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

• US 10,478,309 B2
• Filed: 01/08/2015
• Issued: 11/19/2019
• Est. Priority Date: 01/10/2014
• Status: Active Grant

• Current Assignee: MBP Ltd
• Original Assignee: MBP Ltd
• Inventors: Camprasse, Georges, Camprasse, Serge
• Primary Examiner(s): Lucchesi, Nicholas D
• Application Number:
  US14/592,156
• Publication Number:
  US 20150196398A1
• Time in Patent Office: 1,776 Days
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/8057 the interlocking form comprising a thread
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 17/8605 Heads, i.e. proximal ends projecting from bone
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61C 8/0016 polymeric material
• CPC Class Codes: A61C 8/0074 with external threads
• CPC Class Codes: A61C 8/008 Healing caps or the like
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: 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
• CPC Class Codes: 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
• CPC Class Codes: A61F 2002/0817 Structure of the anchor
• CPC Class Codes: A61F 2002/30164 dovetail-shaped
• CPC Class Codes: A61F 2002/30261 parallelepipedal
• CPC Class Codes: A61F 2002/30797 internally-threaded
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/4629 connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2310/00347 Nacre or mother-of-pearl
• CPC Class Codes: A61L 2430/02 : for reconstruction of bones; weight-bearing implants
• CPC Class Codes: 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
• CPC Class Codes: A61L 27/365 : Bones
• CPC Class Codes: A61L 27/446 : with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46
• CPC Class Codes: A61L 31/005 : Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/128 : containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
• CPC Class Codes: B29K 2995/0056 : Biocompatible, e.g. biopolymers or bioelastomers
• CPC Class Codes: B29L 2031/753 : Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: Y10T 29/4998 : Combined manufacture including applying or shaping of fluent material
• CPC Class Codes: Y10T 29/49995 : Shaping one-piece blank by removing material

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

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.

2. 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.

3. 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.

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

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).

6. 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.

7. 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.

8. 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.

9. 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.

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

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