# US 10,869,954 B2 · Surface treated biocomposite material, medical implants comprising same and methods of treatment thereof

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- Number: US 10,869,954 B2
- Document ID: US10869954B2
- Status: Granted
- Kind: B2
- Application number: 16/081,605
- Filed: 2017-03-07
- Published: 2019-04-04
- Granted: 2020-12-22
- Earliest claimed: 2016-03-07
- Assignees: Ossio, Ltd.
- Applicants: Orahn Preiss-Bloom; Ossio Ltd
- Inventors: Orahn Preiss-Bloom; Taly Pnina Lindner
- Web page: https://patentgrep.com/patent/US10869954B2

## CPC

- A61L 27/58: Materials at least partially resorbable by the body
- A61L 27/46: with phosphorus-containing inorganic fillers
- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 31/127: {containing fillers of phosphorus-containing inorganic materials}
- A61L 31/14: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 31/148: {Materials at least partially resorbable by the body}
- A61L 2400/18: Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- 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)

## Abstract

Reinforced biocomposite materials having a unique treated surface, in which the surface may comprise a plurality of layers. According to at least some embodiments, medical implants are provided that incorporate novel structures, alignments, orientations and forms comprised of such reinforced bioabsorbable materials, as well as methods of treatment thereof.

## Claims

### Claim 1

An implant with a body composition of mineral and polymer with a surface comprising a different composition than the implant body, wherein 10-70% w/w of the body composition comprises mineral material, wherein said material comprises 1-15% w/w calcium, wherein the body comprises an interspersed composition of mineral and polymer, and a surface layer, wherein said surface layer comprises a surface composition of at least 10% of the surface that is of a different composition than the body composition and comprises less than 4% w/w silica; wherein the body comprises more than 8% w/w silica; wherein the calcium content of the surface is 50% w/w less than the calcium content of the body composition; and wherein the mineral to polymer weight ratio in the surface composition is less than 50% of mineral to polymer weight ratio than the body composition.

### Claim 2 (depends on 1)

The implant of claim 1, wherein 30-55% w/w of the body composition comprises mineral material.

### Claim 3 (depends on 2)

The implant of claim 2, wherein 45-55% w/w of the body composition comprises mineral material.

### Claim 4 (depends on 1)

The implant of claim 1, wherein said polymer comprises poly (L-co-D, L lactic acid) (PLDLA).

### Claim 5 (depends on 1)

The implant of claim 1, wherein said mineral material of said body composition comprises ranges of the following compounds, all mol %:
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 %; and
SiO2: 67-73 mol %.

### Claim 6 (depends on 1)

The implant of claim 1, wherein said mineral material of said body composition comprises ranges of the following compounds, all mol %:
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 7 (depends on 1)

The implant of claim 1, wherein said mineral material of said body composition comprises ranges of the following compounds, all mol %:
Na2O: 11.0-19.0 mol %;
CaO: 8.0-14.0 mol %;
MgO: 2-8.0 mol %;
B2O3: 1-3.0 mol %;
Al2O3: 0-0.5 mol %;
P2O3: 1-2 mol %; and SiO2: 66-70 mol %.

### Claim 8 (depends on 1)

The implant of claim 1, wherein more than 30% of the surface is of a different composition than the body.

### Claim 9 (depends on 8)

The implant of claim 8, wherein more than 50% of the surface is of a different composition than the body.

### Claim 10 (depends on 1)

The implant of claim 1, wherein a portion of the surface layer is treated to partially expose a body composition, and wherein the treated portion of the surface layer has a roughness increase by more than five times the untreated surface.

### Claim 11 (depends on 10)

The implant of claim 10, wherein the treated portion of the surface layer has a roughness increase by more than ten times the untreated surface.

### Claim 12 (depends on 11)

The implant of claim 11, wherein the treated surface area increases the surface area by more than 15%.

### Claim 13 (depends on 12)

The implant of claim 12, wherein the treated surface area increases the surface area by more than 50%.

### Claim 14 (depends on 10)

The implant of claim 10 wherein the surface maximum roughness is more than 2 microns.

### Claim 15 (depends on 14)

The implant of claim 14, wherein the surface maximum roughness is more than 3 microns.

### Claim 16 (depends on 1)

The implant of claim 1, comprising an absorbable structural material, comprising a resorbable, reinforcement filler, characterized in that strength and stiffness properties are anisotropic of at least 10%, at least 20% at least 30%, 40%, 50%, 60%, 70′%, 80%, 90% or 100%, or any number in between, wherein said implant is reduced in volume as compared to an equivalent implant that is not constructed of said absorbable structural material.

### Claim 17 (depends on 16)

The implant of claim 16, comprising a load bearing absorbable bone implant, wherein said load is at least 200 MPa, above 300 MPa, above 400 MPa; and wherein said implant has a similar stiffness to cortical bone.

### Claim 18 (depends on 1)

The implant of claim 1, wherein the biodegradable composite has a maximum flexural modulus in the range of 6 GPa to 30 GPa and flexural strength in the range of 100 MPa to 1000 MPa.

### Claim 19 (depends on 1)

The implant of claim 1, wherein said biodegradable composite comprises a biodegradable polymer; wherein said biodegradable polymer comprises a homopolymer or 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, dioxanones, δ-valerolactone, 1,dioxepanones, ethylene glycol, ethylene oxide, esteramides, γ-hydroxyvalerate, β-hydroxypropionate, alpha-hydroxy acid, hydroxybuterates, poly (ortho esters), hydroxy alkanoates, tyrosine carbonates, polyimide carbonates, polyimino carbonates, (polyurethanes, polyanhydrides, polymer drugs, 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, terpolymers of PLA, polydepsipeptides; unsymmetrically—3,6-substituted poly-1,4-dioxane-2,5-diones; polyhydroxyalkanoates; 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 (PVA); 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 20 (depends on 1)

The implant of claim 1, wherein the 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 (poly (L-co-D,L lactic acid), PGA, (poly-glycolic acid) PLGA (poly-lactide-glycolic acid) PCL (Polycaprolactone) PLLA PCL and a combination thereof.

### Claim 21 (depends on 20)

The implant of claim 20, wherein if PLLA is used, the matrix comprises at least 30% w/w, 50% w/w, or at least 70% w/w PLLA.

### Claim 22 (depends on 20)

The implant of claim 20, wherein if PDLA is the matrix comprises at least 5% w/w, at least 10% w/w, or at least 20% w/w.

### Claim 23 (depends on 1)

The implant of claim 1 wherein the implant is selected from the groups consisting of bone fixation plates, intramedullary nails, hip joint implants, knee joint implants, elbow joint implants, spine implants, and devices for fracture fixation, tendon reattachment, spinal fixation, and spinal cages.

### Claim 24 (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 25 (depends on 1)

The implant of claim 1, wherein the mineral to polymer weight ratio in the surface composition is less than 30% of mineral to polymer weight ratio than in the body composition.

### Claim 26 (depends on 25)

The implant of claim 25, wherein the mineral to polymer weight ratio in the surface composition is less than 10% of mineral to polymer weight ratio than in the body composition.

### Claim 27 (depends on 1)

The implant of claim 1, wherein the surface layer comprises a surface composition with at least 10% higher polymer content than the body composition.

### Claim 28 (depends on 27)

The implant of claim 27, wherein the surface layer comprises a surface composition with at least 20% higher polymer content than the body composition.

### Claim 29 (depends on 28)

The implant of claim 28, wherein the surface layer comprises a surface composition with at least 30% higher polymer content than the body composition.

### Claim 30 (depends on 29)

The implant of claim 29, wherein the surface layer comprises a surface composition with at least 50% higher polymer content than the body composition.

### Claim 31

An implant with a body composition of mineral and polymer with a surface comprising a different composition than the implant body, wherein 10-70% w/w of the body composition comprises mineral material, wherein said material comprises 1-15% w/w calcium, wherein the body comprises an interspersed composition of mineral and polymer, and a surface layer, wherein said surface layer comprises a surface composition of at least 10% of the surface that is of a different composition than the body composition and comprises less than 4% w/w silica; wherein the body comprises more than 8% w/w silica; wherein the calcium content of the surface is 50% w/w less than the calcium content of the body composition; and wherein the surface layer comprises a surface composition with at least 10%, higher polymer content than the body composition.