Devices, methods, and systems for shrinking tissues

• US 6,587,731 B1
• Filed: 06/20/2000
• Issued: 07/01/2003
• Est. Priority Date: 11/08/1996
• Status: Expired due to Term

• 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
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): Ruddy, David M.
• Application Number:
  US09/598,076
• Time in Patent Office: 1,106 Days
• Field of Search: 606/27-51, 128/898, 607/97, 607/98, 607/101, 607/102, 607/105, 607/122, 607/119
• 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 for treating reflux disease, the method comprising:

engaging at least one electrode of a probe against diaphragm tissue, wherein the at least one electrode is energized with RF power; and

applying sufficient RF energy to the diaphragm tissue adjacent a sphincter to heat the diaphragm tissue so that the diaphragm tissue shrinks and mitigates reflux disease.

2. A method as claimed in claim 1, wherein the sphincter comprises a lower esophageal sphincter.

3. A method as claimed in claim 1, wherein the tissue energized comprises diaphragm tissue adjacent a hiatal hernia.

4. A method as claimed in claim 1, wherein the applying energy step further comprises selectively heating and shrinking the tissue without substantially ablating the tissue.

5. A method as claimed in claim 1, further comprising limiting the temperature of the heated tissue to a temperature range between about 60°

C. and 110°

C.

6. A method as claimed in claim 1, wherein diaphragm shrinkage decreases a diameter of an esophageal hiatus.

7. A method as claimed in claim 1, further comprising grasping an upper or lower surface of the diaphragm tissue.

8. A method as claimed in claim 1, further comprising forming a reinforcing adhesion between the contracted diaphragm tissue and a superior surface of a stomach.

9. A method for treating reflux disease, the method comprising:

introducing a probe having at least one tissue-penetrating electrode into a patient body;

positioning the probe adjacent a sphincter within the patient body;

penetrating the at least one tissue-penetrating electrode into collagenous tissue; and

energizing the positioned probe to shrink the collagenous tissue so that reflux is inhibited.

10. A method as claimed in claim 9, wherein the sphincter comprises a lower esophageal sphincter.

11. A method as claimed in claim 9, wherein the tissue comprises fascia around the sphincter, and wherein the fascia shrinks so that the closure of the sphincter is enhanced.

12. A method as claimed in claim 9, wherein the tissue comprises diaphragm tissue external to the sphincter.

13. A method as claimed in claim 9, wherein the tissue comprises tissue at and around an esophageal hiatus.

14. A method as claimed in claim 13, wherein the energizing step effects contracting of the tissue so as to mitigate a hiatal hernia.

15. A method as claimed in claim 9, wherein the energizing step effects contracting of the tissue so as to mitigate at least one of the following symptoms selected from the group consisting of regurgitation of acidic stomach juices, erosion of an esophagus wall, and heartburn.

16. A method as claimed in claim 9, further comprising selectively heating and contracting the tissue without substantially ablating the tissue.

17. A method as claimed in claim 9, wherein the at least one electrode of the probe is energized with RF power.

18. A method as claimed in claim 9, wherein the at least one tissue-penetrating electrode comprises a needle.

19. A method as claimed in claim 9, wherein the at least one tissue-penetrating electrode comprises an electrode tip having a sharpened distal end.

20. A method for treating reflux disease, the method comprising:

applying sufficient energy to diaphragm tissue adjacent a sphincter to heat the diaphragm tissue so that the diaphragm tissue shrinks and mitigates reflux disease; and

limiting the temperature of the heated tissue to a temperature range between about 60°

C. and 110°

C.

21. A method for treating reflux disease, the method comprising:

applying sufficient energy to diaphragm tissue adjacent a sphincter to heat the diaphragm tissue so that the diaphragm tissue shrinks and mitigates reflux disease, wherein diaphragm shrinkage decreases a diameter of an esophageal hiatus.

22. A method for treating reflux disease, the method comprising:

grasping an upper or lower surface of a diaphragm tissue; and

applying sufficient energy to the grasped diaphragm tissue adjacent a sphincter to heat the diaphragm tissue so that the diaphragm tissue shrinks and mitigates reflux disease.

23. A method for treating reflux disease, the method comprising:

applying sufficient energy to diaphragm tissue adjacent a sphincter to heat the diaphragm tissue so that the diaphragm tissue shrinks and mitigates reflux disease; and

forming a reinforcing adhesion between the contracted diaphragm tissue and a superior surface of a stomach.