Spinal cord stimulator system

• US 10,335,597 B2
• Filed: 06/08/2018
• Issued: 07/02/2019
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Cirtec Medical Corp.
• Inventors: Khalil, Saif, Angara, Raghavendra, Curtis, Miles, Biele, Christopher, Fellmeth, Daniel
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US16/003,251
• Publication Number:
  US 20180289962A1
• Time in Patent Office: 389 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 1/36071 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 outsource, 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. A method of providing electrical pulse therapy to patient via an implantable spinal cord stimulation device, comprising the steps of:

providing an implantable pulse generator with a microcontroller and an application specific integrated circuit (ASIC), wherein the ASIC comprises a digital circuit and an analog circuit;

receiving one or more commands sent by an external remote at a transceiver within the implantable pulse generator and transmitting the one or more commands to the microcontroller;

receiving, by the ASIC data representing the one more commands;

performing, by the digital circuit of the ASIC, signal processing in accordance with the one or more commands to generate one or more corresponding signals for the electrical pulse therapy, wherein the corresponding signals include timing information for the electrical pulse therapy; and

delivering the one or more signals for the electrical pulse therapy to an epidural space of a patient as directed by the analog circuit of the ASIC.

2. The method of claim 1, wherein the step of providing the implantable pulse generator further includes a step of providing a circuit assembly housed in a casing, the circuit assembly including a plurality of output capacitors positioned within the implantable pulse generator.

3. The method of claim 2, wherein the digital circuit further comprises a plurality of timing generators and an arbitrator and wherein the signal processing comprises the arbitrator suppressing activity from one or more of the timing generators when one or more of the timing generators are active.

4. The method of claim 1, wherein the step of providing the implantable pulse generator further includes a step of providing at least one rechargeable implantable battery which is housed in a casing and operably connected with the ASIC and the microcontroller.

5. The method of claim 4, further comprising charging the implantable pulse generator via an external charger including a primary charging coil and at least one battery.

6. The method of claim 5, wherein the step of providing the implantable pulse generator further comprises providing a circuit board operably connected with the primary charging coil and the at least one rechargeable battery.

7. The method of claim 6, further comprising recharging the implantable pulse generator, via the at least one rechargeable battery, using transcutaneous power transmissions between the primary charging coil and a secondary charging coil disposed in the implantable pulse generator.

8. The method of claim 1, wherein the signal processing by the provided ASIC comprises the digital circuit developing the timing information, and wherein delivering the one or more signals comprises the analog circuit providing amplitude information in response to information provided by the microcontroller.

9. The method of claim 1, further comprising generating a high speed burst pulse.

10. The method of claim 9, further comprising combining the high speed burst pulse with a stimulation pulse to generate a bursted bi-phasic pulse train, and wherein delivering the one or more signals for electrical pulse therapy comprises delivering the bursted bi-phasic pulse train.

11. A method of providing electrical pulse therapy to patient via an implantable spinal cord stimulation device, comprising the steps of:

providing an implantable pulse generator with a circuit assembly, wherein the circuit assembly includes a microcontroller and an application specific integrated circuit (ASIC) and wherein the ASIC comprises a digital circuit and an analog circuit;

receiving one or more commands sent by an external remote at a transceiver within the implantable pulse generator and transmitting the one or more commands to the microcontroller;

receiving, by the ASIC, digital data representing the one more commands;

performing, by the digital circuit of the ASIC, signal processing in accordance with the one or more commands to generate one or more corresponding signals for the electrical pulse therapy, wherein the corresponding signals include timing information for the electrical pulse therapy; and

positioning electrodes on a patient in an epidural space,

delivering the one or more signals for the electrical pulse therapy to an epidural space of a patient, as directed by the analog circuit of the ASIC,

wherein the electrical pulse therapy is delivered by one or more electrodes disposed in the epidural space.

12. The method of claim 11, further comprising providing a casing to house the circuit assembly and wherein the circuit assembly includes a plurality of output capacitors.

13. The method of claim 12, wherein the digital circuit further comprises a plurality of timing generators and an arbitrator, and wherein the signal processing comprises the arbitrator suppressing activity from one or more of the timing generators when one or more of the timing generators are active.

14. The method of claim 13, wherein the method comprises the step of providing at least one rechargeable implantable battery is housed in the casing and operably connected with the circuit assembly.

15. The method of claim 14, further comprising charging the rechargeable implantable battery via an external charger including a primary charging coil and at least one battery.

16. The method of claim 15, further comprises providing, a circuit board operably connected with the primary charging coil and the at least one rechargeable battery.

17. The method of claim 16, further comprising recharging the implantable pulse generator, via the at least one rechargeable battery, using transcutaneous power transmissions between the primary charging coil and a secondary charging coil disposed in the implantable pulse generator.

18. The method of claim 11, wherein the signal processing by the ASIC comprises the digital circuit developing the timing information, and wherein delivering the one or more signals comprises the analog circuit providing amplitude information in response to information provided by the microcontroller.

19. The method of claim 11, further comprising generating a high speed burst pulse.

20. The method of claim 19, further comprising combining the high speed burst pulse with a stimulation pulse to generate a bursted bi-phasic pulse train, and wherein delivering the one or more signals for electrical pulse therapy comprises delivering the bursted bi-phasic pulse train.