# US 10,478,309 B2 · Method for producing osteosynthesis devices, osteosynthesis devices and implants made of semi-synthetic hybrid material obtained by structural modification of the components of a natural marine biomaterial

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- Number: US 10,478,309 B2
- Document ID: US10478309B2
- Status: Granted
- Kind: B2
- Application number: 14/592,156
- Filed: 2015-01-08
- Published: 2015-07-16
- Granted: 2019-11-19
- Earliest claimed: 2014-01-10
- Assignees: Mbp (Mauritius) Ltd
- Applicants: Mbp (Mauritius) Ltd
- Inventors: Georges Camprasse; Serge Camprasse
- Web page: https://patentgrep.com/patent/US10478309B2

## CPC

- A61F 2/442: {Intervertebral or spinal discs, e.g. resilient (non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455)}
- A61B 17/80: Cortical plates {, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates}
- A61B 17/86: Pins or screws {or threaded wires; nuts therefor (A61B17/72 take precedence)}
- A61B 17/866: {Material or manufacture}
- A61C 8/0016: {polymeric material}
- A61C 8/0074: {with external threads}
- A61C 8/008: {Healing caps or the like}
- 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)}
- A61L 27/3604: {characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel}
- A61L 27/365: {Bones}
- A61L 27/446: {with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46}
- A61L 31/005: {Ingredients of undetermined constitution or reaction products thereof}
- A61L 31/128: {containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127}
- A61B 17/72: Intramedullary devices, e.g. pins or nails
- A61B 17/8057: {the interlocking form comprising a thread}
- A61B 17/8605: {Heads, i.e. proximal ends projecting from bone}
- A61B 2090/037: {with a frangible part, e.g. by reduced diameter}
- A61F 2/0811: {Fixation devices for tendons or ligaments}
- A61F 2002/0817: {Structure of the anchor}
- A61F 2002/30164: {dovetail-shaped}
- A61F 2002/30261: {parallelepipedal}
- A61F 2002/30797: {internally-threaded}
- A61F 2002/30971: {Laminates, i.e. layered products}
- A61F 2002/4629: {connected to the endoprosthesis or implant via a threaded connection}
- A61F 2310/00347: Nacre or mother-of-pearl
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- B29K 2995/0056: Biocompatible, e.g. biopolymers or bioelastomers
- B29L 2031/753: {Medical equipment; Accessories therefor (bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008)}
- Y10T 29/4998: Combined manufacture including applying or shaping of fluent material
- Y10T 29/49995: Shaping one-piece blank by removing material
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61C: DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE (non-driven toothbrushes A46B; {tongue scrapers A61B17/24;} preparations for dentistry A61K6/00; preparations for cleaning the teeth or mouth A61K8/00, A61Q11/00)
- 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)
- B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A semi-synthetic hybrid material having a pH from 7 to 7.4 includes an inorganic fraction and a cross-linked organic fraction. The method for producing this material, and osteosynthesis devices or implants made of semi-synthetic hybrid material are also described.

## Claims

### Claim 1

A method for producing a semi-synthetic hybrid material from a nacreous aragonitic layer of bivalve mollusks selected from the group consisting of Pinctada maxima, Pinctada margaritifera, Tridacnae maxima, Tridacnae gigas and other Pinctada species, said nacreous aragonitic layer comprising an inorganic fraction and an organic fraction, said organic fraction comprising biopolymer chains,
said method comprising:
a step of modifying the pH of said nacreous aragonitic layer; and
a step of cross-linking the biopolymer chains of the organic fraction of said nacreous aragonitic layer with the aid of a cross-linking agent and a physical agent.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the step of modifying the pH is performed by immersion in a bath of microbiologically controlled water, brought to boiling point.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the cross-linking agent is selected from the group consisting of riboflavin, vitamin C, and a polyol, and the physical agent is ionizing radiation.

### Claim 4 (depends on 3)

The method according to claim 3, wherein the cross-linking agent is riboflavin and the physical agent is UVA.

### Claim 5

A method for producing an osteosynthesis device or implant made of a nacreous aragonitic layer of bivalve mollusks selected from the group consisting of Pinctada maxima, Pinctada margaritifera, Tridacnae maxima, Tridacnae gigas and other Pinctada species, said nacreous aragonitic layer comprising an inorganic fraction and an organic fraction comprising cross-linked biopolymer chains and having a pH from 7 to 7.4, the method comprising the steps of:
a) selecting bivalves, having previously undergone exposure of the nacreous aragonitic layer,
b) cutting out pre-forms from the bivalves selected at step a) and producing the osteosynthesis device or implant,
c) modifying the pH of the nacreous aragonitic layer,
d) cross-linking the biopolymer chains of the organic fraction of the nacreous aragonitic layer produced at step c) using a cross-linking agent and a physical agent, and
e) modifying a surface state of the osteosynthesis device or implant produced at step b).

### Claim 6 (depends on 5)

The method according to claim 5, wherein the step e) of modifying the surface state comprises operations of sandblasting, cleaning by ultrasound, cryogenics and application of mechanically structured nanoparticles of said nacreous aragonitic layer.

### Claim 7 (depends on 5)

The method according to claim 5, further comprising step f) impregnating the device obtained after step e) with biological liquids and/or compositions containing pharmaceutically active substances.

### Claim 8 (depends on 5)

The method according to claim 5, wherein the step of modifying the pH is performed by immersion in a bath of microbiologically controlled water, brought to boiling point.

### Claim 9 (depends on 5)

The method according to claim 5, wherein the cross-linking agent is selected from the group consisting of riboflavin, vitamin C, and a polyol, and the physical agent is ionizing radiation.

### Claim 10 (depends on 9)

The method according to claim 9, wherein the cross-linking agent is riboflavin and the physical agent is UVA.

### Claim 11 (depends on 5)

The method according to claim 5 wherein step b) is performed after digital modeling.