Devices, methods, and systems for shrinking tissues

• US 7,689,290 B2
• Filed: 06/10/2004
• Issued: 03/30/2010
• Est. Priority Date: 11/08/1996
• Status: Expired due to Term

• Current Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Carter, Garry L., Ingle, Frank W., Laufer, Michael D.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US10/866,052
• Publication Number:
  US 20040260368A1
• Time in Patent Office: 2,119 Days
• Field of Search: 607/96, 607 98-102, 607/113, 606 41- 51
• 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 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 comprising:

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

at least two electrodes disposed near the distal end of the probe body, each electrode fixedly attached to a common elongate flexible member reciprocatably mounted in the lumen of the probe body so that when the probe body is disposed in the vagina, said electrodes can be extended from a first position wherein the electrodes are disposed within the lumen of the probe body to a second position wherein the electrodes extend from the distal end of the probe body through a wall of the vagina and into the supporting tissues;

a handle adjacent the proximal end of the probe body for manipulating the at least two electrodes; and

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

wherein the at least two electrodes each deploy into a V-shaped array to engage tissue on opposite sides of the urethra from the vagina.

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 least invasive probe for heating and contracting endopelvic fascia of a patient body, the endopelvic 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 endopelvic fascia and the adjacent tissue layer, the electrode in the wide configuration exposed to engage the endopelvic fascia, the electrode in the narrow configuration being disposed along the axis of the shaft to facilitate axial insertion and withdrawal of the probe;

a deployable, bilaterally asymmetric structure mounted to the shaft and structured to indicate orientation of the electrode, the deployable asymmetric structure defining a substantially flat major surface when the electrode is in the wide configuration, the deployable asymmetric structure supporting the electrode on the major surface; and

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

4. A least invasive probe as claimed in claim 3, wherein the deployable asymmetric structure extends eccentrically from the shaft to help orient the electrode toward the fascia.

5. A least invasive probe as claimed in claim 3, wherein the deployable asymmetric structure comprises a balloon.

6. A least invasive probe as claimed in claim 3, further comprising a second electrode each of the electrodes mounted along an elongate flexible member, and a mechanism for deflecting the flexible members laterally from outside the patient body.

7. A probe for shrinking collagenated tissue of a patient'"'"'s body, the probe comprising:

a shaft having a proximal end and a distal end;

a grasper disposed near the distal end of the shaft, said grasper comprising a pair of arms that rotate about a hinge 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.

8. A probe as claimed in claim 7, wherein the energy applying member comprises at least one electrode disposed between the arms and oriented so as to engage the grasped tissue.

9. A probe as claimed in claim 7, wherein the grasper includes a vacuum system adapted to grip a surface of the tissue.

10. 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 two surface electrodes near the distal end of the probe body structured to engage the urethral wall to apply energy into the urethral wall in the region of the urethral sling when the probe body is disposed in the urethra, wherein the electrodes are axially spaced-apart to apply energy upstream of the urethral sling and downstream of the urethral sling;

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

a bilaterally asymmetric expansion member carrying the at least two electrodes on the probe body and structured to indicate an orientation of the electrodes from outside the urethra.

11. A least invasive probe for heating and contracting endopelvic fascia of a patient body, the endopelvic 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 endopelvic fascia and the adjacent tissue layer, the electrode in the wide configuration exposed to engage the endopelvic fascia, the electrode in the narrow configuration being disposed along the axis of the shaft to facilitate axial insertion and withdrawal of the probe;

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, wherein the deployable structure extends eccentrically from the shaft to help orient the electrode toward the fascia; and

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

12. A least invasive probe for heating and contracting endopelvic fascia of a patient body, the endopelvic 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 endopelvic fascia and the adjacent tissue layer, the electrode in the wide configuration exposed to engage the endopelvic fascia, the electrode in the narrow configuration being disposed along the axis of the shaft to facilitate axial insertion and withdrawal of the probe;

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

an asymmetric structure attached to the shaft to indicate an orientation of the deployed electrode from outside the patient body.

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

a shaft having a proximal end, a distal end and a lumen formed therebetween;

first and second electrodes disposed near the distal end of the shaft and each fixedly attached to an elongate flexible member disposed within the lumen of the shaft, the elongate flexible members being axially moveable relative to the shaft such that the attached first and second electrodes may be moved between a first position and a second position by axial movement of the elongate flexible members, the electrodes in the first position being disposed within the lumen to facilitate axial insertion and withdrawal of the probe, the electrodes in the second position extending from the distal end of the shaft and structured to engage the endopelvic fascia;

a handle adjacent the proximal end of the shaft for manipulating the electrodes from outside the patient body; and

a mechanism for deflecting the flexible members laterally from outside the patient body when the first and second electrodes are in the second position.

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, the length in the range from 5 cm to 20 cm and the diameter in the range from 1 mm to 6 mm;

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 probe body is disposed in the urethra;

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

a bilaterally asymmetric expansion member carrying the at least one electrode on the probe body and structured to indicate an orientation of the at least one electrode from outside the urethra.

15. A device for applying energy into tissues which support the urethral sphincter comprising:

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

at least two electrodes, each electrode reciprocatably mounted along an elongate flexible member disposed within the lumen, the elongate flexible members structured so that when the probe body is disposed in the vagina, said electrodes can be extended from a first position wherein the electrodes are disposed within the lumen to a second position wherein the electrodes extend from the distal end of the probe body;

a mechanism for deflecting the flexible members laterally from outside the vagina when the electrodes are extended from the distal end of the probe body; and

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

16. A least invasive probe for heating and contracting endopelvic fascia of a patient body, the endopelvic 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 endopelvic fascia and the adjacent tissue layer, the electrode in the wide configuration exposed to engage the endopelvic fascia, the electrode in the narrow configuration being disposed along the axis of the shaft to facilitate axial insertion and withdrawal of the probe;

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, wherein the deployable structure extends eccentrically from the shaft to help orient the electrode toward the fascia;

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

a position indicator for indicating an orientation of the electrode from outside the patient body.

17. A least invasive probe for heating and contracting endopelvic fascia of a patient body, the endopelvic 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;

first and second electrodes disposed near the distal end of the shaft, each electrode mounted on an elongate flexible member and laterally deployable from a narrow configuration to a wide configuration between the endopelvic fascia and the adjacent tissue layer, the first and second electrodes in the wide configuration exposed to engage the endopelvic fascia, the first and second electrodes in the narrow configuration being disposed along the axis of the shaft to facilitate axial insertion and withdrawal of the probe;

a handle adjacent the proximal end of the shaft for manipulating the first and second electrodes from outside the patient body;

a mechanism for deflecting the flexible members laterally from outside the patient body; and

a position indicator for indicating an orientation of the first and second electrodes from outside the patient body.

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

a probe body having a proximal end, a distal end and a lumen extending therebetween, 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, the length in the range from 5 cm to 20 cm and the diameter in the range from 1 mm to 6 mm;

first and second electrodes structured to apply energy into the urethral wall in the region of the urethral sling when the probe body is disposed in the urethra, each electrode fixedly attached to an elongate flexible member disposed within the lumen of the probe body, the elongate flexible members being axially moveable relative to the probe body such that the attached first and second electrodes may be moved between a first position wherein the electrodes are disposed within the lumen and a second position wherein the electrodes extend from the distal end of the probe body by axial movement of the elongate flexible members;

a mechanism for deflecting the flexible members laterally from outside the urethra when the first and second electrodes are in the second position; and

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