Combined modality treatment systems, methods and apparatus for body contouring applications

• US 8,676,338 B2
• Filed: 07/20/2010
• Issued: 03/18/2014
• Est. Priority Date: 07/20/2010
• Status: Active Grant

• Current Assignee: ZELTIQ Aesthetics, Inc. (Abbvie Incorporated)
• Original Assignee: ZELTIQ Aesthetics, Inc. (Abbvie Incorporated)
• Inventors: Levinson, Mitchell E.
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): SMITH, KAITLYN ELIZABETH
• Application Number:
  US12/840,235
• Publication Number:
  US 20120022518A1
• Time in Patent Office: 1,337 Days
• Field of Search: 607/101, 607/96
• US Class Current: 607/101
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00464 Subcutaneous fat, e.g. liposuction, lipolysis
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00994 combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure

Abstract

Systems and methods that enable delivery of radiofrequency energy and cryotherapy applications to adipose tissue for reduction and contouring of body fat are described herein. Aspects of the disclosure are directed to methods for reducing surface irregularities in a surface of a subject'"'"'s skin resulting from an uneven distribution of adipose tissue in the subcutaneous layer. The method can include delivering capacitively coupled or conductively coupled radiofrequency energy to a target region of the subject at a frequency which selectively heats fibrous septae in a subcutaneous layer of the target region to a maximum temperature less than a fibrous septae denaturation temperature. Furthermore, the method can include removing heat such that lipid-rich lobules in the subcutaneous layer are affected while non-lipid-rich cells and lipid-rich regions adjacent to the fibrous septae are not substantially affected.

Claims

1. A system for non-invasive, transdermal removal of heat from subcutaneous lipid-rich cells of a subject, comprising:

a treatment unit in thermal communication with a fluid chamber, the fluid chamber being configured to house and provide a coolant;

a radiofrequency (RF) energy generating unit for generating RF current;

a treatment device in fluid communication with the treatment unit and in electrical communication with the RF energy generating unit; and

a controller in communication with the treatment unit, the RF energy generating unit and the treatment device, wherein the controller has instructions for causing the treatment device to;

couple RF energy to the subject selectively to heat connective tissue in a target region beneath an epidermis of the subject to a maximum temperature less than a collagen denaturation temperature; and

reduce a temperature of the target region beneath the epidermis of the subject selectively to reduce the temperature of subcutaneous lipid-rich cells in the target region such that the subcutaneous lipid-rich cells are substantially affected while non-lipid rich cells in the epidermis and subcutaneous lipid-rich cells adjacent to the connective tissue are not substantially affected.

2. The system of claim 1 wherein the treatment device is configured to capacitively couple RF energy to the subject.

3. The system of claim 2 wherein the treatment device capacitively couples monopolar RF energy to the subject, and wherein the system further includes a return electrode positioned adjacent to the epidermis of the subject at a region separated from the target region.

4. The system of claim 1 wherein the treatment device is configured to conductively couple RF energy to the subject.

5. The system of claim 1 wherein the collagen denaturation temperature is approximately 60°

C.

6. The system of claim 1 wherein the connective tissue is selectively heated to a maximum temperature between approximately 0°

C. to approximately 10°

C.

7. The system of claim 1 wherein the connective tissue selectively is heated to a maximum temperature such that subcutaneous lipid-rich cells adjacent to the connective tissue are not cooled to temperatures below approximately 10°

C.-15°

C., and such that subcutaneous lipid-rich cells remote from the connective tissue are cooled to a temperature approximately less than 10°

C.

8. The system of claim 1 wherein the radiofrequency (RF) energy generating unit produces an RF current of approximately 0.3 MHz to approximately 40 MHz.

9. The system of claim 1 wherein the controller is configured to cause the treatment device to remove heat from the target region while delivering the RF energy to the target region.

10. The system of claim 1 wherein the treatment device is configured to deliver the RF energy at a frequency of about 0.3 MHz to about 40 MHz.

11. The system of claim 1 wherein the controller has instructions for causing the treatment device to deliver the RF energy to the target region while removing heat from the target region.

12. The system of claim 1 wherein the controller is configured to cause the treatment device to sequentially remove heat from the target region and deliver the RF energy to the target region.

13. A combined modality treatment system for selectively removing heat from subcutaneous lipid-rich cells in a target region of a subject having skin, comprising:

a treatment unit in thermal communication with a fluid chamber, the fluid chamber being configured to house and provide a coolant;

a radiofrequency (RF) energy source for generating RF current;

a controller; and

a treatment device having a heat exchanging plate coupled to the RF energy source and a thermoelectric cooling element in communication with the treatment unit;

wherein the controller has instructions that cause the treatment device to—

capacitively couple radiofrequency (RF) energy to the skin of the subject selectively to heat fibrous septae in the target region to a final temperature less than a fibrous septae denaturation temperature; and

remove heat from the subcutaneous lipid-rich cells of the subject during a treatment process such that subcutaneous lipid-rich cells are substantially affected while non-lipid-rich cells and subcutaneous lipid-rich cells adjacent to the fibrous septae are not substantially affected.

14. The system of claim 13 wherein the heat exchanging plate is a thermally conductive aluminum plate that can be charged with RF current.

15. The system of claim 13 wherein the treatment device further comprises an interface layer positioned between the heat exchanging plate and the skin of the subject, the interface layer configured to form an RF energy and heat conducting interface with the skin.

16. The system of claim 15 wherein the treatment device further comprises a dielectric layer positioned between the heat exchanging plate and the skin of the subject, the dielectric layer configured to capacitively couple the RF energy from the heat exchanging plate to the skin of the patient.

17. The system of claim 16 wherein the dielectric layer provides a more uniform distribution of RF energy into the target region of the subject.

18. The system of claim 16 wherein the dielectric layer is a dielectric sleeve, the dielectric sleeve including a first sleeve portion and a second sleeve portion extending from the first sleeve portion, the first sleeve portion comprising variable resistance material as insulation between the RF conductive heat exchanging plate and the skin of the patient, and wherein the second sleeve portion is an electrical isolation layer extending from the first sleeve portion.

19. The system of claim 13 wherein the fibrous septae denaturation temperature is approximately 60°

C.

20. The system of claim 13 wherein the fibrous septae are selectively heated to a final temperature between approximately 0°

C. and approximately 60°

C.

21. The system of claim 13 wherein the fibrous septae are selectively heated to a final temperature such that subcutaneous lipid-rich cells adjacent to the fibrous septae are not cooled to temperatures below approximately 10°

C.-15°

C., and such that subcutaneous lipid-rich cells remote from the fibrous septae are cooled to a temperature approximately less than 10°

C.

22. The system of claim 13 wherein the treatment device is configured to deliver the RF energy at a frequency of about 0.3 MHz to about 40 MHz.

23. The system of claim 13 wherein the controller is configured to receive instructions to cause the treatment device to cool the lipid-rich cells to a temperature below about 10°

C.

24. The system of claim 13 wherein the controller is configured to cause the cause the treatment device to deliver the RF energy while the treatment device cools the lipid-rich cells to a temperature below about 10°

.

25. The system of claim 13 wherein the treatment device is configured to deliver ultrasound energy.

26. The system of claim 13 wherein the treatment device is configured to deliver microwave energy.

27. The system of claim 13 wherein the controller has instructions for causing the treatment device to deliver the RF energy to the target region while removing heat from the target region.

28. The system of claim 13, wherein the treatment device is configured to deliver the RF energy from the RF energy source to the skin of the subject and to remove heat from the subject via the heat exchanging plate.

29. The system of claim 13 wherein the treatment device is configured to deliver one or more of optical energy, acoustic energy, and microwave to the subject'"'"'s skin.

30. The system of claim 13 wherein the controller is configured to sequentially remove heat from the target region and deliver the RF energy to the target region.