US-12623080-B2 - Neuromodulation system

US12623080B2US 12623080 B2US12623080 B2US 12623080B2US-12623080-B2

Abstract

Embodiments of the present disclosure may include a neuromodulation system. The neuromodulation system can include an implantable pulse generator configured to provide neuromodulation to a patient based on a sequence of neuromodulation programs. The implantable pulse generator can include alternately accessible memories. The alternately accessible memories can enable the implantable pulse generator to store a second neuromodulation program while providing neuromodulation according to a first neuromodulation program. The IPG can then transition from providing stimulation according to the first neuromodulation program to providing stimulation according to the second neuromodulation program without stopping stimulation. The neuromodulation system can include a parameter memory. Stimulation parameter updates can be written to the parameter memory. The value of the parameter memory can be used to determine the next stimulation pulse. The IPG can accordingly support pulse-to-pulse changes in stimulation parameters.

Inventors

Yoann Dumény

Assignees

ONWARD MEDICAL N.V.

Dates

Publication Date: 20260512
Application Date: 20230621

Claims (20)

1 . A neuromodulation system, comprising: an implantable pulse generator configured to provide neuromodulation to a patient based on a sequence of neuromodulation programs, the implantable pulse generator comprising alternately accessible memories; and wherein a second memory of the memories is configured for receiving and storing a second neuromodulation program of the sequence of neuromodulation programs while the implantable pulse generator provides neuromodulation according to a first neuromodulation program of the sequence of neuromodulation programs, the first neuromodulation program stored in a first memory of the memories.
2 . The neuromodulation system of claim 1 , wherein the sequence of neuromodulation programs is configured to enable one or more functions selected from a group consisting of postural and/or locomotor activity, upper and/or lower limb activity, voluntary voiding of the bladder and/or bowel, sexual function, autonomic control of cardiovascular function, respiratory and/or coughing function, body temperature control, and normalized metabolic processes.
3 . The neuromodulation system of claim 1 , wherein: the implantable pulse generator is further configured to receive the first neuromodulation program and the second neuromodulation program from a programmer that stores the sequence of neuromodulation programs.
4 . The neuromodulation system of claim 3 , further comprising: a controller configured to maintain a communication link with the implantable pulse generator.
5 . The neuromodulation system of claim 4 , wherein: the implantable pulse generator is further configured to cease providing the neuromodulation when the communication link fails for a period of time.
6 . The neuromodulation system of claim 5 , wherein the period of time is in a range of 0.1 second to 5 minutes.
7 . The neuromodulation system of claim 5 , wherein the period of time is in a range of 0.1 second to 60 seconds.
8 . The neuromodulation system of claim 1 , wherein: the implantable pulse generator is further configured to: receive, from the programmer, an update instruction specifying an update of a stimulation parameter; store, in a parameter memory, the update of the stimulation parameter; access, in the parameter memory during provision of the neuromodulation according to a first neuromodulation program, the update of the stimulation parameter; and provide a next pulse of the neuromodulation based on the stimulation parameter.
9 . The neuromodulation system of claim 8 , wherein the stimulation parameter comprises at least one of intensity, amplitude, pulse width, pulse ratio, electrode configuration, frequency, carrier frequency, or burst frequency.
10 . The neuromodulation system of claim 1 , wherein the second memory of the memories is configured for storing the second neuromodulation program according to a second state machine associated with the second memory, wherein: when the second state machine is in a first state, the second memory is accessible for writing the second neuromodulation program; the second state machine is in a second state when the second neuromodulation program is being written to the second memory; when the second state machine is in a third state, the second memory is accessible for reading the second neuromodulation program; and the second state machine is in a fourth state when the second neuromodulation program is being read from the second memory.
11 . The neuromodulation system of claim 10 , wherein: the second state machine transitions from the first state to the second state in response to an update request; the second state machine transitions from the second state to the third state upon completion of the update request; and the second state machine transitions from the third state to the fourth state in response to an execution request upon completion of the neuromodulation provided according to the first neuromodulation program.
12 . The neuromodulation system of claim 11 , wherein a latency between receiving an update request and providing stimulation according to the request is less than 100 millisecond.
13 . The neuromodulation system of claim 11 , wherein a latency between receiving an update request and providing stimulation according to the request is less than 50 milliseconds.
14 . The neuromodulation system of claim 10 , wherein: completion of the neuromodulation according to the first neuromodulation program depends upon a repeat value associated with the first neuromodulation program.
15 . A method for providing neuromodulation according to a sequence of neuromodulation programs, comprising: receiving, by the implantable pulse generator and during provision of neuromodulation according to a first neuromodulation program in the sequence of neuromodulation programs, the first neuromodulation program read from a first memory of the implantable pulse generator, a second neuromodulation program in the sequence of neuromodulation programs; storing, in a second memory of the implantable pulse generator, the second neuromodulation program; and providing, by the implantable pulse generator and upon completion of the provision of the neuromodulation according to the first neuromodulation program, neuromodulation according to the second neuromodulation program stored in the second memory.
16 . The method of claim 15 , wherein the first neuromodulation program and the second neuromodulation program are received from a programmer that stores the sequence of neuromodulation programs.
17 . The method of claim 15 , wherein the method further comprises: receiving, by the programmer from a user, an instruction corresponding to the sequence of neuromodulation programs; providing, by the programmer in response to the receipt of the instruction, the first neuromodulation program, and wherein the instruction enables one or more functions selected from a group consisting of postural and/or locomotor activity, upper and/or lower limb activity, voluntary voiding of the bladder and/or bowel, sexual function, autonomic control of cardiovascular function, respiratory and/or coughing function, body temperature control, and normalized metabolic processes.
18 . The method of claim 15 , wherein the method further comprises: a controller configured to maintain a communication link with the implantable pulse generator.
19 . The method of claim 15 , the method further comprises: ceasing provision of the neuromodulation, by the implantable pulse generator, when the communication link fails for a period of time.
20 . The method of claim 15 , the method further comprises: receiving, by the implantable pulse generator and during the provision of the neuromodulation according to the first neuromodulation program, an update instruction specifying an update of a stimulation parameter; storing, in a parameter memory, the update of the stimulation parameter; accessing, in the parameter memory during provision of the neuromodulation according to a first neuromodulation program, the update of the stimulation parameter; and providing, by the implantable pulse generator, a next pulse of the neuromodulation based on the stimulation parameter.

Description

TECHNICAL FIELD The disclosed systems and methods concern updating stimulation settings for neuromodulation and/or neurostimulation systems. In particular, the disclosed systems and methods concern updating stimulation programs and/or parameters without interrupting the delivery of stimulation. BACKGROUND Neuromodulation and/or neurostimulation systems can address physical or neurological injuries, diseases, or conditions of a patient by providing stimulation to the patient. Conventional neurostimulation systems can be designed to provide stimulation according to a previously programmed configuration, either continuously or in response to satisfaction of a condition. Such designs may require that stimulation be stopped prior to updating stimulation settings (electrode configurations, amplitude, frequency, etc.). SUMMARY The disclosed systems and methods relate to a stimulation updating system. The stimulation updating system can include a pulse generator (e.g., an implanted or external pulse generator) configured with alternatively accessible program memories. The pulse generator can be configured to update a second program memory with a second stimulation program without interrupting the execution of a first stimulation program stored in a first program memory. Furthermore, in some embodiments, the pulse generator can be configured to support updating at least one stimulation parameter while performing stimulation. Embodiments of the present disclosure include a neuromodulation system. The neuromodulation system can include an implantable pulse generator. The implantable pulse generator can be configured to provide neuromodulation to a patient based on a sequence of neuromodulation programs. The implantable pulse generator can include alternately accessible memories. A second memory of the alternately accessible memories can be configured for storing a second neuromodulation program while the implantable pulse generator provides neuromodulation according to a first neuromodulation program stored in a first memory of the memories. Embodiments of the present disclosure include a method for providing neuromodulation according to a sequence of neuromodulation programs. The method can include an operation of receiving a second neuromodulation program in the sequence of neuromodulation programs. The second neuromodulation program can be received by the implantable pulse generator and during provision of neuromodulation according to a first neuromodulation program in the sequence of neuromodulation programs. The first neuromodulation program can be read from a first memory of the implantable pulse generator. The method can include an operation of storing the second neuromodulation program. The second neuromodulation program can be stored in a second memory of the implantable pulse generator. The method can include an operation of providing neuromodulation according to the second neuromodulation program stored in the second memory. The neuromodulation can be provided by the implantable pulse generator and upon completion of the provision of the neuromodulation according to the first neuromodulation program. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosed embodiments, as claimed. BRIEF DESCRIPTION OF THE FIGURES The drawings are not necessarily to scale or exhaustive. Instead, emphasis is generally placed upon illustrating the principles of the embodiments described herein. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments consistent with the disclosure and, together with the description, serve to explain the principles of the disclosure. In the drawings: FIG. 1 depicts an exemplary system for providing stimulation to one or more patients, according to some embodiments of the present disclosure. FIG. 2 depicts an exemplary schematic of a pulse generator, according to some embodiments of the present disclosure. FIG. 3 depicts an exemplary process for providing updated stimulation programs without ceasing stimulation, according to some embodiments of the present disclosure. FIG. 4 depicts an exemplary process for updating stimulation parameters while a stimulation program is executing, according to some embodiments of the present disclosure. FIG. 5 depicts an exemplary logical diagram of state machines, according to some embodiments of the present disclosure. DETAILED DESCRIPTION Reference will now be made in detail to exemplary embodiments, discussed with regards to the accompanying drawings. In some instances, the same reference numbers will be used throughout the drawings and the following description to refer to the same or like parts. Unless otherwise defined, technical or scientific terms have the meaning commonly understood by one of ordinary skill in the art. The disclosed embodiments are described i