Temperature indicating electrosurgical apparatus and methods

• US 7,297,143 B2
• Filed: 02/05/2004
• Issued: 11/20/2007
• Est. Priority Date: 02/05/2003
• Status: Active Grant

• Current Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Original Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Inventors: Woloszko, Jean, Dahla, Robert H., Baker, Michael A., Pacek, James L.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US10/774,222
• Publication Number:
  US 20040186469A1
• Time in Patent Office: 1,384 Days
• Field of Search: 606/31, 606/41, 606/42, 606 45- 50, 607/101, 607/102, 600/549
• US Class Current: 606/41
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/042 using additional gas becoming plasma
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00809 measured thermochromatically
• CPC Class Codes: A61B 2562/0276 comprising a thermosensitive compound
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/015 By temperature mapping of body part
• CPC Class Codes: A61B 5/4528 Joints A61B5/4533, A61B5/4538 take precedence

Abstract

Systems, apparatus, and methods for monitoring temperature at a region near a surgical site during a procedure. A temperature-indicating element of an electrosurgical device comprises an indicator composition adapted to undergo a change in appearance in response to a pre-defined temperature range. The change in appearance of the temperature-indicating element indicates to the operator of the device a temperature condition at the working end of the device.

Claims

1. An electrosurgical device for use with a power supply, comprising:

a shaft having a shaft distal end portion and a shaft proximal end portion;

an electrode assembly comprising at least one active electrode disposed near the shaft distal end portion and adapted to be electrically coupled to a first pole of the power supply;

a connector fixedly engaged to the shaft proximal end portion adapted to couple the device to the power supply; and

at least one temperature-indicating element disposed on an exterior of at least one of the electrode assembly and the shaft to be responsive to temperature changes adjacent to the device, wherein the temperature-indicating element undergoes a change in chromatic appearance over a pre-determined temperature range and wherein said at least one temperature-indicating element is a discrete section disposed axially proximal to said at least one active electrode.

2. The device of claim 1, wherein the pre-determined temperature range is about 40°

C. to 95°

C.

3. The device of claim 1, wherein the at least one temperature-indicating element is adapted to display a temperature value over the pre-determined temperature range.

4. The device of claim 1, wherein the at least one temperature-indicating element displays a message when exposed to a pre-defined temperature.

5. The device of claim 1, wherein the message is alpha-numeric.

6. The device of claim 1, wherein the at least one temperature-indicating element comprises a thermochromic material.

7. The device of claim 1, wherein the at least one temperature-indicating element is adapted to substantially change from a first chromatic appearance to a second chromatic appearance when subject to the pre-determined temperature range and to substantially reverse from the second chromatic appearance to the first chromatic appearance when not subject to the pre-determined temperature range.

8. The device of claim 1, wherein the at least one temperature-indicating element comprises a thermochromic composition selected from the group consisting of a leuco dye and a liquid crystal.

9. The device of claim 1, wherein the at least one temperature-indicating element comprises a thermochromic paint or a thermochromic ink.

10. The device of claim 1, wherein the electrode assembly comprises a support matrix which contains at least one of the active electrodes, wherein the at least one temperature-indicating element is disposed on, or proximal to, the support matrix.

11. The device of claim 10, wherein at least one active electrode extends laterally from the shaft.

12. The device of claim 11, wherein the at least one temperature-indicating element is disposed on a portion of the shaft opposite the direction in which the active electrode extends.

13. The device of claim 1, wherein at least one active electrode extends distally from a distal tip of the shaft, and wherein the at least one temperature-indicating element is disposed proximal to the active electrode.

14. The device of claim 1, wherein the electrode assembly further comprises at least one return electrode adapted to be coupled to a second pole of the power supply and disposed at the distal end portion of the shaft, and wherein the at least one temperature-indicating element is disposed proximal, adjacent, or distal to the return electrode.

15. The device of claim 1, wherein the at least one temperature-indicating element has a length in the range of from about 1 mm to 3 cm, and a width in the range of from about 1 mm to 5 cm.

16. The device of claim 1, further comprising a fluid delivery element for providing an electrically conductive fluid capable of forming a conductive fluid path between the electrode assembly and return electrode.

17. The device of claim 1, wherein the at least one temperature-indicating element comprises an annular band having a thermochromic material incorporated therein.

18. The device of claim 1, wherein the shaft is at least partially encased within a sheath, the sheath encasing the at least one temperature-indicating element, and wherein the sheath comprises a biocompatible material.

19. The device of claim 1, wherein the at least one temperature-indicating element is thermally insulated or thermally isolated from a surface of the shaft.

20. The device of claim 1, wherein the at least one temperature-indicating element comprises a printable medium and a thermochromic pigment.

21. The device of claim 1, wherein the device comprises a bipolar electrosurgical device adapted for applying RF electrical energy to a target tissue.

22. The device of claim 1, wherein the at least one temperature-indicating element comprises a first color and changes appearance to a second color.

23. The device of claim 1, wherein the at least one temperature-indicating element is a first temperature indicating element and the pre-determined range is a first predetermined range, where the device further comprises a second temperature indicating element disposed on an exterior of the shaft, wherein the second temperature indicating element changes appearance over a second pre-determined temperature range.

24. The device of claim 23, wherein the first and second pre-determined ranges are substantially the same.

25. The device of claim 23, wherein the first and second pre-determined ranges are different.

26. The device of claim 1 wherein the at least one temperature-indicating element is located adjacent the electrode assembly.

27. The device of claim 26 wherein the at least one temperature-indicating element is located superior to the at least one active electrode.

28. The device of claim 1 wherein the at least one temperature-indicating element is located proximal to the electrode assembly.

29. The device of claim 1, wherein the connector comprises a cable having a distal end fixedly attached to the shaft proximal end portion, and a proximal portion adapted to engage the power supply.

30. The device of claim 1, wherein the connector is adapted to removably engage a cable where the cable couples the device to the power supply.

31. The device of claim 1, wherein at least one of the temperature-indicating elements is configured about the shaft so that at least a portion of the temperature-indicating element is viewable from any side of the shaft.

32. The device of claim 31, wherein the at least one of the temperature-indicating elements is placed circumferentially about the device shaft.

33. The device of claim 1, wherein the shaft is malleable.

34. A medical device for use with an energy delivery unit, comprising:

a shaft having a shaft distal end portion and a shaft proximal end portion;

an energy delivery assembly comprising at least one energy delivery element disposed near the shaft distal end portion, and an energy delivery return element disposed on said shaft distal end portion and spaced from said energy delivery element and adapted to be coupled to the energy delivery unit, said energy delivery element adapted to generate a tissue ablating plasma when a voltage difference is applied to said energy delivery element in the presence of an electrically conductive fluid;

a connector fixedly engaged to the shaft proximal end portion and adapted to couple the device to the energy delivery unit; and

a first means for providing a visual indication of a particular temperature or range of temperatures in a region adjacent a portion of the shaft and wherein at least a portion of said first means is disposed between said at least one energy delivery element and said return clement.

35. The device of claim 34, further comprising a second means for identifying a particular temperature or range of temperature in a region adjacent a portion of the shaft.

36. The device of claim 35, wherein said electrode assembly further comprises at least one return electrode adapted to be coupled to a second pole of the power supply.

37. The device of claim 35,wherein said first means for identifying is located adjacent the electrode assembly.

38. The device of claim 35, wherein said second means for identifying is located adjacent said first means for identifying.

39. The device of claim 35, wherein said second means for identifying is located along the shaft proximally to said first means for identifying.

40. The device of claim 34, wherein the connector comprises a cable having a distal end fixedly attached to the shaft proximal end portion, and a proximal portion adapted to engage the power supply.

41. The device of claim 34, wherein the connector is adapted to removably engage a cable where the cable couples the device to the power supply.

42. The device of claim 34, wherein the energy delivery assembly is adapted to provide energy selected from the group consisting of ultrasound, radio frequency energy, mechanical, laser, thermal, microwave, chemical, and radiation.