Methods for creating tissue effect utilizing electromagnetic energy and a reverse thermal gradient

• US 7,473,251 B2
• Filed: 03/31/2003
• Issued: 01/06/2009
• Est. Priority Date: 01/05/1996
• Status: Expired due to Fees

• Current Assignee: Thermage Incorporated (Bausch Health Cos., Inc.)
• Original Assignee: Thermage Incorporated (Bausch Health Cos., Inc.)
• Inventors: Knowlton, Edward W., Levinson, Mitchell, Weber, Bryan
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US10/404,971
• Publication Number:
  US 20040002705A1
• Time in Patent Office: 2,108 Days
• Field of Search: 607/96, 607/98, 607/99, 607101-102, 606/1, 606/9
• US Class Current: 606/41
• CPC Class Codes: A45D 44/22 Face shaping devices, e.g. chin straps; Wrinkle removers, e.g. stretching the skin skin stretchers for shaving A45D27/38
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• 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 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• 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 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 2018/00488 Esophagus
• 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 2018/00779 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: A61B 90/02 Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• CPC Class Codes: A61F 2007/0021 Female breast
• CPC Class Codes: A61H 2201/10 : with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
• CPC Class Codes: A61H 7/001 : without substantial movement between the skin and the device
• CPC Class Codes: A61H 9/005 : Pneumatic massage
• CPC Class Codes: A61H 9/0071 : by localized pressure, e.g. air streams or jets
• CPC Class Codes: A61M 2205/3606 : cooled
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/28 : Apparatus for applying thermoelectric currents
• CPC Class Codes: A61N 1/30 : Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia

Abstract

A method of creating a tissue effect at a tissue site delivers electromagnetic energy through a skin surface from an electromagnetic energy delivery device coupled to an electromagnetic energy source. At least one of the electromagnetic energy delivery device or electromagnetic energy source includes a memory. A reverse thermal gradient is created through the skin surface to sufficiently heat an underlying tissue site to provide that a temperature of the skin surface is lower than a temperature of the underlying tissue. Information is stored from the memory to facilitate operation of at least one of the electromagnetic energy delivery device or the electromagnetic energy source. Electromagnetic energy is applied through the skin surface to the underlying tissue. A tissue effect is created on at least a portion of the tissue site.

Claims

1. A method of creating a tissue effect at a tissue site of a patient with an energy delivery device coupled to an electromagnetic energy source, the method comprising:

contacting a skin surface of the patient with the energy delivery device under an applied force;

delivering RF energy with the energy delivery device through the skin surface;

detecting the amount of force being applied to the skin surface by the energy delivery device; and

creating a tissue effect on at least a portion of the tissue site wherein the tissue effect is dermal tightening, wrinkle reduction, elastosis reduction, scar reduction, sebaceous gland removal, sebaceous gland deactivation, a reduction of sebaceous gland activity, hair follicle modification, adipose tissue remodeling, adipose tissue removal, spider vein removal, modification of skin irregularities, creation of scar collagen, creation of nascent collagen, modification of skin pore size, unclogging of skin pores, or modification of muscle tissue.

2. The method of claim 1, wherein the tissue effect is dermal remodeling.

3. The method of claim 1, wherein the tissue effect is a reduction of skin bacteria activity.

4. The method of claim 1, wherein the tissue effect is a modification of facial tissue.

5. The method of claim 1, further comprising:

storing information in a memory coupled to facilitate operation of at least one of the energy delivery device or the electromagnetic energy source.

6. The method of claim 5, wherein the stored information is utilized to assist in controlling an amount of energy delivered from the energy delivery device.

7. The method of claim 5, wherein the stored information is utilized to assist in controlling energy delivery duration time of the energy delivery device.

8. The method of claim 5, wherein the stored information is utilized to assist in controlling a temperature of the energy delivery device relative to a target temperature.

9. The method of claim 5, wherein the stored information is utilized to assist in providing a controllable amount of cooling for a cooling member.

10. The method of claim 5, wherein the stored information is utilized to assist in providing a controllable delivery rate of cooling delivered from a cooling member.

11. The method of claim 5, wherein the stored information is utilized to assist in providing an amount of energy delivered by the energy delivery device.

12. The method of claim 5, wherein the stored information is utilized to assist in providing a status of at least one of the energy delivery device or the electromagnetic energy source.

13. The method of claim 5, wherein the stored information is utilized to assist in controlling an amount of current delivered by the energy delivery device.

14. The method of claim 5, wherein the stored information is utilized to assist in providing a maximum allowed voltage that is deliverable by the energy delivery device.

15. The method of claim 1, further comprising:

creating a reverse thermal gradient through the skin surface to sufficiently heat an underlying tissue, wherein a temperature of the skin surface is lower than a temperature of the underlying tissue;

detecting a temperature of the skin surface; and

heating the skin surface and underlying tissue in response to a detected temperature of the skin surface.

16. The method of claim 1, further comprising:

providing a signal indicating that the detected amount of force is above a minimum threshold or below a maximum threshold.

17. The method of claim 1, wherein delivering the RF energy with the energy delivery device through the skin surface further comprises:

capacitively coupling the RF energy through the skin surface and with the tissue site to create the tissue effect.

18. The method of claim 1, wherein the energy delivery device includes a conductive portion and a dielectric portion contacting the conductive portion, and delivering the RF energy with the energy delivery device through the skin surface further comprises:

passing the RF energy from the conductive portion through the dielectric portion and the skin surface to the tissue site for creating the tissue effect.

19. The method of claim 17, wherein the tissue effect is dermal remodeling.

20. The method of claim 18, wherein the tissue effect is dermal remodeling.

21. A method of creating a tissue effect at a tissue site of a patient with an energy delivery device coupled to an electromagnetic energy source, the method comprising:

contacting a skin surface of the patient with the energy delivery device under an applied force;

reducing a temperature of at least a portion of the skin surface by non-continuously cooling the skin surface, wherein the temperature of the skin surface is less than the temperature of an underlying tissue when the temperature of the skin surface is reduced;

detecting the amount of force being applied to the skin surface by the energy delivery device; and

creating a tissue effect on at least a portion of the tissue site.

22. The method of claim 21, wherein the tissue effect is dermal remodeling.

23. The method of claim 21, wherein the tissue effect is dermal tightening.

24. The method of claim 21, wherein the tissue effect is wrinkle reduction.

25. The method of claim 21, wherein the tissue effect is elastosis reduction.

26. The method of claim 21, wherein the tissue effect is scar reduction.

27. The method of claim 21, wherein the tissue effect is sebaceous gland removal or deactivation.

28. The method of claim 21, wherein the tissue effect is a reduction of sebaceous gland activity.

29. The method of claim 21, wherein the tissue effect is hair follicle modification.

30. The method of claim 21, wherein the tissue effect is adipose tissue remodeling or removal.

31. The method of claim 21, wherein the tissue effect is spider vein removal.

32. The method of claim 21, wherein the tissue effect is modification of skin irregularities.

33. The method of claim 21, wherein the tissue effect is a creation of scar or nascent collagen.

34. The method of claim 21, wherein the tissue effect is a reduction of skin bacteria activity.

35. The method of claim 21, wherein the tissue effect is a modification of skin pore size.

36. The method of claim 21, wherein the tissue effect is an unclogging of skin pores.

37. The method of claim 21, wherein the tissue effect is a modification of fat tissue.

38. The method of claim 21, wherein the tissue effect is a modification of muscle tissue.

39. The method of claim 21, wherein the tissue effect is a modification of facial tissue.

40. The method of claim 21, further comprising:

orienting the energy delivery device in a treatment orientation; and

canceling a portion of the force being applied due to gravity when the device is in the treatment orientation.

41. The method of claim 40, wherein orienting the energy delivery device in the treatment orientation further comprises:

holding the energy delivery device off the skin surface.

42. The method of claim 21, further comprising:

providing a signal indicating that the detected amount of force is above a minimum threshold or below a maximum threshold.

43. A method of creating a tissue effect at a tissue site of a patient with an energy delivery device coupled to an electromagnetic energy source, the method comprising:

contacting a skin surface of the patient with the energy delivery device under an applied force;

delivering electromagnetic energy with the energy delivery device through the skin surface;

storing information in a memory coupled to facilitate operation of at least one of the energy delivery device or the electromagnetic energy source;

utilizing the stored information to assist in providing a maximum number of firings of the energy delivery device;

detecting the amount of force being applied to the skin surface by the energy delivery device; and

creating a tissue effect on at least a portion of the tissue site.

44. A method of creating a tissue effect at a tissue site of a patient with an energy delivery device coupled to an electromagnetic energy source, the method comprising:

contacting a skin surface of the patient with the energy delivery device under an applied force;

delivering electromagnetic energy with the energy delivery device through the skin surface;

storing information in a memory coupled to facilitate operation of at least one of the energy delivery device or the electromagnetic energy source;

utilizing the stored information to assist in providing a history of energy delivery device use;

detecting the amount of force being applied to the skin surface by the energy delivery device; and

creating a tissue effect on at least a portion of the tissue site.

45. A method of creating a tissue effect at a tissue site of a patient with an energy delivery device coupled to an electromagnetic energy source, the method comprising:

contacting a skin surface of the patient with the energy delivery device under an applied force;

delivering electromagnetic energy with the energy delivery device through the skin surface;

storing information in a memory coupled to facilitate operation of at least one of the energy delivery device or the electromagnetic energy source;

utilizing the stored information to assist in providing an amount of time that the energy delivery device can be used;

detecting the amount of force being applied to the skin surface by the energy delivery device; and

creating a tissue effect on at least a portion of the tissue site.

46. A method of creating a tissue effect at a tissue site of a patient with an energy delivery device coupled to an electromagnetic energy source, the method comprising:

contacting a skin surface of the patient with the energy delivery device under an applied force;

delivering electromagnetic energy with the energy delivery device through the skin surface;

storing information in a memory coupled to facilitate operation of at least one of the energy delivery device or the electromagnetic energy source;

utilizing the stored information to assist in providing a number of areas treated by the energy delivery device;

detecting the amount of force being applied to the skin surface by the energy delivery device; and

creating a tissue effect on at least a portion of the tissue site.

47. A method of creating a tissue effect at a tissue site of a patient with an energy delivery device coupled to an electromagnetic energy source, the method comprising:

contacting a skin surface of the patient with the energy delivery device under an applied force;

delivering electromagnetic energy with the energy delivery device through the skin surface;

storing information in a memory coupled to facilitate operation of at least one of the energy delivery device or the electromagnetic energy source;

utilizing the stored information to assist in providing a number of times the energy delivery device has been moved relative to the skin;

detecting the amount of force being applied to the skin surface by the energy delivery device; and

creating a tissue effect on at least a portion of the tissue site.

48. A method of creating a tissue effect at a tissue site of a patient with an energy delivery device coupled to an electromagnetic energy source, the method comprising:

contacting a skin surface of the patient with the energy delivery device under an applied force;

delivering electromagnetic energy with the energy delivery device through the skin surface;

storing information in a memory coupled to facilitate operation of at least one of the energy delivery device or the electromagnetic energy source;

utilizing the stored information to assist in providing at least one of time or date of energy delivery device usage;

detecting the amount of force being applied to the skin surface by the energy delivery device; and

creating a tissue effect on at least a portion of the tissue site.

49. A method of creating a tissue effect at a tissue site of a patient with an energy delivery device coupled to an electromagnetic energy source, the method comprising:

contacting a skin surface of the patient with the energy delivery device under an applied force;

orienting the energy delivery device in a treatment orientation;

delivering electromagnetic energy with the energy delivery device through the skin surface;

canceling a portion of the force being applied due to gravity when the device is in the treatment orientation;

detecting the amount of force being applied to the skin surface by the energy delivery device; and

creating a tissue effect on at least a portion of the tissue site.

50. The method of claim 49, wherein orienting the energy delivery device in the treatment orientation further comprises:

holding the device off the skin surface.

51. An apparatus for creating a tissue effect at a tissue site of a patient, comprising:

an energy delivery device having a skin surface contact member;

an electromagnetic energy source coupled to said energy delivery device and operable to supply electromagnetic energy to said energy delivery device;

a force sensor coupled to said skin surface contact member and operative to detect an amount of force being applied to a skin surface by said skin surface contact member; and

a tare activation element operative to cancel the force due to gravity on said skin surface contact member when said skin surface contact member is in a treatment orientation relative to the skin surface.