Devices and methods for performing subcutaneous surgery

• US 9,510,849 B2
• Filed: 06/04/2014
• Issued: 12/06/2016
• 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: Clark, Robert L. III, Chomas, James E., Merchant, Adnan I., Brian, Ben F. III
• Primary Examiner(s): Eastwood, David C
• Application Number:
  US14/296,353
• Publication Number:
  US 20150066011A1
• Time in Patent Office: 916 Days
• Field of Search: 606161-162, 606166-167, 606170-172, 606/185, 606190-191, 606/198, 600/131, 600/132, 600135-137, 600/565, 600/571, 604115-117, 604/542
• US Class Current: 1/1
• 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 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 18/06 caused by chemical reaction , e.g. moxaburners
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• 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 18/1815 using microwaves
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• 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 2017/320052 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 2017/3409 : including needle or instrument drives
• 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 2018/00434 : Neural system
• CPC Class Codes: A61B 2018/00452 : Skin
• CPC Class Codes: A61B 2018/00458 : Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains
• CPC Class Codes: A61B 2018/0047 : Upper parts of the skin, e.g. skin peeling or treatment of wrinkles
• CPC Class Codes: A61B 2018/00571 : for achieving a particular surgical effect
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/00601 : Cutting
• CPC Class Codes: A61B 2018/00607 : Coagulation and cutting with the same instrument
• CPC Class Codes: A61B 2018/00648 : using more than one sensed parameter
• 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 2018/1415 : multiple blades
• CPC Class Codes: A61B 2018/1425 : Needle
• 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 2218/002 : Irrigation
• CPC Class Codes: A61B 90/02 : Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• CPC Class Codes: A61F 2/0059 : Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61F 2/0063 : Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61M 37/00 : Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• 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

Devices and methods for performing subcutaneous surgery in a minimally invasive manner are provided. The methods include application of reduced air pressure in a recessed area of a handpiece placed over a section of skin and drawing the section of skin and subcutaneous tissue into the recessed area. In a subsequent step a tool is inserted through a tool conduit in the handpiece and through the skin into the subcutaneous tissue, enabling the performance of the desired surgery. Common surgical procedures include dissection and ablation. The devices and methods can be directed at the treatment of skin conditions like atrophic scars, wrinkles, or other cosmetic issues, at treatments like or promoting wound healing or preventing hyperhidrosis, or can be used for creating space for various implants.

Claims

1. A method for treating tissue, comprising:

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

wherein the recessed chamber comprises a top and wherein the recessed chamber is in communication with the vacuum port;

coupling a guidance track to the handpiece;

coupling the vacuum port to a vacuum source and applying vacuum pressure to the recessed chamber to cause the target tissue underlying the recessed chamber to contact the top of the recessed chamber;

engaging a cutting tool comprising a cutting blade with the handpiece;

moving the cutting tool relative to the handpiece to insert a portion of the cutting blade into the recessed chamber and into the target tissue and further moving the cutting tool along the guidance track, wherein movement of the cutting tool along the guidance track defines forward and reverse and side to side movements of the cutting blade within the target tissue, thereby treating the target tissue.

2. The method of claim 1, wherein the epidermis is contacted with the top of the recessed area.

3. The method of claim 2, wherein the handpiece comprises a conduit through which the cutting blade passes to enter the subcutaneous region, wherein the cutting blade moves within the subcutaneous region of the target tissue, and wherein the cutting blade moves in the subcutaneous region at a depth of between 3 mm and 15 mm below the dermis.

4. The method of claim 1, wherein the target tissue has a deformity selected from a scar, a wrinkle and a skin surface irregularity resulting from liposuction, and wherein treatment of the target tissue improves the appearance of the deformity.

5. The method of claim 1, further comprising moving the cutting tool to remove the cutting blade from the target tissue;

removing the vacuum pressure to allow the target tissue of come out of contact with the top of the recessed chamber;

positioning the handpiece over a second region of target tissue;

applying vacuum pressure to cause the second region of target tissue to contact the top;

engaging the cutting tool with the handpiece and moving the cutting blade in forward and reverse directions and side to side within the second region of target tissue.

6. The method of claim 5, wherein the cutting blade is moved at the same depth from the top of the recessed chamber in the first and second regions of target tissue.

7. The method of claim 5, wherein the cutting blade is moved within the second region of target tissue at a depth from the top of the recessed chamber that is different from the depth within the first region of target tissue.

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

9. The method of claim 7, wherein the second region of target tissue is adjacent to the first region of target tissue.

10. The method of claim 1, further comprising activating a motor of the cutting tool to move the cutting blade in a reciprocating pattern.

11. The method of claim 1, further comprising programming a microprocessor to control the movement of the cutting tool.

12. The method of claim 1, wherein the top comprises a threaded top having an inner edge and an outer edge, wherein a rim of the recessed chamber is threaded, wherein the inner and outer edges of the threaded lid interact with the threaded rim of the recessed chamber, such that the threaded lid is configured to move up and down with respect to the recessed chamber when the threaded lid is rotated.

13. A method for treating tissue, comprising:

positioning a handpiece comprising a recessed chamber defined by a perimeter wall and a top at a first region of tissue to be treated, wherein the tissue to be treated comprises a subcutaneous region;

capturing a portion of the tissue to be treated within the recessed chamber by application of a force to the handpiece,

wherein said capturing brings an epidermis of the tissue to be treated into contact with the top of the recessed chamber;

engaging the handpiece with a tissue cutting tool and a guidance track;

manipulating the tissue cutting tool along the guidance track to cause a cutting element of the tissue cutting tool to move into the recessed chamber through a conduit in the perimeter wall,

wherein the cutting element enters the subcutaneous region of the tissue to be treated,

wherein manipulation of the tissue cutting tool along the guidance track defines forward and reverse and side to side movements of the cutting element within the subcutaneous region of the tissue to be treated.

14. The method of claim 13, wherein the tissue to be treated is captured by application of vacuum pressure to the recessed area through a vacuum port placed in fluid communication with a vacuum source.

15. The method of claim 13, further comprising removing the cutting element from the tissue to be treated;

disengaging the tissue cutting tool from the handpiece;

engaging a mesh deployment applicator with the handpiece;

advancing the mesh deployment applicator into the subcutaneous region of the tissue to be treated; and

deploying a mesh into the into the subcutaneous region of the tissue to be treated.

16. The method of claim 15, wherein the mesh comprises a flexible material that promotes formation of a high density of fibrous attachments, thereby reducing the heterogeneity of the appearance of the treated tissue.

17. A method of treating tissue, comprising:

positioning a handpiece comprising a base, a recessed chamber having a conduit through a side of the recessed chamber, over a region of target tissue comprising dermis, epidermis and a subcutaneous region;

applying a force to the handpiece to cause a portion of the target tissue to contact an inner top surface of the recessed chamber;

coupling a guidance platform to the handpiece;

engaging a portion of a tissue cutting tool with a portion of the guidance platform;

moving the tissue cutting tool in a pattern defined by the engaged portions of the tissue cutting tool and the guidance platform to cause a portion of the tissue cutting tool to pass through the conduit and into the recessed chamber and into the target tissue within the recessed chamber, and

wherein the movement of the tissue cutting tool in the pattern of the guidance platform causes the portion of the tool within the target tissue to move in forward and reverse and side to side directions to cut a desired subcutaneous portion of the target tissue in a plane parallel to the base of the handpiece, at a desired depth from the top of the recessed chamber.

18. The method of claim 17, wherein the desired depth is between about 4 mm and 20 mm from the top of the recessed chamber with which the target tissue is contacted.

19. The method of claim 17, wherein the engaged portion of the tissue cutting tool comprises a guide pin, and wherein said movement of the tissue cutting tool comprises moving the guide pin along a guidance track of the guidance platform.