IP Library Granted Patent US 11,865,038
Granted Patent B2
US 11,865,038 · App. 17/571,307 · Granted Jan 9, 2024

Methods, systems, and devices for treating nerve spasticity

Inventors: Jwala Karnik (Santa Barbara, CA); John Allison (Los Altos, CA); Clint Carnell (Park City, UT)
Assignee: Pacira CryoTech, Inc.
A61F7/12A61B18/02A61M5/00A61N1/403A61B2018/00041A61B2018/00434A61B2018/0293A61B2018/1425A61F2007/0042A61F2007/0087A61F2007/0285A61M2202/0484A61M2210/086
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Quick Facts
Patent No.
US 11,865,038
App. No.
17/571,307
Granted
Jan 9, 2024
Kind
B2
Abstract

A method in which a nerve associated with a spasticity in a limb of a patient may be identified. The cryogenic cooling needle may be inserted through a skin surface. The cryogenic cooling needle may be positioned to a target tissue such that the distal end of the cryogenic cooling needle is proximate to the nerve by bending the needle, wherein the needle has varying stiffness at a proximal portion and a distal portion. A treatment cycle may be delivered to a target tissue proximate to the nerve, the treatment cycle may comprise a cooling phase wherein cooling fluid flows into the lumen so that liquid from the cooling fluid flow vaporizes within the lumen to provide cooling to the nerve so as to treat spasticity.

Claims (29)

1. A method for treating a spasticity in a limb of a patient, the method comprising:

inserting a cryogenic cooling needle through a skin surface, the needle comprising a proximal end, a distal end, and a lumen therebetween;

positioning the distal end of the cryogenic cooling needle within a target tissue proximate to a motor nerve associated with the spasticity in the limb of the patient by bending the needle outside a body of the patient to access the nerve along a plane of the target tissue, wherein the needle has varying stiffness at a proximal portion and a distal portion, wherein the motor nerve is in the limb of the patient; and

delivering a treatment cycle to the target tissue proximate to the nerve with the cryogenic cooling needle, the treatment cycle comprising a cooling phase wherein cooling fluid flows into the lumen so that liquid from the cooling fluid vaporizes within the lumen to provide cooling to the nerve so as to treat spasticity.

2. The method of claim 1 , wherein the needle has a variable flexibility along its length and a different bending strength at the proximal portion and distal portion such that the distal portion of the needle is more stiff than the proximal portion of the needle so that the proximal portion deflects more easily than the distal portion.

3. The method of claim 1 , wherein the needle has a variable flexibility along its length and a different bending strength at the proximal portion and distal portion such that the proximal portion of the needle is more stiff than the distal portion of the needle so that the distal portion deflects more easily than the proximal portion.

4. The method of claim 1 , wherein the varying stiffness of the needle is provided by material selection, metal tempering, or variation of wall thickness of the needle.

5. The method of claim 1 , wherein the needle is configured to resiliently bend at the distal portion by an angle up to 120 degrees.

6. The method of claim 1 , wherein the treatment cycle is controlled by a processor, at least in part based on a treatment instruction from an operator, further comprising providing an audio or visual alert to the operator by the processor.

7. The method of claim 1 , further comprising:

stopping the treatment cycle in response to an error flag, wherein the error flag is activated in response to an out of normal condition.

8. The method of claim 7 , wherein the cryogenic cooling needle comprises a temperature sensor, and wherein the out of normal condition comprises an indication of insufficient cooling based on a temperature measurement by the temperature sensor.

9. The method of claim 1 , further comprising:

measuring a temperature of the cryogenic cooling needle with a temperature sensor; and

modulating flow rate of the cooling fluid by actuating a supply valve in response to the temperature measured by the temperature sensor.

10. The method of claim 9 , wherein the supply valve is actuated by a control signal from a controller.

11. The method of claim 1 , wherein the nerve associated with the spasticity is in an upper limb of the patient.

12. The method of claim 1 , wherein positioning further comprises using specific anatomical sites of the limb of the patient to verify positioning of the needle proximate to the nerve.

13. The method of claim 1 , wherein positioning further comprises stimulating the nerve with electrical nerve stimulation to identify a location of the target tissue.

14. The method of claim 1 , wherein positioning further comprises locating the nerve using ultrasound.

15. The method of claim 1 , wherein during the cooling phase the cryogenic cooling needle probe generates a cryozone having a volume of 65-105 mm 3 .

16. The method of claim 1 , wherein the cooling phase has a duration of 5 seconds to 120 seconds.

17. The method of claim 1 , wherein the cryogenic cooling needle comprises a length of greater than 7 mm.

18. The method of claim 1 , further comprising:

positioning the distal end of the cryogenic cooling needle at a second location proximate to the nerve; and

delivering a second treatment cycle to the second location proximate to the nerve with the cryogenic cooling needle.

19. The method of claim 1 , further comprising:

thawing the target tissue to allow for safe removal of the needle to avoid physical disruption of the target tissue; and

removing the needle through the skin surface of the patient after thawing the target tissue.

Assignments (4)
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 →
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 5, 2022
From: KARNIK, JWALA; ALLISON, JOHN; CARNELL, CLINT
To: MYOSCIENCE, INC.
Reel/Frame 060735/0743 →
CONFIRMATORY ASSIGNMENT Recorded Aug 5, 2022
From: MYOSCIENCE, INC.
To: PACIRA CRYOTECH, INC.
Reel/Frame 061262/0253 →
Continuity (5)
Continuation 16132205 · Sep 14, 2018
Division 14218146 · Mar 18, 2014
Provisional Application 61801268 · Mar 15, 2013
Provisional Application 61800478 · Mar 15, 2013
Related Publication 20220125630A1 · Apr 28, 2022
Cited By (2)
US 12,458,530 US 12,551,258