# US 11,896,505 B2 · Methods for making and using a structural hydrogel polymer device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,896,505 B2 - Document ID: US11896505B2 - Status: Granted - Kind: B2 - Application number: 17/132,493 - Filed: 2020-12-23 - Published: 2021-06-17 - Granted: 2024-02-13 - Earliest claimed: 2005-10-31 - Applicants: Scott M. Epstein - Inventors: Scott M. Epstein - Web page: https://patentgrep.com/patent/US11896505B2 ## CPC - A61F 2/844: folded prior to deployment - A61F 2/82: Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents (stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07) - A61L 29/041: {obtained by reactions only involving carbon-to-carbon unsaturated bonds} - A61L 29/085: {Macromolecular materials} - A61L 29/14: Materials characterised by their function or physical properties {, e.g. lubricating compositions} - A61L 29/145: {Hydrogels or hydrocolloids} - A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)} - A61L 31/048: {obtained by reactions only involving carbon-to-carbon unsaturated bonds (A61L31/041 takes precedence)} - A61L 31/145: {Hydrogels or hydrocolloids} - A61M 25/0009: {Making of catheters or other medical or surgical tubes} - A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections} - A61M 27/008: {pre-shaped, for use in the urethral or ureteral tract} - A61F 2240/001: Designing or manufacturing processes - A61L 2300/416: Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus - A61M 2207/00: Methods of manufacture, assembly or production - 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) - 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) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract The present invention relates generally a manufacturing process which results in a completely hydrogel polymer device that maintains lumen patency which allows for numerous applications. One or more physical post-implantation dimensions of the device can be controlled by placing it in a solution that has a predetermined osmolarity and/or pH. In addition, the device can deliver an absorbed therapeutic agent to a target anatomical site. Alternatively, the device can function as a selective membrane to selectively absorb one or more target molecules from a body fluid. ## Claims ### Claim 1 A method for manufacturing a medical device, comprising: depositing an inner layer material comprising a hydrogel on a rotating, horizontally-disposed mandrel; coagulating the inner layer material comprising the hydrogel in place on the mandrel; dehydrating the inner layer material; depositing a second layer of material comprising a hydrogel on the inner layer material such that the medical device is produced without thermoplastic processing; and placing the medical device in a solution having a predetermined osmolarity. ### Claim 2 (depends on 1) The method of claim 1, wherein the predetermined osmolarity is approximately equal to an osmolarity of a target body fluid, whereby one or more physical dimensions of the medical device remains about the same after the medical device is implanted in a target anatomical site that includes the target body fluid. ### Claim 3 (depends on 2) The method of claim 2, wherein the solution comprises a hypertonic saline solution. ### Claim 4 (depends on 3) The method of claim 3, wherein the hypertonic saline solution has an NaCl concentration is in a range of about 3.5% NaCl to about 4% NaCl. ### Claim 5 (depends on 4) The method of claim 4, wherein the target body fluid comprises urine. ### Claim 6 (depends on 2) The method of claim 2, wherein the one or more physical dimensions comprises an outer diameter of the medical device. ### Claim 7 (depends on 1) The method of claim 1, wherein the predetermined osmolarity is greater than an osmolarity of a target body fluid, whereby one or more physical dimensions of the medical device increases after the medical device is implanted in a target anatomical site that includes the target body fluid. ### Claim 8 (depends on 7) The method of claim 7, wherein the solution comprises a hypertonic saline solution having an NaCl concentration in a range of about 4% NaCl to about 5% NaCl. ### Claim 9 (depends on 8) The method of claim 8, wherein: the one or more physical dimensions comprises an outer diameter of the medical device, and the outer diameter increases by about 20% to about 30% after the medical device is implanted in the target anatomical site compared to the outer diameter immediately before the medical device is implanted in the target anatomical site. ### Claim 10 (depends on 1) The method of claim 1, wherein the predetermined osmolarity is lower than an osmolarity of a target body fluid, whereby one or more physical dimensions of the medical device decreases after the medical device is implanted in a target anatomical site that includes the target body fluid. ### Claim 11 (depends on 10) The method of claim 10, wherein the solution comprises a saline solution having an NaCl concentration in a range of about 0.1% NaCl to about 2.5% NaCl. ### Claim 12 (depends on 11) The method of claim 11, wherein: the one or more physical dimensions comprises an outer diameter of the medical device, and the outer diameter decreases by about 20% to about 30% after the medical device is implanted in the target anatomical site compared to the outer diameter immediately before the medical device is implanted in the target anatomical site.