interpose ECM layer  72 . Synthetic mesh reinforcement components  68  and  70  may be attached by any acceptable mechanism, e.g. the two components may be attached with a fiber woven therethrough, a suture, melted together (crimped) and/or a biocompatible glue or bonding agent.  
         [0056]     As shown in  FIG. 7 , another embodiment of a bioprosthetic device  94  of the present disclosure may include an ECM layer  96  having (i) a surface  108 , (ii) a length  128 , (iii) a pair of length wise edges  98  and  100  and (iv) a pair of width wise edges  102  and  104 . Bioprosthetic device  94  may include a synthetic mesh reinforcement component  106  positioned in contact with ECM layer  96 . For example, synthetic mesh reinforcement component  106  may be wrapped around ECM layer  96 . As indicated, synthetic mesh reinforcement component  106  may include a number of fibers  110 , cross fibers  114 , and lateral fibers  116  and  118 , organized into a mesh  112 . The fibers  110  of the mesh  112  may be organized into a weave pattern such that the any angle formed by the intersection point of two fibers  110  of the synthetic mesh reinforcement component  106  is either acute or obtuse. For example, angles  120 ,  122 ,  124 , and  126  as shown in  FIG. 7 . Cross fibers  114  may be positioned relative to ECM layer  96  such that they (i) extend across surface  108  and length wise edges  98  and  100  and (ii) are substantially parallel with width wise edges  102  and  104 . In addition, lateral fibers  116  and  118 , may be positioned relative to ECM layer  96  such that (i) they extend at least the length  128  of the of ECM layer  96  and (ii) are orientated relative to ECM layer  96  so that lateral fibers  116  and  118 , are substantially parallel to length wise edges  98  and  100  of ECM layer  96 .  
         [0057]     Now turning to  FIG. 8  and  9 , there is shown another embodiment of a bioprosthetic device  130 . Device  130  may include an ECM member  132 . ECM member  132  includes (i) an ECM layer  134 , (ii) an ECM layer  136 , and (iii) ends  138  and  140 . As shown ECM layers  134  and  136  are sandwiched together. Bioprosthetic device  130  may also include a number of fibers  142  interposed ECM layers  134  and  136  as shown in  FIG. 9 . Each fiber  142  has (i) an inner portion positioned  144  between ECM layers  134  and  136  and (ii) at least one outer portion  146  extending outwardly from an end  138  or  140 . However, as shown in  FIG. 8  one or more fibers  144  may have two outer portions  146 , one extending from each end  138  and  140  of bioprosthetic device  130 . In addition, it should be understood that the fibers  142  are arranged relative to each other so that inner portion  144  of each fiber  144  positioned between ECM layers  134 ,  138  intersects at least one other inner portion  144  so as to only define obtuse or acute angles (e.g. angels  148 ,  150 ,  152 , and  154 ) between the intersecting fibers.  
         [0058]      FIGS. 12 and 13  illustrate a bioprosthetic device  156  similar to device  130  shown in  FIGS. 8 and 9 . A bioprosthetic device  156  may include an ECM member  158  which includes (i) an ECM layer  160 , (ii) an ECM layer  162 , (iii) width wise edges  164  and  166 , (iv) length wise edges  168  and  170 , and (v) ends  172  and  174 . Bioprosthetic device  156  may also include a population  176  of fibers and a population  178  of fibers interposed between ECM layers  160  and  162 . With respect to population  176  and population  178  these populations are arranged relative to one another so that a number of fibers in population  178  intersects a number of fibers of population  176  so as to define an orthogonal angle  184 . One of the two populations may have fibers which have an inner portion positioned between ECM layers and at least one outer portion extending outwardly from an end of an ECM member. For example, each fiber of population  178  (i) is substantially parallel with length wise edges  168  and  170 , (ii) has an inner portion  180  positioned between ECM layers  160  and  162 , and (iii) has at least one outer portion  182  extending outwardly from an end  172  and  174  of ECM member  158 . With respect to population  176  each fiber (i) is substantially parallel with width wise edges  164  and  166 , and (ii) intersects a number of fibers of population  178  so as to only define an orthogonal angle  184 .  
         [0059]     Now turning to  FIGS. 14 and 15 , another embodiment is illustrated. This bioprosthetic device  186  may include an ECM member  188  which includes (i) an ECM layer  190 , (ii) an ECM layer  192 , (iii) width wise edges  194  and  196 , (iv) length wise edges  198  and  200 , and (v) ends  202  and  204 . A population of fibers  206  and  208  are interposed ECM layers  190  and  192 . Each fiber of population  206  (i) is substantially parallel with a length wise edge  198  or  200 , (ii) has an inner portion  210  positioned between ECM layers  190  and  192 , and (iii) has an outer portion  212  extending outwardly from an end  202  and/or  204 . With respect to population  208 , the fibers are positioned relative to one another so as form a nonwoven mesh  214 .  
         [0060]     With respect to the embodiments illustrated in  FIGS. 8-9  and  12 - 15 , in each of these embodiments the ECM member is shown as a rectangle, however, as for any embodiment of the present disclosure, it should be appreciated that other shapes for the ECM member are contemplated as long as (i) the inner portions of the fibers intersect to form an acute or obtuse angle and at least one fiber has an outer portion, or (ii) two populations of fibers intersect to form an orthogonal angle and at least one fiber has an outer portion, or (iii) one population of fibers forms a nonwoven mesh and the other population has at least one fiber with an outer portion.  
         [0061]      FIGS. 10 and 11  illustrate other embodiments of bioprosthetic devices of the present disclosure. In  FIG. 10  bioprosthetic device  216  may include an ECM layer  218 , having (i) a surface  220 , (ii) length wise edges  226  and  230  and (iii) width wise edges  228  and  232 . Bioprosthetic device may also include two populations  222  and  224  of fibers positioned in contact with surface  220  of ECM layer  218 . As indicated in  FIG. 10  (i) each fiber  236  of population  222  is separated by a distance D 1 , (ii) each fiber  238  of population  224  is separated by a distance D 2 , (iii) populations  222  and  224  are separated by a distance D 3 , and (iv) D 3  is larger than both D 1  and D 2 . In one configuration of bioprosthetic device  216  each fiber  236  of population  222  and each fiber  238  of population  224  is positioned relative to ECM layer  218 , so that fibers  236  and  238  are substantially parallel with width wise edges  226  and  230 .  
         [0062]     Bioprosthetic device  216  may also include a population  240  of fibers  242  in contact with surface  220 . Each fiber  242  of population  240  may be positioned relative to ECM layer  218 , so that each fiber  242  of population  240  is substantially parallel with the length wise edges  226  and  230 .  
         [0063]     As shown in  FIG. 11 , populations  222  and  224  may also be positioned relative to ECM layer  218 , so as to be substantially parallel with length wise edges  226  and  230 . In addition, population  240  may be positioned relative to ECM layer  218 , so as to be substantially parallel with width wise edges  228  and  232 .  
         [0064]     As discussed, although ECM layer  218 , of bioprosthetic device  216  has a rectangular shape, any shape can be utilized as long as there are two populations of fibers positioned in contact with the surface of the ECM layer and (i) each fiber of one of the populations is separated by a distance D 1 , (ii) each fiber of the other population is separated by a distance D 2 , (iii) the populations are separated by a distance D 3 , and (iv) D 3  is larger that both D 1  and D 2 .  
         [0065]     The devices disclosed herein provide better integration of the bioprosthetic device with the contiguous soft tissues. These devices also provide a more integrated and stronger fixation technique. Exemplary illustrations of utilizing some of the embodiments of the present disclosure are discussed below.  
         [0066]     For example,  FIG. 16  illustrates how bioprosthetic device  22  could be utilized in a surgical procedure to treat a repair site  252  of damaged tissue  250 . In particular, as discussed above, device  22  includes wing members  24  and  26  which cooperate to form a V-shaped structure  42  and an attachment surface  40 . Repair site  252  of tissue  250  is sandwiched between wing members  24  and  26  and placed in contact with attachment surface  40 , while end  256  of device  22  can be directed toward the bone or tendon. As shown, multiple sutures  254  are passed through both device  22  and the tissue  250  to secure the device  22  to the tissue  250  to be repaired.  
         [0067]     With respect to bioprosthetic device  66 ,  FIGS. 17 and 18 , show this device positioned in contact with a repair site  258  of tissue  256 . In particular, circular or semi-circular-shaped tissue defects may be repaired with device  66  by covering the defect with device  66  as shown in  FIGS. 17 and 18 , and then passing multiple sutures  260  through both device  66  and the tissue  256 .  
         [0068]     An additional use of a bioprosthetic device of the present disclosure is illustrated in  FIG. 19 . Here bioprosthetic device  156  is used to repair tissue  262  by inserting device  156  throughout soft tissue  262  along the longitudinal axis of force transduction. As shown, outer portions  182  of the fibers extend beyond ECM member  158  and are inserted into the tissue  262  via a needle passer paralleled with the longitudinal direction of the tissue. These outer portions  182  are then brought together by any knotting technique if so required. Note  FIG. 19  only shows one set of outer portions  182  extending beyond ECM member  158 , other embodiments may have more than one set as previously described in reference to  FIGS. 8, 12 , and  14 .  
         [0069]     While the disclosure has been illustrated and described in detail in the foregoing description, such illustration and description is to be considered as exemplary and not restrictive in character, it being understood that only the preferred embodiments have been shown and described and that all changes and modifications that come within the spirit of the disclosure are desired to be protected.