# US 2024/0115775 A1 · Continuous-fiber reinforced biocomposite medical implants

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- Number: US 2024/0115775 A1
- Document ID: US20240115775A1
- Status: Published application
- Kind: A1
- Application number: 18/364,476
- Filed: 2023-08-03
- Published: 2024-04-11
- 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/US20240115775A1

## 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 layers, each layer comprising a polymer and a plurality of uni-directionally aligned continuous reinforcement fibers.

## Claims

### Claim 1

A medical implant comprising a biocomposite; wherein the biocomposite comprises a polymer and a plurality of continuous reinforcement fibers; wherein the fibers are present as fiber bundles; wherein said fibers are uni-directionally aligned; wherein said polymer is biodegradable and said implant is bioabsorbable; wherein said continuous fibers are longer than 4 mm; and wherein the diameter of the fiber bundles ranges from 9 to 300 micron.

### Claim at position 2

-19. (canceled)

### Claim 20 (depends on 1)

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

### Claim at position 4

-23. (canceled)

### Claim 24 (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.

### Claim 25 (depends on 24)

The implant of claim 24, wherein said reinforcing fiber length of a majority of said fibers is at least 50%, at least 60% or at least 75% of said longitudinal length of the implant.

### Claim at position 7

-27. (canceled)

### Claim 28 (depends on 1)

The implant of claim 1, wherein a majority of reinforcement fibers within the composite layer are aligned to the longitudinal axis of the medical implant.

### Claim 29 (depends on 1)

The implant of claim 1, wherein a majority of reinforcement fibers within the composite layer are aligned at an angle to the longitudinal axis.

### Claim 30 (depends on 29)

The implant of claim 29, wherein said angle is less than 90°, less than 60°, or less than 45° from the longitudinal axis.

### Claim at position 11

-32. (canceled)

### Claim 33 (depends on 1)

The implant of claim 1, wherein a diameter of said fibers is in a range of 0.1-100 μm, 1-20 μm, 4-16 μm, 10-18 μm, or 14-16 μm.

### Claim at position 13

-38. (canceled)

### Claim 39 (depends on 1)

The implant claim 1, wherein a standard deviation of fiber diameter between fibers is less than 5 μm, less then 3 μm, or less than 1.5 μm.

### Claim at position 15

-41. (canceled)

### Claim 42 (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 at position 17

-45. (canceled)

### Claim 46 (depends on 1)

The implant of claim 1, wherein a weight percentage of fibers is in a range of 20-90%, or a range of 40%-70%.

### Claim 47

(canceled)

### Claim 48 (depends on 1)

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

### Claim at position 21

-53. (canceled)

### Claim 54 (depends on 1)

The implant of claim 1, wherein a density of the biocomposite is between 1 to 2 g/ml, between 1.2 to 1.9 g/ml, or between 1.4 to 1.8 g/ml.

### Claim at position 23

-61. (canceled)

### Claim 62 (depends on 1)

The implant of claim 1, wherein the implant has a flexural modulus exceeding 10 GPa and flexural strength exceeding 100 MPa.

### Claim 63 (depends on 62)

The implant of claim 62, wherein said implant has flexural strength in a range of 400-800 MPa, or a range of 650-800 MPa.

### Claim 64

(canceled)

### Claim 65 (depends on 62)

The implant of claim 62, wherein said implant has an elastic modulus in a range of 10-27 GPa, or a range of 16-27 GPa.

### Claim at position 28

-76. (canceled)

### Claim 77 (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, γ-hydroxyvalerate, β-hydroxypropionate, alpha-hydroxy acid, hydroxybuterates, poly (ortho esters), hydroxy alkanoates, tyrosine carbonates, polyimide carbonates, polyamino carbonates such as poly (bisphenol A-iminocarbonate) and poly (hydroquinoneiminocarbonate, (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/tetra methylglycolide copolymers, lactide/trimethylene carbonate copolymers, lactide/d-valerolactone copolymers, lactide/ε-caprolactone copolymer), 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-caprolactone, poly(ε-caprolactone-OL-lactide) copolymers; methylmethacrylate-N-vinyl pyrrolidone copolymers; polyesteramides; polyesters of oxalic acid; polydihydropoyrans; polyalkyl-2-cyanoacrylates; polyurethanes (PU); polyvinylalcohol (PVA); polypeptides; poly-b-malic acid (PMLA); poly-br-alkanbic acids; polycarbonates; polyorthoesters; polyphosphates; poly(ester anhydrides); and mixtures thereof; and derivatives, copolymers and mixtures thereof.

### Claim at position 30

-80. (canceled)

### Claim 81 (depends on 77)

The implant of claim 77, wherein said polymer is selected from the group consisting of PLLA, PDLA, PGA, PLGA, PCL, PLLA-PCL and a combination thereof.

### Claim 82 (depends on 81)

The implant of claim 81, wherein said PLLA is used in said polymer matrix and said matrix comprises at least 30% PLLA.

### Claim at position 33

-84. (canceled)

### Claim 85 (depends on 81)

The implant of claim 81, wherein said PDLA is used in said polymer matrix and said matrix comprises at least at least 5% PDLA, least 10% PDLA, or at least 20% PDLA.

### Claim at position 35

-87. (canceled)

### Claim 88 (depends on 1)

The implant of claim 1, wherein said fiber comprises a silica-based mineral compound.

### Claim 89 (depends on 88)

The implant of claim 88, 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. % and
P2O3: 0.1-0.8 mol. %.

### Claim 90 (depends on 89)

The implant of claim 89, 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. % and
SiO2: 68-70 mol. %.

### Claim at position 39

-117. (canceled)

### Claim 118 (depends on 1)

A method of treatment for an orthopedic application in a subject in need of treatment thereof, comprising implanting to the subject the medical implant of claim 1.

### Claim at position 41

-120. (canceled)