Clinician programmer system and method for calculating volumes of activation for monopolar and bipolar electrode configurations

• US 8,326,433 B2
• Filed: 05/15/2009
• Issued: 12/04/2012
• Est. Priority Date: 05/15/2008
• Status: Active Grant

• Current Assignee: IntElect Medical, Inc. (Boston Scientific Corporation), Medical College of Wisconsin Incorporated
• Original Assignee: IntElect Medical, Inc. (Boston Scientific Corporation), Medical College of Wisconsin Incorporated
• Inventors: Blum, David Arthur, Carlton, Keith, Greszler, Alan, Kokones, Scott, Sparks, Troy, Butson, Christopher
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US12/454,312
• Publication Number:
  US 20100049276A1
• Time in Patent Office: 1,299 Days
• Field of Search: 607/59
• US Class Current: 607/59
• CPC Class Codes: A61B 2034/104 Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2090/103 Cranial plugs for access to brain
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G06V 40/10 Human or animal bodies, e.g. vehicle occupants or pedestrians; Body parts, e.g. hands
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16H 70/20 relating to practices or guidelines

Abstract

A system and method for providing a volume of activation (VOA) of a stimulation electrode leadwire may include a processor that calculates a VOA for each of a plurality of sets of parameter settings of the leadwire, stores in a database each of the calculated VOAs in association with the respective set of parameter settings for which it was calculated, performs a curve fitting on threshold values determined for a plurality of waveforms to obtain an equation, obtains a set of parameter settings of the leadwire for a stimulation, and determines a VOA for the obtained set of parameter settings based on the stored VOAs, for example, using the equation.

Claims

1. A method of a volume of activation (VOA) providing machine to provide a VOA of a stimulation electrode leadwire, comprising:

plotting, by a processor of the machine, first electric values at anatomical locations for a set of stimulation parameter settings;

determining, by the processor, a threshold for the set of stimulation parameter settings by application of a threshold function that outputs the threshold based on function input variables that include a pulse width, amplitude, and impedance of the stimulation parameter settings;

based on the determined threshold, determining, by the processor, a three dimensional surface of an area that includes one of (a) those of the plotted first electric values that meet the threshold and (b) second electric values corresponding to a subset of the plotted first values and that meet the threshold; and

outputting, by the machine, the area as a VOA.

2. The method of claim 1, wherein:

the plotted first electric values are voltage values;

the threshold is a voltage threshold; and

the threshold function is formed by, for a selected electrode configuration;

plotting voltages at anatomical locations;

for each of a plurality of waveforms, determining an amplitude threshold for activation at various ones of the locations; and

performing a curve fitting on the threshold values determined for the plurality of waveforms, the curve fitting resulting in the threshold function; and

the determined three dimensional surface is of the area that includes those of the plotted voltage values that meet the threshold.

3. The method of claim 1, wherein:

the first electric values are voltage values;

the threshold is one of a voltage threshold and a charge density threshold;

the threshold function is one of a voltage threshold function that outputs the voltage threshold and a charge density function that outputs the charge density threshold; and

the area includes one of (a) those of the voltage values that meet the voltage threshold and (b) charge density values corresponding to a subset of the voltage values and that meet the charge density threshold.

4. A computer-implemented method of providing a volume of activation (VOA) of a stimulation electrode leadwire, comprising:

plotting, by a processor, first electric values at anatomical locations for a set of stimulation parameter settings;

determining, by the processor, a threshold for the set of stimulation parameter settings by application of a threshold function that outputs the threshold based on a pulse width and amplitude of the stimulation parameter settings;

based on the determined threshold, determining, by the processor, a three dimensional surface of an area that includes one of (a) those of the plotted first electric values that meet the threshold and (b) second electric values corresponding to a subset of the plotted first values and that meet the threshold; and

outputting the area as a VOA;

wherein;

the plotted first electric values are voltage values;

the set of stimulation parameter settings includes a bipolar electrode configuration;

the threshold is a charge density threshold;

the determined three dimensional surface is of the area that includes the second electric values corresponding to the subset of the plotted voltage values that meet the charge density threshold;

the second electric values are charge density values;

the charge density threshold function is formed by, for a selected monopolar electrode configuration;

plotting voltages at anatomical locations;

for each of a plurality of waveforms;

determining an amplitude threshold for activation at various ones of the locations;

determining an electric field based on the plotted voltages;

obtaining a current density field based on the electric field; and

obtaining a charge density field based on the current density field and a pulse width of the waveform, the charge density field including charge density values at the locations in association with the determined amplitude thresholds; and

performing a curve fitting on the threshold values determined for the plurality of waveforms, the curve fitting resulting in a charge density threshold equation that provides a charge density threshold for a given pulse width, amplitude, and impedance; and

the determining of the three dimensional surface includes;

recording voltage values at anatomical locations for the bipolar configuration;

thresholding the recorded voltage values to one of scale down and remove anodic values;

converting voltage values remaining after the thresholding into charge density values; and

applying the charge density threshold to the charge density values.

5. A volume of activation (VOA) providing system for providing a VOA of a stimulation electrode leadwire, comprising:

an input device, the system configured for obtaining a set of stimulation parameter settings via the input device;

a processor configured to;

plot voltage values at anatomical locations for the set of stimulation parameter settings;

determine one of a voltage threshold and a charge density threshold for the set of stimulation parameter settings by executing one of a voltage threshold function that outputs the voltage threshold and a charge density function that outputs the charge density threshold; and

based on the determined one of voltage threshold and charge density threshold, determine a three dimensional surface of a region that includes one of (a) those of the voltage values that meet the voltage threshold and (b) charge density values corresponding to a subset of the voltage values and that meet the charge density threshold; and

an output device, the system configured to output the region, via the output device, as a VOA;

wherein a pulse width, amplitude, and impedance of the stimulation parameter settings are input variables of the function, each of the pulse, amplitude, and impedance thereby contributing to a result returned by the function.

6. A hardware computer-readable medium having stored thereon instructions, the instructions which, when executed, cause a processor to perform method to provide a volume of activation (VOA) of a stimulation electrode leadwire, the method comprising:

plotting, by a processor of the machine, voltage values at anatomical locations for a set of stimulation parameter settings;

determining, by the processor, one of a voltage threshold and a charge density threshold for the set of stimulation parameter settings by application of one of a voltage threshold function that outputs the voltage threshold and a charge density function that outputs the charge density threshold;

based on the determined one of voltage threshold and charge density threshold, determining, by the processor, a three dimensional surface of an area that includes one of (a) those of the voltage values that meet the voltage threshold and (b) charge density values corresponding to a subset of the voltage values and that meet the charge density threshold; and

outputting, by the machine, the area as a VOA;

wherein a pulse width, amplitude, and impedance of the stimulation parameter settings are input variables of the function, each of the pulse, amplitude, and impedance thereby contributing to a result returned by the function.

7. A computer-implemented method for providing a volume of activation (VOA) of a stimulation electrode leadwire, comprising:

plotting, by a computer processor, voltage values at anatomical locations for a set of stimulation parameter settings;

determining, by the processor, a voltage threshold for the set of stimulation parameter settings by application of a voltage threshold function that outputs the voltage threshold based on function input variables that include a pulse width, amplitude, and impedance of the stimulation parameter settings;

based on the determined voltage threshold, determining, by the processor, a three dimensional surface of an area that includes those of the voltage values that meet the voltage threshold; and

outputting, by the processor, the area as a VOA.

8. A method of a volume of activation (VOA) providing machine to provide a VOA of a stimulation electrode leadwire, comprising:

plotting, by a processor of the machine, first electric values at anatomical locations for a set of stimulation parameter settings;

determining, by the processor, a voltage threshold for the set of stimulation parameter settings by application of a threshold function that outputs the voltage threshold based on function input variables that include a pulse width, an amplitude, and an impedance of the stimulation parameter settings, each of the pulse width, amplitude, and impedance thereby contributing to a result returned by the threshold function;

based on the determined voltage threshold, determining, by the processor, a three dimensional surface of an area that includes one of (a) those of the plotted first electric values that meet the voltage threshold and (b) second electric values corresponding to a subset of the plotted first electric values and that meet the voltage threshold; and

outputting, by the machine, the area as a VOA,

wherein;

the first electric values are voltage values;

the threshold function is formed by, for a selected electrode configuration;

plotting voltages at anatomical locations;

for each of a plurality of waveforms, determining an amplitude threshold for activation at various ones of the locations; and

performing a curve fitting on the threshold values determined for the plurality of waveforms, the curve fitting resulting in the threshold function; and

the determined three dimensional surface is of the area that includes those of the plotted voltage values that meet the threshold.

9. A method of a volume of activation (VOA) providing machine to provide a VOA of a stimulation electrode leadwire, comprising:

plotting, by a processor of the machine, first electric values at anatomical locations for a set of stimulation parameter settings;

determining, by the processor, a threshold for the set of stimulation parameter settings by application of a threshold function that outputs the threshold based on function input variables that include a pulse width and amplitude of the stimulation parameter settings;

based on the determined threshold, determining, by the processor, a three dimensional surface of an area that includes one of (a) those of the plotted first electric values that meet the threshold and (b) second electric values corresponding to a subset of the plotted first values and that meet the threshold; and

outputting, by the machine, the area as a VOA;

wherein;

the first electric values are voltage values;

the threshold is one of a voltage threshold and a charge density threshold;

the threshold function is one of a voltage threshold function that outputs the voltage threshold and a charge density function that outputs the charge density threshold;

an impedance of the stimulation parameter settings is an input variable of and thereby contributes to a result of the one of the voltage threshold function and the charge density threshold outputs the threshold; and

the area includes one of (a) those of the voltage values that meet the voltage threshold and (b) charge density values corresponding to a subset of the voltage values and that meet the charge density threshold.