Neuromodulation system and method for transitioning between programming modes

Patent metadata

Field	Value
Publication number	US-12533516-B2
Application number	US-202217712988-A
Country	US
Kind code	B2
Filing date	Apr 4, 2022
Priority date	Mar 15, 2013
Publication date	Jan 27, 2026
Grant date	Jan 27, 2026

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.

First claim

What is claimed is:

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 s

Assignees

• Boston Scient Neuromodulation Corp

Inventors

• Vansickle Dennis Allen
• Lee Dongchul
• Kothandaraman Sridhar
• Doan Que T
• Zhu Changfang
• Parramon Jordi
• Holley Justin
• Hershey Bradley L
• Gillespie Christopher E
• Carbunaru Rafael
• Wahab Nazim

Classifications

• A61N1/37247 Primary

  User interfaces, e.g. input or presentation means · CPC title

• A61N1/36185

  Selection of the electrode configuration · CPC title

• A61N1/36071 Primary

  Pain · CPC title

• A61N1/36164

  Sub-threshold or non-excitatory signals (non-excitatory signals to the heart A61N1/3628) · CPC title