IP Library Granted Patent US 10,939,947
Granted Patent B2
US 10,939,947 · App. 14/982,728 · Granted Mar 9, 2021

Dermal and transdermal cryogenic microprobe systems

Inventors: Keith Burger (San Francisco, CA); Ronald Williams (Menlo Park, CA); Lisa Elkins (Woodside, CA)
Assignee: Pacira CryoTech, Inc.
A61B18/02A61B2017/00747A61B2018/00452A61B2018/0262A61B2018/0293
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Quick Facts
Patent No.
US 10,939,947
App. No.
14/982,728
Granted
Mar 9, 2021
Kind
B2
Abstract

Medical devices, systems, and methods optionally treat dermatological and/or cosmetic defects, and/or a wide range of additional target tissues. Embodiments apply cooling with at least one small, tissue-penetrating probe, the probe often comprising a needle having a size suitable for inserting through an exposed surface of the skin of a patient without leaving a visible scar. Treatment may be applied along most or all of the insertable length of an elongate needle, optionally by introducing cryogenic cooling fluid into the needle lumen through a small, tightly-toleranced lumen of a fused silica fluid supply tube, with the supply tube lumen often metering the cooling fluid. Treatment temperature and/or time control may be enhanced using a simple pressure relief valve coupled to the needle lumen via a limited total exhaust volume space.

Claims (47)

1. A system for cryogenically treating a nerve associated with a target tissue of a patient, the system comprising:

a plurality of needles, each having a proximal end, a distal tissue penetrating end, and a needle lumen disposed between the proximal end and the distal end;

a plurality of fused silica tubes having polymer coatings, wherein the plurality of fused silica tubes are at least partially disposed together within a single tubing structure, wherein a distal end of the single tubing structure is proximal to the proximal ends of the needles and wherein the fused silica tubes are thereby bonded together by the single tubing structure proximal to the proximal ends of the needles, and wherein each of the fused silica tubes is partially disposed within the needle lumen of one of the needles; and

a cooling fluid source coupleable to the fused silica tubes to direct cooling fluid flow into the needle lumens so as to cryogenically treat the nerve after the needles penetrate the target tissue of the patient.

2. The system of claim 1 , wherein each of the needles comprises a 16 gauge or smaller in diameter needle size.

3. The system of claim 2 , wherein each of the fused silica tubes has an inner diameter of less than 100 μm.

4. The system of claim 1 , wherein an outer diameter of the polymer coatings is less than 800 μm.

5. The system of claim 1 , wherein each of the fused silica tubes extends in cantilever distally into the needle lumens.

6. The system of claim 5 , wherein each of the fused silica tubes has sufficient stiffness to inhibit flow induced buckling of the fused silica tube.

7. The system of claim 1 , wherein the cooling fluid source directs cooling fluid flow into the needle lumens so that liquid from the cooling fluid flow vaporizes within the target tissue when the needles extend into the target tissue.

8. A system for cryogenically treating a nerve associated with a target tissue of a patient, the system comprising:

a plurality of needles, each having a proximal end, a distal tissue penetrating end, and a needle lumen disposed between the proximal end and the distal end, each of the needles comprising a 16 gauge or smaller in diameter needle size;

a plurality of cooling fluid supply tubes each distally extending in cantilever into one of the needle lumens, each of the cooling fluid supply tubes comprising a fused silica tube having a polymer coating, wherein the plurality of fused silica tubes are at least partially disposed together within a single tubing structure, wherein a distal end of the single tubing structure is proximal to the proximal ends of the needles and wherein the fused silica tubes are thereby bonded together by the single tubing structure proximal to the proximal ends of the needles; and

a cooling fluid source releasably coupled to the cooling fluid supply tubes to direct cooling fluid flow into the needle lumens so that liquid from the cooling fluid flow vaporizes within the target tissue when the needles extend into the target tissue to cryogenically treat the nerve.

9. The system of claim 8 , wherein each of the needles comprises a 25 gauge or smaller in diameter needle size.

10. The system of claim 9 , wherein each of the cooling fluid supply tubes has an inner diameter of less than 100 μm.

11. The system of claim 8 , wherein an outer diameter of the polymer coatings is less than 800 μm.

12. The system of claim 8 , wherein each of the fused silica tubes has sufficient stiffness to inhibit flow induced buckling of the fused silica tube.

13. The system of claim 8 , wherein the cooling fluid source comprises a cartridge containing cooling fluid under pressure.

14. The system of claim 13 , wherein the cartridge has a capacity of 7 g to 40 g of liquid.

15. A method for cryogenically treating a nerve associated with a target tissue of a patient, the method comprising:

directing a cooling fluid flow distally within the target tissue from a cooling fluid source through a plurality of cooling fluid supply tubes, each of the fluid supply tubes partially disposed within a lumen of a plurality of needles that have been advanced distally into the target tissue, each of the cooling fluid supply tubes defined by a tubular fused silica structure having a polymer coating, wherein the plurality of fused silica tubes are at least partially disposed together within a single tubing structure, wherein a distal end of the single tubing structure is proximal to the proximal ends of the needles and wherein the fused silica tubes are thereby bonded together by the single tubing structure proximal to the proximal ends of the needles; and

cooling the target tissue by vaporizing a liquid from the cooling fluid flow within the needle lumens to cryogenically treat the nerve.

16. The method of claim 15 , wherein each of the needles that have been advanced distally into the target tissue comprises a 16 gauge or smaller in diameter needle size.

17. The method of claim 15 , wherein the tubular fused silica structure defining the cooling fluid supply tubes has an inner diameter of less than 100 μm.

18. The method of claim 15 , wherein an outer diameter of the polymer coatings is less than 800 μm.

19. The method of claim 15 , further comprising inhibiting cooling fluid flow by venting the cooling fluid so as to limit vaporization of the liquid within the needle lumens.

20. The system of claim 1 , wherein the cooling fluid flow is configured to cool the target tissue to a temperature between 0 degrees C. and −5 degrees C. to cryogenically treat the nerve.

21. The system of claim 1 , wherein the cooling fluid flow is configured to cool the target tissue to a temperature between −5 degrees C. and −15 degrees C. to cryogenically treat the nerve.

22. The system of claim 1 , wherein the cooling fluid flow is configured to cool the target tissue to a temperature from −15 degrees C. to −25 degrees C. to cryogenically treat the nerve.

23. The system of claim 1 , wherein the cooling fluid flow is configured to cool the target tissue to a temperature from −5 degrees C. to −50 degrees C. to cryogenically treat the nerve.

24. The system of claim 8 , wherein liquid from the cooling fluid flow that vaporizes within the target tissue is configured to cool the target tissue to a temperature between 0 degrees C. and −5 degrees C. to cryogenically treat the nerve.

25. The system of claim 8 , wherein liquid from the cooling fluid flow that vaporizes within the target tissue is configured to cool the target tissue to a temperature between −5 degrees C. and −15 degrees C. to cryogenically treat the nerve.

26. The system of claim 8 , wherein liquid from the cooling fluid flow that vaporizes within the target tissue is configured to cool the target tissue to a temperature from −15 degrees C. to −25 degrees C. to cryogenically treat the nerve.

27. The system of claim 8 , wherein liquid from the cooling fluid flow that vaporizes within the target tissue is configured to cool the target tissue to a temperature from −5 degrees C. to −50 degrees C. to cryogenically treat the nerve.

28. The method of claim 15 , wherein the target tissue is cooled to a temperature between 0 degrees C. and −5 degrees C. to cryogenically treat the nerve.

29. The method of claim 15 , wherein the target tissue is cooled to a temperature between −5 degrees C. and −15 degrees C. to cryogenically treat the nerve.

30. The method of claim 15 , wherein the target tissue is cooled to a temperature from −15 degrees C. to −25 degrees C. to cryogenically treat the nerve.

31. The method of claim 15 , wherein the target tissue is cooled to a temperature from −5 degrees C. to −50 degrees C. to cryogenically treat the nerve.

32. The system of claim 1 , further comprising a handpiece body supporting the plurality of needles and at least one distally oriented and articulatable skin engaging surface supported by the handpiece body, wherein the articulatable skin engaging surface is movable between a first configuration and a second configuration, the articulatable skin engaging surface disposed distally of the plurality of needles in the first configuration and the plurality of needles extending distally of the articulatable skin engaging surface in the second configuration.

33. The system of claim 8 , further comprising a handpiece body supporting the plurality of needles and at least one distally oriented and articulatable skin engaging surface supported by the handpiece body, wherein the articulatable skin engaging surface is movable between a first configuration and a second configuration, the articulatable skin engaging surface disposed distally of the plurality of needles in the first configuration and the plurality of needles extending distally of the articulatable skin engaging surface in the second configuration.

34. The method of claim 15 , further comprising articulating a skin engaging surface supported by a handpiece body from a first configuration wherein the skin engaging surface is disposed distally of the plurality of needles to a second configuration wherein the plurality of needles extend distally of the skin engaging surface prior to advancement of the plurality of needles into the target tissue.

35. The system of claim 1 , wherein the single tubing structure is a polyimide header.

36. The system of claim 1 , wherein the single tubing structure is disposed within a replaceable needle assembly housing, and wherein the single tubing structure is disposed proximally to the needle lumens.

37. The system of claim 36 , wherein the replaceable needle assembly housing further comprising a filter within the replaceable needle assembly housing, wherein the filter is disposed proximally to the single tubing structure and the needle lumens.

38. The system of claim 8 , wherein the single tubing structure is disposed within a replaceable needle assembly housing, and wherein the single tubing structure is disposed proximally to the needle lumens.

39. The system of claim 38 , wherein the replaceable needle assembly housing further comprising a filter within the replaceable needle assembly housing, wherein the filter is disposed proximally to the single tubing structure and the needle lumens.

Assignments (7)
RELEASE OF SECURITY INTEREST Recorded Dec 5, 2025
From: JPMORGAN CHASE BANK, N.A.
To: PACIRA CRYOTECH, INC.; PACIRA PHARMACEUTICALS, INC.; PACIRA THERAPEUTICS, INC. (F/K/A FLEXION THERAPEUTICS, INC.)
Reel/Frame 073779/0532 →
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENTS Recorded Mar 31, 2023
From: JPMORGAN CHASE BANK, N.A.
To: PACIRA CRYOTECH, INC.; PACIRA PHARMACEUTICALS, INC.; PACIRA THERAPEUTICS, INC. (F/K/A FLEXION THERAPEUTICS, INC.)
Reel/Frame 063213/0864 →
CONFIRMATORY GRANT OF SECURITY INTEREST IN UNITED STATES PATENTS Recorded Mar 31, 2023
From: PACIRA CRYOTECH, INC.; PACIRA PHARMACEUTICALS, INC.; PACIRA THERAPEUTICS, INC. (F/K/A FLEXION THERAPEUTICS, INC.)
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 063214/0108 →
SUPPLEMENTAL CONFIRMATORY GRANT OF SECURITY INTEREST IN UNITED STATES PATENTS Recorded Dec 14, 2021
From: PACIRA CRYOTECH, INC.; PACIRA PHARMACEUTICALS, INC.; FLEXION THERAPEUTICS, INC.
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 058516/0636 →
CONFIRMATORY ASSIGNMENT Recorded Jul 15, 2019
From: MYOSCIENCE, INC.
To: PACIRA CRYOTECH, INC.
Reel/Frame 049758/0028 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 18, 2019
From: BURGER, KEITH; WILLIAMS, RONALD; ELKINS, LISA
To: MYOSCIENCE, INC.
Reel/Frame 048627/0437 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 17, 2017
From: BURGER, KEITH; WILLIAMS, RONALD; ELKINS, LISA
To: MYOSCIENCE, INC.
Reel/Frame 044160/0373 →
Continuity (2)
Continuation 11614887 · Dec 21, 2006
Related Publication 20160183996A1 · Jun 30, 2016
Cited By (9)
US 12,369,965 US 12,484,950 US 12,514,628 US 12,514,748 US 12,551,258 US 12,551,259 US 12,558,257 US 12,611,375 US 12,697,247