CA2555009A1 - Contraceptive with permeable and impermeable components - Google Patents

Contraceptive with permeable and impermeable components Download PDF

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Publication number
CA2555009A1
CA2555009A1 CA002555009A CA2555009A CA2555009A1 CA 2555009 A1 CA2555009 A1 CA 2555009A1 CA 002555009 A CA002555009 A CA 002555009A CA 2555009 A CA2555009 A CA 2555009A CA 2555009 A1 CA2555009 A1 CA 2555009A1
Authority
CA
Canada
Prior art keywords
sterilizing device
component
impermeable
occluding
permeable
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
CA002555009A
Other languages
French (fr)
Other versions
CA2555009C (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
Ams Research Corporation
Jeffrey P. Callister
William S. Tremulis
Ovion, Inc.
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 Ams Research Corporation, Jeffrey P. Callister, William S. Tremulis, Ovion, Inc., Conceptus, Inc. filed Critical Ams Research Corporation
Publication of CA2555009A1 publication Critical patent/CA2555009A1/en
Application granted granted Critical
Publication of CA2555009C publication Critical patent/CA2555009C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F6/00Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/20Vas deferens occluders; Fallopian occluders
    • A61F6/22Vas deferens occluders; Fallopian occluders implantable in tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136Balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12163Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a string of elements connected to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177Occluding 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F6/00Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/20Vas deferens occluders; Fallopian occluders
    • A61F6/22Vas deferens occluders; Fallopian occluders implantable in tubes
    • A61F6/225Vas deferens occluders; Fallopian occluders implantable in tubes transcervical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
    • A61B17/1215Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices
    • A61B2017/12054Details concerning the detachment of the occluding device from the introduction device
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices
    • A61B2017/12054Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12095Threaded connection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F6/00Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/20Vas deferens occluders; Fallopian occluders

Abstract

An device for occluding a body lumen such as a reproductive lumen which includes an occluding component having an impervious barrier to provide initial occlusion of the body lumen and a permeable body to facilitate tissue ingrowth which provides long term occlusion of the body lumen. The device and the method of using the device is particularly suitable for contraception.

Claims (67)

1. An sterilizing device for a patient's reproductive lumen, comprising an expandable occluding component configured for deployment within the patient's reproductive lumen which has at least one impermeable barrier component which is substantially impermeable to the passage of reproductive cells, and at least one permeable component which facilitates tissue growth into or onto the occluding component.
2. The sterilizing device of claim 1 wherein the barrier component is disposed within the occluding component.
3. The sterilizing device of claim 2 wherein the barrier component disposed within the occluding component adjacent.
4. The sterilizing device of claim 1 wherein one barrier component is secured to one end of the occluding component.
5. The sterilizing device of claim 3 wherein a second barrier component is secured to a second end of the occluding component.
6. The sterilizing device of claim 1 wherein the barrier component is formed of closed cell polymeric material.
7. The sterilizing device of claim 1 wherein the barrier component in a impermeable membrane.
8. The sterilizing device of claim 1 wherein the barrier component comprises at least one inflatable member formed of impermeable polymeric material.
9. The sterilizing device of claim 1 wherein the barrier component has at least two inflatable members formed of impermeable polymeric material.
10. The sterilizing device of claim 7 wherein the two inflatable members are interconnected together by a tubular member to provide inflation fluid to interior portions of the inflatable members.
11. The sterilizing device of claim 7 wherein the permeable component is disposed between the two inflatable members.
12. The sterilizing device of claim 10 wherein the permeable component is an open cell polymeric body.
13. The sterilizing device of claim 1 wherein the occluding component is at least in part an expandable, stent-like member.
14. The sterilizing device of claim 12 wherein the expandable stent-like member has an elongated tubular shape with first and second ends and an inner lumen extending between the first and second ends.
15. The sterilizing device of claim 12 wherein the barrier component has an impermeable membrane.
16. The sterilizing device of claim 13 wherein the barrier component has an impermeable membrane which is disposed over the first end of stent like member.
17. The sterilizing device of claim 15 wherein the barrier component has a second impermeable membrane which is disposed over the second end of the stent-like member.
18. The sterilizing device of claim 13 wherein the barrier component comprises an impermeable body which is secured to a leading end of the stent-like member and which is configured to secure the sterilizing device within the body lumen of a patient.
19. The sterilizing device of claim 13 wherein the permeable component has a fibrous mass within the inner lumen of the stent-like member.
20. The sterilizing device of claim 18 wherein the fibrous mass is disposed within one end of the stent-like member.
21. The sterilizing device of claim 18 wherein the permeable component has two fibrous masses within the inner lumen of the stent-like member, a first fibrous mass within the first end of the stent-like member and a second fibrous mass within the second end of the stent-like member.
22. The sterilizing device of claim 20 wherein the permeable component has a third fibrous mass disposed within the inner lumen of the stent-like member at an intermediate location between the first and second fibrous masses.
23. The sterilizing device of claim 13 wherein the permeable component has a porous polymeric body within the inner lumen of the stent-like member.
24. The sterilizing device of claim 22 wherein the porous polymeric body is disposed within one end of the stent-like member.
25. The sterilizing device of claim 22 wherein the permeable component has two porous polymeric bodies within the inner lumen of the stent-like member, a first porous polymeric body within the first end of the stent-like member and a second porous polymeric body within the second end of the stent-like member.
26. The sterilizing device of claim 24 wherein the permeable component has a third porous polymeric body disposed within the inner lumen of the stent-like member at an intermediate location between the first and second porous polymeric bodies.
27. The sterilizing device of claim 13 wherein the permeable component has at least one fibrous mass disposed within the inner lumen of the stent-like member and at least one open cell polymeric body disposed within the inner lumen of the stent-like body.
28. The sterilizing device of claim 1 wherein the occluding component comprises an elongated plug formed of expandable segments.
29. The sterilizing device of claim 27 wherein at least one of the segments of the elongated plug comprises the barrier component.
30. The sterilizing device of claim 27 wherein the barrier component is a body of impermeable polymeric material.
31. The sterilizing device of claim 29 wherein the barrier component is in the form of closed cell polymeric foam.
32. The sterilizing device of claim 27 wherein at least one of the segments of the elongated plug is a permeable component configured to enhance or facilitate tissue ingrowth.
33. The sterilizing device of claim 31 wherein the permeable component is an open cell polymeric body.
34. The sterilizing device of claim 27 wherein the plug comprises at least one impermeable segment and at least one permeable segment.
35. The sterilizing device of claim 33 wherein the plug alternates impermeable and permeable segments.
36. The sterilizing device of claim 34 wherein an impervious membrane is disposed between adjacent impermeable and permeable segments.
37. The sterilizing device of claim 27 wherein a first attachment ring is secured to a first end of the plug to hold the sterilizing device within the patient's body lumen.
38. The sterilizing device of claim 37 wherein a second attachment ring is secured to a second end of the plug.
39. The sterilizing device of claim 1 wherein the occluding component has a plurality of expandable disks.
40. The sterilizing device of claim 39 wherein at least one of the disks comprises the barrier component.
41. The sterilizing device of claim 40 wherein the disk comprising the barrier component is a body of impermeable polymeric material.
42. The sterilizing device of claim 41 wherein the body of impermeable polymeric material is in the form of closed cell polymeric foam.
43. The sterilizing device of claim 40 wherein at least one of the disks comprises the permeable component configured to enhance or facilitate tissue ingrowth.
44. The sterilizing device of claim 43 wherein the permeable component is an open cell polymeric body.
45. The sterilizing device of claim 39 wherein the occluding component comprises at least one impermeable disk and at least one permeable disk.
46. The sterilizing device of claim 45 wherein the occluding component alternates impermeable and permeable disks.
47 The sterilizing device of claim 39 wherein the plurality of disks are collapsible to facilitate delivery through a delivery sheath.
48. The sterilizing device of claim 1 wherein the occluding component has at least one spider-like elements with a plurality of expandable legs.
49. The sterilizing device of claim 48 wherein the spider-like element has the barrier component secured thereto.
50. The sterilizing device of claim 50 wherein the barrier component is an impermeable membrane.
51. The sterilizing device of claim 51 wherein the impermeable membrane is formed of polymeric material.
52. The sterilizing device of claim 51 wherein the impermeable membrane is formed at least in part of closed cell polymeric foam.
53. The sterilizing device of claim 50 wherein the impermeable membrane is formed of heterologous tissue.
54. The sterilizing device of claim 40 wherein at least one of the spider like element has the permeable component secured thereto.
55. The sterilizing device of claim 54 wherein the permeable component is an open cell polymeric body.
56. The sterilizing device of claim 40 wherein the occluding component comprises at least one spider-like element with at least one impermeable barrier component and at least one spider-like element with at least one permeable component.
57. The sterilizing device of claim 56 wherein the occluding component alternates one spider-like element with the impermeable barrier component and one spider-like element with a permeable component.
58 The sterilizing device of claim 40 wherein the plurality of spider-like element of the occluding component are collapsible to facilitate delivery through a delivery sheath.
59. The sterilizing device of claim 1 wherein the occluding component is expandable from a first configuration to a second configuration having greater transverse cross-sectional dimensions than the first configuration.
60. The sterilizing device of claim 1 wherein the barrier component is bioabsorbable.
61. The sterilizing device of claim 1 wherein the permeable component is bioabsorbable.
62. The sterilizing device of claim 1 wherein the occluding component is bioabsorbable.
63. The sterilizing device of claim 1 wherein the occluding component has at least one anchoring element to attach the component a wall defining in part a body lumen.
64. The sterilizing device of claim 1 wherein the barrier element has at least one anchoring element to attach the barrier element to a wall defining at least part of the reproductive lumen.
65. A system for sterilizing a patient by occluding a reproductive lumen to prevent the passage of a reproductive cells, comprising:
a. means for providing an sterilizing device comprising an expandable occluding component configured for deployment within the patient's reproductive lumen which has at least one impermeable barrier component which is substantially impermeable to the passage of reproductive cells, and at least one permeable component which facilitates tissue growth into or onto the occluding component b. means for inserting the sterilizing device into an inner lumen of a delivery catheter;
c. means for advancing the delivery catheter into a location within a reproductive lumen where the sterilizing device is to be deployed;
d. means for holding the sterilizing device relatively stationery in a longitudinal direction relative to the reproductive lumen; and e. means for withdrawing the delivery sheath from over the sterilizing device to expand the sterilizing device within the reproductive lumen to at least the transverse dimension of the body lumen.
66. An occluding device for a patient's body lumen, comprising an expandable occluding component configured for deployment within the patient's body lumen which has at least one impermeable barrier component which is substantially impermeable to the passage of biological components, and at least one permeable component which facilitates tissue growth into or onto the occluding component.
67. An occluding device for a patient's body lumen, comprising an expandable occluding means configured for deployment within the patient's body lumen which has at least one impermeable barrier means which is substantially impermeable to the passage of biological components, and at least one permeable means which facilitates tissue growth into or onto the occluding means.
CA2555009A 2004-02-02 2005-01-31 Contraceptive with permeable and impermeable components Expired - Fee Related CA2555009C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US54182104P 2004-02-02 2004-02-02
US60/541,821 2004-02-02
US11/047,319 2005-01-31
PCT/US2005/003185 WO2005074844A1 (en) 2004-02-02 2005-01-31 Contraceptive with permeable and impermeable components
US11/047,319 US9713549B2 (en) 2004-02-02 2005-01-31 Contraceptive with permeable and impermeable components

Publications (2)

Publication Number Publication Date
CA2555009A1 true CA2555009A1 (en) 2005-08-18
CA2555009C CA2555009C (en) 2012-08-07

Family

ID=34840542

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2555009A Expired - Fee Related CA2555009C (en) 2004-02-02 2005-01-31 Contraceptive with permeable and impermeable components

Country Status (5)

Country Link
US (1) US9713549B2 (en)
EP (1) EP1711143B1 (en)
AU (1) AU2005209844B2 (en)
CA (1) CA2555009C (en)
WO (1) WO2005074844A1 (en)

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AU2005209844A1 (en) 2005-08-18
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WO2005074844A1 (en) 2005-08-18
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CA2555009C (en) 2012-08-07
AU2005209844B2 (en) 2010-07-08

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