Method and apparatus for sterilization

• US 7,846,160 B2
• Filed: 12/21/2006
• Issued: 12/07/2010
• Est. Priority Date: 12/21/2006
• Status: Expired due to Fees

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Cytyc Corporation (Hologic Incorporated)
• Inventors: Sampson, Russel M., Payne, F. Mark
• Primary Examiner(s): Dvorak; Linda C
• Assistant Examiner(s): DELLA, JAYMI E
• Application Number:
  US11/614,900
• Publication Number:
  US 20080154256A1
• Time in Patent Office: 1,447 Days
• Field of Search: 606 45- 46, 606/49
• US Class Current: 606/45
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/4233 Operations on Fallopian tubes, e.g. sterilization A61B2017/1125 takes precedence
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61F 6/225 transcervical

Abstract

A medical device and procedure is described for sterilizing a female. A two-part procedure includes an immediate sterilization part and a permanent sterilization part. The immediate sterilization part provides immediate sterility that endures at least until the permanent effects of a tubal occlusion procedure provide permanent sterility.

Claims

1. A method for female sterilization comprising, for each fallopian tube:

transcervically inserting and implanting a tubal occlusion device into the fallopian tube where the tubal occlusion device immediately occludes the fallopian tube;

transcervically positioning a radio frequency (RF) applicator including one or more bipolar electrodes at a tubal ostium of the fallopian tube such that the one or more bipolar electrodes are positioned proximally relative to the implanted tubal occlusion device; and

passing current through the RF applicator to destroy tissue to a known depth and to precipitate a healing response in surrounding tissue that over time scars, the scar tissue permanently occluding the fallopian tube;

wherein the tubal occlusion device remains in the fallopian tube after the RF applicator is removed from the respective fallopian tube and provides immediate and at least temporary sterilization before the scar tissue resulting from the application of current through the RF applicator is formed.

2. The method of claim 1, wherein the tubal occlusion device is formed at least partially from a biodegradable material and is configured to provide tubal occlusion for at least as long as a period of time required for the scar tissue to permanently occlude the fallopian tube.

3. The method of claim 1, wherein the tubal occlusion device is formed from a non-biodegradable material.

4. The method of claim 1, wherein the tubal occlusion device is configured as a screw and can be rotated within the tube upon insertion such that threads included on an exterior service of the tubal occlusion device are threaded into surrounding tissue providing a tight seal between the tubal occlusion device and the tissue.

5. The method of claim 1, wherein the tubal occlusion device is configured as a plug including one or more fixation elements configured to fixate onto surrounding tissue.

6. The method of claim 1, wherein the RF applicator comprises an RF applicator head including an electrode carrier with the one or more bipolar electrodes thereon and having an open and a closed position, the method further comprising:

positioning the RF applicator such that a distal tip of the RF applicator head in a closed position advances into the tubal ostium;

deploying the RF applicator head into an open position such that the RF applicator head approximates the shape of the uterine cavity in a region of the tubal ostium; and

passing current through the one or more bipolar electrodes to the tubal ostium to destroy the tissue to a known depth.

7. The method of claim 1, further comprising:

advancing an illuminator and an optical instrument into the uterine cavity; and

wherein positioning the RF applicator head at the tubal ostium of a fallopian tube includes using the optical instrument to visualize the tubal ostium.

8. A method for fallopian tubal occlusion, comprising:

transcervically inserting and implanting a tubal occlusion device into a fallopian tube where the tubal occlusion device occludes the fallopian tube;

transcervically positioning a radio frequency (RF) applicator including one or more bipolar electrodes at a tubal ostium of the fallopian tube such that the one or more bipolar electrodes are positioned proximally relative to the implanted tubal occlusion device; and

passing current through the RF applicator to destroy tissue to a known depth and to precipitate a healing response in surrounding tissue that over time scars, the scar tissue permanently occluding the fallopian tube;

wherein, the tubal occlusion device is inserted into the fallopian tube first and the RF applicator is inserted second and, upon removal of the RF applicator, the tubal occlusion device inserted into the fallopian tube remains in the fallopian tube and provides immediate and at least temporary tubal occlusion before the scar tissue resulting from the application of current through the RF applicator is formed.

9. The method of claim 8, wherein the tubal occlusion device is formed at least partially from a biodegradable material and is configured to provide tubal occlusion for at least as long as a period of time required for the scar tissue to permanently occlude the fallopian tube.

10. The method of claim 9, wherein the tubal occlusion device is configured to provide tubal occlusion for at least three months from the date of insertion.

11. The method of claim 8, wherein the tubal occlusion device is formed from a non-biodegradable material.

12. The method of claim 8, wherein the tubal occlusion device is configured as a screw and can be rotated within the tube upon insertion such that threads included on an exterior surface of the tubal occlusion device are threaded into surrounding tissue providing a tight seal between the tubal occlusion device and the tissue.

13. The method of claim 8, wherein the tubal occlusion device is configured as a plug including one or more fixation elements configured to fixate into surrounding tissue.

14. The method of claim 8, wherein the RF applicator comprises an RF applicator head including an electrode carrier with the one or more bipolar electrodes thereon and having an open and a closed position, the method further comprising:

positioning the RF applicator such that a distal tip of the RF applicator head in a closed position advances into the tubal ostium;

deploying the RF applicator head into an open position such that the RF applicator head approximates the shape of the uterine cavity in a region of the tubal ostium; and

passing current through the one or more bipolar electrodes to the tubal ostium to destroy the tissue to a known depth.

15. The method of claim 14, wherein passing current through the one or more bipolar electrodes to the tubal ostium to destroy tissue comprises vaporizing endometrium and destroying superficial myometrium.

16. The method of claim 14, further comprising:

applying suction through the electrode carrier to draw surrounding tissue into contact with the electrodes and to draw moisture generated during ablation away from the electrodes to substantially prevent the formation of a low impedance liquid layer at the electrodes.

17. The method of claim 14, wherein passing current through the one or more bipolar electrodes comprises delivering radio frequency energy to the one or more bipolar electrodes.

18. The method of claim 14, further comprising:

automatically terminating the flow of current into the tissue once ablation has approximately reached a predetermined depth of ablation.

19. The method of claim 14, further comprising:

before positioning the RF applicator head at the tubal ostium, insufflating the uterine cavity; and

before passing current through the one or more bipolar electrodes, ceasing insufflating the uterine cavity and allowing the uterine cavity to collapse onto the RF applicator head.

20. The method of claim 14, wherein the electrode carrier includes a fabric having conductive metallized regions and one or more non-conductive regions formed thereon to create the one or more bipolar electrodes.

21. The method of claim 8, further comprising:

advancing an illuminator and an optical instrument into the uterine cavity; and

wherein positioning the RF applicator head at the tubal ostium of a fallopian tube includes using the optical instrument to visualize the tubal ostium.

22. A method for fallopian tubal occlusion, comprising:

transcervically inserting a tubal occlusion device through a uterine cavity and implanting the device into a fallopian tube where the tubal occlusion device occludes the fallopian tube;

transcervically inserting a substantially rigid, curved elongate member including a substantially cylindrically shaped electrode carrier positioned at a distal end with one or more bipolar electrodes formed thereon into the uterine cavity at a location proximal to the implanted tubal occlusion device such that the one or more bipolar electrodes are positioned proximally relative to the implanted tubal occlusion device;

positioning the electrode carrier at a tubal ostium of the fallopian tube such that a distal end of the electrode carrier advances into the tubal ostium; and

passing radio frequency energy through the one or more bipolar electrodes to the tubal ostium to destroy tissue to a known depth and to precipitate a healing response in surrounding tissue that over time scars and occludes the fallopian tube;

wherein the tubal occlusion device remains in the fallopian tube after the elongate member is removed from the respective fallopian tube and provides immediate and at least temporary tubal occlusion before the scar tissue resulting from the application of current through the electrodes is formed.

23. The method of claim 22, wherein passing radio frequency energy through the one or more bipolar electrodes comprises:

passing a current at an initial current level through the one or more bipolar electrodes to the target tissue site to apply an initial power density to destroy tissue for an initial time period; and

after the initial time period, ramping up the power density by increasing the current passed through the one or more bipolar electrodes to the target tissue site for a second time period.

24. The method of claim 23, wherein ramping up the power density comprises gradually increasing the current over the second time period.

25. The method of claim 23, wherein ramping up the power density comprises suddenly increasing the current from the initial current level to a second current level and applying the second current level for the second time period.

26. The method of claim 23, further comprising:

monitoring an impedance level at an interface between the electrode carrier and the tubal ostium;

where the initial time period is a time period after which a threshold decrease in the impedance level from an initial impedance level is detected.

27. The method of claim 23, where the initial time period is determined empirically as a time period after which an initial depth of tissue destruction has been achieved.