# US 9,433,709 B2 · Interventional medical device and manufacturing method thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,433,709 B2 - Document ID: US9433709B2 - Status: Granted - Kind: B2 - Application number: 14/677,741 - Filed: 2015-04-02 - Published: 2015-07-30 - Granted: 2016-09-06 - Earliest claimed: 2011-09-29 - Assignees: Shanghai Microport Medical (Group) Co., Ltd. - Applicants: Dadong Zhang; Xu Cai; Chengyun Yue; Junfei Li; Yan Hu; Peng Huang; Zhirong Tang; Qiyi Luo - Inventors: Dadong Zhang; Xu Cai; Chengyun Yue; Junfei Li; Yan Hu; Peng Huang; Zhirong Tang; Qiyi Luo - Web page: https://patentgrep.com/patent/US9433709B2 ## CPC - A61L 31/10: Macromolecular materials - 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 31/146: {Porous materials, e.g. foams or sponges} - A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} - A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body - A61F 2250/0068: the pharmaceutical product being in a reservoir - A61L 2300/416: Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus - A61L 2420/02: Methods for coating medical devices - 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) ## Abstract An interventional medical device and manufacturing method thereof. The interventional medical device comprises: a stent body (1); a surface of the stent body (1) being provided with a drug releasing structure (3), and drug in the drug releasing structure (3) being drug for suppressing proliferation of adventitial fibroblasts and a drug for suppressing proliferation of intimal and/or smooth muscle cells. In use, after interventional medical device is implanted into a human body, the drug for suppressing proliferation of adventitial fibroblasts carried thereon can promote the compensatory expansion of the vessel, and the drug for suppressing proliferation of intimal cells and/or smooth muscle cells carried thereon can suppress intimal proliferation of the vessel. The combination of the two kinds of drugs greatly reduces the occurrence rate of in-stent restenosis. ## Claims ### Claim 1 An interventional medical device, comprising a stent body with a drug releasing structure on its surface and at least one drug for suppressing proliferation of adventitial fibroblast fibroblasts and at least one drug for suppressing proliferation of intimal cells and/or smooth muscle cells loaded on or in said drug releasing structure, wherein said at least one drug for suppressing adventitial fibroblast proliferation is or includes asiaticoside and said at least one drug for suppressing proliferation of intimal cells and/or smooth muscle cells is or includes rapamycin, wherein the ratio between the weight of asiaticoside and that of rapamycin present in the drug releasing structure is from 2:1 to 5:1. ### Claim 2 (depends on 1) The interventional medical device according to claim 1, wherein said drug releasing structure is a dense mixed layer formed by a polymer and the drug for suppressing adventitial fibroblast proliferation and the drug for suppressing proliferation of intimal cells and/or smooth muscle cells. ### Claim 3 (depends on 2) The interventional medical device according to claim 2, wherein said polymer includes polylactic acid, polyethylene glycol, styrene-butene copolymer, polycaprolactone, poly(butyl methacrylate), poly (ethyl methacrylate), polyvinyl ethyl acetate, polyurethane, polyvinyl pyrrolidone, polyphosphorylcholine, silk protein, gelatin, chitin and/or hyaluronic acid. ### Claim 4 (depends on 1) The interventional medical device according to claim 1, wherein, said drug releasing structure is a microporous structure prepared on the surface of said stent body or a microporous coating structure formed on the surface of said stent body, and the drugs are loaded into said microporous structure or microporous coating structure. ### Claim 5 (depends on 1) The interventional medical device according to claim 1, wherein said at least one drug for suppressing adventitial fibroblast proliferation additionally includes at least one drug selected from the group consisting of tanshinone, madecassoside, ligustrazine, dracorhodin, rosuvastatin, and angiotensin. ### Claim 6 (depends on 1) The interventional medical device according to claim 1, wherein said at least one drug for suppressing proliferation of intimal cells and/or smooth muscle cells additionally includes at least one drug selected from the group consisting of derivatives of rapamycin and paclitaxel and derivative thereof. ### Claim 7 (depends on 1) The interventional medical device according to claim 1, wherein said stent body comprises a coronary artery stent, an intracranial vascular stent, a peripheral vascular stent, an intraoperative stent, a heart valve stent, a biliary tract stent, an esophageal stent, an intestinal tract stent, a pancreatic duct stent, an urethral stent or a tracheal stent. ### Claim 8 A method for preparing an interventional medical device, wherein said method comprises: preparing a microporous structure on the surface of the stent body; formulating a solution containing at least one drug for suppressing proliferation of adventitial fibroblasts and at least one drug for suppressing proliferation of intimal cells and/or smooth muscle cells, wherein said at least one drug for suppressing adventitial fibroblast proliferation is or includes asiaticoside and said at least one drug for suppressing proliferation of intimal cells and/or smooth muscle cells is or includes rapamycin, loading the drugs within the formulated solution into said microporous structure, wherein the ratio between the weight of asiaticoside and that of rapamycin present in the microporous structure is from 2:1 to 5:1; drying the stent body to obtain said interventional medical device. ### Claim 9 (depends on 8) The method according to claim 8, wherein, preparing a microporous structure on the surface of the stent body comprises forming micropores on the surface of the stent body by anodic oxidation, micro-arc oxidation and/or chemical corrosion. ### Claim 10 (depends on 8) The method according to claim 8, wherein preparing a microporous structure on the surface of the stent body comprises preparing a coating having micropores on the surface of said stent body. ### Claim 11 (depends on 8) The method according to claim 8, wherein loading the drugs within the formulated solution into said microporous structure comprises loading the drugs within said solution into said microporous structure by ultrasonic spraying, air spraying and/or dipping. ### Claim 12 A method for preparing an interventional medical device, wherein said method comprises: formulating a mixed solution of a drug for suppressing adventitial fibroblast proliferation and a polymer, as well as a mixed solution of a drug for suppressing proliferation of intimal cells and/or smooth muscle cells and a polymer, respectively, or formulating a mixed solution of a drug for suppressing adventitial fibroblast proliferation, a drug for suppressing proliferation of intimal cells and/or smooth muscle cells and a polymer, wherein said drug for suppressing adventitial fibroblast proliferation is asiaticoside and said drug for suppressing proliferation of intimal cells and/or smooth muscle cells is rapamycin; successively coating the surface of the stent body with the mixed solution of the drug for suppressing adventitial fibroblast proliferation and the polymer, as well as the mixed solution of the drug for suppressing proliferation of intimal cells and/or smooth muscle cells and the polymer, or coating the surface of the stent body with the mixed solution of the drug for suppressing adventitial fibroblast proliferation, the drug for suppressing proliferation of intimal cells and/or smooth muscle cells and the polymer; drying the stent body to obtain the interventional medical device, wherein the ratio between the weight of asiaticoside and that of rapamycin present in the interventional medical device is from 2:1 to 5:1. ### Claim 13 (depends on 12) The method according to claim 12, wherein said coating comprises ultrasonic spraying, air spraying and/or dipping.