Methods, systems, and devices for treating neuromas, fibromas, nerve entrapment, and/or pain associated therewith
View Patent ↗A method in which a location is determined on the skin that is proximate to a sensory nerve that is associated with a painful condition. At least one needle of a cryogenic device is inserted into the location on the skin such that the needle is proximate to the sensory nerve. The device is activated such that the at least one needle creates a cooling zone about the sensory nerve, thereby eliminating or reducing severity of the painful condition.
1. A method for treating a neuroma or nerve entrapment associated with a nerve in a limb of a patient, the method comprising:
identifying a location of pain experienced by the patient and associated with the neuroma and/or nerve entrapment;
identifying the nerve based in-part on the identified location;
positioning a distal portion of a cryogenic cooling needle having a needle lumen proximal the nerve;
delivering a treatment cycle to a target tissue with the cryogenic cooling needle, the treatment cycle comprising at least one cooling phase where cooling fluid flows into the needle lumen so that liquid from the cooling flow vaporizes within the needle lumen to provide cooling to the nerve such that the neuroma decreases in size or pain associated with the neuroma or nerve entrapment is reduced;
wherein the cryogenic cooling needle further comprises a heating element coupled with a proximal portion of the needle; and wherein the treatment cycle further comprises at least one heating phase;
providing a degree of skin warming with the heating element during the at least one heating phase; and
monitoring power draw from the heating element during the treatment cycle, wherein power draw from the heating element is used to at least one of characterize tissue type, perform diagnostics, provide feedback for a treatment algorithm, indicate a malfunction, or indicate whether the needle is incorrectly positioned.
2. The method of claim 1 , wherein the treatment cycle generates a cryozone having a cross-sectional area between 14-40 mm 2 , the cryozone being defined by a 0 ° C. isotherm.
3. The method of claim 1 , wherein the treatment cycle generates a cryozone having a volume between 65-105 mm 3 , the cryozone being defined by a 0 ° C. isotherm.
4. The method of claim 1 , wherein providing the degree of skin warming comprises providing the warming throughout the delivery of the treatment cycle.
5. The method of claim 4 , wherein the degree of skin warming comprises 20-42° C. skin warming throughout the treatment cycle.
6. The method of claim 1 , wherein the at least one heating phase comprises a pre-warm phase with the heating element before the at least one cooling phase.
7. The method of claim 6 , wherein the pre-warm phase has a duration of 8-12 seconds.
8. The method of claim 6 , wherein the at least one cooling phase has a duration of 20-65 seconds after the pre-warm phase.
9. The method of claim 8 , wherein the at least one cooling phase has a duration of less than 40 seconds, and wherein the at least one cooling phase creates a cryozone having a cross-sectional area between 14-40 mm 2 , the cryozone being defined by a 0 ° C. isotherm.
10. The method of claim 8 , wherein the at least one cooling phase has a duration of less than 40 seconds, and wherein the at least one cooling phase creates a cryozone having a volume between 65-105 mm 3 , the cryozone being defined by a 0° C. isotherm.
11. The method of claim 8 , wherein the at least one heating phase further comprises a post-warm phase.
12. The method of claim 11 , wherein the post-warm phase has a duration of 12-18 seconds and wherein the distal portion of the needle has a temperature of at least 0 ° C. at the end of the post-warm phase.
13. The method of claim 1 , wherein the needle comprises a length of 5-12 mm.
14. The method of claim 1 , further comprising comparing a duration of the treatment cycle to a threshold value and deactivating the heating element if the duration exceeds the threshold value.
15. The method of claim 1 , wherein the distal portion of the cryogenic cooling needle is thermally isolated from the proximal portion of the cryogenic cooling needle by a junction.
16. The method of claim 1 , wherein the proximal portion of the cryogenic cooling needle is constructed from a first material and the distal portion of the cryogenic cooling needle is constructed from a second material, the first material having a greater conductivity than the second material.
17. The method of claim 1 , wherein the heating element comprises a heater.
18. The method of claim 1 , further comprising a cladding on an exterior of the proximal portion of the cryogenic cooling needle, wherein the cladding has a higher thermal conductivity than the cryogenic cooling needle and the heating element is coupled with the cladding.
19. The method of claim 18 , wherein the cladding extends distally at a length of at least 2 mm along the cryogenic cooling needle.
20. The method of claim 18 , wherein the cladding comprises a layer of gold.
21. The method of claim 18 , wherein the needle further includes a second cladding on an interior of the distal portion of the cryogenic cooling needle.