Noninvasive devices, methods, and systems for shrinking of tissues

• US 20010018606A1
• Filed: 01/23/2001
• Published: 08/30/2001
• Est. Priority Date: 08/13/1997
• Status: Active Grant

• 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.
• Granted Patent: US 6,629,535 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• 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 probe for therapeutically heating a target tissue of a patient body through an intermediate tissue, the probe comprising:

an electrode with an electrode surface which is engageable against the intermediate tissue, the electrode surface being substantially flat; and

a cooling system coupled to the electrode so that the electrode surface can cool the engaged intermediate tissue while an electrical current flux from the electrode surface therapeutically heats the target tissue.

2. A probe as claimed in

claim 1

, wherein the electrode surface is sufficiently flat to direct the current flux from the electrode surface, through the cooled intermediate tissue, and into the target tissue, wherein the cooling system is capable of maintaining the intermediate tissue at or below a maximum safe tissue temperature while the current flux heats the target tissue.

3. A probe as claimed in

claim 2

, further comprising a control system coupled to the electrode and a temperature sensor coupled to the control system and adapted for measuring a temperature of at least one of the intermediate tissue and the target tissue, the control system adapted to selectively energize the electrode in response to the temperature so as to heat the target tissue to a treatment temperature while the cooling system maintains the intermediate tissue below the maximum safe tissue temperature.

4. A probe as claimed in

claim 3

, wherein the target tissue comprises collagenated tissue, and wherein the treatment temperature is sufficient to shrink the collagenated tissue.

5. A probe as claimed in

claim 1

, wherein the electrode comprises an electrode array, and wherein the 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 electrode surface segments to vary the current flux within the target tissue.

6. A probe as claimed in

claim 1

wherein the probe is adapted for insertion into a patient body.

7. A probe for applying energy to fascia from within a vagina of a patient body, the fascia separated from the vagina by vaginal wall, the probe comprising:

a probe body having a proximal end and a distal end, the probe having a length and a cross-section selected to permit introduction into the vagina;

an energy transmitting element mounted to the probe body, the transmitting element capable of transmitting sufficient heating energy through the vaginal wall to heat and contract the fascia; and

a cooling system disposed adjacent the transmitting element, the cooling system capable of maintaining the vaginal mucosa adjacent the probe at or below a maximum safe temperature when the fascia is heated by the transmitting element.

8. A method for shrinking a target collagenated tissue within a patient body through an intermediate tissue, the method comprising:

directing energy from a probe, through the intermediate tissue, and into the target tissue, wherein the energy heats the target tissue so that the target tissue contracts; and

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

9. A method for directing energy into a target tissue of a patient body through an intermediate tissue, 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 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.

10. A method for therapeutically heating a target zone of a tissue within a patient body, the method comprising:

engaging a tissue adjacent to the target zone with a probe;

pre-cooling the adjacent tissue with the probe; and

heating the target zone by directing energy from the probe, through the pre-cooled adjacent tissue, and into the target zone.

11. A kit for shrinking a target collagenated tissue within a patient body through an intermediate tissue, the kit comprising:

a probe comprising;

an energy transmitting element adapted to direct an energy flux through the intermediate tissue and into the target tissue; and

a cooling system adjacent to the transmitting element to cool the intermediate tissue; and

instructions for operating the probe, the instructions comprising the steps of;

directing energy from the energy transmitting element of the probe, through the intermediate tissue, and into the target tissue so as to heat and shrink the target tissue; and

cooling the intermediate tissue with the cooling system of the probe to avoid injuring the intermediate tissue.

12. 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.

13. 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.

14. A system as claimed in

claim 13

, wherein the first and second electrode surfaces are substantially flat to distribute the current flux throughout the tissue between the electrodes.

15. A system as claimed in

claim 14

, 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.

16. A system as claimed in

claim 13

, 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.

17. 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.

18. A probe for heating a target tissue of a patient body through an intermediate tissue, the probe comprising:

a probe body supporting a plurality of electrode surface segments, the electrode surface segments simultaneously engageable against the intermediate tissue;

a cooling system coupled to the probe for cooling the electrode surface segments; and

a control system coupled to the electrode surface segments, the control system adapted to selectively energize the electrode surface segments so as to heat the target tissue to a treatment temperature while the cooling system maintains the intermediate tissue disposed between the electrode array and the target zone below a maximum safe tissue temperature.

19. A probe as claimed in

claim 18

, wherein the electrode segments define an electrode surface which is substantially flat so as to direct current flux through the intermediate tissue and into the target tissue.

20. A probe as claimed in

claim 18

, wherein the control system can apply a bipolar electrical potential between electrode segments, wherein the cooling system cools the engaged intermediate tissue disposed between the bipolar electrode segments, and wherein the bipolar electrode segments are adapted to direct a current flux through the engaged intermediate tissue and into the target tissue.

21. A probe as claimed in

claim 18

, further comprising an ultrasound transducer disposable adjacent the intermediate tissue to facilitate aligning the probe with the target tissue.

22. A probe as claimed in

claim 21

, further comprising a needle extendable from the probe within a field of view of the ultrasound transducer, the needle coupled to a temperature sensor for monitoring a temperature of the target tissue.

29. A method for teaching comprising demonstrating the method of

claim 18

.

23. A method for therapeutically heating a target zone of a tissue within a patient body, the method comprising:

engaging a probe against the tissue, the probe having a plurality of electrode surface segments;

cooling the tissue adjacent the probe with the electrode surface segments; and

directing an electrical current flux from the electrode surface segments, through the cooled tissue, and into the target zone by selectively energizing the electrode surface segments so that the current flux substantially evenly heats the target zone.

24. 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.

25. 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.

26. 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.

27. 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.

28. 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.

30. 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:

coupling an electrode of a probe to the tissue surface;

cooling the intermediate tissue with the probe;

intermittently energizing the electrode to heat the target tissue through the cooled intermediate tissue.

31. 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.

32. The system of

claim 31

, 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.

33. 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.

34. A device as claimed in

claim 33

, further comprising a clamp structure mechanically coupling the electrodes for compressing the tissue between the electrode surfaces.

35. A device as claimed in

claim 34

, 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.

36. A device as claimed in

claim 34

, 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.

37. A device as claimed in

claim 36

, wherein a separation distance between the first probe and a support structure for the second electrode increases proximally of the first electrode.

38. A device as claimed in

claim 36

, wherein the second electrode is adapted to limit heating of the tissue adjacent the surface of the second electrode.

39. A device as claimed in

claim 38

, further comprising a cooling system thermally coupled to the second electrode.

40. A device as claimed in

claim 39

, 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.

41. A device as claimed in

claim 40

, 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.

42. A device as claimed in

claim 34

, wherein the clamp structure comprises threads coupling the first and second probes so that a separation distance between the electrode surfaces can be varied.

43. A device as claimed in

claim 33

, further comprising a temperature sensor extendable from adjacent one of the electrode surfaces toward the other for sensing a tissue temperature therebetween.

44. 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.

45. 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.

46. A method as claimed in

claim 45

, wherein the energy focussing step is performed such that the target tissue shrinks, the target tissue comprising a collagenated tissue.

47. A method as claimed in

claim 46

, 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.

48. 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.

49. A system as claimed in

claim 48

, 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.

50. A system as claimed in

claim 48

, 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.

51. 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;

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.

52. The method of

claim 51

, wherein the temperature differential generating step comprises pre-cooling the adjacent tissue to enhance an impedance of the adjacent tissue sufficiently to locally reduce current density within the adjacent tissue so that heating of the adjacent tissue by the heating current is significantly diminished.

53. The method of

claim 52

, further comprising controlling the pre-cooling step so as to align the temperature differential between the target tissue and the adjacent tissue.

54. The method of

claim 51

, wherein the temperature differential generating step comprises pre-heating the target tissue to reduce an impedance of the target tissue sufficiently to locally enhance current density within the target tissue such that heating of the target tissue by the heating electrical current is significantly increased.

55. The method of

claim 54

, further comprising controlling the pre-heating step so as to align the temperature differential between the target tissue and the adjacent tissue.

56. The method of

claim 51

, wherein the temperature differential generating step comprises 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.

57. The method of

claim 56

, wherein the target tissue is pre-cooled by a cooled surface of a probe.

58. The method of

claim 57

, 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.

59. The method of

claim 51

, wherein the target tissue and the adjacent tissue define a boundary region therebetween, and wherein at least a portion of the heating electrical current is sufficiently parallel to the boundary region that the temperature differential tailors heating by urging the current from the adjacent tissue to the target tissue.

60. The method of

claim 51

, wherein the heating step effects shrinkage of the target tissue, the target tissue comprising collagen.

61. The method of

claim 60

, wherein the target tissue comprises an endopelvic support tissue, and wherein the shrinkage of the target tissue inhibits incontinence.

62. The method of

claim 61

, 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 further comprising circulating a cooling fluid within the bladder.

63. The method of

claim 51

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

64. 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.

65. The system of

claim 64

, further comprising a processor coupled to the member to align the temperature differential between the target tissue and the adjacent tissue.

66. The system of

claim 65

, wherein the processor initiates heating once a predetermined temperature differential is achieved.

67. The system of

claim 66

, 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.

68. The system of

claim 65

, 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.

69. The system of

claim 68

, 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.

70. The system of

claim 65

, 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.

71. The system of

claim 65

, 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.

72. The system of

claim 64

, wherein the at least one heating electrode is mounted to the probe.

73. The system of

claim 72

, 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.

74. The system of

claim 73

, 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.

75. The system of

claim 74

, 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.

76. The system of

claim 74

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

77. The system of

claim 64

, 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.

78. The system of

claim 64

, 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.

79. A probe for selectively heating a target tissue, the target tissue separated form a tissue surface by an intermediate tissue, the probe comprising:

a surface oriented for engaging the tissue surface;

a pair of bi-polar electrodes disposed along the probe surface; and

a cooling system thermally coupled to the electrodes and to the probe surface adjacent the electrodes so as to cool the intermediate tissue.