Granted Patent B2

US 12,521,161 · App. 17/140,334 · Granted Jan 13, 2026

Inventor: John Allison (Los Altos, CA)

Assignee: Pacira CryoTech, Inc.

A61B18/02A61F7/00A61B2018/00023A61B2018/00321A61B2018/00434A61B2018/00452A61B2018/0262A61B2018/0293

Abstract

Claims (36)

1 . A method for cryogenically treating a branch nerve proximal to a spine of a patient, the method comprising:

positioning a cannula to create an access site within tissue, the cannula defining a tubular member having a lumen and extending between a proximal end and a distal end of the cannula, the tissue comprising spinal tissue beneath a skin surface and a branch nerve proximal to a spine of the patient;

inserting a cryogenic probe into the lumen of the cannula, the cryogenic probe comprising a distal tip extending from an elongated body, a cryogenic treating portion, and a cooling fluid supply tube extending within the elongated body from a proximal end of the elongated body to the cryogenic treating portion;

resiliently bending a distal portion of the elongated body and cooling fluid supply tube of the cryogenic probe, wherein the distal tip of the cryogen probe comprises a balloon and an inflation lumen routed through the cryogen probe configured to deliver fluid to and inflate the balloon for forming an atraumatic tip, wherein the cryogenic probe is configured to resiliently bend at a distal portion by an angle up to 120 degrees, wherein the cryogenic probe comprises a first polymer coating and a second polymer coating, the second polymer coating for aiding in resiliency, wherein the distal portion of the elongated body includes an insulated portion on a first side of the cryogenic probe and an uninsulated portion on a second side of the cryogenic probe opposite the first side, the uninsulated portion extending along the second side of the elongated body and terminating prior to the distal tip, the uninsulated portion for forming a cooling treatment zone, wherein the cryogenic probe comprises a cladding of conductive material conductively coupled to a proximal portion of the elongated body such that a proximal portion of the cryogenic probe is configured to be stiffer than the distal portion of the cryogenic probe, such that the distal portion deflects more easily than the proximal portion;

advancing the cryogenic probe distally through the lumen of the cannula to position the cryogenic treating portion at a location adjacent to the branch nerve; and

activating the cryogenic treating portion to generate the treatment zone at the location to cause a therapeutic effect in the branch nerve.

2 . The method of claim 1 , wherein positioning the cannula further comprises:

inserting the cannula disposed over a sharpened insertion needle into the tissue; and

retracting the sharpened insertion needle after the cannula is positioned such that the needle is removed from the cannula.

3 . The method of claim 2 , wherein the distal end of the cannula is tapered and wherein positioning further comprises dilating the skin when inserting the cannula.

4 . The method of claim 1 , further comprising repeatedly moving and activating the cryogenic treating portion of the cryogenic probe such that a plurality of treatment zones are created adjacent to the branch nerve.

5 . The method of claim 4 , wherein the treating portion of the cryogenic probe is moved to the plurality of treatment zones by adjusting a depth or a rotation of the cryogenic probe, wherein the depth or rotation of the cryogenic probe is adjusted without fully retracting the cryogenic probe from the cannula.

6 . The method of claim 4 , wherein the treating portion of the cryogenic probe is moved to the plurality of treatment zones by at least partially retracting the cryogenic probe from the cannula and re-advancing the cryogenic probe at a changed probe angle through the lumen of the cannula.

7 . The method of claim 1 , wherein the distal tip of cryogenic probe is sharpened, wherein advancing the cryogenic probe distally through the lumen of the cannula further comprises penetrating tissue with a sharped distal tip of the cryogenic probe.

8 . The method of claim 1 , wherein the distal tip of cryogenic probe is blunt to minimize trauma to the tissue while advancing the cryogenic probe adjacent to the branch nerve.

9 . The method of claim 1 , wherein the cryogenic probe has a variable flexibility along the elongated body, such that a proximal portion of the cryogenic probe is configured to be stiffer than the distal portion of the cryogenic probe, such that the distal portion deflects more easily than the proximal portion.

10 . The method of claim 1 , wherein the cannula is curved such that the cryogenic probe resiliently bends while advancing through the lumen of the cannula.

11 . The method of claim 1 , wherein the cannula further comprises an annular flange disposed on an outside surface of the cannula, wherein the annular flange is configured to serve as a stop to assist in positioning the cannula.

12 . The method of claim 1 , wherein the cannula further comprises an insulated portion, wherein the insulated portion of the cannula is configured to minimize therapeutic treatment of non-target portions of the tissue.

13 . The method of claim 1 , further comprising verifying the positioning of the cryogenic treating portion of the cryogenic probe relative to the location adjacent to the branch nerve using an electro-myographic system (EMG).

14 . The method of claim 1 , wherein the cryogenic probe further comprises an electrical insulating coating disposed along the elongated body and wherein the distal tip is uninsulated.

15 . The method of claim 14 , wherein the uninsulated portion of the elongated body acts as an electrode, further comprising stimulating the branch nerve proximal to the spine with the electrode to identify the branch nerve prior to activating the cryogenic treating portion to generate a treatment zone.

16 . The method of claim 1 , further comprising verifying the positioning of the cryogenic treating portion of the cryogenic probe relative to the location adjacent to the branch nerve using ultrasound imaging.

17 . The method of claim 1 , further comprising verifying the positioning of the cryogenic treating portion of the cryogenic probe relative to the location adjacent to the branch nerve using fluoroscopy.

18 . The method of claim 1 , wherein the cryogenic probe has a size of 20 gauge or smaller.

19 . The method of claim 1 , wherein the cryogenic probe has a length greater than 30 mm.

20 . A method for cryogenically treating a branch nerve proximal to a spine of a patient, the method comprising:

identifying one or more landmarks along a skin surface relative to a spine of the patient;

applying a predetermined template to or between the identified one or more landmarks to determine a pattern for forming a treatment zone to cause a therapeutic effect in a branch nerve;

inserting a sharpened insertion needle into a tissue of the patient at a location determined by the predetermined template, the tissue comprising spinal tissue beneath the skin surface;

inserting a cannula disposed over the sharpened insertion needle so as to create an access site within the tissue to the branch nerve proximal to a spine of the patient, the cannula defining a tubular member having a lumen and extending between a proximal end and a distal end of the cannula;

retracting the sharpened insertion needle after the cannula is positioned such that the needle is removed from the cannula;

inserting a cryogenic probe into the lumen of the cannula, the cryogenic probe comprising an elongated body, a cryogenic treating portion, and a cooling fluid supply tube extending within the elongated body from a proximal end of the elongated body to the cryogenic treating portion;

resiliently bending a distal portion of the elongated body and cooling fluid supply tube of the cryogenic probe, wherein the cryogenic probe is configured to resiliently bend at a distal portion by an angle up to 120 degrees, wherein a distal tip of the cryogen probe comprises a balloon and an inflation routed through the cryogen probe configured to deliver fluid to and inflate the balloon for forming an atraumatic tip, wherein the cryogenic probe comprises a first polymer coating and a second polymer coating, the second polymer coating for aiding in resiliency, wherein the distal portion of the elongated body includes an insulated portion on a first side of the cryogenic probe and an uninsulated portion on a second side of the cryogenic probe opposite the first side, the uninsulated portion extending along the second side of the elongated body and terminating prior to a distal tip of the elongated body, the uninsulated portion for forming a cooling treatment zone;

advancing the cryogenic probe distally through the lumen of the cannula to position the cryogenic treating portion at a location adjacent to the branch nerve; and

activating the cryogenic treating portion to generate the treatment zone at the location to cause a therapeutic effect in the branch nerve.

Assignments (6)

Continuity (4)

References Cited (377)