System and method to display subject signals

Abstract

A system and method to analyze information from a subject is disclosed. The information may include local field potential signals from the subject. The signals may be recorded over time. The signals may have a range determined, such as for display. The signals may be received in real time or a static data set.

Description

SYSTEM AND METHOD TO DISPLAY SUBJECT SIGNALSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 516,262, filed on July 28, 2023. The entire disclosure of the above application is incorporated herein by reference.FIELD

[0002] The present disclosure relates to a method and system to evaluate sensed signals from a subject, particularly related to neurological signals.BACKGROUND

[0003] This section provides background information related to the present disclosure which is not necessarily prior art.

[0004] A system may sense a signal in a human patient. The signal may be referred to as local field potential (LFP) signal which includes the electric potential recorded in the extracellular space in brain tissue. The signal may be sensed in a selected portion of the patient, such as at a probe positioned within the brain of the patient. The probe may be temporarily or chronically positioned. The probe may sense the LFP signal over time as a plurality of LFP signals. The LFP signals may be viewed on a timeline.SUMMARY

[0005] This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.

[0006] A device, which may be an implantable or implanted device, may be configured to measure activity, such as local field potentials (LFP), or transmit LFP signals of a subject. The subject may be a human patient. The subject, however, may also be in an inanimate subject or a nonhuman patient that generates electrical signals that may be sensed by an implant. The implant may be temporarily or chronically implanted in the subject.

[0007] A system may be used to view, review, or analyze the subject's or patient's LFP. This may occur for reviewing or analyzing changes in one or more treatment parameter(s) relative to the subject. In various embodiments, the signal may be viewedto analyze the subject in a selected state, e.g., a steady or static state. Other reviews may occur based on a change, such as a treatment parameter change or subject state change (e.g., standing up or sitting down). Treatment parameter changes may include changes in various parameters such as stimulation frequency, stimulation amplitude, or other selected parameters. A change in parameters may be used to view changes in an LFP timeline. The LFP timeline may be a portion in a timeline sequence of an LFP sequence for comparison to other timeline sequences. The change in one or more parameters may be used to identify the at least one of an end or a beginning of a timeline sequence.

[0008] According to various embodiments, a system allows a user to selected various configurations of a display. The display may be configured to ensure that selected data or relevant data is displayed. The display may be scaled to ensure that selected data is displayed.

[0009] According to various embodiments, a selected portion of data may be automatically displayed. For example, a display on a display device may be scaled to ensure that selected or appropriate data is displayed for viewing by a user. The automatic display may be made or displayed atomically to ensure that a used is able to efficiently or appropriate view selected data regarding selected signals.

[0010] Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.DRAWINGS

[0011] The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations and are not intended to limit the scope of the present disclosure.

[0012] Fig. 1 is a schematic view illustrating an exemplary deep brain stimulation (DBS) system, according to various embodiments;

[0013] Fig. 2 is a graph of a received signal (e.g., a trace of a local field potential (LFP)), over time, according to various embodiments;

[0014] Fig. 3 is an augmented graph of a received signal (e.g., a trace of a local field potential (LFP)), over time, according to various embodiments;

[0015] Fig. 4 is an augmented graph of a received signal (e.g., a trace of a local field potential (LFP)), over time, according to various embodiments;

[0016] Fig. 5A is a graph a received signal (e.g., a trace of a local field potential (LFP)), over time, according to various embodiments;

[0017] Fig. 5B is an augmented graph of a received signal (e.g., a trace of a local field potential (LFP)), over time, according to various embodiments; and

[0018] Fig. 6 is a process for generating a graph or an augmented graph of a received signal (e.g., a trace of a local field potential (LFP)), over time, according to various embodiments.

[0019] Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.DETAILED DESCRIPTION

[0020] Example embodiments will now be described more fully with reference to the accompanying drawings.

[0021] This disclosure is directed towards a system and method for viewing, reviewing, or analyzing signals from a subject. A system, for example, may be useful for viewing or analyzing such signals. As used herein, analyzing may refer to displaying a signal, such as for viewing by a user. Additionally, or alternatively, analyzing may refer to an automatic, manual, or a combination thereof, process for displaying or determining a nature (e.g., one or more physical characteristics) of a signal. Thus, analyzing a signal can include displaying, viewing, or providing a manual or automatic analysis (e.g., determining a nature or cause) of the signal. Analyzing a signal may include other appropriate process related to the signal.

[0022] A review or analysis of signals (e.g., LFP signals) obtained from a patient may be useful in treating movement disorder symptoms. In an example, a deep brain stimulation (DBS) system may be useful for treating Parkinson's Disease (PD). Such treatment may include a combination of one or more treatment options such as electrical stimulation, medication delivery, physical motion or placement, or other selected treatment options.

[0023] The systems and methods of this disclosure, according to various embodiments, use sensed brain activity. The brain activity may relate to, or may be useful for, determining whether one or more disease states (e.g., biomarkers) are present in the brain of a patient. Brain activity may be recorded, for example, in the form of electricalsignals derived or generated from sensed (e.g., detected) local field potentials (LFP). The LFPs (e.g., the electrical signals derived or generated from sensed LFPs) may be analyzed alone or in relation to other sensed or recorded features (e.g., signals), such as electroencephalogram (EEG) or electrocorticogram (ECoG) signals sensed by an implantable or external medical device. Entrainment generally refers to the process of using stimuli to affect brain activity, e.g., oscillations within a frequency band in the brain. Gamma frequency band oscillations, e.g., ordinarily between about 35 Hertz (Hz) and about 120 Hz or more, in the central nervous system (CNS), recorded using LFPs, for example, are associated with normal information processing in movement and sensory structures. Beta frequency band oscillations between about 8 Hz and about 35 Hz, have been associated with dysfunctions of CNS circuits that control behavioral movements and cognitive states. Higher frequency stimulation, e.g., about 130 Hz, of subcortical brain areas involved with movement, e.g., subthalamic nucleus, globus pallidus internus, and ventralis intermedius nucleus of the thalamus, may reduce behaviors associated with essential tremor and Parkinson's disease such as rigidity, bradykinesia, and tremor.

[0024] In general, PD patients have phasic changes in their levels of symptom relief and side effects as medication is absorbed into the blood stream, and then is eliminated. For example, a PD patient may show signs of dystonia when not on medication or receiving stimulation. As the treatment (e.g., medication or stimulation) reaches the therapeutic window, the dystonia symptoms may subside. This may also show that the medication or stimulation is causing the side-effect such as dystonia or muscle contraction, etc.

[0025] Brain signals include several biomarkers that may be used to indicate when adjustments to patient treatment may be beneficial to keep a patient within the therapeutic window. Brain signals may be collected from, for example, the patient's motor cortex, zona incerta (Zi), subthalmic nucleus (STN), basal ganglia, cerebellum, pedunculopontine nucleus, red nucleus, or lateral globus pallidus. The signals from the motor cortex may be collected from the primary motor cortex (M1 ), the premotor cortex, the supplementary motor area (SMA), the posterior parietal cortex, or the primary somatosensory cortex. One or more biomarkers may be found in the signals collected from each region of the brain.

[0026] For example, LFP signals measured or sensed in the patient's motor cortex and STN may be used as a biomarker or may be analyzed as discussed herein forevaluating, such as comparing, different time frames of a patient. The LFP or related biomarker may be monitored by an implantable medical device (IMD) or external programmer or controller. The biomarkers may be used to assess the patient's current disease state. Disease progression over time may also be considered. The biomarker may also be used to serve as an indicator of therapy effectiveness in a device or system. The system could analyze / compare various time domains to each other, as a signal, which could demonstrate increased / decreased efficacy or potentially a disease state worsening. Other signals, such as other than LFPs, may include evoked potentials or evoked compound action potentials.

[0027] With initial reference to Fig. 1 , a schematic or diagrammatic exemplary deep brain stimulation (DBS) system is illustrated that may be used to implement the system and techniques of this disclosure. In Fig. 1 , a therapy or recording / measuring system 10 is illustrated. The system 10 may include any appropriate system such as the SenSight® directional deep brain stimulation (DBS) lead system or the Percept® PC DBS system or related software, for example the Brainsense® software that may be used to operate and control a medical device, all sold by Medtronic, Inc. These systems may sense or transmit a signal, such as associated with LFPs sensed in a subject. In various embodiments, systems may include features such as those disclosed in U.S. Pat. No. 10,016,606, incorporated herein by reference.

[0028] The system 10 may deliver electrical stimulation therapy to a patient to assist in treating a patient condition, such as a movement disorder or a neurodegenerative impairment of a patient 12. The system 10 may also be used to measure or record signals from the patient 12, such as LFP signals. Patient 12 may be a human patient. In some cases, however, therapy system 10 may be applied to other mammalian or non-mammalian non-human patients. Further, the system 10 may measure signals in non-living systems, such as electrical signal systems. While movement disorders and neurodegenerative impairment are primarily referred to in this disclosure, in other examples, therapy system 10 may provide therapy to manage symptoms of other patient conditions, such as, but not limited to, seizure disorders or psychological disorders. For example, the disclosed system may receive signal data from areas of the brain that are not the area of stimulation interest but relevant to how the therapy may be delivered or understanding of how the various neuro / chemically tied systems work together and rely of various feedback loop[s to function properly. Somespecific examples of this include monitoring more than the STN or GPI in the basal ganglia system. Or in epilepsy listen to other key areas such as cortical structure or deep structures using either a surface electrode or depth electrode to help the stimulation lead located in another area of the brain stimulate correctly so that the entire brain structure system run harmoniously.

[0029] A movement disorder or other neurodegenerative impairment may include symptoms such as, for example, muscle control impairment, motion impairment or other movement problems, such as rigidity, bradykinesia, rhythmic hyperkinesia, non-rhythmic hyperkinesia, and akinesia. In some cases, the movement disorder may be a symptom of PD. The movement disorder may be attributable to other patient conditions. Although PD may be referred to here, therapy systems and methods described herein may also be useful for controlling symptoms of other conditions, such as other movement disorders or neurodegenerative impairment.

[0030] In the example of Fig. 1 , therapy system 10 includes a device programmer 14, a subject device 16, a lead or connector 18, and one or more leads 20a and 20b. The subject device 16 may be, such as referred to herein, an implantable medical device (IMD), however one skilled in the art will understand that the device need not be implanted. Each lead 20a, 20b may include one or more electrodes 24, 26. Each electrode 24, 26 may include one or more electrode contacts. It is understood by one skilled in the art, however, that the number of leads 20a, 20b may be greater than two or less than two. Further, the number of electrodes or contacts for each lead may be any appropriate number. The electrode contacts may be used to provide stimulation or record a signal, such as a LFP at or near each of the electrode contacts of the electrodes 24, 26. In various embodiments, the leads 20a, 20b may be separate leads, or bifurcated segments on a single lead.

[0031] In the example shown in Fig. 1 , electrodes 24, 26 of leads 20a, 20b may be positioned to sense LFPs or deliver electrical stimulation to a tissue site within a brain 28 within a skull 32 of the patient 12, such as a deep brain site under the dura mater of the brain 28 of the patient 12. In various embodiments, the electrodes 24, 26 may be positioned in various regions of the brain 28, such as a subthalamic nucleus (STN), a globus pallidus internus (GPi), a motor cortex, or a thalamus. The placement of the electrodes 24, 26 in these positions may be effective for recording or treatment to manage movement disorders, such as Parkinson's Disease or essential tremor. Whilethe subject disclosure exemplary refers to sensing LFP, it is understood by one skilled in the art that any appropriate signal may be sensed. Further, the electrodes 24, 26 may sense only one signal or many signals. Similarly, one of the electrodes may sense a signal and the other may provide a stimulation signal selectively or permanently.

[0032] While Fig. 1 illustrates the electrodes 24, 26 one skilled in the art will understand that more than two leads may be implanted. One or more of the leads may monitor various brain signals bands providing brain system data to the system. The data, include signals from any appropriate portion of the brain system, may help provide key input on how a stimulation will regulate the system.

[0033] The IMD 16 may include a therapy module that includes a stimulation generator that generates and delivers electrical stimulation therapy to the patient 12 via at least a subset of the electrodes or the contacts of the electrodes 24, 26 of leads 20a and 20b. The subset of electrodes 24, 26 may have a selected or changeable polarity and a therapy parameter may be altered thereat, such as frequency or changing polarity over time. Further, the stimulation therapy may be altered over time by changing which of the subset of electrodes 24, 26 are combined to provide stimulation.

[0034] Using generally known techniques, a subset of electrodes 24, 26, may be used to deliver electrical stimulation to the patient 12 in order to re-establish, or re-induce, gamma frequency band activity within the brain 28. In some examples, beta frequency band activity in the brain may be decreased and gamma frequency band activity in the brain may be increased by delivering electrical stimulation to a portion of the brain at a predetermined ratio between the detected activity in the gamma band and the frequency of stimulation. In one example, the frequency of the electrical stimulation delivered to the portion of the brain may be at a constant frequency at some predetermined ratio between the detected activity in the gamma band and the frequency of electrical stimulation. For example, electrodes 24, 26 may be used to deliver electrical stimulation to patient 12 at a selected frequency or provided in a biphasic manner. For example, stimulation may be provided at a particular frequency at a voltage that alternates between +2V and -2V. In another example, the frequency of the electrical stimulation delivered to the portion of the brain may be applied in a sweeping manner. For example, the frequency of the electrical stimulation may be swept through a range of frequency values. In a frequency sweep, the frequency of the electrical stimulation may begin at one value and then may be varied, e.g., increased or decreased, from a first frequency to a second frequency.

[0035] The IMD 16 may be connected to the lead 18 at a connection or connector 40. The connector 40 allows the lead 18 to be connected, such as electrically connected, to the IMD 16. The IMD 16 may further include various components or portions such as a battery 44, a processor module 48, or a telemetry module 50. The battery 44 may provide power to the IMD 16 such as for stimulating the subject 12 or transmitting data, such as signals sensed form the subject 12. The processor 48 may process various instructions, such as stimulation or sensing instructions. Further, the telemetry module 50 may allow for communication, such as wired or wireless, with the programmer 14 or a clinician module or system 54. The telemetry module 50 may be any appropriate module, such as those generally known in the art.

[0036] The clinician system 54 may include various portions such as a screen or display 56. The display 56 may be a touch screen display and allow for a clinician or user to input or receive or review various information. The clinician system 54 may further include a processor or processor module 57 and may include a memory portion or the processor may access a memory. The clinician module 54, therefore, may display selected information, as discussed herein, on the display 56 that may be processed at the clinician system 54 or at a separate system and transmitted to the clinician system 54. Further, the clinician system 54 may include one or more hard or selectable buttons 58. Buttons 58 may allow the user to input or interact with data displayed on the display 56.

[0037] The programmer 14 may be used to program or also receive information from of the IMD 16. The programmer 14 may, therefore, include a processor or processor module 60 that is able to execute instructions. A memory may also be included with the processor 60 or accessible by the processor 60. The programmer 14 may further include a telemetry module 64. Thus, the programmer 14 may communicate with the IMD 16, such as via the telemetry module 50 of the IMD 16. The programmer 14 may send instructions for providing therapy to the subject 12 or receiving information from the IMD 16.

[0038] With additional reference to Fig. 2, the system 10, including the electrodes 20a, 20b may be used to sense or record activity in the subject 12. For example, as discussed above, LFP signals may be sensed and measured in the subject 12. Fig. 2 illustrates a graph 70 of LFP signals over time. In the graph 70 an LFP signal trace or line 74 is representative of a signal that has varying intensity as illustrated on the Y-axis78. The displayed intensity may include a complete or full intensity such that all of the received or recorded data may be displayed. As discussed herein, the intensity scale may be altered tor set to show less than all of the data or allow viewing with greater clarity a selected portion of the date. The LFP signals may be measured over time as illustrated on the X-axis 82. The line 74 of the LFP intensities may illustrate a varying intensity over time, as illustrated in the graph 70. The difference of the intensity of the graph 74 may be viewed by a user.

[0039] The user may view the graph 70 on the user system 54, or other appropriate display device. The graph 70 may include several portions, such as a first portion 84 and a second portion 88. As illustrated in Fig. 2, the first portion 84 may have a large or greater scale than the second portion 88. For example, the first portion 84 may include a maximum value or intensity of at least 10,000. A maximum of the second portion 88 may only be about 2000. Thus, the user, however, may only be able to effectively view less than all of the graph trace 74 given the Y-axis scale 78. As such, the user may not be able to quickly interpret the graph 74 of the LFP intensity. As illustrated in Fig. 2, the graph 74 of the LFP intensity may include sharp changes in a short period of time and viewing and understanding a change over a long period of time (e.g., greater than a selected value of seconds, minutes, hours, days, weeks, months, fractions of any of the aforementioned, etc.) may be difficult.

[0040] With continuing reference to Fig. 2, the graph 70 including the trace 74 may be displayed for the user. The user may understand that the first portion 84 of the trace 74 may flatten and, therefore, reduce the detail in the second portion of the trace 88 given the scale 78 when the scale is set to a full scale to illustrate all of the peaks of the trace 74 in the first portion 84. It may be desirable or selected, therefore, that the scale of the graph 70 be altered to illustrate the trace portion 74 of the second portion 88 on a scale to illustrate the peaks of the second portion 88 only. It is understood, however, that the scale may be altered to illustrate any selected portion of the trace. For example, the scale may be changed to ensure that selected artifacts (e.g., movement of the subject) are removed or not illustrated.

[0041] A user 53 may provide inputs, such as a time span, maximum intensity value, identification of an average or mean value, or the like to assist in changing the scale of the intensity scale 78. The user 53 may be any appropriate person such as a clinician, surgeon, technician, etc. According to various embodiments, the time scale 82may also be provided in any appropriate manner such as in seconds, minutes, hours, or the like. The time scale 82 may be based upon an average or type of data being displayed and slash / or based upon a selection of the user.

[0042] With reference to Fig. 3, the graph 70 may be altered such that the intensity scale is from 0 to 2000 rather than 0 to 10,000. As illustrated in Fig. 3, a graph 70’ may be displayed, such as for the user. The graph 70’ may be referred to as an augmented or altered graph. The graph 70’ may include a set display value that allows for greater clarity of a selected portion of the data, including the received signal such as from the LFP of the subject 12. The selected set value may be less than a complete or full value for a data set and may also be referred to as a set selected value for a display or augmented value. The set display value may allow for viewing of a portion of the data and may omit a portion of the data that is greater than a selected value.

[0043] The first portion of the data 84 may, therefore, include intensity cropping such that a top portion 84’ (Fig. 2) may be cropped or not illustrated in the cropped or altered graph 70’. The cropping of the first portion 84 to the augmented or altered scale, 0 to 2000, allows for the second portion 88 of the trace 74 to be shown in greater detail. For example, the height of the intensity scale may illustrate a graduation between 0 and 2000 rather than requiring graduation between 0 and 10,000, or any other scale that may be larger (e.g., 1 ,000,000; 100,000,00 or more). The intensity scale, therefore, may be altered to show the trace 74 of the second portion 88 of the data with greater detail, such as illustrating an intensity peak of 500 to be about one quarter of the height of the graph 70’ rather than less than 1 / 20thof the graph 70.

[0044] According to various embodiments, an altered graph 70” may also or alternatively entirely remove or crop the first portion 84 of the trace 74. For example, turning reference to Fig. 4, the graph 70” is illustrated. The graph 70” may have the scale of intensity 78b changed to 0 to 2000. The graph 70” may be displayed, such as for the user 53. The graph 70” may be referred to as an augmented or altered graph. The graph 70” may include a set display value that allows for greater clarity of a selected portion of the data, including the received signal such as from the LFP of the subject 12. The selected set value may be less than a complete or full value for a data set and may also be referred to as a set selected value for a display or augmented value. The set display value may allow for viewing of a portion of the data and may omit a portion of the data that is greater than a selected value.

[0045] The first portion of the data or trace 84 may be entirely eliminated from the graph 70”. An indication 76, also referred to as a marking or delineation, that certain data has been deleted or removed from the display may be made. The indication may be provided as a color coding, visual or written indication, or the like. The indication 76 may include coloring a portion of the graph 70” to provide a visual indication that a portion of the graph has been deleted or is not being shown, particularly on a time scale relative to the intensity scale. For example, the time scale may include seconds, minutes, days, or the like. Therefore, user 53 may be provided a visual indication that data was collected, but does not fit on the intensity scale currently being displayed. Therefore, the user 53 may understand or view greater detail of the second portion of the data 88 while understanding that the first portion 84 of the data was also collected, even if not displayed.

[0046] The user 53 may choose to view the first portion of the data 84, if selected, to understand the first portion of the data 84. However, the first portion of the day that 84 may be entirely removed or not displayed on the display in the graph 70” to be allow a better understanding of a detail of the second portion of the data 88. It is understood by one skilled in the art, that the indication 76 that the first portion of the data 84 is not displayed may include a cross hatching of a portion of the graph 70", the color coding of the graph 70”, a written indication that may be displayed, or other appropriate indication that the data is not displayed on the graph. 70”.

[0047] Turning in reference to Fig. 5A and Fig. 5B, a selected data may be collected by a selected system, such as the over a time that may be illustrated on a time axis 1 12. The data set may be a static data set, such as a data set that is collected over a selected portion of time in the past. The data set may also or alternatively include a streaming or real time data set that is collected in real time and displayed in real time.

[0048] The time axis may be for any appropriate length of time or graduations thereof. For example, the time axis may be for 40 seconds in selected graduations, such as 0.5 seconds. Further, the intensity axis may be any appropriate value and intensity graduation, such as in volts, millivolts, amperes, or any other appropriate intensity. Nevertheless, the trace 104 may include spikes or peaks that may occur along the trace 104. The spikes of the trace 104 may be identified in any appropriate manner, such as having a maximum value greater than an average maximum value of the entire trace 104, a maximum value greater than an average or mean maximum value of a surroundingtime frame. For example, a value may be a moving average of 5 seconds, 10 seconds, 20 seconds, or any appropriate portion of time and the spike may be a value or some multiple thereof. Further, any individual values in the above noted range, or may be identified by the user.

[0049] As illustrated in Fig. 5A, for example, a first peak 1 0 and a second peak 124 may be identified in the trace 104. Therefore, the trace 104 may include selected value portions including the two peaks 120, 124 relative to the other peak portions 128. The peaks may be identified substantially automatically manually, or combinations thereof, as noted herein. Nevertheless, once the peaks at 120, 124 are identified the intensity scale may be altered to illustrate the non-peak value in greater detail.

[0050] Turning to Fig. 5B, for example, a graph 100a may be displayed, such as for the user 53. The graph 100a may be referred to as an augmented or altered graph. The graph 100a may include a set display value that allows for greater clarity of a selected portion of the data, including the received signal such as from the LFP of the subject 12. The selected set value may be less than a complete or full value for a data set and may also be referred to as a set selected value for a display or augmented value. The set display value may allow for viewing of a portion of the data and may omit a portion of the data that is greater than a selected value.

[0051] According to various embodiments, the graph 100a may include markings, also referred to as indications or delineations, 120a, 124a to indicate the position of the previously identified peaks 120,124. The markings 120a, 124a may be displayed as a visual indication to the user 53 that data is not displayed in the graph 100a. Therefore, with the peaks 120,124 removed a tracel 04a may only include the other portions 128 of the trace 104, previously discussed.

[0052] The lower intensity portions 128 may be displayed on an augmented intensity axis 108a to illustrate in a greater detail the lower intensity portions 128. Therefore, the trace 104a illustrated in the graph 100a may allow the user 53 to view or understand (e.g., evaluate) the lower intensity data 128 in the trace 104, such as in the augmented trace 104a.

[0053] In addition to the markings 120a, 124a, further indications that the graph 100a does not include all available data may be a marking or indicator 134 displayed on the graph 100a. The indicator 134 may be any appropriate indication such as a flashing bar, solid bar, colored bar, written indication, or the like. Further, the indication 134 neednot be an indication on any particular portion of the graph 100a but, for example, may include a visual indication behind the entire graph 100a. For example, a blinking color background, a written indication, or the like. Thus, the indicator 134 may be provided in any appropriate manner to the user 53 and the indicator 134 as a bar in an upper portion of the graph 100a is merely exemplary.

[0054] Accordingly, the user 53 may view the graph 100a to understand or evaluate the trace 104a of the lower intensity data 128 on an intensity scale 108a relative to the lower intensity data 128. The user 53 may understand with the indication 134 that selected data is not displayed. The user 53 may select to toggle between the two displays or two graphs 100, 100a on the display 56 or any appropriate display. Therefore, the user 53 may view data in any appropriately selected manner to assist in understanding or evaluating the recorded or collected signal data from the subject 12.

[0055] The recorded data may be collected with the system 10 in any appropriate manner. The display of the data may be manipulated and generated as a trace, according to various embodiments, for viewing by the user 53. The data including various and multiple intensity graduations may be automatically altered, such as changing the intensity axis value by a system to provide an efficient display to the user 53. The automatic changes to the data or the graphs, such as a change in the intensity scale, or scaling of the data, may be made based upon various user selections or analysis of the collected data, as discussed herein.

[0056] With continuing reference to Figs. 1 -5B and additional reference to Fig. 6, a process is illustrated in a flowchart 160. The process 160, according to various embodiments, automatically or assists in providing a selected display or analysis of a data set. The data set may be signals received with the system 10 (e.g., LFP) for display to the user 53. The process 160 may assist in automatically determining portions of the trace to display or an appropriate scale for at least a portion of the graph to be displayed. The process 160, as discussed further herein, may further include or receive inputs to allow for determination of portions of a data set to be analyzed, removed, or otherwise determined to be scaled or not scaled for displaying on a selected graph or display. The process 160, generally, allows for an automatic determination of a scale of a display of a data set. The data set may be static or streaming.

[0057] The process 160 starts in START block 164. The process 160 then acquires a signal data set in block 168. The signal data set may be a static data set or a real timeor streaming data set. For example, the data set may be a signal data set that is collected over a set period of time, such as over a1 minute, 5 minute, 10 minute, etc. at a selected past time span. Alternatively or additionally to a static data set, a streaming or real time data set may be acquired. The streaming data set may be a data set that is acquired from the subject 12 in real time or substantially near real time. For example, the user 53 may observe the subject 12 at a selected time or over a selected period. The subject 12 may perform various actions, such as standing up, moving a digit or limb, or the like. The user 53 may view the display 56 of a trace of the selected signal data, such as the LFP, as discussed above. Therefore, the acquired data set may be a static data set that may be recalled from a memory or may be a streaming or real time data set that is collected displayed for viewing by the user 53.

[0058] After acquiring the data set in block 168, a determination of a range of the data set is made in block 112.. The range of the data set may include any appropriate range termination, including an intensity range. As discussed above, the data may have an intensity range that may be any appropriate value range such as measured in millivolts, amperes, or the like. As an example, as illustrated in Fig. 2, the range may be from about 0 to about 10,000 of any appropriate unit. The data set, assuming that the entire data set is illustrated in Fig. 2, may therefore have an intensity range of 0 to 10,000. The determined range, therefore, may be based upon the entire data set that is acquired in block 168.

[0059] The determined range may, however, also be for a selected period. For example, with the streaming data set the determined range of data set may be a range of a last or most recently ended period, such as 5 seconds, 10 seconds, or any appropriate period of time. For example, a data set that is streaming may be streamed substantially continuously and at a selected sampling rate, such as 10 times a second. The data set may, therefore, include 10 seconds of samples. The determined range of the data set may include the last 10 seconds of samples. Therefore, the range may change continuously in a streaming of real time data set.

[0060] Based on the above analysis and data set, a set display range or axis for the determined range may be made in block 176. The set display range may be based upon the entire determined range of the data set that is determined in block 172. Accordingly, if the data set includes the data set illustrated in Fig. 2, the range may be 0 to 10,000. Therefore, the set display range may be 0 to 10,000, as illustrated in fig. 2.The display trace 74, therefore, may be based upon the set display range set in block 176.

[0061] Optionally, the data set may then be output in block 180. For example, the display of the data trace 74 Fig. 2 may be the output of the complete data set in block 180. Thus, a determined range for an entire data set may be made at any appropriate time and the set display range may be made and the data may be displayed such as selected by the user 53 or automatically. It is understood, however, that outputting the complete data set in block 180 is optional.

[0062] A determination of a selected value related to a data set range may be made in block 190. The determined selected value for a range may be based upon data in the data set, and the values thereof. The determined selected value may be a value less than a maximum or total value. Briefly, as discussed herein, the selected value may be a range of 0 to 2,000 even if a data set includes an intensity value of greater than 2,000 (e.g., 10,000).

[0063] According to various embodiments, the selected value may be a statistical median of the data in the data set, a statistical mean of the data in the data set, a standard deviation or selected number of standard deviations relative to a mean or including a mean of the data set, or other appropriate determined selected values. The determined selected values may be automatically determined by the processor system that is executing instructions, such as once data is received in block 168.

[0064] The instructions regarding determining the value in block 190 may include determining a mean of the acquired signal data set from block 168. The instructions may also include determining a selected number of standard deviations, such as one standard deviation, from the mean. Therefore, the determine selected value may be a mean and a standard deviation. The data set range determined block 190, therefore, may be a determined value based upon the entire data set, but not inclusive of the entire data set. For example, as discussed above, the selected determined value may include identifying a mean and a standard deviation of the data and removing values or data points that are outside of mean and one standard deviation.

[0065] Briefly, as an example, as illustrated in Fig. 5B, the augmented or updated trace 104a includes only the lower intensity 128. The lower intensity data has removed from the displayed trace 104a the higher intensity peaks 120, 124. This is based on the augmented intensity scale 108a that is the determined selected value form block 190.Thus, the determined selected value may be based upon an evaluation or calculation of the data set.

[0066] In addition to the determined selected value in block 190, one or more inputs may be received in block 200. The inputs may be any appropriate input that may be automatically determined, input by the user, or predetermined and evaluated by the system. The inputs may include a time range (such as a range of time less than the entire range of time for the acquired data set), a definition of an artifact open (e.g., a value greater than a set value), a maximum display range or set range value (e.g., a predetermined or selected maximum intensity, an additional sensor or second sensor inputs (e.g., an accelerometer), evoked potential amplitude, or other appropriate inputs. For example, the received inputs may be an input from the user 53 that defines one or more artifacts, such as a maximum value or a maximum change over a selected period of time. A time range may also be input by a user or predetermined and identified by the system when executing instructions relative to the acquired data set. In another example, a time offsets may be one or more of the inputs. The time offset may allow an adjustment in the time range or offsets of other inputs; or adjust the output selected value range to account for potential recorded time discrepancies between input signals. This may allow tuning the inputs to put the various inputs into focus, which may include achieving a selected specific outcome.

[0067] Additionally or alternatively, a second sensor or second input may be provided. For example, the LFP signal may change due to a physical movement of the subject. An accelerometer may be used to determine a movement of the subject, such as the subject standing up. A spike in the received signal may be equated to the sensed movement and the data set or related trace may be augmented, such as by being cropped or clipped, to remove the spike value or the data at the movement event. Therefore, the data set value may be determined based upon additional inputs from block 200.

[0068] Further, it is understood that a plurality of inputs, including a combination, may be made to determine a selected value for a data set range in block 190. The combination may include a sensor input and a mean alone or with a standard deviation determination. Therefore, the determination of the selected value related to a data set range in block 190 may include a calculation or additional inputs, such as inputs from block 200.

[0069] Further, it is understood that different to determined selected values may be applied to subsets of the acquired data. As discussed above, the acquired signal in block 168 may be static or a streaming real time data set. The selected value may be applied to any portion of the data, such as a selected time period of the data. For example, as noted above, the acquired data signal may be separated into selected time periods, such as 10 second time periods. The determined selected value may be applied to each of the or it's determined by the user 53. Other sub-portions may be those that relate to a second sensor, etc.

[0070] Nevertheless, based upon the determined selected value related to a data set range, a set display range may be made in block 210. The set display range may be similar to the set range discussed above. For example, as illustrated in Fig. 3, Fig. 4, or Fig. 5B, the respective graphs 70’, 70”, and 100a, also referred to as augmented or altered graphs, have set intensity values that differ from a set range for the entire data set. The selected or set display range values allow for illustration of a lower intensity range of the data with greater detail, as discussed and illustrated above. In other words, the set display range made in block 210 may set a display range.

[0071] The data set may then be output in block 214 at the set display range. An exemplary output is a display of a trace with the set display value. Thus, the user 53 may view the traces at the set display range, such as with the user device 54. Therefore, the user 53 may view the graph 100a rather than the graph 100. The user may be able to view and evaluate the displayed graph. Further, the displayed graph may be used to provide treatment or understand treatment provided to the subject 12. Thus, the system 10 may provide or alter a treatment to the subject, such as with the IMD 16, or with additional programming or treatment various made by the user 53.

[0072] The process 160 may further determine whether a display is to be continued in block 218. If a determination is made that display is to continue, a YES path 220 may be followed to acquire a data set in block 168. Therefore, the process 160 is understood to be an iterative process to allow for the continued acquisition in collection of data and display thereof such as with an automatic display and scaling of the acquired image data set. The process 160, therefore, may allow the user 53 or a treatment to the subject 12 to be continuously monitored or displayed.

[0073] If a determination is made that the display is not to be continued, a NO path 224 may be followed to end the process and block 226. Therefore, the process 160 mayend in block 226. Ending the process in block 226 may include ceasing collection of data, providing a therapy program for a selected period of time, or evaluating the prior acquired data set. It is understood, however, that the process 160 may be restarted at any appropriate time, such as by the user 53 such as via the user device 54.

[0074] Regardless, the data collected with an appropriate system, such as the system 10, including the IMD 16 and the electrodes 24, 26 may be displayed for the user 53 or other appropriate individual. The collected data may be displayed at an appropriate set display range to assist in comprehension and evaluation thereof by a selected user. As disclosed herein, the collected data may be displayed substantially automatically, including setting a display range and access value, that is substantially automatic to allow for an efficient and appropriate display and understanding of the data.

[0075] A therapy, such as stimulation or pharmaceutical treatment, may be reviewed or altered based on the received and reviewed signals. The graph of the signals may indicate a subject’s response, symptom, or biophysical state. The subject’s response may be evaluated in light of the graph, according to various embodiments, such as by the user 53 to assist in therapy.

[0076] A subject’s response may include a change in LFP such as determined by the LFP thresholds, including an elevation or suppression of the LFP signal. The subject’s response may include sleep state which may further related to a circadian rhythm. The subject’s response may include a number of symptom events that may be determined in the graph. The subject’s response may further include a tremor or dyskinesia score. A subject’s heart rate variability or the hearts specific rate at a given time may be included as a subject’s response. Thus, the subject’s response may include one or more response of the subject to a change in one or more of the parameters.

[0077] A subject’s symptom may include a rigidity of the subject. The subject’s symptom may include a tremor or dyskinesia score or state at a given timestamp. Further, a subject’s symptom may include any measured or selected motor disorder symptoms.

[0078] A subject’s biophysical state may include whether the subject currently is taking a medication or has an effective concentration of a medication as related to time. The subject’s biophysical state may include an active or sedentary state or type or amount of movement. The subject’s biophysical state may include the subject being awake or asleep.

[0079] Examples

[0080] Example 1 - A system to evaluate for display of a signal from a subject, comprising: a processor configured to execute instructions to: receive a signal data set indicative of the signal from the subject; evaluating the received signal data set; determining a selected value of the received signal data set; and outputting a selected set display range based on the determined selected value of the received signal data set; wherein the selected set display range is operable to assist in an efficient display of at least a portion of the received signal data set.

[0081] Example 2 - The system of Example 1 , further comprising: a display device; wherein the selected set display range includes a mean and a standard deviation and the selected set display range is configured to define a scale of a displayed axis displayed with the display device.

[0082] Example 3 - The system of Example 1 , wherein the processor is configured to execute further instructions to determine a selected range of the received signal data set and outputting a complete set display range; wherein the complete set display range is configured to define a complete scale of the displayed axis displayed with the display device.

[0083] Example 4 - The system of Example 1 , further comprising: an electrode configured to be positioned within the subject; wherein the electrode is configured to sense a signal within the subject.

[0084] Example 5 - The system of Example 4, further comprising: an implantable medical device; and an transmitter included with the implantable medical device; wherein the electrode is connected to the implantable medical device and the transmitter is configured to transmit the sensed signal.

[0085] Example 6 - The system of Example 1 , wherein the signal is an LFP signal in a brain of the subject.

[0086] Example 7 - The system of Example 1 , wherein the processor executes the instructions to automatically determine the selected value of the received signal data set and output the selected set display range based on the determined selected value of the received signal data set.

[0087] Example 8 - The system of Example 7, wherein the selected set display range is determined to display at least one intensity of the signal less than a maximum intensity of the signal.

[0088] Example 9 - The system of Example 7, wherein the processor is configured to execute further instructions to receive an input including at least one of a motion sensor input, a selected time period range, an artifact definition, a maximum display value, or combinations thereof.

[0089] Example 10 - The system of Example 9, wherein the determined selected value of the received signal data set is based at least in part on at least the input.

[0090] Example 11 - A method for preparing or displaying a signal from a subject, comprising: receiving a signal data set indicative of the signal from the subject; evaluating the received signal data set; determining a selected value of the received signal data set; and outputting a selected set display range based on the determined selected value of the received signal data set; wherein the selected set display range is operable to assist in an efficient display of at least a portion of the received signal data set.

[0091] Example 12 - The method of Example 11 , further comprising: operating a processor to execute instructions to at least determine the selected value of the received signal data set and output the selected set display range based on the determined selected value of the received signal data set.

[0092] Example 13 - The method of Example 11 , further comprising: displaying at least the portion of the received signal data set within the selected set display range.

[0093] Example 14 - The method of Example 13, wherein displaying at least the portion of the received signal data set within the selected set display range is displaying only the portion of the received signal data set within the output selected set display range.

[0094] Example 15 - The method of Example 11 , wherein outputting the selected set display range includes a mean and a standard deviation and the selected set display range is configured to define a scale of a displayed axis displayed with the display device.

[0095] Example 16 - The method of Example 15, wherein outputting the selected set display range includes is determined to display at least one intensity of the signal less than a maximum intensity of the signal.

[0096] Example 17 - The method of Example 1 1 , further comprising: determining a complete range of the received signal data set and outputting a selected set display range; wherein the complete set display range is configured to define a complete scale of the displayed axis displayed with the display device.

[0097] Example 18 - The method of Example 11 , further comprising: providing an implantable medical device; providing a transmitter included with the implantable medical device; providing an electrode configured to be connected to the implantable medical device and positioned within the subject.

[0098] Example 19 - The method of Example 11 , further comprising: receiving an input including at least one of a motion sensor input, a selected time period range, an artifact definition, a maximum display value, or combinations thereof.

[0099] Example 20 - A method for preparing or displaying a signal from a subject, comprising: operating a processor to execute instructions to: receive a signal data set indicative of the signal from the subject; evaluate the received signal data set; determine a selected value of the received signal data set; output a selected set display range based on the determined selected value of the received signal data set; generate a graph including a trace of the received signal data set within the selected set display range; and receive an input indicative of the selected set display range; displaying the generated graph; wherein the selected set display range is operable to assist in an efficient display of at least a portion of the received signal data set.

[0100] Example embodiments are provided so that this disclosure will be thorough, and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. In some example embodiments, well- known processes, well-known device structures, and well-known technologies are not described in detail.

[0101] Instructions may be executed by a processor and may include software, firmware, or microcode, and may refer to programs, routines, functions, classes, data structures, and / or objects. The term shared processor circuit encompasses a single processor circuit that executes some or all code from multiple modules. The term group processor circuit encompasses a processor circuit that, in combination with additional processor circuits, executes some or all code from one or more modules. References to multiple processor circuits encompass multiple processor circuits on discrete dies, multiple processor circuits on a single die, multiple cores of a single processor circuit,multiple threads of a single processor circuit, or a combination of the above. The term shared memory circuit encompasses a single memory circuit that stores some or all code from multiple modules. The term group memory circuit encompasses a memory circuit that, in combination with additional memories, stores some or all code from one or more modules.

[0102] The apparatuses and methods described in this application may be partially or fully implemented by a processor (also referred to as a processor module) that may include a special purpose computer (i.e., created by configuring a processor) and / or a general purpose computer to execute one or more particular functions embodied in computer programs. The computer programs include processor-executable instructions that are stored on at least one non-transitory, tangible computer-readable medium. The computer programs may also include or rely on stored data. The computer programs may include a basic input / output system (BIOS) that interacts with hardware of the special purpose computer, device drivers that interact with particular devices of the special purpose computer, one or more operating systems, user applications, background services and applications, etc.

[0103] The computer programs may include: (i) assembly code; (ii) object code generated from source code by a compiler; (iii) source code for execution by an interpreter; (iv) source code for compilation and execution by a just-in-time compiler, (v) descriptive text for parsing, such as HTML (hypertext markup language) or XML (extensible markup language), etc. As examples only, source code may be written in C, C++, C#, Objective-C, Haskell, Go, SQL, Lisp, Java®, ASP, Perl, Javascript®, HTML5, Ada, ASP (active server pages), Perl, Scala, Erlang, Ruby, Flash®, Visual Basic®, Lua, or Python®.

[0104] Communications may include wireless communications described in the present disclosure can be conducted in full or partial compliance with IEEE standard 802.11 -2012, IEEE standard 802.16-2009, and / or IEEE standard 802.20-2008. In various implementations, IEEE 802.1 1 -2012 may be supplemented by draft IEEE standard 802.11 ac, draft IEEE standard 802.11 ad, and / or draft IEEE standard 802.1 1 ah.

[0105] A processor, processor module, module or ‘controller’ may be used interchangeably herein (unless specifically noted otherwise) and each may be replaced with the term ‘circuit.’ Any of these terms may refer to, be part of, or include: an Application Specific Integrated Circuit (ASIC); a digital, analog, or mixed analog / digitaldiscrete circuit; a digital, analog, or mixed analog / digital integrated circuit; a combinational logic circuit; a field programmable gate array (FPGA); a processor circuit (shared, dedicated, or group) that executes code; a memory circuit (shared, dedicated, or group) that stores code executed by the processor circuit; other suitable hardware components that provide the described functionality; or a combination of some or all of the above, such as in a system-on-chip.

[0106] Instructions may be executed by one or more processors or processor modules, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” or “processor module” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements. Moreover, the processor or processor module may automatically perform certain functions and / or analyses such as based on executing selected instructions. The instructions may be saved on a memory system. The instructions may include a process that is to be executed (e.g., an algorithm) for analyzing received data, making a determination, or performing additional acts including performing outputs such as to a user or subject.

[0107] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0108] The foregoing description of the embodiments has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit theinvention. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the invention, and all such modifications are intended to be included within the scope of the invention.

Claims

CLAIMSWhat is claimed is:1 . A system to evaluate for display of a signal from a subject, comprising: a processor configured to execute instructions to: receive a signal data set indicative of the signal from the subject; evaluating the received signal data set; determining a selected value of the received signal data set; and outputting a selected set display range based on the determined selected value of the received signal data set; wherein the selected set display range is operable to assist in an efficient display of at least a portion of the received signal data set.

2. The system of Claim 1 , further comprising: a display device; wherein the selected set display range includes a mean and a standard deviation and the selected set display range is configured to define a scale of a displayed axis displayed with the display device.

3. The system of any of the Claims 1 to 2, wherein the processor is configured to execute further instructions to determine a selected range of the received signal data set and outputting a complete set display range; wherein the complete set display range is configured to define a complete scale of the displayed axis displayed with the display device.

4. The system of any of the Claims 1 to 3, further comprising: an electrode configured to be positioned within the subject; wherein the electrode is configured to sense a signal within the subject.

5. The system of Claim 4, further comprising: an implantable medical device; and an transmitter included with the implantable medical device; wherein the electrode is connected to the implantable medical device and the transmitter is configured to transmit the sensed signal.

6. The system of any of the Claims 1 to 5, wherein the signal is an LFP signal in a brain of the subject.

7. The system of any of the Claims 1 to 6, wherein the processor executes the instructions to automatically determine the selected value of the received signal data set and output the selected set display range based on the determined selected value of the received signal data set.

8. The system of any of the Claims 1 to 7, wherein the selected set display range is determined to display at least one intensity of the signal less than a maximum intensity of the signal.

9. The system of any of the Claims 1 to 8, wherein the processor is configured to execute further instructions to receive an input including at least one of a motion sensor input, a selected time period range, an artifact definition, a maximum display value, or combinations thereof.

10. The system of any of the Claims 1 to 9, wherein the determined selected value of the received signal data set is based at least in part on at least the input.

11. A method for preparing or displaying a signal from a subject, comprising: receiving a signal data set indicative of the signal from the subject; evaluating the received signal data set; determining a selected value of the received signal data set; and outputting a selected set display range based on the determined selected value of the received signal data set; wherein the selected set display range is operable to assist in an efficient display of at least a portion of the received signal data set.

12. The method of Claim 11 , further comprising:operating a processor to execute instructions to at least determine the selected value of the received signal data set and output the selected set display range based on the determined selected value of the received signal data set.

13. The method of any of the Claims 11 to 12, further comprising: displaying at least the portion of the received signal data set within the selected set display range.

14. The method of Claim 13, wherein displaying at least the portion of the received signal data set within the selected set display range is displaying only the portion of the received signal data set within the output selected set display range.

15. The method of any of the Claims 11 to 14, wherein outputting the selected set display range includes a mean and a standard deviation and the selected set display range is configured to define a scale of a displayed axis with the display device.

16. The method of any of the Claims 11 to 15, wherein outputting the selected set display range includes determining to display at least one intensity of the signal less than a maximum intensity of the signal.

17. The method of any of the Claims 11 to 16, further comprising: determining a complete range of the received signal data set and outputting a selected set display range; wherein the complete set display range is configured to define a complete scale of the displayed axis displayed with the display device.

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