IP Library Granted Patent US 11,890,472
Granted Patent B2
US 11,890,472 · App. 17/107,101 · Granted Feb 6, 2024

Selective stimulation systems and signal parameters for medical conditions

Inventors: Eyad Kishawi (San Carlos, CA); Mir A. Imran (Los Altos, CA); Brian J. Mossop (San Francisco, CA); Jeffery M. Kramer (San Francisco, CA); Richard W. O'Connor (Redwood City, CA)
Assignee: TC1 LLC
A61N1/36071A61N1/0551A61N1/37247A61N1/3616
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Quick Facts
Patent No.
US 11,890,472
App. No.
17/107,101
Granted
Feb 6, 2024
Kind
B2
Abstract

Devices, systems and methods are provided for targeted treatment of a variety of conditions, particularly conditions that are associated with or influenced by the nervous system, such as pain. Targeted treatment of such conditions is provided with minimal deleterious side effects, such as undesired motor responses or undesired stimulation of unaffected body regions. This is achieved by directly neuromodulating a target anatomy associated with the condition while minimizing or excluding undesired neuromodulation of other anatomies.

Claims (27)

1. A method of treating pain of a patient via electrical stimulation of a portion of a dorsal root ganglion of the patient, the method comprising:

positioning a lead having at least one electrode so that at least one of the at least one electrode resides in proximity to the portion of a dorsal root ganglion using an implant tool, wherein the implant tool has a curved distal end to introduce the lead from within an epidural space of the patient and through a foramen to access the dorsal root ganglion; and

operating a programmer device to control provision of a plurality of stimulating signals by a pulse generator to the at least one electrode to stimulate the dorsal root ganglion to determine optimal therapy parameters to treat the pain of the patient, wherein (1) the operating the programmer device comprises performing mapping operations to identify sets of parameters that activate distinct sub-dermatome regions associated with the dorsal root ganglion, (2) the programmer device provides a current step size that is selectable from a plurality of values, and (3) the plurality of values includes at least one current step size that is sufficiently small to permit identification of sub-dermatomal stimulation.

2. The method of claim 1 , wherein the optimal therapy parameters alleviate the pain of the patient without causing a perceptible motor response.

3. The method of claim 1 , wherein the operating the programmer device comprises determining a threshold for one or more electrode settings.

4. The method of claim 3 , wherein the threshold is configured to maintain the one or more electrode settings below an energy level for stimulation of a ventral root associated with the dorsal root ganglion.

5. The method of claim 1 , wherein the lead comprises a plurality of electrodes that includes the at least one electrode.

6. The method of claim 5 , further comprising selectively provisioning the plurality of stimulating signals via one or more electrodes of the plurality of electrodes.

7. The method of claim 5 , wherein each electrode of the plurality of electrodes is separated from at least one adjacent electrode of the plurality of electrodes by a distance.

8. A system for treating pain of a patient via electrical stimulation of a portion of a dorsal root ganglion of the patient, the system comprising:

a lead comprising at least one electrode disposed on a distal end; and

a pulse generator configured to provide a plurality of stimulating signals to the at least one electrode to stimulate the dorsal root ganglion; and

a programmer device operable to determine optimal therapy parameters to treat the pain of the patient, wherein the programmer device is configured to:

perform mapping operations to identify sets of parameters that activate distinct sub-dermatome regions associated with the dorsal root ganglion,

provide a current step size that is selectable from a plurality of values, wherein the plurality of values includes at least one current step size that is sufficiently small to permit identification of sub-dermatomal stimulation.

9. The system of claim 8 , wherein the optimal therapy parameters are configured to alleviate the pain of the patient without causing a perceptible motor response.

10. The system of claim 8 , wherein the programmer device is configured to determine a threshold for one or more electrode settings.

11. The system of claim 10 , wherein the threshold is configured to maintain the one or more electrode settings below an energy level for stimulation of a ventral root associated with the dorsal root ganglion.

12. The system of claim 8 , wherein the lead comprises a plurality of electrodes that includes the at least one electrode.

13. The system of claim 12 , wherein the pulse generator is configured to selectively provide the plurality of stimulating signals to one or more electrodes of the plurality of electrodes.

14. The system of claim 12 , wherein each electrode of the plurality of electrodes is separated from at least one adjacent electrode of the plurality of electrodes by a distance.

15. The system of claim 8 , further comprising a second lead configured to stimulate a second dorsal root ganglion of the patient.

16. The system of claim 15 , wherein the second lead is in electrical communication with the pulse generator.

17. The system of claim 8 , wherein the programmer device is configured to perform mapping operations for a second dorsal root ganglion.

18. The system of claim 17 , wherein the second dorsal root ganglion includes neural tissue for sub-dermatome regions that overlap with sub-dermatome regions of the dorsal root ganglion.

19. The system of claim 18 , wherein the sub-dermatome regions corresponding to the dorsal root ganglion and the second dorsal root ganglion include at least a lower back sub-dermatome region and a leg sub-dermatome region.

20. The system of claim 8 , wherein the programmer device is configured to automatically switch between the plurality of values for the current step size.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 18, 2023
From: ST. JUDE MEDICAL LUXEMBOURG HOLDINGS SMI S.A.R.L ("SJM LUX SMI")
To: TC1 LLC
Reel/Frame 064293/0215 →
CHANGE OF NAME Recorded Mar 25, 2022
From: SPINAL MODULATION, INC.
To: SPINAL MODULATION LLC
Reel/Frame 059510/0921 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 25, 2022
From: KISHAWI, EYAD; IMRAN, MIR A.; MOSSOP, BRIAN J.; KRAMER, JEFFERY M.; O'CONNOR, RICHARD W.
To: SPINAL MODULATION, INC.
Reel/Frame 059398/0067 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 25, 2022
From: SPINAL MODULATION LLC
To: ST. JUDE MEDICAL LUXEMBOURG HOLDINGS SMI S.A.R.L. ("SJM LUX SMI")
Reel/Frame 059398/0311 →
Continuity (7)
Continuation 16167958 · Oct 23, 2018
Continuation 15688546 · Aug 28, 2017
Continuation 15231555 · Aug 8, 2016
Continuation 14726359 · May 29, 2015
Division 12607009 · Oct 27, 2009
Provisional Application 61108836 · Oct 27, 2008
Related Publication 20210093866A1 · Apr 1, 2021