Methods and systems for preventing neuroma formations
View Patent ↗The present invention generally relates to improved medical devices, systems, and methods. In many embodiments, devices, systems, and methods for amputating a limb of a patient are provided. In many embodiments, devices, systems, and methods may provide chronic denervation of one or more nerves of a patient as part of a therapeutic treatment. The methods may employ cold for the prevention of neuromas or fibromas associated with amputation of a limb of a patient. Embodiments of the invention include needles that can be advanced through skin or other tissues to cause axonotmesis of a target nerve of the patient and to repeatedly interrupt a regeneration of the nerve so as to provide therapeutic chronic denervation of the target nerve. The therapeutic chronic denervation may delay the formation of neuromas or fibromas in a patient's residual limb and/or may provide long lasting and permanent pain relief associated with the target nerve.
1. A method of preventing neuroma formation in nerve tissue associated with transection of a nerve during a medical intervention, the method comprising:
identifying a nerve extending across a transection path which separates a distal portion of the nerve from a proximal portion of the nerve;
administering a first cooling therapy to the identified nerve at a location proximal to the transection path so as to degenerate the identified nerve across the transection path prior to, during, or within a predetermined time after surgical transection along the transection path to transect the identified nerve, wherein cooling the identified nerve prevents or reduces neuroma formation at a transected end of the nerve after transection of the nerve; and
selecting an interval for a repeated application of a second cooling therapy based on a distance between the location proximal to the transection path where degeneration was induced and the transection path, wherein shorter intervals are selected as the distance decreases and longer intervals are selected as the distance increases.
2. The method of claim 1 , wherein the repeated application of the second cooling therapy is configured to target a regeneration of the identified nerve at one or more locations along a length of the identified nerve and proximal to the regeneration of the nerve extending toward a location of the transection of the identified nerve.
3. The method of claim 2 , wherein the repeated application of the second cooling therapy reduces an expression of nerve growth factors.
4. The method of claim 2 , wherein the repeated application of the second cooling therapy repeatedly disrupts reinnervation, regeneration, or growth of an axon of the identified nerve thereby reducing a regenerative rate of the identified nerve so as to prevent or reduce neuroma formation.
5. The method of claim 4 , wherein the repeated application of the second cooling therapy to disrupt the reinnervation, regeneration, or growth of the identified nerve induces chronic denervation of the identified nerve.
6. The method of claim 4 , wherein the regenerative rate of the identified nerve is reduced to less than 1 mm per day.
7. The method of claim 6 , wherein the regenerative rate of the identified nerve is reduced to less than 0.5 mm per day.
8. The method of claim 1 , wherein administering the first cooling therapy to the identified nerve comprises:
positioning a needle of a cryotherapy probe across the identified nerve;
aligning visual indicia of the needle of the cryotherapy probe with the nerve, the visual indicia being indicative of a treatment area along a length of the needle; and
activating the cryotherapy probe to deliver the first cooling therapy.
9. The method of claim 8 , wherein the visual indicia comprise a marker identifying a distal end of the treatment area along the length of the needle.
10. The method of claim 8 , wherein the visual indicia comprise a marker identifying a proximal end of the treatment area along the length of the needle.
11. The method of claim 8 , wherein the visual indicia comprise a marker identifying a center of the treatment area along the length of the needle.
12. The method of claim 8 , wherein the length of the needle is at least 10 mm.
13. The method of claim 8 , wherein administering the first cooling therapy to the nerve is performed without medical imaging.
14. The method of claim 8 , wherein the length of the needle is at least 6 mm.
15. The method of claim 1 , wherein administering the first cooling therapy to the nerve comprises: positioning a needle of a cryotherapy probe along a length of the identified nerve and activating the cryotherapy probe to deliver the first cooling therapy.
16. The method of claim 1 , wherein the identified nerve is a peripheral nerve.
17. The method of claim 1 , wherein the medical intervention comprises a surgical amputation of a body extremity of a body of a patient and wherein surgically transecting along the transection path separates the body extremity from the body of the patient.
18. The method of claim 17 , wherein surgically transecting along the transection path to separate the body extremity from the body of the patient is performed after degeneration of the identified nerve across the transection path.
19. The method of claim 1 , wherein the repeated application of the second cooling therapy is configured to target a regeneration of the identified nerve at one or more locations along a length of the identified nerve, wherein the repeated application of the second cooling therapy is administered over a period of one month to three months before or after the transection of the nerve.
20. The method of claim 1 , wherein the repeated application of the second cooling therapy is configured to target a regeneration of the identified nerve at one or more locations along a length of the identified nerve, wherein the repeated application of the second cooling therapy is applied between a daily interval and a four week interval.
21. The method of claim 1 , wherein the first cooling therapy is administered after surgically transecting and within a month after transection.
22. A method of transecting a nerve extending to a target tissue, the method comprising:
degenerating a portion of the nerve by treating the nerve at a treatment location along the nerve, wherein the treatment degenerates an axon of the nerve distal to the treatment location while preserving a connective tissue framework of the nerve;
transecting the preserved connective tissue framework of the nerve at a transection location distal to the treatment location;
selecting an interval for a repeated disruption of a regeneration of the nerve based on a distance between the treatment location and the transection location, wherein shorter intervals are selected as the distance decreases and longer intervals are selected as the distance increases; and
repeatedly disrupting the regeneration of the nerve at the selected interval for a period of time so as to induce chronic denervation of the nerve, wherein the chronic denervation of the nerve reduces a regenerative rate of the nerve and delays neuroma formation at the transection location of the nerve.
23. The method of claim 22 , wherein repeatedly disrupting the regeneration of the nerve comprises repeatedly applying cooling therapy to the nerve at a location proximal to the target tissue.
24. The method of claim 23 , wherein the repeated application of cooling therapy is administered over a period of one month to three months after the transection of the nerve.
25. The method of claim 24 , wherein the repeated application of cooling therapy reduces an expression of nerve growth factors.
26. The method of claim 23 , wherein the repeated application of cooling therapy is applied between a daily interval and a four week interval.
27. The method of claim 23 , wherein the cooling therapy comprises:
positioning a needle of a cryotherapy probe across the nerve;
aligning visual indicia of the needle of the cryotherapy probe with the nerve, the visual indicia being indicative of a treatment area along a length of the needle, wherein the length of the needle is at least 6 mm; and
activating the cryotherapy probe to deliver the cooling therapy.
28. The method of claim 22 , wherein treating the nerve at the treatment location along the nerve while preserving a connective tissue framework of the nerve comprises applying thermal ablation therapy with a radiofrequency, ultrasound, microwave, or laser treatment of the nerve.
29. The method of claim 22 , wherein treating the nerve at the treatment location along the nerve while preserving a connective tissue framework of the nerve comprises applying a cooling therapy using a cryogenic cooling device.
30. The method of claim 22 , wherein the preserved connective tissue framework of the nerve is transected with a surgical amputation of a body extremity of a patient.