Medical devices for treating urological and uterine conditions

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.

1 - 33 . (canceled) 
     
     
         34 . A uterine device for the treatment of a uterine condition comprising a contoured structure of a flexible material having the general contours of an interior cavity of a human female uterus wherein the device comprises a therapeutic agent for treating a uterine condition. 
     
     
         35 . The device of  claim 34 , wherein said device further comprises a second therapeutic agent. 
     
     
         36 . The device of  claim 34 , wherein said device comprises a release region that comprises a biocompatible polymer and wherein the therapeutic agent is disposed beneath or within the release region. 
     
     
         37 . The device of  claim 36 , wherein said release region comprises a plurality of biocompatible polymers. 
     
     
         38 . The device of  claim 36 , wherein said device comprises a plurality of said release regions. 
     
     
         39 . The device of  claim 36 , wherein said release region comprises a biocompatible biodegradable polymer. 
     
     
         40 . The device of  claim 36 , wherein said release region comprises a biocompatible non-biodegradable polymer. 
     
     
         41 . The device of  claim 40 , 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, silicone, and vinyl aromatic copolymers. 
     
     
         42 . The device of  claim 39 , wherein said biodegradable polymer is selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone, and copolymers and mixtures thereof. 
     
     
         43 . The device of  claim 40 , wherein said non-biodegradable polymer is an ethylene vinyl acetate copolymer. 
     
     
         44 . The device of  claim 34 , wherein the therapeutic agent is selected from the group consisting of non-steroidal anti-inflammatory agents, steroidal anti-inflammatory agents, contraceptives, hormonal replacement therapy agents, LUPRON®, PANAZOL®, GnRH agonists, danazol, antiprogestins comprising gestrinone and mifepristone, selective progesterone receptor modulators comprising asoprisnil, selective estrogen receptor modulators, aromatase inhibitors comprising anastrozole, letrozole and exemestane, and antiestrogens comprising tamoxifen and fulvestrant and combinations thereof. 
     
     
         45 . The device of  claim 34 , wherein the therapeutic agent is selected from the group consisting of contraceptives and GnRH agonists, or combinations thereof. 
     
     
         46 . The device of  claim 36 , wherein the release region comprises a biocompatible non-biodegradable polymer comprising therapeutic agent is selected from the group consisting of Ethylene Vinyl Acetate (EVA) and the therapeutic agent is selected from the group consisting of GnRH agonists, LUPRON®, progestins and oral contraceptives. 
     
     
         47 . The device of  claim 36 , wherein said release region is a barrier layer at least partially covering a source of therapeutic agent. 
     
     
         48 . The device of  claim 34 , further comprising an antimicrobial agent present in an amount effective to inhibit the growth of microbes on and around the device. 
     
     
         49 . The device of  claim 48 , wherein the antimicrobial agent is selected from the group consisting of triclosan, chlorhexidine and combinations thereof. 
     
     
         50 . The device of  claim 34 , further comprising a lubricious hydrophilic coating on a surface of said device. 
     
     
         51 . The device of  claim 34 , wherein said device is produced by injection molding. 
     
     
         52 . The device of  claim 34 , wherein the uterine condition comprises uterine fibroids or endometriosis. 
     
     
         53 . The device of  claim 34 , wherein the contoured structure comprises a hollow three-dimensional shape selected from a balloon, an irregular cone, an irregular sphere. 
     
     
         54 . The device of  claim 34 , wherein the contoured structure comprises a continuous hoop comprising an irregular ring.