Medical devices for treating urological and uterine conditions

• US 7,862,552 B2
• Filed: 05/09/2005
• Issued: 01/04/2011
• Est. Priority Date: 05/09/2005
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: McIntyre, Jon T., Daignault, Kenneth
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Vu; Quynh-Nhu H
• Application Number:
  US11/125,296
• Publication Number:
  US 20060264912A1
• Time in Patent Office: 2,066 Days
• Field of Search: 604/8, 604/19, 604/21, 604/27, 604/36, 604/48, 604/502, 604/506, 604/523, 604/544, 604/73, 604/83, 604/93.01, 604/95.02, 604/164.01, 604/164.12, 604/171, 604/239, 604/264, 604/272, 604/277, 604/891.1
• US Class Current: 604/891.1
• 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 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.

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 release region comprises a plurality of biocompatible polymers.

5. The device of claim 1, wherein said first therapeutic agent is released only from said second release region of the bladder retention structure.

6. 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.

7. 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.

8. The device of claim 7, wherein the retraction means comprises a suture or thread.

9. 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.

10. 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).

11. The device of claim 1, wherein the first therapeutic agent is released at higher concentrations in the bladder retention structure.

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

13. The device of claim 1, wherein said release region(s) comprises a biocompatible biodegradable polymer.

14. 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.

15. The device of claim 1, wherein said release region(s) comprise a biocompatible non-biodegradable polymer.

16. 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.

17. The device of claim 15, wherein said non-biodegradable polymer is an ethylene vinyl acetate copolymer.

18. 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.

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

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

21. The device of claim 1, wherein said release region is a barrier layer at least partially covering a source of therapeutic agent.

22. 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.

23. The device of claim 1, wherein the antimicrobial agent is selected from the group consisting of triclosan, chlorhexidine and combinations thereof.

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

25. The device of claim 1, wherein said device comprises a melt-extruded polymeric tubular shaft.

26. The device of claim 1, wherein the device comprises a ureteral stent, a urethral stent or a urinary catheter.