METHODS AND APPARATUSES FOR SKIN TREATMENT USING NON-THERMAL TISSUE ABLATION

• US 20160192961A1
• Filed: 08/08/2014
• Published: 07/07/2016
• 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
• Granted Patent: US 10,555,754 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 method of treating skin comprising:

(a) positioning said skin using a compressive or a stretching force applied across said skin;

(b) forming a plurality of ablated tissue portions; and

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

2. The method of claim 1, wherein said plurality of ablated tissue portions have a width to depth ratio of between about 1:

0.3 to about 1;

75.

3. The method of claim 1 or 2, wherein said compressive force applied across said skin compresses said skin in a direction orthogonal to Langer lines.

4. The method of any one of claims 1-3, wherein said plurality of ablated tissue portions is removed using needles with 21G.

5. The method of any one of claims 1-4, wherein said plurality of ablated tissue portions being removed is about 10% of said skin within a treatment area.

9. The method of any one of claims 1-9, wherein step (b) comprises pulling, squeezing, resorbing, desiccating, or liquefying said plurality of ablated tissue portions.

6. A method of treating skin comprising:

(a) 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; and

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

10. The method of any one of claims 6-9, further comprising (c) positioning said skin using a compressive force applied across said skin prior to step (a) and/or (b).

11. The method of claim 10, wherein step (a) is performed with an ablative apparatus of any one of claims 21-47 and/or step (b) is performed with a removal apparatus of any one of claims 48-53 and/or step (c) is performed with a positioning apparatus of any one of claims 13-20.

12. The method of claim 11, wherein said ablative apparatus, said removal apparatus, and said positioning apparatus are configured in a single device.

7. A method of treating skin comprising:

(a) forming a plurality of ablated tissue portions having 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; and

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

8. A method of treating skin comprising:

(a) forming a plurality of ablated tissue portions comprising a serrated cross-sectional dimension; and

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

13. A positioning apparatus for positioning skin, said apparatus comprising at least two sufficiently parallel tensioning rods configured to compress skin, wherein said rods are separated by a distance of more than about 0.5 mm and exert a compressing force.

56. The device of claim 54, further comprising:

a positioning apparatus for positioning skin of any one of claims 13-20, 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.

60. The kit of claim 58 or 59, further comprising a positioning apparatus for positioning skin of any one of claims 13-20.

61. The kit of claim 60, wherein said positioning apparatus comprises a tension rod, a microhook, a microbarb, vacuum, a cryoprobe, a cryosource, an adhesive, a switch, and/or a sensor.

14. A positioning apparatus for positioning skin, said apparatus comprising at least two sufficiently parallel tensioning rods configured to stretch skin, wherein said rods are separated by a distance of more than about 0.5 mm and exert a stretching force.

17. The positioning apparatus of claim 14 or 16, wherein said separation distance of more than about 1 mm.

15. A positioning apparatus for positioning skin, said apparatus comprising a plurality of needles configured to grip skin, wherein said needles exert a gripping force.

16. A positioning apparatus for positioning skin, said apparatus comprising 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.

18. A positioning apparatus for positioning skin, said apparatus comprising 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.

19. A positioning apparatus for positioning skin, said apparatus comprising 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 degrees C. or lower.

20. A positioning apparatus for positioning skin, said apparatus comprising an adhesive layer having at least one dimension of about 1 mm.

21. An ablative apparatus for non-thermal tissue ablation, said apparatus comprising a skin-penetrating component configured to provide an ablated tissue portion having 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.

23. The ablative apparatus of claim 21 or 22, 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;

75.

25. The ablative apparatus of any one of claims 21-23, wherein said skin-penetrating component comprises a drill, a microauger, a tube comprising cutting teeth, a spoon bit, a wire, a fiber, a blade, a high-pressure fluid jet, a cryoprobe, a cryoneedle, an ultrasound needle, a multi-hole needle comprising one or more chemical agents, a microelectrode, and/or a vacuum.

26. The ablative apparatus of any one of claims 21-24, further comprising one or more components, wherein said components produce a mechanical force.

27. The ablative apparatus of claim 26, wherein said 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.

28. The ablative apparatus of any one of claims 21-27, further comprising a plurality of said skin-penetrating components in an array.

45. The ablative apparatus of any one of claims 21-44, wherein said apparatus is configured to provide from about 10 to about 10000 ablated tissue portions per cm² area of the skin region.

46. The ablative apparatus of any one of claims 21-45, wherein said needles comprise needles with 21G.

47. The ablative apparatus of any one of claims 21-46, wherein said ablative apparatus removes about 10% of skin within a treatment area.

54. A device comprising:

(a) an ablative apparatus for non-thermal tissue ablation of any one of claims 21-47; and

(b) a removal apparatus for removing one or more ablated tissue portion(s) of any one of claims 48-53, wherein said removal apparatus is configured to remove one or more ablated tissue portion(s) ablated with said ablative apparatus.

55. The device of claim 54, wherein said device comprises:

(a) the ablative apparatus of claim 23 and the removal apparatus of any one of claim 48, 49, or 50;

(b) the ablative apparatus of claim 21 and the removal apparatus of any one of claim 48, 49, or 50;

(c) the ablative apparatus of claim 22 and the removal apparatus of any one of claim 48, 49, or 50;

(d) the ablative apparatus of claim 29 and the removal apparatus of any one of claim 48, 49, or 50;

(e) the ablative apparatus of 30 and the removal apparatus of claim 48, 49;

or

(f) the ablative apparatus of 32 and the removal apparatus of any one of claims 48, 49.

57. The device of claim 54 or 56, further comprising one or more sensors to detect position, temperature, skin proximity, skin contact, and/or changes in inductive coupling.

58. A kit comprising:

(a) an ablative apparatus for non-thermal tissue ablation of any one of claims 21-47; and

(b) a removal apparatus for removing one or more ablated tissue portion(s) of any one of claims 48-53.

59. The kit of claim 58, wherein said removal apparatus comprises a pin, an adhesive, a probe array, a vacuum, a compression element, a laser source, a high-pressure fluid jet, a cryoprobe, a cryosource, a cryoneedle, a multi-hole needle comprising one or more chemical or bioactive agents, a microelectrode, a wire, and/or a fiber.

22. An ablative apparatus for non-thermal tissue ablation, said apparatus comprising a skin-penetrating component configured to provide an ablated tissue portion comprising a serrated cross-sectional dimension.

24. An ablative apparatus for non-thermal tissue ablation, said apparatus comprising a skin-penetrating component 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.

29. An ablative apparatus for non-thermal tissue ablation, said apparatus comprising:

a. a skin-penetrating component comprising a drill bit comprising one or more spiral channels, a microauger comprising a spiral flange, a hollow drill bit, a tube comprising cutting teeth, and/or a spoon bit; and

b. a motor configured to rotate said component, wherein said motor is configurably attached to said component.

30. An ablative apparatus for non-thermal tissue ablation, said apparatus comprising:

a. a skin-penetrating component comprising a wire and/or a fiber having a first attachment point and a second attachment point;

b. an axle having a sharpened distal end, a center portion, and a proximal end, wherein said first attachment point of said component is configurably attached to said distal end of said axle; and

c. a motor configured to rotate said component, wherein said motor is configurably attached to said proximal end of said axle.

31. The ablative apparatus of claim 30, wherein said skin-penetrating component further comprises a second attachment point and said second attachment point of said component is configurably attached to said center portion of said axle.

32. An ablative apparatus for non-thermal tissue ablation, said apparatus comprising a skin-penetrating component comprising a plurality of cylindrical blades or a plurality of straight blades assembled in a fractional pattern.

33. The ablative apparatus of claim 32, wherein at least one of said plurality of cylindrical blades is configurably attached to an actuator for pushing the blade into the skin.

34. The ablative apparatus of claim 33, wherein said actuator is a vibrating mechanism.

35. An ablative apparatus for non-thermal tissue ablation, said apparatus comprising:

a. a skin-penetrating component comprising a high pressure fluid jet;

b. an in-flow tube configured to deliver one or more fluids to be emitted from said fluid jet; and

c. an optional out-flow tube configured to collect said one or more fluids after being emitted from said fluid jet.

36. An ablative apparatus for non-thermal tissue ablation, said apparatus comprising:

a. a skin-penetrating component comprising one or more cryoprobes and/or one or more cryoneedles;

b. a cryosource, wherein each cryoprobe and/or cryoneedle is configurably attached to said cryosource to provide cryotemperature treatment to skin; and

c. an optional insulator portion to shield regions of non-treated skin from exposure to said cryotemperature treatment, wherein said insulator portion is configurably attached to said component.

37. The ablative apparatus of claim 36, wherein said skin-penetrating component comprising two or more cryoprobes and/or one or more cryoneedles.

38. An ablative apparatus for non-thermal tissue ablation, said apparatus comprising:

(a) a skin-penetrating component comprising one or more needles, wherein each needle comprises a plurality of holes configured to deliver one or more chemical or bioactive agents to skin; and

(b) a depot comprising said one or more chemical or bioactive agents, wherein each needle is configurably attached to said depot for delivering said one or more chemical or bioactive agents.

39. The ablative apparatus of claim 38, wherein said skin-penetrating component comprising two or more needles.

40. An ablative apparatus for non-thermal tissue ablation, said apparatus comprising:

(a) a skin-penetrating component comprising one or more microelectrodes, wherein each microelectrode comprises an active electrode and a return electrode, or comprising a femtosecond laser;

(b) a generator configurably attached to each of said microelectrodes or laser; and

(c) an optional electrical insulator portion to shield regions of non-treated skin from exposure to electrical and/or thermal energy, wherein said electrical insulator portion is configurably attached to said component.

41. The ablative apparatus of claim 40, wherein said skin-penetrating component comprising two or more microelectrodes.

42. An ablative apparatus for non-thermal tissue ablation, said apparatus comprising:

(a) a skin-penetrating component comprising one or more needles, wherein each needle comprises a plurality of holes configured to deliver vacuum to skin; and

(b) a vacuum source, wherein each needle is configurably attached to said source.

43. The ablative apparatus of claim 42, wherein said skin-penetrating component comprises two or more needles.

44. The ablative apparatus of claim 42 or 43, wherein said vacuum source comprises an absolute pressure less than about 6.3 kPa.

48. A removal apparatus for removing one or more ablated tissue portion(s), said apparatus comprising:

(a) a substrate comprising a plurality of holes; and

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

49. A removal apparatus for removing one or more ablated tissue portion(s), said apparatus comprising an adhesive layer or an array of probes configured to contact each of said one or more ablated tissue portion(s).

50. A removal apparatus for removing one or more ablated tissue portion(s), said apparatus comprising:

(a) one or more needles configured to contact each of said one or more ablated tissue portion(s); and

(b) a heat source configured to deliver heat through the lumen of each needle and to each of said one or more ablated tissue portion(s).

51. The removal apparatus of claim 50, wherein said apparatus comprises two or more needles.

52. The removal apparatus of claim 50 or 51, wherein said heat source is selected from the group consisting of a laser source, a hot needle, radiofrequency, ultrasound, a heated gas, or a heated liquid.

53. A removal apparatus for removing one or more ablated tissue portion(s), said apparatus comprising:

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

(b) 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);

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

(d) a vacuum source, and

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

62. A method of treating skin comprising

(a) forming a plurality of ablated tissue portions using a 21 G needle;

and

(b) removing said plurality of ablated tissue portions, wherein 10% of said skin within a treatment area is removed.

63. The method of claim 62, wherein said plurality of ablated tissue portions are removed with a multiple needle array.

64. The method of claim 62, wherein said treating results in a reduction of skin surface area.

65. The method of claim 64, wherein said reduction in skin surface area occurs in a direction orthogonal to Langer lines.