Methods and system for treating subcutaneous tissues

• US 7,588,547 B2
• Filed: 01/17/2006
• Issued: 09/15/2009
• Est. Priority Date: 09/07/2005
• Status: Active Grant

• Current Assignee: Ulthera Inc. (Merz Pharma GmbH & Company Kgaa)
• Original Assignee: Cabochon Aesthetics, Inc. (Merz Pharma GmbH & Company Kgaa)
• Inventors: Gifford, Hanson S. III, Deem, Mark E., Sutton, Douglas
• Primary Examiner(s): Casler; Brian
• Assistant Examiner(s): KISH, JAMES M
• Application Number:
  US11/334,794
• Publication Number:
  US 20070055180A1
• Time in Patent Office: 1,337 Days
• Field of Search: 604/22, 604/506, 604/511, 604/518, 600/458, 424/9.5, 424/9.52
• US Class Current: 601/2
• CPC Class Codes: A61B 2017/00747 Dermatology
• CPC Class Codes: A61B 2017/22008 used or promoted
• CPC Class Codes: A61K 41/0028 Disruption, e.g. by heat or ultrasounds, sonophysical or sonochemical activation, e.g. thermosensitive or heat-sensitive liposomes, disruption of calculi with a medicinal preparation and ultrasounds
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61N 1/0412 Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 2007/0008 Destruction of fat cells
• CPC Class Codes: A61N 2007/0039 using microbubbles
• 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

Abstract

An apparatus and method for treating subcutaneous tissues using acoustic waves in the range of low acoustic pressure ultrasound waves is disclosed. The method includes injections of enhancing agents, wherein disruption of subcutaneous tissues and subcutaneous cavitational bioeffects are produced by ultrasound waves having a power that will not produce tissue cavitation in the absence of the enhancing agents. The apparatus and method of use is useful for treatment of subcutaneous abnormalities including cellulite, lipomas, and tumors.

Claims

1. A method for reducing cellulite, comprising:

providing a microbubble solution having a microbubble concentration ranging from 10³ to 10¹⁰ bubbles per mL;

percutaneously injecting the microbubble solution into a treatment area located in a subdermal fat layer between 1 mm and 5 mm below a dermis and proximal to a group of fat cells in the treatment area;

cavitating at least a portion of the microbubbles with ultrasound energy supplied from outside the treatment area to indirectly induce irreversible cavitational bioeffects in the group of fat cells in the treatment area; and

irreversibly effecting the group of fat cells while leaving cells outside the treatment area unaffected.

2. The method of claim 1, further comprising:

generating the microbubble solution by mixing a solution with a gas in a solution agitator.

3. The method of claim 1, further comprising:

coordinating injection of the microbubble solution into the treatment area and an insonation of the microbubble solution in the treatment area to control dispersion of the microbubbles in the treatment area.

4. A system for reducing cellulite, comprising:

a microbubble solution containing a plurality of microbubbles;

an injection device including a plurality of needles disposed in a tubular member having a central channel, wherein the needles are configured for movement between an extended position in which the needles protrude out from the central channel in a fanned configuration and a retracted position in which the needles are fully retracted in the central channel, and wherein the injection device is configured to be percutaneously inserted into a treatment area located between 1 mm and 5 mm below a dermis and to deploy the plurality of needles substantially parallel to a surface of the dermis, and wherein the injection device is configured to disperse the microbubble solution into the treatment area; and

at least one delivery device configured for applying ultrasonic energy to the treatment area from outside the treatment area at a mechanical index selected above a cavitation threshold of the microbubbles and below a cavitation threshold of the treatment area in order to induce cavitation bioeffects in the treatment area only through the cavitation of the microbubbles.

5. The system of claim 4, wherein the at least one delivery device includes a suction member for sucking a patient'"'"'s skin towards the at least one delivery device using subatmospheric pressures.

6. The system of claim 4, wherein the at least one delivery device includes an ultrasound transducer.

7. The system of claim 4, wherein the at least one delivery device includes the injection device configured for injecting the solution into the tissue.

8. The system of claim 7, wherein the at least one delivery device is integrated with the injection device.

9. The system of claim 4, wherein the solution includes a tumescent solution.

10. The system of claim 4, wherein the solution includes an ultrasonic contrast agent.

11. The system of claim 10, wherein the ultrasonic contrast agent is microbubbles.

12. The system of claim 4, further including a device for agitating the solution.

13. The system of claim 12, wherein the device for agitating the solution is configured for agitating the solution with at least one gas.

14. The system of claim 4, wherein the plurality of needles may be moved to various tissue depths manually.

15. The system of claim 4, wherein the plurality of needles may be moved to various tissue depths automatically by a control device.

16. The system of claim 4, wherein the at least one delivery device includes a security chip.

17. The system of claim 4, further including a tissue cooling device.

18. A method for reducing cellulite, comprising:

percutaneously injecting a solution comprising microbubbles into a treatment area located in a subdermal fat layer between 1 mm and 5 mm below a dermis and proximal to at least one fibrous structure below the dermis responsible for creating a chamber of fat cells in the treatment area;

delivering an ultrasonic energy from outside the treatment area to cavitate at least a portion of the microbubbles in the treatment area to cause an indirect irreversible disruption of the at least one fibrous structure; and

irreversibly disrupting the at least one fibrous structure while leaving fibrous structures outside the treatment area unaffected.

19. The method of claim 18, wherein the ultrasonic energy insonates the solution between one second and one minute after injecting the solution into the treatment area.

20. The method of claim 18, wherein the ultrasonic energy insonates the solution between 5 seconds and 20 seconds after injecting the solution into the treatment area.

21. The method of claim 18, wherein the ultrasonic energy insonates the solution between 20 seconds and 60 seconds after injecting the solution into the treatment area.

22. The method of claim 18, wherein the ultrasonic energy has a mechanical index between about 0.7 and 5.0.

23. The method of claim 18, wherein the ultrasonic energy insonates the solution between 50 milliseconds and 1000 milliseconds after injecting the solution into the treatment area.

24. The method of claim 18, further comprising:

insonating the treatment area with a low amplitude ultrasound to disperse the microbubbles.

25. The method of claim 18, further comprising:

providing a fanned needle array having a plurality of needles moveably disposed within a tubular member, the needles being movable between an undeployed position in which the needles are retained within the tubular member and a deployed position in which the needles extend outside the tubular member;

inserting at least a distal end of the tubular member into the treatment area; and

deploying the needles substantially parallel to the dermis, wherein percutaneously injecting a solution comprises dispersing the solution from the fanned needle array.

26. The method of claim 25, wherein the needles comprise sharp cutting elements.

27. The method of claim 25, wherein at least one of the needles is solid.

28. The method of claim 25, wherein at least one of the needles comprises a channel for injecting a fluid.

29. The method of claim 18, wherein percutaneously injecting a solution comprises an initial relatively deeper injection of microbubbles followed by a relatively shallower injection of microbubbles, and wherein the ultrasonic energy is delivered following each injection.

30. A method for reducing cellulite, comprising:

percutaneously injecting a solution comprising microbubbles into a treatment area located in a subdermal fat layer between 1 mm and 5 mm below a dermis and proximal to a chamber of fat cells in the treatment area;

delivering an ultrasonic energy from outside the treatment area to cavitate at least a portion of the microbubbles in the treatment area to irreversibly destroy the chamber of fat cells in the treatment area; and

irreversibly destroying the chamber of fat cells while leaving cells outside the treatment area unaffected to contour a portion of an outer surface of the dermis and to reduce the cellulite.