CN116569267A - Interactive clinician reports for medical device treatments - Google Patents

Abstract

A user interface of a computing device for programming a medical device, the user interface configured to review historical user session data when disconnected from the medical device. During a programming session, the user interface on the computing device may include features for controlling the functionality of the medical device and viewing and manipulating available data stored at the medical device. The user interface may use the programming user interface to interactively view screens and features and manipulate data while disconnected from the medical device and not in a real-time programming session, for example, as if an external programming device were in a real-time programming session with the medical device. As one example, the user interface of the external programming device may allow for flexible, wide-ranging manipulation and viewing of sensed signals, patient events, and operational information, such as patient adjustments made over time or concurrently with a particular signal or event.

Description

Interactive clinician reports for medical device treatments

This application is a PCT application claiming priority to U.S. Patent Application No. 17/454,454, filed November 10, 2021, which claims the benefit of U.S. Provisional Patent Application No. 63/124,481, filed December 11, 2020, The entire content of each application is incorporated herein by reference.

technical field

The present disclosure relates to medical devices and user interfaces for interacting with medical devices.

Background technique

Medical devices can be external or implanted and can be used to monitor patient conditions and/or deliver therapy to patients. Delivering therapy to a patient may include delivering electrical stimulation therapy to various tissue sites in the patient to treat various symptoms or conditions, such as chronic pain, tremors, Parkinson's disease, epilepsy, urinary or fecal incontinence, sexual Functional impairment, obesity, or gastroparesis. The medical device may monitor patient condition and/or deliver therapy via one or more leads comprising electrodes positioned near a target location associated with the patient's brain, spinal cord, pelvic nerves, peripheral nerves, or gastrointestinal tract . Thus, electrical stimulation can be used for different therapeutic applications, such as deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, targeted drug delivery (TDD) pumps or peripheral neural field stimulation (PNFS).

Contents of the invention

In general, this disclosure describes a user interface for an external programming device, such as for programming a medical device. The user interface is configured to present historical user session data to the user for review while disconnected from the medical device in a manner similar to the user interface used to program the medical device while connected to the medical device. As a medical device gains increased functionality, more features of the medical device can be programmed and more data can be used for analysis, such as more data related to sensed conditions, sensed signals, or operational data .

During a programming session, the user interface on the external programming device may include features for controlling functions of the medical device as well as viewing and manipulating available data. While disconnected from the medical device, the clinician may be limited to relatively static, non-interactive outputtable reports. However, in the present disclosure, the user interface can interactively display screens and features and allow the user to manipulate patient-specific data using the programming user interface, for example, as if the external programming device were in a live programming session with the medical device Same, but actually offline, eg disconnected from the medical device and not in a live programming session. As an example, the user interface of the external programming device may allow for flexible extensive manipulation and viewing of sensed signals, patient events, and operational data, such as over time based on actual data collected from a patient's medical device. A patient adjustment that is made over time or concurrently with one or more patient-specific signals or events.

Thus, the external programming device retrieves data in one format and manipulates or reconfigures the data into a uniform format similar to the format in which the data was presented during programming, while providing flexibility in viewing the data. Using a uniform user interface format, users can access and review data of interest more quickly than techniques that rely on non-interactive outputtable reports. Exemplary techniques may provide technical solutions with practical application by manipulating retrieved data for display in an interactive manner similar to display during a programming session.

In one example, the present disclosure describes a device that includes memory configured to store previous session data; a display screen configured to present a graphical user interface (GUI); processing circuitry that Processing circuitry is operatively coupled to the memory. When the device is communicatively disconnected from the medical device, the processing circuitry is configured to: retrieve previous session data from the memory, wherein the previous session data includes information related to one or more previous sessions with the medical device ; causing the GUI to present the retrieved information on the display screen; and causing the GUI to manipulate at least a portion of the retrieved information in response to user input received via the GUI.

In another example, the present disclosure describes a method comprising: communicatively connecting, by processing circuitry, communication circuitry to a medical device for a session with the medical device; download session data from the medical device by the processing circuitry and via the communication circuitry; store the session data at a memory location operatively coupled to the processing circuitry by the processing circuitry; The system disconnects the communication circuitry from the medical device; while communicatively disconnected from the medical device, previous session data is retrieved from the memory by the processing circuitry. The previous session data may include information related to one or more previous sessions with the medical device. The method also includes: causing, by the processing circuitry, a display screen to present the retrieved information on the display screen, wherein the display screen is configured to present a graphical user interface (GUI); responsive to user input received via the GUI, by The processing circuitry causes the GUI to manipulate at least a portion of the retrieved information.

In another example, the present disclosure describes a system that includes: a medical device; an external programming device having a display screen configured to present a graphical user interface (GUI); communication circuitry that communicates circuitry configured to be communicatively connected to the medical device for a session with the medical device; processing circuitry operatively coupled to memory and the communication circuitry, wherein when the external programming device communicates with the When the medical device is communicatively disconnected, the processing circuitry is configured to: retrieve previous session data from the memory, wherein the previous session data includes information related to one or more previous sessions with the medical device. The processing circuitry may also cause the GUI to present the retrieved information on the display screen; causing the GUI to manipulate at least a portion of the retrieved information in response to user input received via the GUI.

The details of one or more examples of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the present disclosure will be apparent from the description and drawings, and from the claims.

Description of drawings

FIG. 1 is a conceptual and schematic diagram illustrating an exemplary system including an implantable medical device (IMD) and leads implanted in a patient's brain.

2A and 2B are conceptual views of a recess in a patient's skull for receiving the IMD of Fig. 1 .

FIG. 3 is a conceptual and schematic block diagram of the IMD of FIG. 1 .

FIG. 4 is a conceptual and schematic block diagram of the exemplary external programmer of FIG. 1 .

5 is a conceptual diagram illustrating an example programming session selection screen for a user interface, according to one or more techniques of this disclosure.

6 is a conceptual diagram illustrating an example data set selection screen for a user interface, according to one or more techniques of this disclosure.

7 is a conceptual diagram illustrating an exemplary findings screen for spatial local field potential data.

FIG. 8 is a conceptual diagram illustrating an exemplary event summary screen.

FIG. 9 is a conceptual diagram illustrating an exemplary event timeline screen.

FIG. 10 is a conceptual diagram illustrating an exemplary local field potential classification bar graph.

11 is a conceptual diagram illustrating an exemplary screen for presenting a local field potential snapshot.

12 is a conceptual diagram illustrating an exemplary device usage bar graph event timeline screen.

FIG. 13 is a conceptual diagram illustrating an exemplary local field potential band display screen.

FIG. 14 is a conceptual diagram illustrating an exemplary streamed sensed signal screen.

FIG. 15 is a flowchart illustrating exemplary operation of the system of the present disclosure.

Detailed ways

This disclosure describes techniques for presenting interactive clinician reports of medical device treatments. An external device (e.g., an external programming device for programming and/or monitoring a medical device) may include a user interface configured to be disconnected from the medical device (e.g., not in active programming or monitoring session) present historical user session data using a user interface similar to that otherwise used to program and/or monitor a medical device. The external device can provide historical session data in an interactive manner, which can allow users to flexibly select and view various session information.

The phrase "while disconnected from the medical device" should not be interpreted as requiring that there be no communication between the programming device and the medical device. For example, periodic "ping" or other handshake type communications are possible, as a few non-limiting examples. In some examples, "while disconnected from the medical device" may mean that the programming device and/or the medical device is configured in a state where the programming device is not programming the medical device.

As a medical device gains increased functionality, more features of the medical device can be programmed and more data can be used for analysis, such as more data related to sensed conditions, sensed signals, or operational data . During a programming session, the user interface on the external programming device may include features for controlling functions of the medical device as well as viewing and manipulating available data. When disconnected from the medical device, the clinician may be limited to relatively static non-interactive outputtable reports, such as reports in .pdf, .csv, or .json format. While these reports may contain some data, these reports may limit the clinician's ability to manipulate and view broader data sets, eg, to zoom in to a specific condition, signal, event or point in time.

In the present disclosure, processing circuitry (e.g., of a programming device) may cause the user interface to interactively display screens and features and allow the user to manipulate data using the programming user interface as if the external programming device were in a real-time programming session with the medical device Same, but physically offline, eg disconnected from the medical device and not in a live programming session. In some examples, a record of all interactions with the medical device may be stored on an external programming device that serves as a repository for clinician session data. As an example, the user interface of the external programmer may allow flexible extensive manipulation and viewing of sensed signals, patient events, and operational data, such as patient behavior over time or concurrently with specific signals or events. Tuning, system state changes, system integrity checks, and telemetry interactions with external devices. For example, a user may provide input to the user interface to cause the processing circuitry to draw, zoom, filter, select, and deselect particular conditions, signals, events, or points in time. Viewing and manipulating available data while offline may provide advantages such as allowing clinicians to prepare and thereby reserve valuable clinical appointment time for interaction with a patient ahead of time.

In this manner, the user interface of the present disclosure may provide clinicians with an opportunity to review data offline and determine therapy or adjustments to treatment for a particular patient. Historical user session data patterns are different than, for example, training patterns. In training mode, the user can operate the user interface while offline, but based on a generic session dataset (i.e., "virtual" data) designed to highlight the functionality of the user interface, rather than viewing and manipulating data from one or more specific patients. the actual data.

In other words, the application executed by the processing circuitry of the external programmer of the present disclosure is configured to allow historical viewing of previous programming sessions using the same user interface as when actively programming an implanted device. The external programmer may use an interface where a user may provide input to the programmer's user interface to sort and filter the list of previous programming sessions and select programming sessions that the user may be interested in reviewing. Rather than just being able to export a canned report from this session, the application on the programmer can provide the user with the ability to repopulate and interact with the user interface of the programming application as viewed when the implanted device is actually programmed .

The techniques of the present disclosure address technical challenges unique to external programmers for medical devices. Technical solution of the present disclosure that an external programmer can retrieve data in a format and reconfigure that data into a format that is consistent with the format in which the data is presented during an online programming session For a technique for retrieving and analyzing data from a programmable medical device Environments are specific. The techniques of the present disclosure differ from those suggested by routine or routine use in the art, for example, exporting canned reports without interactively viewing the information contained in the reports or exporting report data (e.g., .csv, .json formats ) and the ability to configure external software tools to aid in reviewing that data. Furthermore, the technology of the present disclosure is necessarily derived from computer technology, such as exchanging data wirelessly using digital communication, and providing a unified presentation on a display screen in a manner familiar to the user while offline. In this way, the techniques of the present disclosure provide an improvement over conventional use because, when in a familiar, uniform format, users can access, understand, and review reports more quickly than techniques that rely on non-interactive outputtable reports the data of interest.

FIG. 1 is a conceptual diagram illustrating an example system 100 including an implantable medical device (IMD) 106 configured to deliver adaptive deep brain stimulation to a patient 112 . In other words, IMD 106 may be described in this disclosure as an electrical stimulation device. The example of FIG. 1 will focus on the DBS to simplify the description, but the techniques described can be applied to other devices as well. Exemplary medical devices include implantable deep brain stimulation (DBS) devices, spinal cord stimulation (SCS) devices, sacral nerve stimulation (SNS) devices, pelvic stimulation devices, and targeted drug delivery (TDD) devices.

The IMD 106 may respond to a change in patient activity or movement, the severity of one or more symptoms of the patient's disease, the presence of one or more side effects due to DBS, or one or more sensed signals of the patient, etc. A DBS may be adaptive in the sense that it adjusts, increases, or decreases the magnitude of one or more stimulation parameters of the DBS. For example, one or more sensed signals of the patient may be used as control signals such that IMD 106 correlates the magnitude of the one or more parameters of electrical stimulation with the magnitude of the one or more sensed signals.

In some examples, IMD 106 delivers electrical stimulation therapy with one or more parameters, such as voltage or current amplitude. For example, the system may sense a first neural signal (such as a signal in the beta band of the brain 120 of patient 112 within a first corresponding steady-state window) and a second neural signal (such as a signal in the beta frequency band of patient 112 within a second corresponding steady-state window). Signals within the gamma band of the brain 120). In one exemplary system, IMD 16 dynamically selects the first or second signal based on determining which of the first or second signal most accurately corresponds to the severity of one or more symptoms of the patient. one of the parameters in order to control the adjustment of the one or more parameters. In another example system, IMD 106 adjusts the one or more parameters based on a ratio of the first signal to the second signal. In some examples, the amplitude of one or more frequencies in the gamma frequency band increases with increasing stimulus intensity such that higher gamma frequency amplitudes may be associated with side effects. Conversely, the amplitude of one or more frequencies in the beta band decreases with increasing stimulus intensity, so that lower gamma frequency amplitudes can be associated with side effects (eg, dyskinesias).

The sensed signals, delivered therapy, and responses to therapy over time may be stored in memory of IMD 106 and subsequently retrieved, stored, and analyzed by programmer 104 . As one example, when programmer 104 and IMD 106 are communicatively connected, programmer 104 may retrieve and store information indicative of sensed signals, delivered therapy, etc. Related information about previous session data. Then, when disconnected from IMD 106 , programmer 104 may display information related to one or more previous sessions via a graphical user interface (GUI) in a manner similar to that displayed when connected to IMD 106 .

The above description of adaptive DBS is one example of adjusting one or more parameters during operation of IMD 106 . However, exemplary techniques are not limited thereto. For example, unlike adaptive DBS, IMD 106 may be configured to deliver therapy according to parameters that are not dynamically adjusted but can be adjusted by the patient or clinician. In addition to or instead of using a steady state window, there may be other ways of adjusting patient parameters.

In some examples, the medication taken by patient 112 is medication for controlling one or more symptoms of Parkinson's disease, such as tremor or stiffness due to Parkinson's disease. Such drugs include extended-release dopamine agonists; conventional dopamine agonists; controlled-release carbidopa/levodopa (CD/LD); conventional CD/LD, entacapone, ray Sagiline, selegiline, and amantadine. Typically, to set the upper and lower thresholds of the steady state window, the patient is off the drug, ie, the upper and lower thresholds are set when the patient is not taking the drug chosen to alleviate these symptoms. A patient is considered drug-naive if: for extended-release dopamine agonists, the patient has not taken drug for at least approximately 72 hours prior to the time at which the upper limit is set; for regular-release dopamine agonists and controlled-release For CD/LD, the patient has not taken the drug for at least approximately 24 hours; medicine for at least about 12 hours. If the stimulation only suppresses brain signals (eg, LFP signals), the system can measure these brain signals for various values of the stimulation parameters without external input. Once the upper and lower thresholds are established, the system can identify when the effect of the drug wears off because the brain signal will cross the lower or upper threshold. In response to identifying the brain signal crossing the threshold, the system may turn on electrical stimulation to restore the brain signal amplitude back between the lower threshold and the upper threshold.

As used herein, "reducing" or "suppressing" a patient's symptoms refers to a complete or partial alleviation of the severity of one or more symptoms in a patient. In one example, clinicians refer to the Unified Parkinson's Disease Rating Scale (UPDRS) or the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (UPDRS). Disease Rating Scale, MDS-UPDRS) to determine the severity of one or more symptoms of Parkinson's disease in patient 112. Discussion on the application of the MDS-UPDRS courtesy of the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Scale Presentation and Clinical Metrics Scale Presentation and Clinicimetric Testing Results, C. Goetz et al., Movement Disorders, Vol. 23, No. 15, pp. 2129-2170 (2008), the full text of which is included in into this article.

As described herein, the clinician determines the upper threshold of the steady state window when the patient is not taking medication and when the electrical stimulation therapy is being delivered to the brain 120 of the patient 112 via the IMD 106 . In one example, a clinician determines a point in time at which increasing the magnitude of one or more parameters defining electrical stimulation therapy, such as voltage amplitude or current amplitude, begins to cause one or more side effects in patient 112 . For example, the clinician may incrementally increase the magnitude of the one or more parameters defining the electrical stimulation therapy and determine a point in time at which further increases in the magnitude of the one or more parameters defining the electrical stimulation therapy cause perceivable side effects by the patient 112 .

In some examples, a clinician can use programmer 104 and while disconnected from IMD 106 to analyze the patient's condition, response to medication and electrical stimulation therapy. For example, clinicians can use the techniques of this disclosure to manipulate and view sensed signals, patient events, and operational data, such as patient follow-up appointments over time or concurrently with specific signals or events after a follow-up appointment when the patient is no longer present. Adjustment. Other examples of operational data may include system state changes, system integrity checks, and telemetry interactions with external devices. Based on the ability to interactively view the session data, the clinician can make changes, for example, to the patient's treatment plan to be implemented at subsequent follow-up appointments.

For example, as described above, the clinician determines the lower threshold when the patient is off medication and when electrical stimulation therapy is being delivered to the brain 120 of the patient 112 via the IMD 106 . In one example, a clinician determines a point in time at which reducing the magnitude of one or more parameters defining the electrical stimulation therapy causes one or more symptoms of patient 112 to break-through. The symptom flare may refer to the recurrence of at least some of the symptoms that were substantially suppressed up to the recurrence time point due to a decrease in the magnitude of the one or more electrical stimulation therapy parameters. For example, during a connected programming session, the clinician may gradually decrease the magnitude of one or more parameters defining the electrical stimulation therapy and determine the point in time at which symptoms of Parkinson's disease in patient 112 appear, as per the UPDRS or MDS- Patient 112 was measured by a sudden increase in tremor or stiffness scores, as specified in the UPDRS. In another example, the clinician measures a physiological parameter of the patient 112 related to one or more symptoms of the disease in the patient 112 (e.g., wrist flexion of the patient 112) and determines one or more parameters that define the electrical stimulation therapy A further decrease in the magnitude of causes a sudden exacerbation of one or more symptoms of the disease in patient 112 (eg, the point in time when patient 112 begins to experience inability to flex the wrist). While disconnected from the IMD 106, the clinician can later analyze the altered results and sensed signals.

At the magnitude of the one or more parameters defining the electrical stimulation therapy (at which time a further reduction in the magnitude of the one or more parameters defining the electrical stimulation therapy causes the one or more of the disease in the patient 112 sudden exacerbation of symptoms), the clinician measures the magnitude of the patient's 112 signal and sets this magnitude as the lower threshold of the steady state window. In some examples, the clinician may select the lower threshold of the steady-state window to be a predetermined amount higher than the magnitude of one or more electrical stimulation parameters when these symptoms of patient 112 first occurred during a decrease in magnitude, e.g. 5% or 10% higher to prevent these symptoms in Patient 112 during subsequent use.

In another example, the clinician sets the lower threshold by first ensuring that the patient is off medication that treats the one or more symptoms. In this example, a clinician delivers electrical stimulation having a value of the one or more parameters approximately equal to an upper threshold of a therapeutic window. In some examples, the clinician delivers electrical stimulation at values of the one or more parameters that are slightly below the magnitude that induces side effects in patient 112 . Typically, this results in a greater reduction in the one or more symptoms of the disease in patient 112 and thus a greater reduction in the signal. At the magnitude of the one or more parameters, the clinician measures the magnitude of the patient's 112 signal and sets the magnitude via external programmer 104 as the lower threshold of the steady state window. In some examples, the clinician may select the value of the lower threshold of the steady-state window to be a predetermined amount, such as 5% or 10%, higher than the magnitude at which these symptoms of patient 112 occur, to prevent the Patient 112's symptoms developed.

Additionally, in one example of the disclosed technology, the system monitors the patient for signals. In one example, the signal is a patient's neural signal, such as a signal within the beta or gamma band of the patient's brain. In yet another example, the signal is a signal indicative of a physiological parameter of the patient, such as severity of symptoms of the patient, position of the patient, respiratory function of the patient, or activity level of the patient.

The system delivers electrical stimulation to the patient via IMD 106, wherein one or more parameters defining the electrical stimulation are proportional to the magnitude of the monitored signal. IMD 106 may store parameters and sensed signals. Programmer 104 may download stored parameters, stored signals, and other data and store the information at a memory location within programmer 104 associated with patient 112 .

System 100 may be configured to treat a patient condition, such as a movement disorder, neurodegenerative injury, mood disorder, or epilepsy in patient 112 . Patient 112 is typically a human patient. In some cases, however, therapeutic system 100 may be applied to other mammalian or non-mammalian, non-human patients. While movement disorders and neurodegenerative injuries are primarily referred to herein, in other examples, therapy system 100 may provide therapy to manage symptoms of other patient conditions, such as, but not limited to, epilepsy (e.g., epilepsy) or mood (or psychological) Disorders (eg, major depressive disorder (MDD), bipolar disorder, anxiety disorder, post-traumatic stress disorder, dysthymic disorder, and obsessive-compulsive disorder (OCD)). At least some of these disorders may manifest as one or more of the patient's motor behaviors. As described herein, movement disorders or other neurodegenerative impairments can include symptoms such as impairment of muscle control, motor impairment, or other movement problems such as stiffness, spasticity, bradykinesia, rhythmic hyperkinesia, nonrhythmic hyperkinesia, and akinesia . In some instances, dyskinesias can be a symptom of Parkinson's disease. However, dyskinesias can be attributed to other patient conditions.

Exemplary therapeutic system 100 includes medical device programmer 104 , implantable medical device (IMD) 106 , lead extension 110 , and leads 114A and 114B with corresponding electrode sets 116 , 118 . In the example shown in FIG. 1 , electrodes 116 , 118 of leads 114A, 114B are positioned to deliver electrical stimulation to a tissue site within brain 120 , such as a deep brain site below the dura mater of brain 120 of patient 112 . In some examples, delivering stimulation to one or more regions of the brain 120 such as the subthalamic nucleus, globus pallidus, or thalamus may be an effective treatment for managing movement disorders such as Parkinson's disease. Some or all of the electrodes 116 , 118 may also be positioned to sense neurobrain signals within the brain 120 of the patient 112 . In some examples, some of electrodes 116 , 118 may be configured to sense neuro-brain signals and others of electrodes 116 , 118 may be configured to deliver adaptive electrical stimulation to brain 120 . In other examples, all of electrodes 116 , 118 are configured to sense neurobrain signals and deliver adaptive electrical stimulation to brain 120 .

IMD 106 includes a therapy module (e.g., which may include processing circuitry, signal generating circuitry, or other circuitry configured to perform the functions attributed to IMD 106) that includes a stimulation generator configured to Electrical stimulation therapy is generated and delivered to patient 112 via subsets of electrodes 116, 118 via leads 114A and 114B, respectively. The subset of electrodes 116, 118 used to deliver electrical stimulation to the patient 112, and in some cases, the polarity of the subset of electrodes 116, 118, may be referred to as a stimulating electrode combination. As described in further detail below, stimulation electrode combinations may be selected (eg, selected based on the patient's condition) for a particular patient 112 and target tissue site. The electrode sets 116, 118 include at least one electrode and may include a plurality of electrodes. In some examples, plurality of electrodes 116 and/or 118 may have complex electrode geometries such that two or more electrodes are located at different locations around the perimeter of the respective lead. In other words, in some examples, electrodes 116 and 118 may comprise ring electrodes surrounding the circumference of leads 114A and 114B. In other examples, one or more of electrodes 116 and 118 may be configured with complex geometries, such as segmented electrodes that encircle only a portion of the circumference of leads 114A and 114B.

In some examples, neural signals sensed within brain 120 may reflect current changes resulting from the sum of potential differences throughout brain tissue. Examples of neural brain signals include, but are not limited to, electrical signals generated by local field potentials (LFPs) sensed within one or more regions of the brain 120, such as electroencephalogram (EEG) signals or electrocorticograms (ECoG). Signal. However, local field potentials may include a wider variety of electrical signals within brain 120 of patient 112 .

In some examples, the neurobrain signals used to select stimulation electrode combinations may be sensed within the same region of brain 120 as the target tissue site for electrical stimulation. As previously noted, these tissue sites may include tissue sites within anatomical structures such as the thalamus, subthalamic nucleus, or globus pallidus of the brain 120, as well as other target tissue sites. A particular target tissue site and/or region within brain 120 may be selected based on the patient's condition. Thus, in some examples, the electrodes used to deliver electrical stimulation may be different than the electrodes used to sense neuro-brain signals. In other examples, the same electrodes can be used to deliver electrical stimulation as well as sense brain signals. However, this configuration can switch between stimulus generation and sensing circuitry and can reduce the amount of time the system can sense brain signals.

Electrical stimulation generated by IMD 106 can be configured to manage various disorders and conditions. In some examples, stimulation generator of IMD 106 is configured to generate and deliver electrical stimulation pulses to patient 112 via electrodes of a selected stimulation electrode combination. However, in other examples, the stimulation generator of IMD 106 may be configured to generate and deliver a continuous wave signal, such as a sine wave or a triangle wave. In either case, a stimulation generator within IMD 106 may generate electrical stimulation therapy for DBS according to a therapy program selected at a given time in therapy. In examples where IMD 106 delivers electrical stimulation in the form of stimulation pulses, a therapy program may include a set of therapy parameter values (e.g., stimulation parameters), such as the stimulation electrode combination used to deliver stimulation to patient 112, pulse frequency, pulse width, and The current or voltage amplitude of the pulse. As previously noted, an electrode combination may indicate the particular electrodes 116, 118 selected for delivering stimulation signals to the tissue of the patient 112, as well as the corresponding polarity of the selected electrodes. IMD 106 may also store electrode configurations, therapy and sensing parameter values, etc., in memory locations that may be retrieved by programmer 104 while in a connected programming session and analyzed by programmer 104 while disconnected.

IMD 106 may be implanted in a subcutaneous pocket above the collarbone, or alternatively, on or within skull 122 , or at any other suitable site within patient 112 . In general, IMD 106 is constructed of biocompatible materials that resist corrosion and degradation by bodily fluids. IMD 106 may include an airtight enclosure to substantially enclose components such as the processor, therapy module, and memory.

As shown in FIG. 1 , implant lead extension 110 is coupled to IMD 106 via connector 108 (also referred to as a connector block or tab of IMD 106 ). In the example of FIG. 1 , lead extension 110 traverses from the implant site of IMD 106 and along the neck of patient 112 to skull 122 of patient 112 to access brain 120 . In the example shown in FIG. 1 , leads 114A and 114B (collectively "leads 114") are implanted in the right and left hemispheres of patient 112, respectively, to deliver electrical stimulation to one or more regions of brain 120. , the one or more regions may be selected based on the patient condition or disorder being managed by the therapeutic system 100 . However, a particular target tissue site and stimulation electrodes for delivering stimulation to that target tissue site may be selected, for example, based on identified patient behavior and/or other sensed patient parameters. Other lead 114 and IMD 106 implantation sites are contemplated. For example, IMD 106 may be implanted on or within skull 122 in some examples. Either leads 114 may be implanted in the same hemibrain, or IMD 106 may be coupled to a single lead implanted in a single hemibrain.

As noted above, FIG. 1 may refer to an IMD 106 for deep brain stimulation therapy, but is not limited to referring to other types of medical devices. For example, IMD 106 may be used with leads 114 deployed anywhere in the head or neck, including, for example, leads deployed on or near the surface of the skull, leads deployed below the skull such as near or on the dura mater. , leads placed near cranial nerves or other nerves in the neck or head, or leads placed directly on the surface of the brain. Furthermore, IMD 106 is not limited to implanting near the collarbone or skull 122 . In other examples, IMD 106 may be implanted anywhere within patient 112 (eg, near the upper buttocks, near the abdominal region, near the chest region, etc.).

Existing lead sets include axial leads carrying ring electrodes arranged at different axial positions and so-called "paddle" leads carrying planar array electrodes. In some examples, more complex lead array geometries may be used.

Although leads 114 are shown in FIG. 1 as being coupled to common lead extension 110 , in other examples, leads 114 may be coupled to IMD 106 via separate lead extensions or directly to connector 108 . Leads 114 may be positioned to deliver electrical stimulation to one or more target tissue sites within brain 120 to manage patient symptoms associated with patient 112's movement disorders. Leads 114 may be implanted to position electrodes 116 , 118 at desired locations on brain 120 through corresponding holes in skull 122 . Leads 114 may be placed anywhere within brain 120 to enable electrodes 116, 118 to provide electrical stimulation to target tissue sites within brain 120 during treatment. For example, electrodes 116, 118 may be surgically implanted under the dura mater of brain 120 or within the cerebral cortex of brain 120 via a borehole in brain 122 of patient 112 and electrically coupled to the IMD via one or more leads 114. 106.

In the example shown in FIG. 1 , the electrodes 116 , 118 of the lead 114 are shown as ring electrodes. Ring electrodes can be used in DBS applications because they are relatively easy to program and can deliver an electric field to any tissue adjacent to the electrodes 116 , 118 . In other examples, the electrodes 116, 118 may have different configurations. For example, in some examples, at least some of the electrodes 116, 118 of the lead 114 may have complex electrode array geometries capable of generating a shaping electric field. Complex electrode array geometries may include multiple electrodes (eg, partial ring or segmented electrodes) around the outer perimeter of each lead 114 rather than one ring electrode. In this way, electrical stimulation can be directed from lead 114 in a specific direction to enhance therapeutic efficacy and reduce possible adverse side effects due to stimulation of large amounts of tissue. In some examples, the housing of IMD 106 may include one or more stimulation and/or sensing electrodes. In alternative examples, lead 114 may have a shape other than the elongated cylinder shown in FIG. 1 . For example, lead 114 may be a paddle lead, a ball lead, a bendable lead, or any other type of shape that is effective in treating patient 112 and/or minimizing lead 114 invasiveness.

In the example shown in FIG. 1 , IMD 106 includes memory for storing a plurality of therapy programs, each therapy program defining a set of therapy parameter values. In some examples, IMD 106 may select a therapy program from memory based on various parameters, such as sensed patient parameters and identified patient behavior. IMD 106 may generate electrical stimulation based on the selected therapy program to manage patient symptoms associated with movement disorders or other patient conditions.

External programmer 104 communicates wirelessly with IMD 106 as needed to provide or retrieve therapy information. Programmer 104 is an external computing device that a user (eg, a clinician and/or patient 112 ) can use to communicate with IMD 106 . For example, programmer 104 may be a clinician programmer that a clinician uses to communicate with IMD 106 and program IMD 106 with one or more therapy programs. Alternatively, programmer 104 may be a patient programmer that allows patient 112 to select a program and/or view and modify therapy parameters. Clinician programmers may include more programming features than patient programmers. In other words, the clinician-only programmer may allow more complex or sensitive tasks to prevent unintended changes to the IMD 106 by untrained patients. Some examples or more complex tasks limited to clinician programmers may include offline analysis and manipulation of data downloaded from the memory of IMD 106 in accordance with one or more techniques of this disclosure.

In other words, the application executed by the processing circuitry of programmer 104 is configured to allow historical viewing of previous programming sessions using the same user interface as when actively programming an implanted device. The clinician programmer may use an interface through which the user may provide input to the user interface of the programmer 104 to sort and filter previous programming sessions, thereby selecting programming sessions that the user may be interested in reviewing. However, rather than just being able to derive a fixed report from this session, the application on programmer 104 will provide the user with the ability to repopulate the user interface of the programming application as viewed when actually programming the implanted device. In addition, the user interface will be interactive such that the user can click on the screens and features of the programmed user interface as if they were in session with the medical device while offline, eg, when not communicatively connected to the medical device. This functionality can provide advantages over fixed reports, as an interactive graphical user interface can greatly enhance a user's ability to understand and analyze underlying information and determine a patient's treatment plan.

Programmer 104 may be used to transmit initial programming information to IMD 106 when programmer 104 is configured for use by a clinician. This initial information may include hardware information such as the type of lead 114 and electrode placement, the location of the lead 114 within the brain 120, the configuration of the electrode arrays 116, 118, the initial program defining the values of the therapy parameters, and the clinician's desire to program into the IMD 106. any other information in the . Programmer 104 is also capable of performing functional testing (eg, measuring the impedance of electrodes 116, 118 of leads 114).

A clinician may also store therapy programs within IMD 106 via programmer 104 . During a programming session, a clinician can determine one or more treatment programs that can provide effective treatment to patient 112 to address symptoms associated with the patient's condition, and in some cases, specific to a patient's condition. Symptoms of one or more different patient states, such as a sleeping state, a moving state, or a resting state. For example, a clinician may select one or more stimulation electrode combinations with which to deliver stimulation to brain 120 . During a programming session, the clinician may assess one or more physiological parameters (e.g., muscle activity, muscle tone, stiffness, tremor, etc.) ) Efficacy of the specific procedure assessed. A connection session may include a programming or monitoring session, and may include adjusting therapy parameters or other operational aspects; receiving sensed signals, conditions, events, and/or recorded operational information.

Alternatively, identified patient behavior from the video information may be used as feedback during the initial programming session and subsequent programming sessions. While communicatively connected or communicatively disconnected, eg, offline, programmer 104 may assist a clinician in creating/identifying a therapy program by providing a coherent system for identifying potentially beneficial therapy parameter values. In some examples, programmer 104 may operate by not actively participating in the actual programming or interrogation of the medical device while offline or communicatively disconnected. However, in some examples, programmer 104 may analyze and manipulate information from IMD 106 while offline, but may send or receive some communications from IMD 106 without initiating a full programming or interrogation session.

Programmer 104 may also be configured for use by patient 112 . When configured as a patient programmer, programmer 104 may have limited functionality (compared to a clinician) to prevent patient 112 from altering critical functions of IMD 106 or applications that may be harmful to patient 112 . In this manner, programmer 104 may only allow patient 112 to adjust the values of certain therapy parameters or to set available ranges of values for particular therapy parameters.

Programmer 104 may also provide an indication to patient 112 when therapy is being delivered, when patient input has triggered a therapy change, or when a power source within programmer 104 or IMD 106 needs to be replaced or recharged. For example, programmer 104 may include an alert LED, may send a message to patient 112 via the programmer display, generate an audible sound or somatosensory prompt to confirm receipt of patient input, eg, to indicate patient status or to manually modify therapy parameters.

Therapy system 100 may be implemented to provide chronic stimulation therapy to patient 112 over the course of months or years. However, the system 100 may also be used on a trial basis to evaluate therapy prior to full implantation. Certain components of system 100 may not be implanted in patient 112 if implemented temporarily. For example, patient 112 may be fitted with an external medical device, such as a trial stimulator, instead of IMD 106 . An external medical device may be coupled to a percutaneous or implanted lead via the percutaneous extension. If the trial stimulator indicates that the DBS system 100 is providing effective therapy to the patient 112, the clinician may implant a chronic stimulator into the patient 112 for relatively long-term therapy.

While IMD 106 is described as delivering electrical stimulation therapy to brain 120 , in other examples, IMD 106 may be configured to direct electrical stimulation to other anatomical regions of patient 112 . In other examples, system 100 may include an implantable drug pump in addition to or instead of IMD 106 . Further, the IMD may provide other electrical stimulation, such as spinal cord stimulation, to treat movement disorders, incontinence, or other patient conditions.

In one example, when communicatively connected, external programmer 104 issues commands to IMD 106 such that IMD 106 delivers electrical stimulation therapy via electrodes 116 , 118 via leads 114 . As described above, a therapy window defines upper and lower limits for one or more parameters that define the delivery of electrical stimulation therapy to patient 112 . For example, the one or more parameters include current amplitude (for current control systems) or voltage amplitude (for voltage control systems), pulse frequency or frequency, and pulse width. In examples where electrical stimulation is delivered in terms of "bursts" of pulses or a series of electrical pulses defined by an "on time" and an "off time," the one or more parameters may also define the number of pulses per burst , one or more of on-time and off-time. In one example, the therapy window defines upper and lower limits for one or more parameters, such as upper and lower thresholds for current amplitude for electrical stimulation therapy (in a current control system) or voltage amplitude for electrical stimulation therapy (in a voltage control system) The upper and lower thresholds of . While the examples herein are generally given with respect to adjusting voltage amplitude or current amplitude, the techniques herein are equally applicable to steady state and therapeutic windows using other parameters such as, for example, pulse frequency or pulse width. Exemplary embodiments of therapeutic windows are provided in further detail below.

In general, patient programmer 104 may not have authority to adjust any thresholds or limits for sensing or stimulation related to adaptive DBS. For example, the patient programmer 104 may only enable the patient to adjust stimulation parameter values between the limits set by the clinician programmer. However, in other examples, system 100 may provide adaptive DBS by allowing patient 112 to indirectly adjust the activation, deactivation, and amount of electrical stimulation, such as via patient programmer 104, by adjusting the lower and upper thresholds of the steady-state window. value. In one example, patient programmer 104 may only be enabled to adjust the upper or lower threshold by a small amount or percentage of the clinician set value. In another example, by adjusting one or both thresholds of the steady-state window, the patient 112 can adjust the point at which the sensed signal deviates from the steady-state window, thereby triggering the system 100 to operate within the threshold defined by the lower and upper thresholds of the therapeutic window. Adjust one or more parameters of the electrical stimulation within the parameter range.

In some examples, the patient may provide feedback, eg, via programmer 104, to adjust one or both thresholds of the steady state window. In another example, programmer 104 and/or IMD 106 may automatically adjust one or both thresholds of the steady state window and one or both thresholds of electrical stimulation within parameters defined by the lower and upper thresholds of the therapeutic window. multiple parameters. For example, IMD 106 may automatically adjust one or more thresholds (e.g., in some examples, an upper threshold and a lower threshold) of the steady-state window by, for example, responding to physiological parameters sensed by one or more sensors 109 of system 100. , thereby adjusting the delivery of the adaptive DBS. As another example, programmer 104 and/or IMD 106 may automatically adjust one or more thresholds of the steady-state window based on one or more physiological or neural signals of patient 112 sensed by IMD 106 . For example, in response to a deviation of the patient's signal outside the steady-state window, system 100 (e.g., IMD 106 or programmer 104) may define one or more parameters in a manner proportional to the magnitude of the sensed signal The one or more parameters defining the electrical stimulation therapy delivered to the patient are automatically adjusted within a therapy window of the lower threshold and the upper threshold. The adjustment of the one or more stimulation therapy parameters based on the deviation of the sensed signal may be proportional or inversely proportional to the magnitude of the signal.

Thus, in some examples, system 100 may adjust the steady state window based on patient input via programmer 104 or IMD 106 or based on one or more signals such as sensed physiological parameters or sensed neural signals, or both. or a combination of more to adjust one or more parameters of electrical stimulation, such as voltage or current amplitude, within a therapeutic window. Specifically, the system 100 may adjust parameters of the electrical stimulation automatically and/or in response to patient input that adjusts the steady-state window, provided that the values of the electrical stimulation parameters are constrained to remain within the values specified by the upper and lower thresholds of the therapeutic window. within range. The range can be considered to include the upper and lower thresholds themselves. In some examples, IMD 106 may store the patient adjustment at a memory location along with a timestamp of the adjustment.

Programmer 104 may download and store the adjustment record at a memory location of programmer 104 during a connected session. While communicatively disconnected, the clinician can provide inputs to the user interface that cause the processing circuitry of programmer 104 to manipulate the retrieved data by zooming in on the data (e.g., using zoom capabilities to adjust the time scale) to view Time-stamped session data for the selected duration. In other words, by zooming in, programmer 104 can graphically present a portion of the previous session's data along a portion of the time scale, eg, to present that portion of the data in more detail. In some examples, the clinician may compare the first portion of the first selected duration of session data along the time scale with the second portion of the first selected duration of session data. For example, a clinician may compare sensed brain signals for a selected duration to stored patient adjustments and/or electrical stimulation therapy delivered for the selected duration. Similarly, a user may compare changes over different time periods (eg, daily, weekly, different times of day such as sleep, wakefulness, activity, etc.) by providing input to the user interface of programmer 104 .

In other examples, based on input to the user interface, the processing circuitry of programmer 104 may filter and select specific data of interest. For example, the processing circuitry may present controls on the user interface for the user to intentionally select certain data and intentionally deselect other data that may be less relevant to the clinician's analysis goals.

In some examples where system 100 adjusts multiple parameters of electrical stimulation, system 100 may adjust at least one of voltage or current amplitude, stimulation frequency, pulse width, or electrode selection, among others. In such an example, the clinician may set an order or sequence for adjusting these parameters (eg, adjust voltage amplitude or current amplitude, then adjust stimulation frequency, then adjust electrode selection). In other examples, the system 100 may randomly select the sequence of adjustments for the plurality of parameters. In either example, system 100 may adjust the value of a first of these parameters of electrical stimulation. If the signal does not appear to respond to adjustment of the first parameter, system 100 may adjust the value of a second of these parameters of electrical stimulation, and so on, until the signal returns within the steady state window.

In some examples, each sensor within IMD 106 is an accelerometer, bonded piezoelectric crystal, mercury switch, or gyroscope. In some examples, these sensors may provide signals indicative of physiological parameters of the patient, which in turn vary according to patient activity. For example, the device may monitor signals indicative of the patient's heart rate, electrocardiogram (ECG) pattern, electroencephalogram (EEG) pattern, respiration rate, respiration volume, core body temperature, subcutaneous temperature, or muscle activity.

In some examples, the sensors generate signals based on both patient activity and patient position. For example, accelerometers, gyroscopes, or magnetometers may generate signals indicative of the activity and position of patient 112 . External programmer 104 may use such information about body position to determine whether external programmer 104 should perform an adjustment to the therapy window. Programmer 104 may also download and store signals from sensors, for example along a timeline, for online or later offline analysis.

For example, to recognize body position, sensors such as accelerometers may be oriented substantially orthogonally with respect to each other. In addition to being oriented orthogonally with respect to each other, each sensor for detecting the position of patient 112 may also be substantially aligned with the axis of patient 112's body. When the accelerometer is aligned in this manner, for example, the magnitude and polarity of the DC component of the signal generated by the accelerometer is indicative of the patient's orientation relative to Earth's gravity, such as the patient's 112 position. More information related to determining patient position using orthogonally aligned accelerometers can be found in commonly assigned US Patent No. 5,593,431 to Todd J. Sheldon, which is incorporated herein by reference in its entirety.

Other sensors that may generate signals indicative of the patient's 112 position include electrodes that generate signals based on electrical activity within the patient's 112 muscles, such as electromyographic (EMG) signals, or bonded piezoelectric crystals that generate signals based on muscle contractions. . Electrodes or bonded piezoelectric crystals may be implanted in the leg, hip, chest, abdomen, or back of patient 112 and coupled to one or more of external programmer 104 and IMD 106, either wirelessly or via one or more leads. By. Alternatively, when IMD 106 is implanted in the buttocks, chest, abdomen, or back of patient 112, the electrodes may be integrated into the housing of IMD 106, or piezoelectric crystals may be bonded to the housing. The signals generated by such sensors when implanted in these locations may vary based on the position of the patient 112, eg, may vary based on whether the patient is standing, sitting, or lying down.

Additionally, the patient's 112 position may affect the patient's thoracic impedance. Accordingly, the sensor may include an electrode pair including one electrode integrated with the housing of the IMD 106 and one of the electrodes 116, 118 that generates a signal based on the chest impedance of the patient 112 and based on which the IMD 106 may detect Patient 112's position or change in position. In one example (not depicted), the electrodes of the pair may be located on opposite sides of the patient's chest cavity. For example, the electrode pair may include electrodes located proximal to the patient's spine for delivering SCS therapy, and the IMD 106 with the electrodes integrated into its housing may be implanted in the abdomen or chest of the patient 112 . As another example, in addition to leads 114 implanted in the brain of patient 112, IMD 106 may include electrodes implanted to detect thoracic impedance. Position or changes in position can affect the delivery of DBS or SCS therapy to patient 112 for the treatment of any type of neurological disorder, and can also be used to monitor patient sleep, as described herein. Programmer 104 may download and store sensor signals and neural signals, for example, where neural signals may include brain signals, neural signals, or muscle signals.

Additionally, changes in the patient's 112 position may cause pressure changes in the patient's cerebrospinal fluid (CSF). Accordingly, the sensor may include a pressure sensor coupled to one or more intrathecal catheters or intraventricular catheters, or a pressure sensor coupled to IMD 106 wirelessly or via one of leads 114 . Changes in CSF pressure associated with body position changes can be particularly evident in the patient's brain, eg, in intracranial pressure (ICP) waveforms.

Thus, in some examples, instead of monitoring the patient's neural signals, system 100 monitors one or more signals from sensors indicative of the magnitude of a physiological parameter of patient 112 . Upon detecting that one or more signals from the sensors exceed the upper limit of the steady state window, the system 100 increases stimulation at a maximum ramp rate determined by the clinician until the one or more signals from the sensors return within the steady state window, or Until the magnitude of the electrical stimulation reaches the upper limit of the therapeutic window determined by the clinician. Similarly, upon detecting that one or more signals from the sensors fall below the lower limit of the steady state window, the system reduces stimulation at a maximum ramp rate determined by the clinician until the one or more signals from the sensors return to within the steady-state window, or until the magnitude of the electrical stimulation reaches the lower limit of the therapeutic window as determined by the clinician. The system keeps the magnitude of the electrical stimulation constant upon detecting that one or more signals from the sensor are within the threshold of a steady state window.

Furthermore, such a system 100 may use external sensors (such as accelerometers) instead of internal sensors (such as electrodes) to detect symptoms of a patient's disease and control adjustments to the magnitude of one or more parameters of the therapy. For example, the system 100 may use wrist sensors to detect wrist flexion or tremor in a patient with Parkinson's disease. Programmer 104 may download and store data from other sensors via data stored by IMD 106 directly from external sensors (eg, wrist sensors) or via a server that stores information retrieved from external sensors.

The architecture of system 100 shown in FIG. 1 is shown as an example. The techniques set forth in this disclosure may be implemented in the exemplary system 100 of FIG. 1 , as well as other types of systems not specifically described herein. For example, a clinician may determine an upper threshold and a lower threshold for a steady state window. In other examples, one of external programmer 104 and IMD 104 determines the upper and lower thresholds of the steady state window. Additionally, external programmer 104 or IMD 106 may receive signals representative of patient 112 signals and determine adjustments to one or more parameters defining electrical stimulation therapy delivered by IMD 106 to patient 112 . Nothing in this disclosure should be construed to limit the techniques of this disclosure to the exemplary architecture shown in FIG. 1 .

2A is a conceptual diagram illustrating an exemplary system including a cranial implantable medical device and leads. In example FIGS. 2A and 2B , system 200 is an example of system 100 described above with respect to FIG. 1 , and components of system 200 have the same functions and characteristics as described for components of system 100 .

Like system 100, system 200 in the example of FIG. 2A includes an IMD, such as IMD 212, in combination with a patient 218, which is typically a human patient. In some examples, IMD 212 may be a chronic electrical stimulator that remains implanted in patient 218 for weeks, months, or years. In the example of FIG. 2A , leads 214 are received by IMD 212 and similarly implanted in patient 218 . Lead 214 passes through brain tissue of patient 218 to a target site in patient 218's brain. IMD 212 and leads 214 may be directed to deliver DBS therapy, such as by sensing the patient's biocomputer signals, motion signals, etc. and/or delivering electrical stimulation to the patient's 218 brain. In other examples, system 200 may include two or more leads, eg, as described above with respect to FIG. 1 (not shown in FIG. 2A ). In other examples, IMD 212 may be a temporary or trial stimulator for screening or evaluating the efficacy of electrical stimulation for chronic therapy, or IMD 212 may be a local field potential (LFP) sensing for improved medical diagnosis or detection device.

In the example shown, leads 214 received by IMD 212 extend through holes in skull 232 to enter the brain of patient 218 . In some examples, one or more leads 214 of system 10 may include lead extensions or other sections that may aid in implantation or positioning of leads 214 . Leads 214 may include a plurality of electrodes, and IMD 212 may deliver stimulation to the brain of patient 218 via the electrodes. IMD 212 may receive any number of leads 214 . The proximal end of lead 214 may include a connector (not shown) that is electrically coupled to the head of IMD 212 . In some examples, IMD 212 may receive two leads 214 that extend through a single hole in skull 232 or through two separate holes in skull 232 (e.g., to access the brain of patient 218). separate hemispheres). Alternatively, system 10 may include two IMDs 212 each receiving a single lead 214 that extends through a corresponding hole in skull 232 to a corresponding hemisphere of patient 218 brain. Alternatively, in some examples, IMD 212 may not receive any leads 214 (not depicted).

IMD 212 may be implanted adjacent to the outer surface of skull 20 such that the surface of IMD 212 is configured to be secured to skull 232 . Because IMD 212 is configured to be implanted adjacent to skull 232 of patient 218, system 10 may include relatively shorter leads 214 than would be the case if IMD 212 were implanted at a relatively more distant location, as described above with respect to FIG. IMD 106 as described. The relatively short leads 214 of the system 200 can advantageously improve the accuracy of any sensors acquiring information or electrodes providing therapy by reducing noise attributable to the leads 214 . Shorter leads 214 may also advantageously reduce the negative impact of imaging techniques, such as Magnetic Resonance Imaging (MRI), on a person implanted with IMD 212 .

As noted above, leads 214 may include one or more electrodes that are implanted or otherwise placed adjacent to the target tissue. One or more electrodes may be disposed at the distal end of lead 214 and/or at other locations along lead 214 at intermediate points. Electrodes of leads 214 may deliver electrical stimulation (eg, generated by an electrical stimulation generator in IMD 212 ) to tissue of patient 218 . The electrodes may be electrode pads on paddle leads, circular (e.g., ring) electrodes surrounding the body of the lead, conformal electrodes, cuff electrodes, segmented electrodes, or capable of forming monopolar, bipolar, multipolar electrodes for therapy. Any other type of electrode in a polar electrode configuration. In general, ring electrodes disposed at different axial positions of the distal end of lead 214 will be described for purposes of illustration.

While leads 214 are described as generally delivering or transmitting electrical stimulation signals, leads 214 may additionally or alternatively transmit electrical signals from patient 218 to IMD 212 for monitoring. For example, IMD 212 may additionally or alternatively monitor one or more physiological parameters and/or activities of patient 218 and may include sensors for these purposes. One or more sensors may be provided in addition to or instead of therapy delivery through lead 214 . Using these sensors, IMD 212 may utilize detected nerve impulses to diagnose the condition of patient 218 or adjust delivered stimulation therapy. For example, IMD 212 may additionally or alternatively monitor one or more physiological parameters and/or activities of patient 218 . In the case of delivering therapy, IMD 212 may operate in an open-loop mode (also referred to as non-responsive operation) or in a closed-loop mode (also referred to as responsive or adaptive, as described above with respect to FIG. 1 ). IMD 212 may also provide warnings based on monitoring.

Alternatively or additionally, leads 214 and IMD 212 may be configured to provide other types of therapy by delivering therapeutic agents to target tissues of patient 218 . For example, IMD 212 may additionally or alternatively deliver a therapeutic agent, such as a pharmaceutical, biological, or genetic agent. In these examples, lead wire 214 may serve as a catheter, or IMD 212 may otherwise be mechanically attached to the catheter. Further, IMD 212 may include a pump to deliver therapeutic agents via the catheter.

Housing 216 of IMD 212 may be constructed of any polymer, metal, or composite material sufficient to contain the components of IMD 212 (eg, those shown in FIG. 3 ) within patient 218 . In this example, IMD 212 may be constructed with a biocompatible housing, such as titanium (e.g., grade 23, 5, 9, or commercially pure titanium) or stainless steel, or a polymeric material, such as silicone or polyurethane, or a combination of them. In some examples, IMD 212 can include housing 216 made of a relatively rigid biocompatible material (eg, titanium or stainless steel) and a housing 216 made of a relatively flexible biocompatible material (eg, silicone or low-density polyethylene). (LDPE)) and receive the tethering member of the lead wire 214. The housing (and, where applicable, the tether) of IMD 212 may be configured to provide a hermetic seal for the components. Additionally, the housing of IMD 212 may be selected from materials that facilitate receiving energy (eg, using electrical current from an electromagnetic field) to charge the internal power source. The materials and construction of IMD 212 of the present disclosure may be selected such that IMD 212 is MRI compatible such that a patient with IMD 212 secured to the patient can undergo an MRI with substantially no damage to IMD 212 or the MRI device.

In operation, a user, such as a clinician or patient 218 , may interact with a user interface of external programmer 222 to program IMD 212 . For example, programmer 222 may transmit programs, parameter adjustments, program selections, group selections, or other information to control the operation of IMD 212, eg, via wireless telemetry or a wired connection. For example, as described above with respect to FIG. 1 , the processing circuitry of external programmer 222 may program one or more therapy parameter settings of the medical device when communicatively connected to the medical device for a session. Programmer 222 may download data from the medical device, such as one or more of sensed signals, conditions, events, and operations from the medical device, and store the downloaded data at a memory of programmer 222 . In the present disclosure, conditions may include patient conditions such as movement disorders, neurodegenerative injuries, mood disorders, chronic pain, and the like. Conditions can also refer to environmental conditions (such as warm or cold temperatures) and short-term conditions (such as fever, hypoglycemia or hyperglycemia, etc.). Events can be associated with one or more time periods. Exemplary events may be patient events indicated by the patient when these events occur, such as taking medication, falls, dyskinesia events, and "time to get better." "Time to better" can be the amount of time a patient feels well and symptoms have been reduced or eliminated. Other events may be certain types of signals sensed by IMD 212 over a certain period of time. Some examples of sensed events may include a sensed signal exceeding a threshold, a particular pattern (eg, a power shift from a first sub-band to a second sub-band), an indication of epileptic activity at a certain time, and the like. In other examples, session data may include continuous monitors of underlying brain activity, such as continuous data streams as well as specific events.

In some examples, programmer 222 can automatically retrieve information from IMD 212 , such as current session or previous session information, which can be used for later offline analysis. In other examples, programmer 222 may retrieve information from IMD 212 in response to user input received via a graphical user interface (GUI) or other user interface of programmer 222 . In some examples, the retrieved information also includes one or more electrical stimulation parameter values associated with electrical stimulation therapy delivered by the medical device, as described above with respect to FIG. 1 .

While communicatively connected to IMD 212, a user (eg, a clinician) can present and/or manipulate the retrieved information. Additionally, programmer 222 may also present retrieved information, including presenting operational information for the medical device, while disconnected from IMD 212 (eg, offline), as described above with respect to FIG. 1 . Operational information may include operational settings and operational data. Examples of operational settings may include programmed settings of IMD 212, such as device configuration, eg, stimulation amplitude, pulse width, rate, therapy delivery electrode selection, sensing frequency band, sensing electrodes, adaptive therapy parameters, patient adjustable parameters, and the like. Examples of operational data may include patient adjustments to stimulation parameters using a patient programmer, such as turning electrical stimulation therapy on or off, increasing/decreasing therapy energy, and therapy program changes. Operational data may also include system state changes (e.g., battery charging, battery depletion, and MRI mode entry/exit), system integrity checks (e.g., lead impedance checks and lead integrity checks), and communication with other external devices, including patient programming telemetry interaction with devices, clinician programmers, chargers, data upload tools, etc.).

In other examples, programmer 222 may be configured to perform statistical analysis on the retrieved information in order to manipulate the retrieved information, for example, the processing circuitry of programmer 222 may perform various statistical calculations, including mean, median, Mode, deviation, kurtosis, skewness, etc. The processing circuitry may present the statistical analysis as tables, graphs, histograms, and other similar presentations. Other examples of manipulating data may include selecting or deselecting data sets, sorting, changing time scales, zooming, scrolling, and filtering data. As described above with respect to FIG. 1 , the processing circuitry of programmer 222 can reconfigure the data off-line into a uniform format similar to the format in which the data was presented when communicatively coupled during programming.

In some examples, manipulating and presenting information can include presenting sensed signals, conditions, events, and actions for the same patient over two or more time periods (eg, multiple sessions), which can help define patient 218 or any variation or lack thereof in IMD 212. In other words, the user interface of programmer 222 may present user-selectable controls for the user to select a single session or to select two or more sessions. For multiple sessions, the processing circuitry of programmer 222 may stitch together a long stream of events based on the multiple sessions and cause the user interface to present controls for the user to scroll through the events and select and/or zoom in on events from the multiple sessions. specific event. For example, the processing circuitry may cause the user interface to display a view of all impedance/lead integrity tests of the same implantable device to show possible trends or patterns.

In other examples, programmer 222 may display patient-specific programming settings as well as other information retrieved from IMD 212 . Examples of retrieved information may also include one or more electrical stimulation parameter values associated with electrical stimulation therapy delivered by IMD 212 . In other examples, programmer 222 may select from different data sets for different patients in response to user input to the user interface. In other words, programmer 222 may display information from two or more patients, and display the various sessions of those patients for selection by the user. In some examples, the processing circuitry of programmer 222 may retrieve previous session data from a "cloud-based" review system or "digital wellbeing" platform that includes data from multiple external programmers. In some examples, programmer 222 may download data to memory of programmer 222 to retrieve, view, and manipulate previous session data. In other examples, the selection, viewing and storage of previous sessions may be server or cloud based, where previous session data may flow to and from programmer 222 during an online connection session to a central memory storage location. When offline previous session data is presented, programmer 222 may retrieve previous session data not only from local storage but also from combined cloud storage for many external programmers. The user can provide input to the user interface to present data from similar patients with similar conditions, compare treatment settings, which can help define the profile of one or more of the selected patients or different patients with similar conditions or exhibiting similar symptoms. treatment plan.

In some examples, the processing circuitry may perform some comparative analysis and present the analysis to the user. As just one example, based on user input, the processing circuitry of programmer 222 may display the frequency activity of two different patients and provide a comparative analysis, such as a percentage difference between the peaks of frequency activity, superimposing one frequency plot on the other to highlight similarities and/or differences etc.

FIG. 2B is a top view further illustrating IMD 212 implanted on skull 232 of patient 218 . The location on skull 232 where IMD 212 is shown implanted in FIG. 2B is depicted for illustrative purposes only, as IMD 212 may be implanted anywhere on the surface of skull 232 . To implant IMD 212 on skull 20 , a clinician may make an incision 224 through the scalp of patient 218 and pull the resulting flap back to expose a desired area of skull 232 . When system 10 includes more than one IMD 212 , the clinician can position both IMDs 212 under the same area under the flap of skull 232 .

Bore 26 may be drilled through skull 20 after which leads 214 may be inserted through bore 26 into the brain of patient 218 . As discussed above, in examples where system 10 includes more than one lead 214 , more than one bore 26 may be drilled through skull 232 . In some examples, a cap may be placed over bore 26 . One or more leads 214 may be connected to IMD 212 directly or via lead extensions, and IMD 212 may be placed at least partially within a pocket formed adjacent bore 26 under the scalp using a hand or tool. In some examples, IMD 212 is placed fully or partially within recess 228 partially drilled into skull 232 . Recess 228 may allow housing 216 of IMD 212 to be seated closer to the outer surface of skull 20 , thereby reducing the profile of IMD 212 relative to the outer surface of skull 232 . The shape and size of housing 216 may dictate the shape and size of recess 228 . In some examples, IMD 212 may include curved or angled housing 216 to approximate the curvature of skull 232 . Configuring housing 216 to approximate the curvature of skull 232 can further reduce the profile of IMD 212 and/or increase the extent to which IMD 212 can be securely attached to skull 232 .

In some examples, once positioned (or partially sunk) on skull 232 within the pocket as desired, IMD 212 may then be sutured directly to surrounding tissue using attachment mechanisms (such as bone screws), sutured to a fixed (screwed) Mechanical components (eg, anchors) into the skull, fastened with various types of straps (eg, non-metallic straps) that screw down, etc. are secured to the skull 232 . The flap can be closed on the IMD 212 and the incision can be stapled or sutured.

3 is a block diagram of an exemplary implantable medical device in accordance with one or more techniques of this disclosure. IMD 106 in the example of FIG. 3 is an example of IMD 106 depicted in FIG. 1 and IMD 212 depicted in FIGS. 2A and 2B , and may have the same or similar functions as those described above with respect to FIGS. 1-2B and properties. For example, IMD 106 is connected to electrode 116 of lead 114A and electrode 118 of lead 114B to sense bioelectrical signals and deliver electrical stimulation therapy, as described above with respect to FIGS. 1 , 2A, and 2B. The example of FIG. 3 shows two leads 114A and 114B, but in other examples, the medical device of the present disclosure may be connected to a single lead or to two or more leads (not shown in FIG. 3 ).

In the example shown in FIG. 3, IMD 106 includes processor 210, memory 211, stimulation generator 202, sensing module 204, switching module 206, telemetry module 208, sensor 212, recharging coil 242, connection interface 240, and power supply. 220. Each of these modules may be or include circuitry configured to perform the functions attributed to each respective module. For example, processor 210 may include processing circuitry, connection interface 240 may include switching circuitry, sensing module 204 may include sensing circuitry, and telemetry module 208 may include telemetry circuitry. In some examples where IMD 106 includes multiple current source and current sink configurations, IMD 106 may not include connection interface 240 . Memory 211 may be operatively connected to processing circuitry 210 and may include any volatile or nonvolatile media, such as random access memory (RAM), read only memory (ROM), nonvolatile RAM (NVRAM), ), Electrically Erasable Programmable ROM (EEPROM), flash memory, etc. Memory 211 may store computer readable instructions that, when executed by processor 210 , cause IMD 106 to perform various functions. Memory 211 may be a storage device or other non-transitory medium.

In the example shown in FIG. 3 , memory 211 stores therapy program 214 and electrode combination 218 in a separate memory within memory 211 or in a separate area within memory 211 . Each stored therapy program 214 defines a specific set of electrical stimulation parameters (eg, a therapy parameter set), such as stimulating electrode combination, electrode polarity, current or voltage amplitude, pulse width, and pulse frequency. In some examples, individual treatment programs may be stored as treatment groups, which define a set of treatment programs that may be used to generate stimuli. The stimulation signals defined by the treatment programs of the treatment groups may be delivered together on an overlapping or non-overlapping (eg, time-staggered) basis.

Sensing and stimulating electrode combinations 218 stores sensing electrode combinations and associated stimulating electrode combinations. As noted above, in some examples, the sensing and stimulating electrode combinations may include the same subset of electrodes 116, 118, the housing of IMD 106 used as electrodes, or may include a different subset or combination of such electrodes. Accordingly, the memory 211 may store a plurality of sensing electrode combinations and, for each sensing electrode combination, store information identifying the stimulating electrode combination associated with the respective sensing electrode combination. The association between the sensing electrode combination and the stimulating electrode combination can be determined, for example, by a clinician or automatically by the processor 210 . In some examples, corresponding sensing electrode combinations and stimulating electrode combinations may include some or all of the same electrodes. However, in other examples some or all of the electrodes in the corresponding sensing and stimulating electrode combinations may be different. For example, a stimulating electrode combination may include more electrodes than a corresponding sensing electrode combination in order to increase the efficacy of stimulation therapy. In some examples, as discussed above, stimulation may be delivered via a stimulating electrode combination to a tissue site that is different from the tissue closest to the corresponding sensing electrode combination but within the same region of the brain 120 (e.g., the thalamus). site in order to mitigate any irregular oscillations or other irregular brain activity within the tissue site associated with the sensing electrode combination. An external device (eg, external programmer 104 described above with respect to FIG. 1 ) can download specific settings and combinations of settings from memory 211 and store those settings.

Under the control of processor 210 , stimulation generator 202 generates stimulation signals for delivery to patient 112 via selected combinations of electrodes 116 , 118 . Exemplary ranges of electrical stimulation parameters believed to be effective in managing a patient's dyskinesias in DBS include:

1. Pulse frequency, ie frequency: between about 40 Hz and about 500 Hz, such as between about 40 Hz and 185 Hz or such as about 140 Hz.

2. For the voltage control system, the voltage amplitude: between about 0.1 volts and about 50 volts, such as between about 2 volts and about 3 volts.

3. In the alternative case of a current control system, current amplitude: between about 0.2 mA to about 100 mA, such as between about 1.3 mA and about 2.0 mA.

4. Pulse width: between about 10 microseconds and about 5000 microseconds, such as between about 100 microseconds and about 1000 microseconds, or between about 180 microseconds and about 450 microseconds.

Thus, in some examples, stimulation generator 202 generates electrical stimulation signals based on the electrical stimulation parameters described above and is applied to one or more of these parameters in accordance with upper and lower thresholds of the therapeutic window such that the applicable parameters lie within the window prescribed. In the range. Various ranges of treatment parameter values may also be useful and may depend on the target stimulation site within the patient 112 body. Although stimulation pulses are described, the stimulation signal may be in any form, such as a continuous time signal (eg, a sine wave), or the like.

Processor 210 may include fixed-function processing circuitry and/or programmable processing circuitry, and may include, for example, one or more of the following: a microprocessor, a controller, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), Field Programmable Gate Array (FPGA), discrete logic circuitry, or any other processing circuitry configured to provide the functionality attributed to processor 210, which may be firmware, hardware, software, or their any combination of . Processor 210 may control stimulation generator 202 according to a therapy program 214 stored in memory 211 to apply one or more program-specified values for particular stimulation parameters, such as voltage or current amplitude, pulse width, or pulse frequency.

In the example shown in FIG. 3 , the set of electrodes 116 includes electrodes 116A, 116B, 116C, and 116D, and the set of electrodes 118 includes electrodes 118A, 118B, 118C, and 118D. Processor 210 also controls connection interface 240 to apply stimulation signals generated by stimulation generator 202 to selected combinations of electrodes 116 , 118 . In particular, connection interface 240 may couple stimulation signals to selected conductors within leads 114 , which in turn deliver stimulation signals across selected electrodes 116 , 118 . Connection interface 240 may include any type of circuitry that connects stimulation and sensing circuitry to electrodes on one or more leads connected to IMD 106 . In other words, the connection interface 240 may be configured to selectively couple stimulation energy to selected electrodes 116, 118, such as via contacts, connection terminals, any switch, switch array, switch matrix, multiplexer, and Any other type of switching module that selectively senses neurobrain signals with selected electrodes 116, 118 provides interconnection of the stimulation and sensing circuitry with the electrodes.

In some examples, IMD 106 may sense or apply electrical stimulation signals to any electrode, eg, an electrode may be dual purpose in that an electrode may be selectively used for stimulation delivery or sensing. In some examples, one or more switches may selectively connect or activate stimulation circuitry or sensing circuitry. In some examples, stimulation circuitry 202 may be time multiplexed across different electrodes of one or more of leads 114A and 114B to deliver stimulation. In other examples, each electrode may have its own separate current regulator (eg, current source and current sink). In this manner, IMD 106 may not require the functionality of connection interface 240 for time-staggered multiplexing. Alternatively, processing circuitry 210 may cause stimulation circuitry 202 to selectively activate corresponding regulators and drive corresponding electrode combinations (eg, as cathodes or anodes) to provide current steering to specific tissues within the patient.

In other words, stimulus generator 202 may be a single-channel or multi-channel stimulus generator. Specifically, stimulation generator 202 may be capable of delivering a single stimulation pulse, multiple stimulation pulses, or a continuous signal at a given time via a single electrode combination, or multiple stimulation pulses at a given time via multiple electrode combinations. As noted above, stimulation generator 202 and connection interface 240 may be configured to deliver multiple channels on a time-staggered basis. For example, connection interface 240 may be used to time-share the output of stimulation generator 202 across different electrode combinations at different times to deliver multiple programs or channels of stimulation energy to patient 112 .

The electrodes 116, 118 on the respective leads 114 can be constructed from a variety of different designs. For example, one or both of leads 114 may include two or more electrodes at each longitudinal position along the length of the lead, such as at each of positions A, B, C, and D around Multiple electrodes at different peripheral locations around the perimeter of the lead. In one example, the electrodes may be electrically coupled to the connection interface 240 via respective wires that are straight or coiled within the lead's housing and extend to a connector at the proximal end of the lead. In another example, each of the electrodes of the lead may be an electrode deposited on a thin film. The membrane may include a conductive trace for each electrode that extends along the length of the membrane to the proximal connector. The film may then be wrapped (eg, spiral wrapped) around the internal components to form leads 114 . These and other configurations can be used to form leads with complex electrode geometries.

In various examples, lead 114A and lead 114B may each carry a plurality of electrodes, such as four, eight, or sixteen electrodes. In the example of FIG. 3 , each lead 114A and 114B carries four electrodes that may be configured as ring electrodes and/or electrodes at different axial locations (or levels) near the distal end of lead 114 . Or segmented electrodes at different axial positions. As an example, lead wires 114 may each include two ring electrodes at two different axial positions, and between the two ring electrodes, lead wires 114 may include a plurality of segmented electrode sets, wherein the plurality of sets A segmented electrode set includes two or more electrodes all at approximately the same axial position. For example, one segmented electrode set may be arranged as multiple segmented electrodes at the same axial position but at different circumferential positions along the length of the lead. Another set of segmented electrodes may be arranged as another plurality of segmented electrodes at another axial position along the length of the lead but at a different circumferential position. The ring electrode may extend around the circumference of the lead at a given axial position of the lead. In some examples, at least some of the segmented electrodes can be independently addressable to allow targeted delivery of stimulation and/or targeted sensing of neural signals. Throughout the remainder of this disclosure, for the sake of brevity, this disclosure generally refers to electrodes carried on "leads", which may be "electrode portions" or the entire lead.

Although sensing module 204 is incorporated into a common housing along with stimulus generator 202 and processor 210 in FIG. The communication technology communicates with the processor 210 . Exemplary neuro-brain signals include, but are not limited to, signals generated by local field potentials (LFPs) within one or more regions of a patient's brain. EEG and ECoG signals are examples of local field potentials that can be measured in the brain. However, local field potentials can include a wider variety of electrical signals within the patient's brain.

Sensors 212 may include one or more sensing elements that sense values of respective patient parameters. For example, sensors 212 may include one or more accelerometers, optical sensors, chemical sensors, temperature sensors, pressure sensors, or any other type of sensor. Sensors 212 can output patient parameter values that can be used as feedback to control therapy delivery. IMD 106 may include additional sensors within the housing of IMD 106 and/or coupled via one of leads 114 or other leads. Additionally, IMD 106 may wirelessly receive sensor signals from remote sensors, eg, via telemetry module 208 . In some examples, one or more of these remote sensors may be located outside the patient's body (eg, carried on the outer surface of the skin, attached to clothing, or otherwise positioned outside the patient's body).

Telemetry module 208 supports wireless communication between IMD 106 and external programmer 104 or another computing device described above with respect to FIG. 1 , eg, under the control of processor 210 . As an update to the program, processor 210 of IMD 106 may receive values for various stimulation parameters, such as magnitude and electrode combination, from programmer 104 via telemetry module 208 . Updates to the therapy program may be stored in the therapy program 214 portion of memory 211 . Telemetry module 208 in IMD 106, as well as telemetry modules in other devices and systems described herein, such as programmer 104, may communicate via radio frequency (RF) communication techniques. Additionally, telemetry module 208 may communicate with external medical device programmer 104 via proximal inductive interaction of IMD 106 with programmer 104 . Accordingly, telemetry module 208 may send information to external programmer 104 continuously, at periodic intervals, or upon request from IMD 106 or programmer 104 .

Power supply 220 delivers operating power to the various components of IMD 106 . The power source 220 may include a small rechargeable or non-rechargeable battery and a power generation circuit to generate operating power. Recharging may be accomplished through proximal inductive interaction between an external charger and inductive charging coil 242 within IMD 220 . In some examples, the power requirements may be small enough to allow IMD 220 to exploit patient motion and implement a kinetic energy scavenging device to trickle charge the rechargeable battery. In other examples, power source 220 may include a conventional battery that may be used for a limited period of time.

According to the techniques of the present disclosure, processor 210 of IMD 106 delivers electrical stimulation therapy to patient 112 via electrodes 116 , 118 (and optionally connection interface 240 ) interposed along leads 114 . Adaptive DBS therapy is defined by one or more therapy programs 214 having one or more parameters stored in memory 211 . For example, the one or more parameters include current amplitude (for current control systems) or voltage amplitude (for voltage control systems), pulse frequency or frequency, and pulse width or number of pulses per cycle. In examples where electrical stimulation is delivered in terms of "bursts" of pulses or a series of electrical pulses defined by an "on time" and an "off time," the one or more parameters may also define the number of pulses per burst , one or more of on-time and off-time. In one example, the therapy window defines upper and lower limits of voltage amplitude for electrical stimulation therapy. In another example, the therapy window defines upper and lower limits of current amplitude for electrical stimulation therapy. Specifically, parameters of electrical stimulation therapy such as voltage or current amplitude are limited to a therapy window with upper and lower limits such that the voltage or current amplitude can be adjusted as long as the amplitude remains greater than or equal to the lower limit and less than or equal to the upper limit. Note that in some examples a single limit may be used.

In one example, processor 210 monitors, via electrodes 116 , 118 of IMD 106 , the behavior of a signal of patient 112 within a steady-state window related to one or more symptoms of a disease or other condition of patient 112 . The processor 210 delivers adaptive DBS to the patient 112 via the electrodes 116, 118 and can adjust the defined electrical stimulation within parameters defined by the lower and upper thresholds of the therapeutic window based on the activity of the sensed signal within the steady state window. One or more parameters of the .

In one example, the signal is a neural signal (eg, an LFP signal) within the beta band of the brain 120 of the patient 112 . Signals in the beta band of patient 112 may be associated with one or more symptoms of Parkinson's disease in patient 112 . In general, the patient's 112 neural signal within the beta band may be approximately proportional to the severity of the patient's 112 symptoms. For example, as tremors induced by Parkinson's disease increase, one or more of electrodes 116, 118 detects an increase in the magnitude of neural signals in the beta band of patient 112.

Similarly, as tremors induced by Parkinson's disease decrease, processor 210 detects a decrease in magnitude of neural signals in the beta band of patient 112 via one or more of electrodes 116, 118. In another example, the signal is a neural signal in the gamma band of the brain 120 of the patient 112 . Signals within the gamma band of patient 112 may additionally be associated with one or more side effects of electrical stimulation therapy. In general, however, neural signals in the gamma frequency band of patient 112 may be generally inversely proportional to the severity of side effects of electrical stimulation therapy, as opposed to neural signals in the beta frequency band. For example, as side effects due to electrical stimulation therapy increase, the magnitude of the signal detected by processor 210 in the gamma band of patient 112 via one or more of electrodes 116, 118 decreases. Similarly, as side effects due to electrical stimulation therapy decrease, processor 210 detects an increase in the magnitude of the signal in the gamma band of patient 112 via one or more of electrodes 116, 118.

In response to detecting that a signal from the patient, such as a sensed physiological parameter signal or a sensed neural signal, has deviated from a steady state window, the processor 210 dynamically adjusts the magnitude of the one or more parameters of the electrical stimulation therapy, such as pulse current Amplitude or pulse voltage amplitude to drive the patient's signal back to the steady state window. For example, where the signal is a neural signal within the beta frequency band of the brain 120 of the patient 112 , the processor 210 monitors the beta magnitude of the patient 112 via one or more of the electrodes 116 , 118 . Upon detecting that the magnitude of beta in patient 112 exceeds the upper limit of the steady-state window, processor 210 increases the magnitude of electrical stimulation delivered via electrodes 116, 118 at a maximum ramp rate, e.g., automatically or determined by a clinician, until β The magnitude of the neural signal within the frequency band falls back within the steady state window, or until the magnitude of the electrical stimulation reaches the upper limit of the therapeutic window determined by the clinician. Similarly, upon detecting that the beta magnitude of patient 112 falls below the lower limit of the steady state window, processor 210 decreases the stimulus magnitude at a maximum ramp rate determined by the clinician until the beta magnitude rises back to the steady state window within, or until the magnitude of electrical stimulation reaches the lower limit of the therapeutic window determined by the clinician. Upon detecting that the beta magnitude is now within or has returned to within the threshold of the steady state window, the processor 210 keeps the magnitude of the electrical stimulation constant. In other examples, the processor 210 may automatically determine the ramp rate when adjusting the stimulation parameters to bring the brain signal back into the target range. The ramp rate may be selected based on previous data indicative of general patient comfort or a specific patient's comfort or preference.

In some examples, processor 210 continuously measures the signal in real time. In other examples, the processor 210 samples the one or more bioelectrical signals periodically according to a predetermined frequency or after a predetermined amount of time. In some examples, processor 210 samples the signal periodically at a frequency of about 150 Hertz. Processor 210 may store at memory 211 real-time or sampled signals that may be downloaded and stored by an external programmer, such as programmer 104 of FIG. 1 and programmer 222 of FIG. 2A . As described above with respect to FIGS. 1-2B , while communicatively connected to IMD 106 or communicatively disconnected, a user may manipulate the stored data via the external programmer's user interface.

Additionally, processor 210 delivers electrical stimulation therapy bounded by upper and lower limits of the therapy window. In some examples, values defining the therapy window are stored in memory 211 of IMD 106 . For example, in response to detecting that the brain signal has deviated from the steady-state window, processor 210 of IMD 106 may adjust one or more parameters of the electrical stimulation therapy to provide responsive therapy to patient 112 . For example, in response to detecting that the signal has exceeded the upper threshold of the steady state window and prior to delivering electrical stimulation therapy, processor 210 increases the amplitude of the stimulation (eg, but not above the upper limit) to bring the signal back below the upper threshold. For example, in a voltage controlled system where the clinician has set the upper limit of the therapeutic window to 3 volts, the processor 210 may increase the voltage amplitude to a value no greater than 3 volts in an attempt to reduce the brain signal below the upper threshold.

In another example, in response to detecting that the signal has fallen below the lower threshold of the steady state window and prior to delivering the electrical stimulation therapy, the processor 210 reduces, for example, the magnitude of the voltage amplitude, but not below the lower limit. For example, in the voltage control system described above where the clinician has set the lower limit of the therapeutic window to 1.2 volts, the processor 210 may reduce the voltage amplitude to no less than 1.2 volts in an attempt to boost the brain signal back above the lower threshold and enter the steady state window. Accordingly, processor 210 of IMD 106 may deliver adaptive DBS to patient 112, wherein the one or more parameters defining adaptive DBS are within a treatment window defined by the lower and upper bounds of the parameters.

In the foregoing examples, the limits of the therapeutic window are inclusive (ie, the upper and lower limits are valid values for the one or more parameters). However, in other examples, the limits of the therapeutic window are non-inclusive (ie, the upper and lower limits are not valid values for the one or more parameters). In such an example of a non-inclusive treatment window, processor 210 instead sets the adjustment to the one or more parameters to the second highest effective value (where the adjustment potentially exceeds the upper limit) or the second highest value. Two low effective values (in case the adjustment potentially exceeds the lower limit).

In another example, values defining the treatment window are stored in memory 311 of external programmer 104 . In this example, in response to detecting that the signal has deviated from the steady-state window, processor 210 of IMD 106 transmits data representing measurements of the signal to external programmer 104 via telemetry module 208 . In one example, in response to detecting that the signal has exceeded the upper threshold of the steady-state window, processor 210 of IMD 106 transmits data representing measurements of the signal to external programmer 104 via telemetry module 208 . External programmer 104 may determine to adjust the parameter value to reduce the signal below the upper threshold so long as the parameter value remains within the one or more limits for that parameter.

In another example, processor 210 receives instructions from external programmer 104 via telemetry module 208 to adjust one or more limits of the treatment window. For example, such instructions may be responsive to patient feedback regarding the efficacy of the electrical stimulation therapy, or to one or more sensors that have detected a signal from the patient. Such signals from sensors may include neural signals, such as signals in the beta band or signals in the gamma band of the brain 120 of the patient 112, or physiological parameters and measurements, such as those indicative of one of the patient's activity level, body position, and respiratory function. one or more signals). Furthermore, such signals from sensors may indicate that one or more symptoms of patient 112 are not being alleviated (such as tremor or stiffness) or that there are side effects (such as paresthesias) from the electrical stimulation therapy. In response to these instructions, processor 210 may adjust one or more thresholds of the steady-state window. For example, processor 210 may adjust the magnitude of the upper threshold, the lower threshold, or move the overall position of the steady state window such that the threshold defined by the steady state window for adjusting the one or more parameters of electrical stimulation adjusts itself. Processor 210 then delivers the adjusted electrical stimulation to patient 112 via electrodes 116 and 118 .

4 is a block diagram of an external programmer configured to communicate with the medical device and manipulate and analyze device settings and data when connected and disconnected from the medical device. Programmer 104 in the example of FIG. 4 is an example of programmer 104 of FIG. 1 and programmer 222 of FIG. 2A and may have the same or similar characteristics as described above with respect to FIGS. 1-3 for an external programmer. characteristic.

Although programmer 104 may generally be described as a handheld device, programmer 104 may be a larger portable device or a more stationary device. In some examples, programmer 104 may be referred to as a tablet computing device. Additionally, in other examples, programmer 104 may be included as part of or include the functionality of an external charging device. As shown in FIG. 4 , programmer 104 may include processor 310 , memory 311 , user interface 302 , telemetry module 308 and power supply 320 . Each of these components or modules may include circuitry configured to perform some or all of the functions described herein. For example, processor 310 may include processing circuitry configured to perform the processes discussed with respect to processor 310 . Memory 311 may store instructions that, when executed by processor 310 , cause processor 310 and external programmer 104 to provide the functionality ascribed to external programmer 104 throughout this disclosure. Memory 311 may also store information retrieved from a medical device, such as IMD 106 depicted in FIGS. 1 and 3 . Processing circuitry 310 may be configured to display and manipulate stored information while on- or off-line with IMD 106, as described above with respect to FIGS. 1-3.

In general, programmer 104 includes any suitable hardware arrangement, alone or in combination with software and/or firmware, to perform the techniques attributed to programmer 104 and to programmer 104's processor 310, user interface 302, and telemetry module 308. In various examples, programmer 104 may include one or more processors, which may include fixed-function processing circuitry and/or programmable processing circuitry, such as those powered by, for example, one or more microprocessors. device, DSP, ASIC, FPGA, or any other equivalent integrated or discrete logic circuitry, and any combination of such components. In various examples, programmer 104 may also include memory 311 (such as RAM, ROM, PROM, EPROM, EEPROM, flash memory, hard disk, CD-ROM) that includes Executable instructions that execute actions attributed to them. Furthermore, although the processor 310 and the telemetry module 308 are described as separate modules, in some examples the processor 310 and the telemetry module 308 may be functionally integrated with each other. In some examples, processor 310 and telemetry module 308 correspond to respective hardware units, such as ASICs, DSPs, FPGAs, or other hardware units.

Memory 311 (eg, a storage device) may store instructions that, when executed by processor 310 , cause processor 310 and programmer 104 to provide the functionality ascribed to programmer 104 throughout this disclosure. For example, memory 311 may include instructions that cause processor 310 to obtain a parameter set from memory, select a spatial electrode motion mode, or receive user input and send corresponding commands to IMD 104 , or for any other function. Additionally, memory 311 may include a plurality of programs, where each program includes a set of parameters defining a stimulation therapy.

User interface 302 may include buttons, knobs or keypads, lights, a speaker and microphone for voice commands, a display such as liquid crystal (LCD), light emitting diode (LED) or organic light emitting diode (OLED). In some examples, the display can be a touch screen. User interface 302 may be configured to display any information related to the delivery of stimulation therapy, identified patient behavior, sensed patient parameter values, patient behavior criteria, or any other such information. User interface 302 may also receive user input via user interface 302 . For example, input may be in the form of pressing a button on a keypad or selecting an icon from a touch screen of a graphical user interface, as described above with respect to FIG. 1 . While offline and not connected to a medical device, a user may operate the user interface 302 to interactively manipulate retrieved and stored data. For example, a user can zoom in on data for a specific patient or two or more specific patients to view session data for a selected duration along a time scale, select or deselect data sets, sort information, change time scales, scroll Table or series of graphs, filtering data, selecting various data presentations, etc., as described above with respect to Figures 1-3. In other words, user interface 302 may provide an interface for displaying output as well as for a user to provide input. Processing circuitry (eg, processor 310 ) may determine what to do with input from a user and or how to cause user interface 302 to display output. Any description of user interface 302 performing a function may be construed as processing circuitry causing user interface 302 to perform that function, eg, when executing instructions stored at memory 311 .

Under the control of processor 310 , telemetry module 308 may support wireless communication between IMD 106 and programmer 104 . The telemetry module 308 may also be configured to communicate with another computing device via wireless communication techniques or directly with another computing device through a wired connection. In some examples, telemetry module 308 provides wireless communication via RF or a proximal inductive medium. In some examples, telemetry module 308 includes an antenna, which may take various forms, such as an internal antenna or an external antenna, such as an induction coil.

Examples of local wireless communication technologies that may be used to facilitate communication between programmer 104 and IMD 106 include RF communication according to 802.11 or the Bluetooth set of specifications or other standard or proprietary telemetry protocols. In this manner, other external devices can communicate with programmer 104 without establishing a secure wireless connection. As described herein, telemetry module 308 may be configured to transmit spatial electrode motion patterns or other stimulation parameter values to IMD 106 to deliver stimulation therapy.

5 is a conceptual diagram illustrating an example programming session selection screen for a user interface, according to one or more techniques of this disclosure. Processor 310 may cause the display unit of user interface 302 described above with respect to FIG. 4 to display session selection screen 350 of FIG. 5 and other exemplary feature sets on the user interface displays depicted in FIGS. 5-14 . Each of the feature sets depicted in FIGS. 5-14 may include several screens that are functionally identical (e.g., identical) to the therapy application when programming the device, minus the time spent actually programming/interacting with the device. ability. Processor 310 executing applications stored at memory 311 may cause each screen to retain the functions of selecting/deselecting data sets, sorting, changing time scale, zooming, scrolling, filtering, performing statistics and displaying programming settings when offline. This interactive review facilitates a more meaningful user experience when compared to outputting fixed reports or outputting data files that must be analyzed using, for example, spreadsheet or scripting language applications, thus saving users time and effort and allowing more More time is spent on patient care. In some examples, the user interface displays depicted in FIGS. 5-14 may be reporting views that may only be accessible outside of a telemetry session when presenting the unified display and set of controls as an online user interface display, e.g., only Available when communicatively disconnected.

In the example of FIG. 5, a user may select a previous session 352 for a particular patient by entering the patient's name or other identifying characteristic 354 (eg, an identification number). As described above with respect to FIG. 2A, the user may also select two or more sessions from a particular patient, or select sessions from multiple patients. A user may filter the data set by entering a start date 356 and/or an end date 358 and selecting a filter button 360 . The user may select other types of reports by viewing reports screen 362 .

6 is a conceptual diagram illustrating an example data set selection screen for a user interface, according to one or more techniques of this disclosure. Once a user selects a session 364 from the example session selection screen 350 of FIG. 5, the processor 310 may cause the user interface 302 to present an option for selecting a particular data set from previous session data for review. Some examples as shown in FIG. 6 may include survey results 366 , events 368 , activity in selected frequency bands 370 , and streaming results 372 .

7 is a conceptual diagram illustrating an exemplary findings screen for spatial local field potential data. While offline, using the survey results screen of FIG. 7 , the user can interactively select sensing channels 374 , which can correspond to particular sensing electrode combinations 378 . The graphical display shows the local field potential activity in the beta band 376 and the gamma band 377 of the sensing channel comprising electrodes zero to three from selected previous session data. According to the techniques of the present disclosure, when disconnected from the medical device from which the external programmer retrieved the session data, the user can change the selected sensing channel, change the selected hemisphere, zoom in on a specific frequency range, cross-sensor The displayed previous session data can be manipulated by analyzing the amplitude of a particular frequency by sensing channels, making comparisons between frequency ranges (eg, analyzing the amplitude of a particular frequency across previously investigated sensing channels), and the like. The user may further select data from a different one or more leads 380 .

FIG. 8 is a conceptual diagram illustrating an exemplary event summary screen. A user can interactively filter events by session 382 and time range 384 , as well as by event type 386 and date range 390 . As described above with respect to FIG. 2B , events may include patient-indicated events, such as taking medication, feeling symptoms of dyskinesia (e.g., involuntary erratic movements that may be caused by certain medications), and other patient-indicated events . As described above with respect to FIG. 1 , events may also include detected events based on sensed bioelectrical signals. When multiple sessions are selected, the processor 310 can stitch together event streams based on the multiple sessions and cause the user interface to present controls for the user to scroll through the events and select and/or zoom in on a particular event from the multiple sessions.

FIG. 9 is a conceptual diagram illustrating an exemplary event timeline screen. A user can interactively present the retrieved information by presenting a portion of previous session data along a time scale. For example, the user may select the day 392 from the time scale of the day in the selected month 396 . The user can further zoom in to a specific time duration 398 of the day to view events, such as local field potentials. As described above with respect to FIGS. 2A and 8 , selecting multiple session processing circuitry 310 may cause user interface 302 to display event streams based on multiple sessions. The processor 310 may chronologically present previous session data on the view, and the data in the view may include any one or all of sensed data, event data, and operation data.

FIG. 10 is a conceptual diagram illustrating an exemplary local field potential classification bar graph. Using the example of FIG. 10 , a user can view a graph to compare changes in local field potential over different time periods (eg, daily 394 , weekly, different times of day, such as sleep, wakefulness, activity, etc.). The user can also interactively scroll through different time periods of previous session data (400). Processing circuitry 310 may perform calculations on previous session data to cause user display 302 to present a bar graph of sorted LFP data. Classification can be above/below/between user-specified LFP thresholds. By manipulating the user interface 302, the user can view the bar graph of the LFP in chronological order by day, week, month, etc. FIG. If a particular stimulation setting somehow affects the amount of time the LFP is classified, the corresponding stimulation amplitude for that time period can also be used for correlation, i.e. LFP can be above the upper threshold when the electrical stimulation treatment is too low.

11 is a conceptual diagram illustrating an exemplary screen for presenting a local field potential snapshot. For the example of FIG. 11 , the user may cause the processing circuitry 310 to display a comparison graph to a portion of the retrieved previous session data (e.g., the frequency distribution of the local field potential 402), and how the local field potential compares to the retrieved previous session data. The second part (eg, the selected patient event 404) of . Based on the input received, the user interface 302 can also present a comparison of data for different hemispheres, different patient annotations of events, and compare the amplitude of local field potentials at user-adjustable frequencies across multiple events. As described above with respect to FIGS. 1-10 , the example of FIG. 11 can present a unified depiction of data while offline or online with the medical device.

12 is a conceptual diagram illustrating an exemplary device usage bar graph screen. The user may select weekly 392 , daily, or other time period and cause user interface 302 to present a portion of the session data along time scale 408 . Bar graph 410 in the example of FIG. 12 may highlight device usage for group 412, for example, user interface 302 would format previous session data to show the user that the patient is using a specific set of settings (i.e., stimulation and sensing settings A vs. B vs. C vs. D) amount of time. Time scale (if selectable) is day/week/month.

FIG. 13 is a conceptual diagram illustrating an exemplary local field potential band display screen. A user may select a screen in the example of FIG. 13 by making selections as described above with respect to FIG. 6 . The example of FIG. 13 presents the retrieved session data as frequency activity, eg, in the beta and gamma frequency bands. While offline, the user can interactively scroll 414 the frequency graph to present details of a portion of the retrieved data. By scrolling interactively, the user is able to perform improved analysis of the retrieved previous session data when compared to simply viewing a static chart in, for example, a pdf file. The techniques of the present disclosure provide an improved experience for the user when compared to downloading raw data from a device and viewing and manipulating the data in a spreadsheet or some other data viewing software. Applications executed by processor 310 may present the ability to interactively manipulate retrieved previous session data while offline with the same unified user interface used to actively program and communicate with medical devices. The user may not need another software tool, but may use a familiar therapy programming application that the user already owns. In this way, the techniques of the present disclosure may provide advantages over other techniques, such as a reduced learning curve, faster analysis, better use of limited clinical appointment time, and more time available for clinicians to work on other patients.

FIG. 14 is a conceptual diagram illustrating an exemplary streamed sensed signal screen. A user may select a screen in the example of FIG. 14 by making selections as described above with respect to FIG. 6 . When communicatively disconnected from the medical device, the user can analyze the retrieved data displayed by a user interface (e.g., user interface 302 of external programmer 104 described above with respect to FIG. 4 ) in the same manner as when connected to the medical device. and stored data. In some examples, a user (e.g., a clinician) may ask a patient to perform certain actions (e.g., cough), perform tasks such as write, walk, speak, drink from a cup, or move into certain postures, and the action is recorded or brain-sensing data of gestures. In some examples, a clinician may ask a patient to perform one or more functional tasks for which impairments are observed, such as a spiral test, a stiffness test with limb flexion, and the like. As described above with respect to FIG. 2A , the user can later view and analyze the streamed data while offline from the medical device. Users can interactively filter or zoom in on portions of the data to perform analysis and, in some examples, adjust a patient's treatment plan.

FIG. 15 is a flowchart illustrating exemplary operation of the system of the present disclosure. Unless otherwise indicated, the blocks of FIG. 15 will be described with respect to FIGS. 1 , 3 and 4 .

Processing circuitry (eg, processor 310 ) may communicatively couple communication circuitry (eg, circuitry within telemetry module 308 ) to IMD 106 for sessions with the medical device ( 90 ). In other words, once communicatively connected, programmer 104 will be in an online session with IMD 106 and can actively change settings, upload or download data, or otherwise program IMD 106 .

Processor 310 may download session data from IMD 106 when communicatively connected to IMD 106, eg, via telemetry module 308 and telemetry module 208 (92). Downloaded session data may include data from the current online session as well as previous session data from previous sessions.

Processor 310 may store the session data at a memory location (eg, memory 311 ) operatively coupled to the processing circuitry (94). Once the clinician has completed programming IMD 106, the clinician may provide inputs to user interface 302 that, when interpreted by processor 310, disconnect telemetry module 308 from telemetry module 208 of IMD 106 (95).

While communicatively disconnected from IMD 106, processor 310 may retrieve previous session data from memory 311 (96). Previous session data may include information related to one or more previous sessions of the medical device. As described above with respect to FIG. 1 , in some examples programmer 104 may be out of range and unable to communicate with IMD 106 , eg, the patient has left the clinic and the user is reviewing previous session data. In other examples, programmer 104 can be offline but still within range of IMD 106 and can still send or receive telemetry messages from IMD 106 when not in an online programming session.

As described above with respect to FIGS. 1-14, processor 310 may cause the display to present the retrieved information on the display (97). In some examples, a display screen such as user interface 302 may be configured to present a graphical user interface (GUI). Processor 310 may further cause the GUI to manipulate at least a portion of the retrieved information in response to user input received via the GUI (98).

In one or more examples, the functions described above may be implemented in hardware, software, firmware, or any combination thereof. For example, the various components of FIGS. 1-4, such as processor 210, processor 310, telemetry module 208, telemetry module 308, connection interface 240, etc., may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored or transmitted as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. The computer-readable medium may include a computer-readable storage medium, which corresponds to a tangible medium such as a data storage medium, or a communication medium that facilitates transferring a computer program from one place to another, for example, according to a communication protocol. Any medium from another location. As such, a computer-readable medium may generally correspond to: (1) a non-transitory tangible computer-readable storage medium or (2) a communication medium such as a signal or carrier wave. Data storage media may be any available media that can be accessed by one or more computers or one or more processors to retrieve instructions, code and/or data structures for implementation of the techniques described in this disclosure. A computer program product may comprise a computer readable medium.

The term "non-transitory" may indicate that the storage medium is not embodied in a carrier wave or propagated signal. In some examples, a non-transitory storage medium may store data that may change over time (eg, in RAM or cache memory).

By way of example and not limitation, such computer-readable storage media such as memory 211 and memory 311 may include random access memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), erasable Programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, hard disk, compact disk ROM (CD-ROM), floppy disk, cassette tape, magnetic media, optical media, or other computer System-readable media. In some examples, an article of manufacture may include one or more computer-readable storage media.

Also, any connection is properly termed a computer-readable medium. For example, if instructions are transmitted from a website, server, or other remote source using coaxial cable, fiber optic cable, twisted pair wire, digital subscriber line (DSL), or wireless technologies such as infrared, radio, and microwaves, then coaxial cable, fiber optic cable, Twisted pair, DSL, or wireless technologies such as infrared, radio, and microwave are included in the definition of media. It should be understood, however, that computer-readable storage media and data storage media do not encompass connections, carrier waves, signals, or other transitory media, but are instead directed to non-transitory, tangible storage media. Combinations of the above should also be included within the scope of computer-readable media.

Instructions may be executed by one or more processors, such as one or more DSPs, general purpose microprocessors, ASICs, FPGAs, CPLDs or other equivalent integrated or discrete logic circuitry. Accordingly, the term "processor," such as ECS controller 202, as used herein may refer to any of the foregoing structure or any other structure suitable for implementation of the techniques described herein. Additionally, the technology may be fully implemented in one or more circuits or logic elements.

The techniques of this disclosure may be implemented in a variety of devices or devices including integrated circuits (ICs) or collections of ICs (eg, chipsets). Various components, modules, or units are described in this disclosure to emphasize functional aspects of apparatus configured to perform the disclosed techniques, but do not necessarily require realization by different hardware units. Rather, as described above, the various units may be combined in a hardware unit in conjunction with suitable software and/or firmware, or provided by a collection of interoperable hardware units comprising one or more processor.

The techniques of the present disclosure are described in the following examples.

Embodiment 1: An apparatus comprising: a memory configured to store previous session data; a display screen configured to present a graphical user interface (GUI); processing circuitry, the Processing circuitry is operatively coupled to the memory, wherein when the device is communicatively disconnected from the medical device, the processing circuitry is configured to: retrieve previous session data from the memory, wherein the previous session data comprising information related to one or more previous sessions with the medical device; causing the GUI to present the retrieved information on the display screen; and causing the GUI to respond to user input received via the GUI. The GUI manipulates at least a portion of the retrieved information.

Embodiment 2: The apparatus of embodiment 1, wherein presenting the retrieved information comprises presenting a portion of the previous session data along a time scale.

Embodiment 3: The apparatus of embodiments 1 and 2, wherein manipulating the retrieved information comprises zooming in to view the previous session data for the selected duration along the time scale.

Embodiment 4: The apparatus of any one of Embodiments 1 to 3, wherein manipulating the retrieved information comprises combining a first portion of the previous session data along a first selected duration of the time scale with A second portion of the previous session data of the first selected duration is compared.

Embodiment 5: The apparatus of any one of Embodiments 1 to 4, wherein the first portion includes local field potential frequency information, and the second portion includes patient-selected events.

Embodiment 6: The apparatus of any one of Embodiments 1 to 5, wherein manipulating the retrieved information comprises zooming in to view the selected portion of the previous session data.

Embodiment 7: The apparatus of any one of embodiments 1 to 6, wherein the selected portion of the previous session data comprises a sub-band of a frequency band.

Embodiment 8: The apparatus of any one of Embodiments 1 to 7, wherein presenting the retrieved information comprises presenting one or more operating settings of the medical device, and wherein in communicating with the medical device The first format for presenting the operational settings when disconnected is substantially similar to the second format for presenting the operational settings when communicatively connected to the medical device.

Embodiment 9: The apparatus of any one of Embodiments 1 to 8, wherein manipulating the retrieved information comprises performing statistical analysis on the retrieved information, wherein the processing circuitry is configured to compute the selected statistical value and causing the GUI to present the calculated statistical values on the display screen.

Embodiment 10: The device of any one of Embodiments 1 to 9, wherein presenting the retrieved information comprises: selecting or deselecting data sets; sorting data; changing time scales; zooming; scrolling; filtering; executing Statistical analysis; presentation of sensed signals, conditions, events, and operations; and display of patient-specific programming settings.

Embodiment 11: The apparatus of any one of Embodiments 1 to 10, wherein when communicatively connected to the medical device for a session, the processing circuitry is further configured to: programming one or more treatment parameter settings for the medical device; downloading data from the medical device, the data including one or more of sensed signals, conditions, events, and operations from the medical device; The data is stored at the memory.

Embodiment 12: The apparatus of any one of Embodiments 1 to 11, wherein the medical device comprises an electrical stimulation device.

Embodiment 13: The apparatus of any one of Embodiments 1 to 12, wherein the retrieved information includes one or more electrical stimulation parameter values associated with electrical stimulation therapy delivered by the medical device, and wherein The first format for presenting the parameter value while communicatively disconnected from the medical device is substantially similar to the second format for presenting the parameter value while communicatively connected to the medical device.

Embodiment 14: The apparatus of any one of Embodiments 1 to 13, wherein the retrieved information includes information related to neural signals sensed by the medical device, and wherein is used in connection with the medical device The first format for presenting the neural signal when the device is communicatively disconnected is substantially similar to the second format for presenting the neural signal when communicatively connected with the medical device.

Embodiment 15: The device of any one of Embodiments 1 to 14, wherein the neural signal comprises a brain signal, a neural signal or a muscle signal.

Embodiment 16: The apparatus of any combination of embodiments 1 to 15, wherein the medical device comprises one of a deep brain stimulation (DBS) device, a spinal cord stimulation (SCS) device, or a pelvic stimulation device.

Embodiment 17: The device of any one of Embodiments 1 to 16, wherein the retrieved information includes a frequency distribution of sensed neural signals, and wherein manipulating the retrieved data includes scrolling along the frequency distribution to One or more details of a portion of the frequency distribution are displayed.

Embodiment 18: The device of any one of Embodiments 1 to 17, wherein presenting the retrieved information comprises presenting session data for a first session and session data for a second session, wherein the second session occurred in conjunction with The first sessions are different times, and wherein for the GUI to be manipulated, the processing circuitry is configured to respond to user input of a selection of data from the first session or from the second session Instead, the GUI is caused to manipulate at least the portion of the retrieved information.

Embodiment 19: The apparatus of any one of Embodiments 1 to 18, wherein presenting the retrieved information comprises presenting session data for a first session and session data for a second session, wherein the first session includes a first patient's data, and the second session includes data for a second patient, and wherein the GUI is configured to enable the user to select data from the first session or from the second session for further review.

Embodiment 20: The device of any one of Embodiments 1 to 19, wherein to cause the GUI to present the retrieved information, the processing circuitry is configured to cause the GUI to be used in the The retrieved information is presented in a GUI-like user interface that generates the information during a programming session of the medical device.

Embodiment 21: The apparatus according to any one of Embodiments 1 to 20, wherein to cause the GUI to be manipulated, the processing circuitry is configured to cause the GUI to operate in a manner similar to that programmed in the medical device Manipulating at least the portion of the retrieved information in a manner that manipulates the information during the session.

Embodiment 22: A method for using the apparatus according to any one of Embodiments 1 to 21, the method comprising controlling, by processing circuitry, communication circuitry communicatively coupled to a medical device for communicating with the session with the medical device; when communicatively connected to the medical device, session data is downloaded from the medical device via the communication circuitry by the processing circuitry; and the session data is downloaded by the processing circuitry stored at a memory location operatively coupled to the processing circuitry; disconnecting, by the processing circuitry, the communication circuitry from the medical device; when communicatively disconnected from the medical device, by The processing circuitry retrieves previous session data from the memory, wherein the previous session data includes information related to one or more previous sessions with the medical device; presenting the retrieved information on the display screen, wherein the display screen is configured to present a graphical user interface (GUI); causing the GUI, by the processing circuitry, to manipulate the retrieved information in response to user input received via the GUI; at least part of the information.

Embodiment 23: The method of Embodiment 22, further comprising, when communicatively connected to the medical device: causing, by the processing circuitry, the display to present information on the display, wherein The information includes data related to a current online session with the medical device; and causing, by processing circuitry, the GUI to manipulate the information from the current online session in response to user input received via the GUI at least partly.

Embodiment 24: A system comprising: a medical device; an external programming device comprising a display screen configured to present a graphical user interface (GUI); communication circuitry configured to communicatively connect to the medical device for a session with the medical device; processing circuitry operatively coupled to memory and the communication circuitry, wherein when the external programming device communicates with the medical device When disconnected, the processing circuitry is configured to: retrieve previous session data from the memory, wherein the previous session data includes information related to one or more previous sessions with the medical device; The GUI presents the retrieved information on the display screen; the GUI is caused to manipulate at least a portion of the retrieved information in response to user input received via the GUI.

Embodiment 25: The system of Embodiment 24, wherein the external programming device comprises any one of Embodiments 2-21.

Various embodiments of the present disclosure have been described. These and other examples are within the scope of the following claims.

Claims (19)

1. A device comprising: a memory configured to store previous session data; a display screen configured to present a graphical user interface (GUI); processing circuitry operatively coupled to the memory, wherein when the device is communicatively disconnected from the medical device, the processing circuitry is configured to: retrieving previous session data from the memory, wherein the previous session data includes information related to one or more previous sessions with the medical device; causing the GUI to present the retrieved information on the display screen; and The GUI is caused to manipulate at least a portion of the retrieved information in response to user input received via the GUI. 2. The device of claim 1, wherein presenting the retrieved information comprises presenting a portion of the previous session data along a time scale. 3. An apparatus according to any one of claims 1 or 2, wherein manipulating the retrieved information comprises zooming in to view the previous session data along the time scale for the selected duration. 4. The apparatus according to any one of claims 1 to 3, wherein manipulating the retrieved information comprises combining a first portion of the previous session data along a first selected duration of the time scale with the A second portion of the previous session data of the first selected duration is compared. 5. The apparatus of any one of claims 1 to 4, wherein the first portion includes local field potential frequency information and the second portion includes patient-selected events. 6. Apparatus according to any one of claims 1 to 5, wherein manipulating the retrieved information includes zooming in to view a selected portion of said previous session data, and wherein said selected portion of said previous session data comprises a sub-band of a frequency band. 7. Apparatus according to any one of claims 1 to 6, wherein presenting the retrieved information comprises presenting one or more operating settings of the medical device, and Wherein the first format for presenting the operational settings when communicatively disconnected from the medical device is substantially similar to the second format for presenting the operational settings when communicatively connected to the medical device. 8. The apparatus of any one of claims 1 to 7, wherein manipulating the retrieved information includes performing statistical analysis on the retrieved information, wherein the processing circuitry is configured to compute the selected statistical value and to use The GUI presents the calculated statistical values on the display screen. 9. The device of any one of claims 1 to 8, wherein presenting the retrieved information comprises: selecting or deselecting data sets; sorting data; changing time scales; zooming; scrolling; filtering; performing statistical analysis ; presenting sensed signals, conditions, events, and operations; and displaying patient-specific programming settings. 10. The apparatus of any one of claims 1 to 9, wherein when communicatively connected to the medical device for a session, the processing circuitry is further configured to: programming one or more treatment parameter settings of the medical device, downloading data from the medical device, the data comprising one or more of sensed signals, conditions, events and operations from the medical device; The downloaded data is stored at the memory. 11. Apparatus according to any one of claims 1 to 10, wherein the retrieved information includes one or more electrical stimulation parameter values associated with electrical stimulation therapy delivered by the medical device, and Wherein the first format for presenting the parameter value while communicatively disconnected from the medical device is substantially similar to the second format for presenting the parameter value while communicatively connected to the medical device. 12. Apparatus according to any one of claims 1 to 11, wherein the retrieved information includes information related to neural signals sensed by the medical device, and Wherein the first format for presenting the neural signal while communicatively disconnected from the medical device is substantially similar to the second format for presenting the neural signal while communicatively connected to the medical device. 13. The device of any one of claims 1 to 12, wherein the retrieved information includes a frequency distribution of sensed neural signals, and wherein manipulating the retrieved data includes scrolling along the frequency distribution to display the One or more details of a portion of the frequency distribution described above. 14. Apparatus according to any one of claims 1 to 13, wherein presenting the retrieved information comprises presenting session data for the first session and session data for the second session, wherein the second session occurs at a different time than the first session, and wherein in order to cause the GUI to be manipulated, the processing circuitry is configured to respond to requests from the first session or from the first session User input of a selection of data for a second session causes the GUI to manipulate at least the portion of the retrieved information. 15. Apparatus according to any one of claims 1 to 14, wherein presenting the retrieved information comprises presenting session data for the first session and session data for the second session, wherein said first session includes data for a first patient and said second session includes data for a second patient, and Wherein the GUI is configured to enable the user to select data from the first session or from the second session for further review. 16. The apparatus of any one of claims 1 to 15, wherein in order for the GUI to present the retrieved information, the processing circuitry is configured to cause the GUI to be The retrieved information is presented in a GUI-like user interface that generates the information during a programming session. 17. The apparatus according to any one of claims 1 to 16, wherein in order to cause the GUI to be manipulated, the processing circuitry is configured to cause the GUI to operate in a manner similar to that during a programming session of the medical device. At least the portion of the retrieved information is manipulated in a manner that manipulates the information. 18. A method for using an apparatus according to any one of claims 1 to 17, said method comprising: communicatively coupling the communication circuitry to the medical device through the processing circuitry for session with the medical device; downloading, by the processing circuitry and via the communication circuitry, session data from the medical device while communicatively connected to the medical device; storing, by the processing circuitry, the session data at a memory location operatively coupled to the processing circuitry; disconnecting, by the processing circuitry, communication circuitry from the medical device; When communicatively disconnected from the medical device, previous session data is retrieved from the memory by the processing circuitry, wherein the previous session data includes information related to one or more previous sessions with the medical device Information; causing, by the processing circuitry, a display screen to present the retrieved information on the display screen, wherein the display screen is configured to present a graphical user interface (GUI); The GUI is caused, by the processing circuitry, to manipulate at least a portion of the retrieved information in response to user input received via the GUI. 19. A system comprising: medical devices; and Apparatus according to any one of claims 1 to 17.