# US 11,998,654 B2 · Securing implants and medical devices > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,654 B2 - Document ID: US11998654B2 - Status: Granted - Kind: B2 - Application number: 16/508,356 - Filed: 2019-07-11 - Published: 2020-05-21 - Granted: 2024-06-04 - Earliest claimed: 2018-07-12 - Assignees: Bard Shannon Limited - Applicants: Bard Shannon Limited - Inventors: Gideon Sturlesi; Guy Tomer; Aurelie Benaddi; Mary Hainrichson; Amir Hadid; Ofer Yatziv - Web page: https://patentgrep.com/patent/US11998654B2 ## CPC - A61L 24/043: {Mixtures of macromolecular materials} - A61L 31/045: {Gelatin} - A61L 24/0036: {Porous materials, e.g. foams or sponges} - A61L 31/146: {Porous materials, e.g. foams or sponges} - 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) ## Abstract A biocompatible material for securing such implantable medical devices, for example by using an adhesive path. ## Claims ### Claim 1 An implantable medical device having a patch affixed to only a portion of a surface of the implantable medical device but not covering an entirety of the surface of the implantable medical device, the patch able to secure the implantable medical device to a tissue, wherein the patch comprises an adhesive layer positioned to adhere the implantable medical device to the tissue and a non-adhesive backing layer covering the adhesive layer, wherein the adhesive layer comprises foamed and lyophilized biocompatible gelatin and transglutaminase. ### Claim 2 (depends on 1) The implantable medical device of claim 1, wherein said backing layer is a reinforcing backing layer, wherein said reinforcing backing layer comprises at least one water erodible, film-forming polymer. ### Claim 3 (depends on 2) The implantable medical device of claim 2, wherein said reinforcing backing layer comprises at least one of cellulose ether derivatives, such as HPMC (hydroxypropyl methylcellulose) or HPC (hydroxypropyl cellulose), HEC (hydroxyethyl cellulose), EC (ethyl cellulose) or crosslinked gelatin, or a combination thereof. ### Claim 4 (depends on 1) The implantable medical device of claim 1, wherein said backing layer has a thickness of from 50 mm to 1000 mm. ### Claim 5 (depends on 1) The implantable medical device of claim 1, wherein said backing layer is removable. ### Claim 6 (depends on 1) The implantable medical device of claim 1, wherein said backing layer remains after adhering said implantable medical device to the tissue. ### Claim 7 (depends on 1) The implantable medical device of claim 1, wherein the foamed and lyophilized biocompatible gelatin and transglutaminase has a density in the range of 5 to 100 mg/cm3. ### Claim 8 (depends on 7) The implantable medical device of claim 7, wherein the density is in the range of 10 to 50 mg/cm3. ### Claim 9 (depends on 1) The implantable medical device of claim 1, wherein the foamed and lyophilized biocompatible gelatin and transglutaminase is formed by foaming a gelatin solution, and wherein prior to foaming, a concentration of gelatin in the gelatin solution is between 0.1% and 30% w/w. ### Claim 10 (depends on 9) The implantable medical device of claim 9, wherein prior to foaming, the concentration of gelatin in the gelatin solution is between 1% and 20% w/w. ### Claim 11 (depends on 10) The implantable medical device of claim 10 wherein prior to foaming, the concentration of gelatin in the gelatin solution is between 5% and 15% w/w. ### Claim 12 (depends on 1) The implantable medical device of claim 1, wherein the gelatin is incorporated with said transglutaminase in the adhesive layer such that one or more of the following occur: a majority of transglutaminase activity is preserved throughout a process of preparation; transglutaminase is equally distributed across the adhesive layer surface; and/or transglutaminase is embedded into the depth of the adhesive layer (gradient or equal distribution). ### Claim 13 (depends on 1) The implantable medical device of claim 1, wherein said transglutaminase is incorporated into said adhesive layer according to one or more of mixing before drying said adhesive layer or after drying said adhesive layer. ### Claim 14 (depends on 1) The implantable medical device of claim 1, wherein said adhesive layer is dried to comprise no more than 10% moisture content. ### Claim 15 (depends on 1) The implantable medical device of claim 1, wherein said transglutaminase is present in the adhesive layer at a concentration of from 0.0006 to 2 mg transglutaminase/cm3. ### Claim 16 (depends on 1) The implantable medical device of claim 1, wherein said adhesive layer has a thickness of from 0.6 cm to 2 cm. ### Claim 17 (depends on 1) The implantable medical device of claim 1, wherein said patch has a surface area from 2 cm2 to 600 cm2. ### Claim 18 (depends on 17) The implantable medical device of claim 17, wherein said patch is in a shape of a square, rectangle, circle, or oval. ### Claim 19 (depends on 1) The implantable medical device of claim 1, wherein said adhesive layer is configured and positioned to adhere said implantable medical device to the tissue at a plurality of contact points on a surface of the tissue. ### Claim 20 (depends on 1) The implantable medical device of claim 1, wherein the patch is attached by adhesion to the implantable medical device.