US 6,516,227 B1 · Rechargeable spinal cord stimulator system

Abstract

A spinal cord stimulation (SCS) system provides multiple stimulation channels, each capable of producing up to 10 mA of current into a 1 KΩ load. The SCS system further includes a replenishable power source, e.g., a rechargeable battery, that requires only an occasional recharge, and offers a life of at least 10 years at typical settings. Each of the multiple stimulus channels of the system may be combined with other channels to deliver more than 10 mA of current. Additionally, the SCS system has the capability to stimulate simultaneously on all available channels. Each channel has at least two outputs (one positive and one negative) that can be mapped via a low impedance switching matrix to any electrode contact or the system case, thereby allowing a clinician to provide unique electrical stimulation fields for each current channel. Moreover, this feature, combined with multi-contact electrodes arranged in two or three dimensional arrays, allows “virtual electrodes” to be realized. When the system's replenishable power source is fully charged, the user may operate the SCS system independent of external controllers or power sources. The replenishable power source may be replenished using non-invasive means. The SCS system monitors the state of charge of the internal power source and controls the charging process by monitoring the amount of energy used by the SCS system, and hence the state of charge of the power source. A suitable bidirectional telemetry link allows the SCS system to inform the patient or clinician regarding the status of the system, including the state of charge, and makes requests to initiate an external charge process. Processing circuitry within the implanted portions of the system automatically controls the applied stimulation pulses as a new burst of pulses begins in order to gradually ramp up the amplitude of the pulses to a desired level. Other processing circuitry allows electrode impedance measurements to be regularly made.

Claims58

Dependent claims

A spinal cord stimulation (SCS) system comprising implantable components, external components, and surgical components;

wherein the implantable components comprise a multichannel implantable pulse generator (IPG) having a rechargeable power source and an electrode array detachably connected to the IPG, the electrode array having a multiplicity of electrodes (En) thereon;
and wherein the surgical components comprise tools that assist a surgeon in positioning the IPG and electrode array;
and wherein the external components comprise a handheld programmer that may be selectively placed in telecommunicative contact with the IPG, a clinician programmer that is selectively coupled with the handheld programmer (HHP), and a portable charger that may be inductively coupled with the IPG in order to recharge the IPG power source, wherein the implantable components further comprise a lead extension that connects the electrode array to the IPG;
and wherein the surgical components further comprise an insertion needle and tunneling tools to aid in implanting the electrode array and lead extension.

1 more element

A spinal cord stimulation (SCS) system comprising implantable components, external components, and surgical components;

wherein the implantable components comprise a multichannel implantable pulse generator (IPG) having a rechargeable power source and an electrode array detachably connected to the IPG, the electrode array having a multiplicity of electrodes (En) thereon;
and wherein the surgical components comprise tools that assist a surgeon in positioning the IPG and electrode array;
and wherein the external components comprise a handheld programmer that may be selectively placed in telecommunicative contact with the IPG, a clinician programmer that is selectively coupled with the handheld programmer (HHP), and a portable charger that may be inductively coupled with the IPG in order to recharge the IPG power source, wherein the IPG comprises:
an hermetically sealed case wherein the rechargeable power source and electronic circuitry are housed;
a processor IC, including memory circuits;
a digital IC coupled to the processor IC;
an analog IC controlled by the digital IC, the analog IC having a multiplicity of output current DACs, each output current DAC being connected through a coupling capacitor and header connector to a respective electrode on the electrode array, each output current DAC including circuitry that generates an output stimulus current having a selected amplitude and polarity;
an RF telemetry circuit within the sealed case that receives externally-generated programming signals that define current stimulation pulse parameters;
a rechargeable battery that provides operating power for the electronic circuitry housed within the hermetically sealed case;
a secondary coil;
a rectifier circuit;
and
battery charger and protection circuitry that receives externally generated energy through the secondary coil and rectifier circuit, and uses the externally generated energy to charge the rechargeable battery.

10 more elements

A spinal cord stimulation (SCS) system comprising:

implantable components;
external components;
and
wherein the implantable components include a multichannel implantable pulse generator (IPG) having a replenishable power source and an electrode array having a plurality of electrodes, wherein the plurality of electrodes are detachably connected to the IPG;
and
wherein the external components include a handheld programmer (HHP) that may be selectively placed in telecommunicative contact with the IPG, a clinician programmer that may be selectively placed in telecommunicative contact with the HHP, and a portable charger than may be inductively coupled with the IPG in order to replenish the IPG power source, and wherein the multichannel IPG comprises:
an hermetically sealed case wherein the replenishable power source is housed;
a multiplicity of current sources within the sealed case;
a low impedance switching matrix within the sealed case having a multiplicity of input ports selectively connected to a multiplicity of output nodes;
a connector that provides detachable electrical connection with each of the multiplicity of output nodes of the switching matrix through respective feedthrough connectors, wherein the electrode array may connect with the multiplicity of output nodes of the switching matrix through the connector;
telemetry means within the sealed case for receiving externally-generated programming signals that define current stimulation pulse parameters;
and
processing circuitry within the sealed case coupled to the current sources and switching matrix and responsive to stimulation pulse parameters that generates control signals that define current stimulation pulses.

10 more elements

A spinal cord stimulation (SCS) system comprising:

implantable components;
external components;
and
wherein the implantable components include a multichannel implantable pulse generator (IPG) having a replenishable power source and an electrode array having a plurality of electrodes, wherein the plurality of electrodes are detachably connected to the IPG;
and
wherein the external components include a handheld programmer (HHP) that may be selectively placed in telecommunicative contact with the IPG, a clinician programmer that may be selectively placed in telecommunicative contact with the HHP, and a portable charger than may be inductively coupled with the IPG in order to replenish the IPG power source, and wherein the multichannel IPG comprises:
an hermetically sealed case wherein the replenishable power source and electronic circuitry are housed;
a processor IC, including memory circuits;
a digital IC coupled to the processor IC;
an analog IC controlled by the digital IC, the analog IC having a multiplicity of independent bi-directional output current DACs, each output current DAC being connected through a coupling capacitor and header connector to a respective electrode on the electrode array, each output current DAC including circuitry that generates an output stimulus current having a selected amplitude and polarity;
an RF telemetry circuit within the sealed case that receives externally-generated programming signals that define current stimulation pulse parameters;
a secondary coil;
a rectifier circuit;
and
power source replenisher and protection circuitry that receives externally generated energy through the secondary coil and rectifier circuit, and uses the externally generated energy to replenish the replenishable power source.

12 more elements

An implantable pulse generator (IPG) system for use with a spinal cord stimulation system, the IPG system comprising an implantable pulse generator and an external portable charger, wherein the IPG comprises:

an hermetically sealed case;
electronically circuitry including memory circuits, housed within said hermetically sealed case, said electronic circuitry including a multiplicity of independent bi-directional output current sources, each output current source being connected to an electrode node;
a multiplicity of coupling capacitors, each coupling capacitor being connected to a respective one of said electrode nodes;
a header connecter attached to said sealed case, the header connecter having a multiplicity of feedthrough pins that pass therethrough, wherein each of said multiplicity of coupling capacitors is connected on the sealed side of said case to one of said feedthrough pins;
an electrode array having a multiplicity of electrodes thereon external to said sealed case, wherein each electrode of the multiplicity of electrodes is detachably electrically connected to one of said feedthrough pins on a nonsealed side of said sealed case;
wherein each output current source generates an output stimulus current having a selected amplitude and polarity that, when the output current source is enabled, is directed to the electrode connected thereto through its respective feedthrough pin and coupling capacitor;
a rechargeable battery that provides operating power for the electronic circuitry;
a secondary coil;
a rectifier circuit;
and
battery charger and protection circuitry that receives externally generated energy through the secondary coil and rectifier circuit, and uses the externally generated energy to charge the rechargeable battery.

8 more elements

A spinal cord stimulation (SCS) system comprising implantable components and external components, wherein the implantable components comprise a multichannel implantable pulse generator (IPG) having a power source and an electrode array detachably connected to the IPG, the electrode array having n electrodes thereon, where n is an integer of at least eight;

and wherein the external components comprise a handheld programmer (HHP) that may be selectively placed in telecommunicative contact with the IPG in order to provide limited control of the IPG, and a clinician programmer that may be selectively coupled with the HHP in order to program operation of the IPG, and wherein the multichannel IPG includes an independent bi-directional current source for each of the n electrodes, and wherein each of the bi-directional current sources is electrically connected through a coupling capacitor to one of said n electrodes, and further wherein each of the current sources may be separately controlled to actively direct a current pulse of a selected amplitude and polarity to its respective electrode.

Dependencies are inferred from the claim text.

Rechargeable spinal cord stimulator system

Life of this patent

Rechargeable spinal cord stimulator system

Life of this patent

Abstract

Claims58