# US 8,540,658 B2 · Bone-regeneration material > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,540,658 B2 - Document ID: US8540658B2 - Status: Granted - Kind: B2 - Application number: 10/370,606 - Filed: 2003-02-24 - Published: 2005-04-07 - Granted: 2013-09-24 - Earliest claimed: 2001-08-13 - Assignees: DePuy Synthes Products, Inc. - Applicants: Thierry Stoll - Inventors: Thierry Stoll - Web page: https://patentgrep.com/patent/US8540658B2 ## CPC - A61L 27/365: {Bones} - A61L 27/12: Phosphorus-containing materials, e.g. apatite - A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} - A61L 27/56: Porous materials, {e.g. foams or sponges} - A61F 2/28: Bones - A61F 2/4601: {for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity} - A61F 2/4644: {Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material (bone material A61F2/28; disintegrating or milling devices B02C)} - A61F 2002/2817: {Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]} - A61F 2310/00293: containing a phosphorus-containing compound, e.g. apatite - 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) - 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) ## Abstract The invention relates to a process for producing a bone-regeneration material. According to the method, a bio-compatible, open-pored body is exposed to a vacuum and osteoinductive and/or osteogenic substances are absorbed into the pores of the body, for example by means of a vacuum generated therein. It is thus possible to produce a bone-regeneration material, which contains osteoinductive and/or osteogenic substances in the pores of the bio-compatible body, said substances acting as a network structure for new somatic cells that are to grow into the porous body. ## Claims ### Claim 1 A process for the production of a bone regeneration material which contains a drawable substance that includes (i) at least one osteoinductive substance, (ii) at least one osteogenic substance, or (iii) at least one osteoinductive substance and at least one osteogenic substance, the process being performed with a syringe with a hollow cylinder, a piston, and an air tight seal and comprising: (a) housing a biocompatible, interconnected open-pore body in the hollow cylinder of the syringe; (b) forming a perforation in the air tight seal; (c) drawing the drawable substance through the perforation; (d) after drawing the drawable substance through the perforation, sealing the perforation; and (e) after sealing the perforation, drawing the drawable substance into pores of the biocompatible, interconnected open-pore body by further displacing the piston to create negative pressure within the hollow cylinder of the syringe. ### Claim 2 (depends on 1) The process according to claim 1, wherein the osteogenic substance is somatic cells in blood or an aqueous suspension, and the somatic cells are chosen from the group consisting of: (a) autologous bone marrow, (b) separated, concentrated cells from autologous bone marrow, (c) cultivated autologous stem cells, (d) differentiated autologous stem cells, and (e) mesenchymal cells. ### Claim 3 (depends on 1) The process according to claim 1, wherein the osteoinductive substance is contained in a body-compatible liquid. ### Claim 4 (depends on 1) The process according to claim 1, wherein the osteogenic substance is suspended in an aqueous solution. ### Claim 5 (depends on 1) The process according to claim 1, wherein the osteogenic substance is present in the form of somatic cells in flowable form, and the somatic cells are chosen from the group consisting of: (a) blood, (b) blood components, (c) bone marrow, and (d) bone cells. ### Claim 6 (depends on 1) The process according to claim 1, wherein the osteogenic substance is somatic cells of an autologous nature. ### Claim 7 (depends on 1) The process according to claim 1, wherein the osteoinductive substance is chosen from the group consisting of: (a) synthetic growth factors, (b) recombinant growth factors, (c) β growth factor (TGF-β), (d) FGF-2 (fibroblast growth factor), (e) natural or synthetic peptides, (f) platelet-derived growth factor (PDGF), (g) insulin-like growth factor (IGF), (h) fibrin as end product of blood coagulation, and (i) synthetic fibrin. ### Claim 8 A method, comprising: placing a biocompatible open-pore body in a chamber of a syringe; drawing at least one flowable substance into the chamber through a needle inserted through a membrane; removing the needle from the membrane to form an air tight seal; and after sealing the membrane, continuing to draw a syringe piston to produce a level of vacuum that is maintained within the chamber to draw the flowable substance into pores of the biocompatible open-pore body. ### Claim 9 (depends on 8) The method of claim 8, wherein the needle is in a removable adapter. ### Claim 10 (depends on 9) The method of claim 9, wherein the removable adapter is configured to couple to a cannula system chosen from a group consisting of a hub connection system, an injection needle, a catheter, and a butterfly. ### Claim 11 (depends on 10) The method of claim 10, wherein a removable head part including the membrane is coupled between the chamber and the removable adapter. ### Claim 12 (depends on 11) The method of claim 11, further including removing the removable head part after drawing the flowable substance into pores of the biocompatible open-pore body to provide an exit pathway, and expelling the biocompatible open-pore body through the exit pathway. ### Claim 13 (depends on 1) The method of claim 1 wherein step (f) further comprises expelling air from the biocompatible, interconnected open-pore body. ### Claim 14 A method, comprising: placing a biocompatible resorbable open-pore body in a chamber of a hollow cylinder; coupling a membrane to said hollow cylinder to form an airtight seal; inserting a cannula through said membrane; drawing a flowable substance into the chamber through the cannula; removing the cannula from the membrane to reform the air tight seal; and after removing the cannula from the membrane to reform the air tight seal, producing and maintaining a level of vacuum within the chamber to draw the at least one flowable substance into pores of the biocompatible resorbable open-pore body and expel air from the biocompatible open-pre body as the flowable substance is drawn into the biocompatible resorbable open-pore body. ### Claim 15 (depends on 14) The method of claim 14, wherein coupling the membrane to the hollow cylinder includes attaching a head part to the hollow cylinder, said head part including the membrane. ### Claim 16 (depends on 15) The method of claim 15, wherein the head part has a first portion engageable with the hollow cylinder and a second portion engageable with an adapter, wherein the first portion of the head part has a diameter larger than a diameter of the second portion of the head part. ### Claim 17 (depends on 15) The method of claim 15, wherein inserting the cannula through the membrane includes attaching an adapter to the head part, the adapter including the cannula. ### Claim 18 (depends on 17) The method of claim 17, wherein the adapter has a first portion engageable with the head part and a second portion engageable with a Luer system, wherein the first portion of the adapter has a diameter larger than a diameter of the second portion of the adapter. ### Claim 19 (depends on 18) The method of claim 18, wherein the Luer system includes one or more of an injection needle, a catheter and a butterfly needle.