Apparatus and methods for the destruction of adipose tissue

• US 20070055156A1
• Filed: 04/27/2006
• Published: 03/08/2007
• 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: Pollock, Cameron, Desilets, Charles
• Granted Patent: US 7,857,773 B2
• Time in Patent Office: Days
• 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 7/02 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.

Claims

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

determining a volume of adipose tissue to be treated;

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

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

applying therapeutic ultrasound energy into said volume of adipose tissue such that a plurality of necrosed tissue cells and denatured collagen fibrils are produced.

2. The method as described in claim 1, wherein moving the HIFU therapy transducer is performed in a raster scan pattern.

3. The method as described in claim 1, wherein the plurality of cells form a contiguous lesion field.

4. The method as described in claim 1, wherein the moving the transducer is done in a continuous motion.

5. The method as described in claim 1, wherein the moving the transducer is done in a discontinuous motion.

6. The method as described in claim 1, wherein moving the transducer over the surface area of the skin further comprises:

scanning the transducer across said surface area at a velocity and line spacing sufficient to promote a cooperative effect of thermal energy build up in said volume of adipose tissue.

7. The method as described in claim 1 wherein moving the HIFU transducer is done while applying therapeutic ultrasound energy.

8. The method as described in claim 1, wherein moving the HIFU transducer is done when the transducer is not applying ultrasound energy.

9. The method as described in claim 1, wherein the applying of therapeutic ultrasound energy raises the temperature of the focal zone to at least 46°

C.

10. The method as described in claim 1, wherein the applying of therapeutic ultrasound energy raises the temperature of the adipose tissue to at least 56°

C. for at least one second.

11. The method as described in claim 1, further comprising:

marking out a surface area of skin corresponding to the volume of adipose tissue.

12. The method as described in claim 1, further comprising:

creating a plurality of guide markers on said surface area of skin.

13. The method of claim 1, wherein the thermal energy may be measured as an energy flux (EF) and determined by the relationship:

[(p)×

(l/v)33 (dc)×

(nl)]/(sa)

wherein

p=power,

l=line length,

v=velocity,

dc=duty cycle,

nl=number of lines

and

sa=scanned area.

14. The method of claim 13, wherein the energy flux is between 35 J/cm² and 460 J/cm².

16. The method as described in claim 13, wherein the energy flux is between 35 J/cm² and 460 J/cm².

15. A method of reducing adipose tissue volume in a patient using high intensity focused ultrasound, the method comprising the steps of:

determining a volume of adipose tissue to be treated;

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

applying high intensity focused ultrasound energy to said area in a manner sufficient to induce the gradual destruction of said adipose tissue and denaturing of collagen fibrils, the energy flux being of at less than 35 J/cm².

17. An apparatus for the delivery of therapeutic ultrasound energy into a patient, said apparatus having a scan head having at least one ultrasound transducer, a suspension device for supporting said scan head, and a therapy controller for controlling said ultrasound transducer wherein said therapy controller is programmable for variables to deliver an energy flux (EF) greater than 35 J/cm², wherein EF is determined by the formula:

[(p)×

(l/v)×

(dc)33 (nl)]/(sa)

wherein

p=power,

l=line length,

v=velocity,

dc=duty cycle,

nl=number of lines,

and

sa=scanned area.

18. The apparatus of claim 17, wherein the apparatus can deposit sufficient ultrasound energy to produce an Ef value greater than 109 J/cm².

19. A stencil for producing crosshairs on a patient skin, the stencil comprising a flexible plate with a plurality of evenly spaced apertures wherein said apertures are shaped substantially like crosshairs.