Methods and devices for occluding body lumens and/or for delivering therapeutic agents

• US 20050045183A1
• Filed: 06/28/2004
• Published: 03/03/2005
• Est. Priority Date: 12/18/1996
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Ovion Inc. (Endo International PLC)
• Inventors: Tremulis, William S., Callister, Jeffrey P.
• Granted Patent: US 7,694,683 B2
• Time in Patent Office: Days
• US Class Current: 128/831
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 6/225 transcervical

Abstract

Devices, systems and methods for occluding the lumens of anatomical passageways and/or for delivering drugs or other substances to the bodies of human or animal subjects.

Claims

1. A device for implantation within a body lumen of a human or veterinary subject, said device comprising:

an intraluminal member that is implantable in a body lumen to cause occlusion of the body lumen; and

a quantity of a therapeutic substance disposed on, in or near the intraluminal member such that the substance will be delivered to some target tissue for at least some period of time following implantation of the intraluminal member within the body lumen.

2. A device according to claim 1 wherein the device is implanted in a fallopian tube or other lumen of the female reproductive tract and is effective to occlude that lumen following implantation.

3. A device according to claim 2 wherein the therapeutic substance delivered by the device comprises a contraceptive.

4. A device according to claim 3 wherein the contraceptive substance is selected from the group consisting of:

synthetic progestins, levonorgestrel, medroxyprogesterone acetate, norethisterone enanthate, progestogen, levonorgestrel, levonorgestrel (as progestogen), ethinyl estradiol (as estrogen), norgestrel (as progestogen), levonorgestrel in combination with ethinyl estradiol, Norethisterone enanthate, norgestrel in combination with ethinyl estradiol and quinacrine.

5. A device according to claim 2 wherein the therapeutic substance delivered by the device comprises a spermicidal agent.

6. A device according to claim 5 wherein the spermicidal agent is selected from the group consisting of:

nonoxynol-9, octoxynol-9, menfegol, benzalkonium chloride and N-docasanol.

7. A device according to claim 2 wherein the therapeutic substance delivered by the device comprises an antimicrobial agent.

8. A device according to claim 7 wherein the antimicrobial agent is selected form the group consisting of:

acyclovir, an aminoglycoside, gentamicin, tobramycin, amoxicillin, amoxicillin+clavulanate, amphotericin B, ampicillin, ampicillin/sulbactam, atovaquone, azithromycin, cefazolin, cefepime, cefotaxime, cefotetan, cefpodoxime, ceftazidime, ceftizoxime, ceftriaxone, cefuroxime, cephalexin, chloramphenicol, clotrimazole, ciprofloxacin, clarithromycin, clindamycin, dapsone, dicloxacillin, doxycycline, erythromycin, fluconazole, foscarnet, ganciclovir, gatifloxacin, imipenem, cilastatin, imipenem+cilastatin, isoniazid, itraconazole, ketoconazole, metronidazole, nafcillin, nafcillin, nystatin, penicillin, penicillin G, pentamidine, piperacillin, tazobactam, piperacillin+tazobactam;

rifampin, quinupristin, dalfopristin, quinupristin+dalfopristin, ticarcillin, clavulanate, ticarcillin+clavulanate, trimethoprim, sulfamethoxazole, trimethoprim+sulfamethoxazole, valacyclovir, vancomycin, mafenide, silver sulfadiazine, mupirocin, nystatin, triamcinolone, nystatin, triamcinolone+nystatin, clotrimazole+betamethasone, butoconazole, miconazole, tioconazole, a detergent-like substances that disrupt or disable microbes, nonoxynol-9, octoxynol-9, benzalkonium chloride, menfegol, N-docasanol, a chemical that blocks microbial attachment to target cells and/or inhibits entry of infectious pathogens into cells, sulphated and sulponated polymers, carrageenan, Pro-2000, dextrin 2 sulphate, antiretroviral agents, PMPA gel, genetically engineered or naturally occurring antibodies that combat pathogens, agents which change the condition of the tissue to make it hostile to the pathogen, substances which alter vaginal pH, buffer gel, acidform, microbes that cause the production of hydrogen peroxide within the vagina, and lactobacillus.

9. A device according to claim 1 wherein the device is implanted in a lumen of the vas deferens or other lumen of the male reproductive tract and is effective to occlude that lumen following implantation.

10. A device according to claim 9 wherein the therapeutic substance delivered by the device comprises a spermicidal agent.

11. A device according to claim 10 wherein the spermicidal agent is selected from the group consisting of:

nonoxynol-9, octoxynol-9, menfegol, benzalkonium chloride and N-docasanol.

12. A device according to claim 1 wherein the device is implanted in a brouchus or other lumen of the lung.

13. A device according to claim 1 where the substance is gradually released over time.

14. A device according to claim 1 where the intraluminal member has legs, and wherein the substance is delivered from said legs.

15. A device according to claim 14 wherein said legs are hollow, and said substance is contained within said legs.

16. A device according to claim 14 wherein said legs have substance delivering particles disposed thereon.

17. A device according to claim 14 wherein said legs comprise have pores and wherein said substance is initially contained within said pores.

18. A device according to claim 1 wherein said intraluminal member comprises a matrix, and wherein said substance is initially contained within said matrix.

19. A device according to claim 18 wherein said matrix comprises hollow fibers and wherein said substance is initially contained within said hollow fibers.

20. A device according to claim 18 wherein said matrix comprises pores and wherein said substance is initially contained within said pores.

21. A device according to claim 1 wherein the substance is initially contained within a substance delivery implant that is implantable near the intraluminal member.

22. A system according to claim 1 wherein the intraluminal member comprises a capsule, said substance being initially contained within said capsule.

23. A system according to claim 22, wherein said capsule is refillable.

24. A contraceptive delivery system for delivery of an occluding apparatus into the lumen of a fallopian tube of a human or animal subject, said system comprising:

an occluding apparatus sized for placement in a fallopian tube of the subject;

delivery cannula that is insertable through the uterus and into the fallopian tube into which the occluding apparatus is to be placed, said delivery cannula being useable to deliver said occluding apparatus into the fallopian tube, said delivery cannula having at least one length marking which may be utilized to discern the length of the delivery cannula that has been advanced into the fallopian tube; and

,

an imaging apparatus useable to view the delivery cannula and said at least one length marking to determine the length of the delivery cannula that has been advanced into the fallopian tube.

25. A contraceptive delivery system as in claim 24 wherein the at least one marking comprises a colored area on said delivery cannula.

26. A contraceptive delivery system as in claim 24 wherein said indicia is a series of ruler-like marks on said outer surface.

27. A contraceptive delivery system as in claim 24 wherein the imaging apparatus comprises a scope.

28. A contraceptive delivery system as in claim 27 wherein the scope comprises a hysteroscope.

29. A contraceptive delivery system as in claim 24 wherein the imaging apparatus comprises an ultrasound imaging apparatus.

30. A contraceptive delivery system as in claim 24 wherein the imaging apparatus comprises a fluoroscope.

31. A system for causing contraception in a human or animal subject, said system comprising:

an expandable occluding member which is implantable in a reproductive passageway of the subject, said occluding member being a) disposable in a first configuration wherein it is sufficiently compact to allow the occluding member to be advanced into the reproductive passageway and b) subsequently expandable to a second configuration wherein the occluding member engages a wall of the reproductive passageway; and

,

a quantity of a contraceptive substance which is delivered from the occluding member in sufficient amount to cause a pharmacologic contraceptive effect in the patient for a period of time following implantation of the occluding member within the reproductive passageway.

32. A system according to claim 31 wherein the substance comprises a hormone.

33. A system according to claim 32 wherein the substance comprises a progestin.

34. A system according to claim 31 wherein the substance comprises a synthetic progestin.

35. A system according to claim 31 wherein the substance comprises levonorgestrel.

36. A system according to claim 31 wherein the substance comprises (d (−

)-13-beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one).

37. A system according to claim 31 wherein the substance comprises (d (−

)-13-beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one) having a molecular weight of 312.45.

38. A system according to claim 31 wherein the occluding member is sized and configured to be implanted within the lumen of a fallopian tube.

39. A system according to claim 31 wherein the occluding member facilitates tissue or cellular ingrowth into the occluding member.

40. A system according to claim 31 wherein the occluding member comprises an expandable frame and a matrix disposed substantially within or on the frame.

41. A system according to claim 31 wherein the substance is disposed on or in the matrix.

42. A system according to claim 31 where the substance is gradually released over time.

43. A system according to claim 31 where the occluding member has legs, and wherein the substance is delivered from said legs.

44. A system according to claim 43 wherein said legs are hollow, and said substance is contained within said legs.

45. A system according to claim 43 wherein said legs have substance delivering particles disposed thereon.

46. A system according to claim 43 wherein said legs comprise have pores and wherein said substance is initially contained within said pores.

47. A system according to claim 31 wherein said occluding member comprises a matrix, and wherein said substance is initially contained within said matrix.

48. A system according to claim 47 wherein said matrix comprises hollow fibers and wherein said substance is initially contained within said hollow fibers.

49. A system according to claim 47 wherein said matrix comprises pores and wherein said substance is initially contained within said pores.

50. A system according to claim 31 further containing a capsule, said substance being initially contained within said capsule.

51. A system according to claim 50, wherein said capsule is refillable.

52. A system according to claim 31 wherein the occluding member causes a reversible occlusion of the reproductive passageway.

53. A system according to claim 52 wherein the occlusion of the reproductive passageway is reversible by removing a least a portion of the occluding member and any tissue that has grown into the occluding member or that portion of the occluding member.

54. A system according to claim 31 wherein the occluding member provokes an inflammatory response which augments occlusion of the lumen of the reproductive passageway.

55. A system according to claim 31 wherein the occluding member further comprises means for securing the occluding member to the wall of the reproductive passageway.

56. A system according to claim 55 wherein the means for securing the occluding member to the wall of the reproductive passageway comprises a mechanical securing apparatus.

57. A system according to claim 55 wherein the means for securing the occluding member to the wall of the reproductive passageway comprises an adhesive.

58. A method for preventing pregnancy in a human or animal subject having a fallopian tube or vas deferens, said method comprising the steps of:

providing a device that i) is implantable in the fallopian tube or vas deferens to cause occlusion of the fallopian tube or vas deferens and ii) delivers a contraceptive or spermicidal substance in an amount that is the effective to cause contraception or spermicide for at least a period of time following implantation of the device; and

implanting the device within a fallopian tube or vas deferens.

59. A method according to claim 58 wherein wherein the substance comprises a hormone.

60. A method according to claim 58 wherein the device is implanted in a fallopian tube and wherein the substance comprises a progestin.

61. A method according to claim 58 wherein the device is implanted in a fallopian tube and wherein the substance comprises a synthetic progestin.

62. A method according to claim 58 wherein the device is implanted in a fallopian tube and wherein the substance comprises levonorgestrel.

63. A method according to claim 62 wherein the device delivers from about 10 micrograms to about 70 micrograms of levonorgestrel per day.

64. A method according to claim 58 wherein the device is implanted in a fallopian tube and wherein the substance comprises (d (−

)-13-beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one).

65. A method according to claim 58 wherein the device is implanted in a fallopian tube and wherein the substance comprises (d (−

)-13-beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one) having a molecular weight of 312.45.

66. A method according to claim 58 wherein the device comprises an expandable frame and a matrix disposed substantially within or on the frame.

67. A method according to claim 66 wherein the matrix facilitates tissue ingrowth.

68. A method according to 66 wherein the substance is initially disposed on or in the matrix.