US2022151673A1PendingUtilityA1

Methods and Systems for Preventing Neuroma Formations

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Assignee: PACIRA CRYOTECH INCPriority: Mar 12, 2015Filed: Feb 2, 2022Published: May 19, 2022
Est. expiryMar 12, 2035(~8.7 yrs left)· nominal 20-yr term from priority
A61B 2018/0293A61B 18/02A61B 2018/00434A61B 2090/3925A61B 2090/3937
66
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Claims

Abstract

In some embodiments, a method includes identifying a nerve extending across a transection path; administering a 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 or during surgical transection along the transection path, wherein cooling the identified nerve prevents or reduces neuroma formation at a transected end of the nerve after transection of the nerve. In some embodiments, a method includes degenerating a portion of a nerve while preserving a connective tissue framework of the nerve. During or after the degeneration, the preserved connective tissue framework may be transected at a transection location distal to the treatment location. The regeneration of the nerve may be repeatedly disrupted for a period of time to reduce a regenerative rate of the nerve and delay neuroma formation.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A cryotherapy probe configured to prevent neuroma formation in nerve tissue associated with transection of a nerve during a medical intervention, the cryotherapy probe comprising:
 a handle configured to be held by an operator of the probe;   a needle extending distally from the handle and having a proximal end, a distal end, and a length therebetween;   wherein the needle is configured to produce a cooling therapy zone along the length of the needle when the cryotherapy probe is activated to administer a cooling therapy to a target nerve to prevent or reduce neuroma formation in a residual limb of a patient that remains after amputation; and   wherein the needle includes at least one visible mark along the length of the needle to indicate at least one of a distal end, a proximal end, and a center of the cooling therapy zone so as to aid in alignment of the needle of the cryotherapy probe with the target nerve.   
     
     
         2 . The cryotherapy probe of  claim 1 , wherein the needle includes visible marks for each of the distal end, the proximal end, and the center of the cooling therapy zone produced when the cryotherapy probe is activated to administer the cooling therapy. 
     
     
         3 . The cryotherapy probe of  claim 1 , wherein the length of the needle is 10 cm or more. 
     
     
         4 . The cryotherapy probe of  claim 1 , wherein the distal end thereof has a blunt tip that is configured for blunt dissection of tissue of a patient. 
     
     
         5 . The cryotherapy probe of  claim 1 , wherein the distal end thereof has a sharp distal tip that is configured for piercing tissue of a patient. 
     
     
         6 . The cryotherapy probe of  claim 1 , wherein the needle further includes visible marks identifying a distance from the distal end of the needle. 
     
     
         7 . The cryotherapy probe of  claim 1 , wherein the needle comprises a coating that enhances visibility of at least a portion of the needle in ultrasound imaging. 
     
     
         8 . The cryotherapy probe of  claim 7 , wherein the coating of the needle is provided to correspond with the at least one visible mark such that visibility of at least one of the distal end, the proximal end, and the center of the cooling therapy zone is enhanced in ultrasound imaging. 
     
     
         9 . The cryotherapy probe of  claim 7 , wherein the coating of the needle is provided along the length of the needle except for at locations of the at least one visible mark. 
     
     
         10 . The cryotherapy probe of  claim 7 , wherein the coating of the needle is provided from the proximal end of the needle to a position along the length of the needle indicative of the center of the cooling therapy zone. 
     
     
         11 . The cryotherapy probe of  claim 1 , wherein the cooling therapy is configured to induce axonotmesis of the nerve such that connective tissue framework of the nerve is preserved. 
     
     
         12 . The cryotherapy probe of  claim 1 , wherein the needle is configured for insertion into a skin of a patient at a depth that is sufficient to prevent injury to the skin without requiring active heating of the skin. 
     
     
         13 . The cryotherapy probe of  claim 1 , wherein the cryotherapy probe is configured for repeated application of the cooling therapy to the target nerve. 
     
     
         14 . The cryotherapy probe of  claim 13 , wherein a treatment interval of a second cooling therapy is administered based on a distance between the cooling therapy zone and a transection path of the target nerve. 
     
     
         15 . The cryotherapy probe of  claim 14 , wherein shorter treatment intervals are selected as the distance decreases and longer treatment intervals are selected as the distance increases. 
     
     
         16 . The cryotherapy probe of  claim 1 , wherein the cooling therapy is applied to the target nerve at a location proximal to a transection path so as to degenerate the target nerve across the transection path prior to a surgical transection along the transection path to transect the target nerve. 
     
     
         17 . A cryotherapy probe configured to prevent neuroma formation in nerve tissue associated with transection of a nerve during a medical intervention, the cryotherapy probe comprising:
 a handle configured to be held by an operator of the probe;   a first needle extending distally from the handle and having a proximal end, a distal end, and a length therebetween;   wherein the first needle is configured to produce a first cooling therapy zone along the length of the first needle when the cryotherapy probe is activated to administer a cooling therapy to a target nerve to prevent or reduce neuroma formation in a residual limb of a patient that remains after amputation;   wherein the first needle includes at least one visible mark along the length of the first needle to indicate at least one of a distal end, a proximal end, and a center of the first cooling therapy zone so as to aid in alignment of the first needle of the cryotherapy probe with the target nerve;   a second needle extending distally from the handle and having a proximal end, a distal end, and a length therebetween, wherein the second needle is configured to produce a second cooling therapy zone along the length of the second needle when the cryotherapy probe is activated to administer the cooling therapy to the target nerve to prevent or reduce neuroma formation in the residual limb of the patient that remains after amputation; and   wherein the second needle includes at least one visible mark along the length of the second needle to indicate at least one of a distal end, a proximal end, and a center of the second cooling therapy zone so as to aid in alignment of the second needle of the cryotherapy probe with the target nerve.   
     
     
         18 . The cryotherapy probe of  claim 17 , wherein the second cooling therapy zone of the second needle is continuous with the first cooling therapy zone of the first needle. 
     
     
         19 . The cryotherapy probe of  claim 17 , wherein the first needle and the second needle of the cryotherapy probe are configured to be positioned on opposite sides of the target nerve such that the first cooling therapy zone of the first needle and the second cooling therapy zone of the second needle are produced on opposite sides of the target nerve. 
     
     
         20 . The cryotherapy probe of  claim 17 , wherein the first needle and the second needle are spaced apart by 2 millimeters or less.

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