IP Library Granted Patent US 12673209
Granted Patent B2
US 12673209 · App. 18/314,624 · Granted Jul 7, 2026

Apparatus for delivering enhanced stimulation waveforms

Inventor: Lakshmi Narayan Mishra (Carlsbad, CA)
Assignee: Nalu Medical, Inc.
A61N1/36139A61N1/36178
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Quick Facts
Patent No.
US 12673209
App. No.
18/314,624
Granted
Jul 7, 2026
Kind
B2
Abstract

An apparatus for delivering stimulation energy to a patient is provided. The apparatus comprises an algorithm for determining a stimulation paradigm comprising one or more stimulation parameter settings, and an implantable system comprising an implantable device. The implantable device comprises at least one sensor for measuring evoked compound action potentials (eCAPs), muscle responses, and/or other neural responses, and multiple stimulation elements configured to deliver the stimulation energy to tissue based on the stimulation paradigm. The algorithm is configured to determine the stimulation paradigm based on the measured neural responses. Methods of delivering stimulation energy are also provided.

Claims (44)

1 . A method for treating a patient, comprising:

delivering a plurality of pulses to tissue of the patient via one or more stimulation elements of an implantable device;

measuring, via a sensor of the implantable device, a first neural response induced by a first pulse of the plurality of pulses and a second neural response induced by a second pulse of the plurality of pulses, wherein the first pulse is a discrete pulse and the second pulse is an initial pulse of a pulse train;

comparing a magnitude of the second neural response to a neural response threshold, wherein the neural response threshold is defined by a percentage of the magnitude of the first neural response; and

configuring one or more stimulation parameters of a stimulation waveform for the patient based on the comparison.

2 . The method of claim 1 further comprising measuring a neural response after each pulse of the pulse train.

3 . The method of claim 1 , wherein the neural response threshold is less than or equal to 50% of the magnitude of the first neural response.

4 . The method of claim 1 , wherein the one or more stimulation parameters comprises a number of pulses of the stimulation waveform, and wherein the configuring comprises setting the number of pulses such that a third, subsequent neural response is below the neural response threshold.

5 . The method of claim 4 further comprising adjusting a number of pulses of the pulse train to change a magnitude of the third neural response.

6 . The method of claim 1 , wherein the neural response threshold is equal to or within 20% of the magnitude of the first neural response.

7 . The method of claim 1 , wherein the one or more stimulation parameters comprise a refractory waiting period (RWP), wherein the RWP is a time period configured to allow neurons of the tissue of the patient to repolarize.

8 . The method of claim 7 , wherein configuring the one or more stimulation parameters comprises increasing the RWP.

9 . The method of claim 7 , wherein the RWP is at least 0.5 ms.

10 . The method of claim 1 , wherein an external device communicably coupled to the implantable device configures the one or more stimulation parameters.

11 . The method of claim 1 , wherein both of the first and second neural responses comprise one or both of an eCAP measurement and an EMG measurement.

12 . A method for treating a patient, comprising:

delivering energy to tissue of the patient via one or more stimulation elements of an implantable device;

measuring, via sensor of the implantable device, a plurality of neural responses induced by the delivered energy;

determining a measured neural response of the plurality of measured neural responses meets a neural response condition, wherein the neural response condition defines a threshold for a magnitude of the measured neural response; and

configuring one or more stimulation parameters of a stimulation waveform for the patient based on the determination.

13 . The method of claim 12 , wherein the energy comprises one or more pulse trains and one or more discrete pulses, wherein each pulse train comprises a plurality of pulses.

14 . The method of claim 12 , wherein delivering the energy to the tissue comprises delivering a discrete pulse and a pulse train, wherein the plurality of neural responses comprises a discrete neural response induced by the discrete pulse, wherein a first pulse of the pulse train is configured to induce the measured neural response, and wherein the threshold for the magnitude of the measured neural response is equal to a magnitude of the discrete neural response.

15 . The method of claim 12 , wherein the one or more stimulation parameters comprise a refractory waiting period (RWP), wherein the RWP is a time period configured to allow neurons of the tissue of the patient to repolarize.

16 . The method of claim 15 , wherein configuring one or more stimulation parameters comprises increasing the time period of the RWP.

17 . The method of claim 15 , wherein the RWP is at least 0 . 5 ms.

18 . The method of claim 12 , wherein the energy comprises a pulse train, and wherein measuring the plurality of neural responses comprises measuring a first neural response after a first pulse of the pulse train and a second neural response after a last pulse of the pulse train.

19 . The method of claim 18 further comprising comparing a magnitude of the second neural response to a neural response threshold and adjusting a number of pulses of the stimulation waveform based on the comparison.

20 . The method of claim 12 , wherein the implantable device comprises a trial implantable device, wherein the energy is delivered and the measured neural response is determined during a trialing session for the trial implantable device.

21 . The method of claim 20 further comprising delivering the stimulation waveform to the patient via one or both of the trial implantable device and a long-term implantable device based on the measured neural response determined with the trial implantable device.

22 . The method of claim 12 , wherein the implantable device comprises a long-term implantable device, and wherein the energy is delivered and the measured neural response is determined during an implantation procedure of the long-term device.

23 . A stimulation system for a patient, comprising:

an implantable device comprising:

one or more stimulation elements configured to deliver a plurality of pulses to tissue of the patient; and

a sensor configured to interface with the tissue of the patient and measure a first neural response induced by a first pulse of the plurality of pulses and a second neural response induced by a second pulse of the plurality of pulses, wherein the first pulse is a discrete pulse and the second pulse is an initial pulse of a pulse train; and

an external device communicably coupled to the implantable device and configured to;

compare a magnitude of the second neural response to a neural response threshold, wherein the neural response threshold is defined by a percentage of the magnitude of the first neural response; and

configure one or more stimulation parameters of a stimulation waveform for the patient based on the comparison.

24 . A stimulation system for a patient, comprising:

an implantable device comprising:

one or more stimulation elements configured to deliver stimulation energy to tissue of the patient; and

a sensor configured to interface with the tissue of the patient and measure a plurality of neural responses induced by the delivered energy; and

an external device communicably coupled to the implantable device and configured to:

determine a measured neural response of the plurality of measured neural responses meets a neural response condition, wherein the neural response condition defines a threshold for a magnitude of the measured neural response; and

configure one or more stimulation parameters of a stimulation waveform for the patient based on the determination.