Compositions, systems, kits, and methods for neural ablation
Disclosed are compositions, devices, systems, kits, and methods for neural ablation.
1. A method for ameliorating pain in a subject in need thereof, the method comprising:
inserting an introducer cannula into the subject and positioning a distal end of the introducer cannula proximate a treatment site comprising a nerve that transmits a pain impulse;
injecting a liquid composition comprising a heat-activated biocompatible polymer through the introducer cannula and into the treatment site,
advancing an ablation probe through the introducer to a region proximate to the treatment site;
ablating the nerve with the ablation probe, thereby forming a lesion on the nerve; retracting the ablation probe;
wherein the liquid composition exhibits a viscosity of less than 1000 cP at 4° C.;
wherein upon heating to a temperature of from 40° C. to 70° C., the heat-activated biocompatible polymer forms a polymeric matrix that exhibits a viscosity of at least 25,000 cP at 37° C.; and
wherein the heat generated by the ablation probe induces the heat-activated biocompatible polymer to form the polymeric matrix at the treatment site.
2. The method of claim 1 , wherein the ablation probe comprises radiofrequency (RF) ablation probe, and the ablating step comprises applying energy using the RF probe to ablate the nerve.
3. The method of claim 1 , wherein the introducer cannula is actively or passively cooled during the ablating step, during the injecting step, or any combination thereof.
4. The method of claim 1 , wherein the polymeric matrix is a solid or gel.
5. The method of claim 1 , wherein the polymeric matrix substantially surrounds the lesion.
6. The method of claim 1 , wherein at least a portion of the polymeric matrix remains at the treatment site at least 72 hours after injection.
7. The method of claim 1 , wherein the polymeric matrix further comprises a contrast agent, and wherein the method further comprises imaging the matrix to confirm placement of the matrix at the treatment site, to monitor clearance of the matrix from the treatment site, or any combination thereof.
8. The method of claim 1 , wherein the heat-activated biocompatible polymer comprises a crosslinkable polymer and a thermally activated crosslinker.
9. The method of claim 8 , wherein the thermally activated crosslinker comprises a crosslinking agent encapsulated in a lipid vesicle.
10. The method of claim 8 , wherein the crosslinkable polymer comprises a polymer selected from the group consisting of polylactides, polyglycolides, polycaprolactones, polyanhydrides, polyamines, polyurethanes, polyesteramides, poly(alkylene oxides), polyorthoesters, polydioxanones, polyacetals, polyketals, polycarbonates, polyphosphoesters, polyoxaesters, polyorthocarbonates, polyphosphazenes, succinates, poly(malic acid), poly(amino acids), polyvinylpyrrolidone, polyethylene glycol, polydimethylsiloxanes, polyhydroxycellulose, chitin, alginates, chitosan, hyaluronic acid, and copolymers, terpolymers and mixtures thereof.
11. The method of claim 8 , wherein the crosslinkable polymer is crosslinked by the thermally activated crosslinker at a temperature of from 40° C. to 70° C.
12. A system for neural ablation comprising:
(i) a liquid composition comprising a heat-activated biocompatible polymer;
(ii) a syringe comprising
a barrel defining a volume for containing the liquid composition, a distal end of the barrel including a delivery tip; and
a plunger sized and configured to move within the volume of the barrel to convey the liquid composition through the delivery tip;
(iii) an ablation probe; and
(iv) an introducer cannula comprising a central channel sized and configured to receive the ablation probe and the delivery tip therethrough;
wherein the liquid composition exhibits a viscosity of less than 1000 cP at 4° C.; and
wherein upon heating to a temperature of from 40° C. to 70° C., the heat-activated biocompatible polymer forms a polymeric matrix that exhibits a viscosity of at least 25,000 cP at 37° C.
13. The system of claim 12 , wherein the ablation probe is an actively or passively cooled ablation probe.
14. The system of claim 12 , wherein the liquid composition is loaded in the barrel of the syringe.
15. The system of claim 12 , wherein the heat-activated biocompatible polymer comprises a crosslinkable polymer and a thermally activated crosslinker.
16. The system of claim 15 , wherein the thermally activated crosslinker comprises a crosslinking agent encapsulated in a lipid vesicle.
17. The system of claim 15 , wherein the crosslinkable polymer comprises a polymer selected from the group consisting of polylactides, polyglycolides, polycaprolactones, polyanhydrides, polyamines, polyurethanes, polyesteramides, poly(alkylene oxides), polyorthoesters, polydioxanones, polyacetals, polyketals, polycarbonates, polyphosphoesters, polyoxaesters, polyorthocarbonates, polyphosphazenes, succinates, poly(malic acid), poly(amino acids), polyvinylpyrrolidone, polyethylene glycol, polydimethylsiloxanes, polyhydroxycellulose, chitin, alginates, chitosan, hyaluronic acid, and copolymers, terpolymers and mixtures thereof.
18. The system of claim 15 , wherein the crosslinkable polymer is crosslinked by the thermally activated crosslinker at a temperature of from 40° C. to 70° C.
19. A kit for performing a neural ablation procedure comprising the system of claim 12 enclosed within sterile packaging.