WO2024105655A1

WO2024105655A1 - Fiber-reinforced orthopedic compression staple

Info

Publication number: WO2024105655A1
Application number: PCT/IL2023/051093
Authority: WO
Inventors: Sagi ROICHMAN; Tal ZEEVI; Orahn Preiss-Bloom
Original assignee: Ossio Ltd.
Priority date: 2022-11-16
Filing date: 2023-10-23
Publication date: 2024-05-23

Abstract

A biodegradable fiber-reinforced orthopaedic staple for use for tissue and bone fixation to restore anatomical relationships. The staple comprises a biocomposite composition which comprises a bioabsorbable polymer and reinforcing mineral fibers. The staple further comprises a bridge section attached to two or more shoulder sections, each of which is attached to a leg section. The mineral fibers are of at least two different lengths.

Description

FIBER-REINFORCED ORTHOPEDIC COMPRESSION STAPLE

BACKGROUND OF THE INVENTION

Staples are commonly used in orthopedic surgery to fixate bones or fixate soft tissues to bones. Typically, in a compression staple, the legs of the staple create compression between them such that the injury site (fracture site, osteotomy, etc.,) is positioned between the two legs and the compression of the staple legs helps maintain approximation of the two sides of the injury site to each other.

Compression staples in orthopedic surgery are usually comprised of shape memory materials, typically nitinol alloys. The staple has a bridge that sits on top of the bone (or other tissue being fixated) and two or more legs connected to the bridge that are inserted into the bone or tissue. The legs, in their native position, usually form an angle of more than 90 degrees to the bridge. During insertion, the legs of the staple are opened, such that they each form an angle of around 90 degrees to the staple bridge, and the legs are inserted into the bone (or other tissue) in this open position. Following insertion, the legs will apply compression force relative to each other as they push the bone together in the direction of trying to recover their native position (FIG 18).

There are currently no non-permanent or biodegradable orthopedic compression staples on the market largely due to insufficient mechanical properties of prior biodegradable material technologies. A compression staple for use in orthopedic fixation must have a bridge with high flexural strength and a high flexural modulus to support the bending forces that the staple will experience. Additionally, as described above, the staple legs must compress the bone, which occurs by the opening of the legs which then apply compressive force as they recover their native position. This opening followed by recovery requires the staple to be able to withstand the deformation of the opening within the elastic range of its material such that it can recover without plastic deformation. There is a need for biodegradable staples to overcome the problems with removal of nitinol type staples and complications caused by having these staples in the body long term.

BRIEF SUMMARY OF THE INVENTION

A fiber-reinforced orthopedic staple for use for tissue and bone fixation to restore anatomical relationships has been discovered. Such fixation optionally and preferably includes one or more, and more preferably all, of stable fixation, preservation of blood supply to the bone and surrounding soft tissue, and early, active mobilization of the part and patient.

The inventors have discovered a fiber-reinforced orthopedic staple, which is comprised entirely of biodegradable components, which unexpectedly has the mechanical properties to provide secure bone fixation and to apply compression across the bone fixation site.

The staples of the present invention overcome the limitations of the commercially available staples because they have sufficient mechanical properties to both support bone fixation and to apply compression across fixated bones. The background art fails to teach or suggest staples that have sufficient mechanical properties to create an orthopedic compression staple and yet are biodegradable.

In one embodiment the present invention is an orthopaedic staple, comprising a biocomposite composition which comprises a bioabsorbable polymer and reinforcing mineral fiber; wherein the staple further comprises a bridge section attached to two or more shoulder sections, each of which is attached to a leg section, wherein the mineral fibers are of at least two different lengths. In one embodiment, one length fibers are full length fibers, which are 100%, at least 99%, at least 98%, at least 95% or at least 90% of the entire span of the staple. In another embodiment, the fibers are comprised of one length of full length fibers and a second length of shoulder length fibers.

In one embodiment the present invention is an orthopaedic staple, comprising a biocomposite composition which comprises a bioabsorbable polymer and reinforcing mineral fiber; wherein the staple further comprises a bridge section attached to two or more shoulder sections, each of which is attached to a leg section, wherein the mineral fibers are of at least two different lengths. In one embodiment, the ratio of numbers 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.

In one embodiment the present invention is an orthopaedic staple, comprising a biocomposite composition which comprises a bioabsorbable polymer and reinforcing mineral fiber; wherein the staple further comprises a bridge section attached to two or more shoulder sections, each of which is attached to a leg section, wherein the mineral fibers are of at least two different lengths. In one embodiment, the ratio of the width of the bridge to the height of the bridge is in the range of 8: 1 to 2: 1.

In one embodiment the present invention is an orthopaedic staple, comprising a biocomposite composition which comprises a bioabsorbable polymer and reinforcing mineral fiber; wherein the staple further comprises a bridge section attached to two or more shoulder sections, each of which is attached to a leg section, wherein the mineral fibers are of at least two different lengths. In one embodiment, the width of the bridge is greater than the width of the legs by at least 2%, 5%, 10%, 15%, 20%, 30% or 50%.

In one embodiment the present invention is an orthopaedic staple, comprising a biocomposite composition which comprises a bioabsorbable polymer and reinforcing mineral fiber; wherein the staple further comprises a bridge section attached to two or more shoulder sections, each of which is attached to a leg section, wherein the mineral fibers are of at least two different lengths. In one embodiment, the ratio of number of fibers in the bridge to number of fibers in the leg is in the range of 1 : 1 - 20: 1, 1.1 : 1 - 10: 1, or 1.2: 1 -5: 1.

The present invention provides a solution to the problems of the prior art staples by providing, in at least some embodiments, implant compositions with fiber reinforced biocompatible composite materials that are a significant step forward from previous implants in that they can achieve sustainably high, load bearing strengths and stiffness. Furthermore, the biocomposite materials described herein are also optionally and preferably bioabsorbable. The present invention therefore overcomes the limitations of previous approaches and provides medical implants comprising biodegradable biocomposite compositions featuring fiber reinforced staples that have superior mechanical properties and subsequently retain their mechanical strength and stiffness for an extended period.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in order to provide what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. In the drawings:

Figure 1, is a front view of an example of a staple of the present invention, 100 is the bridge, 101 is a shoulder, 102 is a leg, 103 is the tip of a leg and 104 is the teeth.

Figure 2, is a front view of an example of a staple of the present invention, 200 is the start of the shoulder, 201 is the end of the shoulder. Figures 3A and 3B, Figure 3A is a side view of a staple of the present invention representing the direction of measurement of the width 302 of the staple; Figure 3B is a front view of a staple of the present invention representing the direction of the measurements of the staple 300 is the height, and 301 is the length of the staple.

Figures 4A and B, Figure 4A is a cross-section of the shoulder representing the direction of measurements of the bridge, 400 is the height “x” axis, 401 is the width “y” axis; Figure 4B is a cross-section of the leg representing the measurements of the leg 402 is the length or “x^A” axis, and 403 is the width of “y” axis.

Figure 5, is an angled top view of a 3-D representation of an example of the staples of the present invention further representing the direction of measurements of the staple 500 is the bridge width, 501 is the bridge length, 502 is the leg height, 503 is the leg length and 504 is the leg width.

Figure 6, is a front view of an example of a staple of the present invention, 600 is the angle of the leg to the bridge.

Figure 7, is a front view of an example of a staple of the present invention representing the height 700 of the teeth and the length 701 of the teeth.

Figure 8, is a front view of an example of a staple of the present invention representing a full- length fiber 800.

Figure 9, is a front view of an example of a staple of the present invention representing a single group of similar length full length fibers.

Figure 10, is a front view of an example of a staple of the present invention representing two groups of different length fibers: full length fibers and shoulder length fibers.

Figure 11, is a front view of an example of a staple of the present invention representing two groups of mid-length fibers, one at either end of the staple.

Figure 12, is a front view of an example of a staple of the present invention representing two groups of different length fibers: full length fibers and bridge length fibers.

Figure 13, is a front view of an example of a staple of the present invention representing three different groups of fibers: leg length fibers and bridge length fibers.

Figures 14 A and B, Figures 14A and B are representative examples of insertion devices for use in the methods of the present invention Figure 14 A the device is locked in the open position, Figure 14B the device is closed.

Figures 15 A-D, Figures 15A-D are representative examples of insertion devices for use in the methods of the present invention Figures 15 A-B the device is closed, Figures 14 C-D the device is locked in the open position. Figure 16, is a representative example of a tamp for use in the methods of the present invention. Figure 17, is a representative of a drill guide for use in the methods of the present invention. Figure 18, is a representative of the direction of the compression force of the staple leg as they push, for example, bone together in the direction of trying to recover their native position for use in the methods of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

In one embodiment of the present invention, the staples of the present invention are comprised of a biocomposite composite comprising a reinforced bioabsorbable polymer comprised of any of the herein mentioned bioabsorbable polymers and a reinforcing filler, preferably in fiber form.

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

"Biodegradable" as used herein is a generalized term that includes materials, for example polymers, which break down due to degradation in vivo. In one embodiment, the decrease in mass of the biodegradable material within the body is the result of a passive process, which is catalyzed by the physicochemical conditions (e.g., humidity, pH value) within the host tissue. In another embodiment of biodegradable, the decrease in mass of the biodegradable material within the body is eliminated through natural pathways either because of simple filtration of degradation by-products or after the material's metabolism ("Bioresorption" or "Bioabsorption"). In either embodiment, the decrease in mass may result in a partial or total elimination of the initial foreign material. In one embodiment, elimination of the initial foreign material includes partial or complete dispersion in vivo or additionally/alternatively includes incorporation or remodeling of part of the initial foreign material into the surrounding in vivo environment. In one embodiment, the staples of the present invention comprise a biodegradable composite which comprises a biodegradable polymer that undergoes a chain cleavage due to macromolecular degradation in an aqueous environment.

As used herein a polymer is "bioabsorbable" if it is capable of breaking down into small, nontoxic segments which can be metabolized and/or eliminated from the body. In one embodiment, bioabsorbable polymers swell, hydrolyze, and degrade upon exposure to bodily tissue, resulting in a significant weight loss. In one embodiment, the hydrolysis reaction is enzymatically catalyzed. In one embodiment, complete bioabsorption, i.e., greater than 70%, 80%, 90%, 95%, 98% or 100% weight loss, occurs within 24 months or 12 months. As used herein the term "polymer degradation" means a decrease in the molecular weight of the respective original polymer. In one embodiment, degradation is induced by free water due to the cleavage of ester bonds. In another embodiment, the degradation of the polymers as for example used in the biomaterial as described in the examples follows the principle of bulk erosion. Thereby a continuous decrease in molecular weight precedes a highly pronounced mass loss. Said mass loss is attributed to the solubility of the degradation products. Methods for determination of water induced polymer degradation are well known in the art such as titration of the degradation products, viscometry, differential scanning calorimetry (DSC).

The term "biocomposite" as used herein is a composite material formed by a matrix and a reinforcement of fibers wherein both the matrix and fibers are biocompatible and optionally bioabsorbable. In one embodiment, the matrix is a polymer resin, and 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 comprise mineral, ceramic, cellulosic, or other type of material.

As used herein, a “staple” is an orthopedic implant in the form of a two, or more, legged (pronged) fastener for joining or binding tissue or bone together in a subject in need thereof. Physical characteristics of the staple as described herein will refer to the staple in a “standing” position, unless otherwise specified, and the terms used to describe the staple will be from the point of view of a user looking down at the top of the bridge of the staple (FIG 5). The terms “implant” and “staple” are used interchangeably herein to describe the staples of the present invention.

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

As used herein, the term the “entire span” of the staple includes the length of the legs, shoulders and bridge of the staple and runs from the tip of one leg up through the shoulder across the bridge, through the second shoulder and down the second leg to the tip of the second leg (FIG 1 and 8). As used herein, a "shoulder” is the region of the staple connecting the bridge to a leg that begins at the start of the inner curvature at the junction where the bridge turns into the radius of curvature of the shoulder and ends at the end of the inner curvature that turns into the leg (FIG 2).

As used herein, a “leg” is the region below the shoulder that does not have a radius of curvature (FIG 1).

As used herein, a “bridge” is the region between the two shoulders (FIG 1). In one embodiment, the bridge of the staples of the present invention does not have a radius of curvature. In another embodiment, the radius of curvature of the bridge is in the range of 5-200 mm, 10-100, or 15- 50 mm. In yet another embodiment, the bridge of the staples of the present invention has a bigger radius than the radius curvature of the shoulder.

In one embodiment the staples of the present invention, are in the shape of a flat arch, round arch, semi-circular arch, segmental arch, three centered arch, pseudo three centered arch or a tudor arch when in the open position.

In one embodiment of the staples of the present invention, the width of the bridge is greater than the width of the legs (FIGs 3-5). In one embodiment of the staples of the present invention, the width of the bridge is greater than the width of the legs by at least 2%, 5%, 10%, 15%, 20%, 30% or 50%.

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

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

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

In one embodiment of the staples of the present invention, the cross-sectional area of the bridge is in the range of 1-20 mm², 3-15 mm², or 5.3-10.6 mm². In one embodiment of the staples of the present invention, the cross-sectional area of the leg is in the range of 1-10 mm², 2-8mm², or 3.1-5.9 mm².

In one embodiment of the staples of the present invention, the ratio of cross-sectional area of the bridge to cross-sectional area of the leg is 10: 1, 5:2, or 3.4:0.9.

In one embodiment of the staples of the present invention, the cross sectional area of the shoulder is tapered from the start of the shoulder to the end of the shoulder (FIGs 3-5). In one embodiment of the staples of the present invention, the cross-sectional area of the shoulder is equal to that of the bridge where the shoulder meets the bridge at the start of the shoulder (0° of shoulder curvature) and equivalent to that of a leg where the shoulder meets the leg at the end of the shoulder (90°+ of shoulder curvature) (FIGs 3-5)

In one embodiment of the staples of the present invention, the diameter of the shoulder at the midpoint (i.e., approximately 45° of curvature) is in the range of 1 - 10mm more preferably 1.5 - 5mm, most preferably 2.3-3.3mm.

In one embodiment of the staples of the present invention, the width 401 of the bridge is in the range of 1-10 mm, 2-7 mm, or 3.2-4.8 mm (FIG 4). The width of the bridge is measured at the widest point as shown in FIG 4.

In one embodiment of the staples of the present invention, the height 400 of the bridge is in the range of 1-8 mm, 1.5-4 mm, or 1.8-2.4 mm (FIG 4). The height of the bridge 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 4.

In one embodiment of the staples of the present invention, the ratio of the 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 staples of the present invention, the ratio of the 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).

In one embodiment of the staples of the present invention, the length 301 of the bridge is in the range of 5-35 mm, 7-30 mm, or 9-25mm (FIG 3). The length 301 of the bridge is measured at the longest point of the bridge see FIG 3.

In one embodiment of the staples of the present invention, the width 403 of a leg is in the range of 1-8 mm, 1.5-5mm, orl.8-2.3 mm (FIG 4). The width of the leg is measured at the widest point see FIG 4.

In one embodiment of the staples of the present invention, the length 402 of a leg is in the range of 1-8 mm, 1.5-5 mm, or 1.8-2.3 mm (FIG 4). The length of the leg is measured as shown in FIG 3 and 4. In one embodiment of the staples of the present invention, the ratio of the leg width 403 to leg length 402 is in the range of 0.3: 1 - 5: 1, 0.5: 1 - 3: 1, 0.7: 1 - 1.3: 1, or 0.7: 1 - 0.9: 1.

In one embodiment of the staples of the present invention, the height 300 of the leg is in the range of 4-30 mm, 6-25 mm, or 8-22 mm (FIG 3). The height 300 of the leg is measured as shown in FIG 3.

In one embodiment of the staples of the present invention, the cross-sectional shape of the bridge is a square, rhombus, pentagon, hexagon, heptagon, octagon, trapezium. In another embodiment, the cross-sectional shape of the bridge is a pentagon, hexagon, heptagon, octagon, trapezium.

In one embodiment of the staples of the present invention, the cross-sectional shape of the leg is a square, pentagon, hexagon, heptagon, octagon, trapezium in another embodiment, the cross-sectional shape of the leg is a pentagon, hexagon, heptagon, octagon, trapezium.

In one embodiment of the staples of the present invention, the outer radius of curvature of the shoulder is in the range of 1 - 10 mm, 1.5 - 5 mm, or 2.3 -3.5 mm.

In one embodiment of the staples of the present invention, the inner radius of curvature of the shoulder is in the range of 1 - 10 mm, 1.2 - 5 mm, or 1.5 - 2.3 mm.

In one embodiment of the staples of the present invention, the outer radius of curvature of the shoulder is greater than the inner radius of curvature.

In one embodiment of the staples of the present invention, the ratio of outer radius of curvature to the inner radius of curvature i s 10 : 1 , 5 : 1 , or 2: 1.

In one embodiment of the staples of the present invention, the tip of the leg is tapered. In one embodiment, the tip is in the height range of 0.1 - 5 mm, 0.2 - 3 mm, or 0.3 - 1.9 mm.

In one embodiment of the staples of the present invention, the leg is partially tapered. In one embodiment, the tapered height is preferably 1 - 10 mm, 1 - 5 mm, or 1 - 3mm. In one embodiment the partial tapering of the leg does not include the tip of the leg.

Preferably, the cross-sectional area in the tapered section is reduced by 0.1% to 70%, 5% to 50%, or 10 to 30%.

In one embodiment of the staples of the present invention, the legs optionally have teeth or barbs to improve the bone purchase of the staple on the bone. In one embodiment of the staples of the present invention, the teeth or barbs are around the entire circumference of the leg. In another embodiment of the staples of the present invention, the teeth or barbs are on the inner and outer sides of leg. In another embodiment of the staples of the present invention, the teeth or barbs are only on inner side of leg. In one embodiment, the height 700 of the teeth or barbs is in the range of 0.05 - 3 mm, 0.1-2 mm, or 0.2-0.4 mm. The height 700 is measured as shown in FIG 7.

In one embodiment of the staples of the present invention, the length 701 of the teeth or barbs is 0 - 20 mm, or 1 - 10 mm. The length 701 is measure as shown in FIG 7.

Bioabsorbable Polymers

In one embodiment of the present invention, the biodegradable composite comprises a bioabsorbable polymer.

The medical implant described herein may be made from any biodegradable polymer. The biodegradable polymer may be a homopolymer or a copolymer, including random copolymer, block copolymer, or graft copolymer. The biodegradable polymer may be a linear polymer, a branched polymer, or a dendrimer. The biodegradable polymers may be of natural or synthetic origin. Examples of suitable biodegradable polymers include, but are not limited to polymers such as those made from lactide, glycolide, caprolactone, valerolactone, carbonates (e.g., trimethylene carbonate, tetramethylene carbonate, and the like), dioxanones (e.g., 1,4- dioxanone), 6-valerolactone, l,dioxepanones )e.g., 1,4-dioxepan -2-one and l,5-dioxepan-2- one), ethylene glycol, ethylene oxide, esteramides, y-ydroxyvalerate, P-hydroxypropionate, alpha-hydroxy acid, hydroxybuterates, poly (ortho esters), hydroxy alkanoates, tyrosine carbonates , polyimide carbonates, polyimino carbonates such as poly (bisphenol A- iminocarbonate) and poly (hydroquinoneiminocarbonate, (polyurethanes, polyanhydrides, polymer drugs (e.g., polydiflunisol, 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.

According to the present invention, the biodegradable polymer may be a copolymer or terpolymer, for example: polylactides (PLA), poly-L-lactide (PLLA), poly-DL-lactide (PDLLA), poly-LD-lactide (PLDLA); polyglycolide (PGA); copolymers of glycolide, glycolide/trimethylene carbonate copolymers (PGA/TMC); other copolymers of PLA, such as lactide/tetramethylglycolide copolymers, lactide/trimethylene carbonate copolymers, lactide/d-valerolactone copolymers, lactide/a-caprolactone copolymers, L-lactide/DL-lactide copolymers, glycolide/Llactide copolymers (PGA/PLLA), polylactide-co-glycolide; terpolymers of PLA, such as lactide/glycolide/trimethylene carbonate terpolymers, lactide/glycolide/ a caprolactone terpolymers, PLA/polyethylene oxide copolymers; polydepsipeptides; unsymmetrically - 3,6-substituted poly-I ,4-dioxane-2, 5-diones; polyhydroxyalkanoates; such as polyhydroxybutyrates (PHB); PHB/bhydroxyvalerate copolymers (PHB/PHV); poly-b-hydroxypropionate (PHP A); poly-pdioxanone (PDS); poly-d- valerolactone - poly-s-capralactone, poly(s-caprolactoneDL-lactide) copolymers; methylmethacrylate-N-vinyl pyrrolidone copolymers; polyesteramides; polyesters of oxalic acid; polydihydropyrans; polyalkyl-2-cyanoacrylates; polyurethanes (PU); polyvinylalcohol (PV A); polypeptides; poly-b-malic acid (PMLA): poly-b-alkanbic acids; polycarbonates; polyorthoesters; polyphosphates; poly(ester anhydrides); and mixtures thereof; and natural polymers, such as sugars; starch, cellulose and cellulose derivatives, polysaccharides, collagen, chitosan, fibrin, hyalyronic acid, polypeptides and proteins. Mixtures of any of the above- mentioned polymers and their various forms may also be used.

Preferably polymer is PLDLA and ratio of L isomer to D isomer is in the range of 60:40, L:D to 99: 1, L:D, and more preferably, the ratio is between 70:30 and 96:4.

Reinforced Bioabsorbable Polymers

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 previously described polymer and also incorporates a reinforcing filler, generally in fiber form, to increase the mechanical strength of the polymer).

In a more preferred embodiment of the present invention, the reinforced bioabsorbable polymer is a reinforced polymer composition comprised of any of the above-mentioned bioabsorbable polymers and a reinforcing filler, preferably in fiber form. The reinforcing filler may be comprised of organic or inorganic (that is, natural or synthetic) material. Reinforcing filler may be a biodegradable glass, a cellulosic material, a nano-diamond, or any other filler known in the art to increase the mechanical properties of a bioabsorbable polymer. The filler is preferably made from a material or class of material other than the bioabsorbable polymer itself. However, it may also optionally be a fiber of a bioabsorbable polymer itself.

Numerous examples of such reinforced polymer compositions have previously been documented. For example: A biocompatible and resorbable melt derived glass composition where glass fibers can be embedded in a continuous polymer matrix (EP 2 243 749 Al), Biodegradable composite comprising a biodegradable polymer and 20-70 vol% glass fibers (W02010128039 Al), Resorbable and biocompatible fiber glass that can be embedded in polymer matrix (US 2012/0040002 Al), Biocompatible composite and its use (US 2012/0040015 Al), Absorbable polymer containing polyfsuccinimide] as a filler (EP0 671177 Bl).

In a more preferred embodiment of the present invention, the reinforcing filler is bound to the bioabsorbable polymer such that the reinforcing effect is maintained for an extended period. Such an approach has been described in US 2012/0040002 Al and EP 2243500B1, which discusses a composite material comprising biocompatible glass, a biocompatible matrix polymer and a coupling agent capable of forming covalent bonds.

Preferably, a sizer or compatibilizer is included in the biocomposite implant composition to increase the bond between the polymer and the fiber. Preferably, such compatibilizer or sizer makes up <1 % of the overall implant composition by weight and/or by volume. Preferably, such compatibilizer or sizer makes up <0.5% but weight and/or by volume. Most preferably, such compatibilizer or sizer makes up <0.3% by weight and/or by volume.

Preferably, the majority of said compatibilizer or sizer is comprised of a bioabsorbable polymer selected from above-mentioned list of absorbable polymers. Preferably, the polymer within the sizer is of a different composition, intrinsic viscosity, or average molecular weight than the bioabsorbable polymer comprising the polymeric structural component of the implant. Such a compatibilizer is preferably a lower molecular weight (shorter chain) than the polymeric structural component of the implant. Non-limiting examples of such a compatibilizer are given in W02010122098, hereby incorporated by reference as if fully set forth herein. For example, optionally the compatibilizer comprises a polymer wherein at least 10% of the structural units of the compatibilizer are identical to the structural units of the structural polymer, and the molecular weight of the compatibilizer is less than 30000 g/mol. Optionally, at least 30 % of the structural units of the compatibilizer are identical to the structural units of the structural polymer and the molecular weight of the compatibilizer is less than 10000 g/mol. More preferably the molecular weight of the compatibilizer is less than 10000 g/mol. Alternatively, 0% of the structural units of the compatibilizer are identical to the structural units of the structural polymer.

The biodegradable composite is preferably embodied in a polymer matrix, which may optionally comprise any of the above polymers. Optionally and preferably, it may comprise a polymer selected from the group consisting of PLLA (poly-L-lactide), PDLLA (poly-DL- lactide), PLDLA, PGA (poly-glycolic acid), PLGA (polylactide-glycolic acid), PCL (Polycaprolactone), PLLA-PCL and a combination thereof. If PLLA is used, the matrix preferably comprises at least 30% PLLA, more preferably 50%, and most preferably at least 70% PLLA. If PLDLA is used, the matrix preferably comprises at least 5% PLDLA, more preferably at least 10%, most preferably at least 20% PLDLA.

Preferably, the inherent viscosity (IV) of the polymer matrix (independent of the reinforcement fiber) 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. Inherent 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 the 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 - 400 kDa. More preferably, the average molecular weight is in the range of 120 kDa - 250 kDa. Most preferably, the average molecular weight is in the range of 150 kDa - 250 kDa.

Reinforcement Fiber

The reinforcing filler in the staples of the present invention may be comprised of organic or inorganic (that is, natural or synthetic) material. Reinforcing filler may be a biodegradable glass, a cellulosic material, a nano-diamond, or any other filler known in the art to increase the mechanical properties of a bioabsorbable polymer. The filler is preferably made from a material or class of material other than the bioabsorbable polymer itself. However, it may also optionally be a fiber of a bioabsorbable polymer itself. Numerous examples of such reinforced polymer compositions have previously been documented. For example: A biocompatible and resorbable melt derived glass composition where glass fibers can be embedded in a continuous polymer matrix (EP 2 243 749 Al), Biodegradable composite comprising a biodegradable polymer and 20-70 vol% glass fibers (W02010128039 Al), Resorbable and biocompatible fiber glass that can be embedded in polymer matrix (US 2012/0040002 Al), Biocompatible composite and its use (US 2012/0040015 Al), Absorbable polymer containing polyfsuccinimide] as a filler (EP0 671177 Bl).

In one embodiment of the present invention, the reinforcing filler is bound to the bioabsorbable polymer such that the reinforcing effect is maintained for an extended period. Such an approach has been described in US 2012/0040002 Al and EP 2243500B1, which discusses a composite material comprising biocompatible glass, a biocompatible matrix polymer and a coupling agent capable of forming covalent bonds.

In one embodiment of the present invention, the biodegradable composite and fibers are preferably arranged in the form of biodegradable composite fiber bundles, where each bundle comprises unidirectionally aligned continuous reinforcement fibers embedded in a polymer matrix comprised of one or more bioabsorbable polymers, see for example WO 2019/123462 the entire content of which are incorporated herein by reference.

In one embodiment, the reinforcement fiber is comprised of silica-based mineral compound such that reinforcement fiber comprises a bioresorbable glass fiber, which can also be termed a bioglass fiber composite.

Bioresorbable mineral fiber may optionally have oxide compositions in the following mol. % ranges:

Na₂O: 10.0 - 19.0 mol. %

CaO: 9.0-14.0mol%

MgO: 1.5 - 8.0 mol. %

B2O3: 0.5 - 3.0 mol. %

AhCh: 0 - 0.8 mol. %

P2O3: 0.1 -0.8 mol.%

SiO₂: 67 - 73 mol. %

And more preferably in the following mol. % ranges:

Na2O: 11.5 - 13.0 mol. %

CaO: 9.0 - 10.0 mol. %

MgO: 7.0- 8.0 mol.%

B2O3: 1.4 - 2.0 mol. %

P2O3: 0.5 - 0.8 mol. %

SiO₂: 67 - 70 mol. %

K2O: 0 - 0.4 mol. %

Alternatively, above mineral composition ranges are applicable as weight% (w/w) rather than as mol%.

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

Additional optional bioresorbable glass compositions are described in the following patent applications, which are hereby incorporated by reference as if fully set forth herein: Biocompatible composite and its use (W02010122098); and Resorbable and biocompatible fiber glass compositions and their uses (W02010122019).

In one embodiment of the preset invention, the fibers are continuous fibers. “Continuous fibers” as used herein are single uninterrupted fibers that extend continuously through a specific length of the implant. These fibers can be of any length that is longer than a nominal particle but generally would be a length greater than 1 mm, 3 mm, or 5 mm. The length of a continuous fiber can also be defined in context of geometric features of the specific type of implant, as described below specific to the staple: for example, “full length fibers”, “shoulder length fibers” or “bridge length fibers”. As used herein, "plurality” is more than one fiber of the same or similar orientation. In one embodiment the plurality of fibers are of the same or similar length. In one embodiment, pluralities of fibers form at least 10%, 20 or 30% of the overall number of fibers in a particular cross-section of the staples of the present invention.

In one embodiment of the staples of the present invention, fibers run along the entire span 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 to 90%, 30-80%, or 50 to 75% of fibers are aligned along the entire span of the staple

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

In one embodiment of the staples of the present invention, the number of fibers running through a cross-sectional area of the bridge is in the range of 1K-200K, 5K-150K, or 9K-110K.

In one embodiment of the staples of the present invention, the number of fibers aligned along a vertical axis “x” (height, 400 see FIG 4) of the bridge of the staple is in the range of 30-600, 60-400, or 80-240.

In one embodiment of the staples of the present invention, the number of fibers aligned along a horizontal axis “y” (width, 401 see FIG 4) of the bridge of the staple is in the range of 50- 1000, 100-700, or 150-480.

In one embodiment of the staples of the present invention, the number of fibers running across a cross-sectional area of a leg of the staple is in the range of 1-150K, 5k-100K, or 7k-70K.

In one embodiment of the staples of the present invention, the number of fibers aligned along a second horizontal axis “x^A” (length, 402 see FIG 4) of the leg of the staple is in the range of 40-800, 70-500, or 100-300.

In one embodiment of the staples of the present invention, the number of fibers aligned along a horizontal axis “y” (width, 403 see FIG 4) of the leg of the staple is in the range of 40-700, 70-400, or 90-230.

In one embodiment of the staples of the present invention, there are pluralities of fibers of at least two different lengths running partially or completely along the entire span of the staple. In one embodiment of the staples of the present invention, the ratio of numbers 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. In one embodiment of the staples of the present invention, the weight % ratio of fiber content of one fiber length to the fiber content of a second length is in the range of 20: 1 to 1 : 1, or 10: 1 to 1.5: 1, or 5: 1 to 2: 1.

In one embodiment of the staples of the present invention, the fibers are “full length fibers” which run completely along the entire span of the staple. In one embodiment of the staples of the present invention, for the full-length fibers “completely” means they run along 100%, at least 99%, at least 98%, at least 95% or at least 90% of the entire span of the staple.

In one embodiment of the staples of the present invention, the fibers are “shoulder length fibers” which run across the bridge of the staple and extend past the shoulders of the staple at each side of the staple and run into the leg of the stable, but do not extend completely along the entire span staple. In one embodiment, the shoulder length 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 past the end of the shoulder. In one embodiment, the shoulder length fibers extend partially along the entire span of the staple.

In one embodiment of the staples of the present invention, the fibers are “bridge length fibers” which run across the bridge of the staple but do not extend past the end of shoulders 201. In one embodiment, the bridge length fibers do not extend past the start of the shoulder 200 (FIG 2).

In one embodiment of the staples of the present invention, fibers are “mid-length fibers” which run from the tip of the staple leg past the shoulder and into the bridge of the staple. In one embodiment the mid-length fibers run from the tip of the stable leg past the shoulder and 10%, 20%, 30%, 40% or 50% of the length of the bridge.

In one embodiment of the staples of the present invention, the fibers are “leg length fibers” which run from the tip of the staple leg through the top of the staple leg and extends past the shoulder into the bridge. In one embodiment, the leg length fibers do not extend past the start of the shoulder 200. In one embodiment, the leg length fibers do not extend past the end of the shoulder 201 (FIG 2).

In one embodiment of the staples of the present invention, the staple is comprised of a plurality of full length fibers and a plurality of shoulder length fibers.

In one embodiment of the staples of the present invention, the ratio between full length fibers and shoulder length fibers is 10: 1 to 1 : 1, 4: 1 to 1: 1, or 2.5: 1 to 1.5: 1.

In one embodiment of the staples of the present invention, the length of the full length fibers is in the range of 10-200 mm, 20-150 mm, or 25-70 mm. In one embodiment of the staples of the present invention, the length of the shoulder length fibers is in the range of 8-150 mm, 10-80 mm, or 15-32 mm.

In one embodiment of the staples 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.

In one embodiment of the present invention, the weight % fiber content of the bridge is equivalent to the weight % fiber content of the leg. In one embodiment, the weight% fiber content of the bridge and leg is in the range of 30-70%, 40-60%, or 45-50%.

In one embodiment of the present invention, the ratio of number of fibers in the bridge to number of fibers in the leg is in the range of 1 : 1 - 20: 1, more preferably 1.1 : 1 - 10: 1, most 1.2: 1 -5: 1.

In one embodiment of the staples of the present invention, an average diameter of reinforcing fiber is in the range of 0.1-100 pm, 1-20 pm, or 8-18 pm.

In one embodiment of the staples of the present invention, the density of the biocomposite composition between 1 to 2 g/mL, 1.2 to 1.9 g/mL, or 1.4 to 1.8 g/mL.

Optional Additional Features

The below features and embodiments may optionally be combined with any of the above features and embodiments.

Tensile strength of the reinforcement fiber is preferably in the range of 1200-2800 MPa, more preferably in the range of 1600-2400 MPa, and most preferably in the range of 1800-2200 MPa. Elastic modulus of the reinforcement fiber is preferably in the range of 30-100 GPa, more preferably in the range of 50-80 GPa, and most preferably in the range of 60-70 GPa.

Optionally, a majority of reinforcement fibers aligned to the longitudinal axis of the medical implant are of a length of at least 50% of the total length of the implant, preferably at least 60%, more preferably at least 75%, and most preferably at least 85%.

Production Method

Continuous-fiber reinforced bioabsorbable implants of the present invention may optionally be produced using any method known in the art such as WO2016/035088, WO2016/035089, W02016/103049, WO2017155956, WO2018/002917, WO2019/049062, and

WO2019/123462 the entire contents of each of which are incorporated herein by reference in their entirety.

In one embodiment the staples of the present invention are produced using manufacturing method that subjects implant to compressive pressure, such as compression molding. Preferably, moisture content of implant following molding is less than 30%, more preferably less than 20%, even more preferably less than 10%, 8%, 6%, 5%.

Fabrication of the Implant

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

Load-bearing mechanical strength

The present invention particularly relates to bioabsorbable composite materials that can be used in medical applications that require high strength and a stiffness compared to the stiffness of bone. These medical applications require the medical implant to bear all or part of the load applied by or to the body and can therefore be referred to generally as "load-bearing" applications. These include fracture fixation, tendon reattachment, joint replacement, spinal fixation, and spinal cages.

The flexural strength preferred from the herein described load-bearing medical implant is at least 200 MPa, preferably above 400 MPa, more preferably above 600 MPa, and even more preferably above 800 MPa. The Elastic Modulus (or Young's Modulus) of the bioabsorbable composite for use with the present invention is preferably at least 5 GPa, more preferably above 10 GPa, and even more preferably above 15 GPa, 20 GPa but not exceeding 100 GPa and preferably not exceeding 60 GPa.

Sustained mechanical strength

There is a need for the bioabsorbable load-bearing medical implants of the present invention to maintain their mechanical properties (high strength and stiffness) for an extended period to allow for sufficient bone healing. The strength and stiffness preferably remain above the strength and stiffness of cortical bone, approximately 150-250 MPa and 15-25 GPa respectively, for a period of at least 3 months, preferably at least 6 months, and even more preferably for at least 9 months in vivo (i.e. in a physiological environment).

More preferably, the flexural strength remains above 400 MPa and even more preferably remains above 600 MPa.

In another embodiment of the present invention, the mechanical strength degradation rate of the coated medical implant approximates the material degradation rate of the implant, as measured by weight loss of the biodegradable composite. In a preferred embodiment, the implant retains greater than 50% of its mechanical strength after 3 months of implantation while greater than 50% of material degradation and hence weight loss occurs within 12 months of implantation.

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

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

In a preferred embodiment, the implant retains greater than 70% of its mechanical strength after 6 months of implantation while greater than 70% of material degradation and hence weight loss occurs within 9 months of implantation.

The mechanical strength degradation and material degradation (weight loss) rates of the medical implant can be measured after in vivo implantation or after in vitro simulated implantation. In the case of in vitro simulated implantation, the simulation may be performed in real time or according to accelerated degradation standards.

Methods of use

In one embodiment the present invention is the method of use of the staples described herein for fixating bone or tissue in a patient in need thereof. In one embodiment of the methods of the present invention, the staple is opened prior to insertion by spreading the legs from the natural closed position to position approximating 90 degrees angle between legs and the bridge. In one embodiment of the staples of the present invention, an insertion device (FIG 14) is used to spread staple legs prior to insertion. In one embodiment, the insertion device locks its position at a specific opening amount of the staple. In one embodiment, the insertion device is used as a tamp to tamp staple into position. In one embodiment, the insertion device includes one or more measuring templates.

In one embodiment in the methods of use of the staples of the present invention, a staple is mounted onto the inserter teeth when inserter handle is open (FIG 15). Once the staple is mounted, inserter handle is closed such that inserter teeth exercise outward force on the staple legs, spreading the staple legs to an angle approximating 90 degrees with staple bridge. When handle is closed and staple legs are spread, the latch on one side of the handle locks onto an inner cavity in the second side of the handle. The position of the inserter is then locked. The staple can then be inserted by inserting or tamping staple downwards into pre-drilled holes. Once the staple has been inserted in the holes, the latch on the inserter is lifted, releasing the inserter handle and allowing the inserter teeth to move inwards from the staple legs, and thereafter be removed easily from under the staple bridge.

In one embodiment in the methods of use of the staples of the present invention, following removal of the staple insertion device, the staple may be subsequently tamped further into place using a separate tamp (FIG 16) or the inserter itself.

In one embodiment in the methods of use of the staples of the present invention, prior to insertion of the staple, a drill guide (FIG 17) may be used to allow for drilling of appropriately positioned holes for insertion of the staple.

In one embodiment in the methods of use of the staples of the present invention, additional locating pins may be used to hold the position of the holes while drilling is occurring or after drill guide is removed.

In one embodiment in the methods of use of the staples of the present invention, drill hole size is in the range of 1.5 - 4 mm, 2 - 3 mm, or 2.3 - 2.7 mm.

In one embodiment in the methods of use of the staples of the present invention, drill hole depth exceeds length of staple leg. In one embodiment in the methods of use of the staples of the present invention, drill hole depth is at least 5 mm, 2 mm, or 1mm

In one embodiment in the methods of use of the staples of the present invention, a drill bit for use with staple includes drill depth lines.

EXAMPLES

Example 1 - Continuous Fiber-Reinforced Staple with Multiple Fiber Lengths

This example demonstrates how continuous fiber-reinforced compression staples manufactured from continuous fibers of different lengths can have different performance properties with regard to flexural stiffness and peak load, relating to the fiber length and orientation of each type of staple.

Materials & Methods

Five types of staple implants, each of bridge length 25 mm and of leg length 15mm were produced using reinforced composite material. The cross-sectional area of the staple bridges was 10.6 while the cross-sectional area of the staple legs was 5.9. Material composite was comprised of PLDLA 70/30 polymer reinforced with 45-50%~50% w/w continuous mineral fibers. Mineral fibers composition was approximately Na2O 14%, MgO 5.4%, CaO 9%, B2O3 2.3%, P2O5 1.5%, and SiCh 67.8% w/w. Testing samples were manufactured by compression moulding of composite material strips into a staple shaped mold. Each strip was comprised of the PLDLA polymer with embedded uni-directionally aligned continuous fibers. There were full length strips (comprised of full length mineral fibers) and shoulder length strips (comprised of shoulder length mineral fibers). The full length fibers were approximately 51mm in length while the shoulder length fibers were approximately 33mm in length. There were also bridge length strips and tip of leg to middle of bridge length strips. The bridge length strips were approximately 23mm in length and the tip of leg to middle of bridge length strips were approximately 25mm in length. All fibers were aligned in the axis of the staple. Each strip was approximately 0.18 mm thick. Four staple samples were produced and tested for each staple group.

Implant samples were tested in a tensile testing system (MTS Criterion Machine, MN, USA) for stiffness and maximum flexural load according to modified standard test method, ASTM F564-17 (Standard Test Methods for Metallic Bone Staples, ASTM International, PA, USA). Mechanical testing was performed using a 500N load cell and an appropriate fixture for Static Bending testing. Sample span was 40 between the upper pins and 120 between the lower pins mm at the beginning of the test and cross head speed was set at 25.4 mm/min. Dimensions, weight and density of samples were recorded.

Results

TABLE 1 A: Mean values and standard deviations of the mechanical properties of the implants (n=4).

Table 1 A shows the mechanical performance results of implant staples made from five different configurations of fiber lengths.

As can be seen in Table 1A, the mechanical properties of continuous fiber-reinforced staples produced from pluralities of different continuous fiber lengths can be superior (as in group 1.1 and group 1.4) to the mechanical properties of continuous fiber-reinforced staples produced entirely from one fiber length, even when that fiber length is the full length of the implant (group 1.2). Furthermore, the specific configuration of group 1.1 (-50% full length fibers / 50% shoulder length fibers) is superior to other configurations of fiber lengths.

Example 2 - Fiber Content for Continuous Fiber-Reinforced Staple

Materials & Methods

Staples with bridge length of 20mm and leg length of 22mm from group 1.1 in Example 1 were prepared as described in above example.

The cross-sectional area of the staple bridges was 10.6 mm² while the cross-sectional area of the staple legs was 5.9 mm².

The mineral fiber content of each of the bridge and the legs were analysed separately using the loss on ignition testing method as follows: A muffle furnace was set to 600°C. Empty crucibles are heated at 600 °C for 30 min. Then crucibles were cooled to room temperature (at least for 30 minutes) in a desiccator. Empty crucibles were then weighed. lg-2g of the sample (either staple bridge or staple leg) were then added to the crucible and the sample + crucible were then weighed.

Crucibles containing the samples were placed into the muffle furnace heated to 600 °C. This temperature was maintained for a minimum 3 hours until all the carbonaceous material disappeared. This can be confirmed visually. If black or grey residues are present in the crucibles, burning was continued.

Crucibles were then removed from the muffle furnace and placed into the desiccator and cooled down to ambient temperature for at least 1 hour. The sample + crucible was then weighted again.

The ignition loss of weight in percent as follows:

Mineral fiber content =

where

W1 = mass of test sample (g)

W2 = mass of crucible and the residue together (g)

WC = mass of the empty crucible (g)

Results

Staple Bridge

Staple Legs

The average mineral fiber content for the staple bridge samples was 48.8 ± 0.2 while the average mineral fiber content for the staple leg samples was 49.8 ± 0.6. These values are very similar and statistically indistinguishable. Despite the different cross-section areas of the legs and bridge, the mineral content in each of the bridge and legs were essentially the same.

It will be appreciated that various features of the invention which are, for clarity, described in the contexts 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. It will also be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the invention is defined only by the claims which follow.

Claims

WHAT IS CLAIMED IS:

1. An orthopaedic staple, comprising a biocomposite composition which comprises a bioabsorbable polymer and reinforcing mineral fiber; wherein the staple further comprises a bridge section attached to two or more shoulder sections, each of which is attached to a leg section, wherein the mineral fibers are of at least two different lengths.

2. The orthopaedic staple of Claim 1, wherein one length fibers are full length fibers, which are 100%, at least 99%, at least 98%, at least 95% or at least 90% of the entire span of the staple.

3. The orthopaedic staple of Claim 1, wherein one length fibers are shoulder length fibers which run across the bridge of the staple and extend past the shoulders of the staple at each side of the staple and run into the leg of the stable.

4. The orthopaedic staple of Claim 1, wherein one length fibers are shoulder length fibers which 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 into the leg.

5. The orthopaedic staple of Claim 1, wherein one length fibers are bridge length fibers which run across the bridge of the staple into the shoulder but do not extend into the leg.

6. The orthopaedic staple of Claim 1, wherein one length fibers are bridge length fibers which run across the bridge of the staple but do not extend into the shoulder.

7. The orthopaedic staple of Claim 1, wherein one length fibers are mid-length fibers which run from the tip of the leg past the shoulder to the middle of the staple bridge.

8. The orthopaedic staple of Claim 1, wherein one length fibers are leg length fibers which run from the tip of the leg past into the shoulder but do not extend past the start of the shoulder. The orthopaedic staple of any one of Claims 2-4, wherein the fibers are comprised of one length of full length fibers and a second length of shoulder length fibers. The orthopaedic staple of any one of Claims 2 or 5-6, wherein the fibers are comprised of a one length full length fibers and a second length of bridge length fibers. The orthopaedic staple of any of Claims 5-6 or 8, wherein the fibers are comprised of one length of bridge length fibers and a second length of leg length fibers. The orthopaedic staple of any of the above claims, wherein the ratio of numbers 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. The orthopaedic staple of any of the above claims, wherein the ratio of the width of the bridge to the height of the bridge is in the range of 8: 1 to 2: 1. The orthopaedic staple of any of the above claims, wherein the width of the bridge is in the range of 1-10 mm, 2-7 mm, or 3.2-4.8 mm. The orthopaedic staple of any of the above claims, wherein the height of the bridge is in the range of 1-8 mm, 1.5-4 mm, or 1.8-2.4 mm. The orthopaedic staple of any of the above claims, wherein the width of the bridge is greater than the width of the legs by at least 2%, 5%, 10%, 15%, 20%, 30% or 50%. The orthopaedic staple of any of the above claims, wherein the width of a leg is in the range of 1-8 mm, 1.5-5mm, orl.8-2.3 mm. The orthopaedic staple of any of the above claims, wherein the length of the leg is in the range of 5-35 mm, 7-30 mm, or 9-25mm. The orthopaedic staple of any of the above claims, wherein the cross-sectional area of the bridge is in the range of 1-20 mm², 3-15 mm², or 5.3-10.6 mm². The orthopaedic staple of any of the above claims, wherein the cross-sectional area of the leg is in the range of 1-10 mm², 2-8mm², or 3.1-5.9 mm². The orthopaedic staple of any of the above claims, wherein the ratio of cross-sectional area of the bridge to cross-sectional area of the leg is 10: 1, 5:2, or 3.4:0.9. The orthopaedic staple of any of the above claims, wherein the ratio of number of fibers in the bridge to number of fibers in the leg is in the range of 1 : 1 - 20: 1, 1.1 :1 - 10: 1, or 1.2: 1 -5: 1. The orthopaedic staple of any of the above claims, wherein the cross-sectional shape of the bridge is a pentagon, hexagon, heptagon, octagon, or trapezium. The orthopaedic staple of any of the above claims, wherein the cross-sectional shape of the leg is a pentagon, hexagon, heptagon, octagon, or trapezium. The orthopaedic staple of any of the above claims, wherein the staple further comprises teeth are around the entire circumference of the leg. The orthopaedic staple of any of the above claims, wherein the staple further comprises teeth on the inner and outer side of the leg. The orthopaedic staple of any of the above claims, wherein the staple further comprises teeth on inner side of the leg. The orthopaedic staple of any of the above claims, wherein said bioabsorbable polymer comprises a homopolymer or a copolymer; wherein said copolymer comprises a random copolymer, block copolymer, or graft copolymer; wherein said polymer comprises a linear polymer, a branched polymer, or a dendrimer, of natural or synthetic origin; wherein said polymer comprises lactide, glycolide, caprolactone, valerolactone, carbonates (e.g., trimethylene carbonate, tetramethylene carbonate, and the like), dioxanones (e.g., 1,4-dioxanone), 8 -valerolactone, l,dioxepanones )e.g., 1,4-dioxepan- 2-one and l,5-dioxepan-2-one), ethylene glycol, ethylene oxide, esteramides, y- ydroxyvalerate, —hydroxypropionate, alpha-hydroxy acid, hydroxybuterates, poly

T1 (ortho esters), hydroxy alkanoates, tyrosine carbonates, polyimide carbonates, polyimino carbonates such as poly (bisphenol Aiminocarbonate) and poly (hydroquinone-iminocarbonate,(pol yurethanes, polyanhydrides, polymer drugs (e.g., polydiflunisol, polyaspirin, and protein therapeutics), sugars; starch, cellulose and cellulose derivatives, polysaccharides, collagen, chitosan, fibrin, hyaluronic acid, polypeptides, proteins, poly (amino acids), polylactides (PLA), poly-L-lactide (PLLA), poly-DL-lactide (PDLLA); polyglycolide (PGA); copolymers of glycolide, glycolide/trimethylene carbonate copolymers (PGA/TMC); other copolymers of PLA, such as lactide/tetramethylglycolide copolymers, lactide/trimethylene carbonate copolymers, lactide/d- valerolactone copolymers, lactide/£-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/poly ethylene oxide copolymers; polydepsipeptides; unsymmetrically 3,6- substituted poly-I ,4-dioxane-2, 5-diones; polyhydroxyalkanoates; such as polyhydroxybutyrates (PHB); PHB/bhydroxyvalerate copolymers (PHB/PHV); poly-b- hydroxypropionate (PHP A); poly-p-dioxanone (PDS); poly-d-valerolactone - poly-c:- capralactone, poly(c:caprolactone- D L-lactide) copolymers; methylmethacrylate-N- vinyl pyrrolidone copolymers; polyesteramides; polyesters of oxalic acid; polydihydropyrans; polyalkyl-2-cyanoacrylates; polyurethanes (PU); polyvinylalcohol (PV A); polypeptides; poly-b-malic acid (PMLA): poly-b-alkanbic acids; polycarbonates; polyorthoesters; polyphosphates; poly(ester anhydrides); and mixtures thereof; and derivatives, copolymers and mixtures thereof. The orthopaedic staple of any of the above claims, wherein the ioabsorbable polymer is in a form of a polymer matrix; wherein said polymer matrix comprises 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 a combination thereof. The orthopaedic staple of any of the above claims, wherein if PLLA is used, the matrix comprises at least 30% 50%, or at least 70% PLLA. The orthopaedic staple of any of the above claims, wherein if PLDLA is used, the matrix comprises at least 5%, at least 10%, or at least 20% PLDLA. The orthopaedic staple of any of the above claims, wherein said reinforcing mineral fiber comprises ranges of the following elements:

Na₂O: 11.0 - 19.0 mol. %;

CaO: 8.0- 14.0 mol. %;

MgO: 2 - 8.0 mol. %;

B2O3: 1 - 3.0 mol. %;

AI2O3: 0-0.5 mol. %;

P2O3: 1-2 mol. %; and

SiO₂: 66 - 70 mol %. The orthopaedic staple of any of the above claims, wherein the mineral content within the staple is in the range of 40%-60% w/w. The orthopaedic staple of any of the above claims, wherein the mineral content within the staple is in the range of 45%-55% w/w. The orthopaedic staple of any of the above claims, wherein the mineral content within the staple is in the range of 40%-70% w/w. The orthopaedic staple of any of the above claims, wherein the density of the biocomposite composition is between 1 to 2 g/mL. The orthopaedic staple of any of the above claims, wherein the density of the biocomposite composition is between 1.2 to 1.9 g/mL. The orthopaedic staple of any of the above claims, wherein the density of the biocomposite composition is between 1.4 to 1.8 g/mL. The orthopaedic staple of any of the above claims, wherein an average diameter of the reinforcing mineral fiber is in the range of 0.1-100 pm. The orthopaedic staple of any of the above claims, wherein an average diameter of the reinforcing mineral fiber is in the range of 1-20 pm. The orthopaedic staple of any of the above claims, wherein an average diameter of the reinforcing mineral fiber is in the range of 4-16 pm. The orthopaedic staple of any of the above claims, wherein an average diameter of the reinforcing mineral fiber is in the range of 9-14 pm.