# US 7,862,552 B2 · Medical devices for treating urological and uterine conditions > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 7,862,552 B2 - Document ID: US7862552B2 - Status: Granted - Kind: B2 - Application number: 11/125,296 - Filed: 2005-05-09 - Published: 2006-11-23 - Granted: 2011-01-04 - Earliest claimed: 2005-05-09 - Assignees: Boston Scientific Scimed, Inc. - Inventors: Jon T. McIntyre; Kenneth Daignault - Web page: https://patentgrep.com/patent/US7862552B2 ## CPC - A61M 27/008: {pre-shaped, for use in the urethral or ureteral tract} - A61K 9/0034: {Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants} - A61K 9/0036: {Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms} - A61K 9/0039: {Devices retained in the uterus for a prolonged period, e.g. intrauterine devices for contraception} - A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} - A61P 15/02: for disorders of the vagina - A61L 2300/602: Type of release, e.g. controlled, sustained, slow - A61M 2025/0056: {provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir} - A61M 2210/1078: Urinary tract - A61M 2210/1433: Uterus - A61M 2210/1475: Vagina - 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)} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - 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) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present invention relates to implantable or insertable medical devices that treat uterine and urological conditions that cause chronic pelvic pain and other symptoms. In another aspect, the present invention relates to methods of manufacturing such implantable or insertable medical devices. ## Claims ### Claim 1 A urological medical device comprising a renal retention structure having a first release region and a bladder retention structure having a second release region, wherein the first and second release regions each comprise a biocompatible polymer and a first therapeutic agent disposed beneath or within the biocompatible polymer, wherein the first and second release regions both contain said first therapeutic agent in different concentrations such that a concentration gradient exists in the device, wherein the concentration of said first therapeutic agent is greater in the second release region than in the first release region. ### Claim 2 (depends on 1) The device of claim 1, wherein the urological condition comprises interstitial cystitis. ### Claim 3 (depends on 1) The device of claim 1, wherein said device further comprises a second therapeutic agent. ### Claim 4 (depends on 1) The device of claim 1, wherein said release region comprises a plurality of biocompatible polymers. ### Claim 5 (depends on 1) The device of claim 1, wherein said first therapeutic agent is released only from said second release region of the bladder retention structure. ### Claim 6 (depends on 1) The device of claim 1, wherein said device comprises a hollow three dimensional structure comprising a balloon, an annular ring, a disk, or a shaft. ### Claim 7 (depends on 1) The device of claim 1, wherein the device further comprises a retraction means for removing the device from the bladder and out of the body, wherein the retraction means is attached to a proximal portion of the structure. ### Claim 8 (depends on 7) The device of claim 7, wherein the retraction means comprises a suture or thread. ### Claim 9 (depends on 1) The device of claim 1, wherein at least one of the first and second release regions further comprises a second therapeutic agent, which is different from said first therapeutic agent. ### Claim 10 (depends on 1) The device of claim 1, wherein the first therapeutic agent comprises pentosan polysulfate or heparin, amitripyline, imipramine, hydroxyzine, dihydrochloride, hydroxyzine hydrochloride, hyoscyamine sulfate, hyosyamine, oxybutynin chloride, flavoxate, urised, phenazopyridine hydrochloride, DMSO, sodium oxychlorosene, lidocaine, hydrocortisone sodium succinate, sodium bicarbonate, capsaicin, hyaluronic acid silver nitrate or bacillus of Calmette and Guerin (BCG). ### Claim 11 (depends on 1) The device of claim 1, wherein the first therapeutic agent is released at higher concentrations in the bladder retention structure. ### Claim 12 (depends on 1) The device of claim 1, wherein the urological condition comprises interstitial cystitis. ### Claim 13 (depends on 1) The device of claim 1, wherein said release region(s) comprises a biocompatible biodegradable polymer. ### Claim 14 (depends on 13) The device of claim 13, wherein said biodegradable polymer is selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone, and copolymers and mixtures thereof. ### Claim 15 (depends on 1) The device of claim 1, wherein said release region(s) comprise a biocompatible non-biodegradable polymer. ### Claim 16 (depends on 15) The device of claim 15, wherein said non-biodegradable polymer is selected from the group consisting of ethylene vinyl acetate copolymers, copolymers of ethylene with acrylic acid or methacrylic acid, elastomeric polyurethanes and polyurethane copolymers, metallocene catalyzed polyethylene, ionomers and vinyl aromatic copolymers. ### Claim 17 (depends on 15) The device of claim 15, wherein said non-biodegradable polymer is an ethylene vinyl acetate copolymer. ### Claim 18 (depends on 1) The device of claim 1, wherein the therapeutic agent is selected from the group consisting of non-steroidal anti-inflammatory agents, steroidal anti-inflammatory agents, antihistamines, tricyclic antidepressants, selective serotonin reuptake inhibitors, calcium channel blockers, dimethyl sulfoxide, pentosan polysulfate sodium, anesthetic agents comprising lidocaine, bupivacaine and ropivacaine, heparinoids comprising heparin, heparin-binding epidermal growth factor-like growth factor, glycosaminoglycans comprising hyaluronic acid, antibiotics, analgesics comprising salicylic acid, antimicrobial agents comprising triclosan, cephalosporins, aminoglycosides or nitrofurantoin, potassium chelating agents comprising potassium citrate, sodium succinate, sodium bicarbonate, capsaicin, silver nitrate, and bacillus of Calmette and Guerin, or combinations thereof. ### Claim 19 (depends on 1) The device of claim 1, wherein the therapeutic agent is selected from the group consisting of pentosan polysulfate sodium and heparin, or combinations thereof. ### Claim 20 (depends on 1) The device of claim 1, wherein said polymer further comprises a radio-opacifying agent. ### Claim 21 (depends on 1) The device of claim 1, wherein said release region is a barrier layer at least partially covering a source of therapeutic agent. ### Claim 22 (depends on 1) The device of claim 1, further comprising an antimicrobial agent present in an amount effective to inhibit the growth of microbes on and around the device. ### Claim 23 (depends on 1) The device of claim 1, wherein the antimicrobial agent is selected from the group consisting of triclosan, chlorhexidine and combinations thereof. ### Claim 24 (depends on 1) The device of claim 1, further comprising a lubricious hydrophilic coating on a surface of said device. ### Claim 25 (depends on 1) The device of claim 1, wherein said device comprises a melt-extruded polymeric tubular shaft. ### Claim 26 (depends on 1) The device of claim 1, wherein the device comprises a ureteral stent, a urethral stent or a urinary catheter.