Pulse generating system

• US 10,252,065 B2
• Filed: 07/13/2017
• Issued: 04/09/2019
• Est. Priority Date: 07/15/2016
• Status: Active Grant

• Current Assignee: Onward Medical BV
• Original Assignee: GTX Medical B.V. (GTX medical SA)
• Inventors: Delattre, Vincent, Von Zitzewitz, Joachim, Deckers, Sjaak
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US15/649,524
• Publication Number:
  US 20180015292A1
• Time in Patent Office: 635 Days
• Field of Search: None
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/36535 controlled by body position or posture
• CPC Class Codes: A61N 1/3688 configured for switching the pacing mode, e.g. from AAI to DDD
• CPC Class Codes: A61N 1/3718 Monitoring of or protection against external electromagnetic fields or currents
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/3931 Protecting, e.g. back-up systems

Abstract

The present disclosure relates to a pulse generating system comprising a pulse generator for generating a pulse or pulses and a controller for controlling the pulse generating means, where the pulse generating system is capable to work in at least a regular mode and a safety mode, where in the regular mode the pulse generator and the controller are connected and where in the safety mode there is no connection between the pulse generator and the controller and where in the safety mode the pulse generator automatically switches to a baseline stimulation command.

Claims

1. A pulse generating system, comprising:

a pulse generator adapted to generate a pulse or pulses; and

a controller designed to be continuously connected to the pulse generator and adapted to control the pulse generator, wherein the pulse generating system is adapted to operate in at least a regular mode and a safety mode, wherein in the regular mode the pulse generator and the controller are connected and wherein in the safety mode there is no or limited connection between the pulse generator and the controller and wherein in the safety mode the pulse generator automatically switches to a baseline stimulation command, wherein the controller is connected with one or more sensors and forms a closed-loop system together with the one or more sensors.

2. The pulse generating system according to claim 1, wherein each of the controller, the pulse generator, and the one or more sensors are adapted to be attached to or implanted within a patient.

3. The pulse generating system according to claim 2, wherein in the regular mode the controller is configured to control the pulse generator by providing control commands, where the control commands are based on a sensor input by at least one sensor of the one or more sensors and wherein the pulse generator and the controller are separated from each other.

4. The pulse generating system according to claim 1, wherein the controller is adapted to communicate with the pulse generator one-way by sending control signals only.

5. The pulse generating system according to claim 1, wherein the controller is adapted to communicate with the pulse generator two-way by sending and receiving control signals and signals and wherein the baseline stimulation command for the safety mode is selected based on a last known patient orientation of a patient to which the pulse generating system is coupled.

6. The pulse generating system according to claim 1, wherein the baseline stimulation command for the safety mode is a default value set during a baseline parameterization session.

7. The pulse generating system according to claim 1, wherein the baseline stimulation command for the safety mode is set NULL by default.

8. The pulse generating system according to claim 1, wherein the pulse generating system further comprises an automatic switching unit, wherein the automatic switching unit is an electronic module contained within the controller, configured to switch automatically from the regular mode to the safety mode and vice versa.

9. The pulse generating system according to claim 8, wherein the automatic switching unit is configured to switch automatically from the regular mode to the safety mode, if a signal is received by the automatic switching unit which indicates that the controller has determined that the most adapted stimulation command to be provided by the pulse generator is the baseline stimulation command.

10. The pulse generating system according to claim 8, wherein the automatic switching unit is configured to switch automatically from the regular mode to the safety mode, if a signal is received by the automatic switching unit which indicates that the connection between the pulse generator and the controller is lost or reduced to a level below a threshold level.

11. The pulse generating system according to claim 8, wherein the automatic switching unit is configured to switch automatically from the safety mode to the regular mode, if a signal is received by the automatic switching unit which indicates that the controller has determined that the most adapted stimulation command to be provided by the pulse generator is a command different from the baseline stimulation command.

12. The pulse generating system according to claim 8, wherein the automatic switching unit is configured to switch automatically from the safety mode to the regular mode, if a signal is received by the automatic switching unit which indicates that the connection between the pulse generator and the controller is restored after it was lost or reduced.

13. The pulse generating system according to claim 1, wherein the pulse generating system further comprises a user input switching unit to switch, upon user input, from the regular mode to the safety mode and vice versa and wherein the baseline stimulation command is less than a stimulation command provided during the regular mode but greater than a NULL command.

14. The pulse generating system according to claim 1, wherein the pulse generating system further comprises a safety mode switching switch, which is configured switch the pulse generating system automatically from the regular mode to the safety mode when triggered by technical system parameters.

15. The pulse generating system according to claim 1, wherein the pulse generating system further comprises a connection bridge, which is configured to bridge the no or limited connection by replacing it with stored data, including stored data obtained by simulation.

16. A method for controlling a pulse generating system, comprising:

automatically switching between a regular mode where a controller and implantable pulse generator (IPG) of the pulse generating system are communicatively coupled with one another and the IPG provides stimulation pulses to a patient as commanded by the controller and a safety mode where the controller and the IPG are not communicatively coupled with one another and the IPG provides a baseline stimulation pulse to the patient, where the baseline stimulation pulse is pre-set and not commanded by the controller, in response to one or more conditions for switching modes, including a change in one or more of a communicative connection between the controller and the IPG, an orientation of the patient, and a power signal of the pulse generating system, wherein the controller determines the commanded stimulation pulses based on inputs from one or more sensors of the pulse generating system that are positioned on the patient and sends the determined commanded stimulation pulses to the IPG, and wherein operation in the regular mode and the communicative coupling between the controller and the IPG is maintained until one or more of the conditions for switching modes is met.

17. The method of claim 16, wherein the controller is attached to the patient and the IPG is implanted within the patient.

18. The method of claim 16, further comprising switching from the regular mode to the safety mode in response to one or more of losing the communicative connection, the change in orientation being a change in orientation from an active position to a resting position, and a low power signal of the pulse generating system.

19. The method of claim 16, further comprising switching from the safety mode to the regular mode in response to one or more of restoring the communicative connection and the change in orientation being a change in orientation from a resting position to an active position.

20. A pulse generating system, comprising:

an implantable pulse generator implanted in a patient and configured to deliver stimulation pulses to the patient via a lead containing one or more electrodes coupled to the patient;

at least one sensor positioned on the patient; and

a controller positioned on the patient and in electronic communication with each of the at least one sensor and the implantable pulse generator, the controller designed to be in continuous electronic communication with the controller, the controller including instructions stored in memory for;

determining a stimulation pulse based on an input received from the sensor;

commanding the implantable pulse generator, via sending a control signal to the implantable pulse generator, to apply the determined stimulation pulse to the patient; and

switching to applying a pre-determined, baseline stimulation pulse to the patient with the implantable pulse generator in response to one or more of losing the electronic communication between the controller and the implantable pulse generator and a lower power signal of the pulse generating system.