# US 10,307,194 B2 · Spinal implant and method of manufacture > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,307,194 B2 - Document ID: US10307194B2 - Status: Granted - Kind: B2 - Application number: 15/666,281 - Filed: 2017-08-01 - Published: 2019-02-07 - Granted: 2019-06-04 - Earliest claimed: 2017-08-01 - Assignees: Warsaw Orthopedic, Inc. - Applicants: Warsaw Orthopedic, Inc - Inventors: Dale A. Tempco; Rodney Ray Ballard; Matthew D. May - Web page: https://patentgrep.com/patent/US10307194B2 ## CPC - A61B 17/863: {with thread interrupted or changing its form along shank, other than constant taper} - A61B 17/70: Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant - A61B 17/84: Fasteners therefor {or fasteners being internal fixation devices} - A61B 17/86: Pins or screws {or threaded wires; nuts therefor (A61B17/72 take precedence)} - A61B 17/8625: {Shanks, i.e. parts contacting bone tissue} - A61B 17/8635: {Tips of screws} - A61B 17/866: {Material or manufacture} - B22F 5/00: Manufacture of workpieces or articles from metallic powder characterised by the special shape of the product - B22F 10/28: Powder bed fusion, e.g. selective laser melting [SLM] or electron beam melting [EBM] - B29C 64/153: using layers of powder being selectively joined, e.g. by selective laser sintering or melting - B29C 64/245: Platforms or substrates (support structures intended to be sacrificed after manufacture B29C64/40) - B29C 64/386: Data acquisition or data processing for additive manufacturing - B29C 64/393: for controlling or regulating additive manufacturing processes - B33Y 10/00: Processes of additive manufacturing - B33Y 30/00: Apparatus for additive manufacturing; Details thereof or accessories therefor - B33Y 50/00: Data acquisition or data processing for additive manufacturing - B33Y 50/02: for controlling or regulating additive manufacturing processes - B33Y 80/00: Products made by additive manufacturing - A61B 17/7098: {wherein the implant is permeable or has openings, e.g. fenestrated screw (hollow surgical screws A61B17/864)} - A61B 17/8605: {Heads, i.e. proximal ends projecting from bone} - A61B 17/864: {hollow, e.g. with socket or cannulated} - A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive} - A61B 2017/00526: {Methods of manufacturing} - A61B 2017/00889: {antimicrobial, disinfectant} - A61B 2017/00893: {pharmaceutically effective} - A61B 2017/00964: {composite} - A61B 2017/561: {Implants with special means for releasing a drug} - A61B 2017/568: {produced with shape and dimensions specific for an individual patient} - A61B 2017/8655: {with special features for locking in the bone} - A61F 2002/30962: {using stereolithography} - B22F 3/1103: {with particular physical characteristics} - B22F 5/06: of threaded articles, e.g. nuts - B22F 7/06: of composite workpieces or articles from parts, e.g. to form tipped tools {(B22F7/002 takes precedence)} - B22F 7/062: {involving the connection or repairing of preformed parts} - B22F 7/08: with one or more parts not made from powder {(B22F7/062 takes precedence)} - B22F 10/00: Additive manufacturing of workpieces or articles from metallic powder (apparatus or devices therefor B22F12/00) - B22F 2005/004: {Article comprising helical form elements (B22F5/085 takes precedence)} - B22F 2207/17: density or porosity gradients - B22F 2998/10: Processes characterised by the sequence of their steps - B22F 2999/00: Aspects linked to processes or compositions used in powder metallurgy - B29K 2105/251: {Particles, powder or granules (expandable particles B29K2105/046)} - Y02P 10/25: Process efficiency - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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 - B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00) - 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 - 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) - B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS - Y02P: CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS ## Abstract A bone fastener includes a screw shaft having a proximal portion and a distal portion. The proximal portion is formed by a first manufacturing method and defines a distal face. The distal portion is formed onto the distal face by a second manufacturing method. In some embodiments, systems, spinal constructs, surgical instruments and methods are disclosed. ## Claims ### Claim 1 A bone fastener comprising: a screw shaft including a proximal portion and a distal portion, the proximal portion being formed by a first manufacturing method and defining a distal face, the distal portion being formed onto the distal face by a second manufacturing method. ### Claim 2 (depends on 1) A bone fastener as recited in claim 1, wherein the distal face comprises a fabrication platform such that the distal portion is fused with the proximal portion by the second manufacturing method. ### Claim 3 (depends on 1) A bone fastener as recited in claim 1, wherein the proximal portion is connectable with a part of an additive manufacturing apparatus to form the distal portion onto the distal face by the second manufacturing method. ### Claim 4 (depends on 1) A bone fastener as recited in claim 1, wherein the second manufacturing method includes an additive manufacturing method. ### Claim 5 (depends on 1) A bone fastener as recited in claim 1, wherein the second manufacturing method includes selective laser melting with a powder bed process to fabricate the distal portion onto the distal face. ### Claim 6 (depends on 1) A bone fastener as recited in claim 1, wherein the distal face includes a planar configuration. ### Claim 7 (depends on 1) A bone fastener as recited in claim 1, wherein the distal face includes an angled configuration. ### Claim 8 (depends on 1) A bone fastener as recited in claim 1, wherein the distal portion is fabricated via the second manufacturing method based on a digital rendering of a selected implant configuration. ### Claim 9 (depends on 1) A bone fastener as recited in claim 1, wherein the distal portion is fabricated via the second manufacturing method based on patient anatomy and surgical treatment. ### Claim 10 (depends on 1) A bone fastener as recited in claim 1, wherein the distal portion is fabricated via the second manufacturing method to include a selected porosity. ### Claim 11 (depends on 1) A bone fastener as recited in claim 1, wherein the distal portion is fabricated via the second manufacturing method to include cannulation. ### Claim 12 (depends on 1) A bone fastener as recited in claim 1, wherein the distal portion is fabricated via the second manufacturing method to include a plurality of fenestrations. ### Claim 13 (depends on 1) A bone fastener as recited in claim 1, wherein the distal portion is fabricated via the second manufacturing method to include a lock. ### Claim 14 (depends on 1) A bone fastener as recited in claim 1, wherein the distal portion is fabricated via the second manufacturing method with a material including stainless steel, titanium, cobalt-chromium, polymers and/or silicone powder. ### Claim 15 (depends on 1) A bone fastener as recited in claim 1, wherein the second manufacturing method includes a finishing process. ### Claim 16 (depends on 1) A bone fastener as recited in claim 1, wherein the proximal portion is formed by the first manufacturing method to include a first thread form configuration and the distal portion is formed by the second manufacturing method to include a second thread form configuration. ### Claim 17 (depends on 1) A bone fastener as recited in claim 1, wherein the first manufacturing method includes cutting, grinding, rolling, forming; molding, casting, forging, extruding and/or cold working. ### Claim 18 A method for fabricating a bone fastener, the method comprising the steps of: forming a proximal portion of a screw shaft of a bone fastener by a first manufacturing method, the proximal portion defining a distal face; generating a digital representation of a configuration of a distal portion of the screw shaft; storing the digital representation on a database coupled to a processor; and forming the distal portion by a second manufacturing method that includes an additive manufacturing method such that the processor instructs an additive manufacturing apparatus to form the distal portion onto the distal face. ### Claim 19 (depends on 18) A method as recited in claim 18, wherein the additive manufacturing method includes heating a material in a layer by layer formation of the distal portion onto the distal face. ### Claim 20 A bone fastener comprising: a head; and a threaded shaft including a proximal portion and a distal portion, the proximal portion being formed by a subtractive, deformative or transformative manufacturing method to include a first thread form and define a distal face, the distal portion being formed onto the distal face in a layer by layer formation by an additive manufacturing method, the distal portion including a second thread form.