Dissection handpiece and method for reducing the appearance of cellulite

• US 9,364,246 B2
• Filed: 06/26/2012
• Issued: 06/14/2016
• Est. Priority Date: 09/07/2005
• Status: Active Grant

• Current Assignee: Ulthera Inc. (Merz Pharma GmbH & Company Kgaa)
• Original Assignee: Ulthera Inc. (Merz Pharma GmbH & Company Kgaa)
• Inventors: Clark, Robert L. III, Chomas, James E., Merchant, Adnan I., Brian, Ben F. III
• Primary Examiner(s): Mendez, Manuel
• Application Number:
  US13/533,745
• Publication Number:
  US 20120277674A1
• Time in Patent Office: 1,449 Days
• Field of Search: 604/198, 604/117, 604 65- 67, 604/131, 128/DIG.12, 128/DIG.13
• US Class Current: 1/1
• 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
• 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 minimally invasive skin treatment device, comprising:

a handpiece having a perimeter elevation and a top which cooperatively define a recessed area, an inner side of the perimeter elevation and the top defining an apposition surface facing into the recessed area;

a conduit extending through a side of the perimeter elevation to the recessed area;

a needle configured to at least partially extend through the conduit and into the recessed area;

a guidance track operably connected to the handpiece, wherein the guidance track is configured to constrain a portion of the needle in contact with the guidance track to move along a predetermined path to cooperatively move a distal end of the needle within the recessed area in a plane substantially parallel to the top of the handpiece and within a region of a predetermined shape defined by the predefined path;

a pump;

a source of injectable fluids in fluid communication with said pump; and

wherein the needle is in fluid communication with the pump, the needle being configured to inject the injectable fluids into a tissue disposed in the recessed area;

a microprocessor having graphical user interface, wherein the pump is configured to communicate information specifying a volume of a fluid injected into the tissue to the microprocessor;

wherein the microprocessor is configured to use the graphical user interface to prompt a user to enter information specifying at least one of a concentration of a component of the fluid and a weight of a patient;

wherein the microprocessor includes logic for determining a maximum dosage the fluid injected based on the weight of the patient, the concentration of the component of the fluid, and the volume of the fluid injected;

wherein the microprocessor is configured to cause the graphical interface to display at least one warning message when the volume of the fluid injected exceeds a predefined threshold which is less than the maximum dosage; and

wherein the microprocessor is configured to instruct the pump to terminate an injection when the volume of the fluid injected reaches the maximum dosage.

2. The minimally invasive skin treatment device of claim 1,

wherein the conduit is configured to allow the needle to be pivoted in an arc about the conduit to allow the distal end of the needle to move throughout the predetermined region.

3. The minimally invasive skin treatment device of claim 2, wherein the needle comprises:

a lumen;

a tip for piercing a dermis; and

at least two injection ports in communication with the lumen, wherein the ports are linearly disposed along an outer surface of the needle and flush with a side of the needle.

4. The minimally invasive skin treatment device of claim 3, wherein the ports are configured to discharge a fluid in a direction substantially orthogonal to an axis of the needle and substantially parallel to the top of the handpiece.

5. The minimally invasive skin treatment device of claim 1,

wherein the guidance track comprises:

a plurality of first tracks defining a treatment area; and

a second track for preventing the distal end of the needle from being withdrawn from the recessed area.

6. The minimally invasive skin treatment device of claim 5, wherein the needle is attached to a control module, and wherein the control module has a guidance pin configured for movement in the plurality of first tracks and the second track.

7. The minimally invasive skin treatment device of claim 6, wherein an enlarged opening in one of the plurality of first tracks receives the guidance pin as an entry point into the plurality of first tracks.

8. The minimally invasive skin treatment device of claim 1, wherein the graphical user interface is configured to enable the user to over-ride the maximum dosage such that the pump continues to inject the fluid once the maximum dosage has been reached.

9. The minimally invasive skin treatment device of claim 1, wherein the microprocessor is configured to track an amount of elapsed time since the pump initiated pumping the fluid and to calculate a recommended treatment end time using information selected from a group consisting of the volume of fluid injected and the elapsed time.

10. The minimally invasive skin treatment device of claim 1, wherein the guidance track forms a first planar surface and the apposition surface forms a second planar surface that is parallel to the first planar surface.

11. The minimally invasive skin treatment device of claim 10, wherein after the needle extends through the conduit and the skin, the needle is parallel to the first planar surface and the second planar surface.

12. The minimally invasive skin treatment device of claim 11, wherein the needle remains parallel to the first planar surface and the second planar surface as the control module moves along the plurality of first tracks.

13. The minimally invasive skin treatment device of claim 1, wherein the conduit is configured to position the portion of the needle extending into the recessed area to be at a distance ranging from 0 mm to 30 mm from the apposition surface.

14. The minimally invasive skin treatment device of claim 1, wherein the needle is configured to inject fluids into a tissue positioned in the treatment area and in contact with the apposition surface at a depth below a dermis of the tissue in a range from 4 mm to 20 mm.

15. A skin treatment device, comprising:

a handpiece having a perimeter elevation and a top which cooperatively define a recessed area, an inner side of the perimeter elevation and the top defining an apposition surface facing into the recessed area;

a conduit extending through a side of the perimeter elevation to the recessed area;

a needle configured to at least partially extend through the conduit and into the recessed area;

a guidance track operably connected to the handpiece, wherein the guidance track is configured to constrain a portion of the needle in contact with the guidance track to move along a predetermined path to cooperatively move a distal end of the needle within the recessed area in a plane substantially parallel to the top of the handpiece and within a region of a predetermined shape defined by the predefined path;

a pump;

a source of injectable fluids in fluid communication with said pump; and

wherein the needle is in fluid communication with the pump, the needle being configured to inject the injectable fluids into a tissue disposed in the recessed area;

a microprocessor having a graphical user interface, wherein the pump is configured to communicate information specifying a volume of a fluid injected into the tissue to the microprocessor;

wherein the graphical user interface is configured to enable the user to over-ride the maximum dosage such that the pump continues to inject the fluid once the maximum dosage has been reached;

wherein the microprocessor is configured to use the graphical user interface to prompt a user to enter information specifying at least one of a concentration of a component of the fluid and a weight of the patient;

wherein the microprocessor includes logic for determining a maximum dosage of the fluid injected based on the weight of the patient, the concentration of the component of the fluid, and the volume of the fluid injected;

wherein the microprocessor is configured to cause the graphical interface to display at least one warning message when the volume of the fluid injected exceeds a predefined threshold which is less than the maximum dosage; and

wherein the microprocessor is configured to instruct the pump to terminate an injection when the volume of the fluid injected reaches the maximum dosage.

16. The skin treatment device of claim 15, wherein the guidance track is configured to allow the needle to deliver the fluid to the entire predetermined shape of the tissue disposed within the recessed area with a single needle puncture to the tissue.

17. The skin treatment device of claim 15, wherein the conduit is configured to allow the needle to be pivoted in an arc about the conduit to allow the distal end of the needle to move throughout the predetermined region.

18. A skin treatment device, comprising:

a handpiece having a perimeter elevation and a top which cooperatively define a recessed area, an inner side of the perimeter elevation and the top defining an apposition surface facing into the recessed area;

a conduit extending through a side of the perimeter elevation to the recessed area;

a needle configured to at least partially extend through the conduit and into the recessed area;

a guidance track operably connected to the handpiece, wherein the guidance track is configured to constrain a portion of the needle in contact with the guidance track to move along a predetermined path to cooperatively move a distal end of the needle within the recessed area in a plane substantially parallel to the top of the handpiece and within a region of a predetermined shape defined by the predefined path;

a pump;

a source of injectable fluids in fluid communication with said pump; and

wherein the needle is in fluid communication with the pump, the needle being configured to inject the injectable fluids into a tissue disposed in the recessed area;

a microprocessor having a graphical user interface, wherein the pump is configured to communicate information specifying a volume of a fluid injected into the tissue to the microprocessor;

wherein the microprocessor is configured to track an amount of elapsed time since the pump initiated pumping the fluid and to calculate a recommended treatment end time using information selected from a group consisting of the volume of fluid injected and the elapsed time;

wherein the microprocessor is configured to use the graphical user interface to prompt a user to enter information specifying at least one of a concentration of a component of the fluid and a weight of the patient;

wherein the microprocessor includes logic for determining a maximum dosage of the fluid injected based on the weight of the patient, the concentration of the component of the fluid, and the volume of the fluid injected;

wherein the microprocessor is configured to cause the graphical interface to display at least one warning message when the volume of the fluid injected exceeds a predefined threshold which is less than the maximum dosage; and

wherein the microprocessor is configured to instruct the pump to terminate an injection when the volume of the fluid injected reaches the maximum dosage.

19. The skin treatment device of claim 18, wherein the conduit is positioned to allow the needle to enter the recessed area at a depth ranging from 0 mm to 30 mm from the apposition surface.

20. The minimally invasive skin treatment device of claim 18, wherein the needle is attached to a control module, and wherein the control module has a guidance pin configured for movement in the plurality of first tracks and the second track, wherein an enlarged opening in one of the plurality of first tracks receives the guidance pin as an entry point into the plurality of first tracks, wherein the guidance track forms a first planar surface and the apposition surface forms a second planar surface that is parallel to the first planar surface.