# US 10,765,775 B2 · Implantable medical devices comprising bio-degradable alloys with enhanced degradation rates > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,765,775 B2 - Document ID: US10765775B2 - Status: Granted - Kind: B2 - Application number: 16/255,093 - Filed: 2019-01-23 - Published: 2019-12-12 - Granted: 2020-09-08 - Earliest claimed: 2013-03-14 - Assignees: Bio DG, Inc.; U.S. Department of Energy - Applicants: Bio DG, Inc.; U.S. Department of Energy - Inventors: Herbert Radisch; Paul Jablonski - Web page: https://patentgrep.com/patent/US10765775B2 ## CPC - A61L 27/042: {Iron or iron alloys} - A61C 8/0012: {characterised by the material or composition, e.g. ceramics, surface layer, metal alloy (use of specific materials A61K6/00)} - A61L 31/022: {Metals or alloys} - A61L 31/148: {Materials at least partially resorbable by the body} - A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} - Y10T 428/12292: Workpiece with longitudinal passageway or stopweld material [e.g., for tubular stock, etc.] - 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) - A61C: DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE (non-driven toothbrushes A46B; {tongue scrapers A61B17/24;} preparations for dentistry A61K6/00; preparations for cleaning the teeth or mouth A61K8/00, A61Q11/00) - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract The invention provides medical devices comprising high-strength alloys which degrade over time in the body of a human or animal, at controlled degradation rates, without generating emboli and which have enhanced degradation due to the presence of a halogen component. In one embodiment the alloy is formed into a bone fixation device such as an anchor, screw, plate, support or rod. In another embodiment the alloy is formed into a tissue fastening device such as staple. In yet another embodiment, the alloy is formed into a dental implant or a stent. ## Claims ### Claim 1 A method of producing a biodegradable alloy that is austenitic in structure and includes iron, at least one additional metallic element, and an iron reactive component, wherein the iron reactive component is dispersed within the biodegradable alloy at a concentration between about 0.1 ppm to about 500 ppm, and wherein the degradation rate of the biodegradable alloy, when implanted in a biological subject, is greater than the degradation rate of an alloy having the same composition as the biodegradable alloy except the absence of the iron reactive component, the method comprising: melting iron, the at least one additional metallic element, and a salt containing the iron reactive component to produce a mixture; and contacting the mixture with a gas containing the iron reactive component to produce the biodegradable alloy. ### Claim 2 (depends on 1) The method of claim 1, wherein the salt containing the iron reactive component is selected from the group consisting of sodium fluoride, sodium chloride, copper chloride, copper fluoride, magnesium chloride, silver chloride, calcium chloride, calcium fluoride, iron chloride, and a combination thereof. ### Claim 3 (depends on 1) The method of claim 1, wherein the gas containing the iron reactive component has a partial pressure of at least about 0.1 torr, at least about 0.2 torr, at least about 0.5 torr, at least about 0.8 torr, at least about 1 torr, at least about 2 torr, at least about 5 torr, at least about 10 torr, at least about 50 torr, or at least about 100 torr. ### Claim 4 (depends on 1) The method of claim 1, the iron reactive component is a halogen component. ### Claim 5 (depends on 4) The method of claim 4, wherein the halogen component is selected from the group consisting of chloride, fluoride, bromide, and iodide. ### Claim 6 (depends on 5) The method of claim 5, wherein the halogen component is chloride or fluoride. ### Claim 7 (depends on 5) The method of claim 5, wherein the gas containing the iron reactive component is selected from the group consisting of chlorine, fluorine, bromine, and iodine. ### Claim 8 (depends on 1) The method of claim 1, further comprising mixing the iron reactive component with argon gas to produce the gas containing the iron reactive component. ### Claim 9 (depends on 8) The method of claim 8, wherein the argon gas has a partial pressure of at least about 10 torr, at least about 20 torr, at least about 50 torr, at least about 80 torr, at least about 100 torr, at least about 150 torr, at least about 200 torr, at least about 250 torr, at least about 300 torr, or at least about 500 torr. ### Claim 10 (depends on 1) The method of claim 1, wherein the biodegradable alloy includes an austenite-promoting component and a corrosion-resisting component. ### Claim 11 (depends on 1) The method of claim 1, wherein the biodegradable alloy contains between about 20% to 40% manganese by weight. ### Claim 12 (depends on 1) The method of claim 1, wherein the biodegradable alloy contains less than about 0.3% niobium by weight. ### Claim 13 (depends on 1) The method of claim 1, wherein the biodegradable alloy contains less than about 1% carbon by weight. ### Claim 14 (depends on 1) The method of claim 1, wherein the biodegradable alloy includes manganese and niobium. ### Claim 15 (depends on 1) The method of claim 1, wherein the biodegradable alloy includes at least about 0.01% to about 0.1% a non-metallic element by weight. ### Claim 16 (depends on 15) The method of claim 15, wherein the biodegradable alloy includes at least about 0.01% to about 0.1% carbon by weight. ### Claim 17 (depends on 1) The method of claim 1, wherein the biodegradable alloy is in a form of an implantable medical device. ### Claim 18 (depends on 17) The method of claim 17, wherein the implantable medical device is a bone screw, a bone anchor, a tissue staple, a craniomaxillofacial reconstruction plate, a fastener, a reconstructive dental implant, or a stent. ### Claim 19 (depends on 17) The method of claim 17, further comprising coating the implantable medical device with a therapeutic agent. ### Claim 20 (depends on 17) The method of claim 17, further comprising coating the implantable medical device with a biodegradable hydrogel. ### Claim 21 (depends on 17) The method of claim 17, wherein the implantable medical device has a geometry that maximizes the surface to mass ratio. ### Claim 22 (depends on 17) The method of claim 17, wherein the implantable medical device includes a hollow opening or passageway formed therein. ### Claim 23 (depends on 1) The method of claim 1, wherein the concentration of the iron reactive component in the biodegradable alloy is between about 1 ppm to about 500 ppm, between about 10 ppm to about 300 ppm, or between about 50 ppm to about 150 ppm. ### Claim 24 (depends on 1) The method of claim 1, wherein the concentration of the iron reactive component in the biodegradable alloy is about 200 ppm. ### Claim 25 (depends on 1) The method of claim 1, wherein the iron, the at least one additional metallic element, and the salt containing the iron reactive component are melted in the presence of the gas containing the iron reactive component. ### Claim 26 (depends on 1) A biodegradable alloy produced by the method of claim 1.