Method and apparatus for treatment of cutaneous and subcutaneous conditions

• US 7,276,058 B2
• Filed: 06/19/2003
• Issued: 10/02/2007
• Est. Priority Date: 06/19/2002
• Status: Active Grant

• Current Assignee: Palomar Medical Technologies Incorporated (Hologic Incorporated)
• Original Assignee: Palomar Medical Technologies Incorporated (Hologic Incorporated)
• Inventors: Altshuler, Gregory B., Prikhodko, Konstantin, Yaroslavsky, Ilya, Belikov, Andre Viacheslavovitch
• Primary Examiner(s): FARAH, AHMED M
• Application Number:
  US10/465,757
• Publication Number:
  US 20040073079A1
• Time in Patent Office: 1,566 Days
• Field of Search: 606/3, 606 9- 12, 606/20, 606 22- 29, 607/88, 607/89, 607/91, 607/96, 607/100, 607/104, 128/898
• US Class Current: 606/9
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/203 applying laser energy to the outside of the body
• CPC Class Codes: A61B 2018/00005 Cooling or heating of the probe or tissue immediately surrounding the probe
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00452 Skin
• CPC Class Codes: A61B 2018/00458 Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains
• CPC Class Codes: A61B 2018/00476 Hair follicles
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61N 1/20 continuous direct currents
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/328 for improving the appearance of the skin, e.g. facial toning or wrinkle treatment
• CPC Class Codes: A61N 2005/0659 infrared
• CPC Class Codes: A61N 2007/0008 Destruction of fat cells
• CPC Class Codes: A61N 2007/0034 Skin treatment
• CPC Class Codes: A61N 5/0613 Apparatus adapted for a specific treatment
• CPC Class Codes: A61N 5/0616 Skin treatment other than tanning
• CPC Class Codes: A61N 5/0625 Warming the body, e.g. hyperthermia treatment
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

The present invention provides method and apparatus for treating tissue in a region at depth while protecting non-targeted tissue by cyclically applying cooling to the patients skin, and preferably to the region, and by applying radiation to the patient'"'"'s skin above the region to selectively heat tissue during and/or after cooling is applied. At least one of cooling and radiation my be applied by successivly passing a continuous output applicator over the patient'"'"'s skin. Treatment may also be enhanced by applying mechanical, acoustic or electrical stimulation to the region.

Claims

1. A method for treating at least a selected target region at depth of a patient'"'"'s body while protecting non-targeted tissue comprising:

(a) cooling the patient'"'"'s skin surface to a temperature below normal body temperature for a selected duration;

(b) selectively applying radiation to the patient'"'"'s skin above said region at least one of before, during and after step (a); and

(c) repeating at least one of steps (a) and (b) for a selected number of cycles, the temperature to which the patient'"'"'s skin surface is cooled and said duration being sufficient to cool said region to a selected temperature below normal body temperature during at least cooling portions of cycles, wherein said region is at or below the border zone of the dermis and hypodermis.

2. A method as claimed in claim 1 wherein said selected duration is at least about 10 seconds.

3. A method as claimed in claim 2 wherein said selected duration is between approximately 10 seconds and 30 minutes.

4. A method as claimed in claim 1 wherein step (b) is performed after step (a) and has a duration of from approximately 1 second to 4 minutes.

5. A method as claimed in claim 1 wherein step (a) is performed continuously and step (b) is performed at intervals during step (a).

6. A method as claimed in claim 1 wherein said selected region is subcutaneous fat, and wherein said selected temperature is low enough to result in at least a selective phase change of at least a portion of said fat.

7. A method as claimed in claim 6 wherein said radiation is of sufficient power and duration and of appropriate wavelength to heat said region to at least a temperature where the phase of the fat cells is altered.

8. A method as claimed in claim 1 and wherein said radiation is of sufficient power and duration and of appropriate wavelength to heat said region to at least a temperature where at least one of the biophysical and biochemical characteristics of cells in the selected region is altered.

9. A method as claimed in claim 1 wherein said radiation is of sufficient power and duration and of appropriate wavelength to heat tissue above said selected region to protect said tissue, but not to significantly heat said region.

10. A method as claimed in claim 1 wherein said treatment involves cycling cooling and heating of said region, step (b) being performed after step (a), and said radiation being of sufficient power and duration and of appropriate wavelength to heat said region to an appropriate temperature to effect said treatment.

11. A method as claimed in claim 1 including detecting a selected condition of the patient during at least one of steps (a) and (b), and utilizing said detecting step to control at least one of steps (a) and (b).

12. A method as claimed in claim 1 including stimulating said selected region during at least one of before, during and after at least one of steps (a) and (b).

13. A method as claimed in claim 12 wherein said stimulating is performed at least one of mechanically, acoustically and electrically.

14. A method as claimed in claim 1 wherein at least one of the period and phase of cycles of steps (a) and (b) are correlated with a sub-circadian biological rhythm of the patient.

15. A method as claimed in claim 1 wherein said radiation is from a continuous wave (CW) source and cooling is also performed from a substantially continuously operating source, and wherein step (a) is performed by passing an applicator outputting said cooling source over the patient'"'"'s skin overlying said selected region at a selected rate, and step (b) is performed by passing an applicator outputting said radiation over the patient'"'"'s skin overlying said selected region at a selected rate.

16. A method as claimed in claim 15 wherein the same applicator is used to perform both steps (a) and (b).

17. A method as claimed in claim 16 wherein steps (a) and (b) are performed during the same passes of the applicator over the patient'"'"'s skin.

18. A method for treating at least a selected target region at depth of a patient'"'"'s body while protecting non-targeted tissue comprising:

(a) cooling the patient'"'"'s skin surface to a temperature below normal body temperature for a selected duration;

wherein step (a) is performed by passing an applicator outputting said cooling over the patient'"'"'s skin overlying said selected region at a selected rate,

(b) selectively applying radiation to the patient'"'"'s skin above said region at least one of before, during and after step (a);

wherein step (b) is performed by passing an applicator outputting said radiation over the patient'"'"'s skin overlying said selected region at a selected rate, radiation power is increased by a factor of T v/d over the power required for a stationary applicator, where T is the interval between passes over the same region, v is the rate of movement of the applicator and d is applicator aperature size; and

(c) repeating at least one of steps (a) and (b) for a selected number of cycles, the temperature to which the patient'"'"'s skin surface is cooled and said duration being sufficient to cool said region to a selected temperature below normal body temperature during at least cooling portions of cycles,

wherein said radiation is from a continuous wave (CW) source and cooling is also performed from a substantially continuously operating source.

19. A method as claimed in claim 18 wherein treatment time where the applicator is passed over the patient'"'"'s skin is also increased by a factor of T v/d.

20. A method as claimed in claim 18 wherein T is less then the thermal relaxation time of tissue in said selected region.

21. Apparatus for treating at least a selected target region at depth of a patient'"'"'s body while protecting non-targeted tissue comprising:

a mechanism for cooling the patient'"'"'s skin surface to a temperature below normal body temperature for a selected duration;

a mechanism for selectively applying radiation to the patient'"'"'s skin above said region at least one of before, during and after the cooling of the patient'"'"'s skin surface; and

controls for causing at least one of the mechanism for cooling and the mechanism for applying radiation to be operated for a selected number of cycles, and for controlling the temperature to which the patient'"'"'s skin surface is cooled and said duration to sufficiently cool said region to a selected temperature below normal body temperature during at least cooling portions of cycles, wherein said region is at or below the border zone of the dermis and hypodermis.

22. Apparatus as claimed in claim 21 wherein said selected duration is at least about 10 seconds.

23. Apparatus as claimed in claim 22 wherein said selected duration is between approximately 10 seconds and 30 minutes.

24. Apparatus as claimed in claim 21 wherein said mechanism for applying radiation is operated after said mechanism for cooling and the applied radiation has a duration of from approximately 1 second to 4 minutes.

25. Apparatus as claimed in claim 21 wherein said mechanism for cooling is operated continuously and said mechanism for applying radiation is operated at intervals during the operation of the mechanism for cooling.

26. Apparatus as claimed in claim 21 wherein said selected region is subcutaneous fat, and wherein said selected temperature is low enough to result in at least a selective phase change of at least a portion of said fat.

27. Apparatus as claimed in claim 26 wherein said radiation is of sufficient power and duration and of appropriate wavelength to heat said region to at least a temperature where the phase of the fat cells is altered.

28. Apparatus as claimed in claim 21 wherein said radiation is of sufficient power and duration and of appropriate wavelength to heat said region to at least a temperature where at least one of the biophysical and biochemical characteristics of cells in said selected region is altered.

29. Apparatus as claimed in claim 21 wherein said radiation is of sufficient power and duration and of appropriate wavelength to heat tissue above said selected region to protect said tissue, but not to significantly heat said region.

30. Apparatus as claimed in claim 21 wherein said treatment involves cycling cooling and heating of said region, said mechanism for applying radiation being operated after said mechanism for cooling, and said radiation being of sufficient power and duration and of appropriate wavelength to heat said region to an appropriate temperature to effect said treatment.

31. Apparatus as claimed in claim 21 including a mechanism for detecting a selected condition of the patient during operation of at least one of said mechanisms, said controls utilizing the output from said mechanism for detecting to control at least one of the mechanism for cooling and the mechanism for applying radiation.

32. Apparatus as claimed in claim 21 including a stimulator stimulating said selected region during at least one of before, during and after operation of at least one of said mechanisms.

33. Apparatus as claimed in claim 32 wherein said stimulator is at least one of a mechanical, acoustical and electrical stimulator.

34. Apparatus as claimed in claim 21 wherein said mechanism for applying radiation includes a continuous wave (CW) source and said mechanism for cooling also operates substantially continuously, an applicator outputting said CW source passing over the patient'"'"'s skin overlying said selected region at a selected rate, and an applicator for said cooling mechanism passing over the patient'"'"'s skin overlying said selected region at a selected rate.

35. Apparatus as claimed in claim 34 wherein the same applicator is used for both said cooling and said radiation applying mechanisms.

36. Apparatus as claimed in claim 35 wherein said cooling and said radiation applying mechanisms are operated during the same passes of the applicator over the patient'"'"'s skin.

37. Apparatus for treating at least a selected target region at depth of a patient'"'"'s body while protecting non-targeted tissue comprising:

a mechanism for cooling the patient'"'"'s skin surface to a temperature below normal body temperature for a selected duration;

a mechanism for selectively applying radiation to the patient'"'"'s skin above said region at least one of before, during and after the cooling of the patient'"'"'s skin surface, wherein said mechanism for applying radiation includes a continuous wave (CW) source and said mechanism for cooling also operates substantially continuously, an applicator outputting said CW source passing over the patient'"'"'s skin overlying said selected region at a selected rate, and an applicator for said cooling mechanism passing over the patient'"'"'s skin overlying said selected region at a selected rate.; and

controls for causing at least one of the mechanism for cooling and the mechanism for applying radiation to be operated for a selected number of cycles, the temperature to which the patient'"'"'s skin surface is cooled and said duration being sufficient to cool said region to a selected temperature below normal body temperature during at least cooling portions of cycles,

wherein when the radiation applying mechanism is operated with the applicator being passed over the patient'"'"'s skin, radiation power is increased by a factor of T v/d over the power required for a stationary applicator, where T is the interval between passes over the same region, v is the rate of movement of the applicator and d is applicator aperature size.

38. Apparatus as claimed in claim 37 wherein treatment time where the applicator is passed over the patient'"'"'s skin is also increased by a factor of T v/d.

39. Apparatus as claimed in claim 37 wherein T is less then the thermal relaxation time of tissue in said selected region.

40. A method for treating at least a selected region at depth of a patient'"'"'s body while protecting tissue above the selected region, comprising:

(a) selectively delivering radiation to the patient'"'"'s body above said selected region to heat said region;

(b) concurrently cooling patient tissue above said selected region to a temperature below that of the selected region; and

(c) cooling said region to a temperature below that of normal body temperature at least one of before and after heating of the region, there being at least one cycle of heating and cooling for said region, wherein said region is at or below the border zone of the dermis and hypodermis.

41. A method as claimed in claim 40 including:

(d)applying at least one of mechanical, acoustic and electrical stimulation to said region.

42. A method for treating at least a selected region at depth of a patient'"'"'s body comprising:

cyclically applying radiation and cooling to the surface of the patient'"'"'s skin above the selected region through at least one applicator providing substantially continuous cooling and radiation output, which applicator is passed over the patient'"'"'s skin over the region multiple times for each cooling and radiation cycle, such that said selected region is cooled to a selected temperature below normal body temperature for at least a portion of said application, wherein said region is at or below the border zone of the dermis and hypodermis.

43. A method as claimed in claim 42 wherein a single applicator simultaneously applies cooling and radiation as it is passed over the patient'"'"' skin.

44. A method as claimed in claim 42 wherein a single applicator successively applies cooling and radiation during cooling and radiation portions respectively of each cycle, the applicator making multiple passes over the patient'"'"'s skin for at least one of said portions.

45. A method for treating at least a selected target region at depth of a patient'"'"'s body while protecting non-targeted tissue comprising:

(a) cooling the patient'"'"'s skin surface to a temperature below normal body temperature for a selected duration;

(b) selectively applying radiation to the patient'"'"'s skin above said region after step (a), said radiation being of sufficient power and duration and of appropriate wavelength to heat said region to an appropriate temperature to, in conjunction with step (a), effect said treatment; and

(c) repeating at least one of steps (a) and (b) for a selected number of cycles, the temperature to which the patient'"'"'s skin surface is cooled and said duration being sufficient to cool said region to a selected temperature below normal body temperature during at least cooling portions of cycles, wherein said region is at or below the border zone of the dermis and hypodermis.

46. A method for treating at least a selected target region at depth of a patient'"'"'s body while protecting non-targeted tissue comprising:

(a) passing an applicator outputting a substantially continuously operating cooling source over the patient'"'"'s skin overlying said selected region at a selected rate to cool the patient'"'"'s skin surface to a temperature below normal body temperature for a selected duration;

(b) passing an applicator outputting radiation from a substantially continuous wave radiation source over the patient'"'"'s skin overlying said selected region at a selected rate to selectively applying radiation to said region at least one of before, during and after step (a); and

(c) repeating at least one of steps (a) and (b) for a selected number of cycles, the temperature to which the patient'"'"'s skin surface is cooled and said duration being sufficient to cool said region to a selected temperature below normal body temperature during at least cooling portions of cycles, wherein said region is at or below the border zone of the dermis and hypodermis.

47. A method as claimed in claim 46 wherein the same applicator is used to perform both steps (a) and (b).

48. A method as claimed in claim 47 wherein steps (a) and (b) are performed during the same passes of the applicator over the patient'"'"'s skin.