Implantable devices for thermal therapy and related methods

• US 10,179,065 B2
• Filed: 03/21/2017
• Issued: 01/15/2019
• 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): Philogene, Pedro
• Assistant Examiner(s): Comstock, David C
• Application Number:
  US15/465,046
• Publication Number:
  US 20170348146A1
• Time in Patent Office: 665 Days
• Field of Search: 606246, 606279, 606 27- 31, 607 96-114
• CPC Class Codes: A61B 2018/00339 Spine, e.g. intervertebral disc
• CPC Class Codes: A61F 2007/0018 Trunk or parts thereof
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0055 of gas, e.g. hot air or steam
• CPC Class Codes: A61F 2007/0059 with an open fluid circuit
• CPC Class Codes: A61F 2007/0075 using a Peltier element, e.g. near the spot to be heated or cooled
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities

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 a malleable or deformable thermal device in proximity to the targeted tissue. 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. The thermal device can be connectionless or can include penetrable regions, pre-attached tubing, or detachable connectors to facilitate application of cooling or heating means to the device. Methods are disclosed for utilizing thermal devices and for carrying out various treatment regimens that involve cooling or heating tissue using such devices.

Claims

1. A method of applying thermal therapy to tissue, the method comprising:

forming a tissue opening in a patient to access a target site within the patient;

performing a laminectomy to expose a posterior surface of the spinal cord dura mater;

passing a thermal device comprising a malleable pad through the tissue opening;

placing the thermal device at the target site;

closing the tissue opening with the thermal device at the target site; and

after closing the tissue opening, applying or continuing to apply thermal therapy to the target site through the thermal device.

2. The method of claim 1, further comprising installing one or more spinal fixation implants prior to closing the tissue opening.

3. The method of claim 1, wherein placing the thermal device comprises conforming a malleable outer membrane of the thermal device to the target site.

4. The method of claim 1, wherein the target site is spinal cord dura mater.

5. The method of claim 4, wherein the thermal device is placed on the exposed posterior surface of the spinal cord dura mater.

6. A method of applying thermal therapy to tissue, the method comprising:

forming a tissue opening in a patient to access a target site within the patient, wherein the target site is spinal cord dura mater;

performing a laminectomy to expose a posterior surface of the spinal cord dura mater;

passing a thermal device comprising a rigid pad through the tissue opening; and

placing the thermal device at the target site and applying thermal therapy to the target site through the thermal device, wherein the target site is spinal cord dura mater.

7. The method of claim 6, further comprising installing one or more spinal fixation implants prior to closing the tissue opening.

8. The method of claim 6, wherein the thermal device is placed on the exposed posterior surface of the spinal cord dura mater.

9. The method of claim 6, wherein the thermal device has a rigid thermal transfer surface shaped to contour the spinal cord dura mater;

and placing the thermal device at the target site comprises placing the contoured rigid thermal transfer surface in contact with the spinal cord dura mater.

10. The method of claim 9, wherein the rigid thermal transfer surface is in contact with an internal fluid reservoir.

11. The method of claim 10, further comprising supplying the internal fluid reservoir with a thermal transfer fluid of a controlled temperature.