Parameter context switching for an implanted device

• US 6,381,496 B1
• Filed: 09/25/2000
• Issued: 04/30/2002
• Est. Priority Date: 10/01/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Meadows, Paul M., Mann, Carla M.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/668,925
• Time in Patent Office: 582 Days
• Field of Search: 607/59, 607/60, 607/30
• US Class Current: 607/59
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

An implant device provides context switching, meaning the ability to change one set of operational parameters for another. The implant device is controlled by a set of operational parameters. The patient may swap the current set of operational parameters with another set of operational parameters. Further, the implant device may include a time-of-day clock, and/or a sensor, and is configured to automatically change its operational parameters from one set of operational parameters to another at certain times of the day, week, or month, or upon the occurrence of certain prescribed events. In one embodiment, the patient may define selected operational parameters within a new set of operational parameters for use with the implant device, providing such patient-defined parameters remain within set limits. The ability to change the current operational parameter set (OPS) is achieved, in a first embodiment, by including memory circuitry within the implant device wherein a plurality of OPS'"'"'s are stored. Upon receipt of an appropriate command, manually provided by the patient user through a hand-help programmer, or automatically generated by time-of-day or sensor circuits within the implant device, the current OPS is exchanged by another OPS. In a second embodiment, a plurality of OPS'"'"'s are externally stored, e.g., in a hand-held programming device, and only the currently-used OPS is stored in the implant device. Changes to the OPS are made by transmitting the replacement OPS to the implant device through a telemetry link established with the implant device from the hand-held programming device. When the patient wishes to change the OPS, he manually activates the appropriate controls on the hand-held programming device, and such activation causes the new OPS to be telemetered to the implant device, where it replaces the current OPS.

Claims

1. An implant device comprising:

an implantable case;

electronic circuitry housed within said implantable case for performing a prescribed function, the electronic circuitry including

a control register wherein a control set of operational parameters is stored,

a controller that controls the operation of the implant device as a function of the control set of operational parameters stored in the control register, and

a plurality of sets of operational parameters; and

selection means for selecting one of the plurality of sets of operational parameters as the control set of operational parameters that is stored in the control register;

whereby the operation of the implant device may be changed through selection of a different set of operational parameters.

2. The implant device of claim 1 wherein the electronic circuitry further includes memory circuitry wherein the plurality of sets of operational parameters are stored, and wherein the selection means comprises memory access control means for retrieving a selected set of operational parameters from the memory circuitry and loading it into the control register.

3. The implant device of claim 1 wherein the selection means comprises:

memory means external to the implant device wherein the plurality of sets of operational parameters are stored; and

telemetry means for transmitting a selected one of the plurality of sets of operational parameters to the electronic circuitry for loading into the control register.

4. The implant device of claim 1 further including change means for allowing a user of the implant device to change individual parameters included within a selected one of the plurality of operational parameters.

5. The implant device of claim 4 wherein the change means allows the user of the implant device to change only certain ones of the individual parameters included within the selected one of the plurality of operational parameters.

6. The implant device of claim 1 wherein the prescribed function performed by the electronic circuitry comprises a stimulation pulse generator, and wherein the operational parameters included within the control set of operational parameters include pulse width, pulse amplitude and pulse rate.

7. The implant device of claim 6 wherein the operational parameters included within the control set of operational parameters further include electrode configuration, ramp rate, and treatment time.

8. A method of changing the operational parameters used to control an implant device, comprising:

defining a plurality of sets of operational parameters, each set including individual parameters that define respective characteristics associated with the operation of the implant device;

storing the plurality of sets of operational parameters;

selecting one of the stored sets of operational parameters as a control set of operational parameters; and

providing the control set of operational parameters to the implant device, and using the provided control set of operational parameters to control the operation of the implant device.

9. The method of claim 8 wherein the defining step comprises defining each set of the plurality of sets of operational parameters so that each of the individual parameters within each set are within prescribed safe operating limits.

10. The method of claim 9 wherein the storing step comprises storing each of the sets of operational parameters within memory circuitry included within the implant device.

11. The method of claim 9 wherein the storing step comprises storing each of the sets of operational parameters within memory circuitry that is external to the implant device.

12. The method of claim 9 further including allowing a user of the implant device to define a new set of operational parameters that replaces an existing set of operational parameters.

13. The method of claim 9 further including the step of limiting changes made to a set of operational parameters to changes in just prescribed ones of the individual parameters included within the set of operational parameters.

14. An implant system that permits parameter context switching comprising:

an implant device comprising;

electronic circuitry that performs a prescribed function as controlled by a set of operational parameters,

a first memory element wherein the set of operational parameters is stored,

a replenishable power source that provides operating power for the implant device,

a first telemetry circuit that receives control data from an external source, and

a second telemetry circuit that receives power to replenish the replenishable power source;

an external control device comprising a first transmission circuit that transfers control data through the first telemetry circuit of the implant device that defines the set of operational parameters stored in the first memory element of the implant device; and

an external charging device comprising;

a power source, and

a second transmission circuit that transfers power from the power source through the second telemetry circuit to the replenishable power source of the implant device.

15. The implant system of claim 14 wherein the first memory element within the implant device has a plurality of sets of operational parameters stored therein, and wherein the external control device transfers control data to the implant device that selects one of the plurality of sets of operational parameters as a control set of operational parameters to be used to control the electronic circuitry.

16. The implant system of claim 14 wherein the external control device includes a second memory element wherein a plurality of sets of operational parameters are stored, and further wherein the external control device includes means for selecting one of the plurality of sets of operational parameters and sending the selected set of operational parameters to the implant device for storage in the first memory means, from which location the selected set of operational parameters controls the operation of the electronic circuitry within the implant device.

17. The implant system of claim 16 further including:

limited memory access control circuitry within the external control device that allows access to a selected plurality of individual operating parameters within each of the sets of operational parameters included within the plurality of sets of operational parameters stored within the second memory element;

full memory access control circuitry within the external control device that allows access to all of the individual operating parameters of each of the sets of operational parameters included within the plurality of sets of operational parameters stored within the second memory element;

a manual patient selection circuit that allows a patient user of the external control device to selectively alter the selected plurality of individual operating parameters accessible through the limited memory access control circuitry; and

a clinician programmer selectively coupled to the full memory access control circuitry that allows a clinician user of the clinician programmer to selectively alter all of the individual operating parameters of each of the sets of operational parameters included within the plurality of sets of operational parameters stored within the second memory element.

18. The implant system of claim 17 wherein the external control device further includes limit checking circuitry that prevents an alteration of individual operating parameters contained within the plurality of sets of operational parameters that exceeds a respective predefined limit.