Spinal cord stimulator system

• US 9,872,986 B2
• Filed: 08/03/2016
• Issued: 01/23/2018
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Globus Medical, Inc.
• Inventors: Khalil, Saif, Angara, Raghavendra, Curtis, Miles, Biele, Christopher, Fellmeth, Daniel
• Primary Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US15/227,259
• Publication Number:
  US 20160339246A1
• Time in Patent Office: 538 Days
• Field of Search: 607 2, 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 1/36071 Pain
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• 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 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: A61N 1/3754 Feedthroughs
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Spinal cord stimulation (SCS) system having a recharging system with self alignment, a system for mapping current fields using a completely wireless system, multiple independent electrode stimulation outsources, and IPG control through software on Smartphone/mobile device and tablet hardware during trial and permanent implants. SCS system can include multiple electrodes, multiple, independently programmable, stimulation channels within an implantable pulse generator (IPG) providing concurrent, but unique stimulation fields. SCS system can include a replenishable power source, rechargeable using transcutaneous power transmissions between antenna coil pairs. An external charger unit, having its own rechargeable battery, can charge the IPG replenishable power source. A real-time clock can provide an auto-run schedule for daily stimulation. A bi-directional telemetry link informs the patient or clinician the status of the system, including the state of charge of the IPG battery. Other processing circuitry in current IPG allows electrode impedance measurements to be made.

Claims

1. An implantable pulse generator configured to produce electrical stimulation pulses to the spinal cord, said implantable pulse generator comprising:

a lead contact assembly configured to deliver the electrical stimulation pulses to a plurality of stimulation electrodes, wherein each of the plurality of stimulation electrodes provide stimulation to an epidural space of a patient, wherein each of the plurality of stimulation electrodes are grouped into one or more channels, and wherein each channel comprises at least two stimulation electrodes; and

a circuit board comprising an application specific integrated circuit (ASIC) and a microcontroller, the microcontroller in communication with the application specific integrated circuit;

wherein the application specific integrated circuit comprises arbitration control configured to analyze timing generator envelope signals and permits only one signal to be active at a time in order to provide one active channel among the one or more channels, and

wherein the application specific integrated circuit receives a first clock from the microcontroller for internal digital circuitry of the ASIC and receives a second clock from which the electrical stimulation pulses are based.

2. The implantable pulse generator of claim 1, wherein the circuit board comprises a communication device.

3. The implantable pulse generator of claim 2, wherein the communication device is a wireless dongle.

4. The implantable pulse generator of claim 2, wherein the communication device is configured to operate in the 402 MHz to 405 MHz range utilizing up to 10 channels for telemetry.

5. The implantable pulse generator of claim 1, further comprising a rechargeable battery comprised of an implantable grade lithium ion battery having zero-volt technology wherein the battery is configured to be inductively charged via an external charger.

6. The implantable pulse generator of claim 1, further comprising the plurality of stimulation electrodes.

7. The implantable pulse generator of claim 6, wherein the plurality of stimulation electrodes are grouped in stimulation sets, each stimulation set programmable with different stimulation parameters.

8. The implantable pulse generator of claim 1, wherein the application specific integrated circuit further comprises a pulse burst conditioner.

9. The implantable pulse generator of claim 8, wherein the pulse burst conditioner is configured to output a bursted bi-phasic pulse train and the timing generator generates rising and falling edge triggers for each phase of the bi-phasic pulse.

10. The implantable pulse generator of claim 9, wherein the application specific integrated circuit further comprises an analog section that is configured to analyze the bi-phasic pulse and convert it to an analog signal outputted to one of the plurality of stimulation electrodes.

11. The implantable pulse generator of claim 1, wherein the implantable pulse generator is configured to communicate with a clinician programmer application provided on a computing device, and wherein the clinician programmer application is configured to perform all data processing functions and transmit operational data only to the microcontroller.

12. The implantable pulse generator of claim 5, wherein the rechargeable battery is recharged by a voltage doubler full wave rectifier that is configured to convert an induced AC voltage into usable DC voltage.

13. The implantable pulse generator of claim 5, wherein a primary coil of an external charger is electronically coupled to a secondary coil of the implantable pulse generator to resonant at a common frequency during recharging of the rechargeable battery.

14. The implantable pulse generator of claim 13, wherein an alignment sensor associated with the implantable pulse generator denotes when the primary charging coil and the secondary charging coil are properly aligned, and wherein the alignment sensor is configured to provide feedback to indicate alignment.

15. The implantable pulse generator of claim 1, further comprising a casing having a header.

16. The implantable pulse generator of claim 1, wherein the circuit board further comprises a plurality of output capacitors.

17. The implantable pulse generator of claim 1, further comprising a feedthrough having pins that connect to the circuit board.

18. The implantable pulse generator of claim 1, further comprising a RF antenna.

19. The implantable pulse generator of claim 1, wherein the application specific integrated circuit further comprises a digital section and an analog section.

20. The implantable pulse generator of claim 19, wherein the digital section comprises digital elements, timing generators, a plurality of comparators, the arbitration control, pulse burst conditioner, and electrode logic, and wherein the analog section comprises field effect transistors and a plurality of digital-to-analog convertors.