ARBITRARY WAVEFORM GENERATOR & NEURAL STIMULATION APPLICATION

• US 20120259383A1
• Filed: 04/07/2011
• Published: 10/11/2012
• Est. Priority Date: 04/07/2011
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Trier, Stephen, Weisgarber, Jeffrey A., Polefko, Richard J.
• Granted Patent: US 8,874,219 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: G06F 1/0328 in which the phase increment is adjustable, e.g. by using an adder-accumulator

Abstract

A method, device and/or system for generating arbitrary waveforms of a desired shape that can be used for generating a stimulation pulse for medical purposes such as for spinal cord stimulation therapy.

Claims

1. A method for providing a therapy to a patient, the method comprising the steps of:

storing a plurality of discrete samples of a shape waveform in a memory;

defining a step size;

retrieving a series of the plurality of the samples from the memory, based on the step size;

reconstructing at least a part of the shape waveform using the retrieved series of samples; and

providing a stimulation pulse with at least a substantial portion in a shape resembling the reconstructed waveform for stimulating a stimulation region of the patient.

2. The method of claim 1, further comprising the step of defining an offset value, wherein changing a value of the offset value causes a different series of samples to be retrieved.

3. The method of claim 1, wherein the retrieved series of samples is a subset of the plurality of discrete samples.

4. The method of claim 1, further comprising the step of scaling the shape waveform in time based on a scaling factor.

5. The method of claim 4, further comprising the step of also scaling the shape waveform amplitude using the scaling factor such that the magnitude of the charge delivered during the pulse is the same as the pulse resulting from not using the scaling factor to scale in amplitude and time.

6. A method for providing a therapy to a patient, the method comprising the steps of:

storing a plurality of discrete samples of a shape waveform in a memory;

defining a step size;

defining an offset value;

retrieving a subset of the plurality of samples from the memory, wherein which of the plurality of samples is chosen depends on both the step size and the offset value;

reconstructing at least a part of the shape waveform using the retrieved subset of samples; and

providing a stimulation pulse with at least a substantial portion in a shape resembling the reconstructed waveform for stimulating a stimulation region of the patient.

7. A method for providing a therapy to a patient, the method comprising the steps of:

storing a plurality of discrete samples of a shape waveform in a memory;

defining a step size;

defining an offset value;

retrieving a subset of the plurality of samples from the memory, wherein which of the plurality of samples is chosen depends on both the step size and the offset value, and wherein the value of the offset is chosen to ensure that a desired at least one of the discrete samples is retrieved, and wherein a value of the step size determines the number of samples and/or the time spacing of the samples in the subset;

reconstructing at least a part of the shape waveform using the retrieved subset of samples; and

providing a stimulation pulse with at least a substantial portion in a shape resembling the reconstructed waveform for stimulating a stimulation region of the patient.

8. A method for providing a therapy to a patient, the method comprising the steps of:

providing a waveform generating circuit for generating a waveform of a desired shape;

providing a rectangle generating circuit for generating a rectangular wave;

selecting one or both of a rectangular wave or the shaped waveform based on a control input; and

providing a stimulation pulse with at least a substantial portion in a shape resembling the waveform and/or with at least a substantial portion in a shape resembling the rectangular wave based on the selection, the stimulation pulse for stimulating a stimulation region of the patient.

9. The method of claim 8, wherein the stimulation pulse has a first pulse phase in a shape resembling the waveform and a second pulse phase in a shape resembling the rectangular wave provided in series or vice versa.

10. A method for providing a therapy to a patient, the method comprising the steps of:

generating a first waveform part based on a first desired waveform;

generating a second waveform part based on a second desired waveform different than the first desired waveform;

combining the first waveform part with the second waveform part in series to generate a stimulation pulse waveform; and

providing a stimulation pulse with at least a substantial portion in a shape resembling the stimulation pulse waveform for stimulating a stimulation region of the patient.

11. The method of claim 10, wherein the first waveform part is generated by retrieving a series of a plurality of samples of the desired waveform from a memory.

12. The method of claim 11, wherein the second waveform part is a rectangular wave.

13. The method of claim 10, wherein the second waveform part is a rectangular wave.

14. The method of claim 10, wherein the second waveform part is used to substantially cancel a charge provided in the stimulation region by the first waveform part.

15. The method of claim 10, further comprising the step of inserting a programmable delay, during which no charge is delivered, between the first waveform part and the second waveform part.

16. A stimulation device for stimulating a stimulation region within a patient comprising:

a first waveform generation circuit for generating a first waveform part;

a second waveform generation circuit for generating a second waveform part different than the first waveform part;

a switch for selecting between an output of the first waveform generation circuit and an output of the second waveform generation circuit as an output of the switch;

a stimulation pulse generating circuit connected to the output of the switch for generating a stimulation pulse comprised of a first pulse phase generated from the first waveform part and a second pulse phase generated from the second waveform part, with the first pulse phase and the second pulse phase provided in series, wherein

the stimulation pulse is provided to a stimulation region of the patient.

17. The device of claim 16, wherein the first waveform generation circuit is comprised of a first memory storing a plurality of samples of a desired waveform, and wherein the stimulation device is further comprised of:

a register for storing, or an input for receiving, a step size; and

an offset register for storing, or an input for receiving, an offset value, wherein

at least a subset of the plurality of samples is retrieved from the first memory based on both the step size and the offset value for generating the first waveform part.

18. The device of claim 17, wherein the second waveform generation circuit is comprised of a second memory or another area of the first memory for storing a plurality of additional samples of another desired waveform, wherein at least a subset of the plurality of additional samples is retrieved from the second memory or the another area of the first memory based one or both of another step size and/or another offset for generating the second waveform part.

19. The device of claim 18, wherein the second waveform generation circuit is a circuit for generating a waveform based on a mathematical function.

20. The device of claim 17, wherein the second waveform generation circuit is a register for storing, or an input for receiving, the amplitude value of a rectangular wave, and wherein the second waveform part resembles the rectangular wave.

21. The device of claim 16, wherein the first waveform generation circuit is a circuit for generating the first waveform part based on a mathematical equation.

22. The device of claim 16, wherein the first waveform generation circuit is a register for storing, or an input for receiving, the amplitude value of a rectangular wave, and wherein the first waveform part resembles the rectangular wave.

23. The device of claim 16, further comprising a circuit for inserting a variable delay between the first pulse phase and the second pulse phase, wherein the delay is controllable;

24. The device of claim 16, wherein the device is contained within a hermetically sealed case for implanting in the patient.

25. A stimulation device for stimulating a stimulation region within a patient comprising:

a controlling component;

a first waveform generation circuit for generating a first waveform part;

a second waveform generation circuit for generating a second waveform part different than the first waveform part;

a switch for selecting between an output of the first waveform generation circuit and an output of the second waveform generation circuit as an output of the switch, wherein the switch operation of the switch is controlled by the controlling component;

a stimulation pulse generating circuit connected to the output of the switch for generating a stimulation pulse generated from a first pulse phase generated from the first waveform part and a second pulse phase generated the second waveform part, with the first pulse phase and the second pulse phase provided in series;

a circuit for inserting a variable delay equal to or greater than zero between the first pulse phase and the second pulse phase, wherein the delay is controlled by the controlling component and no charge is delivered during the delay; and

at least one electrode connected to the stimulation pulse generating circuit for providing the stimulation pulse for stimulating a stimulation region of the patient.

26. The stimulation device of claim 25, further adapted for implantation in the patient.

27. A device for stimulating a stimulation region within a patient comprising:

a controlling component;

a first waveform generation circuit comprised of a first memory storing a plurality of samples of a first desired waveform for generating a first waveform part;

a register for storing, or an input for inputting, a step size, wherein at least a subset of the plurality of samples is retrieved from the memory based on the step size for generating the first waveform part;

a second waveform generation circuit for generating a second waveform part different than the first waveform part;

a switch for selecting between an output of the first waveform generation circuit and an output of the second waveform generation circuit as an output of the switch, wherein the switch operation of the switch is controlled by the controlling component;

a stimulation pulse generating circuit connected to the output of the switch for generating a stimulation pulse generated from at least one of the first waveform part or the second waveform part; and

at least one electrode connected to the stimulation pulse generating circuit for providing the stimulation pulse for stimulating a stimulation region of the patient.

28. The stimulation device of claim 27 adapted for implantation in the patient.

29. The stimulation device of claim 27, further comprising an offset register for storing, or an input for inputting, an offset value, wherein the at least a subset of the plurality of samples retrieved from the memory is based on both the step size and the offset value for generating the first waveform part.

30. The stimulation device of claim 29, further comprising a time scaling circuit for scaling the time duration of either one or both of the first phase pulse or the second phase pulse.

31. A stimulation device for stimulating a stimulation region within a patient comprising:

a first waveform generation circuit comprised of a first memory storing a plurality of samples of a first desired waveform for generating a first waveform part;

a register for storing a step size;

an offset register for storing an offset, wherein at least a subset of the plurality of samples is retrieved from the memory by the first waveform generation circuit based on both the step size and the offset for generating the first waveform part;

a second waveform generation circuit for generating a second waveform part different than the first waveform part;

a stimulation pulse generating circuit for generating a stimulation pulse generated from a first pulse phase generated from the first waveform part and a second pulse phase generated from the second waveform part, with the first pulse phase and the second pulse phase provided in series; and

a circuit for inserting a variable delay equal to or greater than zero between the first pulse phase and the second pulse phase, and no charge is delivered during the delay; and

at least one electrode connected to the stimulation pulse generating circuit for providing the stimulation pulse for stimulating a stimulation region of the patient.

32. A device for stimulating a stimulation region within a patient comprising:

a waveform generation circuit comprised of a memory storing a plurality of samples of a first desired waveform;

a register for storing, or an input for inputting, a step size for input into the waveform generation circuit for generating a waveform part, wherein

the device is adapted such that a subset of the plurality of samples is retrieved from the memory based on the step size for generating the first waveform part, such that a different step size would result in a different subset of the plurality of samples being retrieved from the memory for generating a different waveform part;

a stimulation pulse generating circuit for generating a stimulation pulse based at least partly on the waveform part; and

at least one electrode connected to the stimulation pulse generating circuit for providing the stimulation pulse for stimulating a stimulation region of the patient.

33. A stimulation system for stimulating a stimulation region of the spine of a patient comprising:

an implantable pulse generation device (IPG) adapted to be implanted in the patient, the IPG including;

an energy storage device for providing power to the IPG,

a first waveform generation circuit for generating a first waveform part,

a second waveform generation circuit for generating a second waveform part different than the first waveform part,

a switch for selecting between an output of the first waveform generation circuit and an output of the second waveform generation circuit as an output of the switch,

a circuit for inserting a variable delay between the first waveform part and the second waveform part, wherein the delay is controllable, and

a stimulation pulse generating circuit connected to the output of the switch for generating a stimulation pulse comprised of a first pulse phase generated from the first waveform part and a second pulse phase generated from the second waveform part, with the first pulse phase and the second pulse phase provided in series;

at least one electrode connected to the IPG and adapted to be provided near the stimulation region for providing the stimulation pulse to the stimulation region;

an external device for wirelessly connecting to the IPG for controlling an operation of the IPG; and

an external energy transmitter for wirelessly providing electrical energy to the energy storage device.

34. The stimulation system of claim 33, wherein the IPG further comprises a control device for controlling the first and second waveform generation circuits and for controlling the circuit for inserting the variable delay.

35. A stimulation system for stimulating a stimulation region of the spine within a patient comprising:

an implantable pulse generation device (IPG) adapted to be implanted in the patient, the IPG including;

a controlling device,

an energy storage device for providing power to the IPG,

a first waveform generation circuit comprised of a first memory storing a plurality of samples of a first desired waveform for generating a first waveform part,

a register for storing a step size,

an offset register for storing an offset, wherein at least a subset of the plurality of samples is retrieved from the memory based on both the step size and the offset for generating the first waveform part,

a second waveform generation circuit for generating a second waveform part different than the first waveform part,

a delay circuit for inserting a variable delay between the first waveform part and the second waveform part, wherein the delay is controllable, and

a stimulation pulse generating circuit for generating a stimulation pulse comprised of a first pulse phase generated from the first waveform part and a second pulse phase generated from the second waveform part, with the first pulse phase and the second pulse phase provided in series with a delay inserted by the delay circuit between the first pulse phase and the second pulse phase;

at least one electrode connected to the IPG and adapted to be provided near the stimulation region for providing the stimulation pulse to the stimulation region;

an external device for wirelessly connecting to the IPG for controlling an operation of the IPG; and

an external energy transmitter for wirelessly providing electrical energy to the energy storage device.