Noninvasive devices, methods, and systems for shrinking of tissues

• US 6,035,238 A
• Filed: 08/13/1997
• Issued: 03/07/2000
• 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, Carter, Garry
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): CARTER, RYAN CHRISTOPHER
• Application Number:
  US08/910,369
• Time in Patent Office: 937 Days
• Field of Search: 607/96, 607/98-102, 607/104, 607/115-116, 607/119, 607/122, 607/126, 607/149, 607/154, 600/372, 600/382, 600/386, 128/898
• US Class Current: 607/98
• 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 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/0022 Balloons
• 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 2018/00791 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 2018/1467 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 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

The invention provides improved devices, methods, and systems for shrinking of collagenated tissues, particularly for treating urinary incontinence in a noninvasive manner by directing energy to a patient'"'"'s own support tissues. This energy gently heats fascia and other collagenated support tissues, causing them to contract. The energy will preferably be applied between a pair of large plate electrodes having cooled flat electrode surfaces. Such cooled plate electrodes are capable of directing electrical energy through an intermediate tissue and into fascia while the cooled electrode surface prevents injury to the intermediate tissue. Ideally, the plate electrode comprises an electrode array including discrete electrode surface segments so that the current flux can be varied to selectively target the fascia.

Claims

1. A system for therapeutically heating a target zone within a tissue, the system comprising:

a first electrode having a first electrode surface which is engagable against the tissue;

a second electrode having a second electrode surface which can be aligned substantially parallel to the first electrode surface with the tissue therebetween so that an electrical current flux between the electrodes can substantially evenly heat the target zone, the first and second electrode surfaces substantially flat to distribute the current flux throughout the tissue between the electrodes;

a cooling system coupled to at least one of the electrodes for cooling at least one of the electrode surfaces; and

a positioning system coupled to at least one of the first electrode and the second electrode, the positioning system capable of aligning the electrode surfaces along substantially opposed surfaces of the tissue.

2. A device as claimed in claim 1, wherein each electrode surface comprises a plurality of electrode surface segments, and further comprising a control system coupled to each electrode surface segment, the control system capable of selectively energizing the electrode surface segments to vary the current flux within the target zone.

3. A method for therapeutically heating a target zone of a patient body, the target zone disposed within a tissue between first and second tissue surfaces, the method comprising:

engaging a first electrode surface against the first tissue surface;

aligning a second electrode surface substantially parallel with the first electrode surface and against the second tissue surface with a positioning system coupled to at least one of the first electrode surface and the second electrode surface;

applying an electrical potential between the first and second electrodes, the electrical potential producing an electrical current flux between the electrodes which heats the target zone, the electrode surfaces being sufficiently large and sufficiently flat to distribute the current flux throughout the target zone; and

cooling at least one of the first and second tissue surfaces with the engaged electrode.

4. A method as claimed in claim 3, further comprising monitoring a temperature of the tissue and varying the current flux in response to the temperature.

5. A method as claimed in claim 3, further comprising directing the current flux from the at least one cooled electrode into the tissue so as to evenly heat the target zone.

6. A method as claimed in claim 5, wherein the flux directing step comprises selectively varying the electrical potential across at least one of the electrode surfaces, the at least one electrode surface comprising a plurality of electrode surface segments.

7. A method as claimed in claim 6, wherein the cooling step comprises cooling the first and second electrode surfaces.

8. A method as claimed in claim 7, further comprising clamping the tissue between the electrode surfaces so that a gap between the electrode surfaces is less than a width and a length of each electrode surface.

9. A method as claimed in claim 5, wherein the cooling step comprises maintaining the tissue adjacent the first tissue surface below a safe tissue temperature, the target zone being separated from the first tissue surface by a cooled tissue depth.

10. A method as claimed in claim 9, wherein the energy directing step further comprises selectively energizing a plurality of electrode surface segments of the first electrode so as to vary an effective size of the first electrode and change the cooled tissue depth.