Noninvasive devices, methods, and systems for shrinking of tissues

• US 6,216,704 B1
• Filed: 08/12/1998
• Issued: 04/17/2001
• Est. Priority Date: 08/13/1997
• Status: Expired due to Term

• Current Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Original Assignee: SURX, Inc. (Endo International PLC)
• Inventors: Ingle, Frank, Laird, Robert J., Claude, John P., Carter, Garry L., Do, Paul, Mosel, Brian J.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/133,496
• Time in Patent Office: 979 Days
• Field of Search: 606/41, 606/42, 606/45-50, 607/101-105, 607/138, 128/898
• US Class Current: 128/898
• 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 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• 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 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/0022 Balloons
• 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 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1273 : including multiple generators in one device
• 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: A61B 2018/1472 : for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

The invention provides improved devices, methods, and systems for shrinking of collagenous tissues, particularly for treating urinary incontinence in a noninvasive manner by directing energy to a patient'"'"'s own support tissues. This energy heats fascia and other collagenous support tissues, causing them to contract. Pre-cooling and/or pre-heating may induce a temperature difference between the target tissue and the intermediate tissue prior to initiating RF heating. This allows the dimensions of tissue reaching the treatment temperature to be controlled and/or minimized, the dimensions of protected intermediate tissue to be maximized, and the like.

Claims

1. A method for shrinking a target collagenous endopelvic support tissue within a patient body through an intermediate tissue, the method comprising:

positioning a probe within a vagina of the patient;

directing energy from the probe, through a vaginal wall, and into the target tissue, wherein the energy heats the target tissue so that the target tissue contracts and the contracted target tissue inhibits incontinence; and

cooling the vaginal wall with the probe to avoid injuring the vaginal wall when the target tissue is heated by the probe.

2. A method for directing energy into a target collagenous endopelvic support tissue of a patient body through an intermediate tissue, the intermediate tissue comprising a vaginal wall, the method comprising:

electrically coupling a first electrode to the patient body;

electrically coupling a second electrode to the intermediate tissue, the second electrode mounted on a vaginal probe;

cooling the intermediate tissue with the probe; and

applying an electrical potential between the first and second electrodes, wherein an electrode surface of the second electrode is sufficiently large and flat to provide a current flux that extends through the cooled intermediate tissue and into the target tissue so that the current flux heats the target tissue without ablating the target tissue while the cooling of the intermediate tissue inhibits necrosis of the vaginal wall.

3. A method for therapeutically heating a target zone within a patient body so as to inhibit incontinence, a collagenous pelvic support structure being disposed within the target zone the method comprising:

engaging a probe against a tissue surface separated from the target zone the probe having a plurality of electrodes;

cooling the tissue surface adjacent the probe with the electrodes; and

intermittently directing an electrical current flux from the electrodes, through the cooled tissue, and into the target zone by intermittently energizing the electrodes so that the current flux heats the target zone and the pelvic support structure inhibits incontinence, the electrodes cooling the engaged tissue surface while directing flux and between flux directing cycles.

4. A method for selectively heating a predetermined target tissue, the target tissue adjacent another tissue, the method comprising:

generating a temperature differential between the adjacent tissue and the target tissue by pre-heating the target tissue to reduce an impedance of the target tissue sufficiently to locally enhance current density within the target tissue; and

heating the target tissue by conducting a heating electrical current into the target tissue after generating the temperature differential so that the temperature differential urges the heating current from the adjacent tissue into the target tissue, and such that heating of the target tissue by the heating electrical current is significantly increased.

5. The method of claim 4, further comprising controlling the pre-heating step so as to align the temperature differential between the target tissue and the adjacent tissue.

6. A method for selectively heating a predetermined target tissue, the target tissue adjacent another tissue, the method comprising:

generating a temperature differential between the adjacent tissue and the target tissue by pre-cooling of the adjacent tissue and pre-heating the target tissue so as to produce sufficient temperature differential between the adjacent tissue and the target tissue to enhance an impedance of the adjacent tissue relative to an impedance of the target tissue; and

heating the target tissue by conducting a heating electrical current into the target tissue after generating the temperature differential so that the temperature differential urges the heating current from the adjacent tissue into the target tissue.

7. The method of claim 6, wherein the target tissue is pre-cooled by a cooled surface of a probe.

8. The method of claim 7, wherein the adjacent tissue is disposed between the probe surface and the target tissue, wherein the electrical currents are transmitted through the probe surface, and further comprising controlling the pre-cooling to align the temperature differential between the adjacent tissue and the target tissue.

9. A method for selectively heating a predetermined target tissue, the target tissue comprising an endopelvic support tissue and including collagen, the target tissue adjacent another tissue, the method comprising:

generating a temperature differential between the adjacent tissue and the target tissue;

heating the target tissue by conducting a heating electrical current into the target tissue after generating the temperature differential so that the temperature differential urges the heating current from the adjacent tissue into the target tissue, the heating step effecting shrinkage of the target tissue, the shrinkage of the target tissue inhibiting incontinence, wherein the temperature differential generating step and the heating step are performed using a transvaginal probe so as to shrink endopelvic fascia disposed between a vagina and a bladder; and

circulating a cooling fluid within the bladder.