Method and apparatus for controlled contraction of collagen tissue

• US 6,311,090 B1
• Filed: 08/23/1999
• Issued: 10/30/2001
• Est. Priority Date: 05/05/1995
• Status: Expired due to Term

• Current Assignee: Thermage Incorporated (Bausch Health Cos., Inc.)
• Original Assignee: Thermage Incorporated (Bausch Health Cos., Inc.)
• Inventors: Knowlton, Edward W.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/379,555
• Time in Patent Office: 799 Days
• Field of Search: 607/96, 607/98-104, 607/108, 606/2, 606/9, 606/33, 606/41, 606/50
• US Class Current: 607/101
• 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 2018/0066 without feedback, i.e. open loop control
• CPC Class Codes: A61M 15/0028 using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
• CPC Class Codes: A61M 15/0036 hollow piercing means
• CPC Class Codes: A61M 15/0041 with movable piercing or cutting means
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/073 Syringe, piston type
• CPC Class Codes: A61N 5/04 Radiators for near-field treatment

Abstract

A method and apparatus applies radiant energy through the skin to underlying collagen tissue without substantially modifying melanocytes and other epithelial cells in the epidermis. A porous membrane is adapted to receive an electrolytic solution and become inflated to substantially conform a contacting exterior surface of the membrane to a skin layer. The membrane includes a cooling lumen for receiving cooling fluid. One or more thermal electrodes positioned in the membrane and transfers thermal energy to the electrolytic solution. The electrolytic solution and cooling fluid creates a reverse thermal gradient from the skin surface to the underlying collagen tissue. A thermal power source is coupled to the thermal electrodes, and a source of electrolytic solution is coupled to the membrane.

Claims

1. An apparatus for tightening a skin surface overlying a collagen containing tissue site comprising:

a porous membrane having an inflated and a non inflated state, the porous membrane adapted and receive, be at least partially inflated by and controllably release an electrolytic solution, the porous membrane having a tissue contacting surface conformable to at least a portion of the skin surface while in the inflated state;

a cooling lumen disposed within the porous membrane, the lumen adapted to receive a cooling fluid and provide a cooling effect to an epidermal layer substantially overlying a collagen containing tissue layer; and

an energy delivery device coupled to the porous membrane, the energy delivery device configured to deliver energy to one of the electrolytic solution or the collagen containing tissue site, the energy delivery device configured to be coupled to a power source.

2. The apparatus of claim 1, wherein at least a portion of the porous membrane includes one of a fibrous material, a hydrophobic material or a foam material.

3. The apparatus of claim 1, further comprising an electrolytic fluid source fluidically coupled to the porous membrane.

4. The apparatus of claim 1, further comprising an fluid source fluidically coupled to the cooling lumen.

5. The apparatus of claim 1, further comprising a power source coupled to the energy delivery device.

6. The apparatus of claim 5, further comprising a feedback control device electronically coupled to at least one of the sensor, a power source, the energy delivery device, or a multiplier.

7. The apparatus of claim 1, further comprising:

a sensor coupled to the porous membrane.

8. The apparatus of claim 7, wherein the sensor is coupled to the tissue contacting surface.

9. The apparatus of claim 7, wherein the sensor is one of a thermal sensor or an impedance sensor.

10. The apparatus of claim 7, wherein the sensor is configured to a measure a thermal property of the epidermal layer.

11. The apparatus of claim 7, wherein the feedback control device includes one of an electronic controller or a multiplier, multiplexed to at least one of the sensors or the energy delivery devices.

12. The apparatus of claim 1, wherein the electrolytic solution is configured to deliver energy to the collagen containing tissue layer.

13. The apparatus of claim 1, wherein the electrolytic solution is configured to deliver sufficient energy to the collagen containing tissue layer to cause at least a partial denaturization of at least a portion of collagen in the collagen containing a layer.

14. The apparatus of claim 12, wherein at least one of the cooling fluid, the electrolytic fluid or the energy delivery device is configured to produce a reverse thermal gradient, with a temperature of at least a portion of the epidermal layer less than a temperature of a least a portion of the underlying the collagen containing tissue layer.

15. The apparatus of claim 14, wherein the reverse thermal gradient is sufficient to minimize a thermal injury of the tissue site including one of a cell necrosis, a fat cell necrosis, an epithelial cell modification or a melanocyte modification.

16. The apparatus of claim 14, wherein the reverse thermal gradient is about 30°

C. to about 80°

C.

17. The apparatus of claim 1, wherein the energy delivery device is an RF electrode configured to be coupled to an RF power source.

18. The apparatus of claim 17, wherein the RF electrode is one of a monopolar or a bipolar electrode.

19. The apparatus of claim 17, wherein the RF electrode transfers RF energy to the electrolytic solution and the electrolytic solution delivers energy to the tissue site.

20. The apparatus of claim 17, wherein the RF electrode is a plurality of electrodes.

21. The apparatus of claim 20, wherein the plurality of electrodes comprises a flexible circuit.

22. The apparatus of claim 20, wherein at least one of the plurality of electrodes is multiplexed to an RF power source.

23. The apparatus of claim 20, further comprising:

a sensor positioned substantially adjacent to at least one of the plurality of RF electrodes and the sensor is multiplexed to a feedback control device.

24. The apparatus of claim 20, wherein the at least a portion of the plurality of RF electrodes is a phased array.

25. The apparatus of claim 17, wherein the RF electrode comprises at least one coil configured to focus RF energy at a selectable depth beneath the skin surface.

26. The apparatus of claim 17, wherein the membrane has a substantially oval shape.

27. The apparatus of claim 17, wherein the porous membrane has a non-tissue contacting surface opposing the tissue contact surface and the RF electrode is substantially positioned on the non-tissue contacting surface.

28. The apparatus of claim 17, wherein the membrane further comprises:

at least one zone of increased porosity; and

a remainder membrane portion having a lower porosity relative to the zone of increased porosity.

29. The apparatus of claim 28, wherein the at least one zone of increased porosity is configured to at least partially retain a portion of the electrolytic solution for a longer time period than the remainder membrane portion.

30. The apparatus of claim 29, wherein energy transfer to the portion of electrolytic solution is enhanced.

31. The apparatus of claim 29 wherein the RF electrode is substantially disposed within the at least one zone of increased porosity.

32. The apparatus of claim 29, wherein the portion of the electrolytic solution functions as an RF electrode.

33. The apparatus of claim 1, further comprising:

a focusing element coupled to the membrane, the focusing element configured to focus energy at a selectable depth beneath the skin surface.

34. The apparatus of claim 33, further comprising:

a coupling device coupled to at least one of the focusing element or the membrane, the coupling device configured to couple the focusing element to the membrane.

35. The apparatus of claim 1, wherein the porous membrane has one of a variable porosity or a variable electrical resistance.

36. The apparatus of claim 35, wherein the porosity of the membrane varies over at a least a portion of an area of the membrane.

37. The apparatus of claim 1, wherein the energy device is an acoustical transducer.

38. The apparatus of claim 1, wherein the energy device is a microwave antenna configured to be coupled to a microwave power source.

39. The apparatus of claim 1, wherein the energy delivery device is a waveguide configured to be coupled to a light source.

40. The apparatus of claim 39, wherein the light source is a coherent light source.

41. An apparatus for tightening a skin surface overlying a collagen containing tissue site comprising:

a porous membrane having an inflated and a non inflated state, the porous membrane adapted to receive and be at least partially inflated by an electrolytic solution, the porous membrane having higher porosity zone and a lower porosity zone, and a conformable tissue contacting surface configured to be conformable to at least a portion of the skin surface while in the inflated state;

a cooling lumen disposed within the porous membrane, the lumen adapted to receive a cooling fluid and provide a cooling effect to an epidermal layer at substantially overlying a collagen containing tissue layer; and

an energy delivery device coupled to the porous membrane, the energy delivery device configured to deliver energy to one of the electrolytic solution or the collagen containing tissue site, the energy delivery device configured to be coupled to a power source.

42. The apparatus of claim 41, further comprising an electrolytic fluid source fluidically coupled to the porous membrane.

43. The apparatus of claim 41, further comprising a fluid source fluidically coupled to the cooling lumen.

44. The apparatus of claim 41, further comprising a power source coupled to the energy delivery device.

45. The apparatus of claim 41, further comprising:

a sensor coupled to the porous membrane.

46. The apparatus of claim 45, wherein the sensor is coupled to the tissue contacting surface.

47. The apparatus of claim 45, wherein the sensor is one of a thermal sensor or an impedance sensor.

48. The apparatus of claim 45, wherein the sensor is configured to a measure a thermal property of the epidermal layer.

49. The apparatus of claim 45, further comprising a feedback control device electronically coupled to al least one of the sensor, a power source, the energy delivery device, or a multiplier.