Systems, apparatus, methods and procedures for the noninvasive treatment of tissue using microwave energy

• US 8,688,228 B2
• Filed: 12/12/2008
• Issued: 04/01/2014
• Est. Priority Date: 04/19/2007
• Status: Active Grant

• Current Assignee: miraDry, Inc. (Sientra Incorporated)
• Original Assignee: Miramar Labs, Inc. (Sientra Incorporated)
• Inventors: Johnson, Jessi Ernest, Deem, Mark E., Francis, Daniel, Kim, Steven, Salamini, Alexey, Su, Ted, Smith, Peter, Hallock, Daniel, Ben-Haim, Yoav, Saraf, Shailendhar
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): PIKE, JARED WAYNE
• Application Number:
  US12/747,538
• Publication Number:
  US 20100268220A1
• Time in Patent Office: 1,936 Days
• Field of Search: 600/387, 601/6, 606/33, 607/100, 607/101, 604118-121
• 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61F 2007/0075 using a Peltier element, e.g. near the spot to be heated or cooled
• 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

The present invention is directed to systems, apparatus, methods and procedures for the noninvasive treatment of tissue using microwave energy. In one embodiment of the invention a medical device and associated apparatus and procedures are used to treat dermatological conditions using microwave energy.

Claims

1. A method of balancing vacuum pressure in a medical treatment device, wherein said medical treatment device comprises an applicator and a disposable, said disposable comprising a tissue chamber and an applicator chamber separated by a tissue bio-barrier that is flexible and substantially impermeable to air and biological fluids, said method comprising the steps of:

positioning said applicator in said applicator chamber such that said applicator seals an applicator chamber opening;

positioning tissue adjacent said tissue chamber such that said tissue at least partially seals a tissue chamber opening;

drawing air through at least a portion of a vacuum circuit connecting said applicator chamber to said tissue chamber to pull tissue into said tissue chamber;

removing air from said applicator chamber and said tissue chamber to substantially equalize air pressure on either side of said tissue bio-barrier; and

preventing biological fluids from passing from said tissue chamber into said applicator chamber.

2. The method of claim 1 wherein the drawing air step further comprises drawing air through an applicator bio-barrier.

3. The method of claim 2 further comprising preventing biological fluids from passing through said applicator bio-barrier.

4. The method of claim 1 wherein the drawing air step further comprises drawing air through an applicator bio-barrier disposed in the vacuum circuit.

5. The method of claim 1 further comprising pulling tissue into contact with a tissue interface surface of said tissue bio-barrier.

6. The method of claim 1 further comprising positioning tissue adjacent a compliant member disposed around said tissue chamber opening.

7. The method of claim 1 wherein a distal end of said applicator contacts said tissue bio-barrier during the drawing air step.

8. The method of claim 1 wherein a cooling plate of said applicator contacts said tissue bio-barrier during the drawing air step.

9. A method of creating a lesion in a region of skin tissue using a medical treatment device, wherein said medical treatment device comprises an applicator and a disposable, said applicator comprising a cooling interface plate and said disposable comprising a tissue chamber and an applicator chamber separated by a tissue bio-barrier, wherein said tissue bio-barrier is flexible and substantially impermeable to air and biological fluids, said method comprising the steps of:

positioning said applicator in said applicator chamber such that said applicator seals an applicator chamber opening;

positioning said skin tissue adjacent to said tissue chamber such that said skin tissue at least partially seals a tissue chamber opening;

drawing air through at least a portion of a vacuum circuit connecting said applicator chamber to said tissue chamber to pull said skin tissue into said tissue chamber;

removing air from said applicator chamber and said tissue chamber to substantially equalize air pressure on either side of said tissue bio-barrier; and

transmitting microwave energy through said cooling plate and through said tissue bio-barrier into said skin tissue.

10. The method of claim 9 further comprising transmitting microwave energy for approximately 2.5 to 3.5 seconds.

11. The method of claim 9 wherein the transmitting step further comprises switching said microwave energy through a plurality of microwave antennas in said applicator.

12. The method of claim 9 wherein the transmitting step further comprises transmitting said microwave energy through said tissue bio-barrier which comprises a dielectric material.

13. The method of claim 12 wherein said dielectric material has a dielectric constant of between approximately 2 and 15.

14. The method of claim 12 wherein said dielectric material has a dielectric constant of between approximately 3 and 3.5.

15. The method of claim 9 wherein the transmitting step further comprises transmitting said microwave energy through said tissue bio-barrier which is substantially transparent to microwave energy.

16. The method of claim 9 wherein the transmitting step further comprises transmitting microwave energy through said tissue bio-barrier comprising a film having a thickness of between approximately 0.0001 inches and 0.030 inches.

17. The method of claim 9 further comprising placing said skin tissue in thermal contact with said cooling plate.

18. The method of claim 17 wherein the placing step further comprises placing said skin tissue into thermal contact with said cooling plate via said tissue bio-barrier.

19. The method of claim 18 further comprising passing a cooling fluid through said cooling plate to cool said skin tissue.

20. The method of claim 19 wherein said cooling fluid has a temperature of between approximately 8 degrees centigrade and 22 degrees centigrade.

21. The method of claim 19 wherein said cooling fluid has a temperature of approximately 15 degrees centigrade.

22. The method of claim 17 further comprising maintaining said skin tissue in thermal contact with said cooling plate for a predetermined cooling period after said microwave energy is transmitted into said skin tissue.

23. The method of claim 22 wherein said predetermined cooling period is less than approximately sixty seconds.

24. The method of claim 23 wherein said predetermined cooling period is approximately twenty seconds.

25. The method of claim 9 further comprising separating a dermal layer and a hypodermal layer of said skin tissue from a muscular layer by pulling said skin tissue into said tissue chamber.

26. The method of claim 25 further comprising limiting an amount of microwave energy that reaches the muscular layer by separating the dermal and hypodermal layer from said muscular layer.