Patent Application
20070112360
The present disclosure relates to bioprosthetics and particularly, for example, to the use of bioprosthetics for the repair and replacement of connective tissue.
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'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.
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:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 & 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—C6H4—O—(CH2)m—O—C6H4—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.
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.
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.
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.
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's) BMP-1, (BMP-3); BMP-2; OP-1; BMP-2A, -2B, and -7, BMP-14; HBGF-1 and -2; growth differentiation factors (GDF'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.
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.
Illustrative examples of the bioprosthetic device of the present disclosure are described below. Now turning to
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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.
As shown in
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 D1, (ii) each fiber of the other population is separated by a distance D2, (iii) the populations are separated by a distance D3, and (iv) D3 is larger that both D1 and D2.
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.
For example,
With respect to bioprosthetic device 66,
An additional use of a bioprosthetic device of the present disclosure is illustrated in
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.
