# US 2020/0390482 A1 · Device for coaptation of bone fragments and methods for producing such a device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2020/0390482 A1 - Document ID: US20200390482A1 - Status: Published application - Kind: A1 - Application number: 17/007,460 - Filed: 2020-08-31 - Published: 2020-12-17 - Earliest claimed: 2012-08-13 - Assignees: Tornier SAS - Applicants: Tornier - Inventors: Frederic IMPELLIZZERI - Web page: https://patentgrep.com/patent/US20200390482A1 ## CPC - A61B 17/8033: {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} - A61B 17/8028: {Cushions, i.e. elements forming interface between bone plate and bone} - A61B 17/8057: {the interlocking form comprising a thread} - A61B 17/8047: {wherein the additional element surrounds the screw head in the plate hole (A61B17/8052 takes precedence)} - A61B 2017/00526: {Methods of manufacturing} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## 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. ## Claims ### Claim at position 1 1-17. (canceled) ### Claim 18 A device for coaptation of bones, comprising a single molded plate having a support portion formed from a first biocompatible polymer and at least two zones, the plate being provided with a through hole, wherein one of the zones comprises a second biocompatible polymer which is more malleable than the first biocompatible polymer, the zones having mechanical properties enabling tapping of an inside surface of the molded plate defining the hole by a screw adapted for fastening the molded plate to a bone, the support portion and the at least two zones presenting at least a partial melting. ### Claim 19 (depends on 1) The device according to claim 1 wherein the support portion comprises a zone including carbon fibers. ### Claim 20 (depends on 1) The device according to claim 1 wherein the first biocompatible polymer comprises a hardening filler in a matrix formed by the second biocompatible polymer. ### Claim 21 (depends on 1, 2) The device for according to claim 1 or 2 wherein at least one zone is formed from Polyetheretherketone (PEEK). ### Claim 22 (depends on 1) The device according to claim 1 wherein the plate has locally increased thicknesses on the underside at a location of the at least one zone of lower hardness. ### Claim 23 A method for manufacturing a device suitable for coaptation of bones comprising: providing a single molded plate having a support portion formed from a first biocompatible polymer and at least two zones, the plate being provided with a through hole, wherein one of the zones comprises a second biocompatible polymer which is more malleable than the first biocompatible polymer, the zones having mechanical properties enabling tapping of an inside surface of the molded plate defining the hole by a screw adapted for fastening the molded plate to a bone; 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 the plate, 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. ### Claim 24 (depends on 23) The method according to claim 23, wherein the two polymer materials differ only in that said other biocompatible polymer material contains a hardening filler. ### Claim 25 (depends on 23) The method according to claim 23, 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. ### Claim 26 (depends on 23) The method according to claim 23 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. ### Claim 27 (depends on 23) The method according to claim 23, 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. ### Claim 28 (depends on 23) The method according to claim 23, wherein the injection is made in a mold of which the temperature is comprised between 140° C. and 220° C. ### Claim 29 (depends on 24) The method according to claim 24, wherein the biocompatible polymer material with the carbon filler is injected at a temperature comprised between 350° C. and 440° C. ### Claim 30 (depends on 24) The method according to claim 24, wherein the polymer material with the carbon filler is injected at a speed comprised between 50 g/sec and 750 g/sec. ### Claim 31 (depends on 24) The method according to claim 24, wherein the polymer material with the carbon filler is injected at a pressure comprised between 500 and 2000 Bars. ### Claim 32 (depends on 24) The method according to claim 24, wherein the device obtained requires a cooling time comprised between 10 seconds and 30 seconds. ### Claim 33 (depends on 25) The method according to claim 25, wherein the biocompatible polymer material with the carbon fiber filler is injected at a temperature comprised between 350° C. and 440° C. ### Claim 34 (depends on 25) The method according to claim 25, wherein the biocompatible polymer material with the carbon fiber filler is injected at a speed comprised between 50 g/sec and 750 g/sec. ### Claim 35 (depends on 25) The method according to claim 25, wherein the biocompatible polymer material with the carbon fiber filler is injected at a pressure comprised between 500 and 2000 Bars. ### Claim 36 (depends on 25) The method according to claim 25, wherein the device obtained requires a cooling time comprised between 10 seconds and 30 seconds. ### Claim 37 (depends on 23) The method according to claim 23, 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.