Apparatus for treating subcutaneous tissues

• US 7,601,128 B2
• Filed: 01/17/2006
• Issued: 10/13/2009
• 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:
  US11/334,805
• Publication Number:
  US 20070055181A1
• Time in Patent Office: 1,365 Days
• Field of Search: 601/2, 600/437, 600/439, 604/506, 604/511, 604/518
• 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 assembly for treating subcutaneous tissues using acoustic waves in the range of low acoustic pressure ultrasound waves is disclosed. The assembly comprises an acoustic wave generator and transducer for the generation and transmission of unfocused acoustic waves, a source of microbubble solution and solution injection members for percutaneously injecting the solution at a treatment area between 1 mm and 5 mm below the dermis. The assembly is useful for treatment of subcutaneous abnormalities including cellulite, lipomas and tumors.

Claims

1. An assembly for treating subcutaneous tissue and reducing cellulite, comprising:

an acoustic wave generator for generating unfocused acoustic waves;

an acoustic wave transducer operably connected to the acoustic wave generator and configured to apply the unfocused acoustic waves to the subcutaneous tissue of a patient from a point above and external to a dermis of the patient;

a source of a microbubble solution; and

a plurality of non-vibrating solution injection members operably connected to said source of microbubble solution, said plurality of non-vibrating solution injection members being equally spaced apart and configured to percutaneously inject the microbubble solution into a treatment area located between 1 mm and 5 mm below the dermis,

wherein the apparatus is configured to produce irreversible subcutaneous cavitational bioeffects in a substantial amount of the microbubble solution-infused subcutaneous tissue in the treatment area and configured to leave cells outside the treatment area unaffected to contour a portion of an outer surface of the dermis and to reduce the cellulite.

2. The assembly of claim 1, wherein the source of the microbubble solution comprises a gas housing configured to retain a gas therein.

3. The assembly of claim 2, wherein the source of the microbubble solution comprises a solution housing configured to retain a solution therein.

4. The assembly of claim 3, further including a solution agitator operably connected to said source of solution and said source of gas, said solution agitator configured to create microbubbles in the solution.

5. The assembly of claim 1, wherein the solution injection member includes a housing and a plurality of hollow needles.

6. The assembly of claim 5, wherein a distal end of at least one of the hollow injection members is movable between a first configuration inside the solution injection member housing and a second configuration in which the distal end extends outside the solution injection member housing.

7. The assembly of claim 1, wherein the solution injection member includes a fanned needle array.

8. The assembly of claim 1, wherein the acoustic wave transducer is a planar transducer.

9. The assembly of claim 8, wherein a focal zone of the planar transducer extends from a near zone in a tissue depth extending from about 1 to about 15 mm below the epidermis to a far zone in a tissue depth of between about 15 mm and about 30 mm below the epidermis.

10. The assembly of claim 8, further including an acoustically coupled acoustic stand-off operably connected to the transducer that places a focal zone of the planar transducer at a desired tissue depth.

11. The assembly of claim 1, further including a tissue cooling module for cooling the subcutaneous tissue, the cooling module operably connected to one of the transducer and the injection member, wherein discomfort, swelling, scarring or other undesired effects associated with cosmetic or dermatologic treatment with the assembly is reduced.

12. The assembly of claim 1, further including a control module operably connected to the solution injection member and the acoustic wave generator and configured to coordinate injection of the solution with application of the acoustic waves.

13. The assembly of claim 12, wherein the control module is configured to provide staged sequences of injections at various tissue depths coordinated with an application of the acoustic waves.

14. The assembly of claim 1, further including:

a solution agitator configured for mixing the solution with a gas; and

a control module configured to coordinate agitation of the solution, injection of the solution into the subcutaneous tissue, and application of the acoustic waves to the subcutaneous tissue.

15. The assembly of claim 14, wherein the solution agitator agitates the gas with the solution to produce a solution including microbubbles.

16. The assembly of claim 1, wherein the acoustic wave transducer is operably connected to the acoustic wave generator and the acoustic wave transducer is removably mounted on the solution injection member.

17. The assembly of claim 1, wherein the acoustic wave transducer is operably connected to the acoustic wave generator, and the acoustic wave transducer is integrally connected to the solution injection member.

18. An assembly for treating subcutaneous tissue and reducing cellulite, comprising:

an acoustic wave generator configured to produce unfocused acoustic waves having a frequency in the range of about 0.25 MHz to about 20 MHz and a peak negative pressure in the range of 0.1 Mpa to 10.0 MPa;

an acoustic wave transducer operably coupled to the acoustic wave generator and configured to apply the unfocused acoustic waves to the subcutaneous tissue of a patient from a point above and external to a dermis of the patient;

a source of a gas;

a solution agitator operably connected to the gas source and configured for mixing the gas with a solution to produce a solution including gaseous bodies; and

a solution injection member operably connected to the solution agitator and configured for percutaneously injecting the solution including the gaseous bodies into a treatment area located between 1 mm and 5 mm below the dermis; and

a tissue cooling module operably connected to one of the transducer and the injection member, the cooling module configured to cool the subcutaneous tissue,

wherein the acoustic wave generator has a duty cycle selected to produce irreversible subcutaneous cavitational bioeffects in a substantial amount of the solution- infused treatment area and configured to leave cells outside the treatment area unaffected to contour a portion of an outer surface of the dermis and to reduce the cellulite.

19. The assembly of claim 18, further comprising:

a gas housing operably connected to the solution injection member and configured to retain the source of the gas therein.

20. The assembly of claim 19, further comprising:

a solution housing operably connected to the solution injection member and configured to retain a source of the solution therein.

21. The assembly of claim 18, wherein the source of the gas is room air.

22. The assembly of claim 18, wherein the solution injection member includes a housing and a plurality of hollow injection members.

23. The assembly of claim 22, wherein a distal end of at least one hollow injection member is movable between a first configuration inside the solution injection member housing and a second configuration in which the distal end extends outside the solution injection member housing.

24. The assembly of claim 18, wherein the acoustic wave transducer is a planar transducer.

25. The assembly of claim 18, further including a tissue cooling module operably connected to one of the transducer and the injection member, wherein discomfort, swelling, scarring or other undesired effects associated with cosmetic or dermatologic treatment with the assembly is reduced.

26. An assembly for treating subcutaneous tissue and reducing cellulite, comprising:

an ultrasonic wave generator configured to produce unfocused ultrasonic waves having at a first and a second setting;

an ultrasonic wave transducer operably connected to the ultrasonic wave generator and configured to apply the unfocused ultrasonic waves to the subcutaneous tissue of a patient from a point above and external to a dermis of the patient;

a source of a gas;

a source of a solution;

a solution agitator operably connected to the gas source and the solution source and configured for mixing the gas with the solution to form a microbubble solution;

a solution injection member operably connected to the solution agitator and having at least one hollow injection member, a distal end of the least one hollow injection member being movable between a first configuration inside the solution injection member housing and a second configuration in which the distal end of the injection member extends outside the solution injection member housing;

a control module configured to select between and apply the first and second settings,

wherein the first setting disperses the microbubble solution into a treatment area located 1 mm to 5 mm below a dermis, and the second setting irreversibly destroys at least one fat cell and fibrous septae in the treatment area while leaving cells outside the treatment area unaffected to contour a portion of an outer surface of the dermis and to reduce the cellulite.

27. The assembly of claim 26, wherein the control module is further configured to provide staged depths of injection of the microbubble solution followed by application of the ultrasonic waves.

28. The assembly of claim 26, further including a cooling module operably connected one of to the transducer and the injection member.