# US 2014/0195001 A1 · High Strength Injection Molded Orthopedic Devices > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0195001 A1 - Document ID: US20140195001A1 - Status: Published application - Kind: A1 - Application number: 14/150,686 - Filed: 2014-01-08 - Published: 2014-07-10 - Earliest claimed: 2013-01-08 - Assignees: Praxis Power Technology, Inc. - Applicants: Praxis Power Technology, Inc. - Inventors: Joseph A. Grohowski, JR. - Web page: https://patentgrep.com/patent/US20140195001A1 ## CPC - A61L 27/56: Porous materials, {e.g. foams or sponges} - A61F 2/28: Bones - A61L 27/04: Metals or alloys - A61L 27/06: Titanium or titanium alloys - A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials} - B22F 3/1137: {by coating porous removable preforms} - B22F 3/225: {by injection molding} - B22F 5/00: Manufacture of workpieces or articles from metallic powder characterised by the special shape of the product - B22F 7/06: of composite workpieces or articles from parts, e.g. to form tipped tools {(B22F7/002 takes precedence)} - A61F 2002/2835: {Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material} - A61L 2400/08: Methods for forming porous structures using a negative form which is filled and then removed by pyrolysis or dissolution - A61L 2430/02: for reconstruction of bones; weight-bearing implants - B22F 2999/00: Aspects linked to processes or compositions used in powder metallurgy - B33Y 10/00: Processes of additive manufacturing - B33Y 80/00: Products made by additive manufacturing - Y02P 10/25: Process efficiency - 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) - B22F: WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER (making alloys by powder metallurgy C22C); APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER - B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING - Y02P: CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS ## Abstract High strength implantable devices having complex surfaces are injection molded from powder metal wherein the surface is defined by a monolithic insert made by additive manufacturing. The insert defines the surface texture of the device and may also include a portion to form an ingrowth texture and a portion to form a substrate interface texture. The tensile bond strength of the texture is 20 Mega Pascal or greater. ## Claims ### Claim 1 A method of forming an implantable device or part thereof, such method comprising the steps of: blending a binder and a first powder of metal particles to form a first homogeneous mixture; forming a monolithic mold insert by an additive process, wherein the insert has a complex texture; placing the mold insert in a mold; injection molding the first homogeneous mixture into the mold and the mold insert to form an article, wherein the mold insert forms a textured portion in the article; removing the article and the insert from the mold; removing the insert from the article; and sintering the article to form the implantable device, wherein the textured portion has tensile bond strength of 20 Mega Pascal or greater. ### Claim 2 (depends on 1) The method of claim 1, wherein the complex texture comprises a fused pore forming region. ### Claim 3 (depends on 1) The method of claim 1, wherein the textured portion comprises an ingrowth region of the implantable device. ### Claim 4 (depends on 3) The method of claim 3, wherein the ingrowth region has an interconnected porosity of at least 45 percent. ### Claim 5 (depends on 3) The method of claim 3, wherein the textured portion further comprises a fixation region. ### Claim 6 (depends on 5) The method of claim 5, wherein the textured portion further comprises an interface region to a dense portion of the implantable device. ### Claim 7 (depends on 5) The method of claim 5, wherein the fixation region has undercuts. ### Claim 8 (depends on 1) The method of claim 1, further comprising blending a binder and a second powder of metal particles to form a second homogenous mixture and injection molding said second mixture after said step of injection molding the first mixture. ### Claim 9 (depends on 1) The method of claim 1, wherein the first powder metal is selected from the group consisting of commercially pure titanium and titanium alloy. ### Claim 10 A method of forming a textured portion of an implantable device, such method comprising the steps of: blending a binder and a powder of metal particles to form a homogeneous mixture; forming a monolithic mold insert by an additive manufacturing process having a first surface for making contact with a mold and a second surface having a texture; placing the insert in a mold such that the first surface is in contact with the mold; injection molding the homogeneous mixture into the mold to form an article having a textured portion defined entirely by the second surface of the mold insert; removing the article and the mold insert from the mold; removing the insert so as to maintain the textured portion on the article; and sintering the article to form the implantable device with the textured portion. ### Claim 11 (depends on 10) The method of claim 10, wherein the textured portion has tensile bond strength of 20 Mega Pascal or greater. ### Claim 12 (depends on 10) The method of claim 10, wherein the additive manufacturing process comprises three dimensional printing. ### Claim 13 (depends on 10) The method of claim 10, wherein the textured portion comprises the texture of cancellous bone. ### Claim 14 (depends on 10) The method of claim 10, wherein the textured portion comprises a fixation region, a porous ingrowth region, and an interface region. ### Claim 15 (depends on 10) The method of claim 10, wherein the second surface having a texture comprises a fused pore former. ### Claim 16 (depends on 14) The method of claim 14, wherein the ingrowth portion has porosity between 60 and 85 percent. ### Claim 17 An textured implantable device comprising: a fixation texture comprising an array of protruding undercut features, an ingrowth portion with a porosity between 60 and 85 percent, and an interface region to a dense portion of the device, wherein the tensile bond strength of the ingrowth portion is at least 50 Mega Pascal. ### Claim 18 (depends on 17) The implantable device of claim 17, manufactured by powder metal injection molding wherein the fixation texture, ingrowth portion and interface region are formed by a monolithic mold insert. ### Claim 19 A monolithic mold insert for metal injection molding adapted to form a complex implantable device comprising: a portion to form a fixation texture comprising undercuts on the device, wherein such texture is defined entirely by the insert; a portion to form an ingrowth medium on the device comprising fused pore formers; and a portion to form an interface with reduced stress concentrators to a dense portion the device.