Medical devices for treating urological and uterine conditions

• US 20060264912A1
• Filed: 05/09/2005
• Published: 11/23/2006
• Est. Priority Date: 05/09/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: McIntyre, Jon T., Daignault, Kenneth
• Granted Patent: US 7,862,552 B2
• Time in Patent Office: Days
• US Class Current: 604/891.100
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/0036 Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
• CPC Class Codes: A61K 9/0039 Devices retained in the uterus for a prolonged period, e.g. intrauterine devices for contraception
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: 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
• CPC Class Codes: A61M 2210/1078 Urinary tract
• CPC Class Codes: A61M 2210/1433 Uterus
• CPC Class Codes: A61M 2210/1475 Vagina
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract
• CPC Class Codes: A61P 15/02 for disorders of the vagina

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

1. A urological medical device comprising a first therapeutic agent for treating a urological condition, wherein said medical device is adapted, upon implantation or insertion into a patient, to release all or a majority of said first therapeutic agent from a portion of said medical device that occupies the urinary bladder.

2. The device of claim 1, wherein the urological condition comprises interstitial cystitis.

3. The device of claim 1, wherein said device further comprises a second therapeutic agent.

4. The device of claim 1, wherein said therapeutic agent is disposed beneath or within at least one release region that comprises a biocompatible polymer.

5. The device of claim 4, wherein said release region comprises a plurality of biocompatible polymers.

6. The device of claim 1, wherein said therapeutic agent is released only from said portion of said medical device that occupies the urinary bladder.

7. The device of claim 1, wherein said device resides completely in the urinary bladder.

8. The device of claim 7, wherein said device comprises a hollow three dimensional structure comprising a balloon, an annular ring, a disk, or a shaft.

9. The device of claim 7, 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.

10. The device of claim 9, wherein the retraction means comprises a suture or thread.

11. The device of claim 1, wherein said device comprises a tubular member, a renal retention structure on the distal end of the tubular member and a bladder retention structure on the proximal end of the tubular member.

12. The device of claim 11, wherein the bladder retention structure comprises a first release region that comprises a biocompatible polymer and wherein said first therapeutic agent is disposed beneath or within said release region.

13. The device of claim 12, wherein the device further comprises at least one other release region, contained in the tubular member or renal retention structure or both, which comprises a biocompatible polymer and beneath or within which a second therapeutic agent is disposed, which may be the same as or different from said first therapeutic agent.

14. The device of claim 13, wherein the first release region and other release regions contain the same therapeutic agent in different concentrations such that a concentration gradient exists in the device.

15. The device of claim 14, wherein the first release region contains a higher concentration of the therapeutic agent than other release regions.

16. The device of claim 13, wherein the first and second therapeutic agents are different.

17. 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).

18. The device of claim 14, wherein the first release region and other release regions contain the same therapeutic agent and wherein the release regions are adapted such that the therapeutic agent is released at higher concentrations in the bladder retention structure.

19. The device of claim 11, wherein the urological condition comprises interstitial cystitis.

20. The device of claim 4, wherein said release region(s) comprises a biocompatible biodegradable polymer.

21. The device of claim 4, wherein said release region(s) comprise a biocompatible non-biodegradable polymer.

22. The device of claim 21, 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.

23. The device of claim 20, wherein said biodegradable polymer is selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone, and copolymers and mixtures thereof.

24. The device of claim 21, wherein said non-biodegradable polymer is an ethylene vinyl acetate copolymer.

25. 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.

26. The device of claim 1, wherein the therapeutic agent is selected from the group consisting of pentosan polysulfate sodium and heparin, or combinations thereof.

27. The device of claim 1, wherein said polymer further comprises a radio-opacifying agent.

28. The device of claim 4, wherein said release region is a barrier layer at least partially covering a source of therapeutic agent.

29. 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.

30. The device of claim 4, wherein the antimicrobial agent is selected from the group consisting of triclosan, chlorhexidine and combinations thereof.

31. The device of claim 1, further comprising a lubricious hydrophilic coating on a surface of said device.

32. The device of claim 11, wherein said device comprises a melt-extruded polymeric tubular shaft.

33. The device of claim 11, wherein the device comprises a ureteral stent, a urethral stent or a urinary catheter.

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.