Method and system for transcervical tubal occlusion

• US 7,731,712 B2
• Filed: 12/20/2004
• Issued: 06/08/2010
• Est. Priority Date: 12/20/2004
• Status: Expired due to Fees

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Cytyc Corporation (Hologic Incorporated)
• Inventors: Burley, J. Brook, Sampson, Russel M., Hilario, Estela H., Skalnyi, Eugene V.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US11/019,580
• Publication Number:
  US 20060135956A1
• Time in Patent Office: 1,996 Days
• Field of Search: 606/41, 606 45- 50, 607101-105, 607/116, 607/138
• US Class Current: 606/41
• 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2017/4233 Operations on Fallopian tubes, e.g. sterilization A61B2017/1125 takes precedence
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2218/008 for smoke evacuation
• CPC Class Codes: A61F 6/225 transcervical

Abstract

A medical device and procedure is described for occluding a fallopian tube. A tubal occlusion device is inserted into a uterine cavity. The device includes an RF applicator head including an electrode carrier with one or more bipolar electrodes thereon. During insertion, the RF applicator head can be in a closed position. The RF applicator head is positioned at a tubal ostium of a fallopian tube, such that a distal tip of the RF applicator head advances into the tubal ostium. The RF applicator head is deployed into an open position such that the RF applicator head approximates the shape of the uterine cavity in a region of the tubal ostium. Current is passed through the one or more bipolar electrodes to the tubal ostium to destroy tissue to a known depth, which precipitates a healing response in surrounding tissue that over time scars and occludes the fallopian tube.

Claims

1. A system for fallopian tubal occlusion, comprising:

a tubal occlusion device having a distal end and a proximal end, the distal end including an electrode carrier with two faces, each face having two bipolar electrodes thereon, said electrode carrier comprising a structural support member within a fabric sheath having conductive metallized regions and having one or more non-conductive regions formed thereon to create the bipolar electrodes, and is shaped to approximate a uterine cavity in a region of a tubal ostium of a fallopian tube to be occluded, wherein the bipolar electrodes are arranged on the carrier to target tissue destruction over a length of 10 mm to 20 mm along an endometrium from the tubal ostium;

a source of radio frequency energy electrically coupled to the bipolar electrodes;

a controller configured to control the delivery of radio frequency energy to the bipolar electrodes such that passing radio frequency energy through the bipolar electrodes to the tubal ostium can be controlled to destroy tissue to a known depth that precipitates a healing response in surrounding tissue that over time scars and occludes the fallopian tube; and

a vacuum source operable to draw the tissue into contact with the bipolar electrodes and to draw moisture generated during delivery of the radio frequency energy to the bipolar electrodes away from the bipolar electrodes and to substantially eliminate liquid surrounding the bipolar electrodes.

2. The system of claim 1, wherein the bipolar electrodes are adapted to deliver radiofrequency energy to the tubal ostium under conditions which vaporize the endometrium and destroy superficial myometrium.

3. The system of claim 1, wherein the structural support member includes flexible members movable between a closed condition and the open condition.

4. The system of claim 1, further comprising:

an illumination source electrically coupled to the distal end of the tubal occlusion device to illuminate the uterus; and

an optical instrument electrically coupled to the distal end of the tubal occlusion device to provide images of the uterus.

5. An apparatus for occluding a fallopian tube of a patient having two fallopian tubes comprising:

an elongate member having a distal end, a proximal end and a hollow central interior; and

an electrode carrier attached to the distal end of the elongate member and including two faces, each face having two bipolar electrodes formed thereon and operable to couple to a radio frequency energy generator, said electrode further including a structural support member within a fabric sheath having conductive metallized regions and having one or more non-conductive regions formed thereon to create the bipolar electrodes, the electrode carrier is movable between a closed position in which the electrode carrier is collapsed for insertion into a uterine cavity and an open position in which a distal end of the electrode carrier is shaped to fit within a tubal ostium of a single fallopian tube without entering into a tubal ostium of the second fallopian tube, and the hollow central interior of the elongate member is operable to couple to a vacuum source and to draw moisture away from the bipolar electrodes.

6. The apparatus of claim 5, further comprising:

an illuminator attached to the distal end of the elongate member and operable to couple to an illumination source; and

an optical instrument attached to the distal end of the elongate member and operable couple to an image display device.

7. The apparatus of claim 5, wherein the structural support member includes flexible members movable between a closed condition and the open condition.

8. An apparatus as in claim 5, wherein the bipolar electrodes on the electrode carrier are arranged to target treatment to endometrial tissue extending along a length from 10 mm to 20 mm from the tubal ostium.