Cellulite treatment methods

• US 8,894,678 B2
• Filed: 05/29/2014
• Issued: 11/25/2014
• Est. Priority Date: 08/07/2009
• Status: Active Grant

• Current Assignee: Ulthera Inc. (Merz Pharma GmbH & Company Kgaa)
• Original Assignee: Ulthera Inc. (Merz Pharma GmbH & Company Kgaa)
• Inventors: Chomas, James E., Merchant, Adnan I., Brian, Ben F. III, Clark, Robert L III
• Primary Examiner(s): EASTWOOD, DAVID C
• Application Number:
  US14/290,858
• Publication Number:
  US 20140277027A1
• Time in Patent Office: 180 Days
• Field of Search: 606161-162, 606166-167, 606170-172, 606/185, 606/190, 606/191, 606/198, 600/131, 600/132, 600135-137, 600/565, 600/571, 604115-117, 604/542
• US Class Current: 606/172
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/3201 Scissors for biopsy A61B10/02
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00747 Dermatology
• CPC Class Codes: A61B 2017/00761 Removing layer of skin tissue, e.g. wrinkles, scars or cancerous tissue
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61B 2017/320028 with reciprocating movements
• CPC Class Codes: A61B 2017/32004 having a laterally movable cutting member at its most distal end which remains within the contours of said end
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61B 2017/32006 with a cutting strip, band or chain, e.g. like a chainsaw
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2017/3407 : including a base for support on the body
• CPC Class Codes: A61B 2018/0016 : Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00291 : using suction
• CPC Class Codes: A61B 2018/00452 : Skin
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/143 : multiple needles
• CPC Class Codes: A61B 2018/1432 : curved
• CPC Class Codes: A61B 2090/0811 : for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/0815 : Implantable devices for insertion in between organs or other soft tissues
• CPC Class Codes: A61B 2217/005 : with suction drainage system
• CPC Class Codes: A61B 2217/007 : with irrigation system
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61H 2201/0207 : heated
• CPC Class Codes: A61H 2201/10 : with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
• CPC Class Codes: A61H 2201/105 : with means for delivering media, e.g. drugs or cosmetics
• CPC Class Codes: A61H 2207/00 : Anti-cellulite devices
• CPC Class Codes: A61H 23/0245 : with ultrasonic transducers, e.g. piezoelectric
• CPC Class Codes: A61N 1/306 : Arrangements where at least part of the apparatus is introduced into the body
• CPC Class Codes: A61N 1/327 : for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 1/328 : for improving the appearance of the skin, e.g. facial toning or wrinkle treatment
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia
• 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

A dermatological skin treatment device is provided. The device comprises a handpiece and a cutting tool, wherein the tool is inserted through the conduit and percutaneously inserted into a tissue disposed within a recessed area of the handpiece. The device and method cut the fibrous structures under the skin that cause cellulite at an angle substantially parallel to the surface of the skin and replace these structures with a non-cellulite forming structure by deploying a highly fibrous mesh through a single needle hole to create a highly fibrous layer directly or through wound healing processes.

Claims

1. A method for treating cellulite, comprising:

coupling a handpiece comprising a vacuum receptacle to a vacuum source,

wherein the handpiece comprises a recessed chamber comprising a top having an inner surface,

wherein the recessed chamber is in fluidic communication with the vacuum receptacle,

placing the handpiece over a first region of target tissue comprising dermis, epidermis and subcutaneous tissue,

applying vacuum pressure, via the vacuum receptacle, to the recessed chamber, thereby causing the target tissue underlying the recessed chamber to be elevated to contact the inner surface;

coupling a guidance platform comprising a guidance track to the handpiece;

engaging a tissue dissection device comprising a distally positioned cutting element with the guidance track;

moving the tissue dissection device along the guidance track to cause the cutting element to pierce the tissue within the recessed chamber;

creating a dissection plane in the subcutaneous tissue by manipulating the tissue dissection device and shearing fibrous structures within the dissection plane, thereby freeing the tissue from the fibrous structures and treating cellulite.

2. The method of claim 1, wherein the vacuum pressure applied is sufficient to cause at least a portion of the target tissue to conform to the recessed chamber, and wherein the subcutaneous tissue enters the recessed chamber.

3. The method of claim 1, wherein the tissue dissection device comprises a guide pin comprising a flange,

wherein the guidance track comprises an undercut groove,

wherein engaging the tissue dissection device with the guidance track comprises placing the guide pin in the guidance track,

wherein manipulating the tissue dissection device comprises moving the tissue dissection device in a predetermined pattern by tracing the guide pin along at least a portion of the guidance track,

wherein tracing the guide pin along at least a portion of the guidance track allows forward, reverse, and/or side to side movement of the distally positioned cutting element in the tissue within the recessed chamber, and

wherein the placement of the guide pin in the guidance track prevents the tissue dissection device from being lifted off the guidance platform.

4. The method of claim 1, wherein the dissection plane is created at a depth of between 3 mm and 15 mm below the dermis.

5. The method of claim 1, further comprising removing the cutting element from the target tissue;

placing the handpiece over a second region of target tissue;

applying vacuum pressure to the recessed chamber, thereby causing the second region of target tissue to be elevated to contact the inner surface;

moving the tissue dissection device along the guidance track to cause the cutting element to pierce the second region of target tissue within the recessed chamber;

creating a dissection plane in the subcutaneous portion of the second region of tissue by manipulating the tissue dissection device and shearing fibrous structures within the dissection plane.

6. The method of claim 5, wherein the fibrous structures within the second region of target tissue are sheared at a depth that is different from the depth at which the fibrous structures within the first region of target tissue were sheared.

7. The method of claim 6, wherein the top of the recessed chamber is adjustable and the difference in depth is achieved by adjusting the top.

8. The method of claim 7, wherein the top further comprises a rigid upper lid, a rigid inner lid, and a bladder disposed between the rigid upper lid and rigid inner lid, wherein the rigid inner lid is configured to move up and down with respect to a raised perimeter wall of the recessed chamber, the rigid inner lid being at its lowest point when the bladder is fully expanded, and being at its highest point when the bladder is deflated.

9. The method of claim 7, wherein the top further comprises a threaded lid having an inner edge and an outer edge, wherein the inner and outer edges interact with a rim of a raised perimeter wall of the recessed chamber, wherein an inner side of the outer edge and an outer side of the raised perimeter are respectively threaded such that the threaded lid is configured to move up and down with respect to the perimeter wall when the threaded lid is rotated.

10. The method of claim 1, wherein the recessed chamber comprises a raised perimeter wall comprising at least one conduit configured to allow passage of the distal end of the cutting device into the tissue engaging chamber.

11. The method of claim 10, wherein the conduit is configured to allow the distally positioned cutting element to be pivoted in an arc from side to side within the recessed chamber.

12. The method of claim 1, wherein movement of the tissue dissection device along the at least one guidance track and manipulation of the tissue dissection device are microprocessor controlled.

13. The method of claim 1, wherein the cutting element comprises a reciprocating cutting blade driven by a motor module.

14. The method of claim 1, wherein the dissection plane is substantially parallel to the surface of the target tissue.

15. A method for treating cellulite, comprising:

coupling a guidance platform comprising a guidance track to a handpiece comprising a recessed chamber and a vacuum receptacle,

wherein the recessed chamber has a top comprising an inner surface;

positioning the recessed chamber of the handpiece over a first region of target tissue epidermis, dermis and subcutaneous tissue;

applying vacuum pressure to the vacuum receptacle and causing tissue underlying the recessed chamber to contact the inner top surface of the recessed chamber;

contacting a base of a tissue dissection device with the guidance platform and operatively engaging the guidance track;

inserting a cutting element of the tissue dissection device into a subcutaneous layer of the tissue within the recessed chamber; and

moving the tissue dissection device along the guidance track while maintaining contact between the tissue dissection device and the guidance platform to cause the cutting element to sever fibrous structures in the subcutaneous tissue, thereby treating cellulite.

16. The method of claim 15, wherein movement of the tissue dissection device is microprocessor controlled.

17. The method of claim 15, wherein the guidance track of the guidance platform limits the motion of the cutting element within the recessed area to a pattern corresponding to the guidance track.

18. The method of claim 15, wherein a planar subcutaneous lesion is generated at a fixed depth from the inner top surface of the recessed chamber, and wherein the fixed depth is between 3 mm and 15 mm below the dermis.