Active current control using the enclosure of an implanted pulse generator

• US 8,571,667 B2
• Filed: 07/01/2011
• Issued: 10/29/2013
• Est. Priority Date: 07/01/2011
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Weisgarber, Jeff A., Trier, Stephen C.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US13/175,283
• Publication Number:
  US 20130006331A1
• Time in Patent Office: 851 Days
• Field of Search: 607/46, 607 55- 57
• US Class Current: 607/46
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

An electrical stimulation apparatus including a medical device. The medical device includes: a housing component having at least one electrically conductive area. The medical device includes a plurality of conductors configured to be electrically coupled to a distal electrode array. The electrode array are implantable in a human body. The medical device includes a stimulation circuit positioned inside the housing component. The stimulation circuit includes a plurality of controllable stimulation channels. A first subset of the stimulation channels is electrically coupled to the conductors. A second subset of the stimulation channels is electrically coupled to the electrically conductive area of the housing component. The stimulation circuit is operable to simultaneously create a first stimulation path in the electrode array and a second stimulation path that extends from the electrode array to the housing component.

Claims

1. A neurostimulation medical system, comprising:

a controller circuit configured to generate control signals in response to external programming signals;

a stimulation circuit configured to generate stimulation signals in response to the control signals;

a plurality of implantable electrodes;

a plurality of conductors configured to deliver the stimulation signals from the stimulation circuit to the electrodes; and

an enclosure that houses the controller circuit and the stimulation circuit therein, the enclosure containing an area that is electrically conductive, wherein the controller circuit and the stimulation circuit are configured to ramp up a current at the enclosure during an initial calibration stage and determine therefrom a first current level corresponding to a perception threshold at the enclosure and a second current level corresponding to a pain threshold at the enclosure;

wherein the stimulation circuit is configured to activate a first subset of the electrodes to a first polarity, a second subset of the electrodes to a second polarity, and the enclosure to one of the first and second polarities, so as to cause a first stimulation path to be formed between at least one of the electrodes in the first subset and at least one of the electrodes in the second subset, and a second stimulation path to be formed between the enclosure and at least one of the electrodes in the first and second subsets, and wherein the activated enclosure is programmed by the controller circuit to actively sink or source an amount of electrical current that is capped at one of;

the first current level corresponding to the perception threshold, and the second current level corresponding to the pain threshold.

2. The neurostimulation medical system of claim 1, wherein the electrodes in the first subset are activated as anodes, and the electrodes in the second subset are activated as cathodes, and the enclosure is activated as one of:

an anode and a cathode.

3. The neurostimulation medical system of claim 1, wherein the stimulation circuit includes a plurality of stimulation channels that can be selectively activated in response to the control signals, wherein the stimulation channels each include an electrical current source.

4. The neurostimulation medical system of claim 3, wherein a number of activated stimulation channels is equal to X, and a number of activated distal electrodes is equal to Y, and wherein X is greater than Y.

5. The neurostimulation medical system of claim 1, wherein the amount of electrical current at the enclosure is capped at the first current level corresponding to the perception threshold.

6. The neurostimulation medical system of claim 5, wherein the current source contains a current supply for generating current pulses that can be used as the stimulation signals, wherein an amplitude, a width, and a frequency of the current pulses are each tunable in response to the control signals.

7. The neurostimulation medical system of claim 1, wherein the enclosure is a hermetically-sealed device, and wherein the stimulation circuit activates the enclosure through the area that is electrically conductive, and wherein the stimulation circuit activates the enclosure using one or more dedicated current sources.

8. A neurostimulation medical system, comprising:

a controller circuit configured to generate control signals in response to external programming signals;

a stimulation circuit configured to generate stimulation signals in response to the control signals;

a plurality of distal electrodes;

a plurality of conductors configured to deliver the stimulation signals from the stimulation circuit to the electrodes; and

an enclosure that houses the controller circuit and the stimulation circuit therein, the enclosure containing at least one electrically conductive area, wherein the distal electrodes are coupled to the stimulation circuit through the enclosure, wherein the controller circuit and the stimulation circuit are configured to ramp up a current at the enclosure during an initial calibration stage and determine therefrom a first current level corresponding to a perception threshold at the enclosure and a second current level corresponding to a pain threshold at the enclosure;

wherein the stimulation circuit is configured to;

energize a first subset of the distal electrodes with a first polarity;

energize a second subset of the distal electrodes with a second polarity opposite the first polarity, the second subset being different from the first subset; and

energize the enclosure with one of the first and second polarities, and wherein the energized enclosure is programmed by the controller circuit to actively sink or source an amount of electrical current that is capped at one of;

the first current level corresponding to the perception threshold, and the second current level corresponding to the pain threshold.

9. The neurostimulation medical system of claim 8, wherein the stimulation circuit is configured by a microcontroller that is a part of the controller circuit.

10. The neurostimulation medical system of claim 8, wherein the stimulation circuit is configured to energize the first and second subsets of distal electrodes and the enclosure simultaneously, wherein the first and second subsets of distal electrodes and the enclosure are energized with a controlled electrical current.

11. The neurostimulation medical system of claim 8, wherein the amount of electrical current at the enclosure is capped at the first current level corresponding to the perception threshold.

12. The neurostimulation medical system of claim 8, wherein the neurostimulation medical system includes a plurality of stimulation channels that can be driven by the stimulation circuit, each stimulation channel having one or more programmable electrical supplies configured to supply stimulation signals to the distal electrodes.

13. The neurostimulation medical system of claim 12, wherein a number of stimulation channels that can be driven exceeds a sum of the energized distal electrodes.

14. The neurostimulation medical system of claim 8, wherein the neurostimulation medical system includes a charge-balancing capacitor.

15. The neurostimulation medical system of claim 8, wherein the neurostimulation medical system is implantable in a patient'"'"'s body.

16. The neurostimulation medical system of claim 8, wherein the stimulation circuit is further configured to:

energize a third subset of the distal electrodes with the first polarity; and

energize a fourth subset of the distal electrodes with the second polarity, wherein the third and fourth subsets include different electrodes than the first and second subsets, respectively.

17. The neurostimulation medical system of claim 16, wherein an amount of stimulation current flowing through the enclosure while the first and second subsets are energized is different from an amount of stimulation current flowing through the enclosure while the third and fourth subsets are energized.

18. A neurostimulation medical system, comprising:

a controller circuit configured to generate control signals in response to external programming signals;

a stimulation circuit configured to generate stimulation signals in response to the control signals;

a distal electrode array that is implantable in a human body;

a plurality of conductors configured to deliver the stimulation signals from the stimulation circuit to the electrodes; and

a housing component that houses the stimulation circuit therein, the housing component containing at least one electrically conductive area, wherein the controller circuit and the stimulation circuit are configured to ramp up a current at the housing component during an initial calibration stage and determine therefrom a first current level corresponding to a perception threshold at the housing component and a second current level corresponding to a pain threshold at the housing component;

wherein;

the stimulation circuit includes a plurality of controllable stimulation channels, a first subset of the stimulation channels being electrically coupled to the conductors, and a second subset of the stimulation channels being electrically coupled to the electrically conductive area of the housing component; and

the stimulation circuit is operable to simultaneously create a first stimulation path in the electrode array and a second stimulation path that extends from the electrode array to the housing component, and wherein the housing component, while functioning as a part of the second subset of the stimulation channels, actively sinks or sources a programmed amount of electrical current that is capped at one of;

the first current level corresponding to the perception threshold and the second current level corresponding to the pain threshold.

19. The neurostimulation medical system of claim 18, wherein the stimulation channels each include at least one electrical supply for delivering a stimulation signal to the electrode array, and wherein the stimulation channels each further include:

a programmable switch coupled in parallel with the electrical supply; and

a capacitor coupled in series with the electrical supply and between the electrical supply and a respective one of the conductors.

20. The neurostimulation medical system of claim 18, wherein the programmed amount of electrical current at the housing component is capped at the first current level corresponding to the perception threshold.

21. The neurostimulation medical system of claim 18, wherein the stimulation channels each include at least one of:

a current sink and a current source.

22. The neurostimulation medical system of claim 18, wherein:

the electrode array contains a first number of activated distal electrodes;

the stimulation circuit includes a second number of active stimulation channels; and

the first number is less than the second number.

23. The neurostimulation medical system of claim 22, wherein:

the first stimulation path is defined by a first distal electrode and a second distal electrode, the first and second distal electrodes being distal electrodes on the distal electrode array and having opposite polarities; and

the second stimulation path is defined by one of the first and second electrodes and the conductive area of the housing component, the one of the first and second electrodes and the housing component having opposite polarities.

24. The neurostimulation medical system of claim 18, wherein the housing component is a hermetically-sealed enclosure having one or more feedthroughs for receiving the plurality of conductors.

25. A neurostimulation medical system, comprising:

a controller circuit configured to generate control signals in response to external programming signals;

a stimulation circuit configured to generate stimulation signals in response to the control signals, wherein the stimulation circuit contains a plurality of current sources, and wherein at least a subset of the current sources each include at least one adjustable electrical supply;

a plurality of implantable distal electrodes;

a lead wire coupling assembly for electrically coupling the stimulation circuit to the distal electrodes; and

an enclosure that houses the stimulation circuit therein, the enclosure having at least one electrically conductive portion, wherein at least one of the current sources in the subset is electrically coupled to the electrically conductive portion of the enclosure, wherein the controller circuit and the stimulation circuit are configured to ramp up a current at the enclosure during an initial calibration stage and determine therefrom a first current level corresponding to a perception threshold at the enclosure and a second current level corresponding to a pain threshold at the enclosure, and wherein the enclosure is programmed by the controller circuit to actively sink or source an amount of electrical current that is capped at one of;

the first current level and the second current level.

26. The neurostimulation medical system of claim 25, wherein a quantity of current sources exceeds a quantity of distal electrodes.

27. The neurostimulation medical system of claim 25, wherein the stimulation circuit is configured to drive the enclosure to serve as one of:

an anode and a cathode, and wherein the amount of electrical current at the enclosure is capped at the first current level.

28. The neurostimulation medical system of claim 25, wherein the stimulation circuit is configured to simultaneously drive a first subset of the distal electrodes to a first polarity, a second subset of the distal electrodes to a second polarity opposite the first polarity, and the enclosure to one of the first and second polarities.

29. The neurostimulation medical system of claim 28, wherein:

a first stimulation region is formed between one of the distal electrodes in the first subset and one of the distal electrodes in the second subset; and

a second stimulation region is formed between the enclosure and one of the distal electrodes in the first and second subsets.

30. The neurostimulation medical system of claim 25, wherein the electrical supply includes at least one of:

a current sink and a current source.

31. A neurostimulation medical system, comprising:

a controller circuit configured to generate control signals in response to external programming signals;

a stimulation circuit configured to generate stimulation signals in response to the control signals;

a remote electrode array;

a plurality of lead wires configured to provide electrical pulses generated by the stimulation circuit to the remote electrode array; and

an enclosure that surrounds the stimulation circuit, the enclosure containing at least one electrically conductive area, wherein the lead wires are coupled to the stimulation circuit through the enclosure, wherein the controller circuit and the stimulation circuit are configured to ramp up a current at the enclosure during an initial calibration stage and determine therefrom a first current level corresponding to a perception threshold at the enclosure and a second current level corresponding to a pain threshold at the enclosure;

wherein the stimulation circuit is configured to;

cause a first stimulation path to be formed within the remote electrode array; and

cause a second stimulation path to be formed from the remote electrode array to the enclosure;

wherein the enclosure is programmed to actively sink or source an amount of electrical current that is capped at one of;

the first current level corresponding to the perception threshold, and the second current level corresponding to the pain threshold.

32. The neurostimulation medical system of claim 31, wherein the first stimulation path and the second stimulation path each include a current path, and wherein the stimulation circuit is configured to cause the first and second stimulation paths to be formed simultaneously.

33. The neurostimulation medical system of claim 31, wherein the amount of electrical current at the enclosure is capped at the first current level corresponding to the perception threshold.

34. The neurostimulation medical system of claim 31, wherein the electrode array contains a plurality of electrodes, and wherein the stimulation circuit is configured to:

activate at least one cathode from the plurality of electrodes;

activate at least one anode from the plurality of electrodes; and

activate the enclosure to function in a manner similar to one of;

a cathode and an anode.

35. The neurostimulation medical system of claim 34, wherein:

the first stimulation path includes a first stimulation current that passes from one of the activated cathodes to one of the activated anodes; and

the second stimulation path includes a second stimulation current that passes from the enclosure to one of the activated cathodes and anodes.

36. The neurostimulation medical system of claim 31, wherein the stimulation circuit includes a plurality of output channels, the output channels each containing:

a power rail;

a reference voltage;

one or more controllable current supplies;

a first switch coupled to the power rail; and

a second switch coupled to the reference voltage;

wherein;

a first controllable current supply is coupled to the power rail in parallel with the first switch; and

a second controllable current supply is coupled to the reference voltage in parallel with the second switch.

37. The neurostimulation medical system of claim 36, wherein the stimulation circuit is configured to:

turn ‘

off’

all current through the output channels;

open the first switch and the second switch in all output channels;

select a set of anode channels and a set of cathode channels from the output channels;

turn ‘

on’

the first controllable current supply, setting the current to a pre-selected value, and provide current for a first period of time in the anode channels;

turn ‘

on’

the second controllable current supply, setting the current to a pre-selected value, and providing current for the first period of time in the cathode channels;

turn ‘

off’

all current supplies in the anode channels and the cathode channels for a second period of time;

close the second switch in the anode channels and the cathode channels; and

keep the second switch in the anode channels and the cathode channels closed for a third period of time.

38. A neurostimulation medical system, comprising:

a controller circuit configured to generate control signals in response to external programming signals;

a stimulation circuit configured to generate stimulation signals in response to the control signals, wherein the stimulation signals can stimulate a body tissue, and wherein the stimulation circuit includes one or more adjustable electrical supplies;

one or more distal electrodes;

a coupling mechanism configured to electrically couple the stimulation circuit to the one or more distal electrodes; and

an enclosure that houses the stimulation circuit therein, the enclosure containing at least one electrically conductive portion, wherein the controller circuit and the stimulation circuit are configured to ramp up a current at the enclosure during an initial calibration stage and determine therefrom a first current level corresponding to a perception threshold at the enclosure and a second current level corresponding to a pain threshold at the enclosure;

wherein the stimulation circuit is configured to simultaneously drive the enclosure through the conductive portion and drive at least a subset of the distal electrodes, wherein the driven enclosure is programmed to actively sink or source an amount of electrical current that is capped at one of;

the first current level and the second current level.

39. The neurostimulation medical system of claim 38, wherein the stimulation circuit includes a plurality of channels that each contain:

at least one of the adjustable electrical supplies;

means for bypassing the electrical supplies; and

means for providing charge-balancing.

40. The neurostimulation medical system of claim 38, wherein the electrical supplies of the stimulation circuit are adjustable in response to the external programming signal, and wherein the amount of electrical current at the enclosure is capped at the first current level.

41. The neurostimulation medical system of claim 38, wherein the stimulation circuit is configured to simultaneously energize a first subset of the distal electrodes with a first polarity, a second subset of the distal electrodes with a second polarity opposite the first polarity, and the enclosure with one of the first and second polarities.

42. The neurostimulation medical system of claim 38, wherein the stimulation circuit is configured to simultaneously cause:

a first stimulation field to be formed between at least two of the distal electrodes; and

a second stimulation field to be formed between the enclosure and one of the distal electrodes.