Curved Endoscopic Medical Device

• US 20080071269A1
• Filed: 09/18/2006
• Published: 03/20/2008
• Est. Priority Date: 09/18/2006
• Status: Abandoned Application

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Cytyc Corporation (Hologic Incorporated)
• Inventors: Sampson, Russel M., Hilario, Estela H., Kotmel, Robert
• Application Number:
  US11/532,886
• Publication Number:
  US 20080071269A1
• Time in Patent Office: Days
• US Class Current: 606/50
• CPC Class Codes: A61B 1/00154 using guiding arrangements for insertion
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• 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 2017/4233 Operations on Fallopian tubes, e.g. sterilization A61B2017/1125 takes precedence
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/0097 Cleaning probe surfaces
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61B 2218/007 Aspiration
• CPC Class Codes: A61B 5/4325 of the uterine cavities, e.g. uterus, fallopian tubes, ovaries
• CPC Class Codes: A61F 6/202 Means specially adapted for ligaturing, compressing or clamping of oviduct or vas deferens of tubular organs in general A61B17/12

Abstract

A medical device and procedure is described which can be used for occluding a fallopian tube. In one implementation, the apparatus includes an elongate member, an electrode carrier and one or more conductors. The elongate member has a lumen operable to couple to a vacuum source and draw moisture way from one or more electrodes included in the electrode carrier, and a lumen configured to receive a hysteroscope. The electrode carrier includes one or more bipolar electrodes and can to couple to a radio frequency energy generator. The one or more conductors connect to a controller operable to control the delivery of radio frequency energy to the one or more bipolar electrodes. The elongate member is a substantially rigid member configured with a curve to facilitate advancement of the distal end transcervically through a uterus and into a region of a tubal ostium of a fallopian tube to be occluded.

Claims

1. An apparatus for occluding a fallopian tube, comprising:

an elongate member having a distal end, a proximal end and a central interior including at least a first lumen operable to couple to a vacuum source and to draw moisture way from one or more electrodes included in an electrode carrier positioned at the distal end of the elongate member and at least a second lumen configured to receive a hysteroscope, where the first lumen and the second lumen can be the same lumen or can be separate lumens;

an electrode carrier attached to the distal end of the elongate member and including one or more bipolar electrodes formed thereon and operable to couple to a radio frequency energy generator; and

one or more conductors extending from the electrode carrier to the proximal end of the elongate member and configured to connect to a controller operable to control the delivery of radio frequency energy to the one or more bipolar electrodes;

where the elongate member is a substantially rigid member configured with a curve to facilitate advancement of the distal end transcervically through a uterus and into a region of a tubal ostium of a fallopian tube to be occluded.

2. The apparatus of claim 1, further comprising:

a hysteroscope positioned within the first lumen of the elongate member, such that a distal end of the hysteroscope is positioned approximately just proud of a distal end of the electrode carrier.

3. The apparatus of claim 2, wherein the hysteroscope is substantially rigid and configured with a similar curve to the curve of the elongate member.

4. The apparatus of claim 2, wherein the hysteroscope is substantially flexible and can flex to accommodate the curve of the elongate member.

5. The apparatus of claim 1, where the electrode carrier comprises an approximately cylindrically shaped support member within a fabric sheath having conductive metallized regions and one or more non-conductive regions formed thereon to create the one or more bipolar electrodes.

6. The apparatus of claim 5, where the support member is formed from a plastic material, the fabric sheath is formed from a polymer mesh and the conductive metallized regions are formed by selectively coating the polymer mesh with gold.

7. The apparatus of claim 6, where the polymer comprises a combination of nylon and spandex.

8. The apparatus of claim 1, where the electrode carrier is an approximately cylindrically shaped member comprising a metallic mesh insert molded in a support member formed from a plastic material and where the metallic mesh forms conductive regions and the plastic material forms non-conductive regions thereby creating the one or more bipolar electrodes.

9. The apparatus of claim 8, where the metallic mesh insert is formed from a stainless steel material.

10. The apparatus of claim 8, where the metallic mesh insert is formed from a platinum material.

11. The apparatus of claim 1, where the electrode carrier comprises an approximately cylindrically shaped support member having a diameter in the range of approximately five to 10 millimeters.

12. The apparatus of claim 1, further comprising:

a vacuum source in fluid communication with the first lumen included in the elongate member and operable to draw tissue surrounding the electrode carrier into contact with the one or more bipolar electrodes and to draw moisture generated during delivery of the radio frequency energy to the one or more bipolar electrodes away from the one or more bipolar electrodes and to substantially eliminate liquid surrounding the one or more bipolar electrodes.

13. The apparatus of claim 1, further comprising:

a radio frequency energy generator coupled to the one or more bipolar electrodes through the one or more conductors, where the radio frequency energy generator includes or is coupled to a controller operable to control the delivery of radio frequency energy to the one or more bipolar electrodes.

14. An apparatus for occluding a fallopian tube, comprising:

a hysteroscope including a working channel extending from a distal end to a proximal end, where the hysteroscope is substantially rigid and configured with a curve to facilitate advancement of the distal end transcervically through a uterine cavity and into a region of a tubal ostium of a fallopian tube to be occluded;

an elongate member positioned within the working channel of the hysteroscope, the elongate member having a distal end, a proximal end and a central interior including a lumen operable to couple to a vacuum source and to draw moisture way from one or more electrodes included in an electrode carrier positioned at the distal end of the elongate member and where the elongate member is a substantially rigid member configured with a curve similar to the curve of the hysteroscope to facilitate advancement of the distal end of the elongate member to the distal end of the hysteroscope;

an electrode carrier attached to the distal end of the elongate member and including one or more bipolar electrodes formed thereon and operable to couple to a radio frequency energy generator; and

one or more conductors extending from the electrode carrier to the proximal end of the elongate member and configured to connect to a controller operable to control the delivery of radio frequency energy to the one or more bipolar electrodes.

15. An apparatus for ablating tissue, comprising:

an elongate member having a distal end, a proximal end and a central interior including at least a first lumen operable to couple to a vacuum source and to draw moisture way from one or more electrodes included in an electrode carrier positioned at the distal end of the elongate member and at least a second lumen configured to receive an endoscope;

an electrode carrier attached to the distal end of the elongate member and including one or more bipolar electrodes formed thereon and operable to couple to a radio frequency energy generator; and

one or more conductors extending from the electrode carrier to the proximal end of the elongate member and configured to connect to a controller operable to control the delivery of radio frequency energy to the one or more bipolar electrodes;

where the elongate member is a substantially rigid member configured with a curve to facilitate advancement of the distal end through a body cavity to a region of tissue to be ablated.

16. An apparatus for ablating tissue, comprising:

an endoscope including a working channel extending from a distal end to a proximal end, where the endoscope is substantially rigid and configured with a curve to facilitate advancement of the distal end through a body cavity to a region of tissue to be ablated;

an elongate member positioned within the working channel of the endoscope, the elongate member having a distal end, a proximal end and a central interior including a lumen operable to couple to a vacuum source and to draw moisture way from one or more electrodes included in an electrode carrier positioned at the distal end of the elongate member and where the elongate member is a substantially rigid member configured with a curve similar to the curve of the hysteroscope to facilitate advancement of the distal end of the elongate member to the distal end of the endoscope;

an electrode carrier attached to the distal end of the elongate member and including one or more bipolar electrodes formed thereon and operable to couple to a radio frequency energy generator; and

one or more conductors extending from the electrode carrier to the proximal end of the elongate member and configured to connect to a controller operable to control the delivery of radio frequency energy to the one or more bipolar electrodes.

17. An apparatus for occluding a fallopian tube, comprising:

an elongate member having a distal end, a proximal end and a central interior including at least a first lumen operable to couple to a vacuum source and to draw moisture way from one or more electrodes included in an electrode carrier positioned at the distal end of the elongate member and at least a second lumen configured to receive a hysteroscope, where the first lumen and the second lumen can be the same lumen or can be separate lumens;

an electrode carrier attached to the distal end of the elongate member and including one or more bipolar electrodes formed thereon and operable to couple to a radio frequency energy generator, where the electrode carrier has a substantially cylindrical shape; and

one or more conductors extending from the electrode carrier to the proximal end of the elongate member and configured to connect to a controller operable to control the delivery of radio frequency energy to the one or more bipolar electrodes;

where the elongate member includes an aperture formed in a sidewall of the elongate member toward a distal end of the elongate member but proximate to the electrode carrier, the aperture configured to allow a distal end of the hysteroscope to pass through, providing the hysteroscope with a field of view extending from a side of the elongate member.

18. The apparatus of claim 17, where the elongate member is flexible and receiving the hysteroscope in the second lumen causes the elongate member to bend off axis forming a curvature in the elongate member.

19. An apparatus for occluding a fallopian tube, comprising:

an elongate member having a distal end, a proximal end and a central interior including at least a first lumen operable to couple to a vacuum source and to draw moisture way from one or more electrodes included in an electrode carrier positioned at the distal end of the elongate member and at least a second lumen configured to receive a rigid and curved hysteroscope, where the first lumen and the second lumen can be the same lumen or can be separate lumens;

an electrode carrier attached to the distal end of the elongate member and including one or more bipolar electrodes formed thereon and operable to couple to a radio frequency energy generator; and

one or more conductors extending from the electrode carrier to the proximal end of the elongate member and configured to connect to a controller operable to control the delivery of radio frequency energy to the one or more bipolar electrodes;

where the elongate member is a substantially flexible member configured to bend into a curved configuration upon receiving the rigid and curved hysteroscope in the second lumen, where the curve facilitates advancement of the distal end transcervically through a uterus and into a region of a tubal ostium of a fallopian tube to be occluded.

20. A method for fallopian tubal occlusion, comprising:

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 a uterine cavity;

positioning the electrode carrier at a tubal ostium of a 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.

21. The method of claim 20, 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.

22. The method of claim 21, wherein ramping up the power density comprises gradually increasing the current over the second time period.

23. The method of claim 21, 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.

24. The method of claim 21, 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.

25. The method of claim 21, where the initial time period is determined empirically as a time period after which an initial depth of tissue destruction has been achieved.