Spinal cord stimulator system

• US 9,440,076 B2
• Filed: 02/05/2014
• Issued: 09/13/2016
• 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): Koharski, Christopher D
• Assistant Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US14/173,510
• Publication Number:
  US 20140277260A1
• Time in Patent Office: 951 Days
• Field of Search: 607/46
• US Class Current: 1/1
• 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 spinal cord stimulation device comprising:

an implantable pulse generator;

a plurality of implantable stimulation electrodes;

a plurality of implantable leads electrically connecting the implantable pulse generator and the optional trial implantable pulse generator to the plurality of stimulation electrodes;

an external charger having a primary charging coil;

a clinician programmer application provided on a computing device;

an optional patient programmer application provided on a mobile device; and

a communication device allowing communication between the computing device and the optional mobile device and the implantable pulse generator and the optional trial implantable pulse generator

the implantable pulse generator comprising;

a casing having an epoxy header;

a lead contact assembly;

a circuit board comprising a plurality of output capacitors, an application specific integrated circuit and a microcontroller, the microcontroller in communication with the communication device and with the application specific integrated circuit;

a rechargeable battery;

a feedthrough further comprising pins that connect to the circuit board;

a RF antenna; and

a secondary charging coil

wherein the application specific integrated circuit comprising a digital section and an analog section, wherein the digital section comprises digital elements, timing generators, a plurality of comparators, 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,

wherein the arbitration control analyzes the timing generator envelope signals and permits only one signal to be active at a time.

2. The spinal cord stimulation device of claim 1, wherein the communication device comprises a wireless dongle.

3. The spinal cord stimulation device of claim 1, wherein the communication device is configured to operate in the 402 MHz to 405 MHz range utilizing up to 10 channels for telemetry.

4. The spinal cord stimulation device of claim 1, the rechargeable battery comprised of an implantable grade lithium ion battery having zero-volt technology wherein the battery is configured to be inductively charged via the external charger.

5. The spinal cord stimulation device of claim 1, wherein the plurality of implantable stimulation electrodes are grouped in stimulation sets, each stimulation set programmable with different stimulation parameters.

6. The spinal cord stimulation device (1QQ) of claim 1, wherein the pulse burst conditioner outputs a bursted bi-phasic pulse train and the timing generator generates rising and falling edge triggers for each phase of the bi-phasic pulse.

7. The spinal cord stimulation device of claim 6, wherein the analog section is configured to analyze the bi-phasic pulse and convert it to an analog signal outputted to one of the plurality of electrodes.

8. The spinal cord stimulation device of claim 1, 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.

9. The spinal cord stimulation device of claim 4, wherein a voltage doubler full wave rectifier converts an induced AC voltage into usable DC voltage.

10. The spinal cord stimulation device of claim 4, wherein the secondary charging coil and the primary charging coil are combined with capacitors so that the primary and secondary charging coils resonant at a common frequency.

11. The spinal cord stimulation device of claim 4, further comprising an alignment sensor to denote when the primary charging coil and the secondary charging coil are properly aligned, wherein the alignment sensor is configured to provide feedback to indicate alignment.

13. The spinal cord stimulation device of claim 1, wherein stimulation parameters are input to the computing device and the optional mobile device, said stimulation parameters transmitted to the IPG via the communication device.

14. The spinal cord stimulation device of claim 1, further comprising a trial implantable pulse generator.

12. The spinal cord stimulation device comprising:

an implantable pulse generator;

a plurality of implantable stimulation electrodes;

a plurality of implantable leads electrically connecting the implantable pulse generator and the optional trial implantable pulse generator to the plurality of stimulation electrodes;

an external charger having a primary charging coil;

a clinician programmer application provided on a computing device;

an optional patient programmer application provided on a mobile device; and

a communication device allowing communication between the computing device and the optional mobile device and the implantable pulse generator and the optional trial implantable pulse generator,

the implantable pulse generator comprising;

a casing having an epoxy header;

a lead contact assembly;

a circuit board comprising a plurality of output capacitors, an application specific integrated circuit and a microcontroller, the microcontroller in communication with the communication device and with the application specific integrated circuit;

a rechargeable battery;

a feedthrough further comprising pins that connect to the circuit board;

a RF antenna; and

a secondary charging coil

a plurality of locking housings each locking housing defining an aperture, the aperture configured to accept a silicone tube and the silicone tube configured to accept the lead, and wherein the locking housing further defines a second aperture configured to accept a compression lead lock mechanism; and

a plurality of lead contacts, each lead contact separated from an adjacent lead contact by a silicone seal, wherein the lead contacts are configured in stacks of up to 8 lead contacts and each stack is connected at one end to one locking housing and wherein the lead contacts connect to the feedthrough.

15. An implantable pulse generator comprising:

a casing having a header;

a lead contact assembly;

a circuit board comprising a plurality of output capacitors, an application specific integrated circuit and a microcontroller, the microcontroller in communication with a communication device and with the application specific integrated circuit;

a rechargeable battery;

a feedthrough further comprising pins that connect to the circuit board;

a RF antenna; and

a secondary charging coil

wherein the application specific integrated circuit comprising a digital section and an analog section, wherein the digital section comprises digital elements, timing generators, a plurality of comparators, 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,

wherein the arbitration control analyzes the timing generator envelope signals and permits only one signal to be active at a time.