Devices, methods, and systems for shrinking tissues

• US 20040034400A1
• Filed: 06/17/2003
• Published: 02/19/2004
• Est. Priority Date: 11/08/1996
• Status: Active Grant

• Current Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Original Assignee: SURX, Inc. (Endo International PLC)
• Inventors: Laufer, Michael D., Ingle, Frank, Carter, Garry
• Granted Patent: US 7,483,755 B2
• Time in Patent Office: Days
• US Class Current: 607/101
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• 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 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00095 high, i.e. heat conducting
• CPC Class Codes: A61B 2018/00148 with metal
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00505 Urinary tract
• CPC Class Codes: A61B 2018/00517 Urinary bladder or urethra
• CPC Class Codes: A61B 2018/00523 Treatment of incontinence
• CPC Class Codes: A61B 2018/00553 Sphincter
• 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 2018/126 bipolar
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia

Abstract

Devices, systems, and method for treating urinary incontinence generally rely on energy delivered to a patient'"'"'s own pelvic support tissue to selectively contract or shrink at least a portion of that pelvic support tissue so as to reposition the bladder. The energy will preferably be applied to the endopelvic fascia and/or an arcus tendineus fascia pelvis. The invention provides a variety of devices and methods for applying gentle resistive heating of these and other tissues to cause them to contract without imposing significant injury on the surrounding tissue structures. Alternatively, heat-applying probes are configured to heat tissue structures which comprise or support a patient'"'"'s urethra. By applying sufficient energy over a predetermined time, the tissue can be raised to a temperature which results in contraction without significant necrosis or other tissue damage. By selectively contracting the support tissues, the bladder neck, sphincter, and other components of the urinary tract responsible for the control of urinary flow can be reconfigured or supported in a manner which reduces urinary leakage.

Claims

1. A method to treat urinary stress incontinence, the method comprising:

introducing a probe into a patient body;

aligning the probe with a collagenous pelvic tissue which supports the urethra within the patient body; and

energizing the probe to heat a portion of the pelvic support tissue so that the pelvic support tissue is contracted to inhibit incontinence.

2. A method as claimed in claim 1, further comprising engaging first and second electrodes against the pelvic support tissue and applying an electrical potential across the first and second electrodes to heat a portion of the pelvic support tissue disposed therebetween so as to reposition a bladder neck within the patient body.

3. A method as claimed in claim 2, further comprising monitoring a temperature of the heated tissue with a temperature sensor of the probe, the sensor being in thermal contact with the heated tissue.

4. A method as claimed in claim 2, wherein the first and second electrodes engage the pelvic support tissue with a predetermined electrode surface diameter and spacing between the electrodes to limit a tissue heating depth.

5. A method as claimed in claim 4, wherein the depth of tissue heating is less than about 2.0 mm, a surface diameter of the electrodes being between about 0.25 and 4.0 mm, the spacing between the first and second electrodes being between about 1 and 4 times the electrode surface diameter.

6. A method as claimed in claim 2, further comprising sweeping the first and second electrodes across the pelvic support tissue while applying the electrical potential to heat a band of the pelvic support tissue substantially bordered by swept paths of the first and second electrodes.

7. A method as claimed in claim 1, wherein the electrical potential has a frequency of between about 100 and 1,000 khz and an amplitude of between about 20 and 200 volts rms.

8. A method as claimed in claim 7, wherein the pelvic support tissue reaches a maximum temperature of between about 60°

C. and 110°

C. for a time between about 0.5 and 5.0 seconds.

9. A method as claimed in claim 1, further comprising monitoring a temperature of the pelvic support tissue while heating.

10. A method as claimed in claim 1, wherein the aligning step comprises laparoscopically imaging the pelvic support tissue.

11. A method as claimed in claim 1, wherein the introducing step comprises inserting the probe while the probe is in a narrow configuration, and further comprising deploying at least one of the first and second electrodes to a wide configuration prior to the heating step, the wide configuration being wider than the narrow configuration.

12. A method as claimed in claim 1, further comprising laterally repositioning a bladder neck within the patient body by heating an alternative portion of the pelvic support tissue.

13. An endoscopic method for treating urinary stress incontinence, the method comprising:

introducing a probe into a patient body;

optically imaging the probe and a target tissue of the patient body, the target tissue comprising a portion of at least one of an endopelvic fascia and an arcus tendineus fascia pelvis which support the patient'"'"'s urethra;

positioning an electrode of the probe against the target tissue; and

energizing the electrode to heat and contract the target tissue without substantially ablating the target tissue.

14. An endoscopic method as claimed in claim 13, further comprising engaging first and second electrodes against the target tissue and applying an electrical potential across the first and second electrodes to heat a portion of the target tissue disposed therebetween, wherein the first and second electrodes engage the fascia with a predetermined spacing therebetween to limit a depth tissue heating and to avoid damaging tissue below the target tissue.

15. A method for treating urinary incontinence in a patient, said method comprising applying an amount of energy to a collagenous tissue structure supporting the patient'"'"'s urethra wherein the amount of energy is sufficient to cause partial shrinkage of the tissue and the tissue shrinkage inhibits urinary incontinence.

16. A method as in claim 15, wherein the tissue structure is selected from the group consisting of a region of the urethra suspension ligaments, pelvic ligaments, pelvic floor muscles, and fascia.

17. A method as in claim 16, wherein the tissue structure comprises the pubococcygeal muscle, the iliococcygeal muscle, or the detrusor muscle and adjacent fascia, and the applying step comprises penetrating an energy-applying element into the tissue structure from the vagina.

18. A method as in claim 15, where the amount of energy applied is sufficient to raise the tissue structure to a temperature in the range from 60°

C. to 95°

C. for a time in the range from 0.5 minute to 4 minutes.

19. A method for treating urinary incontinence in a patient, said method comprising;

providing a probe having a proximal end, a distal end, and a heat-applying element;

positioning the probe within the patient'"'"'s vagina;

penetrating the heat-applying element from the probe into a collagenous tissue structure which supports the urethra or urinary sphincter;

applying an amount of energy from the probe and into the collagenous tissue structure sufficient to contract the collagenous tissue structure and enhance support of the urethra or urinary sphincter; and

removing the probe from the vagina.

20. A method as in claim 19, wherein the energy applying step comprises:

connecting the probe to a power supply;

supplying energy from the power simply to the probe; and

terminating energy supply to the probe.

21. A method as in claim 19, wherein a power level remains substantially constant and the method further comprises selecting a time between initiating power flow and terminating power flow.

22. A method as in claim 19, further comprising adjusting a power level from the power supply to the probe.

23. A method as in claim 22, wherein the adjusting step comprises measuring a treatment parameter and adjusting the power level in response to a measured value of the treatment parameter.

24. A method as in claim 23, wherein the measuring step comprises measuring internal temperature in the collagenous tissue structure.

25. A method as in claim 19, wherein the amount of energy applied is sufficient to raise the collagenous tissue structure to a temperature in the range from 60°

C. to 95°

C. for a time in the range from 0.5 minute to 4 minutes.

26. A method for treating urinary incontinence in a patient, said method comprising:

inserting a probe into the patient;

advancing a plurality of electrodes from the probe so that the electrodes penetrate a collagenous tissue structure; and

applying electrical energy to the collagenous tissue structure with the electrodes to heat the collagenous tissue structure sufficiently to effect shrinkage of the collagenous tissue structure so that the collagenous tissue structure inhibits urinary incontinence.

27. A method as in claim 26, wherein the energy is applied as a bipolar RF energy transmitted between the electrodes.

28. A method as in claim 26, wherein an axis of the probe extends from the proximal end to the distal end with the electrodes extending asymmetrically relative to the axis, wherein two electrodes deploy from the probe to penetrate the collagenous tissue structure on a first lateral side of the probe, and wherein two electrodes deploy from the probe to penetrate the collagenous tissue structure on a second lateral side of the probe.

29. A method as in claim 26, wherein the collagenous tissue structure comprises at least one member selected from the group consisting of a urethral wall, a bladder, a bladder neck, a ureter, bladder suspension ligaments, a sphincter, pelvic ligaments, pelvic floor muscles, and fascia.

30. A method as in claim 29, wherein the collagenous tissue structure comprises the bladder neck.

31. A method as in claim 26, further comprising adjusting a power level of the energy, wherein the adjusting step is performed in response to internal temperature in the collagenous tissue structure.

32. A method for treating incontinence in a patient, said method comprising:

inserting a probe into a urethra of the patient;

electrically coupling at least one electrode of the inserted probe to a collagenous tissue structure;

applying electrical energy to the collagenous tissue structure with the at least one electrode to heat the collagenous tissue structure; and

controlling an amount of the energy applied in response to a temperature of the collagenous tissue structure so that the collagenous tissue structure inhibits incontinence.

33. A method as in claim 32, wherein the shrinkage provides a kink or closure point along the urethra to inhibit leakage.

34. A method as in claim 32, wherein the energy is applied so as to cause bulking and buttressing of the collagenous tissue structure during healing.

35. A method as in claim 32, wherein the energy is applied so as to effect shrinkage of the collagenous tissue structure, the shrinkage and tissue bulking/buttressing acting to enhance patient continence.

36. A system for treatment of incontinence, the system comprising:

a probe body having a proximal end and a distal end, the distal end suitable for insertion into a patient body for positioning adjacent to a collagenous tissue structure;

a plurality of electrodes near the distal end of the probe body, the electrodes reciprocatably mounted on the probe body so that said electrodes are extendable from the probe body to penetrate into the collagenous tissues;

a connector disposed near the proximal end of the probe body, the connector couplable to a power supply for transmission of electrical energy to the electrodes; and

a controller coupled to the power supply, the controller controlling an amount of the energy of the collagenous tissue structure so as to heat the collagenous tissue structure to a target temperature range such that the collagenous tissue structure will inhibit incontinence.

37. A system as in claim 36, wherein the probe body has an axis extending between the proximal end and the distal end, wherein the electrodes are asymmetrically disposed about the axis, and wherein the electrodes are oriented to reciprocatably deploy into the collagenous tissue on generally opposed lateral sides of the probe body.

38. A system as in claim 36, further comprising a sensor disposed near the electrode, the sensor measuring internal temperature in the collagenous tissue.

39. A system for treatment of incontinence, the system comprising:

a urethral probe body having a proximal end and a distal end, the distal end suitable for insertion into a urethra adjacent to a collagenous tissue structure;

at least one electrode disposed near the distal end of the probe body, the at least one electrode electrically couplable with the collagenous tissue structure;

a power supply coupled to said at least one electrode for transmission of electrical energy therethrough; and

a feedback controller coupled to the power supply, the controller limiting an amount of the energy in response to a temperature of the collagenous tissue structure so as to heat the collagenous tissue structure so that, when healed, the collagenous tissue structure inhibits incontinence.

40. A system as in claim 39, further comprising indicia of rotational alignment disposed adjacent the proximal end of the probe for rotationally aligning the electrodes with the collagenous tissue structure.

41. A system as in claim 40, wherein an axis of the probe extends between the proximal and distal ends, and wherein the electrodes are asymmetrically disposed about the axis.

42. A method for treating urinary incontinence in a patient, said method comprising:

inserting a probe into the patient;

engaging a plurality of electrodes of the probe against a bladder neck; and

applying sufficient electrical energy to the bladder neck so as to inhibit the urinary incontinence.

43. The method of claim 42, further comprising advancing the electrodes from the probe so that the electrodes penetrate into the bladder neck.

44. The method of claim 42, further comprising inserting the probe through the urethra.

45. The method of claim 44, further comprising controlling an amount of the energy in response to a temperature of the bladder neck.