Implantable pulse generator that generates spinal cord stimulation signals for a human body

• US 10,583,291 B2
• Filed: 06/08/2018
• Issued: 03/10/2020
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Cirtec Medical Corp.
• Inventors: Biele, Christopher, Angara, Raghavendra, Khalil, Saif
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US16/003,235
• Publication Number:
  US 20180289961A1
• Time in Patent Office: 641 Days
• Field of Search: 607 46
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: A61N 2001/37294 Means for testing medical devices within the package prior to implantation

Abstract

An implantable pulse generator (IPG) that generates spinal cord stimulation signals for a human body has a programmable signal generator that can generate the signals based on stored signal parameters without any intervention from a processor that controls the overall operation of the IPG. While the signal generator is generating the signals the processor can be in a standby mode to substantially save battery power.

Claims

1. A system for spinal cord stimulation comprising:

one or more stimulation electrodes, wherein the one or more stimulation electrodes are used to provide electrical pulse therapy to a spinal cord of a patient;

one or more leads extending to the one or more stimulation electrodes;

an implantable pulse generator implantable into the patient and connected to the one or more leads, wherein the implantable pulse generator is used to generate signals to transmit to the one or more stimulation electrodes, the implantable pulse generator comprising an ASIC having a digital section and an analog section, wherein the digital section is comprised of registers for storing predetermined timing values, comparators coupled to the registers and at least one counter, and flip-flops coupled to the comparator, wherein outputs of the flip-flops generate the signals to be transmitted to the one or more stimulation electrodes;

an implantable trial generator configured to be temporarily connectable to the plurality of leads for use in developing the signals to be generated by the implantable pulse generator; and

a clinician programmer application provided on a computing device, the clinician programmer application configured to communicate with the implantable pulse generator and the implantable trial generator, the clinician programmer application further capable of setting a plurality of stimulation parameters for use in generating stimulation signals in both the implantable pulse generator and the implantable trial generator.

2. The system of claim 1, wherein the implantable pulse generator comprises a transceiver to accommodate communication with the computing device having the clinician programmer.

3. The system of claim 1, wherein the implantable pulse generator is recharged wirelessly via an induction coil.

4. The system of claim 1, wherein the one or more leads comprise percutaneous stimulation leads.

5. The system of claim 4, wherein the one or more leads are accompanied by a suture configured to secure the one or more leads around tissue.

6. The system of claim 4, wherein the percutaneous stimulation leads are flexible.

7. The system of claim 6, wherein the one or more leads are paddle stimulation leads.

8. The system of claim 1, wherein the one or more leads are configured to drive into a spinal canal of the patient by using a steering stylet.

9. A system for spinal cord stimulation comprising:

one or more stimulation electrodes, wherein the one or more stimulation electrodes are used to provide electrical pulse therapy to a spinal cord of a patient;

one or more leads extending to the one or more stimulation electrodes;

an implantable pulse generator implantable into the patient and connected to the one or more leads, wherein the implantable pulse generator is used to generate signals to transmit to the one or more stimulation electrodes the implantable pulse generator comprising a transceiver and an ASIC wherein the ASIC is comprised of a digital section and an analog section and wherein the digital section is comprised of registers for storing predetermined timing values, comparators coupled to the registers and to at least one counter, and flip-flops coupled to the comparator, wherein outputs of the flip-flops generate the signals to be transmitted to the one or more stimulation electrodes;

a charger for charging the implantable pulse generator wirelessly;

an implantable trial generator configured to be temporarily connectable to the plurality of leads for use in developing the signals to be generated by the implantable pulse generator; and

a clinician programmer application provided on a computing device, the clinician programmer application configured to communicate with the transceiver of the implantable pulse generator and the implantable trial generator through an RF communications link, the clinician programmer application further capable of setting a plurality of stimulation parameters for use in generating stimulation signals for use by the implantable pulse generator and the implantable trial generator.

10. The system of claim 9, wherein the implantable pulse generator is recharged wirelessly via an induction coil.

11. The system of claim 9, wherein the one or more leads comprise percutaneous stimulation leads.

12. The system of claim 11, wherein the one or more leads are accompanied by a suture configured to secure the one or more leads around tissue.

13. The system of claim 11, wherein the percutaneous stimulation leads are flexible.

14. The system of claim 13, wherein the one or more leads are paddle stimulation leads.

15. The system of claim 9, wherein the one or more leads are configured to drive into a spinal canal of the patient by using a steering stylet.