Apparatus and method for treatment of tissue

• US 6,413,255 B1
• Filed: 03/09/2000
• Issued: 07/02/2002
• Est. Priority Date: 03/09/1999
• Status: Expired due to Term

• Current Assignee: Thermage Incorporated (Bausch Health Cos., Inc.)
• Original Assignee: Thermage Incorporated (Bausch Health Cos., Inc.)
• Inventors: Stern, Roger A.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): Ruddy, David M.
• Application Number:
  US09/522,275
• Time in Patent Office: 845 Days
• Field of Search: 606/41, 606/42, 606/50, 606/48, 606/39, 607/97-99, 607/101, 607/102, 607/109, 607/108, 607/103, 607/104, 607/139, 607/140, 607/148, 607/152, 607/105
• US Class Current: 606/41
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• 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 2018/00452 Skin
• CPC Class Codes: A61B 2018/00464 Subcutaneous fat, e.g. liposuction, lipolysis
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/1495 Electrodes being detachable from a support structure
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 5/04 Radiators for near-field treatment

Abstract

An apparatus to treat the skin includes a template having a tissue interface surface and an energy delivery device coupled to the template. The energy delivery device is configured to be coupled to a power source and has a variable resistance portion. A sensor is coupled to one of the template, the energy delivery device, the tissue interface surface or a power source coupled to the energy delivery device.

In another embodiment the variable resistance portion configured to reduce an electrode edge effect

Claims

1. An apparatus for treating a tissue, comprising:

a handpiece assembly;

a dielectric electrode coupled to the handpiece assembly and including at least one RE electrode with a front surface and a back surface that is physically and electrically coupled to a back surface of a dielectric, at least a portion of the dielectric configured to contact a tissue surface;

a cooling media delivery member coupled to the dielectric electrode and configured to deliver a cooling media to the back surface of the RF electrode; and

a sensor coupled to the dielectric electrode.

2. The apparatus of claim 1, wherein the dielectric electrode is configured to reduce at least one of an edge effect, an electrode edge effect, an electrode temperature gradient an electrode current density gradient or a tissue interface surface temperature gradient.

3. The apparatus of claim 1 wherein the sensor is a thermal sensor, a thermocouple, an optical sensor, a current sensor, voltage sensor, an impedance sensor or a flow sensor.

4. The apparatus of claim 1, further comprising:

a source of cooling media coupled to the cooling media delively member.

5. The apparatus of claim 4, wherein the cooling media is one of a cooling fluid, a gas, a cryogenic gas, a liquid, an electrolytic solution, a cooled liquid or a cryogenic liquid.

6. The apparatus of claim 1, wherein the handpiece includes at least one of a connector, an electrical connector, a cooling media connector, a lumen, a fluid lumen, a cooling media lumen;

a flow control device, a control valve or a nozzle.

7. The apparatus of claim 1, wherein the dielectric electrode includes a tissue interface surface.

8. The apparatus of claim 7, wherein the tissue interface surface has a shape configured to conform to an anatomical structure.

9. The apparatus of claim 8, wherein the tissue interface surface has a curved shape.

10. The apparatus of claim 7, wherein the tissue interface surface is conformable.

11. The apparatus of claim 10, wherein the tissue interface surface is conformable to a skin surface.

12. The apparatus of claim 1, wherein the dielectric electrode has a resistance that varies with a temperature.

13. The apparatus of claim 12, wherein the temperature is one of a temperature of a tissue interface surface or a tissue positioned adjacent to the tissue interface.

14. The apparatus of claim 1, further comprising:

a power source coupled to the dielectric electrode.

15. The apparatus of claim 14, further comprising:

feedback control resources coupled to at least one of the power source, the dielectric electrode or the sensor.

16. The apparatus of claim 15, wherein the feedback control resources include at least one of a microprocessor, a controller, a software program set forth in a tangible media, a power control circuit or a voltage and current monitor.

17. The apparatus of claim 1, wherein the RF electrode is a monopolar electrode.

18. The apparatus of claim 17, further comprising:

an RE power supply electronically coupled to e RF electrode; and

a ground pad electrode positioned on the skin and coupled to the RF power source and the RF electrode.

19. The apparatus of claim 1, wherein the RF electrode is a bipolar electrode and includes one of a plurality of electrodes, a plurality of multiplexed electrodes, an array of electrodes or an array of multiplexed electrodes.

20. The apparatus of claim 1, further comprising:

a switching device, wherein the RF electrode includes a plurality of RF electrodes coupled to the switching device.

21. The apparatus of claim 20, wherein the switching device includes one of a multiplexing device or a multiplexing device configured to be coupled to an RF power source.

22. An apparatus for treating to skin, comprising:

a handpiece; and

a dielectric electrode coupled to the handpiece and including at least One RF electrode with a front surface and a back surface that is physically and electrically coupled to a back surface of a dielectric, at least a portion of the dielectric configured to contact a skin surface; and

a sensor coupled to the dielectric electrode.

23. The apparatus of claim 22, wherein the dielectric electrode is configured to be capacitively coupled to the skin.

24. The apparatus of claim 22, wherein the RF electrode is a monopolar electrode.

25. The apparatus of claim 22 further comprising:

an RF power supply electronically coupled to the RF electrode; and

a ground pad electrode positioned on the skin and electronically coupled to the RF power source and the R electrode.

26. The apparatus of claim 22, wherein the RF electrode is a bipolar electrode and comprises one of a plurality of electrodes, a plurality of multiplexed electrodes, an array of electrodes or an array of multiplexed electrodes.

27. The apparatus of claim 26, further comprising:

a switching device coupled to at least a portion of the plurality of RF electrodes, the switching device configured to be coupled to at least one of a power supply or feedback control resources.

28. The apparatus of claim 27, wherein the switching device includes one of a multiplexing device or a multiplexing device coupled to an RF power source.

29. The apparatus of claim 22, wherein the dielectric electrode comprises a plurality of dielectric portions including a first portion and second portion.

30. The apparatus of claim 29, wherein the first and second portions are substantially positioned on an energy delivery device surface.

31. The apparatus of claim 30, wherein the first portion is positioned within an interior area defined by the second portion.

32. The apparatus of claim 31, further comprising:

a gap disposed between the first portion and the second portion.

33. The apparatus of claim 31, wherein the first and second portions have one of a substantially circular shape or an oval shape.

34. The apparatus of claim 33, wherein the first and second portions are substantially concentric.

35. The apparatus of claim 29, further comprising:

a switching device coupled to at least one of the plurality of dielectric portions.

36. The apparatus of claim 35, wherein the switching device includes one of a multiplexing device or a multiplexing device coupled to an RF power source.

47. The apparatus of claim 31, wherein the cooling media delivery member delivers a cooling media to the energy delivery device and cool at least a portion of the energy delivery device by at least one of a conductive effect, an evaporative effect, a convective effect or an ebullient cooling effect.

37. An apparatus for treating the skin, comprising:

a handpiece; and

an energy delivery device coupled to tie handpiece, the energy delivery device having a conductive portion and a dielectric portion, the energy delivery device configured to be coupled to a power source, at least a portion of the dielectric portion configured to contact a skin surface;

a cooling media delivery member coupled to the energy delivery device; and

a sensor coupled to one of the energy delivery device, the energy delivery device, the tissue interface surface or a power source coupled to the energy delivery device.

38. The apparatus of claim 37, further comprising:

a pressure relief valve coupled to the energy delivery device.

39. The apparatus of claim 37, wherein the energy delivery device is configured to reduce at least one of an edge effect, an electrode edge effect, an electrode temperature gradient, an electrode current density gradient or a tissue interface surface temperature gradient.

40. The apparatus of claim 37, wherein the conductive portion is a conductive layer and the dielectric portion is a dielectric layer.

41. The apparatus of claim 40, wherein the conductive portion has a surface area that is less than a dielectric layer surface area.

42. The apparatus of claim 40, wherein the energy delivery device is configured such that substantially all of an energy delivery device current flows through the conductive layer.

43. The apparatus of claim 40, wherein the dielectric layer is a tissue contacting layer and the conductive layer is disposed on a non-tissue contacting side of the dielectric layer.

44. The apparatus of claim 40, wherein the dielectric layer is one of an oxide layer, a metal oxide layer, a polymer, a polyimide or a diamond.

45. The apparatus of claim 40, wherein the dielectric layer has a thickness of about 0.001 inches.

46. The apparatus of claim 40, wherein the conductive layer is one of a metal, a metal alloy, copper or a conductive polymer.

48. The apparatus of claim 37, further comprising:

a source of cooling media coupled to at cooling media delivery member, the cooling media delivery member including at least one of a flow control device and a control valve or a nozzle.

49. The apparatus of claim 48, wherein the cooling media is one of a cooling fluid, a gas, a cryogenic gas, a liquid, an electrolytic solution, a cooled liquid or a cryogenic liquid.

50. The apparatus of claim 37, wherein at least a portion of the energy delivery device is flexible or elastic.

51. The apparatus of claim 50, wherein the energy delivery device is one of a membrane, a flexible membrane, a skin conforming membrane, a film, a flexible film or a skin conforming film.

52. The apparatus of claim 50, wherein the at least a portion of the energy delivery device is deformable in response to a pressure.

53. The apparatus of claim 52, further comprising:

a valve coupled to the handpiece, wherein the valve is one of a control valve, a pressure valve or a pressure relief valve.

54. The apparatus of claim 53, further comprising:

feedback control resources coupled to at least one of the valve or the sensor.

55. The apparatus of claim 37, wherein the conductive portion is an RF electrode.

56. The apparatus of claim 55, wherein the RF electrode is a monopolar electrode.

57. The apparatus of claim 56 further comprising,

an RF power supply electronically coupled to the RF electrode;

and

a ground pad electrode positioned on the skin and electronically coupled to the RF power source and the RF electrode.

58. The apparatus of claim 55, wherein the RF electrode is a bipolar electrode and comprises one of a plurality of electrodes, a plurality of multiplexed electrodes, an array of electrodes or an array of multiplexed electrodes.

59. The apparatus of claim 58, further comprising:

a switching device coupled to at least a portion of the plurality of RF electrodes, the switching device configured to be coupled to at least one of a power supply or feedback control resources.

60. The apparatus of claim 59, wherein the switching device includes one of a multiplexing device or a multiplexing device coupled to an RF power source.