Deployment actuation system for intrafallopian contraception

• US 8,079,364 B2
• Filed: 03/28/2011
• Issued: 12/20/2011
• Est. Priority Date: 08/23/1999
• Status: Expired due to Fees

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Conceptus Incorporated (Bayer AG)
• Inventors: Lowe, Christian, Gurskis, Don, Khera, Ashish, Barnhart, Monica, Bacich, Steven, Swann, Betsy, Silva-Torres, Roberto
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US13/073,910
• Publication Number:
  US 20110226257A1
• Time in Patent Office: 267 Days
• Field of Search: 128830-841
• US Class Current: 128/830
• CPC Class Codes: A61B 2017/2923 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2017/2929 with a head rotatable about the longitudinal axis of the shaft
• CPC Class Codes: A61B 2017/2943 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 6/18 Inserters or removers ; Apparatus for loading an intra-uterine device into an insertion tube
• CPC Class Codes: A61F 6/225 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. The contraceptive device may remain in a small profile configuration while a sheath is withdrawn proximally, and is thereafter expanded to a large profile configuration engaging the surrounding tissues, by manipulating one or more actuators of a proximal handle with a single hand. This leaves the other hand free to manipulate a hysteroscope, minimizing the number of health care professional required to deploy the contraceptive device.

Claims

1. A contraceptive delivery system comprising:

a contraceptive device insertable into a female reproductive organ, the contraceptive device having an inner portion and an outer portion surrounding the inner portion, wherein the outer portion is expandable from a small profile configuration to a large profile configuration;

a release catheter having a proximal end, a distal end and a lumen extending therethrough, wherein the distal end of the release catheter releasably engages the contraceptive device;

a core shaft extending through the lumen of the release catheter, the core shaft being releasably coupled to the contraceptive device;

a handle connected with a proximal end of the core shaft, the handle having a size and shape suitable for gripping with a hand;

a first actuator mounted on the handle, wherein movement of the first actuator by hand causes the contraceptive device to expand and affix to the female reproductive organ; and

a second actuator mounted on the handle, wherein movement of the second actuator by hand causes the contraceptive device to be decoupled from core shaft.

2. The contraceptive delivery system of claim 1, wherein rotation of the first actuator causes the contraceptive device to expand and affix to the female reproductive organ.

3. The contraceptive delivery system of claim 2, wherein the first actuator comprises a thumb wheel.

4. The contraceptive delivery system of claim 1, wherein rotation of the second actuator releases the contraceptive device from the core shaft.

5. The contraceptive delivery system of claim 4, wherein the second actuator comprises a rotatable knob.

6. The contraceptive delivery system of claim 1, wherein the outer portion is fixed to the inner portion with a bond.

7. The contraceptive delivery system of claim 1, wherein the bond is a solder bond.

8. The contraceptive delivery system of claim 6, wherein the contraceptive device further comprises a flexible distal portion extending distally from the bond to aid in tracking of the contraceptive delivery system in the female reproductive organ.

9. The contraceptive delivery system of claim 8, wherein the contraceptive device further comprises a distal ball tip at a distal end of the flexible distal portion.

10. The contraceptive delivery system of claim 9, wherein the distal ball tip has a diameter in a range from about 0.020 inches to about 0.050 inches.

11. The contraceptive delivery system of claim 8, wherein the bond is separated from the distal ball tip by a distance in the range from about 0.3 cm to about 1.0 cm.

12. The contraceptive delivery system of claim 8, wherein the flexible distal portion comprises stainless steel wire.

13. The contraceptive delivery system of claim 12, wherein the stainless steel wire has a diameter of about 0.005 inches.

14. The contraceptive delivery system of claim 12, wherein the stainless steel wire is wound to form a coil.

15. The contraceptive delivery system of claim 14, wherein the coil has an outer diameter of about 0.022 inches.

16. The contraceptive delivery system of claim 1, wherein the core shaft comprises stainless steel.