IP Library Granted Patent US 11,839,766
Granted Patent B2
US 11,839,766 · App. 17/098,183 · Granted Dec 12, 2023

Neuromodulation system

Inventors: Mathieu Scheltienne (Eindhoven, NL); Edoardo Paoles (Eindhoven, NL); Jeroen Tol (Eindhoven, NL); Jurriaan Bakker (Eindhoven, NL)
Assignee: Onward Medical N.V.
A61N1/36062A61B34/10A61N1/0551A61N1/36067A61N1/36175G16H20/40G16H30/20A61B2017/00039A61B2017/00044A61B2034/104A61B2034/105A61B2034/107A61B2090/373A61B2090/374A61B2090/3762A61N1/36103
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Quick Facts
Patent No.
US 11,839,766
App. No.
17/098,183
Granted
Dec 12, 2023
Kind
B2
Abstract

A neuromodulation system comprising: at least one input means for inputting patient data into the neuromodulation system; at least one model calculation and building means for building a patient model, the patient model describing the anatomy and/or physiology and/or pathophysiology and the real and/or simulated reaction of the patient on a provided and/or simulated neuromodulation; at least one computation means for using the patient model (M) and calculating the impact of the provided and/or simulated neuromodulation. The present invention further relates to a method for providing neuromodulation.

Claims (27)

1. A neuromodulation system comprising:

at least one input module for inputting patient data into the neuromodulation system;

at least one model calculation and building module for building a patient model, the patient model comprising three-dimensional reconstructions of dorsal roots of the patient, the three-dimensional reconstructions coupled with electrophysiology models of multiple types of nerve fibers included in the three-dimensional reconstructions of the dorsal roots; and

at least one computation module for calculating an impact of neuromodulation by determining a difference between a target and a simulated percentage activation of nerve fibers for multiple combinations of dorsal root and nerve fiber type using the three-dimensional reconstructions and the coupled electrophysiology models.

2. The neuromodulation system according to claim 1 , wherein the system further comprises an output device for outputting at least one of pre-operative planning data, intra-operative planning data, or post-operative planning data.

3. The neuromodulation system according to claim 2 , wherein the pre-operative planning data include at least one of surgical incision placement data, optimal electrode placement data, eligibility data of the patient, and assessment data of in silico benefit for decision making.

4. The neuromodulation system according to claim 2 , wherein the intra-operative planning data include at least one intra-operative imaging data, the at least one intra-operative planning data including data acquired via a magnetic resonance imaging (MM), computed tomography (CT), Fluoroimaging, X-Ray, interventional radiology (IR), video, laser measuring, optical visualization and imaging system, real-time registration, navigation system imaging, electroencephalogram (EEG), electrocardiogram (ECG), electromyography (EMG), or mechanical feedback imaging systems.

5. The neuromodulation system according to claim 2 , wherein the post-operative planning data include at least one of a recommended electrode configuration, electrode design, plan, stimulation waveforms, or timings schedule for neuromodulation events.

6. The neuromodulation system according to claim 2 , wherein output device provides visualization of at least one of electric currents, potentials, information on location, or probability of depolarization of nerve fibers and/or neurons.

7. The system according to claim 1 , wherein the patient data is acquired via a patient data acquisition modality communicatively coupled to the input module, the patient data acquisition modality including one of a MRI, a CT, a Fluoroimaging, an X-Ray, an IR, a video, a laser measuring, an optical visualization and imaging system, a real-time registration, a navigation system imaging, an EEG, an ECG, an EMG, or a mechanical feedback imaging system.

8. The system according to claim 1 , wherein the at least one model calculation and building module or the at least one computation module is communicatively and operatively coupled to at least one of an implantable pulse generator or a spinal implant having a plurality of electrodes.

9. A method for providing neuromodulation, comprising at least the steps of:

inputting patient data of a patient;

building a patient model, the patient model comprising three-dimensional reconstructions of dorsal roots of the patient, the three-dimensional reconstructions coupled with electrophysiology models of multiple types of nerve fibers included in the three-dimensional reconstructions of the dorsal roots; and

calculating an impact of neuromodulation by determining a difference between a target and a simulated percentage activation of nerve fibers for multiple combinations of dorsal root and nerve fiber type using the three-dimensional reconstructions and the coupled electrophysiology models.

10. The method according to claim 9 , further comprising a step of outputting at least one of pre-operative planning data, intra-operative planning data or post-operative planning data.

11. The method according to claim 10 , wherein the pre-operative planning data includes at least one of surgical incision placement, optimal electrode placement, eligibility of the patient, or assessment in silico benefit for decision making.

12. The method according to claim 10 , wherein, the intra-operative planning data includes at least one intra-operative imaging data, the at least one intra-operative imaging data acquired via a MRI, a CT, a Fluoroimaging, an X-Ray, an IR, a video, a laser measuring, an optical visualization and imaging system, a real-time registration, a navigation system imaging, an EEG, an ECG, an EMG, or a mechanical feedback imaging system.

13. The method according to claim 10 wherein the post-operative planning data includes at least one recommended electrode configuration, electrode design, plan, stimulation waveforms, or timings schedule for neuromodulation events.

14. The method according to claim 9 , wherein the method further comprises outputting a visualization of at least one of electric currents; potentials; or information on:

locations of neurons or nerve fibers, or

probabilities of depolarization of neurons or nerve fibers.

15. The method according to claim 9 , further comprising determining a desired placement of a lead comprising a plurality of electrodes according to the patient model.

16. The method according to claim 9 , wherein the patient model further comprises a three-dimensional reconstruction of at least one of a spinal cord, a vertebral column, an epidural fat, a pia mater, a dura mater, a ventral root, cerebro-spinal fluid, white matter of the patient, or grey matter of the patient.

17. The method according to claim 9 , wherein the patient model further includes a model of a lead, the lead including a plurality of electrodes.

18. The method according to claim 9 , further comprising determining, according to the patient model, at least one of an electrode configuration or stimulation parameter for a nerve fiber or neuron population within a spinal cord of the patient.

19. The method according to claim 18 , wherein the stimulation parameter includes frequency, amplitude, pulse width or polarity applied to a plurality of electrodes of a lead.

Assignments (6)
SECURITY INTEREST Recorded Aug 14, 2024
From: ONWARD MEDICAL N.V.
To: RUNWAY GROWTH FINANCE CORP., AS COLLATERAL AGENT
Reel/Frame 068287/0393 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 25, 2023
From: ONWARD MEDICAL N.V.
To: ONWARD MEDICAL N.V.; ECOLE POLYTECHNIQUE FEDERALE DE LAUSANNE (EPFL); IT'IS FOUNDATION
Reel/Frame 063432/0491 →
CHANGE OF NAME Recorded May 25, 2022
From: GTX MEDICAL B.V.
To: ONWARD MEDICAL B. V.
Reel/Frame 060780/0752 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 11, 2022
From: SCHELTIENNE, MATHIEU; PAOLES, EDOARDO; TOL, JEROEN; BAKKER, JURRIAAN
To: GTX MEDICAL B.V.
Reel/Frame 059887/0818 →
CORRECTIVE ASSIGNMENT TO CORRECT THE THE TYPOGRAPHICAL ERROR THAT LISTED APPLICTION NO. 29/782, 452 INSTEAD OF APPLICATION NO. 29782,453 PREVIOUSLY RECORDED AT REEL: 058600 FRAME: 0518. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Mar 1, 2022
From: ONWARD MEDICAL B.V.
To: ONWARD MEDICAL N.V.
Reel/Frame 059280/0326 →
CHANGE OF NAME Recorded Dec 28, 2021
From: ONWARD MEDICAL B.V.
To: ONWARD MEDICAL N.V.
Reel/Frame 058600/0518 →
Priority Claims (1)
EP 19211698 · Nov 27, 2019 · regional
Continuity (1)
Related Publication 20210154475A1 · May 27, 2021
Cited By (4)
US 12,408,974 US 12,478,806 US 12,539,167 US 12,654,016