# US 10,926,004 B2 · Continuous-fiber reinforced biocomposite medical implants

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- Number: US 10,926,004 B2
- Document ID: US10926004B2
- Status: Granted
- Kind: B2
- Application number: 15/523,389
- Filed: 2015-12-28
- Published: 2017-08-31
- Granted: 2021-02-23
- Earliest claimed: 2014-12-26
- Assignees: Ossio, Ltd.
- Applicants: Ossio Ltd
- Inventors: Orahn Preiss-Bloom; Taly Pnina Lindner; Eyal Epstein; Danielle Poreh
- Web page: https://patentgrep.com/patent/US10926004B2

## CPC

- A61L 31/128: {containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127}
- A61B 17/864: {hollow, e.g. with socket or cannulated}
- A61B 17/866: {Material or manufacture}
- A61F 2/4455: {for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages (intervertebral discs A61F2/442)}
- A61F 2/447: {substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section}
- A61L 27/446: {with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46}
- A61L 27/58: Materials at least partially resorbable by the body
- A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)}
- A61L 31/08: Materials for coatings
- A61L 31/148: {Materials at least partially resorbable by the body}
- A61F 2002/30062: {(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive}
- A61F 2002/30593: {hollow}
- A61F 2002/4495: {having a fabric structure, e.g. made from wires or fibres}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

A medical implant comprising a plurality of biocomposite layers, each layer comprising a polymer and a plurality of uni-directionally aligned continuous reinforcement fibers. The medical implant is suitable for load-bearing orthopedic implant applications and comprises one or more biocomposite materials where sustained mechanical strength and stiffness are critical for proper implant function.

## Claims

### Claim 1

A medical implant comprising a plurality of biocomposite layers, said biocomposite comprising a polymer and a plurality of continuous reinforcement fibers, such that each layer comprises said biocomposite, wherein said fibers are unidirectionally aligned within each layer, wherein a diameter of said fibers is in a range of 0.1-100 μm; wherein said implant is bioabsorbable and said polymer is biodegradable; wherein a distance between layers, as determined by a distance between a last fiber in one layer and a first fiber in an adjacent layer, is between 0-60 μm; and wherein the density of the biocomposite is between 1 to 2 g/mL.

### Claim 2 (depends on 1)

The implant of claim 1, wherein each layer has a directional fiber orientation, and wherein said fiber orientation alternates between adjacent layers such that each adjacent layer is of a different angle, and wherein said angle difference between layers is between 15 to 75 degrees; between 30 to 60 degrees; or between 40 to 50 degrees.

### Claim 3 (depends on 1)

The implant of claim 1, wherein said diameter of said fibers is in the range of 1-20 μm; 4-16 μm; 6-20 μm; 10-18 μm; or 14-16 μm; optionally wherein a standard deviation of fiber diameter between fibers is less than 5 μm; less than 3 μm; or less than 1.5 μm.

### Claim 4 (depends on 1)

The implant of claim 1, wherein each composite layer is of thickness 0.05 mm-0.5 mm; 0.15-0.35 mm; or 0.1-0.25 mm ; and optionally wherein each composite layer is of width 2-30 mm.

### Claim 5 (depends on 1)

The implant of claim 1 wherein fibers are present as part of fiber bundles; wherein the fibers are arranged in bundles within each layer; optionally in a single, non-overlapping layer within each composite layer, or optionally wherein the layers are arranged in circular bundles.

### Claim 6 (depends on 1)

The implant of claim 1 wherein said biodegradable 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; and wherein said polymer comprises lactide, glycolide, caprolactone, valerolactone, carbonates (e.g., trimethylene carbonate, tetramethylene carbonate, and the like), 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, y-ydroxyvalerate, β-hydroxypropionate, alpha-hydroxy acid, hydroxybuterates, poly (ortho esters), hydroxy alkanoates, tyrosine carbonates, polyimide carbonates, polyimino carbonates such as poly (bisphenol A-iminocarbonate) and poly (hydroquinone-iminocarbonate),polyurethanes, 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/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; unsymmetrically-3,6-substituted poly-1 ,4-dioxane-2,5-diones; polyhydroxyalkanoates; such as polyhydroxybutyrates (PHB); PHB/b-hydroxyvalerate copolymers (PHB/PHV); poly-b-hydroxypropionate (PHPA); poly-p-dioxanone (PDS); poly-d-valerolactone - poly-ε-capralactone, poly(ε-caprolactone-DL-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.

### Claim 7 (depends on 6)

The implant of claim 6, wherein said polymer is selected from the group consisting of PLLA, PDLA, PGA, PLGA, PCL, PLLA-PCL and a combination thereof ; optionally wherein said PLLA is used in said polymer matrix said matrix comprises at least 30% PLLA; at least 50% PLLA; or at least 70% PLLA; or optionally wherein said PDLA is used in said polymer matrix and said matrix comprises at least at least 5% PDLA; at least 10% PDLA; or at least 20% PDLA.

### Claim 8 (depends on 1)

The implant of claim 1, wherein said fibers are continuous fibers, and wherein said continuous fibers are longer than 4 mm; longer than 8 mm; longer than 12 mm; longer than 16 mm; or longer than 20 mm.

### Claim 9 (depends on 1)

The implant of claim 1, wherein a distance between adjacent reinforcing fibers within each layer is in a range of 0.5-50 μm; 1-30 μm; 1-20 μm; or 1-10 μm.

### Claim 10 (depends on 1)

The implant of claim 1, wherein a weight percentage of fibers is in the range of 20-90% or 40% to 70%; and optionally wherein a volume percentage of reinforcing fibers within the implant is in a range of 30-90% or 40% -70%.

### Claim 11 (depends on 1)

The implant of claim 1, wherein a density of the biocomposite is between 1.2 to 1.9 g/mL; or 1.4 to 1.8 g/mL.

### Claim 12 (depends on 1)

The implant of claim 1 wherein said fiber comprises a silica-based mineral compound wherein said silica-based mineral compound has at least one oxide composition in at least one of the following mol.% ranges:
Na2O: 11.0-19.0 mol. %
CaO: 9.0-14.0 mol. %
MgO: 1.5-8.0 mol. %
B2O3: 0.5-3.0 mol. %
Al2O3: 0-0.8 mol. %
P2O3: 0.1-0.8 mol. %
SiO2: 67-73 mol. %;
or wherein said silica-based mineral compound has at least one oxide composition in at least one of the following mol. % ranges:
Na2O: 12.0-13.0 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: 68-70 mol. %.

### Claim 13 (depends on 1)

The implant of claim 1, comprising between 2-40 reinforcing fibers in each layer thickness of each biocomposite layer.

### Claim 14 (depends on 1)

The implant of claim 1, wherein a reinforcing fiber length of at least a portion of said fibers is at least 50% of a longitudinal length of the implant; wherein said reinforcing fiber length of a majority of said fibers is at least 50% of said longitudinal length of the implant, wherein said reinforcing fiber length is at 60% of said longitudinal length of the implant; or wherein said reinforcing fiber length is at 75% of said longitudinal length of the implant.