Apparatus for tissue remodeling

• US 6,438,424 B1
• Filed: 01/05/1998
• Issued: 08/20/2002
• 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:
  US09/003,180
• Time in Patent Office: 1,688 Days
• Field of Search: 607/96-104
• US Class Current: 607/101
• 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 18/203 applying laser energy to the outside of the body
• CPC Class Codes: A61B 2018/00452 Skin
• CPC Class Codes: A61B 2018/0047 Upper parts of the skin, e.g. skin peeling or treatment of wrinkles
• CPC Class Codes: A61B 2018/00488 Esophagus
• CPC Class Codes: A61B 2018/00523 Treatment of incontinence
• CPC Class Codes: A61B 2018/0066 without feedback, i.e. open loop control
• 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 2/12 Mammary prostheses and implants
• CPC Class Codes: A61N 1/28 Apparatus for applying thermoelectric currents
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 2/002 in combination with another treatment
• CPC Class Codes: A61N 2005/0645 Applicators worn by the patient
• CPC Class Codes: A61N 5/04 Radiators for near-field treatment
• CPC Class Codes: A61N 5/0616 Skin treatment other than tanning
• CPC Class Codes: G06F 16/9017 using directory or table look-up use of a directory or look-up table in file systems G06F16/13
• CPC Class Codes: G10L 2015/0631 Creating reference templates; Clustering

Abstract

An apparatus to modify a skin surface or a soft tissue structure underlying the skin surface includes a template with a mechanical force application surface and a receiving opening to receive a body structure. The mechanical force application surface is configured to receive the body structure and apply pressure to the soft tissue structure. An energy delivery device is coupled to the template. The energy delivery device is configured to deliver sufficient energy to the template to form a template energy delivery surface.

Claims

1. An apparatus for remodeling collagen matrix in a collagen containing tissue site beneath an epidermis skin surface, comprising:

a semi-solid template that is thermally conductive, the template having a tissue contacting surface that is conformable to the three-dimensional contour of the tissue site;

a handle coupled to the template; and

an energy delivery device for delivering energy to the selected collagen-containing tissue site,

wherein the energy delivery device is incorporated into the template and configured to deliver the energy through the template to the selected collagen-containing tissue site by contacting the epidermis skin surface of the tissue site with the tissue contacting surface of the template.

2. The apparatus of claim 1, wherein the energy delivery device is configured to deliver energy selected from the group consisting of resistive heating, RF, microwave, frictional heating, and ultrasound.

3. The apparatus of claim 1, wherein the energy delivery device includes one or more thermal coils.

4. The apparatus of claim 1, wherein the energy delivery device is configured to deliver radio frequency energy.

5. The apparatus of claim 1, wherein the energy delivery device includes one or more RF electrodes.

6. The apparatus of claim 1, wherein the template is made of material that is capable of transmitting electromagnetic energy.

7. The apparatus of claim 1, further comprising means for receiving and releasing an energy conduction material.

8. The apparatus of claim 7, wherein the energy conduction material is an electrolytic solution or gel.

9. The apparatus of claims 1, wherein the semi-solid template is made of soft plastic.

10. The apparatus of claim 4, wherein the energy delivery device is coupled to an RF energy source.

11. The apparatus of claim 1, further comprising:

a sensor coupled to the energy delivery device for monitoring temperature or impedance.

12. The apparatus of claim 11, further comprising:

a feedback control system coupled to the sensor.

13. A method of treating a skin surface overlying a collagen containing tissue site, the skin surface having elastosis, comprising:

identifying a person suspected of having a skin surface with elastosis;

applying to the skin surface a semi-solid template that is thermally conductive, the template having a tissue contacting surface and a non-tissue contact surface;

applying external mechanical force to the non-tissue contact surface of the template such that the template conforms to the three-dimensional contour of the skin surface;

applying a cooling medium to the skin surface, such that cell necrosis in the skin surface is substantially reduced; and

delivering a sufficient amount of energy to the tissue site through an energy delivery device incorporated into the template, such that the elastosis of the skin surface of the tissue site is reduced.

14. The method of claim 13, wherein delivering a sufficient amount energy includes controlling the amount of energy delivered such that the average temperature of the collagen containing tissue site does not exceed 80 degrees C.

15. The method of claim 13, wherein delivering a sufficient amount energy includes controlling the amount of energy delivered such that the average temperature of the collagen containing tissue site does not exceed 70 degrees C.

16. The method of claim 13, further comprising applying electrolytic media to the skin surface prior to the step of delivery a sufficient amount energy.

17. The method of claim 16, wherein applying the electrolytic media includes applying an electrolytic solution to the skin surface.

18. The method of claim 16, wherein applying the electrolytic media includes applying an electrolytic gel to the skin surface.

19. The method of claim 13, further comprising:

sensing a temperature of the skin surface during delivery of the energy to the skin surface.

20. The method of claim 13, further comprising:

sensing a temperature of the skin surface after delivery of the energy to the skin surface.

21. The method of claim 13, further comprising:

sensing a temperature of a tissue underlying the skin surface during the delivery of the energy to the skin surface.

22. The method of claim 13, further comprising:

sensing a temperature of a tissue underlying the skin surface after delivery of the energy to the skin surface.

23. The method of claim 13, further comprising:

sensing an impedance of the skin surface during delivery of the energy to the skin surface.

24. The method of claim 13, further comprising:

sensing an impedance of the skin surface after delivery of the energy to the skin surface.

25. The method of claim 13, further comprising:

sensing an impedance of a tissue underlying the skin surface during the delivery of the energy to the skin surface.

26. The method of claim 13, further comprising:

sensing an impedance of a tissue underlying the skin surface after delivery of the energy to the skin surface.

27. The method of claim 13, where the collagen-containing tissue site is selected from the group consisting of a subdermal layer, a deep dermal layer, and a subcutaneous layer.