Methods and devices for applying localized thermal therapy

• US 9,308,123 B2
• Filed: 09/16/2014
• Issued: 04/12/2016
• Est. Priority Date: 09/16/2013
• Status: Active Grant

• Current Assignee: Neuraxis, LLC
• Original Assignee: Neuraxis, LLC
• Inventors: Drnek, Michael, Farley, Dan, Sullivan, John
• Primary Examiner(s): Hammond, Ellen C
• Assistant Examiner(s): BRAY, STUART SAMUEL
• Application Number:
  US14/487,802
• Publication Number:
  US 20150080952A1
• Time in Patent Office: 574 Days
• Field of Search: 606250-253, 606/278, 623/17.12, 403/5, 403 30- 37, 607/113
• US Class Current: 1/1
• CPC Class Codes: A61B 17/7049 Connectors, not bearing on the vertebrae, for linking longitudinal elements together A61B17/7055, A61B17/7053, A61B17/7019 take precedence
• CPC Class Codes: A61B 17/7059 Cortical plates A61B17/7007, A61B17/7058 take precedence
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment
• CPC Class Codes: A61F 2007/0024 Back
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0059 with an open fluid circuit
• CPC Class Codes: A61F 2007/0096 with a thermometer
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element

Abstract

Methods and devices are disclosed herein that generally involve applying thermal therapy to tissue (e.g., localized cooling or heating of tissue), and in particular applying thermal therapy to the spinal canal, tissue disposed within the spinal canal, and/or nerve roots extending from the spinal canal. In some embodiments, tissue can be cooled or heated by implanting or positioning a thermal device in proximity to the targeted tissue. A number of exemplary thermal devices are disclosed, including bone anchors, inserts for use with bone anchors, K-wires, bone anchor extensions or towers, cross-connectors, spinous process plates, spinal rods, pedicle markers, bone taps, drill bits, bone plugs, bone plates, clamps, interbody or disc implants, thermal pads, and tubing loops. The thermal device can be left in place following surgery to facilitate application of post-surgical thermal therapy. In some embodiments, the thermal device can be removed post-surgery in a minimally- or non-invasive manner.

Claims

1. A thermal device, comprising:

a connector configured to couple a first spinal fixation rod to a second spinal fixation rod, the connector having a chamber formed therein, a first recess formed therein configured to receive a first spinal fixation rod such that a longitudinal axis of the first spinal fixation rod extends perpendicular to a longitudinal axis of the connector and such that the connector is fixedly attached to the first spinal fixation rod, and a second recess formed therein configured to receive a second spinal fixation rod such that a longitudinal axis of the second spinal fixation rod extends perpendicular to the longitudinal axis of the connector and such that the connector is fixedly attached to the second spinal fixation rod;

a delivery conduit extending from the connector and being configured to supply a thermal medium to the chamber; and

an exhaust conduit extending from the connector and being configured to withdraw the thermal medium from the chamber.

2. The thermal device of claim 1, wherein the chamber comprises an inflatable member.

3. The thermal device of claim 2, wherein the inflatable member is configured to expand outward from the connector when inflated with the thermal medium.

4. The device of claim 2, wherein the chamber comprises a flexible portion.

5. The thermal device of claim 1, wherein a lower surface of the connector is concave and configured to receive at least a portion of a patient'"'"'s dura therein.

6. The thermal device of claim 1, wherein the delivery and exhaust conduits are selectively detachable from the connector.

7. The thermal device of claim 1, wherein the delivery and exhaust conduits are formed by inner lumens of a multi-lumen conduit.

8. A method of applying localized thermal therapy, comprising:

coupling a connector to a first spinal fixation rod disposed on a first side of a midline of a spine of a patient and secured to a posterior portion of the spine and to a second spinal fixation rod disposed on a second, contralateral side of the midline of the spine and secured to the posterior portion of the spine such that a cavity formed in the connector is disposed over the midline of the spine and adjacent to a spinal canal of the patient; and

delivering a thermal medium to the cavity to apply a thermal effect to the spinal canal of the patient.

9. The method of claim 8, wherein delivering the thermal medium comprises supplying a heated or cooled fluid to the cavity and thereby expanding an inflatable member of the connector into contact with or into close proximity to the spinal canal.

10. The method of claim 8, wherein delivering the thermal medium comprises supplying a heated or cooled fluid to the cavity through a delivery conduit coupled to the connector and in fluid communication with the cavity.

11. The method of claim 10, further comprising closing an incision around the delivery conduit such that the delivery conduit extends out of the patient while the connector remains implanted in the patient.

12. The method of claim 11, wherein the thermal medium is delivered after closing the incision.

13. The method of claim 8, further comprising positioning the connector such that at least a portion of the patient'"'"'s spinal cord is received within a concave recess formed in a lower surface of the connector.

14. The method of claim 8, wherein the thermal medium is a liquid.

15. The method of claim 8, wherein the thermal effect comprises reducing a temperature of a portion of the spinal canal to at least 2 degrees below normothermia.

16. A method of applying localized thermal therapy, comprising:

coupling a connector to a first spinal fixation rod and to a second spinal fixation rod secured to a spine of a patient such that a cavity formed in the connector is disposed adjacent to a spinal canal of the patient;

delivering a thermal medium to the cavity to apply a thermal effect to the spinal canal of the patient, wherein delivering the thermal medium comprises supplying a heated or cooled fluid to the cavity through a delivery conduit coupled to the connector and in fluid communication with the cavity;

closing an incision around the delivery conduit such that the delivery conduit extends out of the patient while the connector remains implanted in the patient; and

decoupling the delivery conduit from the connector after closing the incision and pulling the delivery conduit through the closed incision to remove the delivery conduit from the patient.

17. The method of claim 16, wherein removing the delivery conduit comprises removing an inflatable member attached to the delivery conduit.

18. A method of applying localized thermal therapy, comprising:

coupling a connector to a first spinal fixation rod disposed on a first side of a midline of a spine of a patient and secured to a posterior portion of the spine and to a second spinal fixation rod disposed on a second, contralateral side of the midline of the spine and secured to the posterior portion of the spine such that an inflatable member coupled to the connector is disposed over the midline of the spine and adjacent to a spinal canal of the patient; and

delivering a thermal medium to the inflatable member to apply a thermal effect to the spinal canal of the patient.

19. The method of claim 18, wherein the thermal medium is delivered after closing an incision through which the connector is inserted.

20. The method of claim 19, further comprising removing the inflatable member and a delivery conduit attached thereto through the closed incision.

21. The method of claim 18, further comprising removing the inflatable member and a delivery conduit attached thereto from the connector.

22. A thermal device, comprising:

a connector configured to couple a first spinal fixation rod to a second spinal fixation rod, the connector having a first recess formed therein configured to receive a first spinal fixation rod and a second recess formed therein configured to receive a second spinal fixation rod, the connector further including a chamber formed therein;

a delivery conduit extending from the connector and being configured to supply a thermal medium to the chamber; and

an exhaust conduit extending from the connector and being configured to withdraw the thermal medium from the chamber;

wherein the chamber comprises an inflatable member configured to expand outward from the connector when inflated with the thermal medium;

wherein the inflatable member is configured to protrude through a window formed in a sidewall of the connector when inflated with the thermal medium.

23. A thermal device, comprising:

a connector configured to couple a first spinal fixation rod to a second spinal fixation rod, the connector having a first recess formed therein configured to receive a first spinal fixation rod and a second recess formed therein configured to receive a second spinal fixation rod, the connector further including a chamber formed therein;

a delivery conduit extending from the connector and being configured to supply a thermal medium to the chamber; and

an exhaust conduit extending from the connector and being configured to withdraw the thermal medium from the chamber;

wherein the chamber comprises an inflatable member configured to expand outward from the connector when inflated with the thermal medium;

wherein at least one of the delivery and exhaust conduits are attached to the inflatable member such that removing said at least one of the delivery and exhaust conduits from the thermal device is effective to remove the inflatable member from the thermal device.

24. A thermal device, comprising:

a connector configured to couple a first spinal fixation rod to a second spinal fixation rod, the connector having an inflatable member coupled thereto, a first recess formed therein configured to receive a first spinal fixation rod such that a longitudinal axis of the first spinal fixation rod extends perpendicular to a longitudinal axis of the connector and such that the connector is fixedly attached to the first spinal fixation rod, and a second recess formed therein configured to receive a second spinal fixation rod such that a longitudinal axis of the second spinal fixation rod extends perpendicular to the longitudinal axis of the connector and such that the connector is fixedly attached to the second spinal fixation rod;

a delivery conduit extending from the connector and being configured to supply a thermal medium to the inflatable member; and

an exhaust conduit extending from the inflatable member and being configured to withdraw the thermal medium from the inflatable member.