Spinal cord stimulator system

• US 9,492,665 B2
• Filed: 03/14/2014
• Issued: 11/15/2016
• 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): Stice, Paula J
• Application Number:
  US14/213,186
• Publication Number:
  US 20140277263A1
• Time in Patent Office: 977 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 comprising;

a circuit board comprising a plurality of output capacitors, an application specific integrated circuit, and a microcontroller, wherein the microcontroller is operably connected with the output capacitors and the application specific integrated circuit;

a positive digital to analog convertor;

a negative digital to analog convertor wherein the positive digital to analog convertor and the negative digital to analog convertor are configured not to be active concurrently;

a secondary charging coil; and

a voltage doubler full wave rectifier configured to convert a full wave of an induced AC voltage into a usable DC voltage; and

a rechargeable implantable grade lithium ion battery configured to be inductively charged by a Constant Current, Constant Voltage type of regulation of the usable DC voltage;

a plurality of implantable stimulation electrodes, each operably connected to at least one of a plurality of implantable leads which are configured to be electrically connected to the implantable pulse generator;

an external charger having a primary charging coil configured to provide the induced AC voltage to the secondary charging coil;

a wireless communication device configured to provide communication with the implantable pulse generator via the RF antenna; and

an alignment sensor for aligning the external charger to the implantable pulse generator by measuring a reflected impedance.

2. The spinal cord stimulation device of claim 1, wherein the communication device comprises:

a clinician programmer application provided on a computing device; and

an optional patient programmer application provided on a mobile device,

at least one of which includes a wireless dongle to communicate with the RF antenna.

3. The spinal cord stimulation device of claim 2, 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.

4. The spinal cord stimulation device of claim 1, wherein the rechargeable battery has zero-volt technology.

5. 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.

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

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

8. The spinal cord stimulation device of claim 7, 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.

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

10. The spinal cord stimulation device of claim 7, wherein the arbitration control analyzes the timing generator envelope signals and permits only one signal to be active at a time.

11. The spinal cord stimulation device of claim 1, wherein the secondary charging coil and the primary charging coil are configured with capacitors so that the primary and secondary charging coils have a common resonant frequency.

12. The spinal cord stimulation device of claim 11, 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 the lead contact assembly comprises:

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.

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