Methods and apparatuses for skin treatment using non-thermal tissue ablation

• US 10,555,754 B2
• Filed: 08/08/2014
• Issued: 02/11/2020
• Est. Priority Date: 08/09/2013
• Status: Active Grant

• Current Assignee: Cytrellis Biosystems, Inc.
• Original Assignee: Cytrellis Biosystems, Inc.
• Inventors: Ginggen, Alec, Levinson, Douglas, Stone, David
• Primary Examiner(s): Lee, Brandy S
• Application Number:
  US14/910,767
• Publication Number:
  US 20160192961A1
• Time in Patent Office: 2,013 Days
• CPC Class Codes: A61B 17/14 Surgical saws A61B17/1637 takes precedence; tooth saws A61C3/12 ; Accessories therefor
• CPC Class Codes: A61B 17/147 with circularly moving saw blades, i.e. non-reciprocating saw blades
• CPC Class Codes: A61B 17/3203 Fluid jet cutting instruments
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• 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 18/20 using laser
• CPC Class Codes: A61B 18/203 applying laser energy to the outside of the body
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00747 Dermatology
• CPC Class Codes: A61B 2017/00756 Port wine stains
• CPC Class Codes: A61B 2017/00765 Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
• CPC Class Codes: A61B 2017/00769 Tattoo removal
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2017/32007 with suction or vacuum means
• CPC Class Codes: A61B 2017/320082 for incising tissue
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/0047 : Upper parts of the skin, e.g. skin peeling or treatment of wrinkles
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/00613 : Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61B 2018/0262 : using a circulating cryogenic fluid
• CPC Class Codes: A61B 2018/0293 : using an instrument interstitially inserted into the body, e.g. needle
• CPC Class Codes: A61B 2018/143 : multiple needles
• CPC Class Codes: A61B 2018/2005 : with beam delivery through an interstitially insertable device, e.g. needle

Abstract

Disclosed herein are methods, apparatuses, and devices for treating skin, such as skin tightening or for treating diseases, disorders, and conditions that would benefit from tissue area or volume reduction, skin restoration, skin tightening, skin lifting, or skin repositioning. Such methods and devices include an ablative apparatus, a removal apparatus, and/or a positioning apparatus.

Claims

1. A device comprising an ablative apparatus for non-thermal tissue ablation, said apparatus comprising:

a skin-penetrating component configured to provide an ablated tissue portion having a volume of less than 6 mm³ and a change in width as a function of depth, wherein said change in width is of between about 100 μ

m to about 500 μ

m as a function of depth,

wherein said skin-penetrating component is configured to provide the ablated tissue portion without transfer of thermal energy to tissue surrounding the ablated tissue portion; and

wherein said skin-penetrating component comprises a drill configured to rotate at a speed of between 50 rpm and 2500 rpm; and

a positioning apparatus for positioning skin, the positioning apparatus comprising a substrate and a cryosource, wherein the substrate is configurably attached to the cryosource and provides a cryotemperature to the skin of about 0 degrees C. or lower.

2. The device of claim 1, wherein

said skin-penetrating component is configured to provide an ablated tissue portion having a width to depth ratio of between about 1:

0.3 to about 1;

1 or of between about 1;

25 to about 1;

75.

3. The device of claim 1, wherein said apparatus further comprises one or more components that produce a mechanical force.

4. The device of claim 3, wherein said one or more components are selected from the group consisting of a motor, an axle, an adjustable depth stop, an in-flow tube, a return electrode, a generator, and an electrical insulator.

5. The device of claim 1, wherein said apparatus comprises a plurality of said skin-penetrating components in an array.

6. The device of claim 1, wherein said apparatus is configured to provide from about 10 to about 10000 ablated tissue portions per cm² area of the skin region.

7. The device of claim 1, wherein said ablative apparatus removes about 5% of skin within a treatment area.

8. The device of claim 1, further comprising a removal apparatus for removing one or more ablated tissue portion(s).

9. The device of claim 8, wherein the removal apparatus comprises a (i) substrate comprising a plurality of holes;

and (ii) a vacuum source, wherein said substrate is configurably attached to said vacuum source to deliver vacuum through each hole and to each of said one or more ablated tissue portion(s).

10. The device of claim 8, wherein the removal apparatus comprises an adhesive layer or an array of probes configured to contact each of said one or more ablated tissue portion(s).

11. The device of claim 8, wherein the removal apparatus comprises

(i) a wire having a first attachment point and a second attachment point;

(ii) an axle having a sharpened distal end, a center portion, and a proximal end, wherein said first attachment point of said wire is configurably attached to said distal end of said axle and said second attachment point of said wire is configurably attached to said center portion of said axle, and wherein said axle is configured to contact each of said one or more ablated tissue portion(s);

(iii) a motor configured to rotate said wire, wherein said motor is configurably attached to said proximal end of said axle;

(iv) a vacuum source, and

(v) a substrate comprising a plurality of holes, wherein said substrate is configurably attached to the vacuum source to deliver vacuum through each hole and to each of said one or more ablated tissue portion(s).

12. The device of claim 1, wherein the positioning apparatus comprises at least two sufficiently parallel tensioning rods configured to compress or stretch skin, wherein said rods are separated by a distance of more than about 0.5 mm and exert a compressing or stretching force, respectively.

13. The device of claim 1, wherein the positioning apparatus comprises a plurality of needles configured to grip skin, wherein said needles exert a gripping force.

14. The device of claim 1, wherein the positioning apparatus comprises a plurality of microhooks or microbarbs, wherein each microhook or microbarb is separated by a distance of more than about 0.5 mm and exerts a stretching force.

15. The device of claim 1, wherein the positioning apparatus comprises a vacuum tube having at least one dimension of greater than 1 mm and a vacuum source, wherein said vacuum tube is configurably attached to said source and exerts a stretching force.

16. The device of claim 1, wherein the positioning apparatus comprises a substrate having at least one dimension of about 1 mm and a cryosource, wherein said substrate is configurably attached to said cryosource and provides a cryotemperature of about 0°

C. or lower.

17. The device of claim 1, wherein the positioning apparatus comprises an adhesive layer having at least one dimension of about 1 mm, wherein said positioning apparatus is configured to position skin prior to ablation with said ablative apparatus and/or prior to removal with said removal apparatus.

18. The device of claim 1, wherein the positioning apparatus comprises one or more sensors to detect position, temperature, skin proximity, skin contact, and/or changes in inductive coupling.

19. A method of treating skin, comprising:

(i) positioning said skin using a compressive or a stretching force applied across said skin and providing a cryotemperature to the skin of about 0 degrees C. or lower;

(ii) contacting the skin with a skin-penetrating component comprising a drill rotating at a speed of between 50 rpm and 2500 rpm;

(iii) forming a plurality of ablated tissue portions having a volume of less than 6 mm³ and a change in width as a function of depth without transfer of thermal energy to tissue surrounding the ablated tissue portion, wherein said change in width is of between about 100 μ

m to about 500 μ

m as a function of depth; and

(iv) removing said plurality of ablated tissue portions, thereby treating said skin.

20. The method of claim 19, forming a plurality of ablated tissue portions having a width to depth ratio of between about 1:

0.3 to about 1;

1 or of between about 1;

25 to about 1;

75.

21. The method of claim 19, comprising removing said plurality of ablated tissue portions, wherein 5% of said skin within a treatment area is removed.

22. The method of claim 19, wherein said compressive force applied across said skin compresses said skin in a direction orthogonal to Langer lines.

23. The method of claim 19, further comprising positioning said skin using a compressive force applied across said skin prior to forming a plurality of ablated tissue portions and removing said plurality of ablated tissue portions.