Device for coaptation of bone fragments and methods for producing such a device

Patent metadata

Field	Value
Publication number	US-10799274-B2
Application number	US-201816182934-A
Country	US
Kind code	B2
Filing date	Nov 7, 2018
Priority date	Aug 13, 2012
Publication date	Oct 13, 2020
Grant date	Oct 13, 2020

Abstract

A device for coaptation of bone parts or bone fragments, comprising an integral plate obtained by moulding whereof one portion ( 1 ) is made from a first biocompatible polymer comprising at least one or, preferably, a plurality of areas or inserts ( 2 ) provided with a through hole ( 3 ), said areas or inserts being made from a second biocompatible polymer which is more malleable than the first polymer, said areas or inserts having mechanical properties allowing a self-tapping of the inner surface of the holes, by means of screws that can be used for securing said plate to bone tissue, said support portion and said areas or inserts having a partial molecular bond between them.

First claim

The invention claimed is:

1. A method for manufacturing a device suitable for coaptation of bone parts or bone fragments, comprising:
providing a one-piece molded plate comprising a support portion produced from a first biocompatible polymer and comprising at least one zone or insert which is provided with a through hole and which is produced from a second biocompatible polymer which is more malleable than the first polymer, said at least one zone or insert having mechanical properties enabling self-tapping of the inside surface of the through hole, by means of screws adapted for fastening said plate to bone tissues, wherein the support portion and the at least one zone or insert present partial molecular melting together; and
forming in a mold at least one insert from a malleable biocompatible polymer material and injecting around that malleable biocompatible polymer material another biocompatible polymer material to form a support portion of a plate of the coaptation device, under conditions of pressure, duration and temperature such that rheological continuity occurs between the polymer materials resulting in a partial molecular melting together of the polymer materials so as to obtain the plate as one piece.

2. The method according to claim 1 , wherein the two polymer materials differ only in that said other biocompatible polymer material contains a hardening filler.

3. The method according to claim 1 , for manufacturing by overmolding, the method comprising:
placing in a mold, at least one preformed part or insert made from the malleable biocompatible polymer material;
injecting into that mold, around said preformed part or insert, a material formed from the same biocompatible polymer material but with a carbon filler, and having, after polymerization/molding, a higher rigidity than that of said preformed part or insert; and
leaving the device to cool before ejecting the device.

4. The method according to claim 3 , wherein the biocompatible polymer material with the carbon filler is injected at a temperature comprised between 350° C. and 440° C.

5. The method according to claim 3 , wherein the polymer material with the carbon filler is injected at a speed comprised between 50 g/sec and 750 g/sec.

6. The method according to claim 3 , wherein the polymer material with the carbon filler is injected at a pressure comprised between 500 and 2000 Bars.

7. The method according to claim 3 , wherein the device obtained requires a cooling time comprised between 10 seconds and 30 seconds.

8. The method according to claim 1 for manufacturing by bi-material injection, the method comprising:
injecting into a mold, provided with two injection points to supply each of the polymer materials, the malleable biocompatible polymer material to manufacture said at least one insert and a polymer material formed from the same biocompatible polymer material but with a carbon fiber filler to manufacture the support portion, having after polymerization/molding a higher rigidity than that of the at least one insert; and
leaving the device to cool before ejecting the device.

9. The method according to claim 8 , wherein the biocompatible polymer material with the carbon fiber filler is injected at a temperature comprised between 350° C. and 440° C.

10. The method according to claim 8 , wherein the biocompatible polymer material with the carbon fiber filler is injected at a speed comprised between 50 g/sec and 750 g/sec.

11. The method according to claim 8 , wherein the biocompatible polymer material with the carbon fiber filler is injected at a pressure comprised between 500 and 2000 Bars.

12. The method according to claim 8 , wherein the device obtained requires a cooling time comprised between 10 seconds and 30 seconds.

13. The method according to claim 1 , wherein the malleable biocompatible material polymer constituting the at least one insert is polyetheretherketone (natural PEEK) and in that the biocompatible material injected around the at least one insert to constitute the support portion is PEEK with a filler of implantable carbon fibers.

14. The method according to claim 1 , wherein the injection is made in a mold of which the temperature is comprised between 140° C. and 220° C.

15. The method according to claim 1 , wherein said other biocompatible polymer material has a melting point greater than that of the malleable biocompatible polymer material and is injected around the malleable biocompatible polymer material after or at the same time as the at least one insert is formed, the partial melting of the polymer materials being achieved through a solely superficial melting of the at least one insert upon molding of the support portion.

Assignees

• Biotech Ortho
• Tornier Sa

Inventors

• Impellizzeri Frederic

Classifications

• A61B17/8057 Primary

  the interlocking form comprising a thread · CPC title

• A61B17/8047

  wherein the additional element surrounds the screw head in the plate hole (A61B17/8052 takes precedence) · CPC title

• A61B17/8028

  Cushions, i.e. elements forming interface between bone plate and bone · CPC title

• A61B2017/00526

  Methods of manufacturing · CPC title

• A61B17/8033 Primary

  having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers · CPC title