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

• US 10,016,604 B2
• Filed: 11/04/2016
• Issued: 07/10/2018
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Globus Medical, Inc.
• Inventors: Biele, Christopher, Angara, Raghavendra, Khalil, Saif
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US15/343,661
• Publication Number:
  US 20170072199A1
• Time in Patent Office: 613 Days
• 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:

a plurality of stimulation electrodes, wherein each of the stimulation electrodes are used to provide electrical pulse therapy to a spinal cord of a patient;

a plurality of leads, wherein each of the plurality of leads extends to one of the stimulation electrodes;

a lead anchor implantable into the patient, the lead anchor configured to lock one of the plurality of leads to tissue of the patient to prevent migration of a distal tip of the one of the plurality of leads, wherein the lead anchor includes a locking set screw;

an implantable pulse generator configured to be implantable into the patient and connectable to the plurality of leads, wherein the implantable pulse generator is configured to generate signals to transmit to the plurality of stimulation electrodes; and

a trial generator configured to be temporarily connectable to the plurality of leads to determine the signals generated by the implantable pulse generator

wherein the lead anchor includes a blocking set screw, positioned in the lead anchor, to prevent the locking set screw from backing out.

2. The system of claim 1, wherein the implantable pulse generator comprises a transceiver and an ASIC.

3. The system of claim 2, wherein the ASIC comprises a digital section and an analog section.

4. The system of claim 3, wherein the digital section comprises registers configured to store information relating to the electrical pulse therapy.

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

6. The system of claim 1, wherein the plurality of leads comprise percutaneous stimulation leads.

7. The system of claim 6, wherein the plurality of leads are accompanied by a suture configured to secure the one or more leads around tissue.

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

9. The system of claim 8, wherein the plurality of leads are paddle stimulation leads.

10. The system of claim 1, wherein the plurality of leads are configured to drive into a spinal canal of the patient by using a steering stylet.

11. 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;

at least one lead anchor implantable into the patient and configured to lock the one or more leads to tissue of the patient to prevent migration of a distal tip of each of the one more leads, wherein the at least one lead anchor includes a locking set screw;

an implantable pulse generator configured to be implantable into the patient and connectable to the one or more leads, wherein the implantable pulse generator is configured to generate signals to transmit to the one or more stimulation electrodes;

a charger for charging the implantable pulse generator wirelessly; and

a trial generator configured to be temporarily connectable to the one or more leads to determine the signals generated by the implantable pulse generator,

wherein the at least one lead anchor includes a blocking set screw, positioned in the at least one lead anchor, to prevent the locking set screw from backing out.

12. The system of claim 11, wherein the implantable pulse generator comprises a transceiver and an ASIC.

13. The system of claim 12, wherein the ASIC comprises a digital section and an analog section.

14. The system of claim 13, wherein the digital section comprises registers configured to store information relating to the electrical pulse therapy.

15. The system of claim 11, wherein the implantable pulse generator is recharged wirelessly via an induction coil.

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

17. The system of claim 16, wherein the one or more leads are accompanied by a suture configured to secure the one or more leads around tissue.

18. The system of claim 16, wherein the percutaneous stimulation leads are flexible.

19. The system of claim 18, wherein the one or more leads are paddle stimulation leads.

20. The system of claim 11, wherein the one or more leads are configured to drive into a spinal canal of the patient by using a steering stylet.