IP Library › Granted Patent US 12,533,516
Granted Patent B2
US 12,533,516 · App. 17/712,988 · Granted Jan 27, 2026

Neuromodulation system and method for transitioning between programming modes

Inventors: Dennis Allen Vansickle (Lancaster, CA); Dongchul Lee (Agua Dulce, CA); Sridhar Kothandaraman (Valencia, CA); Que T. Doan (West Hills, CA); Changfang Zhu (Valencia, CA); Jordi Parramon (Valencia, CA); Justin Holley (Vejle, DK); Bradley L. Hershey (Carrollton, TX); Christopher E. Gillespie (Stevenson Ranch, CA); Rafael Carbunaru (Valley Village, CA); Nazim Wahab (Valencia, CA)
Assignee: Boston Scientific Neuromodulation Corporation
A61N1/36071A61N1/36185A61N1/37247
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Quick Facts
Patent No.
US 12,533,516
App. No.
17/712,988
Granted
Jan 27, 2026
Kind
B2
Abstract

An external control device, neuromodulation system, and method of providing therapy to a patient using an implantable neuromodulator implanted within the patient. Electrical modulation energy is delivered from the neuromodulator to the patient in accordance with the pre-existing modulation program when in one of the super-threshold delivery mode and the sub-threshold delivery mode. Operation of the neuromodulator is switched to the other of the super-threshold delivery mode and the sub-threshold delivery mode. A new modulation program may be derived from a pre-existing modulation program, and the neuromodulator may deliver the electrical modulation energy to the patient in accordance with the pre-existing modulation program during the other of the super-threshold delivery mode and the sub-threshold delivery mode.

Claims (37)

1 . A neuromodulation system comprising:

an implantable neuromodulator coupled to an electrode array implanted within a patient;

an external control device for programming the implantable neuromodulator, wherein the external control device comprises:

a user interface configured for receiving at least one user input;

telemetry circuitry configured for communicating with the implantable neuromodulator; and

controller/processor circuitry configured for responding to the at least one user input by the implantable neuromodulator to deliver super-threshold modulation, including determining a super-threshold modulation parameter set for the super-threshold modulation that is effective in treating pain, determining a sub-threshold modulation parameter set for sub-threshold modulation based on the super-threshold modulation parameter set, and instructing the implantable neuromodulator to deliver the sub-threshold modulation in accordance with the sub-threshold modulation parameter set to treat the pain, wherein the super-threshold modulation parameter set and the sub-threshold modulation parameter set have different values for at least one parameter, and the at least one parameter having different values includes amplitude,

wherein the determining the sub-threshold modulation parameter set includes computing a pulse amplitude value for the sub-threshold modulation parameter set as a percentage within a range of 30% to 70% of the pulse amplitude value of the super-threshold modulation parameter set, and

wherein the implantable neuromodulator is configured to deliver the sub-threshold modulation in accordance with the sub-threshold modulation parameter set.

2 . The neuromodulation system of claim 1 , wherein the pulse amplitude value of the sub-threshold modulation parameter set is set using a perception threshold.

3 . The neuromodulation system of claim 1 , wherein the super-threshold modulation parameter set and the sub-threshold modulation parameter set have different pulse widths.

4 . The neuromodulation system of claim 1 , wherein the super-threshold modulation parameter set has a pulse width value greater than 200 μs.

5 . The neuromodulation system of claim 1 , wherein both the super-threshold modulation parameter set and the sub-threshold modulation parameter set define biphasic pulses that includes an active charge recover phase.

6 . The neuromodulation system of claim 1 , wherein the super-threshold modulation parameter set and the sub-threshold modulation parameter set provide different electrode fractionalizations.

7 . The system of claim 1 , wherein the implantable neuromodulator includes a spinal cord stimulator (SCS) configured to deliver spinal cord stimulation in accordance with the sub-threshold modulation parameter set.

8 . A method of providing therapy to a patient using a neuromodulation system that includes an external control device and an implantable neuromodulator, comprising responding to at least one user input through a user interface of the external control device to perform a process, including:

instructing the implantable neuromodulator to deliver modulation energy to the patient including determining a super-threshold modulation parameter set for the super-threshold modulation that is effective in treating pain;

determining a sub-threshold modulation parameter set for sub-threshold modulation based on the super-threshold modulation parameter set; and

instructing the implantable neuromodulator to deliver the sub-threshold modulation in accordance with the sub-threshold modulation parameter set to treat the pain, wherein the super-threshold modulation parameter set and the sub-threshold modulation parameter set have different values for at least one parameter, and the at least one parameter having different values includes amplitude,

wherein the determining the sub-threshold modulation parameter set includes computing a pulse amplitude value for the sub-threshold modulation parameter set as a percentage within a range of 30% to 70% of the pulse amplitude value of the super-threshold modulation parameter set, and

wherein the method further includes using the implantable neuromodulator to deliver the sub-threshold modulation in accordance with the sub-threshold modulation parameter set.

9 . The method of claim 8 , wherein the pulse amplitude value of the sub-threshold modulation parameter set is set using a perception threshold.

10 . The method of claim 8 , wherein both the super-threshold modulation parameter set and the sub-threshold modulation parameter set define biphasic pulses that includes an active charge recover phase.

11 . The method of claim 8 , wherein the super-threshold modulation parameter set and the sub-threshold modulation parameter set provide different electrode fractionalizations.

12 . The method of claim 8 , wherein the super-threshold modulation parameter set and the sub-threshold modulation parameter set have different pulse widths.

13 . The method of claim 8 , wherein the super-threshold modulation parameter set has a pulse width value greater than 200 μs.

14 . The method of claim 8 , wherein the implantable neuromodulator includes a spinal cord stimulator (SCS) to deliver spinal cord stimulation, the method further including using the SCS to deliver the spinal cord stimulation in accordance with the sub-threshold modulation parameter set.

15 . A non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to perform a process, comprising responding to at least one user input through a user interface to perform a process, including:

instructing a neuromodulator to deliver modulation energy to a patient including determining a super-threshold modulation parameter set for the super-threshold modulation that is effective in treating pain;

determining a sub-threshold modulation parameter set for sub-threshold modulation based on the super-threshold modulation parameter set, wherein the super-threshold modulation parameter set and the sub-threshold modulation parameter set have different values for at least one parameter, and the at least one parameter having different values includes amplitude; and

instructing the neuromodulator to deliver the sub-threshold modulation in accordance with the sub-threshold modulation parameter set to treat the pain,

wherein the determining the sub-threshold modulation parameter set includes computing a pulse amplitude value for the sub-threshold modulation parameter set as a percentage within a range of 30% to 70% of the pulse amplitude value of the super-threshold modulation parameter set, and

wherein the neuromodulator is configured to deliver the sub-threshold modulation in accordance with the sub-threshold modulation parameter set to treat the pain.

16 . The non-transitory machine-readable medium of claim 15 , wherein both the super-threshold modulation parameter set and the sub-threshold modulation parameter set define biphasic pulses that includes an active charge recover phase.

17 . The non-transitory machine-readable medium of claim 15 , wherein the super-threshold modulation parameter set and the sub-threshold modulation parameter set provide different electrode fractionalizations.

18 . The non-transitory machine-readable medium of claim 15 , wherein the super-threshold modulation parameter set and the sub-threshold modulation parameter set have different pulse widths.

19 . The non-transitory machine-readable medium of claim 15 , wherein the super-threshold modulation parameter set has a pulse width value greater than 200 μs.

20 . The non-transitory machine-readable medium of claim 15 , wherein the pulse amplitude value of the sub-threshold modulation parameter set is set using a perception threshold.

Continuity (4)
Continuation 16275892 · Feb 14, 2019
Continuation 14214752 · Mar 15, 2014
Provisional Application 61801917 · Mar 15, 2013
Related Publication 20220226655A1 · Jul 21, 2022
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