Integrated tissue heating and cooling apparatus

• US 6,273,886 B1
• Filed: 05/04/1999
• Issued: 08/14/2001
• Est. Priority Date: 02/19/1998
• Status: Expired due to Term

• Current Assignee: Mederi Rf, LLC
• Original Assignee: Curon Medical, Inc.
• Inventors: West, Scott, Utley, David, Gaiser, John, Edwards, Stuart, Chin, Jay
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/305,079
• Time in Patent Office: 833 Days
• Field of Search: 606/31, 606/32, 606/34, 606/41, 606/42, 606/45-50, 607/101-105
• US Class Current: 606/34
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• 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 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00041 Heating, e.g. defrosting
• CPC Class Codes: A61B 2018/00077 high, i.e. electrically 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 2018/00261 arranged in a line
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00494 Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00553 Sphincter
• CPC Class Codes: A61B 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/0066 : without feedback, i.e. open loop control
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00755 : Resistance or impedance
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 : measured by a thermistor
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00898 : Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/046 : in liquid form
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/143 : multiple needles
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• 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: A61B 2218/007 : Aspiration

Abstract

Systems and methods integrate the control of an energy generator, to supply energy to an electrode structure to heat a tissue region, and the control of a pumping mechanism, to supply cooling fluid to control tissue temperature in the region.

Claims

1. A device for association with an electrode structure which, in use, is deployed in a tissue region, the device comprising

a housing,

a generator integrated in the housing to generate energy capable of heating tissue and adapted to be coupled to the electrode structure to apply the energy to the tissue region,

a pumping mechanism integrated in the housing and adapted to be attached to tubing to dispense cooling fluid from a source to the tissue region,

a controller integrated in the housing and coupled to the generator and the pumping mechanism, to enable control of the generator in supplying energy to the electrode structure to raise tissue temperature in the tissue region, in concert with operation of the pumping mechanism in supplying cooling fluid to the tissue region to control the tissue temperature,

a control panel on the housing supporting a consolidation of command input devices coupled to the controller, the command input devices including at least one generator control input for receiving from an operator an operating parameter affecting operation of the generator and at least one pump control input for receiving from an operator an operating parameter affecting operation of the pumping mechanism, and

a display screen and an operating system coupled to the display screen to show an animated visual image indicating operation of the generator and an animated visual image indicating operation of the pumping mechanism.

2. A device according to claim 1

wherein the generator generates radio frequency energy.

3. A device according to claim 1

wherein the pumping mechanism includes a peristaltic pump rotor.

4. A device for association with an electrode structure which, in use, is deployed in a tissue region, the device comprising

a housing,

a generator integrated in the housing to generate energy capable of heating tissue and adapted to be coupled to the electrode structure to apply the energy to the tissue region,

a pumping mechanism integrated in the housing and adapted to be attached to tubing to dispense cooling fluid from a source to the tissue region,

a controller integrated in the housing and coupled to the generator and the pumping mechanism, to enable control of the generator in supplying energy to the electrode structure to raise tissue temperature in the tissue region, in concert with operation of the pumping mechanism in supplying cooling fluid to the tissue region to control the tissue temperature,

a control panel on the housing supporting a consolidation of command input devices coupled to the controller, the command input devices including at least one generator control input for receiving from an operator an operating parameter affecting operation of the generator and at least one pump control input for receiving from an operator an operating parameter affecting operation of the pumping mechanism, and

a display screen coupled to the controller, the controller including an operating system that generates a first image on the display screen that represents an operating condition of the generator, the operating system also generating a second image on the display screen concurrently with the first image that represents an operating condition of the pumping mechanism.

5. A device according to claim 4

wherein the pumping mechanism includes a peristaltic pump rotor.

6. A device according to claim 4

wherein the controller includes a pump drive function to monitor pumping rate of the pumping mechanism.

7. A device according to claim 4

wherein the controller includes a pump drive function to select a pumping rate for the pumping mechanism.

8. A device according to claim 4

wherein the controller enables manual control of the operation of the generator.

9. A device according to claim 4

wherein the controller enables automatic control of the operation of the generator.

10. A device according to claim 4

wherein the controller enables manual control of the operation of the pumping mechanism.

11. A device according to claim 4

wherein the controller enables automatic control of the operation of the pumping mechanism.

12. A device according to claim 4

wherein the first image changes according to operation of the generator.

13. A device according to claim 4

wherein the second image changes according to operation of the pumping mechanism.

14. A device according to claim 4

wherein the operating system generates an image of an electrode structure on the display screen.

15. A device according to claim 4

wherein the controller includes an input adapted to be attached to a sensor in the tissue region to monitor an operating condition in concert with operation of the generator and pumping mechanism.

16. A device according to claim 15

wherein the operating system generates an image on the display screen that represents the operation condition monitored by the sensor.

17. A device according to claim 15

wherein the operating system generates an image on the display screen that represents changes in the operating condition monitored by the sensor over time.

18. A device according to claim 15

wherein the operating system generates an image on the display screen of an electrode structure in association with an image that represents the operation condition monitored by the sensor.

19. A device according to claim 15

wherein the controller includes a feed-back function to vary operation of the generator according to the operating condition monitored by the sensor.

20. A device according to claim 15

wherein the controller includes a feed-back function to vary operation of the pumping mechanism according to the operating condition monitored by the sensor.

21. A device according to claim 15

wherein the sensor monitors tissue temperature conditions.

22. A device according to claim 4

further including an aspiration module adapted to be attached to tubing to remove cooling liquid from the tissue region.

23. A device according to claim 22

wherein the aspiration module is integrated in the housing.

24. A device according to claim 22

wherein the aspiration module includes an external vacuum source.

25. A device according to claim 4

wherein the generator generates radio frequency energy.

26. A device for association with an electrode structure which, in use, is deployed in a tissue region and which includes an electrode having a distal end that, in use, penetrates tissue in the tissue region, the device comprising

a housing,

a generator integrated in the housing to generate energy capable of heating tissue and adapted to be coupled to the electrode structure to apply the energy to the tissue region,

a pumping mechanism integrated in the housing and adapted to be attached to tubing to dispense cooling fluid from a source to the tissue region,

a controller integrated in the housing and including a first temperature sensor adapted to be carried by the electrode structure to monitor surface tissue temperature and a second temperature sensor adapted to be carried by the distal end of the electrode to monitor subsurface tissue temperature, the controller also including an input adapted to be attached to the first and second temperature sensors, and a function responsive to monitored surface tissue temperature, or monitored subsurface tissue temperature, or both, to control operation of the generator in concert with operation of the pumping mechanism, to thereby enable command of the generator and the pumping mechanism to controllably heat tissue in the tissue region,

a control panel on the housing supporting a consolidation of command input devices coupled to the controller, the command input devices including at least one generator control input for receiving from an operator an operating parameter affecting operation of the generator and at least one pump control input for receiving from an operator an operating parameter affecting operation of the pumping mechanism, and

a display screen coupled to the controller, the controller including an operating system that generates a first image on the display screen that represents an operating condition of the generator, the operating system also generating a second image on the display screen concurrently with the first image that represents an operating condition of the pumping mechanism.

27. A device according to claim 26

wherein the pumping mechanism includes a peristaltic pump rotor.

28. A device according to claim 26

wherein the controller includes a pump drive function to monitor pumping rate of the pumping mechanism.

29. A device according to claim 26

wherein the controller includes a pump drive function to select a pumping rate for the pumping mechanism.

30. A device according to claim 26

wherein the controller enables manual control of the operation of the generator.

31. A device according to claim 26

wherein the controller enables automatic control of the operation of the generator in response to monitored surface tissue temperature, or monitored subsurface tissue temperature, or both.

32. A device according to claim 26

wherein the controller enables manual control of the operation of the pumping mechanism.

33. A device according to claim 26

wherein the device enables automatic control of the operation of the pumping mechanism in response to monitored surface tissue temperature, or monitored subsurface tissue temperature, or both.

34. A device according to claim 26

wherein the first image changes according to operation of the generator.

35. A device according to claim 26

wherein the second image changes according to operation of the pumping mechanism.

36. A device according to claim 26

wherein the operating system generates an image of an electrode structure on the display screen.

37. A device according to claim 26

wherein the operating system generates an image on the display screen that represents monitored surface tissue temperature, or monitored subsurface tissue temperature, or both.

38. A device according to claim 26

wherein the operating system generates an image on the display screen that represents changes to monitored surface tissue temperature, or monitored subsurface tissue temperature, or both over time.

39. A device according to claim 26

wherein the operating system generates on the display screen a viewable image comprising an idealized image of the distal end of the electrode in spatial relation to an idealized image of the support structure, the viewable image including an indication of the monitored surface tissue temperature shown in spatial association with the idealized image of the support structure and an indication of the monitored subsurface tissue temperature shown in spatial association with the idealized image of the distal end of the electrode.

40. A device according to claim 26

further including an aspiration module adapted to be attached to tubing to remove cooling liquid from the tissue region.

41. A device according to claim 40

wherein the aspiration module is integrated in the housing.

42. A device according to claim 40

wherein the aspiration module includes an external vacuum source.

43. A device according to claim 26

wherein the generator generates radio frequency energy.

44. A device for association with an electrode structure which, in use, is deployed in a tissue region, the device comprising

a housing,

a generator integrated in the housing to generate energy capable of heating tissue and adapted to be coupled to the electrode structure to apply the energy to the tissue region,

a pumping mechanism integrated in the housing and adapted to be attached to tubing to dispense cooling fluid from a source to the tissue region, and

a controller integrated in the housing and coupled to the generator and the pumping mechanism, the controller including an ON input to command application of energy to the electrode structure and a function that, in response to the ON input, commences operation of the pumping mechanism for a prescribed time period while delaying operation of the generator until the prescribed time period lapses,

a control panel on the housing supporting a consolidation of command input devices coupled to the controller, the command input devices including at least one generator control input for receiving from an operator an operating parameter affecting operation of the generator and at least one pump control input for receiving from an operator an operating parameter affecting operation of the pumping mechanism, and

a display screen coupled to the controller, the controller including an operating system that generates a first image on the display screen that represents an operating condition of the generator, the operating system also generating a second image on the display screen concurrently with the first image that represents an operating condition of the pumping mechanism.

46. A device according to claim 44 or 45

wherein the generator generates radio frequency energy.

47. A device according to claim 44 or 45

wherein the pumping mechanism includes a peristaltic pump rotor.

45. A device for association with an electrode structure which, in use, is deployed in a tissue region, the device comprising

a housing,

a generator integrated in the housing to generate energy capable of heating tissue and adapted to be coupled to the electrode structure to apply the energy to the tissue region,

a pumping mechanism integrated in the housing and adapted to be attached to tubing to dispense cooling fluid from a source to the tissue region, and

a controller integrated in the housing and coupled to the generator and the pumping mechanism, the controller including an OFF input to command termination of the application of energy to the electrode structure and a function that, in response to the OFF input, operates the pumping mechanism for a prescribed time period after the supply of energy is terminated,

a control panel on the housing supporting a consolidation of command input devices coupled to the controller, the command input devices including at least one generator control input for receiving from an operator an operating parameter affecting operation of the generator and at least one pump control input for receiving from an operator an operating parameter affecting operation of the pumping mechanism, and

a display screen coupled to the controller, the controller including an operating system that generates a first image on the display screen that represents an operating condition of the generator, the operating system also generating a second image on the display screen concurrently with the first image that represents an operating condition of the pumping mechanism.

48. A device for association with an electrode structure which, in use, is deployed in a tissue region, the device comprising

a housing,

a generator integrated in the housing to generate energy capable of heating tissue and adapted to be coupled to the electrode structure to apply the energy to the tissue region,

a pumping mechanism integrated in the housing and adapted to be attached to tubing to dispense cooling fluid from a source to the tissue region, and

a controller integrated in the housing and coupled to the generator and the pumping mechanism, the controller including an ON input to command application of energy to the electrode structure in concert with operation of the pumping mechanism and an OFF input to command termination of the application of energy to the electrode structure, the controller further including a display screen and an operating system coupled to the display screen to generate, after the ON input, an ON image comprising a time record of changes in at least one operating condition over time during operation of the generator and the pumping mechanism and, after the OFF input, a PAUSE image that preserves the time record.

49. A device according to claim 48

wherein the PAUSE image updates the time record according to changes in the operating condition after the OFF input.

50. A device according to claim 48

wherein the controller includes a function that, in response to the ON input, commences operation of the pumping mechanism for a prescribed time period while delaying operation of the generator until the prescribed time period lapses.

51. A device according to claim 48

wherein the controller includes and a function that, in response to the OFF input, operates the pumping mechanism for a prescribed time period after the supply of energy is terminated.

52. A device according to claim 51

wherein the PAUSE image updates the time record according to changes in the operating condition after the OFF input.