Application of energy and substances in the treatment of uro-genital disorders

• US 6,463,331 B1
• Filed: 03/30/2000
• Issued: 10/08/2002
• Est. Priority Date: 04/19/1999
• Status: Expired due to Term

• Current Assignee: Verathon Incorporated (Roper Technologies, Inc.)
• Original Assignee: Novasys Medical, Inc. (Roper Technologies, Inc.)
• Inventors: Edwards, Stuart D.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/539,264
• Time in Patent Office: 922 Days
• Field of Search: 607/96, 607/98, 607/99, 607/101, 607/102, 607/104, 607/105, 607/113, 607/115, 607/116, 606/41-50, 606/13, 606/14, 606/15, 606/27-29
• US Class Current: 607/101
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2018/00553 Sphincter
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1432 curved

Abstract

This invention provides a method and system for the curative treatment of female uro-genital disorders. One aspect of the invention is that it allows the gynecologist to coagulate the entire endometrium and upper layers of the myometrium in one short procedure that can be performed in a physician'"'"'s office or other outpatient setting, using local or regional anesthesia. A second aspect of the invention is that it can be used to tighten the urethral sphincter and bladder outlet.

Claims

1. An apparatus for treating female incontinence by remodeling tissue surrounding a patient'"'"'s urethra, comprising:

a plurality of electrodes adapted to deliver energy to urethral tissue;

means for individually controlling each electrode of said plurality of electrodes; and

means for delivering fluids in the vicinity of said plurality of electrodes, said means for delivering fluids comprising a sponge.

2. An apparatus as in claim 1, wherein said plurality of electrodes are needle shaped.

3. An apparatus as in claim 1, wherein said plurality of electrodes is disposed to deliver radio frequency energy.

4. An apparatus as in claim 1, wherein said plurality of electrodes are disposed to deliver microwave energy.

5. An apparatus as in claim 1, wherein said plurality of electrodes are disposed to deliver laser energy.

6. An apparatus as in claim 1, wherein said plurality of electrodes are disposed to deliver extremely low frequency energy.

7. An apparatus as in claim 1, wherein said plurality of electrodes are two to four in number.

8. An apparatus as in claim 1, wherein said plurality of electrodes are engaged to penetrate the muscosal tissue so as to become embedded in the muscle wall.

9. Apparatus as in claim 1, wherein each electrode of said plurality of electrodes also includes a thermocouple.

10. Apparatus as in claim 1, wherein said means for controlling includes a means for adjusting said electrodes so that said electrodes protrude at different distances so as to be deployed at different depths in a targeted tissue.

11. Apparatus as in claim 1, wherein said means for controlling includes a means for adjusting the temperature of each electrode.

12. Apparatus as in claim 1, wherein said electrodes are situated so as to emerge at an angle from said means for delivering fluids with the tip of said electrodes splayed out in a distal orientation, said angle ranging from ten to one hundred and seventy degrees.

13. An apparatus as in claim 1, wherein said electrodes are situated so as to emerge at an angle from said means for delivering fluids with the tip of said electrodes splayed out in a distal orientation, said angle ranging from ten to one hundred and seventy degrees and wherein said electrodes are longitudinally staggered along the length of said means for delivering.

14. Apparatus as in claim 1, wherein said means for delivering is disposed to deliver cooling liquids to a portion of the urethral muscosa.

15. Apparatus as in claim 1, wherein said means for delivering is disposed to deliver pharmaceutical agents to a portion of the urethral mucosa.

16. A method for treating female urinary incontinence comprising:

inserting a treatment element including a plurality of electrodes and a sponge into a urethra;

deploying the plurality of electrodes so as to penetrate the urethral mucosa and penetrate into the underlying muscle; and

delivering energy so as to create a pattern of lesions within the urethral sphincter that remodels the sphincter.

17. A method as in claim 16, including a step for:

infusing said sponge with cooling fluids.

18. A method as in claim 16, wherein the step for inserting is performed using an introducer and sheath.

19. A method as in claim 16, wherein said step for inserting includes inserting the treatment element into the middle third of a urethra.

20. A method as in claim 16, wherein said step for infusing the sponge also include the step of infusing said sponge with pharmacological agents and drugs.

21. A method as in claim 16, wherein said step for delivering energy includes delivery of RF energy, microwave energy, laser energy or other extremely low frequency energy.

22. A method as in claim 16, includes steps for removing said treatment element from the urethra.

23. Apparatus for treating female incontinence by remodeling the urethral wall, the apparatus comprising:

an elongated shaft having a distal region;

a plurality of electrodes disposed in the distal region, the plurality of electrodes movable from a retracted position disposed within the elongated shaft to a deployed position extending from the distal region; and

a sponge disposed in the distal region to deliver fluids to the urethral wall in the vicinity of the plurality of electrodes.

24. The apparatus of claim 23, wherein each one of the plurality of electrodes comprises a curved needle.

25. The apparatus of claim 23, wherein the plurality of electrodes includes between two and four electrodes.

26. The apparatus of claim 23, wherein the plurality of electrodes are configured to penetrate the muscosal tissue in the deployed position.

27. The apparatus of claim 23, wherein each electrode of the plurality of electrodes further comprises a thermocouple.

28. The apparatus of claim 23 further comprising means for individually controlling each one of the plurality of electrodes.

29. The apparatus of claim 28, wherein the means for controlling further comprises means for adjusting the extent to which each one of the electrodes extend from the elongated shaft in the deployed position.

30. The apparatus of claim 23, wherein the means for controlling further comprises means for adjusting a temperature of each one of the plurality of electrodes.

31. The apparatus of claim 23, wherein the plurality of electrodes extend through the sponge in the deployed state.

32. The apparatus of claim 23, wherein the plurality of electrodes are longitudinally staggered along the distal region.

33. The apparatus of claim 23, wherein the sponge is adapted to deliver a cooling liquid to a portion of the urethral muscosa.

34. The apparatus of claim 23, wherein the sponge is adapted to deliver pharmaceutical agents to a portion of the urethral muscosa.

35. A method for treating female incontinence comprising:

providing a treatment device comprising a shaft having a distal region, a plurality of electrodes disposed in the distal region, and a sponge for delivering fluids in the vicinity of the plurality of electrodes;

inserting the distal region of the treatment device into a patient'"'"'s urethra;

moving the plurality of electrodes to a deployed position, wherein the plurality of electrodes penetrate the urethral mucosa and extend into tissue surrounding the urethra;

infusing a cooling fluid to the urethral mucosa through the sponge; and

delivering energy to the plurality of electrodes to create a pattern of lesions in the tissue surrounding the urethra.

36. The method of claim 35 wherein inserting the distal region comprises inserting the distal region using an introducer sheath.

37. The method of claim 36 wherein inserting the distal region comprises inserting the distal region into a middle third of the urethra.

38. The method of claim 36 further comprising infusing a pharmacological agent or drug to the urethral mucosa through the sponge.

39. The method of claim 36 wherein delivering energy to the plurality of electrodes comprises delivering RF energy.

40. The method of claim 36 wherein each one of the plurality of electrodes further comprises a thermocouple, the method further comprising monitoring a temperature of each one of the plurality of electrodes.

41. The method of claim 40 further comprising, during delivery of energy to the plurality of electrodes, adjusting the temperature of each one of the plurality of electrodes.

42. The method of claim 36 wherein moving the plurality of electrodes to the deployed position further comprises individually adjusting an extent to which each one of the plurality of electrodes laterally extends from the shaft.