Noninvasive devices, methods, and systems for shrinking of tissues

• US 20030139790A1
• Filed: 01/07/2003
• Published: 07/24/2003
• Est. Priority Date: 08/13/1997
• Status: Active Grant

• Current Assignee: Verathon Incorporated (Roper Technologies, Inc.)
• Original Assignee: SURX, Inc. (Endo International PLC)
• Inventors: Ingle, Frank, Laird, Robert J., Claude, John P., Carter, Garry L., Do, Paul, Mosel, Brian J.
• Granted Patent: US 6,976,492 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 18/1485 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 collagenated 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 collagenated support tissues, causing them to contract. The energy can be applied intermittently, often between a pair of large plate electrodes having cooled flat electrode surfaces, the electrodes optionally being supported by a clamp structure. 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, particularly where the electrode surfaces are cooled before, during, and after an intermittent heating cycle. 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. Alternatively, chilled “liquid electrodes” may direct current through a selected portion of the bladder (or other body cavity) while also cooling the bladder wall, an insulating gas can prevent heating of an alternative bladder portion and the adjacent tissues, and/or ultrasound transducers direct energy through an intermediate tissue and into fascia with little or no injury to the intermediate tissue. Cooled electrodes may be used to chill an intermediate engaged tissue so as to cause the maximum 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 teaching, the method comprising:

demonstrating cooling of a surface with a probe; and

demonstrating directing of energy from the probe through the surface and into an underlying structure to effect shrinkage of the structure.

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

a first electrode having a first electrode surface which is engageable 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; and

a cooling system coupled to at least one of the electrodes for cooling the electrode surface.

3. A system as claimed in claim 2, wherein the first and second electrode surfaces are substantially flat to distribute the current flux throughout the tissue between the electrodes.

4. A system as claimed in claim 3, further comprising 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.

5. A system as claimed in claim 2, 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.

6. 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;

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; and

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

7. A method for heating a target tissue within a patient body, the tissue separated from a body cavity by an intermediate tissue, the method comprising:

providing a conductive fluid within the cavity;

passing an electrical current from or through the conductive fluid, through the intermediate tissue, and into the target tissue to effect heating of the target tissue; and

cooling the intermediate tissue.

8. A method for shrinking a target tissue within a patient body, the target tissue separated from a body cavity by an intermediate tissue, the method comprising:

introducing a conductive fluid into the cavity;

introducing an insulating fluid into the cavity;

positioning the fluids within the cavity by orienting the patient so that the conductive fluid is disposed adjacent the target tissue and the insulating fluid is disposed away from the target tissue, the conductive and insulating fluids having different densities;

heating the target tissue by passing an electrical current from the conductive fluid, through the intermediate tissue, and into the target tissue; and

cooling the intermediate tissue.

9. A method for treating urinary incontinence, the method comprising:

introducing a fluid into the bladder;

transmitting electrical current from or through the fluid, through a bladder wall, and into a pelvic support tissue so that the current heats and shrinks the pelvic support tissue and inhibits urinary incontinence; and

cooling the bladder wall with the conductive fluid.

10. A system for shrinking a pelvic support tissue of a patient body, the pelvic support tissue separated from a urinary bladder by a bladder wall, the system comprising:

a first probe having a proximal end, a distal end adapted for transurethral insertion into the bladder, a first electrode near the distal end, a fluid inflow port near the distal end, and a sealing member proximal of the inflow port for sealing a conductive fluid within the bladder such that the first electrode is electrically coupled to the bladder wall by the conductive fluid;

a second electrode adapted for transmitting current to a tissue surface of the patient body; and

a power source coupled to the first and second electrodes to heat and shrink the pelvic support tissue.

11. A system for shrinking a pelvic support tissue of a patient body, the pelvic support tissue separated from a urinary bladder by a bladder wall, the system comprising:

a first probe having a proximal end, a distal end adapted for transurethral insertion into the bladder, and a first electrode near the distal end;

a second probe having a proximal end, a distal end adapted for insertion into the vagina, and a second electrode near the distal end; and

a power source coupled to the first and second electrodes to heat and shrink the pelvic support tissue.

12. A method for teaching comprising demonstrating the method of claim 11.

13. A system for shrinking a target tissue of a patient body through a tissue surface, the system comprising:

a probe having a first electrode for electrically coupling the probe to the tissue surface;

a second electrode for coupling to the patient body;

a controller coupled to the first and second electrodes, the controller adapted to intermittently energize the electrodes with an RF current so that the electrodes heat and shrink the target tissue.

14. The system of claim 13, wherein the target tissue is separated from the tissue surface by an intermediate tissue, the probe including a cooling system adjacent the electrode, wherein the controller is adapted to heat and shrink the target tissue while the cooling system maintains the intermediate tissue below a maximum safe temperature.

15. A device for therapeutically heating tissue, the device comprising:

a first electrode having an electrode surface;

a cooling system thermally coupled to the first electrode;

a second electrode mechanically coupled to the first electrode so that an electrode surface of the second electrode is oriented toward the first electrode surface.

16. A device as claimed in claim 15, further comprising a clamp structure mechanically coupling the electrodes for compressing the tissue between the electrode surfaces.

17. A device as claimed in claim 16, wherein the clamp structure is adapted to maintain the first electrode surface in alignment with and sufficiently parallel to the surface of the second electrode to direct an even electrical current flux through a target region of the clamped tissue.

18. A device as claimed in claim 16, further comprising a first probe having a proximal end attached to the clamp structure and a distal end adapted for insertion into a patient body, the first electrode being mounted near the distal end of the first probe.

19. A device as claimed in claim 18, wherein a separation distance between the first probe and a support structure for the second electrode increases proximally of the first electrode.

20. A device as claimed in claim 18, wherein the second electrode is adapted to limit heating of the tissue adjacent the surface of the second electrode.

21. A device as claimed in claim 20, further comprising a cooling system thermally coupled to the second electrode.

22. A device as claimed in claim 21, further comprising a second probe having a proximal end attached to the clamp structure and a distal end adapted for insertion into a patient body, the second electrode being disposed near the distal end of the second probe so that the clamp structure can compress the tissue between the electrode surfaces.

23. A device as claimed in claim 22, wherein the first probe has a size and a length suitable for transrectal insertion, wherein the second probe has a size and a length suitable for transvaginal insertion.

24. A device as claimed in claim 16, wherein the clamp structure comprises threads coupling the first and second probes so that a separation distance between the electrode surfaces can be varied.

25. A device as claimed in claim 15, further comprising a temperature sensor extendable from adjacent one of the electrode surfaces toward the other for sensing a tissue temperature therebetween.

26. A method for selectively shrinking a target tissue, the method comprising:

clamping a target tissue between a plurality of electrode surfaces;

heating the clamped target tissue by transmitting a current flux between the electrode surfaces;

cooling at least one of the electrodes to limit heating of intermediate tissue disposed between the at least one electrode and the target tissue.

27. A method for heating a target tissue within a patient body, the target tissue separated from a tissue surface by an intermediate tissue, the method comprising:

acoustically coupling an ultrasound transmitter to the tissue surface; and

focussing ultrasound energy from the transmitter through the intermediate tissue and onto the target tissue so that the target tissue is therapeutically heated.

28. A method as claimed in claim 27, wherein the energy focussing step is performed such that the target tissue shrinks, the target tissue comprising a collagenated tissue.

29. A method as claimed in claim 28, wherein the ultrasound transmitter is inserted into a vagina of the patient body, wherein the target tissue comprises an endopelvic support tissue, and wherein the focussing step shrinks to pelvic support tissue so as to inhibit incontinence.

30. A system for heating a target tissue, the target tissue being separated from a tissue surface by an intermediate tissue, the system comprising a probe having an ultrasound transmitter for focussing ultrasound energy through the intermediate tissue so as to heat the target tissue.

31. A system as claimed in claim 30, further comprising a temperature sensor coupled to the probe and exposed to at least one of the intermediate tissue and the target tissue for sensing a tissue temperature.

32. A system as claimed in claim 30, further comprising a controller coupled to the probe, the controller adapted to direct the ultrasound energy from the transmitter into the target tissue so as to heat the target tissue to about 60°

C. or more while limiting a temperature of the intermediate tissue to about 45°

C. or less.

33. 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; 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;

wherein the heating step ablates the target tissue, the target tissue comprising a tumor.

34. A system for selectively heating a predetermined target tissue, the target tissue adjacent another tissue, the system comprising:

a probe having a surface oriented for engaging a tissue surface;

a member selected from the group consisting of a pre-cooler and a pre-heater coupled to the probe surface so as to produce a temperature differential between the target tissue and the adjacent tissue; and

at least one tissue heating electrode coupleable to the target tissue to conduct an electrical current into the tissues, the at least one heating electrode defining a nominal current distribution when the current is conducted into the tissues and the tissues are at a uniform body temperature, the at least one heating electrode producing a tailored current distribution when the current is conducted into the tissues and the tissues exhibit the temperature differential, the tailored current distribution resulting in less collateral damage to the adjacent tissues than the nominal current distribution when the target tissue is heated by the current to a treatment temperature.

35. The system of claim 34, further comprising a processor coupled to the member to align the temperature differential between the target tissue and the adjacent tissue.

36. The system of claim 35, wherein the processor initiates heating once a predetermined temperature differential is achieved.

37. The system of claim 36, wherein the processor is coupled to the pre-heater and to the pre-cooler, and wherein the pre-heater comprises an energy transmitting element that is separate from the at least one electrode.

38. The system of claim 35, further comprising a first temperature sensor coupled to the processor, the first temperature sensor transmitting an adjacent tissue temperature signal to the processor, wherein the processor determines the temperature differential at least in part from the adjacent tissue temperature signal.

39. The system of claim 38, further comprising a second temperature sensor coupled to the processor, the second temperature sensor transmitting a target tissue temperature signal to the processor, wherein the processor determines the temperature differential at least in part from the target tissue temperature signal.

40. The system of claim 35, wherein the member comprises a pre-heat electrode, and wherein the processor can vary at least one element of the group consisting of electrical pre-heat current from the pre-heat electrode, a pre-heat current duty cycle, and a total pre-heat time.

41. The system of claim 35, wherein the member comprises a pre-cooler, and wherein the processor can vary at least one element selected from the group consisting of a total pre-cooling time, a probe surface temperature, and a pre-cooling duty cycle.

42. The system of claim 34, wherein the at least one heating electrode is mounted to the probe.

43. The system of claim 42, wherein the pre-cooler can cool the at least one heating electrode so that the at least one heating electrode pre-cools the adjacent tissue when the adjacent tissue is disposed between the at least one heating electrode and the target tissue.

44. The system of claim 43, wherein the at least one heating electrode comprises a pair of bipolar heating electrodes along the probe surface, wherein the pre-cooler comprises cooled electrode surfaces of the heating electrodes and a cooled heat transfer surface disposed therebetween.

45. The system of claim 44, wherein the heating electrodes define a width and are separated by a separation distance in a range from about ⅓

to about 5 times the width.

46. The system of claim 44, further comprising a pair of bipolar pre-heat electrodes disposed along the probe surface with the heating electrodes disposed therebetween.

47. The system of claim 34, further comprising a processor coupled to the at least one heating electrode and to the member, the processor controlling the temperature differential and the current so as to shrink the target tissue while avoiding collateral damage to the adjacent tissue, the target tissue comprising collagen.

48. The system of claim 34, wherein the probe has a size and shape suitable for transvaginal insertion, the at least one heating electrode, the temperature differential member, and processor being capable of selectively shrinking an endopelvic support tissue so as to inhibit incontinence.