Devices, methods, and systems for shrinking tissues

• US 20040260368A1
• Filed: 06/10/2004
• Published: 12/23/2004
• Est. Priority Date: 11/08/1996
• Status: Active Grant

• Current Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Original Assignee: Solarant Medical, Inc. (Endo International PLC)
• Inventors: Laufer, Michael D., Ingle, Frank, Carter, Garry
• Granted Patent: US 7,689,290 B2
• Time in Patent Office: Days
• US Class Current: 607/99
• 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 relying on energy delivered to a patient'"'"'s 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. A variety of devices and methods are provided for applying gentle resistive heating of these and other tissues to cause them to contract without imposing significant injury on the surrounding tissue structures. 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 device for applying energy into tissues which support the urethral sphincter, said probe comprising:

a probe body having a proximal end and a distal end, wherein the body has a length and a diameter selected to permit introduction into the vagina;

at least two electrodes reciprocatably mounted on the probe body so that said electrodes can be extended from the probe body into the supporting tissues when the probe is disposed in the vagina; and

a connector near the proximal end of the probe body which can be connected to a power supply.

2. A device as in claim 1, wherein the probe body has a length in the range from 5 cm to 20 cm and a diameter in the range from 1 mm to 6 mm.

3. A device as in claim 3, wherein the at least two electrodes deploy into a V-shaped array to engage tissue on opposite sides of the urethra from the vagina.

4. A least invasive probe for heating and contracting fascia of a patient body, the fascia being adjacent to a tissue layer, the probe comprising:

a shaft having a proximal end and a distal end and defining an axis therebetween;

an electrode disposed near the distal end of the shaft, the electrode laterally deployable from a narrow configuration to a wide configuration between the fascia and the adjacent tissue layer, the electrode in the wide configuration exposed to engage the fascia, the electrode in the narrow configuration being disposed along the axis of the shaft to facilitate axial insertion and withdrawal of the probe; and

a handle adjacent the proximal end of the shaft for manipulating the electrode from outside the patient body.

5. A least invasive probe as claimed in claim 4, further comprising a deployable structure mounted to the shaft, the deployable structure defining a substantially flat major surface when the electrode is in the wide configuration, the deployable structure supporting the electrode on the major surface.

6. A least invasive probe as claimed in claim 5, wherein the deployable structure extends eccentrically from the shaft to help orient the electrode toward the fascia.

7. A least invasive probe as claimed in claim 5, wherein the deployable structure comprises a balloon.

8. A least invasive probe as claimed in claim 4, further comprising an asymmetric structure attached to the shaft to indicate an orientation of the deployed electrode from outside the patient body.

9. A least invasive probe as claimed in claim 4, further comprising first and second electrodes, each electrode mounted along an elongate flexible member, and a mechanism for deflecting the flexible members laterally from outside the patient body.

10. A probe for shrinking collagenated tissue of a patient body, the probe comprising:

a shaft having a proximal end and a distal end;

a grasper disposed near the distal end of the shaft, the grasper adapted to draw a region of the tissue inward so as to reduce tension within the region; and

an energy applying member disposed adjacent to the grasper, the energy applying member capable of heating the drawn tissue so that the drawn tissue contracts without ablating the tissue.

11. A probe as claimed in claim 10, wherein the grasper comprises first and second arms, the arms having arm ends which are engageable against a surface of the tissue, the arms articulatable relative to each other to draw the region of tissue inward.

12. A probe as claimed in claim 11, wherein the energy applying member comprises at least one electrode disposed between the arms and oriented so as to engage the grasped tissue.

13. A probe as claimed in claim 10, wherein the grasper includes a vacuum system adapted to grip a surface of the tissue.

14. A device for applying energy to a urethral wall, said device comprising

a probe body having a proximal end and a distal end, wherein the body has a length and a diameter selected to permit introduction into the urethra so that the distal end can be positioned adjacent to the urethral sling;

at least one electrode near the distal end of the probe body disposed to apply energy into the urethral wall in the region of the urethral sling when the catheter body is disposed in the urethra; and

a connector near the proximal end of the probe body which can be connected to a power supply.

15. A device as in claim 14, wherein the probe body has a length in the range from 5 cm to 20 cm and a diameter in the range from 1 mm to 6 mm.

16. A device as in claim 15, wherein the catheter body includes at least two electrodes which are axially spaced-apart to apply energy upstream of the urethral sling and downstream of the urethral sling.

17. A device as in claim 15, further comprising an expansion member carrying the at least one electrode on the catheter body.