Insertion/deployment catheter system for intrafallopian contraception

• US 6,763,833 B1
• Filed: 08/22/2000
• Issued: 07/20/2004
• Est. Priority Date: 08/23/1999
• Status: Expired due to Term

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Conceptus Incorporated (Bayer AG)
• Inventors: That, Dai Ton, Swann, Betsy, Bacich, Steven, Khera, Ashish, Gurskis, Don
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US09/644,277
• Time in Patent Office: 1,428 Days
• Field of Search: 188/30--40
• 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 2017/12095 Threaded connection
• CPC Class Codes: A61F 6/225 transcervical

Abstract

Contraceptive methods, systems, and devices generally improve the ease, speed, and reliability with which a contraceptive device can be deployed transcervically into an ostium of a fallopian tube. A distal portion of the contraceptive device can function as a guidewire. The proximal portion may remain in a small profile configuration while a sheath is withdrawn proximally, and is thereafter expanded to a large profile configuration engaging the surrounding tissues.

Claims

1. A contraceptive method comprising:

guiding a contraceptive device distally into an ostium of a fallopian tube using an exposed distal portion of the contraceptive device, while a sheath covers a proximal portion of the contraceptive device;

uncovering the proximal portion of the guided contraceptive device by withdrawing the sheath proximally from the proximal portion; and

releasing the uncovered contraceptive device so that the distal and proximal portions of the contraceptive device remain in the fallopian tube to inhibit conception.

2. The method of claim 1, wherein the contraceptive device comprises an axially elongate flexible structure, and further comprising supporting the proximal portion of the contraceptive structure with the surrounding sheath during the guiding step.

3. The method of claim 2, further comprising supporting at least a portion of the exposed distal portion with a core support disposed within an axially oriented lumen of the contraceptive structure during the guiding step.

4. The method of claim 3, further comprising removing the core support during the releasing step.

5. The method of claim 1, further comprising maneuvering the contraceptive device into the ostium while the distal portion flexes laterally to track through the uterotubal junction.

6. The method of claim 1, further comprising positioning the contraceptive device across the muscular isthmus of the uterotubal junction.

7. The method of claim 1, further comprising avoiding perforation and facilitating tubal navigation with a distal ball tip of the distal portion, the ball tip having a diameter in a range from about 0.020 to about 0.050 inches.

8. The contraceptive method of claim 1, further comprising delivering at least one of heat, electrical current, a bioactive agent, a biodegradable plug, a caustic agent, and an adhesive adjacent the guided contraceptive device.

9. The contraceptive method of claim 1, further comprising promoting tissue ingrowth into the contraceptive device.

10. A contraceptive method comprising:

inserting a contraceptive device distally into an ostium of a fallopian tube;

uncovering a proximal portion of the inserted contraceptive device by withdrawing a sheath from around the proximal portion;

maintaining an expandable structure of the proximal portion in a small profile configuration during the uncovering step so as to avoid restricting movement of the sheath during the withdrawing step;

radially expanding the uncovered expandable structure to a large profile configuration so as to affix the contraceptive device within the ostium; and

releasing the uncovered contraceptive device so that the contraceptive device inhibits conception.

11. The contraceptive method of claim 10, wherein the expandable structure is maintained in the small profile configuration by sustaining a restraint on the expandable structure between a first elongate body extending from a proximal handle to the expandable structure and a second elongate body extending from the proximal handle to the contraceptive device, whereby the restraint is releasable so as to expand the exposed expandable structure from the proximal handle.

12. The contraceptive method of claim 11, wherein the first and second elongate bodies sustain a wind-down torque on the expandable structure, the radially expanding step comprising actuating the proximal handle so as to release a proximal end of the expandable structure relative to a distal end of the expandable structure, and so that the expandable portion unwinds and expands.

13. The contraceptive method of claim 12, wherein the wind-down torque twists the first elongate body in a first direction, and wherein the releasing step comprises rotating the first elongate body in a second direction opposite the first direction to decouple the first elongate body from the contraceptive device.

14. A contraceptive method comprising:

guiding a contraceptive device distally into an ostium of a fallopian tube of a patient body with an exposed distal portion of the contraceptive device while a sheath supports a proximal portion of the contraceptive device, the contraceptive device comprising an elongate flexible structure;

uncovering the proximal portion of the inserted contraceptive device by withdrawing the sheath from around the proximal portion while maintaining an expandable structure of the proximal portion in a small profile configuration with a wind-down torque between first and second elongate bodies so as to avoid restricting movement of the sheath;

radially expanding the uncovered expandable structure to a large profile configuration so as to affix the contraceptive device within the ostium by actuating a proximal handle disposed outside the patient body, the proximal handle coupling proximal ends of the elongate bodies, so that the expandable portion unwinds and expands; and

releasing the uncovered contraceptive device so that the contraceptive device inhibits conception by rotating the first elongate body in a direction opposite the direction of the wind-down torque to decouple the first elongate body from the contraceptive device, and by removing a core support extending into an axial lumen of the contraceptive device.

15. A contraceptive system comprising:

a contraceptive device having a proximal portion adjacent a proximal end and a distal portion adjacent a distal end, the distal portion having a flexibility suitable to function as a guidewire;

a sheath releasably secured over the proximal portion of the contraceptive device so that the distal portion of the contraceptive device remains exposed when the contraceptive device and sheath are inserted transcervically into an ostium of the fallopian tube; and

a first elongate body extending from a proximal end distally into detachable engagement with the contraceptive device for deploying the inserted contraceptive device from the sheath.

16. The contraceptive device of claim 15, further comprising a proximal housing releasably securing a proximal end of the sheath to a proximal end of the first elongate body so that the distal end of the contraceptive device extends distally beyond the sheath.

17. The contraceptive device of claim 16, wherein the distal portion comprises a coil having a distal ball tip with a diameter in a range from about 0.020 to about 0.050 inches.

18. The contraceptive device of claim 17, wherein the first elongate body comprises a core wire removably extending distally into a lumen of the coil beyond the sheath.

19. The contraceptive system of claim 15, wherein the proximal portion comprises a radially expandable structure having a low profile configuration slidably disposable within the sheath and a large profile configuration for restraining the contraceptive device within the ostium of the fallopian tube.

20. The contraceptive system of claim 19, further comprising a proximal housing adjacent a proximal end of the first elongate body and a second elongate body movable relative to the first elongate body to expand the expandable structure from the small profile configuration to the large profile configuration, the housing releasably securing the first elongate body to the second elongate body to avoid inadvertent expansion of the expandable structure within the sheath.

21. The contraceptive system of claim 20, wherein the proximal housing limits rotation of the first elongate body relative to the second elongate body to maintain a wind-down torque on the expandable structure, the expandable structure comprising a radially expandable helical coil, and wherein the first elongate body threadingly engages the contraceptive device so that rotation of the first elongate body in a direction opposed to the wind-down torque detaches the first elongate body from the contraceptive device.

22. The contraceptive system of claim 21, wherein the expandable structure has a first end rotationally coupled to the first elongate body and a second end defining a bend, wherein the second elongate body comprises a release catheter, the release catheter comprising a tubular catheter body disposed around the first elongate body with a distally protruding member extending from the catheter body through the bend in the expandable structure so that the expandable coil can be wound-down between the first end and the second end, the protruding member disposed between the catheter and an attachment coil.

23. The contraceptive system of claim 15, further comprising means for delivering at least one of heat, electrical current, a bioactive agent, a biodegradable plug, a caustic agent, and an adhesive adjacent the guided contraceptive device.

24. The contraceptive system of claim 15, wherein the contraceptive device further comprises a material which incites a tissue reaction to inhibit expulsion of the contraceptive device, the tissue reaction comprising tissue ingrowth or scar formation.

25. A contraceptive system comprising:

a contraceptive device having a proximal portion adjacent a proximal end and a distal portion adjacent a distal end, the distal portion having a flexibility suitable to function as a guidewire;

a sheath releasably secured over the proximal portion of the contraceptive device so that the distal portion of the contraceptive device remains exposed when the contraceptive device and sheath are inserted transcervically into an ostium of the fallopian tube, wherein the proximal portion comprises a radially expandable structure having a low profile configuration slidably disposable within the sheath and a large profile configuration for restraining the contraceptive device within the ostium of the fallopian tube; and

a first elongate body extending from a proximal end distally into detachable engagement with the contraceptive device for deploying the inserted contraceptive device from the sheath.

26. The contraceptive system of claim 25, further comprising a proximal housing adjacent a proximal end of the first elongate body and a second elongate body movable relative to the first elongate body to expand the expandable structure from the small profile configuration to the large profile configuration, the housing releasably securing the first elongate body to the second elongate body to avoid inadvertent expansion of the expandable structure within the sheath.

27. The contraceptive system of claim 26, wherein the proximal housing limits rotation of the first elongate body relative to the second elongate body to maintain a wind-down torque on the expandable structure, the expandable structure comprising a radially expandable helical coil, and wherein the first elongate body threadingly engages the contraceptive device so that rotation of the first elongate body in a direction opposed to the wind-down torque detaches the first elongate body from the contraceptive device.

28. The contraceptive system of claim 27, wherein the expandable structure has a first end rotationally coupled to the first elongate body and a second end defining a bend, wherein the second elongate body comprises a release catheter, the release catheter comprising a tubular catheter body disposed around the first elongate body with a distally protruding member extending from the catheter body through the bend in the expandable structure so that the expandable coil can be wound-down between the first end and the second end, the protruding member disposed between the catheter and an attachment coil.