CA2530397A1 - Methods and devices for occluding body lumens and/or for delivering therapeutic agents - Google Patents

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

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Publication number
CA2530397A1
CA2530397A1 CA002530397A CA2530397A CA2530397A1 CA 2530397 A1 CA2530397 A1 CA 2530397A1 CA 002530397 A CA002530397 A CA 002530397A CA 2530397 A CA2530397 A CA 2530397A CA 2530397 A1 CA2530397 A1 CA 2530397A1
Authority
CA
Canada
Prior art keywords
substance
fallopian tube
occluding member
matrix
legs
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002530397A
Other languages
French (fr)
Other versions
CA2530397C (en
Inventor
Jeffrey P. Callister
William S. Tremulis
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer Essure Inc
Original Assignee
Ovion, Inc.
Jeffrey P. Callister
William S. Tremulis
Ovion Inc.
Ams Research Corporation
Conceptus, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ovion, Inc., Jeffrey P. Callister, William S. Tremulis, Ovion Inc., Ams Research Corporation, Conceptus, Inc. filed Critical Ovion, Inc.
Publication of CA2530397A1 publication Critical patent/CA2530397A1/en
Application granted granted Critical
Publication of CA2530397C publication Critical patent/CA2530397C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12104—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in an air passage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/20—Vas deferens occluders; Fallopian occluders
    • A61F6/22—Vas deferens occluders; Fallopian occluders implantable in tubes
    • A61F6/225—Vas deferens occluders; Fallopian occluders implantable in tubes transcervical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00893—Material properties pharmaceutically effective
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Reproductive Health (AREA)
  • Vascular Medicine (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Materials For Medical Uses (AREA)
  • Medicinal Preparation (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Devices (10), 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 (68)

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.
CA2530397A 2003-06-27 2004-06-28 Methods and devices for occluding body lumens and/or for delivering therapeutic agents Expired - Fee Related CA2530397C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US48358703P 2003-06-27 2003-06-27
US60/483,587 2003-06-27
PCT/US2004/020976 WO2005000161A2 (en) 2003-06-27 2004-06-28 Methods and devices for occluding body lumens and/or for delivering therapeutic agents

Publications (2)

Publication Number Publication Date
CA2530397A1 true CA2530397A1 (en) 2005-01-06
CA2530397C CA2530397C (en) 2011-12-20

Family

ID=33552065

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2530397A Expired - Fee Related CA2530397C (en) 2003-06-27 2004-06-28 Methods and devices for occluding body lumens and/or for delivering therapeutic agents

Country Status (10)

Country Link
US (1) US7694683B2 (en)
EP (1) EP1648311A4 (en)
JP (1) JP2007521081A (en)
KR (1) KR101200642B1 (en)
CN (1) CN1812746B (en)
AU (1) AU2004251783B2 (en)
BR (1) BRPI0411924A8 (en)
CA (1) CA2530397C (en)
IL (1) IL172655A (en)
WO (1) WO2005000161A2 (en)

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