Contraceptive transcervical fallopian tube occlusion devices and methods

• US 7,686,020 B2
• Filed: 08/31/2006
• Issued: 03/30/2010
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Conceptus Incorporated (Bayer AG)
• Inventors: Nikolchev, Julian N., Bacich, Steven, Khera, Ashish, Gurskis, Donnell W., Ton, Dai T.
• Primary Examiner(s): Brown; Michael A.
• Application Number:
  US11/515,240
• Publication Number:
  US 20070000496A1
• Time in Patent Office: 1,307 Days
• Field of Search: 128830-831, 606/151, 606/191
• US Class Current: 128/830
• 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 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/12059 Joint of soluble material
• CPC Class Codes: A61B 2017/12063 electrolytically detachable
• CPC Class Codes: A61B 2017/12077 Joint changing shape upon application of heat, e.g. bi-metal or reversible thermal memory
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 6/18 Inserters or removers ; Apparatus for loading an intra-uterine device into an insertion tube
• CPC Class Codes: A61F 6/22 implantable in tubes occluding by internal devices A61B17/12022
• CPC Class Codes: A61F 6/225 transcervical
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

The invention provides intrafallopian devices and non-surgical methods for their placement to prevent conception. The efficacy of the device is enhanced by forming the structure at least in part from copper or a copper alloy. The device is anchored within the fallopian tube by a lumen-traversing region of the resilient structure which has a helical outer surface, together with a portion of the resilient structure which is biased to form a bent secondary shape, the secondary shape having a larger cross-section than the fallopian tube. The resilient structure is restrained in a straight configuration and transcervically inserted within the fallopian tube, where it is released. Optionally, permanent sterilization is effected by passing a current through the resilient structure to the tubal walls.

Claims

1. A 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;

wherein the outer diameter of the device is configured to be large enough, in an expanded state, to engage the lumen wall;

wherein the device comprises an outer and inner coil and fibrous element radially disposed between the coils.

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 is disposed within the occluding component adjacent to an end of the sterilizing device.

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 4 wherein a second barrier component is secured to a second end of the occluding component.

6. The sterilizing device of claim 1 wherein the occluding component is at least in part an expandable, stent member.

7. The sterilizing device of claim 6 wherein the expandable stent member has an elongated tubular shape with first and second ends and an inner lumen extending between the first and second ends.

8. The sterilizing device of claim 1 wherein the barrier component has an impermeable membrane.

9. The sterilizing device of claim 6 wherein the barrier component has an impermeable membrane which is disposed over the first end of the stent member.

10. The sterilizing device of claim 9 wherein the barrier component has a second impermeable membrane which is disposed over the second end of the stent-member.

11. The sterilizing device of claim 1 wherein the barrier component comprises an impermeable body which is secured to a leading end of the stent member and which is configured to secure the sterilizing device within the body lumen of a patient.

12. The sterilizing device of claim 6 wherein the permeable component has a fibrous mass within the inner lumen of the stent member.

13. The sterilizing device of claim 6 wherein the fibrous mass is disposed within one end of the stent member.

14. 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.

20. The sterilizing device as in claim 1 wherein the sterilizing device is substantially straight in the expanded state.

15. A method for sterilizing a patient by occluding a reproductive lumen to prevent the passage of a reproductive cells, comprising:

a. 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. advancing the delivery catheter into a location within a reproductive lumen where the sterilizing device is to be deployed;

c. holding the sterilizing device relatively stationery in a longitudinal direction relative to the reproductive lumen; and

d. 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; and

wherein the outer diameter of the sterilizing device is configured to be large enough in an expanded state, to engage the lumen wall;

and wherein the device comprises an outer and inner coil and fibrous element radially disposed between the coils.

16. 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;

and wherein the outer diameter of the occluding device is configured to be large enough in an expanded state, to engage the lumen wall;

and wherein the device comprises an outer and inner coil and fibrous element radially disposed between the coils.

17. A method for occluding a body lumen to prevent the passage of a biological component, comprising:

a. providing an occluding device 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 component, and at least one permeable component which facilitates tissue growth into or onto the occluding component;

b. advancing the delivery catheter into a location within a body lumen where the occluding device is to be deployed;

c. holding the occluding device relatively stationery in a longitudinal direction relative to the body lumen; and

d. withdrawing the delivery sheath from over the occluding device to expand the occluding device within the body lumen to at least the transverse dimension of the body lumen; and

wherein the outer diameter of the occluding device is configured to be large enough in an expanded state, to engage the lumen wall;

and wherein the device comprises an outer and inner coil and fibrous element radially disposed between the coils.

18. 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 and wherein the outer diameter of the occluding device is configured to be large enough in an expanded state, to engage the lumen wall;

and wherein the device comprises an outer and inner coil and fibrous element radially disposed between the coils.

19. A method for occluding a body lumen to prevent the passage of a biological component, comprising:

a. providing an occluding device 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 component, and at least one permeable component which facilitates tissue growth into or onto the occluding component;

b. advancing the delivery catheter into a location within a body lumen where the occluding device is to be deployed;

c. holding the occluding device relatively stationery in a longitudinal direction relative to the body lumen; and

d. withdrawing the delivery sheath from over the occluding device to expand the occluding device within the body lumen to at least the transverse dimension of the body lumen and wherein the outer diameter of the occluding device is configured to be large enough in an expanded state, to engage the lumen wall;

and wherein the device comprises an outer and inner coil and fibrous element radially disposed between the coils.