Fiber-reinforced orthopedic compression staples

Abstract

A biodegradable, fiber-reinforced orthopedic staple for use in fixation of tissue and bone to restore anatomical relationships. The staple comprises a biocomposite composition including a bioabsorbable polymer and reinforcing mineral fibers. The staple further comprises a bridge portion attached to two or more shoulders, each of which is attached to a leg. The mineral fibers have at least two different lengths.

Description

[Technical Field]

[0001] Staples are commonly used in orthopedic surgery to fix bones or to fix soft tissue to bone. Typically, in compression staples, the legs of the staple create compression between them such that an injury site (fracture site, osteotomy, etc.) is positioned between the two legs, and the compression of the staple legs helps to maintain the two sides of the injury site in proximity to each other.

[0002] Compression staples in orthopedic surgery are usually constructed of a shape-memory material, typically a nitinol alloy. The staple has a bridge that sits on top of the bone (or other tissue to be fixed) and two or more legs connected to the bridge that are inserted into the bone or tissue. In their natural position, the legs typically form an angle greater than 90 degrees with respect to the bridge. During insertion, the staple legs are opened so that they each form an angle of approximately 90 degrees with respect to the staple bridge, and the legs are inserted into the bone (or other tissue) in this open position. After insertion, the legs apply a compressive force against each other as they push the bones together in a direction that attempts to restore their natural position (FIG. 18).

[0003] Currently, there are no non-permanent or biodegradable orthopedic compression staples on the market, primarily due to the insufficient mechanical properties of conventional biodegradable material technologies. Compression staples for use in orthopedic fixation must have a bridge with high bending strength and a high bending modulus to support the bending forces experienced by the staple. Additionally, as discussed above, the staple legs must compress the bone, which occurs through the opening of the legs, which then apply a compressive force as the legs return to their natural position. This opening and subsequent healing requires that the staple be able to withstand deformation within the elastic range of its material so that it can recover without plastic deformation. There is a need for a biodegradable staple that overcomes the problems associated with removing Nitinol-type staples and the complications caused by having these staples in the body for extended periods of time. Summary of the Invention

[0004] A fiber-reinforced orthopedic staple has been discovered for use in fixation of tissue and bone to restore anatomical relationships, such fixation optionally and preferably including one or more, and more preferably all, of stable fixation, maintenance of blood supply to the bone and surrounding soft tissue, and early active mobilization of the component and the patient.

[0005] The present inventors have discovered a fiber-reinforced orthopedic staple that is composed entirely of biodegradable components and that unexpectedly has the mechanical properties to provide secure bone fixation and apply compression across the bone fixation site.

[0006] The staples of the present invention overcome the limitations of commercially available staples because they have sufficient mechanical properties to support bone fixation while also applying compression across the fixed bone. The background art does not teach or suggest a staple that has sufficient mechanical properties to make an orthopedic compression staple and is biodegradable.

[0007] In one embodiment, the invention is an orthopedic staple comprising a biocomposite composition comprising a bioabsorbable polymer and reinforcing mineral fibers. The staple further comprises a bridge portion attached to two or more shoulder portions, each of the shoulder portions attached to a leg, and the mineral fibers are of at least two different lengths. In one embodiment, the fibers of one length are full-length fibers that are 100%, at least 99%, at least 98%, at least 95%, or at least 90% of the total span of the staple. In another embodiment, the fibers are composed of one length of full-length fibers and a second length of shoulder-length fibers.

[0008] In one embodiment, the invention is an orthopedic staple comprising a biocomposite composition including a bioabsorbable polymer and reinforcing mineral fibers. The staple further comprises a bridge portion attached to two or more shoulders, each of the shoulders being attached to a leg, and the mineral fibers are of at least two different lengths. In one embodiment, the ratio of the number of fibers of one fiber length to the number of fibers of a second length is in the range of 10:1 to 1:1, 4:1 to 1:1, or 2.5:1 to 1.5:1.

[0009] In one embodiment, the present invention is an orthopedic staple comprising a biocomposite composition including a bioabsorbable polymer and reinforcing mineral fibers. The staple further comprises a bridge portion attached to two or more shoulder portions, each of the shoulders being attached to a leg, and the mineral fibers being of at least two different lengths. In one embodiment, the ratio of bridge width to bridge height is in the range of 8:1 to 2:1.

[0010] In one embodiment, the invention is an orthopedic staple comprising a biocomposite composition including a bioabsorbable polymer and reinforcing mineral fibers. The staple further comprises a bridge portion attached to two or more shoulders, each of the shoulders attached to a leg, and the mineral fibers are of at least two different lengths. In one embodiment, the bridge width is at least 2%, 5%, 10%, 15%, 20%, 30%, or 50% greater than the leg width.

[0011] In one embodiment, the invention is an orthopedic staple comprising a biocomposite composition including a bioabsorbable polymer and reinforcing mineral fibers. The staple further comprises a bridge portion attached to two or more shoulder portions, each of the shoulders attached to a leg, and the mineral fibers are of at least two different lengths. In one embodiment, the ratio of the number of fibers in the bridge to the number of fibers in the leg ranges from 1:1 to 20:1, 1.1:1 to 10:1, or 1.2:1 to 5:1.

[0012] The present invention provides a solution to the problems of prior art staples by providing, at least in some embodiments, implant compositions having fiber-reinforced biocompatible composites that represent a significant advance over previous implants in that they are capable of achieving sustained high load-bearing strength and stiffness. Furthermore, the biocomposites described herein are optionally and preferably bioabsorbable. Thus, the present invention overcomes the limitations of previous approaches and provides medical implants comprising biodegradable biocomposite compositions that feature fiber-reinforced staples that have excellent mechanical properties and subsequently retain their mechanical strength and stiffness over extended periods of time. [Brief explanation of the drawings]

[0013] The present invention is described herein, by way of example only, with reference to the accompanying drawings. Referring now specifically to the drawings in detail, it is emphasized that the details shown are by way of example and merely for purposes of illustrative discussion of preferred embodiments of the invention, and are presented to provide what is believed to be the most useful and readily understood explanation of the principles and conceptual aspects of the invention. In this regard, no attempt has been made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, and the description taken together with the drawings will make apparent to those skilled in the art how several forms of the invention may be embodied in practice. The drawings are as follows: [Figure 1] FIG. 1 is a front view of an example staple of the present invention, where 100 is a bridge, 101 is a shoulder, 102 is a leg, 103 is a tip of the leg, and 104 is a tooth. [Figure 2] FIG. 2 is a front view of an example staple of the present invention, where 200 is the start of the shoulder and 201 is the end of the shoulder. [Figure 3A] FIG. 3 is a side view of a staple of the present invention showing the direction of measurement of staple width 302. [Figure 3B] FIG. 3 is a front view of a staple of the present invention, where the measurement direction of the staple is 300, which is the height, and 301, which is the length of the staple. [Figure 4A]4 is a cross-sectional view of the shoulder showing the measurement directions of the bridge, 400 being the height "x" axis and 401 being the width "y" axis. [Figure 4B] A cross section of the leg showing measurements of the leg, 402 is the length or "x" axis and 403 is the width on the "y" axis. [Figure 5] FIG. 5 is a top oblique view of a 3D representation of an example staple of the present invention, further illustrating that the measurement directions of the staple are 500, bridge width, 501, bridge length, 502, leg height, 503, leg length, and 504, leg width. [Figure 6] FIG. 1 is a front view of an example staple of the present invention, where 600 is the angle of the legs relative to the bridge. [Figure 7] FIG. 7 is a front view of an example staple of the present invention showing tooth height 700 and tooth length 701. [Figure 8] FIG. 8 is a front view of an example staple of the present invention showing full length fiber 800. [Figure 9] FIG. 1 is a front view of an example staple of the present invention, depicting a single group of full length fibers of similar length. [Figure 10] FIG. 1 is a front view of an example staple of the present invention showing two groups of fibers of different lengths: full length fibers and shoulder length fibers. [Figure 11] FIG. 1 is a front view of an example staple of the present invention showing two groups of intermediate filaments, one on each end of the staple. [Figure 12] FIG. 1 is a front view of an example staple of the present invention showing two groups of fibers of different lengths: full length fibers and bridge long fibers. [Figure 13] FIG. 1 is a front view of an example staple of the present invention showing three different groups of fibers: leg long fibers and bridge long fibers. [Figure 14A] 14A and 14B are representative examples of insertion devices for use in the methods of the present invention, with FIG. 14A showing the device locked in the open position and FIG. 14B showing the device locked in the closed position. [Figure 14B]14A and 14B are representative examples of insertion devices for use in the methods of the present invention, with FIG. 14A showing the device locked in the open position and FIG. 14B showing the device locked in the closed position. [Figure 15A] 15A-15B show an exemplary insertion device for use in the methods of the present invention, with FIGS. 15A-15B showing the device in a closed position and FIGS. 14C-14D showing the device locked in an open position. [Figure 15B] 15A-15B show an exemplary insertion device for use in the methods of the present invention, with FIGS. 15A-15B showing the device in a closed position and FIGS. 14C-14D showing the device locked in an open position. [Figure 15C] 15A-15B show an exemplary insertion device for use in the methods of the present invention, with FIGS. 15A-15B showing the device in a closed position and FIGS. 14C-14D showing the device locked in an open position. [Figure 15D] 15A-15B show an exemplary insertion device for use in the methods of the present invention, with FIGS. 15A-15B showing the device in a closed position and FIGS. 14C-14D showing the device locked in an open position. [Figure 16] 1 is a representative example of a tamp for use in the method of the present invention. [Figure 17] 1 depicts a drill guide for use in the method of the present invention. [Figure 18] For use in the methods of the present invention, it refers to the direction of compressive force of the staple legs when, for example, pushing bones together in a direction that attempts to restore their original position. DETAILED DESCRIPTION OF THE INVENTION

[0014] In one embodiment of the present invention, the staple of the present invention is composed of a biocomposite composite comprising a reinforcing bioabsorbable polymer composed of any of the bioabsorbable polymers mentioned herein and a reinforcing filler, preferably in the form of a fiber.

[0015] For the avoidance of doubt, the terms "filler" and "fiber" are used interchangeably to describe the reinforcing material structure.

[0016] As used herein, "biodegradable" is a general term that includes materials, e.g., polymers, that degrade through in vivo degradation. In one embodiment, the loss of mass of a biodegradable material in the body is the result of a passive process catalyzed by physicochemical conditions (e.g., humidity, pH) within the host tissue. In another biodegradable embodiment, the loss of mass of a biodegradable material in the body is eliminated through natural pathways, either due to simple filtration of degradation by-products or after metabolism of the material ("bioresorption" or "bioabsorption"). In either embodiment, the loss of mass can result in partial or complete removal of the initial foreign body. In one embodiment, removal of the initial foreign body includes partial or complete dispersion in vivo, or additionally / alternatively, incorporation or remodeling of a portion of the initial foreign body into the surrounding in vivo environment. In one embodiment, the staple of the present invention comprises a biodegradable composite material including a biodegradable polymer that undergoes chain scission due to polymer degradation in an aqueous environment.

[0017] As used herein, a polymer is "bioresorbable" if it can be metabolized and / or broken down into small, non-toxic segments that can be eliminated from the body. In one embodiment, a bioresorbable polymer swells, hydrolyzes, and degrades upon exposure to body tissue, resulting in significant weight loss. In one embodiment, the hydrolysis reaction is enzyme-catalyzed. In one embodiment, complete bioresorption, i.e., greater than 70%, 80%, 90%, 95%, 98%, or 100% weight loss, occurs within 24 months or 12 months.

[0018] As used herein, the term "polymer degradation" refers to the decrease in molecular weight of each original polymer. In one embodiment, degradation is induced by free water resulting from the cleavage of ester bonds. In another embodiment, degradation of the polymers used in the biomaterials described in the Examples follows the principle of bulk erosion, whereby a continuous decrease in molecular weight precedes a significant mass loss. The mass loss is due to the solubility of the degradation products. Methods for measuring water-induced polymer degradation are well known in the art, such as titration of degradation products, viscosity measurement, and differential scanning calorimetry (DSC).

[0019] As used herein, the term "biocomposite" refers to a composite material formed by a matrix and a reinforcement of fibers, both of which are biocompatible and optionally bioabsorbable. In one embodiment, the matrix is ​​a polymer resin, more specifically a synthetic bioabsorbable polymer. In one embodiment, the fibers are optionally and preferably of a different class of material (i.e., not a synthetic bioabsorbable polymer) and may optionally include minerals, ceramics, cellulose, or other types of materials.

[0020] As used herein, a "staple" is an orthopedic implant in the form of a two or more legged (pronged) fastener for joining or bonding tissue or bone together in a subject in need thereof. The physical characteristics of the staple described herein refer to the staple in the "standing" position unless otherwise specified, and terms used to describe the staple are from the perspective of a user looking down at the top of the staple bridge (FIG. 5). The terms "implant" and "staple" are used interchangeably herein to describe the staples of the present invention.

[0021] In one embodiment, the staple of the present invention has an open position and a closed position. As used herein, a "closed" position is a natural or resting position in which the angle between the legs and bridge of the staple is greater than 90°, 93°, 95°, or 100° (see FIG. 6). As used herein, in the "open" position, the angle between the legs and bridge of the staple (shown in FIG. 6) is equal to 90° or is less than 90°, 85°, 80°, or 75° (not shown). In one embodiment of the staple of the present invention, the angle between the bridge and legs of the staple is within the range of 90-105°, 93-100°, or 96-98° when the staple is in the closed position (FIG. 6).

[0022] As used herein, the term "full span" of a staple includes the length of the legs, shoulders, and bridge of the staple, extending from the tip of one leg, up through the shoulder across the bridge, through the second shoulder, down the second leg, and to the tip of the second leg (FIGS. 1 and 8).

[0023] As used herein, a "shoulder" is the area of ​​the staple that connects the bridge to the leg, beginning at the beginning of the medial curve at the junction where the bridge turns into the radius of curvature of the shoulder and ending at the end of the medial curve where it turns into the leg (Figure 2).

[0024] As used herein, the "leg" is the area below the shoulder that does not have a radius of curvature (FIG. 1).

[0025] As used herein, a "bridge" is the region between two shoulders (FIG. 1). In one embodiment, the bridge of a staple of the present invention has no radius of curvature. In another embodiment, the radius of curvature of the bridge is within the range of 5 to 200 mm, 10 to 100, or 15 to 50 mm. In yet another embodiment, the bridge of a staple of the present invention has a radius that is greater than the radius of curvature of the shoulders.

[0026] In one embodiment, the staples of the present invention, when in the open position, are in the shape of a flat arch, a rounded arch, a semicircular arch, an arcuate arch, a three-centered arch, a pseudo-three-centered arch, or a tudo arch.

[0027] In one embodiment of the staple of the present invention, the bridge width is greater than the leg width (FIGS. 3-5). In one embodiment of the staple of the present invention, the bridge width is at least 2%, 5%, 10%, 15%, 20%, 30%, or 50% greater than the leg width.

[0028] In one embodiment of the staple of the present invention, the circumference of the bridge is greater than the circumference of the legs. In one embodiment of the staple of the present invention, the circumference of the bridge is at least 2%, 5%, 10%, 15%, 20%, 30%, or 50% greater than the circumference of the legs.

[0029] In one embodiment of the staple of the present invention, the width of the bridge and shoulders is greater than the width of the legs (FIGS. 3-5). In one embodiment of the staple of the present invention, the width of the bridge and shoulders is at least 2%, 5%, 10%, 15%, 20%, 30%, or 50% greater than the width of the legs.

[0030] In one embodiment of the staple of the present invention, the cross-sectional area of ​​the bridge and shoulders is greater than the cross-sectional area of ​​the legs. In one embodiment of the staple of the present invention, the cross-sectional area of ​​the bridge and shoulders is at least 2%, 5%, 10%, 15%, 20%, 30%, or 50% greater than the cross-sectional area of ​​the legs.

[0031] In one embodiment of the staple of the present invention, the cross-sectional area of ​​the bridge is 1 to 20 mm 2 , 3~15mm 2 , or 5.3 to 10.6 mm 2 The range is.

[0032] In one embodiment of the staple of the present invention, the cross-sectional area of ​​the legs is 1 to 10 mm 2 , 2~8mm 2 , or 3.1 to 5.9 mm 2 The range is.

[0033] In one embodiment of the staple of the present invention, the ratio of the cross-sectional area of ​​the bridge to the cross-sectional area of ​​the legs is 10:1, 5:2, or 3.4:0.9.

[0034] In one embodiment of the staple of the present invention, the cross-sectional area of ​​the shoulder tapers from the beginning of the shoulder to the end of the shoulder (FIGS. 3-5). In one embodiment of the staple of the present invention, the cross-sectional area of ​​the shoulder is equal to the cross-sectional area of ​​the bridge where the shoulder meets the bridge at the beginning of the shoulder (0° shoulder curvature) and equal to the cross-sectional area of ​​the leg where the shoulder meets the leg at the end of the shoulder (90°+ shoulder curvature) (FIGS. 3-5).

[0035] In one embodiment of the staple of the present invention, the diameter of the shoulder at the midpoint (ie, at about a 45° curvature) ranges from 1 to 10 mm, more preferably from 1.5 to 5 mm, and most preferably from 2.3 to 3.3 mm.

[0036] In one embodiment of the staple of the present invention, the bridge width 401 ranges from 1 to 10 mm, 2 to 7 mm, or 3.2 to 4.8 mm (FIG. 4). The bridge width is measured at its widest point as shown in FIG.

[0037] In one embodiment of the staple of the present invention, the bridge height 400 ranges from 1 to 8 mm, 1.5 to 4 mm, or 1.8 to 2.4 mm (FIG. 4). The bridge height is measured from the top of the bridge to the bottom of the bridge (before the start of the shoulder 200) as shown in FIG.

[0038] In one embodiment of the staple of the present invention, the ratio of bridge height 400 to bridge width 401 is in the range of 1:8, 1.15:5, or 1.3:2.7 (FIG. 4). In one embodiment of the staple of the present invention, the ratio of bridge height 400 to bridge width 401 is in the range of 1:8 to 1:2, 1:5 to 1:3, or 1.15:5 to 1.3:2.7 (FIG. 4).

[0039] In one embodiment of the staple of the present invention, the bridge length 301 ranges from 5 to 35 mm, 7 to 30 mm, or 9 to 25 mm (FIG. 3). The bridge length 301 is measured at the longest point of the bridge (see FIG. 3).

[0040] In one embodiment of the staple of the present invention, the leg width 403 ranges from 1 to 8 mm, 1.5 to 5 mm, or 1.8 to 2.3 mm (FIG. 4). The leg width is measured at its widest point (see FIG. 4).

[0041] In one embodiment of the staple of the present invention, the leg length 402 ranges from 1 to 8 mm, 1.5 to 5 mm, or 1.8 to 2.3 mm (FIG. 4). The leg length is measured as shown in FIGS.

[0042] In one embodiment of the staple of the present invention, the ratio of leg width 403 to leg length 402 is in the range of 0.3:1 to 5:1, 0.5:1 to 3:1, 0.7:1 to 1.3:1, or 0.7:1 to 0.9:1.

[0043] In one embodiment of the staple of the present invention, the leg height 300 ranges from 4 to 30 mm, 6 to 25 mm, or 8 to 22 mm (FIG. 3). The leg height 300 is measured as shown in FIG.

[0044] In one embodiment of the staple of the present invention, the cross-sectional shape of the bridges is a square, diamond, pentagon, hexagon, heptagon, octagon, or trapezoid, hi another embodiment, the cross-sectional shape of the bridges is a pentagon, hexagon, heptagon, octagon, or trapezoid.

[0045] In one embodiment of the staple of the present invention, the cross-sectional shape of the legs is square, pentagonal, hexagonal, heptagonal, octagonal, or trapezoidal, hi another embodiment, the cross-sectional shape of the legs is pentagonal, hexagonal, heptagonal, octagonal, or trapezoidal.

[0046] In one embodiment of the staple of the present invention, the outer radius of curvature of the shoulder is in the range of 1 to 10 mm, 1.5 to 5 mm, or 2.3 to 3.5 mm.

[0047] In one embodiment of the staple of the present invention, the inner radius of curvature of the shoulder is in the range of 1 to 10 mm, 1.2 to 5 mm, or 1.5 to 2.3 mm.

[0048] In one embodiment of the staple of the present invention, the outer radius of curvature of the shoulder is greater than the inner radius of curvature.

[0049] In one embodiment of the staple of the present invention, the ratio of the outer radius of curvature to the inner radius of curvature is 10:1, 5:1, or 2:1.

[0050] In one embodiment of the staple of the present invention, the tips of the legs are tapered, hi one embodiment, the tips have a height within the range of 0.1 to 5 mm, 0.2 to 3 mm, or 0.3 to 1.9 mm.

[0051] In one embodiment of the staple of the present invention, the legs are partially tapered. In one embodiment, the taper height is preferably 1 to 10 mm, 1 to 5 mm, or 1 to 3 mm. In one embodiment, the partial tapering of the legs does not include the tips of the legs.

[0052] Preferably, the cross-sectional area of ​​the tapered portion is reduced by 0.1% to 70%, 5% to 50%, or 10 to 30%.

[0053] In one embodiment of the staple of the present invention, the legs optionally have teeth or barbs to improve the bite of the staple on the bone. In one embodiment of the staple of the present invention, the teeth or barbs are around the entire circumference of the legs. In another embodiment of the staple of the present invention, the teeth or barbs are on the medial and lateral sides of the legs. In another embodiment of the staple of the present invention, the teeth or barbs are only on the medial sides of the legs.

[0054] In one embodiment, the tooth or barb height 700 ranges from 0.05 to 3 mm, 0.1 to 2 mm, or 0.2 to 0.4 mm. The height 700 is measured as shown in FIG.

[0055] In one embodiment of the staple of the present invention, the length 701 of the teeth or barbs is 0 to 20 mm, or 1 to 10 mm. The length 701 is measured as shown in FIG.

[0056] Bioabsorbable polymers In one embodiment of the present invention, the biodegradable composite material comprises a bioabsorbable polymer.

[0057] The medical implants described herein can be made from any biodegradable polymer. The biodegradable polymer can be a homopolymer or a copolymer, including a random copolymer, a block copolymer, or a graft copolymer. The biodegradable polymer can be a linear polymer, a branched polymer, or a dendrimer. The biodegradable polymer can be of natural or synthetic origin. Examples of suitable biodegradable polymers include lactide, glycolide, caprolactone, valerolactone, carbonates (e.g., trimethylene carbonate, tetramethylene carbonate, etc.), dioxanones (e.g., 1,4-dioxanone), δ-valerolactone, 1, dioxepanones (e.g., 1,4-dioxepan-2-one and 1,5-dioxepan-2-one), ethylene glycol, ethylene oxide, esteramides γ-hydroxyvalerate, β-hydroxypropionate, α-hydroxyacid, hydroxybutyric acid, poly(orthoesters), hydroxyalkanoates, tyrosine carbonate, poly(isopropyl alcohol), ... Suitable natural biodegradable polymers include, but are not limited to, polymers such as those made from polyimide carbonates, polyiminocarbonates, e.g., poly(bisphenol A-iminocarbonate) and poly(hydroquinone iminocarbonate), polyurethanes, polyanhydrides, polymeric drugs (e.g., polydiflunisole, polyaspirin, and protein therapeutics) and copolymers and combinations thereof. Suitable natural biodegradable polymers include those made from collagen, chitin, chitosan, cellulose, poly(amino acids), polysaccharides, hyaluronic acid, gut, copolymers and derivatives, and combinations thereof.

[0058] According to the present invention, the biodegradable polymer may be a copolymer or terpolymer, such as polylactide (PLA), poly-L-lactide (PLLA), poly-DL-lactide (PDLLA), poly-LD-lactide (PLDLA), polyglycolide (PGA), copolymers of glycolide, glycolide / trimethylene carbonate copolymer (PGA / TMC), other copolymers of PLA, such as lactide / tetramethylglycolide copolymer, lactide / trimethylene carbonate copolymer, lactide / d-valerolactide. ton copolymers, lactide / ε-caprolactone copolymers, L-lactide / DL-lactide copolymers, glycolide / L-lactide copolymers (PGA / PLLA), polylactide-co-glycolide, terpolymers of PLA such as lactide / glycolide / trimethylene carbonate terpolymers, lactide / glycolide / ε-caprolactone terpolymers, PLA / polyethylene oxide copolymers, polydepsipeptides, asymmetrically 3,6-substituted poly-1,4-dioxane-2,5-dione, polyhydrogen Polyhydroxyalkanoates, polyhydroxybutyrate (PHB), PHB / b-hydroxyvalerate copolymer (PHB / PHV), poly-b-hydroxypropionate (PHPA), polydioxanone (PDS), poly-d-valerolactone-poly-ε-capralactone, poly(ε-(caprolactone DL-lactide) copolymer), methyl methacrylate-N-vinylpyrrolidone copolymer, polyesteramide, polyester of oxalic acid, polydihydropyran, polyalkyl-2-cyanoacrylate, poly The polymers may be polyurethanes (PU), polyvinyl alcohol (PVA), polypeptides, poly-b-maleic acid (PMLA), poly-b-alkanoic acid, polycarbonates, polyorthoesters, polyphosphates, poly(ester anhydrides), and mixtures thereof, as well as natural polymers such as sugars, starches, cellulose and cellulose derivatives, polysaccharides, collagen, chitosan, fibrin, hyaluronic acid, polypeptides, and proteins. Mixtures of any of the above polymers and their various forms may also be used.

[0059] Preferably, the polymer is PLDLA and the ratio of L to D isomers ranges from 60:40 L:D to 99:1 L:D, more preferably the ratio is from 70:30 to 96:4.

[0060] Reinforced bioabsorbable polymer According to at least some embodiments of the present invention, the medical implant comprises a reinforced bioabsorbable polymer (i.e., a bioabsorbable composite that includes the aforementioned polymer and also incorporates a reinforcing filler, typically in the form of a fiber, to increase the mechanical strength of the polymer).

[0061] In a more preferred embodiment of the present invention, the reinforced bioabsorbable polymer is a reinforced polymer composition composed of any of the bioabsorbable polymers described above and a reinforcing filler, preferably in the form of fibers. The reinforcing filler may be composed of organic or inorganic (i.e., natural or synthetic) materials. The reinforcing filler may be biodegradable glass, cellulosic materials, nanodiamonds, or any other filler known in the art to increase the mechanical properties of bioabsorbable polymers. The filler is preferably made from a material or class of materials other than the bioabsorbable polymer itself. However, it may also optionally be the fiber of the bioabsorbable polymer itself.

[0062] Numerous examples of such reinforced polymer compositions have been previously described, such as biocompatible and absorbable molten glass compositions in which glass fibers can be embedded in a continuous polymer matrix (EP 2243749 A1), biodegradable composites comprising a biodegradable polymer and 20-70 vol% glass fibers (WO 2010128039 A1), absorbable and biocompatible glass fibers that can be embedded in a polymer matrix (US 2012 / 0040002 A1), biocompatible composites and uses thereof (US 2012 / 0040015 A1), and absorbable polymers containing poly[succinimide] as a filler (EP 0671177 B1).

[0063] In a more preferred embodiment of the present invention, the reinforcing filler is bonded to a bioabsorbable polymer so that the reinforcing effect is maintained for a long period of time.

[0064] Such approaches are described in U.S. Patent Application Publication No. 2012 / 0040002 (A1) and European Patent Application No. 2243500 (B1), which discuss composite materials comprising a biocompatible glass, a biocompatible matrix polymer, and a coupling agent capable of forming covalent bonds.

[0065] Preferably, a sizer or compatibilizer is included in the biocomposite implant composition to increase bonding between the polymer and the fibers. Preferably, such compatibilizer or sizer comprises less than 1% by weight and / or volume of the total implant composition. Preferably, such compatibilizer or sizer comprises less than 0.5% by weight and / or volume. Most preferably, such compatibilizer or sizer comprises less than 0.3% by weight and / or volume.

[0066] Preferably, the compatibilizer or sizer is composed predominantly of a bioabsorbable polymer selected from the above list of absorbable polymers. Preferably, the polymer in the sizer has a different composition, intrinsic viscosity, or average molecular weight than the bioabsorbable polymer that constitutes the implant's polymeric structural components. Such compatibilizers preferably have lower molecular weights (shorter chain lengths) than the implant's polymeric structural components. Non-limiting examples of such compatibilizers are provided in International Publication No. WO 2010122098, which is incorporated herein by reference as if fully set forth herein. For example, optionally, the compatibilizer comprises a polymer in which at least 10% of the compatibilizer's structural units are identical to the structural units of the structural polymer, and the compatibilizer's molecular weight is less than 30,000 g / mol. Optionally, at least 30% of the compatibilizer's structural units are identical to the structural units of the structural polymer, and the compatibilizer's molecular weight is less than 10,000 g / mol. More preferably, the compatibilizer's molecular weight is less than 10,000 g / mol. Alternatively, 0% of the structural units of the compatibilizer are identical to the structural units of the structural polymer.

[0067] The biodegradable composite material is preferably incorporated into a polymer matrix, which may optionally contain any of the polymers described above. Optionally and preferably, it may contain a polymer selected from the group consisting of PLLA (poly-L-lactide), PDLLA (poly-DL-lactide), PLDLA, PGA (polyglycolic acid), PLGA (polylactide-glycolic acid), PCL (polycaprolactone), PLLA-PCL, and combinations thereof. When PLLA is used, the matrix preferably contains at least 30% PLLA, more preferably 50%, and most preferably at least 70% PLLA. When PLDLA is used, the matrix preferably contains at least 5% PLDLA, more preferably at least 10%, and most preferably at least 20% PLDLA.

[0068] Preferably, the intrinsic viscosity (IV) of the polymer matrix (independent of the reinforcing fibers) is in the range of 1.2 to 2.4 dl / g, more preferably in the range of 1.5 to 2.1 dl / g.

[0069] Intrinsic viscosity (IV) is a viscometric method for measuring molecular size. IV is based on the flow time of a polymer solution through a narrow capillary relative to the flow time of a pure solvent through the capillary. Preferably, the average molecular weight of the polymer matrix, as measured by GPC, is in the range of 100 kDa to 400 kDa. More preferably, the average molecular weight is in the range of 120 kDa to 250 kDa. Most preferably, the average molecular weight is in the range of 150 kDa to 250 kDa.

[0070] Reinforcing Fiber The reinforcing filler in the staple of the present invention can be composed of organic or inorganic (i.e., natural or synthetic) materials. The reinforcing filler can be biodegradable glass, cellulosic materials, nanodiamonds, or any other filler known in the art to increase the mechanical properties of bioabsorbable polymers. The filler is preferably made from a material or class of materials other than the bioabsorbable polymer itself. However, it can also optionally be the fiber of the bioabsorbable polymer itself. Many examples of such reinforcing polymer compositions have been previously described. For example, biocompatible and absorbable molten glass compositions in which glass fibers can be embedded in a continuous polymer matrix (EP 2243749 A1), biodegradable composites comprising a biodegradable polymer and 20-70 vol% glass fibers (WO 2010128039 A1), absorbable and biocompatible glass fibers that can be embedded in a polymer matrix (US 2012 / 0040002 A1), biocompatible composites and uses thereof (US 2012 / 0040015 A1), and absorbable polymers comprising poly[succinimide] as a filler (EP 0671177 B1).

[0071] In one embodiment of the present invention, the reinforcing filler is bonded to a bioabsorbable polymer so that the reinforcing effect is maintained over time. Such an approach is described in U.S. Patent Application Publication No. 2012 / 0040002 (A1) and European Patent No. 2243500 (B1), which discuss composite materials comprising a biocompatible glass, a biocompatible matrix polymer, and a coupling agent capable of forming covalent bonds.

[0072] In one embodiment of the present invention, the biodegradable composite material and fibers are preferably arranged in the form of biodegradable composite fiber bundles, each bundle comprising unidirectionally aligned continuous reinforcing fibers embedded in a polymer matrix composed of one or more bioabsorbable polymers (see, e.g., WO 2019 / 123462, the entire contents of which are incorporated herein by reference).

[0073] In one embodiment, the reinforcing fibers are composed of silica-based inorganic compounds such that the reinforcing fibers include bioabsorbable glass fibers, which may also be referred to as a bioglass fiber composite.

[0074] The bioabsorbable mineral fibers may optionally have an oxide composition in the following mole percent ranges: Na2O: 10.0 to 19.0 mol% CaO: 9.0 to 14.0 mol% MgO: 1.5 to 8.0 mol% B2O3: 0.5 to 3.0 mol% AhO3: 0 to 0.8 mol% P2O3: 0.1 to 0.8 mol% SiO2: 67 to 73 mol%

[0075] And more preferably, in the following mole % ranges: Na2O: 11.5 to 13.0 mol% CaO: 9.0 to 10.0 mol% MgO: 7.0 to 8.0 mol% B2O3: 1.4 to 2.0 mol% P2O3: 0.5 to 0.8 mol% SiO2: 67 to 70 mol% K2O: 0 to 0.4 mol%

[0076] Alternatively, the mineral composition ranges above are applicable as weight percent (w / w) rather than as mole percent.

[0077] Additional optional glass fiber compositions have been previously described by Lehtonen TJ et al. (Acta Biomaterialia 9 (2013) 4868-4877), which is incorporated herein by reference in its entirety. Such glass fiber compositions may optionally be used in place of or in addition to the above compositions.

[0078] Additional optional bioabsorbable glass compositions are described in the following patent applications, which are incorporated herein by reference as if fully set forth herein: Biocompatible Composites and Uses Thereof (WO 2010122098); and Absorbable and Biocompatible Glass Fiber Compositions and Uses Thereof (WO 2010122019).

[0079] In one embodiment of the present invention, the fibers are continuous fibers. As used herein, a "continuous fiber" is a single, uninterrupted fiber that extends continuously through a particular length of the implant. These fibers can be any length longer than the nominal particle, but are generally longer than 1 mm, 3 mm, or 5 mm. The length of a continuous fiber can also be defined in the context of geometric features of a particular type of implant, such as "full length fiber," "shoulder length fiber," or "bridge length fiber," as described below specific to staples.

[0080] As used herein, a "plurality" refers to one or more fibers of the same or similar orientation. In one embodiment, the plurality of fibers are of the same or similar length. In one embodiment, the plurality of fibers forms at least 10%, 20%, or 30% of the total number of fibers in a particular cross-section of a staple of the present invention.

[0081] In one embodiment of the staple of the present invention, the fibers extend along the entire length of the staple. In another embodiment, a majority of the fibers are aligned along the entire span of the staple. In yet another embodiment, all of the fibers are aligned along the entire span of the staple. In yet another embodiment, 10-90%, 30-80%, or 50-75% of the fibers are aligned along the entire span of the staple.

[0082] In one embodiment of the staple of the present invention, the angle between aligned fibers along the entire span of the staple is less than 15 degrees, less than 10 degrees, or less than 5 degrees from each other.

[0083] In one embodiment of the staple of the present invention, the number of fibers passing through the cross-sectional area of ​​the bridge ranges from 1K to 200K, from 5K to 150K, or from 9K to 110K.

[0084] In one embodiment of the staple of the present invention, the number of fibers aligned along the vertical axis "x" (height, 400, see FIG. 4) of the staple bridge ranges from 30 to 600, 60 to 400, or 80 to 240.

[0085] In one embodiment of the staple of the present invention, the number of fibers aligned along the horizontal axis "y" (width, 401, see FIG. 4) of the staple bridge ranges from 50 to 1000, 100 to 700, or 150 to 480.

[0086] In one embodiment of the staple of the present invention, the number of fibers extending across the cross-sectional area of ​​the staple leg ranges from 1 to 150K, 5k to 100K, or 7k to 70K.

[0087] In one embodiment of the staple of the present invention, the number of fibers aligned along the second horizontal axis "x" (length, 402, see FIG. 4) of the staple leg is in the range of 40 to 800, 70 to 500, or 100 to 300.

[0088] In one embodiment of the staple of the present invention, the number of fibers aligned along the horizontal axis "y" (width, 403, see FIG. 4) of the staple leg ranges from 40-700, 70-400, or 90-230.

[0089] In one embodiment of the staple of the present invention, there are a plurality of fibers of at least two different lengths extending partially or completely along the entire span of the staple.

[0090] In one embodiment of the staple of the present invention, the ratio of the number of fibers of one fiber length to the number of fibers of a second fiber length is in the range of 10:1 to 1:1, 4:1 to 1:1, or 2.5:1 to 1.5:1.

[0091] In one embodiment of the staple of the present invention, the weight percent ratio of the fiber content of one fiber length to the fiber content of a second fiber length is in the range of 20:1 to 1:1, or 10:1 to 1.5:1, or 5:1 to 2:1.

[0092] In one embodiment of the staple of the present invention, the fibers are "full length fibers" that extend completely along the entire length of the staple. In one embodiment of the staple of the present invention, for full length fibers, "completely" means extending along 100%, at least 99%, at least 98%, at least 95%, or at least 90% of the entire span of the staple.

[0093] In one embodiment of the staple of the present invention, the fibers are "shoulder-long fibers" that extend across the bridge of the staple, extend beyond the staple shoulders on each side of the staple, and extend into the staple legs, but do not extend completely along the entire span of the staple. In one embodiment, the shoulder-long fibers extend at least 0.5 mm, at least 2 mm, at least 1 mm, at least 4 mm, at least 5 mm, or at least 8 mm beyond the end of the shoulder. In one embodiment, the shoulder-long fibers extend partially along the entire span of the staple.

[0094] In one embodiment of the staple of the present invention, the fibers are "bridge filaments" that extend across the bridge of the staple but do not extend beyond the end of shoulder 201. In one embodiment, the bridge filaments do not extend beyond the beginning of shoulder 200 (FIG. 2).

[0095] In one embodiment of the staple of the present invention, the fibers are "mid-length fibers" that extend from the tips of the staple legs over the shoulders into the bridge of the staple. In one embodiment, the mid-length fibers extend from the tips of the stabilizer legs over the shoulders up to 10%, 20%, 30%, 40%, or 50% of the length of the bridge.

[0096] In one embodiment of the staple of the present invention, the fibers are "leg long fibers" that extend from the tip of the staple leg, through the top of the staple leg, and extend into the bridge over the shoulder. In one embodiment, the leg long fibers do not extend beyond the beginning of the shoulder 200. In one embodiment, the leg long fibers do not extend beyond the end of the shoulder 201 (FIG. 2).

[0097] In one embodiment of the staple of the present invention, the staple is composed of a plurality of full length fibers and a plurality of shoulder length fibers.

[0098] In one embodiment of the staple of the present invention, the ratio of full length fibers to shoulder length fibers is 10:1 to 1:1, 4:1 to 1:1, or 2.5:1 to 1.5:1.

[0099] In one embodiment of the staple of the present invention, the length of the full length fiber is in the range of 10 to 200 mm, 20 to 150 mm, or 25 to 70 mm.

[0100] In one embodiment of the staple of the present invention, the length of the shoulder length fibers ranges from 8 to 150 mm, from 10 to 80 mm, or from 15 to 32 mm.

[0101] In one embodiment of the staple of the present invention, the ratio of the length of the shoulder length fibers to the length of the full length fibers is in the range of 1:1.1 to 1:10, 1:1.5 to 1:5, or 1:1.5 to 1:2.5.

[0102] In one embodiment of the invention, the weight percent fiber content of the bridge is equal to the weight percent fiber content of the legs. In one embodiment, the weight percent fiber content of the bridge and legs ranges from 30-70%, 40-60%, or 45-50%.

[0103] In one embodiment of the present invention, the ratio of the number of bridge fibers to the number of leg fibers ranges from 1:1 to 20:1, more preferably from 1.1:1 to 10:1, and most preferably from 1.2:1 to 5:1.

[0104] In one embodiment of the staple of the present invention, the average diameter of the reinforcing fibers is in the range of 0.1 to 100 μm, 1 to 20 μm, or 8 to 18 μm.

[0105] In one embodiment of the staple of the present invention, the density of the biocomposite composition is 1 to 2 g / mL, 1.2 to 1.9 g / mL, or 1.4 to 1.8 g / mL.

[0106] Optional additional features The following features and embodiments may optionally be combined with any of the above features and embodiments.

[0107] The tensile strength of the reinforcing fiber is preferably in the range of 1200 to 2800 MPa, more preferably in the range of 1600 to 2400 MPa, and most preferably in the range of 1800 to 2200 MPa. The elastic modulus of the reinforcing fiber is preferably in the range of 30 to 100 GPa, more preferably in the range of 50 to 80 GPa, and most preferably in the range of 60 to 70 GPa.

[0108] Optionally, the majority of the reinforcing fibers aligned with the longitudinal axis of the medical implant are at least 50%, preferably at least 60%, more preferably at least 75%, and most preferably at least 85% of the total length of the implant.

[0109] Manufacturing method The continuous fiber-reinforced bioabsorbable implants of the present invention may optionally be manufactured using any method known in the art, such as those described in WO 2016 / 035088, WO 2016 / 035089, WO 2016 / 103049, WO 2017155956, WO 2018 / 002917, WO 2019 / 049062, and WO 2019 / 123462, the entire contents of each of which are incorporated herein by reference in their entirety.

[0110] In one embodiment, the staple of the present invention is manufactured using a manufacturing method that subjects the implant to compressive pressure, such as compression molding. Preferably, the water content of the implant after molding is less than 30%, more preferably less than 20%, and even more preferably less than 10%, 8%, 6%, or 5%.

[0111] Implant manufacturing Any of the bioabsorbable polymers or reinforced bioabsorbable polymers described above can be manufactured into any desired physical form for use with the present invention. The polymer substrate can be manufactured by, for example, compression molding, casting, injection molding, pultrusion, extrusion, filament winding, composite flow molding (CFM), machining, or any other manufacturing technique known to those skilled in the art. The polymer can be fabricated into any shape or configuration suitable for a staple.

[0112] Load-bearing mechanical strength The present invention relates particularly to bioabsorbable composite materials that can be used in medical applications requiring high strength and stiffness relative to the stiffness of bone. These medical applications require medical implants to support all or part of the loads applied by or to the body and therefore can generally be referred to as "load-bearing" applications. These include fracture fixation, tendon reattachment, joint replacement, spinal fusion, and spinal cages.

[0113] The preferred flexural strength of the load-bearing medical implants described herein is at least 200 MPa, preferably greater than 400 MPa, more preferably greater than 600 MPa, even more preferably greater than 800 MPa. The elastic modulus (or Young's modulus) of the bioabsorbable composites for use in the present invention is preferably at least 5 GPa, more preferably greater than 10 GPa, even more preferably greater than 15 GPa, 20 GPa, but not more than 100 GPa, preferably not more than 60 GPa.

[0114] sustained mechanical strength The bioabsorbable load-bearing medical implants of the present invention must maintain their mechanical properties (high strength and stiffness) for extended periods of time to allow adequate bone healing. The strength and stiffness preferably remain greater than those of cortical bone, approximately 150-250 MPa and 15-25 GPa, respectively, in vivo (i.e., in a physiological environment), for at least 3 months, preferably at least 6 months, and even more preferably at least 9 months.

[0115] More preferably, the flexural strength is maintained above 400 MPa, and even more preferably above 600 MPa.

[0116] In another embodiment of the present invention, the degradation rate of the mechanical strength of the coated medical implant approximates the material degradation rate of the implant as measured by weight loss of the biodegradable composite material.

[0117] In a preferred embodiment, the implant retains more than 50% of its mechanical strength 3 months after implantation, while more than 50% of the material degradation, and therefore weight loss, occurs within 12 months of implantation.

[0118] In a preferred embodiment, the implant retains more than 70% of its mechanical strength 3 months after implantation, while more than 70% of the material degradation, and therefore weight loss, occurs within 12 months of implantation.

[0119] In a preferred embodiment, the implant retains more than 50% of its mechanical strength 6 months after implantation, while more than 50% of the material degradation, and therefore weight loss, occurs within 9 months of implantation.

[0120] In a preferred embodiment, the implant retains more than 70% of its mechanical strength 6 months after implantation, while experiencing more than 70% material degradation and therefore weight loss within 9 months of implantation.

[0121] The degradation of mechanical strength and the rate of material degradation (weight loss) of medical implants can be measured after in vivo implantation or after simulated in vitro implantation. In the case of simulated in vitro implantation, the simulation can be performed in real time or according to an accelerated degradation criterion.

[0122] How to use In one embodiment, the present invention is a method of using the staples described herein to fixate bone or tissue in a patient in need thereof. In one embodiment of the method, the staple is opened by spreading the legs from a natural closed position to a position where the angle between the legs and the bridge is approximately 90 degrees prior to insertion. In one embodiment of the staple of the present invention, an insertion device (FIG. 14) is used to spread the staple legs prior to insertion. In one embodiment, the insertion device locks the position at a specific opening amount of the staple. In one embodiment, the insertion device is used as a tamping instrument to tamp the staple into place. In one embodiment, the insertion device includes one or more measurement templates.

[0123] In one embodiment of the method of using the staples of the present invention, staples are loaded onto the inserter teeth when the inserter handles are open (FIG. 15). Once the staples are loaded, the inserter handles are closed so that the inserter teeth exert an outward force on the staple legs, spreading them apart at approximately a 90-degree angle with the staple bridge. Once the handles are closed and the staple legs are spread apart, a latch on one side of the handle locks onto an internal cavity on the second side of the handle. The inserter is then locked in position. Staples can then be inserted by inserting or tamping the staples downward into the pre-drilled holes. Once the staples are inserted into the holes, the inserter latch is lifted, releasing the inserter handle and allowing the inserter teeth to move inward from the staple legs, after which they can be easily removed from under the staple bridge.

[0124] In one embodiment of the method of using the staples of the present invention, following removal of the staple insertion device, the staples may then be further tamped into place using a separate tamping instrument (FIG. 16) or the insertion instrument itself.

[0125] In one embodiment of the method of using the staples of the present invention, a drill guide (FIG. 17) can be used to allow for drilling of properly positioned holes for inserting the staples prior to inserting the staples.

[0126] In one embodiment of the method of using the staples of the present invention, an additional locating pin can be used to hold the hole in place while the hole is being drilled or after the drill guide is removed.

[0127] In one embodiment of the method for using the staple of the present invention, the drill hole size is in the range of 1.5 to 4 mm, 2 to 3 mm, or 2.3 to 2.7 mm.

[0128] In one embodiment of the method of using the staple of the present invention, the depth of the drill hole exceeds the length of the staple leg. In one embodiment of the method of using the staple of the present invention, the depth of the drill hole is at least 5 mm, 2 mm, or 1 mm.

[0129] In one embodiment of the method of using the staples of the present invention, a drill bit for use with the staple includes drill depth lines. [Example]

[0130] Example 1 - Continuous Fiber Reinforced Staple with Multiple Fiber Lengths This example demonstrates how continuous fiber reinforced compression staples made from continuous fibers of different lengths can have different performance characteristics in terms of bending stiffness and peak load related to the fiber length and orientation of each type of staple.

[0131] Materials and Methods Five types of staple implants (each with a bridge length of 25 mm and a leg length of 15 mm) were fabricated using a reinforced composite material. The cross-sectional area of ​​the staple bridge was 10.6 mm, and the cross-sectional area of ​​the staple legs was 5.9 mm. The material composite consisted of PLDLA 70 / 30 polymer reinforced with 45-50% w / w continuous mineral fibers. The mineral fiber composition was approximately 14% Na2O, 5.4% MgO, 9% CaO, 2.3% BO3, 51.5% PO2O, and 67.8% SiO2 w / w. Test specimens were fabricated by compression molding composite strips into staple-shaped molds. Each strip consisted of PLDLA polymer with embedded, unidirectionally aligned continuous fibers. There were full-length strips (composed of full-length mineral fibers) and shoulder-length strips (composed of shoulder-length mineral fibers). The full length fibers were approximately 51 mm in length, while the shoulder length fibers were approximately 33 mm in length. There were also bridge length strips and bridge length strips from the tip to the center of the legs. The bridge length strips were approximately 23 mm in length, and the bridge length strips from the tip to the center of the legs were approximately 25 mm in length. All fibers were aligned with the staple axis. Each strip was approximately 0.18 mm thick. Four staple samples were prepared and tested for each staple group.

[0132] Implant specimens were tested for stiffness and maximum bending load in a tensile testing system (MTS Criterion Machine, MN, USA) according to the modified standard test method, ASTM_F564-17 (Standard Test Methods for Metallic Bone Staples, ASTM International, PA, USA). Mechanical testing was performed using a 500 N load cell and appropriate fixtures for static bending tests. The specimen span at the start of the test was 40 mm between the upper pins and 120 mm between the lower pins, and the crosshead speed was set at 25.4 mm / min. The specimen dimensions, weight, and density were recorded.

[0133] [Table 1]

[0134] Table 1A: Means and standard deviations of implant mechanical properties (n=4).

[0135] Table 1A shows the mechanical performance results of implant staples made from five different configurations of fiber length.

[0136] As can be seen in Table 1A, the mechanical properties of continuous fiber-reinforced staples made from multiple different continuous fiber lengths are superior to those of continuous fiber-reinforced staples made entirely from a single fiber length (such as Groups 1.1 and 1.4), even when that fiber length is the entire length of the implant (Group 1.2). Furthermore, the specific configuration of Group 1.1 (approximately 50% full-length fibers / 50% shoulder-length fibers) is superior to other configurations of fiber lengths.

[0137] Example 2 - Fiber Content of Continuous Fiber Reinforced Staple Materials and Methods Staples with a bridge length of 20 mm and leg length of 22 mm from Group 1.1 of Example 1 were prepared as described in the previous example.

[0138] The cross-sectional area of ​​the staple bridge is 10.6 mm 2 and the cross-sectional area of ​​the staple leg is 5.9 mm 2 It was.

[0139] The mineral fiber content of each of the bridge and legs was analyzed separately using the loss on ignition test method as follows.

[0140] The muffle furnace was set to 600°C. The empty crucible was heated at 600°C for 30 minutes. The crucible was then cooled to room temperature (for at least 30 minutes) in a desiccator. The empty crucible was then weighed. 1g to 2g of sample (either the staple bridge or staple legs) was then added to the crucible, and the sample + crucible were then weighed.

[0141] The crucible containing the sample was placed in a muffle furnace heated to 600°C. This temperature was maintained for a minimum of 3 hours until all carbonaceous material had disappeared, which could be confirmed visually. If a black or grey residue was present in the crucible, combustion was continued.

[0142] The crucible was then removed from the muffle furnace and placed in a desiccator to cool to ambient temperature for at least 1 hour. The sample plus crucible was then weighed again.

[0143] The loss on ignition (%) is as follows:

[0144] Mineral fiber content =

[0145]

number

[0146] result

[0147] [Table 2]

[0148] [Table 3]

[0149] The average mineral fiber content of the staple bridge samples was 48.8 ± 0.2, and the average mineral fiber content of the staple leg samples was 49.8 ± 0.6. These values ​​are very similar and statistically indistinguishable. Despite the different cross-sectional areas of the legs and bridges, the mineral content of the bridges and legs was essentially the same.

[0150] It will be understood that various features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination. Those skilled in the art will also appreciate that the present invention is not limited to what has been particularly shown and described above. Rather, the scope of the present invention is defined only by the following claims.

Claims

1. 1. An orthopedic staple comprising a biocomposite composition comprising a bioabsorbable polymer and reinforcing mineral fibers, said staple further comprising a bridge portion attached to two or more shoulders, each of the shoulders being attached to a leg, and said mineral fibers being of at least two different lengths.

2. 10. The orthopedic staple of claim 1, wherein one length of fibers is full length fibers that is 100%, at least 99%, at least 98%, at least 95%, or at least 90% of the total span of the staple.

3. 2. The orthopedic staple of claim 1, wherein a length of fiber extends across the bridge of the staple, extends beyond the shoulder of the staple on each side of the staple, and is a shoulder length fiber that extends into the legs of the staple.

4. 10. The orthopedic staple of claim 1, wherein one length of fiber is a shoulder-length fiber that extends into the leg at least 0.5 mm, at least 2 mm, at least 1 mm, at least 4 mm, at least 5 mm, or at least 8 mm.

5. 10. The orthopedic staple of claim 1, wherein one length of fiber is a bridge filament that extends across the bridge of the staple into the shoulder but not into the legs.

6. The orthopedic staple of claim 1, wherein one length of fiber is a bridge filament that extends across the bridge of the staple but does not extend into the shoulder.

7. The orthopedic staple of claim 1 , wherein one length of fiber is a medium length fiber that extends from the tip of the leg, over the shoulder, to the center of the staple bridge.

8. 10. The orthopedic staple of claim 1, wherein one length of fiber is a leg-long fiber that extends from the distal end of the leg across and into the shoulder but does not extend beyond the beginning of the shoulder.

9. The orthopedic staple of any one of claims 2 to 4, wherein the fibers are comprised of one length of full length fibers and a second length of shoulder length fibers.

10. The orthopedic staple of any one of claims 2 or 5-6, wherein the fibers are comprised of one length of full-length fibers and a second length of bridge length fibers.

11. The orthopaedic staple of any one of claims 5-6 or 8, wherein the fibers are comprised of one length of bridge long fibers and a second length of leg long fibers.

12. 12. The orthopedic staple of any one of claims 1 to 11, wherein the ratio of the number of fibers of one fiber length to the number of fibers of a second length is in the range of 10:1 to 1:1, 4:1 to 1:1, or 2.5:1 to 1.5:

1.

13. The orthopedic staple according to any one of claims 1 to 12, wherein the ratio of the bridge width to the bridge height is in the range of 8:1 to 2:

1.

14. The orthopaedic staple of any one of claims 1 to 13, wherein the bridge width ranges from 1 to 10 mm, 2 to 7 mm, or 3.2 to 4.8 mm.

15. The orthopedic staple of any one of claims 1 to 14, wherein the bridge height ranges from 1 to 8 mm, 1.5 to 4 mm, or 1.8 to 2.4 mm.

16. 16. The orthopedic staple of any one of claims 1 to 15, wherein the width of the bridge is at least 2%, 5%, 10%, 15%, 20%, 30%, or 50% greater than the width of the legs.

17. The orthopaedic staple of any one of claims 1 to 16, wherein the leg width is within the range of 1 to 8 mm, 1.5 to 5 mm, or 1.8 to 2.3 mm.

18. The orthopedic staple of any one of claims 1 to 17, wherein the leg lengths range from 5 to 35 mm, 7 to 30 mm, or 9 to 25 mm.

19. The cross-sectional area of ​​the bridge is 1 to 20 mm ２ , 3 to 15 mm ２ , or 5.3 to 10.6 mm ２ The orthopedic staple according to any one of claims 1 to 18, wherein the thickness of the staple is in the range of

20. The cross-sectional area of ​​the leg is 1 to 10 mm ２ , 2 to 8 mm ２ , or 3.1 to 5.9 mm ２ The orthopedic staple according to any one of claims 1 to 19, wherein the thickness of the staple is in the range of

21. The orthopedic staple according to any one of claims 1 to 20, wherein the ratio of the cross-sectional area of ​​the bridge to the cross-sectional area of ​​the legs is 10:1, 5:2, or 3.4:0.

9.

22. 22. The orthopedic staple of any one of claims 1 to 21, wherein the ratio of the number of fibers in the bridge to the number of fibers in the legs ranges from 1:1 to 20:1, 1.1:1 to 10:1, or 1.2:1 to 5:

1.

23. The orthopedic staple according to any one of claims 1 to 22, wherein the cross-sectional shape of the bridge is pentagonal, hexagonal, heptagonal, octagonal, or trapezoidal.

24. The orthopedic staple according to any one of claims 1 to 23, wherein the cross-sectional shape of the legs is pentagonal, hexagonal, heptagonal, octagonal, or trapezoidal.

25. The orthopaedic staple of any preceding claim, wherein the staple further comprises teeth around the entire circumference of the legs.

26. The orthopedic staple of any one of claims 1 to 25, wherein the staple further comprises teeth on the medial and lateral sides of the legs.

27. The orthopedic staple of any one of claims 1 to 26, wherein the staple further comprises teeth on the inside of the legs.

28. The bioabsorbable polymer may comprise a homopolymer or a copolymer, the copolymer may comprise a random copolymer, a block copolymer, or a graft copolymer, the polymer may comprise a linear polymer, a branched polymer, or a dendrimer of natural or synthetic origin, the polymer may comprise a lactide, glycolide, caprolactone, valerolactone, carbonates (e.g., trimethylene carbonate, tetramethylene carbonate, etc.), dioxanones (e.g., 1,4-dioxanone), 8-valerolactone, 1,dioxepanone (e.g., 1,4-dioxanone), 1,4-dioxanone, 1,5-dioxanone, 1,6-dioxanone, 1,7-dioxanone, 1,8-dioxanone, 1,9 ... 1,5-dioxepan-2-one and 1,5-dioxepan-2-one), ethylene glycol, ethylene oxide, ester amides, gamma-hydroxyvalerate, alpha-hydroxypropionate, alpha-hydroxy acid, hydroxybutyric acid, poly(orthoesters), hydroxyalkanoates, tyrosine carbonate, polyimide carbonates, polyiminocarbonates such as poly(bisphenol Aiminocarbonate) and poly(hydroquinone-iminocarbonate), polyurethanes, polyanhydrides, polymeric drugs (e.g., poly(diflunizole)), Polysaccharides, including but not limited to, cellulose, polyaspirin, and therapeutic proteins, sugars, starches, cellulose and cellulose derivatives, polysaccharides, collagen, chitosan, fibrin, hyaluronic acid, polypeptides, proteins, poly(amino acids), polylactide (PLA), poly-L-lactide (PLLA), poly-DL-lactide (PDLLA), polyglycolide (PGA), copolymers of glycolide, glycolide / trimethylene carbonate copolymer (PGA / TMC), other copolymers of PLA, e.g., lactide / tetramethylglycolide copolymer, lactide / trimethylene carbonate copolymer (PGA / TMC), ethylene carbonate copolymers, lactide / d-valerolactone copolymers, lactide / ε-caprolactone copolymers, L-lactide / DL-lactide copolymers, glycolide / L-lactide copolymers (PGA / PLLA), polylactide-co-glycolide, terpolymers of PLA such as lactide / glycolide / trimethylene carbonate terpolymers, lactide / glycolide / c:-caprolactone terpolymers, PLA / polyethylene oxide copolymers, polydepsipeptides, asymmetrically 3,6-substituted poly-1,4-dioxane-2,5-diones, polyhydroxyalkanoates, polyhydroxybutyrate (PHB), PHB / b-hydroxyvalerate copolymer (PHB / PHV), poly-b-hydroxypropionate (PHP A), poly-p-dioxanone (PDS), poly-d-valerolactone-poly-c:-capralactone, poly(c:caprolactone-DL-lactide) copolymer, methyl methacrylate-N-vinylpyrrolidone copolymer, polyesteramides, polyesters of oxalic acid, polydihydropyran, polyalkyl-2-cyanoacrylate, polyurethane (PU), polyvinyl alcohol (PVA), polypeptides, poly-b-maleic acid (PMLA):poly-b-alkanoic acid, polycarbonates, polyorthoesters, polyphosphates, poly(ester anhydrides), and mixtures thereof, as well as derivatives, copolymers, and mixtures thereof.

29. 29. The orthopedic staple of any one of claims 1 to 28, wherein the bioabsorbable polymer is in the form of a polymer matrix, the polymer matrix comprising a polymer selected from the group consisting of PLLA (poly-L-lactide), PDLLA (poly-DL-lactide), PLDLA, PGA (poly-glycolic acid), PLGA (poly-lactide-glycolic acid), PCL (polycaprolactone), PLLA-PCL, and combinations thereof.

30. The orthopedic staple of any one of claims 1 to 29, wherein when PLLA is used, the matrix comprises at least 30%, 50%, or at least 70% PLLA.

31. The orthopedic staple of any one of claims 1 to 30, wherein when PLDLA is used, the matrix comprises at least 5%, at least 10%, or at least 20% PLDLA.

32. The reinforcing mineral fibers include the following range of elements: Na ２ O: 11.0 to 19.0 mol%, CaO: 8.0 to 14.0 mol%, MgO: 2 to 8.0 mol%, B ２ O ３ : 1 to 3.0 mol%, Al ２ O ３ : 0 to 0.5 mol%, P ２ O ３ : 1 to 2 mol%, and SiO ２ : 66 to 70 mol %, the orthopedic staple according to any one of claims 1 to 31.

33. The orthopaedic staple of any one of claims 1 to 32, wherein the mineral content within the staple is in the range of 40% to 60% w / w.

34. The orthopaedic staple of any one of claims 1 to 33, wherein the mineral content within the staple is in the range of 45% to 55% w / w.

35. The orthopaedic staple of any one of claims 1 to 34, wherein the mineral content within the staple is in the range of 40% to 70% w / w.

36. The orthopedic staple of any one of claims 1 to 35, wherein the density of the biocomposite composition is 1 to 2 g / mL.

37. The orthopedic staple according to any one of claims 1 to 36, wherein the density of the biocomposite composition is 1.2 to 1.9 g / mL.

38. The orthopedic staple of any one of claims 1 to 37, wherein the density of the biocomposite composition is 1.4 to 1.8 g / mL.

39. An orthopaedic staple according to any one of claims 1 to 38, wherein the reinforcing mineral fibres have an average diameter in the range of 0.1 to 100 µm.

40. An orthopaedic staple according to any one of claims 1 to 39, wherein the reinforcing mineral fibres have an average diameter in the range of 1 to 20 µm.

41. An orthopedic staple according to any one of claims 1 to 40, wherein the reinforcing mineral fibres have an average diameter in the range of 4 to 16 µm.

42. An orthopaedic staple according to any one of claims 1 to 41, wherein the reinforcing mineral fibres have an average diameter in the range of 9 to 14 µm.

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