Devices, methods, and systems for shrinking tissues

• US 6,091,995 A
• Filed: 08/13/1997
• Issued: 07/18/2000
• Est. Priority Date: 11/08/1996
• Status: Expired due to Term

• Current Assignee: Verathon Incorporated (Roper Technologies, Inc.)
• Original Assignee: SURX, Inc. (Endo International PLC)
• Inventors: Laufer, Michael D., Ingle, Frank, Carter, Garry
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): Ruddy, David M.
• Application Number:
  US08/910,370
• Time in Patent Office: 1,070 Days
• Field of Search: 604/20, 604/114, 606/41-50, 607/122, 607/116, 607/138, 607/46, 607/48, 607/40, 607/41
• US Class Current: 607/138
• 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 comprises or 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 comprise or 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 comprising or 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 urethral wall, the bladder, the bladder neck, the urethra suspension ligaments, the sphincter, pelvic ligaments, pelvic floor muscles, and fascia.

17. A method as in claim 16, wherein the energy is applied to the urethral wall at a single location aligned with the urethral sling.

18. A method as in claim 16, wherein the energy is applied to the urethral wall at at least two sites including a first site upstream of the urethral sling and a second site downstream of the urethral sling.

19. A method as in claim 16, wherein the energy is applied in a substantially uniform circumferential pattern about the lumenal wall of the urethra.

20. A method as in claim 16, wherein the energy is selectively applied on the side of the lumenal wall adjacent to the urethral sling.

21. 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.

22. 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.

23. 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 near its distal end;

positioning the probe within the patient'"'"'s urethra so that the heat applying element is disposed in the region of a urethral sling;

applying an amount of energy from the probe to collagenous tissue of a patient'"'"'s urethral wall sufficient to partially shrink a urethral passage; and

removing the probe from the urethra.

24. A method as in claim 23, wherein the energy applying step comprises:

connecting the probe to a power supply;

supplying energy from the power supply to the probe; and

terminating energy supply to the probe.

25. A method as in claim 24, wherein a power level remains substantially constant and the method further comprises selecting a time between initiating power flow and terminating power flow.

26. A method as in claim 24, further comprising adjusting a power level from the power supply to the probe.

27. A method as in claim 26, wherein the adjusting step comprises measuring a treatment parameter and adjusting the power level in response to a measured value of the treatment parameter.

28. A method as in claim 27, wherein the measuring step comprises measuring a temperature of the urethral wall.

29. A method as in claim 23, 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.

30. A method as in claim 23, further comprising controlling a lumenal cross-sectional area of the urethral passage as or after the energy has been applied.

31. A method as in claim 30, wherein the controlling step comprises inflating a balloon within the urethra to limit constriction as the energy is being applied.

32. 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 sphineter;

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.

33. A method as in claim 32, 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.

34. A method as in claim 32, wherein a power level remains substantially constant and the method further comprises selecting a time between initiating power flow and terminating power flow.

35. A method as in claim 32, further comprising adjusting a power level from the power supply to the probe.

36. A method as in claim 35, wherein the adjusting step comprises measuring a treatment parameter and adjusting the power level in response to a measured value of the treatment parameter.

37. A method as in claim 36, wherein the measuring step comprises measuring internal temperature in the collagenous tissue structure.

38. A method as in claim 32, 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.