Apparatus and methods for the destruction of adipose tissue

• US 8,343,051 B2
• Filed: 09/14/2009
• Issued: 01/01/2013
• Est. Priority Date: 12/30/2003
• Status: Active Grant

• Current Assignee: Solta Medical, Inc. (Bausch Health Cos., Inc.)
• Original Assignee: LipoSonix, Inc. (Bausch Health Cos., Inc.)
• Inventors: Desilets, Charles S., Pollock, Cameron
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): Roy, Baisakhi
• Application Number:
  US12/559,239
• Publication Number:
  US 20100042019A1
• Time in Patent Office: 1,205 Days
• Field of Search: 600/437, 600/439, 601 2- 4
• US Class Current: 600/439
• CPC Class Codes: A61B 8/0858 involving measuring tissue layers, e.g. skin, interfaces
• CPC Class Codes: A61N 2007/0008 Destruction of fat cells
• 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
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

Methods and apparatus are described for modifying unwanted tissue for cosmetic reasons. The methods provide a non-invasive manner to perform body contouring by destroying adipose tissue while simultaneously causing collagen contraction in a single procedure so that as destroyed tissue is removed from a treatment volume, the volume shrinks gradually to maintain the skin tone of the treatment area. The procedure may involve multiple treatments to the same treatment area or location.

Claims

1. A method of modifying adipose tissue using high intensity focused ultrasound energy, the method comprising:

determining a volume of adipose tissue to be treated;

identifying a corresponding surface area of skin over said volume of adipose tissue;

moving a therapy transducer on said surface area of skin; and

applying multiple treatments of the high intensity focused ultrasound energy into a targeted volume of said volume of adipose tissue, each of the multiple treatments being insufficient to provide necrosed tissue cells and denatured collagen fibrils in the targeted volume, and the combined multiple treatments being sufficient such that a plurality of necrosed tissue cells and denatured collagen fibrils are produced in the targeted volume,

wherein an energy flux of the high intensity focused ultrasound energy into the targeted area of each of the multiple treatments is less than 35 J/cm².

2. The method of claim 1, further comprising:

marking the corresponding surface area of skin to create a plurality of guide markers at a predetermined spacing within the corresponding surface area.

3. The method of claim 1, wherein a temperature of the adipose tissue in the targeted volume is less than 37 degrees Celsius between consecutive treatments of the multiple treatments and is greater than 37 degrees Celsius after the multiple treatments are applied.

4. A method of modifying adipose tissue using high intensity focused ultrasound energy, the method comprising:

determining a volume of adipose tissue to be treated;

identifying a corresponding surface area of skin over said volume of adipose tissue;

moving a therapy transducer on said surface area of skin; and

applying multiple treatments of the high intensity focused ultrasound energy into a targeted volume of said volume of adipose tissue, each of the multiple treatments being insufficient to provide necrosed tissue cells and denatured collagen fibrils in the targeted volume, and the combined multiple treatments being sufficient such that a plurality of necrosed tissue cells and denatured collagen fibrils are produced in the targeted volume,

wherein a temperature of the adipose tissue in the targeted volume is less than 37 degrees Celsius between consecutive treatments of the multiple treatments and is greater than 37 degrees Celsius after the multiple treatments are applied.

5. The method of claim 4, further comprising:

marking the corresponding surface area of skin to create a plurality of guide markers at a predetermined spacing within the corresponding surface area.

6. A method of modifying a targeted volume of adipose tissue in a patient using high intensity focused ultrasound energy, the method comprising:

applying a first set of one or more treatments of the high intensity ultrasound energy into the targeted volume of the adipose tissue, the first treatment set subjecting the targeted volume to a cumulative first energy flux so that the first treatment set does not cause a temperature of the adipose tissue in the targeted volume to exceed a predetermined temperature; and

following the application of the first treatment set, applying a subsequent treatment of the high intensity ultrasound energy into the targeted volume of the adipose tissue, the subsequent treatment subjecting the targeted volume to a second energy flux so that the combination of the first cumulative energy flux and the second energy flux causes the temperature of the adipose tissue in the targeted volume to exceed the predetermined temperature and produce the plurality of necrosed tissue cells and denatured collagen fibrils.

7. The method of claim 6, wherein the second energy flux is not greater than the first energy flux.

8. The method of claim 6, wherein the predetermined temperature is not greater than approximately 56 degrees Celsius.

9. The method of claim 8, wherein the predetermined temperature is not greater than approximately 46 degrees Celsius.

10. The method of claim 9, wherein the predetermined temperature is approximately 37 degrees Celsius.

11. The method of claim 6, wherein a pause in application of the high intensity focused ultrasound energy to the adipose tissue in the targeted volume occurs between the first treatment set and the subsequent treatment.

12. The method of claim 11, further comprising:

during the pause, treating adipose tissue of the patient outside of the targeted volume with the high intensity focused ultrasound energy.

13. The method of claim 6, wherein the first energy flux is less than 35 J/cm².

14. The method of claim 13, wherein the second energy flux is not greater than 35 J/cm².

15. The method of claim 6, wherein the second energy flux is not greater than 35 J/cm².