IP Library Granted Patent US 11,515,029
Granted Patent B2
US 11,515,029 · App. 16/988,068 · Granted Nov 29, 2022

Neuromodulation and associated systems and methods for the management of pain

Inventors: Carol Sullivan (Santa Rosa, CA); Neil Barman (Mountain View, CA); Dwayne S. Yamasaki (St. Augustine, FL)
Assignee: MEDTRONIC ARDIAN LUXEMBOURG S.A.R.L.
G16H20/30A61B5/4824A61B18/0206A61F7/12A61N2/008A61N7/00G16H20/40G16H50/30A61B5/02405A61B5/14503A61B5/4035A61B18/1492A61B2018/0022A61B2018/00345A61B2018/00434A61B2018/00791A61B2018/00839A61B2018/0212A61B2018/0262A61F7/123A61F2007/0056A61F2007/126A61N1/36021A61N7/02A61N7/022A61N2007/0026A61N2007/0043G16H10/20Y02A90/10
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Quick Facts
Patent No.
US 11,515,029
App. No.
16/988,068
Granted
Nov 29, 2022
Kind
B2
Abstract

Methods for treating and managing pain in a patient with therapeutic neuromodulation and associated systems and methods are disclosed herein. Chronic or debilitating pain can be associated, for example, with a disease or condition of the abdominal or reproductive viscera. One aspect of the present technology is directed to methods that at least partially inhibit sympathetic neural activity in nerves proximate a target blood vessel of a diseased or damaged organ of a patient experiencing pain. Targeted sympathetic nerve activity can be modulated at least along afferent pathways which can improve a measurable parameter associated with the pain of the patient The modulation can be achieved, for example, using an intravascularly positioned catheter carrying a therapeutic assembly, e.g., a therapeutic assembly configured to use electrically-induced, thermally-induced, and/or chemically-induced approaches to modulate the target sympathetic nerve.

Claims (40)

1. A method for reducing a pain level in a patient, comprising:

measuring a baseline condition of a pain parameter associated with a diagnosed disease or condition in the patient;

intravascularly positioning a neuromodulation assembly within a target blood vessel of the patient and adjacent to a target sympathetic nerve of the patient;

at least partially ablating the target sympathetic nerve using the neuromodulation assembly;

measuring a post-neuromodulation condition of the pain parameter; and

comparing the post-neuromodulation condition to the baseline condition to determine a change in the pain parameter, the change in the pain parameter providing a measurable indicator of a reduction of the pain level in the patient following treatment using the neuromodulation assembly.

2. The method of claim 1 , wherein the pain parameter is at least one of pain severity, pain quality, pain radiation pattern, pain duration, degree of pain level fluctuation, frequency of pain remissions, or level of function of the patient diagnosed with chronic pain.

3. The method of claim 1 , further comprising:

removing the neuromodulation assembly from the patient after at least partially ablating the target sympathetic nerve.

4. The method of claim 1 , wherein at least partially ablating the target sympathetic nerve using the neuromodulation assembly includes delivering energy to the target sympathetic nerve.

5. The method of claim 4 , wherein the delivered energy includes one of radio frequency energy, pulsed radio frequency energy, microwave energy, optical energy, ultrasound energy, cryotherapeutic energy, directed heat energy, chemicals, radiation or combinations thereof.

6. The method of claim 1 , wherein the pain level is associated with a diagnosed disease or condition of a pancreas, liver, biliary tract, gallbladder, spleen, stomach, small intestine, color or of an abdominal visceral artery.

7. The method of claim 1 , wherein the pain parameter is at least one of pain severity, pain quality, pain radiation pattern, pain duration, a degree of pain level fluctuation, frequency of pain remissions, or level of function of the patient diagnosed with chronic pain.

8. The method of claim 1 , further comprising:

assessing the baseline condition and the post-neuromodulation condition of the pain parameter in the patient using a pain scale.

9. The method of claim 1 , wherein the change in the pain parameter is a decrease in sympathetic nerve activity over 1 month, 2 months, 3 months, 6 months, 9 months or 12 months post-neuromodulation.

10. A method for reducing a pain level in a patient, comprising:

measuring a baseline condition of a pain parameter associated with a diagnosed disease or condition in the patient, the pain parameter being at least one of pain severity, pain quality, pain radiation pattern, pain duration, degree of pain level fluctuation, frequency of pain remissions, or level of function of the patient diagnosed with chronic pain;

intravascularly positioning a neuromodulation assembly within a target blood vessel of the patient and adjacent to a target sympathetic nerve of the patient;

at least partially ablating the target sympathetic nerve using the neuromodulation assembly;

measuring a post-neuromodulation condition of the pain parameter; and

comparing the post-neuromodulation condition to the baseline condition to determine a change in the pain parameter, the change in the pain parameter providing a measurable indicator of a reduction of the pain level in the patient following treatment using the neuromodulation assembly.

11. The method of claim 10 , further comprising:

removing the neuromodulation assembly from the patient after at least partially ablating the target sympathetic nerve.

12. The method of claim 10 , wherein at least partially ablating the target sympathetic nerve using the neuromodulation assembly includes delivering energy to the target sympathetic nerve.

13. The method of claim 12 , wherein the delivered energy includes one of radio frequency energy, pulsed radio frequency energy, microwave energy, optical energy, ultrasound energy, cryotherapeutic energy, directed heat energy, chemicals, radiation or combinations thereof.

14. The method of claim 10 , wherein at least partially ablating the target sympathetic nerve changes the post-neuromodulation condition measurement by at least 5% as compared to the baseline condition measurement.

15. The method of claim 10 , wherein at least partially ablating the target sympathetic nerve changes the post-neuromodulation condition measurement by at least 20% as compared to the baseline condition measurement within three months to 12 months following the treatment and removal of the neuromodulation assembly from the patient.

16. The method of claim 10 , wherein the pain level is associated with a diagnosed disease or condition of a pancreas, liver, biliary tract, gallbladder, spleen, stomach, small intestine, color or of an abdominal visceral artery.

17. The method of claim 10 , further comprising:

assessing the baseline condition and the post-neuromodulation condition of the pain parameter in the patient using a pain scale.

18. A method for reducing a pain level in a patient, comprising:

measuring a baseline condition of a pain parameter associated with a diagnosed disease or condition in the patient;

intravascularly positioning a neuromodulation assembly within a target blood vessel of the patient and adjacent to a target sympathetic nerve of the patient;

at least partially ablating the target sympathetic nerve by delivering energy to the target sympathetic nerve via the neuromodulation assembly;

measuring a post-neuromodulation condition of the pain parameter; and

comparing the post-neuromodulation condition to the baseline condition to determine a change in the pain parameter, the change in the pain parameter providing a measurable indicator of a reduction of the pain level in the patient following treatment using the neuromodulation assembly.

19. The method of claim 18 , wherein the pain parameter is at least one of pain severity, pain quality, pain radiation pattern, pain duration, degree of pain level fluctuation, frequency of pain remissions, or level of function of the patient diagnosed with chronic pain.

20. The method of claim 18 , further comprising:

removing the neuromodulation assembly from the patient after at least partially ablating the target sympathetic nerve.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 5, 2021
From: SULLIVAN, CAROL M.; BARMAN, NEIL C.; YAMASAKI, DWAYNE S.
To: MEDTRONIC ARDIAN LUXEMBOURG S.A.R.L.
Reel/Frame 055168/0542 →
Continuity (4)
Continuation 14379874
Provisional Application 61608579 · Mar 8, 2012
Provisional Application 61608437 · Mar 8, 2012
Related Publication 20200398085A1 · Dec 24, 2020
Cited By (14)
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