Spinal cord stimulator system

• US 10,512,777 B2
• Filed: 12/10/2018
• Issued: 12/24/2019
• 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:
  US16/215,454
• Publication Number:
  US 20190105497A1
• Time in Patent Office: 379 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 1/36071 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 [PG 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 spinal cord stimulation device for use in delivering therapy to an epidural space, said spinal cord stimulation device comprising:

an implantable pulse generator sized and configured to be subcutaneously implanted in a patient comprising a microcontroller, an application specific integrated circuit (ASIC) and an RF antenna, at least one battery, a charging coil to accommodate charging of the at least one battery, and a casing, wherein the RF antenna and microcontroller are operably coupled thus allowing signals received by the RF antenna to be passed to the microcontroller and the ASIC is configured to receive commands from the microcontroller which sets a plurality of stimulation parameters thereby configuring the ASIC to generate a stimulation signal without further microcontroller involvement;

a lead extending from the implantable pulse generator to carry the stimulation signal to an epidural space;

an electrode attached to the lead and configured to receive the stimulation signal and deliver the therapy into the epidural space; and

a clinician programmer application provided on a computing device, the clinician programmer application configured to communicate with the implantable pulse generator through an RF communications link which communicates with the RF antenna, the clinician programmer application further capable of sending signals which initiate the setting the plurality of stimulation parameters for use in generating stimulation signals.

2. The spinal cord stimulation device of claim 1, further comprising a communication device, the communication device comprising:

an optional patient programmer application provided on a mobile device separate from the computing device, the optional patient programmer includes a wireless dongle to communicate with the RF antenna attached to the implantable pulse generator.

3. The spinal cord stimulation device of claim 2, wherein the communication device is configured to operate in a 402 MHz to 405 MHz range utilizing up to 10 channels for telemetry.

4. The spinal cord stimulation device of claim 1, wherein the electrode is part of a plurality of implantable stimulation electrodes configured to be grouped in stimulation sets, wherein each stimulation set is programmable by the communication device with different stimulation parameters.

5. The spinal cord stimulation device of claim 4 wherein the lead comprises a paddle lead supporting a plurality of electrodes.

6. The spinal cord stimulation device of claim 1 wherein the implantable pulse generator further comprises a voltage doubler full wave rectifier configured to convert a full wave of an induced AC voltage provided to the charging coil into a usable DC voltage in order to charge the at least one battery.

7. The spinal cord stimulation device of claim 1, further comprising an external rechargeable battery not implanted in the patient configured to wireless charge the at least one battery via inductive means.

8. A spinal cord stimulation device for use in delivering therapy to an epidural space, said spinal cord stimulation device comprising:

an implantable pulse generator comprising a microcontroller and an application specific integrated circuit (ASIC), an RF Antenna, at least one battery, a charging coil to accommodate charging of the at least one battery, and a casing, wherein the microcontroller is configured to receive signals from the RF Antenna and, wherein the ASIC is configured to receive commands from the microcontroller for setting a plurality of stimulation parameters which configure the ASIC to generate one or more stimulation signals without further micro controller involvement;

a lead extending from the implantable pulse generator to carry the stimulation signals to the epidural space;

a clinician programmer application provided on a computing device, the clinician programmer application configured to communicate with the implantable pulse generator through an RF communications link in communication with the RF antenna, the clinician programmer application further capable of sending signals which initiate the setting the plurality of stimulation parameters for use in generating the one or more stimulation signals; and

a plurality of implantable electrodes attached to the lead, each implantable electrode configured to receive at least one of the stimulation signals and deliver electric stimulation into the epidural space, wherein the plurality of implantable electrodes are grouped into one or more stimulation sets,

wherein the implantable pulse generator is configured such that the stimulation sets are configurable to vary an amount of the electric stimulation to the epidural space.

9. The spinal cord stimulation device of claim 8, further comprising a communication device, the communication device comprising:

an optional patient programmer application provided on a mobile device separate from the computing device, the optional patient programmer includes a wireless dongle to communicate with the RF antenna attached to the implantable pulse generator.

10. The spinal cord stimulation device of claim 9, wherein the communication device is configured to operate in a 402 MHz to 405 MHz range utilizing up to 10 channels for telemetry.

11. The spinal cord stimulation device of claim 8, further comprising an external rechargeable battery not implanted in the patient configured to wireless charge the at least one battery via inductive means.

12. The spinal cord stimulation device of claim 8, wherein the clinician programmer application provided on a computing device is configured to perform all data processing functions and transmit operational data only to the microcontroller.

13. The spinal cord stimulation device of claim 8 wherein the lead comprises a paddle lead supporting the plurality of electrodes.

14. The spinal cord stimulation device of claim 8 wherein the implantable pulse generator further comprises a voltage doubler full wave rectifier configured to convert a full wave of an induced AC voltage provided to the charging coil into a usable DC voltage in order to charge the at least one battery.