Patient event information

Patient input indicating the occurrence of an event and information relating to the event may be collected by a computing device. In some examples, the patient input is received via an event indication input mechanism of a medical device programmer. A clinician may review the event information to evaluate the efficacy of a therapy system (e.g., a particular therapy program or program group) or a patient's condition. In one example, a patient may activate an event indication input mechanism to indicate the occurrence of a seizure symptom, and input information relating to the seizure, such as the duration, severity, type of seizure or efficacy of a therapy system implemented to manage seizures.

TECHNICAL FIELD

The disclosure relates to information visualization, and more particularly, collecting and displaying information related to a therapy delivery.

BACKGROUND

Medical devices may be used to deliver therapy to patients to treat a variety of symptoms or conditions, such as epilepsy, chronic pain, tremor, Parkinson's disease, psychiatric disorders, neuralgia, urinary or fecal incontinence, sexual dysfunction, obesity, or gastroparesis. A medical device may deliver stimulation therapy via leads that include electrodes located proximate to the spinal cord, pelvic nerves, stomach, or within the brain of a patient. The stimulation site may be selected on the particular patient condition being managed by the stimulation system. In some cases, at least some electrodes may be integrated with an implantable pulse generator.

In another type of therapy, a medical device may deliver a drug or another therapeutic agent to a specific tissue site within the patient via a catheter attached to the medical device. In any case, the medical device is used to provide treatment to the patient as needed in order in increase the quality of life of the patient, such as to manage a patient condition. The medical device may be implanted or located externally, depending upon the type of therapy and needs of the patient.

A clinician may program the medical device to effectively treat the patient. For example, the clinician may define the therapy to be delivered to a patient by selecting values for one or more programmable therapy parameters. The therapy parameters may define a therapy program, and in some cases, a medical device delivers therapy in accordance with more than one program, which may be arranged in a program group. As one example, in the case of electrical stimulation, the clinician may select an amplitude, which may be a current or voltage amplitude, and a pulse width for a stimulation waveform to be delivered to the patient, as well as a rate at which the pulses are to be delivered to the patient. Programmable therapy parameters also may include electrode combinations and polarities. The clinician may also create multiple programs having various different therapy parameter combinations that the patient may use as desired in order to find the most effective therapy parameters to treat a condition.

SUMMARY

In general, the disclosure is directed to obtaining information relating to a patient event upon receiving an indication that the patient event occurred. The event may be, for example, the occurrence of a symptom related to the patient's condition, such as an aura related to a seizure or a headache related to chronic migraines. In some examples, the indication that a patient event occurred is received via an external programmer that includes an event indication button. The button is not limited to depressible buttons, but may also be presented as a selectable portion of a touch screen, a knob, or any other suitable mechanisms or media of receiving patient input. For convenience, any such media and event indication interfaces may be generally referred to herein as a button or an input mechanism.

A processor of the programmer or another computing device may generate an event marker upon activation of the event indication button by the patient. For example, if the patient detects an aura, the patient may activate the event indication button, and, in response, the processor may generate an event marker. The patient may provide information relating to the patient event (i.e., “event information”). For example, in examples in which the condition of the patient is epilepsy, the event information may include the type of seizure, severity of seizure, duration of seizure, drug type and dose, a subjective rating of the efficacy of therapy that is delivered to manage the patient's seizure disorder, and the like. The programmer may provide a user interface that is configured to receive the event information from the patient, and, in some examples, may prompt the patient for the information.

In some examples, the programmer may also record physiological parameter values, such as, but not limited to, an electroencephalogram (EEG) signal, electrocardiogram (ECG) signal, respiratory signal, blood pressure or body temperature, which may be monitored by a therapy delivery device or a separate implanted or external sensing device. The event information may be associated with an event marker and stored in a memory of the programmer, an implantable medical device, or another computing device for later retrieval and analysis by a clinician.

A clinician may review the event information to evaluate the patient's condition, as well as evaluate a therapy system that may be implemented to manage the patient's condition. In some examples, a computing device, such as a clinician programmer, may present the event information in any one or more of display formats, such as lists, tables, bar graphs, histograms, line graphs, Venn diagrams, pie charts or other graphical or linear display formats. Displaying the event information in one or more of these formats may assist a clinician in understanding the individual events and the progression of events over the course of time. In some examples, displaying the event information in one or more of these formats may assist a clinician in determining the efficacy of a therapy program and in determining whether any changes to the therapy program are desired or necessary. The event information may be presented in a meaningful format that enables the clinician to more quickly review and ascertain relevant data records, relationships between the different data records or trends in the data.

In one aspect, the disclosure is directed to a method comprising receiving an indication of a patient event, where the event is related to a condition of a patient, automatically generating an event marker, receiving event information relating to the patient event from the patient, wherein the event information indicates an efficacy of therapy that is delivered to the patient to manage the condition, associating the event information with the event marker, and storing the event information within a memory.

In another aspect, the disclosure is directed to a system comprising an event indication input mechanism, a user interface, a memory, and a processor that generates an event marker upon activation of the event indication input mechanism and receives event information relating to a patient condition from a patient via the user interface. The processor associates the event marker with the event information and stores the event information and event marker in the memory. The event information comprises an efficacy of therapy that is delivered to the patient to manage the patient condition.

In another aspect, the disclosure is directed to a method comprising receiving seizure event information, wherein the seizure event information comprises an efficacy of therapy system implemented to manage the seizure, and wherein the seizure event information is associated with an event marker, and generating a display of the seizure event information and the event marker.

In another aspect, the disclosure is directed to a system comprising an event indication input mechanism that receives an indication of a patient event from a patient, a processor that generates an event marker in response to the indication of the patient event, a user input mechanism that receives event information relating to the patient event from the patient, wherein the event information comprises an efficacy of a therapy system implemented to manage a seizure, and a memory that stores the event marker and the event information

In another aspect, the disclosure is directed to a computer-readable medium comprising (or storing) instructions. The instructions cause a programmable processor to receive an indication of a patient event, where the event is related to a condition of a patient, generate an event marker, receive event information relating to the patient event from the patient, where the event information indicates an efficacy of therapy that is delivered to the patient to manage the condition, associate the event information with the event marker, and store the event information within a memory.

In another aspect, the disclosure is directed to a computer-readable medium comprising instructions. The instructions cause a programmable processor to receive seizure event information, wherein the seizure event information comprises an efficacy of a therapy system implemented to manage a seizure, and wherein the seizure event information is associated with an event marker, and generate a display of the seizure event information and the event marker.

In another aspect, the disclosure is directed to a system comprising means for receiving an event indication from a patient, means for generating an event marker in response to the event indication, means for receiving event information relating to a patient event from the patient, and means for storing the event marker and the event information. The event information indicates an efficacy of therapy that is delivered to the patient to manage the condition.

In another example, the disclosure is directed to a system comprising means for receiving an event indication from a patient, means for generating an event marker in response to the event indication, means for receiving event information relating to a patient event from the patient, where the event information comprises an efficacy of a therapy system implemented to manage a seizure, and means for storing the even marker and the event information.

In another aspect, the disclosure is directed to a computer-readable medium comprising instructions. The instructions cause a programmable processor to perform any part of the techniques described herein.

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 systems and methods described herein will be apparent from the description and drawings, and from the claims.

DETAILED DESCRIPTION

Systems and techniques described herein are useful for evaluating information relating to a patient's condition. The systems and techniques described herein primarily refer to examples in which the patient condition includes seizures. However, in other examples, the systems and methods described herein may be useful in evaluating information related to other patient conditions, such as, for example, patient conditions addressed by therapy systems that include an electrical stimulator, fluid (e.g., therapeutic agent) delivery device or other therapy device that provides pain mitigation, peripheral neuropathy or post-operative pain mitigation, ilioinguinal nerve stimulation, intercostal nerve stimulation, gastric stimulation for the treatment of gastric mobility disorders and obesity, muscle stimulation (e.g., functional electrical stimulation (FES) of muscles) for mitigation of other peripheral and localized pain (e.g., leg pain or back pain) or sacral nerve stimulation to influence the behavior of the relevant structures, such as the bladder, sphincter and pelvic floor muscles. In addition, the systems and methods described herein may be useful in evaluating information related to other patient conditions such as movement disorders, neurological disorders, psychiatric disorders (e.g., depression, mania, obsessive-compulsive disorder, and the like), and the like. For example, the systems and methods described herein may also be useful with spinal cord stimulation, gastric stimulation, pelvic floor stimulation, peripheral nerve stimulation, peripheral nerve field stimulation, deep brain stimulation and so forth.

Epilepsy is a neurological disorder characterized by the occurrence of seizures, although seizures may also occur in persons who do not have epilepsy. Seizures are typically attributable to abnormal electrical activity of a group of brain cells. A seizure may occur when the electrical activity of certain regions of the brain, or even the entire brain, becomes abnormally synchronized. The onset of a seizure may be debilitating. For example, the onset of a seizure may result in involuntary changes in body movement, body function, sensation, awareness or behavior (e.g., an altered mental state). In some cases, each seizure may cause damage to the brain, which may result in progressive loss of brain function over time.

Therapy delivery systems may be used to treat seizures to mitigate the effects of many patient conditions or disorders. Electrical stimulation therapy or delivery of a fluid (e.g., a drug or another pharmaceutical agent) to the patient may shorten the duration of the seizure, prevent the onset of seizures or minimize the severity of the seizure. In some cases, the electrical stimulation is provided to one or more regions of the brain at regular intervals, substantially continuously or upon the detection or prediction of some event, such as the detection of a seizure by EEG sensors implanted within the brain, or at the direction of the patient or clinician. In the case of drug (or therapeutic agent) delivery therapy, drugs may be orally introduced into the patient or infused directly into a blood stream or one or more regions of the brain of the patient at regular intervals, substantially continuously or upon the detection or prediction of some event, such as the detection of a seizure by EEG sensors implanted within the brain, or at the direction of the patient or clinician.

In open-loop therapy systems, therapy is delivered substantially continuously or at regular intervals for an indefinite period of time without relying on feedback from the system. In contrast, closed-loop or responsive therapy systems deliver therapy in response to the detection or prediction of some event, which may be detected or predicted by monitoring physiological parameters of the patient. In the case of seizures, for example, the closed-loop or responsive therapy system may deliver therapy in response to the detection of a seizure by EEG sensors within the patient's brain or motion detectors that detect the physical symptoms of a seizure. In a closed-loop therapy system, the medical device may continue delivering therapy until it determines the seizure has ceased.

FIG. 1is a conceptual diagram illustrating an example therapy system10that is implanted proximate to brain12of patient14in order to help manage the patient's seizure disorder. While patient14is generally referred to as a human patient, other mammalian or non-mammalian patients are also contemplated. In the example shown inFIG. 1, therapy system10may be a deep brain stimulation (DBS) system because therapy system10provides therapy directly to deep brain sites, such as sites under the dura mater surrounding brain12. However, therapy system10may also deliver therapy to a surface of brain12. Therapy system10includes implantable medical device (IMD)16, lead extension18, leads20A and20B, clinician programmer22, and patient programmer24. IMD16includes a therapy module that delivers electrical stimulation therapy to one or more regions of brain12via leads20A and20B at regular intervals.

In some examples, stimulation sessions (“on-cycles”) are separated by sessions in which no stimulation is delivered (“off-cycles”). Together, the on-cycle and off-cycle define a therapy cycle, which may include more than one on-cycle and/or more than one off-cycle. As one example of a therapy cycle, IMD16may deliver stimulation in five minute intervals, where stimulation is delivered for about one minute. That is, in one example therapy cycle, the on-cycle may be about one minute and the off-cycle may be about five minutes. However, other therapy cycles may also be programmed by a clinician. The therapy cycle may depend upon the patient's condition, such as the type of seizures experienced by patient14, the duration of the seizures or the severity of the seizures, and, in some cases, the therapy delivery site within the patient. In other examples, such as when therapy is delivered substantially continuously, the therapy cycle does not include an off-cycle.

In the example shown inFIG. 1, IMD16is implanted within a chest cavity of patient14. In other examples, IMD16may be implanted within other regions of patient14, such as a subcutaneous pocket in the abdomen of patient14or proximate the cranium of patient14. Implanted lead extension18is coupled to IMD16via connector block26, which may include, for example, electrical contacts that electrically couple to respective electrical contacts on lead extension18. The electrical contacts electrically couple the electrodes carried by leads20A and20B (collectively “leads 20”) to a therapy module within IMD16. Lead extension18traverses from the implant site of IMD16within a chest cavity of patient14, along the neck of patient14and through the cranium of patient14to access brain12. In the example shown inFIG. 1, leads20are implanted within the right and left hemispheres, respectively, of brain12in order deliver electrical stimulation to one or more regions of brain12, which may be selected based on many factors, such as the type of seizures patient14afflicting patient14. Neurological disorders that cause seizures, such as epilepsy, may be generated in one or more of regions of the brain, which may differ between patients.

Although leads20are shown inFIG. 1as being coupled to a common lead extension18, in other examples, leads20may be coupled to IMD16via separate lead extensions or directly coupled to IMD16without the aid of a lead extension. Leads20may deliver electrical stimulation to treat any number of neurological disorders or diseases in addition to seizures, such as movement disorders, pain (including acute and chronic pain) or psychiatric disorders. Examples of movement disorders include a reduction in muscle control, motion impairment or other movement problems, such as tremors, rigidity, bradykinesia, rhythmic hyperkinesia, nonrhythmic hyperkinesia, dystonia, and akinesia. Examples of psychiatric disorders may include, for example, major depressive disorder (MDD), bipolar disorder, anxiety disorders, post-traumatic stress disorder, dysthymic disorder, and obsessive-compulsive disorder (OCD).

Leads20may be implanted within a desired location of brain12via any suitable technique, such as through respective burr holes in a skull of patient14or through a common burr hole in the cranium. Leads20may be placed at any location within brain12such that the electrodes of the leads are capable of providing electrical stimulation to targeted tissue during treatment. Electrical stimulation generated from the signal generator (not shown) within the therapy module of IMD16may help prevent the onset of seizures or minimize the severity of seizures. The exact parameter values of the stimulation therapy, such as the amplitude or magnitude of the stimulation signals, the duration of each stimulus, the waveform of the stimuli (e.g., rectangular, sinusoidal or ramped signals), the frequency of the stimuli, and the like, may be specific for the particular target stimulation site (e.g., the region of brain12) involved as well as the particular patient.

In the case of stimulation pulses, the stimulation therapy may be characterized by selected pulse parameters, such as pulse amplitude, pulse rate, and pulse width. In addition, if different electrodes are available for delivery of stimulation, the therapy may be further characterized by different electrode combinations, i.e., the electrodes of leads20that are selected to deliver therapy to patient14and the polarity of the selected electrodes. Known techniques for determining the optimal stimulation parameter value may be employed. In one example, electrodes of leads20are positioned to deliver stimulation therapy to an anterior nucleus of the thalamus of brain12of patient14, and stimulation therapy is delivered via a select combination of the electrodes to the anterior nucleus of the thalamus with electrical stimulation including a frequency of 145 hertz (Hz), a voltage of about 4 volts to about 5 volts, and a pulse width of about 90 microseconds. However, other examples may implement stimulation therapy including other stimulation parameter values.

Other stimulation targets for epilepsy may include, but are not limited to, the caudate nucleus, locus coeruleus, cerebellum, subthalamic nucleus, cingulate, substantia nigra, and thalamic structures such as the centromedian nucleus, centrolateral nucleus, and dorsomedial nucleus of brain12. Stimulation may also be directed in a brain lobe, such as the frontal, temporal, parietal and occipital lobes. In some examples, if patient12suffers frontal lobe seizures, stimulation electrodes of leads20may be positioned directly in the premotor cortex, the motor cortex, and in neural pathways connecting them. In other examples, if patient12suffers from seizures that originate in medial temporal lobe (MTL) structures, stimulation may be directed at the hippocampus, amygdala, or in both of these structures. For focal seizures, the stimulation lead may be placed at the site of seizure origin, at or near the seizure focus, as identified with seizure onset localization techniques, including EEG monitoring and brain imaging.

The electrodes of leads20are shown as ring electrodes. Ring electrodes may be relatively easy to program and are typically capable of delivering an electrical field to tissue surrounding leads20. In other examples, the electrodes of leads20may have different configurations. For example, the electrodes of leads20may have a complex electrode array geometry that is capable of producing shaped electrical fields. The complex electrode array geometry may include multiple electrodes (e.g., partial ring or segmented electrodes) around the perimeter of each lead20, rather than one ring electrode. In this manner, electrical stimulation may be directed to a specific direction from leads20to enhance therapy efficacy and reduce possible adverse side effects from stimulating a large volume of tissue. In some examples, a housing of IMD16may include one or more stimulation and/or sensing electrodes. In alternative examples, leads20may have shapes other than elongated cylinders as shown inFIG. 1. For example, leads20may be paddle leads, spherical leads, bendable leads, or any other type of shape effective in treating patient14.

In some examples, leads20may include sensing electrodes positioned to detect an EEG signal within one or more region of patient's brain12. Alternatively, another set of sensing electrodes may monitor the EEG signal. In some cases, EEG signals from within brain16may indicate the occurrence of seizure. Electrodes implanted closer to the target region of brain12may help generate an EEG signal that provides more useful information than an EEG generated via a surface electrode array because of the proximity to the target region of brain12. The EEG signal that is generated from implanted electrode array may also be referred to as an electrocorticography (ECoG).

As described in further detail with reference toFIG. 2, IMD16includes a therapy module that generates the electrical stimulation delivered to patient14via leads20. A signal generator (not shown) within IMD16produces the stimulation in the manner defined by the therapy program or group of programs selected by the clinician and/or patient14. Generally, the signal generator is configured to produce electrical pulses to treat patient14. However, the signal generator of IMD16may be configured to generate a continuous wave signal, e.g., a sine wave or triangle wave. In either case, IMD16generates the electrical stimulation therapy for DBS according to therapy parameters selected at that given time in therapy.

In the example shown inFIG. 1, IMD16generates the electrical stimulation according to one or more therapy parameter values, which may be arranged in a therapy program (or a parameter set). The therapy program includes a value for a number of parameters that define the stimulation. For example, the therapy parameter values may define respective values for voltage or current pulse amplitudes, pulse widths, pulse rates, pulse frequencies, electrode combinations, and the like. IMD16may store a plurality of programs. In some cases, the one or more stimulation programs are organized into groups, and IMD16may deliver stimulation to patient14according to a program group. During a trial stage in which IMD16is evaluated to determine whether IMD16provides efficacious therapy to patient14, the stored programs may be tested and evaluated for efficacy.

IMD16may include a memory to store one or more therapy programs (e.g., arranged in groups), and instructions defining the extent to which patient14may adjust therapy parameter values, switch between programs, or undertake other therapy adjustments. Patient14may generate additional programs for use by IMD16via patient programmer24at any time during therapy or as designated by the clinician.

Generally, an outer housing of IMD16is constructed of a biocompatible material that resists corrosion and degradation from bodily fluids. In some examples, IMD16may be implanted within a subcutaneous pocket close to the stimulation site. Although IMD16is shown as implanted within patient14inFIG. 1, in other examples; IMD16may be located external to patient14. For example, IMD16may be a trial stimulator electrically coupled to one or more percutaneous leads during a trial period. If the trial stimulator indicates therapy system10provides effective treatment to patient14, the clinician may implant a chronic stimulator within patient14for long-term treatment.

Clinician programmer22may be a computing device including, for example, a PDA, a laptop computer, a desktop PC, a workstation, and the like that permits a clinician to program electrical stimulation therapy for patient14, e.g., using input keys and a display. For example, using clinician programmer22, the clinician may specify therapy programs that include one or more therapy parameter values and/or organize the therapy programs into therapy program groups (i.e., groups including one or more therapy parameters) for use in delivery of DBS. Clinician programmer22supports telemetry (e.g., radio frequency (RF) telemetry) with IMD16to download stimulation parameters and, optionally, upload operational or physiological data stored by IMD16. In this manner, the clinician may periodically interrogate IMD16to evaluate efficacy and, if necessary, modify the stimulation parameters.

Like clinician programmer22, patient programmer24may be a handheld computing device. Patient programmer24may also include a display and input keys to allow patient14to interact with patient programmer24and IMD16. In this manner, patient programmer24provides patient14with an interface for limited control of electrical stimulation therapy provided by IMD16. For example, patient14may use patient programmer24to start, stop or adjust electrical stimulation therapy. In particular, patient programmer24may permit patient14to adjust stimulation parameters such as duration, amplitude, pulse width and pulse rate within an adjustment range specified by the clinician via clinician programmer22, select from a library of stored stimulation therapy programs, or reset the current therapy cycle.

As described in further detail below, patient programmer24includes an event indication input mechanism that patient14may activate in order to provide input to programmer24indicating that a patient event has occurred. The patient event may include, for example, a detection of a symptom of the patient's condition. As one example of the use of the event indication input mechanism, when patient14begins sensing an aura, which is a symptom for some patients that occurs prior to the actual onset of a severe seizure, patient14may activate the event indication button, e.g., by depressing a button. An aura may be indicated by a wide range of symptoms including, for example, lightheadedness, dizziness, unusual smells, unusual emotions, altered vision and hearing, and the like. In response to patient14activating the event indication button of programmer24, patient programmer24may record a time stamp indicating the time and date when the event indication input mechanism was activated. In some examples, patient programmer24may provide a signal to IMD16that causes IMD16to initiate therapy delivery, modify at least one therapy parameter, or reset therapy in response to receiving the indication from patient14via the event indication button.

While the event indication input mechanism is primarily referred to as an “event indication button” throughout the remainder of the disclosure, the disclosure is not so limited. In other examples, the event indication input mechanism may be any suitable input mechanism, such as a push button, a soft-key, a voice activated command, a means activated by other physical interactions, a magnetically triggered switch, a contact defined by a touch screen, or any other suitable input mechanism that patient14may activate in order to indicate that patient14believes a seizure may occur.

Patient programmer24may also include other input mechanisms to allow patient14to enter information related to an event. For example, any of the above-listed input mechanisms may be used to enter information including, but not limited to, the type or severity of the seizure, the duration of the seizure, the efficacy of a therapy provided during, before or after the seizure, the drug taken prior to or after the event, and the like. Patient programmer24may then associate this entered information with an event indication button press, and store the information in memory for subsequent downloading and viewing using clinician programmer22, or for later viewing using patient programmer24. In this way, patient programmer24may receive and record information specifying the impact therapy system10may have had on the patient event and/or patient condition.

Clinician programmer22may be used to program and/or interrogate IMD16and patient programmer24, as described in further detail below. For example, clinician programmer22may download event information stored in IMD16or patient programmer24. The event information may be entered by patient14, or may be collected by IMD16using sensors communicatively coupled to IMD16. In some examples, clinician programmer22may present the event information to a clinician in textual form, such as a list or table, or in graphical form, including Venn diagrams, bar graphs, line graphs, and the like.

IMD16, clinician programmer22, and patient programmer24may communicate with each other via cables or a wireless communication, as shown inFIG. 1. Clinician programmer22and patient programmer24may communicate, for example, via wireless communication with IMD16using RF telemetry techniques known in the art. Clinician programmer22and patient programmer24also may communicate with each other using any of a variety of local wireless communication techniques, such as RF communication according to the 802.11 or Bluetooth specification sets, infrared communication, e.g., according to the IrDA standard, or other standard or proprietary telemetry protocols.

FIG. 2is a functional block diagram illustrating components of an example IMD16in further detail. IMD16is coupled to leads20A and20B, which include electrodes30A-D and31A-D, respectively. Although IMD16is coupled directly to leads20, in other examples, IMD16may be coupled to leads20indirectly, e.g., via lead extension18(FIG. 1). IMD16includes a therapy module32, a telemetry module33, a processor34, memory35, and a power source36.

IMD16may deliver electrical stimulation therapy to brain12of patient14via electrodes30A-D of lead20A and electrodes31A-D of lead20B (collectively “electrodes 30 and 31”). In the example shown inFIG. 2, implantable medical leads20are cylindrical. As previously described, in other examples, leads20may be, at least in part, paddle-shaped (i.e., a “paddle” lead) or a shape other than cylindrical. In some examples, electrodes30and31may be ring electrodes. In other examples, electrodes30and31may be segmented or partial ring electrodes, each of which extends along an arc less than 360 degrees (e.g., 90-120 degrees) around the outer perimeter of the respective one of leads20. The use of segmented or partial ring electrodes30and31may also reduce the overall power delivered to electrodes30and31by IMD16because of the efficient delivery of stimulation to a target stimulation site by eliminating or minimizing the delivery of stimulation to unwanted or unnecessary regions within patient14. The configuration, type, and number of electrodes30and31illustrated inFIG. 2are merely exemplary. In other examples, IMD16may be coupled to one lead, more than two leads or leads including less than or more than four electrodes. For example, IMD16may be coupled to one lead with eight electrodes on the lead or three or more leads with the aid of bifurcated lead extensions.

Electrodes30and31are electrically coupled to therapy module32of IMD16via conductors within the respective leads20A and20B. Each of electrodes30and31may be coupled to separate conductors so that electrodes30and31may be individually selected, or in some examples, two or more electrodes30and/or two or more electrodes31may be coupled to a common conductor. In one example, an implantable signal generator or other stimulation circuitry within therapy module32delivers electrical signals (e.g., pulses or substantially continuous-time signals, such as sinusoidal signals) to a target tissue site within patient14via at least some of electrodes30and31under the control of processor34. The stimulation energy generated by therapy module32may be delivered from therapy module32to selected electrodes30and31via a switch matrix and conductors carried by leads20, as controlled by processor34.

Processor34may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), discrete logic circuitry, or the like. The functions attributed to processor34herein may be embodied as software, firmware, hardware or any combination thereof. Processor34controls the implantable signal generator within therapy module32to deliver electrical stimulation therapy according to selected therapy parameter values. For example, processor34may control therapy module32to deliver electrical signals with selected voltage or current amplitudes, pulse widths (if applicable), and rates specified by one or more therapy programs, which may be arranged into therapy program groups. In one example, processor34controls therapy module32to deliver stimulation therapy according to one therapy program group at a time. The therapy programs and therapy program groups may be stored within memory35. In another example, therapy programs are stored within at least one of clinician programmer22or patient programmer24, which transmits the therapy programs to IMD16via telemetry module33.

In addition, processor34may also control therapy module32to deliver the electrical stimulation signals via selected subsets of electrodes30and31with selected polarities. For example, two of more of electrodes30and31may be utilized together in various bipolar or multi-polar combinations to deliver stimulation energy to selected sites, such as sites within brain12. The above-mentioned switch matrix may be controlled by processor34to configure electrodes30and31in accordance with a therapy program.

IMD16also includes memory35, which may include any volatile, non-volatile, magnetic, optical, or electrical media, such as a random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory, and the like. Memory35may store program instructions that, when executed by processor34, cause IMD16to perform the functions ascribed to IMD16herein. In some examples, memory35may also store the parameter values for therapy programs or program groups and/or patient physiological data obtained by sensors communicatively coupled to IMD16or another sensing device.

Telemetry module33includes any suitable hardware, firmware, software or any combination thereof for communicating with another device, such as clinician programmer22or patient programmer24(FIG. 1). Under the control of processor34, telemetry module33may receive downlink telemetry from and send uplink telemetry to at least one of the programmers22,24with the aid of an antenna, which may be internal and/or external. Processor34may provide the data to be uplinked to at least one of the programmers22,24and the control signals for the telemetry circuit within telemetry module33, e.g., via an address/data bus.

The various components of IMD16are coupled to power source36, which may include a rechargeable or non-rechargeable battery. A non-rechargeable battery may be selected to last for several years, while a rechargeable battery may be inductively charged from an external device, e.g., on a daily or weekly basis.

FIG. 3is a functional block diagram illustrating components of an example patient programmer24, which includes a processor40, memory42, a user interface44, a telemetry module46and a power source48. Processor40controls user interface44and telemetry module46, and stores and retrieves information and instructions to and from memory42. Patient programmer24may be a dedicated hardware device with dedicated software for programming of IMD16. Alternatively, patient programmer24may be an off-the-shelf computing device running an application that enables programmer24to program IMD16.

Patient14may use patient programmer24to select therapy programs (e.g., sets of stimulation parameters), generate new therapy programs, reset therapy programs or cycles, modify therapy programs through individual or global adjustments, and transmit the new programs to a medical device, such as IMD16(FIGS. 1 and 2). In addition, as described in further detail below, patient14may use patient programmer24to create a log of event occurrences, which may include actual seizure occurrences or potential seizure occurrences.

Patient14may interact with patient programmer24via user interface44, which includes a user input mechanism56, an event indication button58, and a display60. User input mechanism56may include any suitable mechanism for receiving input from patient14or another user. In one example, user input mechanism includes an alphanumeric keypad. In another example, user input mechanism56includes a limited set of buttons that are not necessarily associated with alphanumeric indicators. For example, the limited set of buttons may include directional buttons that permit patient14to scroll up, down, or sideways through a display presented on display60, select items shown on display60, as well as enter information. As another example, the limited set of buttons may also include “increment/decrement” buttons in order to increase or decrease a stimulation frequency or amplitude of stimulation delivered by IMD16.

User input mechanism56may include any one or more of push buttons, soft-keys, voice activated commands, activated by physical interactions, magnetically triggered, activated upon password authentication push buttons, contacts defined by a touch screen, or any other suitable user interface. In some examples, one or more button of user input mechanism56may be reprogrammable. That is, during the course of use of patient programmer24, one or more button of user input mechanism56may be reprogrammed to provide different programming functionalities as the needs of patient14change or if the type of IMD16implanted within patient14changes. User input mechanism56may be reprogrammed, for example, by clinician programmer22(FIG. 1) or another computing device.

Event indication button58may be any one or more of a push button, soft-key, voice activated command, means activated by another physical interaction, magnetically triggered switch, activated upon password authentication push button, contact defined by a touch screen, or any other suitable input mechanism. In the example shown inFIG. 3, event indication button58is a dedicated button that is separate from the buttons of user input mechanism56in order to allow patient14to quickly access and activate event indication button58. In other examples, however, event indication button58may be incorporated with the buttons of user input mechanism56. For example, if user input mechanism56includes a plurality of alphanumeric buttons, depressing one or more of the buttons in a particular pattern or pushing two or more of the buttons simultaneously may also trigger the functionality of event indication button58.

Patient14may “activate” event indication button58by depressing a push button, soft-key, touching the corresponding portion of a touch screen of display60or using any other suitable techniques. A soft-key may include a button or a key of a device, where the button or key is associated with a label presented on display58. As the label on display58changes, the functionality of the soft-key changes. Event indication button58is coupled to processor40. After patient14activates event indication button58, processor40may generate an event marker. The event marker may be, for example, a value, flag or signal that is stored by processor46within event information50of memory42. If patient14is afflicted with seizures, the event marker may also be referred to as a “seizure marker.”

In different examples, the generation of the event marker may result in the performance of different subsequent actions by patient programmer24. The event marker may also result in patient programmer24performing two or more of these actions described herein. In one example, processor40logs the date and time of each event marker within event information50of memory42. The event marker is indicative of the event occurrence (e.g., either actual or potential seizure) as perceived by patient14. In this way, the event indication button58may be used to create an event log, such as a log that details the occurrence of each seizure or seizure symptom.

A clinician may access the event log and analyze the event log to evaluate various aspects of the patient's condition or therapy system10. For example, the clinician may review the event log to determine a temporal pattern in the event occurrences. This may allow a clinician to determine, for example, that the events are being influenced or triggered by a certain factor, such as stress at the patient's home or office. In some cases, processor40associates the event marker with the current therapy program or program group that is being implemented by IMD16in order to evaluate the efficacy of the current therapy program or group. Processor40may determine the current therapy program implemented by IMD16by interrogating IMD16via the respective telemetry modules33,46. Alternatively, the current therapy program implemented by IMD16may be stored within therapy programs52of memory42of patient programmer24.

IMD16may be configured to sense and record physiological parameter values of patient14. For example, leads20may include sense electrodes or another sensor that are electrically coupled to therapy module32, which includes sensing functionality. As another example, in addition to or instead of an IMD16including sensing capabilities, a separate sensor may be implanted within patient14and transmit sense information to IMD16, e.g., via a wired or wireless communication technique. In either case, IMD16may receive physiological parameter values of patient14and transmit the physiological parameter values to patient programmer24, and processor40may associate the event marker with the physiological parameter values and store the data within event information50of memory42. In this way, the event information may include physiological parameter values sensed by IMD16or another sensing device. In some examples, the physiological parameters at the time the event marker was generated, as well as the physiological parameter values during a certain time period before and after the event marker generation may be recorded within event information50. The clinician may determine the relevant range of time for which the physiological parameter values are stored.

Alternatively, IMD16may receive the event marker from patient programmer24and store the marker along with the associated physiological parameter values within memory35(FIG. 2). In another example, processor40of programmer24may generate a record signal that causes IMD16to store the current physiological parameter values, and, in some cases, the parameter values within a particular time span prior to receiving the record signal (e.g., about two seconds to about one minute). Patient programmer24may also record the date and time of the event marker, and a clinician may later retrieve the data from patient programmer24and IMD16and associate the event marker with the patient parameter values, either manually or with the aid of a computing device, such as clinician programmer22.

In another example, upon the generation of the event marker, processor40may transmit the event marker to IMD16via telemetry module46, and IMD16, in response, may modify therapy. For example, in response to receiving the event marker from patient programmer24, IMD16may initiate therapy or restart a therapy cycle. In this way, the event marker may be a signal that controls the operation of IMD16. The settings for IMD16necessary to initiate or restart the therapy cycle (i.e., the therapy adjustment action) may be saved within therapy programs52of memory42of patient programmer24or within memory35of IMD16. If the settings are stored within IMD16, processor40may provide instructions to IMD16to access and implement the stored therapy adjustment action.

In some examples, processor40may generate different types of event markers that provide different control signals to IMD16. As an example, a first type of event marker may be a control signal that causes IMD16to restart a therapy cycle and a second type of event marker may be a control signal that causes IMD16to switch to a different therapy program group stored within memory35of IMD16or memory42of programmer24. However, the event markers do not necessarily need to directly provide a control signal. Rather, processor40of programmer24or processor34of IMD16may generate the necessary control signal based on the event marker.

In yet another example, generation of the event marker may result in the creation of a new data file stored in the event information50section of memory42that is editable by a user, including patient14or a clinician. For example, the data file may include data fields that store information about the patient's therapy or the patient event. As examples, the data file may include information about the type or severity of a seizure, the duration of the seizure, the efficacy of therapy, the drug and/or drug dosage being taken prior to or after the seizure, and the like. User input mechanism56may allow patient14to enter the relevant information at any time following the generation of the event marker and the creation of the data file. For example, in the case of an event related to a seizure, patient14may enter information relating to the seizure following recovery from the seizure event, and may edit the information during some time period following the initial entry of the data.

As indicated above, one or more of the features described above may be combined in a single example. For example, activating event indication button58may reset the current therapy delivered by IMD16, generate an event marker in event information50, create a data file associated with the event marker in event information50, and store physiological parameter values collected by IMD16the data file, or another data file also associated with the event marker.

Event indication button58, as well as other input mechanisms provided by user input mechanism56may be may be designed to help reduce accidental activation of a programming function. For example, the button58may be recessed from an outermost surface of the housing of IMD24. Alternatively or additionally, patient16may be required to hold a button for a predetermined amount of time in order to activate the button, and/or there may be a hold function that prevents the buttons from being activated unless the hold function is deactivated. For example, the hold function may be activated and deactivated via manipulation of a slider bar (not shown) or manipulation of a specified combination of buttons.

Display60may include a color or monochrome display screen, such as a liquid crystal display (LCD), light emitting diode (LED) display or any other suitable type of display. Patient programmer24may present information related to stimulation therapy provided by IMD16on display60, as well as other information, such as historical data regarding the patient's condition and past event information. Processor40may monitor activity from user input mechanism56, and control display60and/or IMD16function accordingly. In some examples, display60may be a touch screen that enables the user to select options directly from the display. In such cases, user input mechanism56may be eliminated, although patient programmer24may include both a touch screen and user input mechanism56. In some examples, user interface44may also include audio circuitry for providing audible instructions or sounds to patient14and/or receiving voice commands from patient14.

Processor40may comprise any combination of one or more processors including one or more microprocessors, DSPs, ASICs, FPGAs, or other equivalent integrated or discrete logic circuitry. Accordingly, processor40may include any suitable structure, whether in hardware, software, firmware, or any combination thereof, to perform the functions ascribed herein to processor40. Memory42may include any volatile or nonvolatile memory, such as RAM, ROM, EEPROM or flash memory. Memory42may also include a removable memory portion that may be used to provide memory updates or increases in memory capacities. A removable memory may also allow patient data to be easily transferred to clinician programmer22, or to be removed before patient programmer24is used by a different patient.

Memory42stores, among other things, event information50, therapy programs52, and operating software54. Memory42may have any suitable architecture. For example, memory42may be partitioned to store event information50, therapy programs52, and operating software54. Alternatively, event information50, therapy programs52, and operating software54may each include separate memories that are linked to processor40. In some examples, event information50may store event information in different resolutions. For example, relatively recent event information may be stored in detail by individual event, while less recent event information may be aggregated and stored in week resolution, month resolution, or any other time period resolution specified by a user, such as a clinician. The differentiation in resolution based on the type of information may be an efficient use of memory42, which may have a limited capacity to store information.

Therapy programs52portion of memory42stores data relating to the therapy programs implemented by IMD16. In some examples, the actual parameter values for the therapy programs, e.g., the stimulation amplitude, pulse rate, pulse frequency and pulse width data, are stored within therapy programs52. In other examples, an indication of each therapy program or group of therapy programs, e.g., a single value associated with each therapy program or group, may be stored within therapy programs52, and the actual parameter values may be stored within memory35of IMD16. The “indication” for each therapy program or group may include, for example, alphanumeric indications (e.g., Therapy Program Group A, Therapy Program Group B, and so forth), or symbolic indications.

As previously described, event information50includes information relating to the patient event (seizure or anticipated seizure) occurrences, such as the time and date patient14activated the event indication button58, and corresponding physiological parameter values (e.g., EEG signals, ECG signals, respiratory signals, blood pressure, body temperature, and so forth), if therapy system10includes a sensing module and sensors to sense such physiological parameters. Patient programmer24may also receive input from patient14relating to event information, such as the type or severity of the seizure, the duration of the seizure, and any drugs, taken after patient14activated seizure indication button58. This information, as well as any other applicable information, may also be stored within event information50and, in some cases, associated with the event marker.

Operating software54may include instructions executable by processor40for operating user interface44, telemetry module46and managing power source48. Memory42may also store any therapy data retrieved from IMD16during the course of therapy. The clinician may use this therapy data to determine the progression of the patient's disease in order to predict or plan a future treatment.

Patient programmer24may communicate via wireless telemetry with IMD16, such as using RF communication or proximal inductive interaction. This wireless communication is possible through the use of the respective telemetry modules46,33. Accordingly, telemetry module46of programmer24may be similar to the telemetry module contained within IMD16. Telemetry module46may also be configured to communicate with clinician programmer22or another computing device via wireless communication techniques, or direct communication through a wired connection. Examples of local wireless communication techniques that may be employed to facilitate communication between patient programmer24and another computing device include RF communication according to the 802.11 or Bluetooth specification sets, infrared communication, e.g., according to the IrDA standard, or other standard or proprietary telemetry protocols. In this manner, other external devices may be capable of communicating with patient programmer24without needing to establish a secure wireless connection.

Power source48delivers operating power to the components of patient programmer24. Power source48may include a battery and a power generation circuit to produce the operating power. In some examples, the battery may be rechargeable to allow extended operation. Recharging may be accomplished electrically coupling power source48to a cradle or plug that is connected to an alternating current (AC) outlet. In addition, recharging may be accomplished through proximal inductive interaction between an external charger and an inductive charging coil within patient programmer24. In other examples, traditional batteries (e.g., nickel cadmium or lithium ion batteries) may be used. In addition, patient programmer24may be directly coupled to an alternating current outlet recharge power source48, or to power patient programmer24. Power source48may include circuitry to monitor power remaining within a battery. In this manner, user interface44may provide a current battery level indicator or low battery level indicator when the battery needs to be replaced or recharged. In some cases, power source48may be capable of estimating the remaining time of operation using the current battery.

User interface44may include an alert LED or other suitable alert feature. In some examples, IMD16may send an alert signal to patient programmer24via the respective telemetry modules33,46to activate the alert LED and indicate to a user that a problem may be present. The alert signal may, for example, signify a low battery, a sensed physiological event, or another problem. For example, the alert feature of user interface44may be triggered in response to receiving a threshold number of event indications via event indication button56, detecting a change in a therapy program or another therapy parameter. As another example, if IMD16is configured to deliver a drug to patient16instead of or in addition to electrical stimulation, the alert feature of user interface44of patient programmer24may be triggered in response to detecting a low level of drug remaining, or to indicate the delivery of a more powerful anti-seizure drug. Activation of the alert feature of patient programmer24may alert patient16to contact a clinician or take other precautions. In some examples, patient programmer24may forward the alert or an indication of the alert to a remote device in a remote location, such as a clinician office.

User interface44may also include an LED or another indication (e.g., via display60) that provides confirmation to patient14that an operation was carried out or that input via event indication button58was received. For example, when event indication button58is activated by patient14, and a programming signal is sent to IMD16to reset a therapy cycle, adjust a therapy parameter, switch to a different therapy program or program group, or otherwise adjust therapy, user interface44may activate an LED to provide positive feedback to patient14regarding the successfully sent programming signal.

FIG. 4is a functional block diagram illustrating components of an example clinician programmer22, which may be similar to patient programmer24, but does not include seizure indication button58. Clinician programmer22may include a processor70, memory72that stores therapy programs82, event information80, and operating software84, user interface74including user input mechanism56and display60, telemetry module76, and power source78. The functions performed by each component may be similar to the functions described above with reference to patient programmer24. Additionally, clinician programmer22may include more features than patient programmer24. For example, while clinician programmer22may be configured for more advanced programming features than patient programmer24. This may allow a user to modify more therapy parameter values with clinician programmer than with patient programmer24. Patient programmer24may have a relatively limited ability to modify therapy parameter values of IMD16in order to minimize the possibility that patient14selects therapy parameters that are harmful to patient14. Similarly, clinician programmer22may conduct more advanced diagnostics of IMD16than patient programmer24.

As described in further detail below, processor70of clinician programmer22may interrogate IMD16and/or patient programmer24to retrieve any collected information stored within memories35,42, such as event markers, physiological parameter values, and information associated with respective event markers, which may include information received from patient14. For example, memory72of clinician programmer22may include software including instructions that cause processor70of clinician programmer22to interrogate IMD16and/or patient programmer24.

Processor70of clinician programmer22may format the collected information in any one of a plurality of information presentation techniques, such as a linear format (e.g., tables or lists) or graphical displays (e.g., line graphs, bar graphs, pie charts, Venn diagrams, histograms, and the like), either automatically or at the request of a clinician. Display of the collected information in one or more of these display types may enable a clinician to more easily determine the efficacy of therapy provided to patient14, and identify any trends in the efficacy of therapy, such as decreasing effectiveness of a drug or stimulation program over time. In some examples, patient programmer24may also display the collected information in formats similar to clinician programmer22.

FIG. 5is a flow diagram illustrating an example method for storing patient event information on patient programmer24. Patient14may detect the occurrence of an event related to a patient condition. In the case of a seizure, for example, patient14may sense an aura, which may be, in some cases, a precursor to a tonic-clonic seizure. An aura may be a simple partial seizure, and may be indicated by a wide range of symptoms including, for example, lightheadedness, dizziness, unusual emotions, altered vision and hearing, and the like. When patient14perceives an aura, patient14may provide an indication to patient programmer24by, for example, activating event indication button58(90). Processor40of patient programmer24is coupled to event indication button58, and, therefore, receives the indication of the event (90), and generates an event marker (92). As previously described, the event marker may be a flag, value or other signal. Processor40may record the date and time of the event marker within event information50of memory42of patient programmer24(94), which may be, for example, the date and time processor40generated the event marker.

The resolution of the time and date stamp of the event marker may be on the order of seconds, for example, or may be less accurate, such as on the order of five minute increments, fifteen minute increments, or even hour increments. The time accuracy may be programmed by the clinician, or may be preprogrammed into patient programmer24. Recording the time and date that each event marker was generated by processor40may indicate each time patient14activated the event indication button58. A clinician may later reference the event markers to determine any patterns or trends in the occurrence of patient events. For example, events occurring repeatedly at approximately the same time of day may indicate an emotional triggering of the event, such as stress at work or school.

Generation of an event marker may also cause patient programmer24to query IMD16and record the therapy program or group of programs being implemented by IMD16at the time processor40generated the event marker. Alternatively, patient programmer24may transmit the event marker to IMD16, which may associate the event marker with a current therapy program or group. Depending upon the type of IMD16or the mode of operation of IMD16, in some cases, processor40may associate the event marker with a single therapy program, rather than a program group, which may include one or more therapy programs. Thus, while program groups are primarily referred to throughout the description ofFIG. 5, in other examples, processor40may associate the event marker with a therapy program.

As previously described, processor40may interrogate IMD16to determine which program group IMD16is currently delivering therapy in accordance with, or processor40may track the current program group within therapy programs52portion of memory42. Patient14may not activate event indication button58as soon as the patient event occurs. For example, if a patient14is struck with a seizure, patient14may not be able to activate event indication button58until after patient14recovers from the seizure, which may be well after the occurrence of the seizure. For example, depending upon the duration and severity of the seizure, recovery may take minutes or even hours. Thus, processor40may associate the event marker with the most recently implemented therapy program or the currently implemented therapy program. Alternatively, patient programmer24may provide patient14with the opportunity to modify the date and time of the event marker. If patient14knew, for example, that the event occurred at least two hours before patient14actually activated event indication button58, patient14may modify the time of the event marker by at least two hours via user input mechanism56(FIG. 3).

As described briefly above, in some examples in which IMD16provides therapy in accordance with a therapy cycle, the therapy cycle is reset when patient14activates event indication button58. In one example, an electrical stimulation program may comprise a therapy cycle including an on-cycle, in which stimulation is delivered to patient14, and an off-cycle, in which no stimulation is delivered to patient14. However, IMD16typically does not shut down during stimulation off-cycle, but rather, therapy module32of IMD16merely stops delivering stimulation to patient14. In some examples, a minimum level of stimulation is provided to patient during the stimulation off-cycle, and the intensity of the stimulation increases during the stimulation on-cycle. Depending upon the patient disorder, it may be undesirable to completely turn stimulation off.

As one example of resetting a therapy cycle, if the event indication button is activated during an off-cycle portion of the therapy cycle, the current therapy cycle may be shortened as compared to a normal therapy cycle. The “normal” therapy cycle may include at least one on-cycle and at least one off-cycle. If the event indication button is received during an on-cycle, the therapy cycle may increase because the on-cycle increases. However, regardless of the shortened or elongated therapy cycles, subsequent therapy cycles return to the normal therapy cycle length. For example, using the therapy cycle including a one minute on-cycle and a five minute off-cycle as an example, if patient14activates event indication button58during the one minute on-cycle, processor40provides a control signal to IMD16or otherwise controls IMD16to restart the one minute on-cycle, regardless of the point during the one minute stimulation session the indication of the patient event was received.

In this way, patient14may directly affect the therapy cycle implemented by IMD16by activating event indication button58. Furthermore, because IMD16maintains the same timing between an on-cycle and off-cycle, but only initiates or restarts the cycle upon generation of the event marker by processor40, therapy system10remains an open loop system that provides stimulation in a regular cycle. Thus, after the therapy on-cycle is restarted, IMD16continues implementing the normal therapy cycle.

In some cases, resetting the therapy cycle implemented by IMD16may help prevent the onset of the seizure because therapy is essentially provided on demand, i.e., in response to the activation of event indication button58. For example, if patient14senses an aura and activates event indication button58, the delivery of therapy resulting from the resetting of the therapy cycle may prevent the aura from developing into a more severe seizure, such as a tonic-clonic seizure, or may lessen the duration or severity of the tonic-clonic seizure.

Regardless of whether processor40initiates adjustment of therapy in response to receiving an indication of the event via event indication button58, patient14may enter information regarding the event and the efficacy of treatment (96) into programmer24at any time following the generation of the event marker. For example, if the aura does not develop into a more severe seizure, such as a tonic-clonic seizure, patient14may enter the data soon after activating event indication button58and the subsequent generation of the event marker. If, however, the aura does develop into a more severe seizure, such as a tonic-clonic seizure, patient14may enter the information at any time after recovering from the seizure.

Information may be input via user input mechanism56of patient programmer24, as described in detail with reference toFIG. 3. Patient14may input the event information into patient programmer24by any suitable technique. As examples, patient14may select a predetermined entry from a list presented by a user interface of patient programmer24, selecting an entry from a drop-down list presented by the user interface, selecting an icon presented by the user interface that represents the desired information, inputting text into patient programmer24, and the like. An example of a user interface is described in further detail with reference toFIGS. 17A-17E.

The information that is inputted by patient14may include, for example, the seizure type or severity of the patient event. Seizure types may be categorized by the extent to which they affect the brain, the affect on a patient's consciousness, and the behavioral effects. For example, a partial seizure may only affect a localized area of brain12(FIG. 1), while a generalized seizure may affect both hemispheres of brain12. Each of these major categories may be further broken up into a number of sub-categories such as, for example, simple partial seizures, complex partial seizures, absence seizures, tonic-clonic seizures, and the like. When a clinician programs patient programmer24, the clinician may populate a list with the types of seizures patient14is most likely to experience or all available seizure types. The list may include a plurality of seizure types, such as less than five, five, or more than five. The clinician may also assign nicknames to each type of seizure according to terms with which patient14may be more familiar. For example, patient14may identify a tonic-clonic seizure as a “Severe Seizure” and an absence seizure as a “Short-term Seizure.” Thus, the clinician and patient14may each use familiar language to identify the seizures. Further, in some examples, the list may include an editable option that allows a patient to enter a seizure type that is not otherwise included in the list.

Another exemplary type of event information input by patient14into patient programmer24may include the seizure duration. The seizure duration may be entered as any suitable time duration, such as, for example, five minute increments, or may be as accurate as patient14is able to determine. In some examples, patient programmer24may present a list including predetermined durations of time in order to provide a uniform time scheme. Seizure duration may be input via alphanumeric buttons, or may be selected from a dropdown list, a checkbox or the like.

Yet another example of information that may be inputted into patient programmer24by patient14may include an efficacy of the therapy. Efficacy of the therapy may refer to the patient's subjective rating of the general efficacy of therapy delivered via IMD16. For example, patient14may assign an efficacy rating to the therapy program or program group implemented by IMD16at the time patient14perceived the patient event. In general, patient14may provide information that indicates whether the therapy delivered by IMD16was effective in prevent the patient event, reducing the severity or of the patient event, reducing the frequency of patient events, or reducing any residual effects of the patient event. In examples in which processor40of patient programmer24initiates the adjustment of one or more therapy parameter values or therapy cycles in response to the activation of event indication button58, patient14may input information regarding the efficacy of the adjustments to therapy. Efficacy information may be especially useful in evaluating therapy system10in examples in which activating event indication button58resets the therapy cycle administered to patient14or initiates a change in the therapy program implemented by IMD16.

In some examples, therapy efficacy information may not be immediately available. For example, patient14may not be able to discern between efficacious and non-efficacious therapy for a period of time after implantation of IMD16and commencement of therapy. In these examples, efficacy of the therapy may be determined by patient14after a plurality of patient events have occurred or after a sufficient time period of therapy delivery has passed.

In some examples, patient14may determine the efficacy of therapy by comparing the duration, severity or type of seizure that occurred after the adjustment to therapy or implementation of therapy system10to a baseline condition. The baseline condition may be, for example, the patient's condition prior to implementation of therapy system10or prior to the adjustment of therapy, if any, that was made in response to activating event indication button58(e.g., at substantially the same time the event marker was generated). In other examples, patient14may determine the efficacy of therapy based on the absence of a seizure after perception of an aura or a relatively less severe seizure (e.g., compared to prior seizures experienced by patient14). Therapy efficacy information may be entered according to a numeric scale, for example, 1-5, where 1 indicates no seizure (a very efficacious therapy) and 5 indicates no change (non-efficacious therapy) or any other technique that indicates the relative effectiveness of therapy.

In some examples, patient programmer24may provide patient14with a user interface that permits patient14to input manually notes relating to event, and the notes may be associated with the event marker and stored within event information50portion of memory42(FIG. 3). For example, patient14may enter notes indicating an activity patient14was engaging in prior to perceiving an aura (e.g., exercise, eating, stressful situation, etc.), diet information, further description of the severity or type of the seizure, if one occurred, the effects of the seizure, or any other information patient14deems applicable to his therapy or condition.

As another example, patient14may enter information relating to the type or dosage of a drug or other pharmaceutical agent taken prior to the event or after a seizure occurred. Patient14may also input information specifying the time at which the drug or other pharmaceutical agent was ingested or otherwise received by patient14. For example, patient14may take one anti-seizure drug in regular doses at consistent time intervals, and after a tonic-clonic seizure, patient14may ingest a more potent anti-seizure medication to prevent any additional seizures from occurring for an amount of time after the tonic-clonic seizure. In other examples, medication information may be stored in memory35of IMD16or memory42of patient programmer24. Medication type and dosage may further help a clinician evaluate the efficacy of the currently prescribed therapy and determine if any changes to therapy are necessary and, if so, determine the nature of the changes.

After receiving event information (96), processor40of patient programmer24may associate the received event information with the corresponding event marker (98) and store the event marker and received information in event information50(100). Alternatively, processor40may transmit the information to IMD16, which may store the data within memory35. In some examples, processor40of patient programmer24may not immediately receive patient event information after the generation of the event marker. In those cases, processor40may associate the information received from patient14with the most recently generated event marker. In some examples, patient programmer24may display all or a portion of the event information associated with each of the event markers to patient14, such as upon the request of patient14. Displaying the event information to patient14may allow patient14to more closely monitor his or her therapy and condition.

In some examples, patient programmer24(or IMD16) may store the event marker and event information until the subsequent clinic visit of patient14. The clinician may review the event information and event markers to monitor the response of patient14to therapy, and, if necessary, generate a new treatment plan for patient14. Upon interrogation by a computing device, such as clinician programmer22, processor40of patient programmer24may control telemetry module46(FIG. 3) to transmit the event information and event marker to the computing device (102). Alternatively, processor40of patient programmer24may initiate the transmittal of the event information and associated event marker.

As discussed in more detail below, a clinician may manipulate and/or select areas of interest in the event information and clinician programmer22or another computing device may generate various displays of information, such as tables, bar graphs, Venn diagrams, and the like that present the event information in a more meaningful way. Graphical displays of information may reveal trends or other information useful to the clinician in treating patient14. For example, event information may be viewed over a time period of multiple months, and a clinician may view the data to determine if a patient's response to a particular therapy parameter set is diminishing, or if the patient's response is unchanging or even improving.

FIG. 6is a flow diagram illustrating an example technique that a computing device, such as clinician programmer22or patient programmer24, may employ to display event information received from patient14and/or physiological parameter sensors. WhileFIG. 6is primarily described with reference to clinician programmer22, in other examples, another computing device such as patient programmer24may perform any part of the technique shown inFIG. 6. Clinician programmer22may couple to patient programmer24through their respective telemetry modules46and76(110). Clinician programmer22may send a query or otherwise interrogate patient programmer24to retrieve event information stored in memory42of patient programmer24(112). In response to receiving the query, patient programmer24may transfer the event information (including the event marker) to clinician programmer22.

After receiving the patient event information, processor70of clinician programmer22may format and display the event information (114). The event information may be displayed in a variety of display formats, including, for example, tables, lists, graphs, charts, and the like. Exemplary display formats will be described in more detail below with reference toFIGS. 8 and 9. Memory72of clinician programmer22may store software that causes processor40to generate different types of displays. In some examples, the clinician programmer22may optionally prompt the clinician or other user to select one or more types of patient event information to display (e.g., duration and severity of seizures or the event markers and corresponding time stamps), as well as the type of display format for displaying the event information. For example, the clinician may wish to view the event information as a bar graph showing number of activations of event indication button58per week for a three month period. As another example, the clinician may wish to view a table of all the event information provided by patient14organized based on the respective event markers.

FIGS. 7A-7Eillustrate example user interfaces that may be presented by patient programmer24to allow a patient14to enter event information. Patient programmer24includes user input mechanisms56a-56f(collectively “user input mechanisms 56”), event indication button58, and display60. Patient14may interact with user input mechanisms56to input event information into patient programmer24, and, in some cases, control aspects of therapy delivered by IMD16within the limits programmed by a clinician. User input mechanisms include buttons56aand56b, which may be used to increase or decrease the therapy intensity, if allowed, and may perform other functions, as allowed by the operating software54(FIG. 3). An intensity of therapy may be modified by, for example, modifying a therapy parameter value, such as the current or voltage amplitude of stimulation signals, the frequency of stimulation signals, the shape of a stimulation signal or the electrode combination used to deliver the stimulation signal.

Multi-directional controller56fmay allow a user to navigate through menus displayed by display60, and may include a button56gthat is actuated when the center of multi-directional controller56fis pressed. Event indication button58is used to perform any of the functions ascribed to it herein, including, for example, generating an event marker and/or resetting or modifying a therapy cycle.

Display60may display graphical user interface screens that provide an interface for patient14to enter event information. While display60shows five individual screens inFIGS. 7A-7E, in other examples, the described screens may be displayed on a single screen divided into multiple sections, may be combined in any of other combinations of display screens, or may be omitted. The five screens shown in the illustrated examples include time stamp screen122(FIG. 7A), seizure type and severity screen126(FIG. 7B), duration screen132(FIG. 7C), notes screen136(FIG. 7D), and therapy efficacy screen138(FIG. 7E). Each screen presents patient14with event information associated with an event marker or allows patient14to enter event information.

Time stamp screen122, illustrated inFIG. 7A, shows the time stamp of an event marker. In some examples, the patient14may change the time stamp displayed by selecting button124aor124b(either via a touch screen interface, or by controlling a cursor via user input mechanisms56). Patient14may review (on screens such as those illustrated inFIGS. 7B-7E) event information associated with other event markers by changing the currently displayed time stamp. By selecting a stored time stamp, patient14is essentially selecting the event marker that was generated at the time reflected in the time stamp or otherwise associated with the time stamp (e.g., in some examples, patient14may modify the time stamp of an event marker). The other user interface screens126,132,136, and138may display the respective information associated with the selected time stamp. In other examples, the time stamp may simply display the time stamp associated with the most recent activation of event indication button58and programmer24may not provide patient14with an option for reviewing event information associated with other event markers.

FIG. 7Bshows seizure type and severity screen126, which allows patient14to input information relating to the type of seizure experienced (if any) and the severity of the seizure. As described above, the clinician may assign nicknames to different seizure types that correspond to the name with which patient14refers to the seizure. In the illustrated example, “Severe” may refer to a tonic-clonic seizure and “Minor” may refer to an absence seizure. Patient14may select the type of seizure using multi-directional controller56for any other suitable element of user input mechanisms56. Selection of a respective seizure type may be indicated by a selected box130. In some examples, selecting “other” may prompt patient14to enter an alphanumeric description of the seizure type. In other examples, the seizure type may be selected from a dropdown menu (similar to the menu shown for duration screen132), selected by an icon, and the like.

Patient14or another user may also input the severity of the seizure in severity subsection128. The severity may be selected from a numeric list, as shown inFIG. 7B, where a rating of “1” represents least severe and a rating of “5” represents most severe, for example. In other examples, the severity may be selected from a textual list, or may be editable by patient14. The severity may be correlated with the type of seizure indicated by the user. For example, a level 5 “Minor” seizure may be viewed by a clinician as less severe than a level 1 “Severe” seizure.

In some examples, however, the severity of the patient's seizure may be detected automatically based on values of one or more monitored physiological parameters of patient14, such as an EEG signal or an ECG signal. As previously described, IMD16or another sensing device may monitor one or more physiological parameters of patient14. The severity of the seizure may be determined based on, for example, the amplitude of the EEG signal waveform. Processor40of programmer24or a processor of another device (e.g., the sensing device or IMD16) may determine the severity of the seizure and automatically record the severity within event information50of memory42of programmer24. Severity may be categorized in terms of a graduated scale (e.g., a numerical scale) or another suitable scale. Alternatively, processor42may merely record the EEG signal and clinician or another computing device may determine the severity of the patient's seizure, if any, at the time the event marker was generated.

As illustrated inFIG. 7C, duration screen132allows a user, such as patient14, to enter the duration of the seizure associated with the time stamp shown in screen122(i.e., a particular event marker). In some examples, the duration may initially be determined by processor40. For example, patient14may activate event indication button58a first time when the patient event is sensed and a second time after patient14perceives the patient event as being complete. The time period between the first press of button58and second press of button58may be determined to be the duration of the event. In some examples, the duration may be edited at a later time by patient14or another user. In the illustrated example, the duration may be selected from dropdown menu134. The dropdown menu may display durations in any desired increment, such as, for example, one minute, five minute or fifteen minute increments. In other examples, the seizure duration may be entered numerically, either through the use of an alphanumeric keypad, a touch screen, or a menu-driven interface.

Notes section136, shown inFIG. 7D, allows a user, such as patient14, to enter any other notes deemed applicable to the therapy, event, or condition of patient14. Information entered in the notes section136may include information regarding any of the other sections, such as seizure type and severity or duration, or may include notes about the current medication and dosage being taken by patient24. For example, patient14may input notes regarding an activity being performed at the time of the event, a particular drug or drug dosage taken prior to or after the event, and the like.

As another example, illustrated inFIG. 7E, patient programmer24may present a therapy efficacy screen138that enables patient14to input information regarding the efficacy of therapy prior to, during or after the generation of the event marker. The therapy efficacy may relate to the duration, severity or type of seizure experienced by patient14. For example, patient14may associate a sensed aura with a certain type or severity of seizure. If, after activating event indication button58and resetting the therapy cycle, the predicted seizure does not occur, patient14may infer that the therapy was efficacious. However, if the predicted seizure still occurs, patient14may infer that the therapy was not efficacious.

Therapy efficacy screen138may include, for example, one or more questions regarding the efficacy of therapy, which patient14may answer by, for example, selecting a box139with a predetermined answer. Questions posed via therapy efficacy screen138may include, for example: “Was the therapy effective?” “Did the anticipated event occur?” “Was therapy as effective as it was X days ago?” In other examples, a numerical scale or another type of graduated scale for assessing relative efficacy may be presented to patient14or patient14may provide another input indicative of efficacy.

Event information relating to the efficacy of therapy may be especially useful for evaluating therapy system10and determining the impact on a specific patient's therapy. While automatically detected physiological parameters are useful for evaluating therapy system10, the subjective feedback from patient14may provide information not otherwise obtainable via the physiological parameter values. The clinician may consider the subjective feedback of patient14to be a valuable factor when determining whether to adjust the treatment plan for patient14or maintain the current plan, as well as for evaluating the condition of patient14.

Efficacy of therapy may be a useful type of event information when processor40is configured to control IMD16(e.g., by generating a control signal that causes IMD16to perform some action) to adjust or modify therapy in response to receiving an indication of the occurrence of the event. As previously described, the therapy adjustments may include resetting a therapy cycle of stimulation or drug delivery, adjusting a therapy parameter value, such as increasing a concentration or size of a drug bolus or increasing intensity of stimulation (e.g., via increasing a current or voltage amplitude or signal frequency), or switching to another therapy program or group. The clinician may evaluate event information received from processor40of patient programmer24, and, in some cases, other sources, such as IMD16or a sensing device, to evaluate the impact the therapy adjustment or modification on patient14.

In other examples, patient programmer24may present other sections or user interface screens for receiving event information. For example, programmer24may present a drug entry screen that allows a patient14to enter drug information, such as the drug type and dose taken prior to the event. The drug entry screen may also allow patient14to enter the time when the drug was taken, or when a course of drugs began and ended. The drug information may be selected from, for example, a dropdown list, a selectable box, or a text entry. The drug entry screen may also allow patient14to enter other drugs taken after an event, such as a more potent anti-seizure medication taken to prevent more seizures for a time period after the initial event. In some examples, a clinician may assign shorter, recognizable names for the respective drugs taken by patient14to assist patient14from identifying and selecting the drug from a dropdown list or the like.

FIGS. 8A-8Hillustrate various example user interfaces that may be presented by clinician programmer22to a user to display event information. The various user interface screens shown inFIGS. 8A-8Hare merely exemplary, and other types of user interfaces are also contemplated.

FIG. 8Ashows an example user interface screen140that may be presented by clinician programmer22after the initial download of event information stored on patient programmer24. Screen140includes a Therapy Overview142window that provides a summary of the stimulation parameter values that defined the stimulation therapy delivered by IMD16as well as other general information. In particular, Therapy Overview142presents the name144of patient14, the date of the last communication session146between clinician programmer22and patient programmer24or IMD16, and the amount of time that therapy was on148since the last session146. Additionally, Therapy Overview142presents electrode configurations150aand150bfor each of the two leads, respectively, and stimulation parameter value152including the pulse voltage, pulse width, pulse frequency and therapy cycle length. The electrode configuration and stimulation parameters may define a therapy program, which may also be associated into a group with one or more other therapy programs.

Therapy Overview142may also display any therapy observations134, such as changes to patient programmer24or IMD16, changes to the therapy program since last session, and the like. Processor70of clinician programmer22may be configured to interrogate IMD16and/or patient programmer24to ascertain whether certain changes, e.g., a change in the IMD16clock, have occurred since clinician programmer22last communicated with IMD16and/or patient programmer24. Therapy Overview142may also include other information including, for example, the number of therapy programs stored on IMD16, the clinician treating patient14, and any other information pertinent to the therapy of patient14.

Therapy Overview142(and all other user interface screens) may also include navigation icons156,158that indicate a user, such as the clinician, may navigate between screens and select options such as print reports, exit, next, back, and the like. If the display of clinician programmer22is a touch screen display, the user may directly select the navigation icons156,158.

In other examples, Therapy Overview142may also indicate other information, including the implantation date of IMD16and the number of switches between therapy groups during the course of therapy delivery by IMD16, if any, based on the number of event markers associated with a particular therapy group. Patient14may manually switch between therapy groups or the switch may automatically be made by IMD16or patient programmer24in response to activation of event indication button58of patient programmer24.

As previously described, in some examples, processor40of patient programmer24or another computing device may determine whether a particular therapy group implemented by IMD16is effective based on the event markers associated with the therapy group. In one example, the number of event markers associated with the therapy program or group may be indicative of the efficacy of the respective program or group. In other examples, as described in U.S. patent application Ser. No. 12/236,316 to Giftakis et al., entitled, “PATIENT EVENT INDICATION” and filed on the same date as the present disclosure, processor40may calculate an event metric for a therapy program or group based on the one or more associated event markers and compare the event metric to a threshold value in order to determine whether the respective program or group provides efficacious therapy to patient14. In some examples, the event metric may include a total number of event markers associated with the program or group, a number of event markers per unit of time associated with the program or group or a change from a baseline condition of patient14during the time the medical device delivered therapy with the particular therapy group. U.S. patent application Ser. No. 12/236,316 to Giftakis et al. is incorporated herein by reference in its entirety.

FIG. 8Billustrates another example user interface screen160that may be presented by clinician programmer22. User interface screen160presents a Patient Activity Overview162window. Patient Activity Overview162may summarize the activities166performed by patient14since the last office visit. For example, activities166may include the total number of times164patient14activated event indication button58of patient programmer24during a certain period of time (e.g., the time since the patient's last clinician visit), the highest number of activations168of event indication button58in a given time period, such as one day, the longest time period between activations170of event indication button58, the total amount of time that IMD16was turned off172by patient14during a certain period of time, and the current status174of IMD16.

FIG. 8Cillustrates another example user interface screen180that may be presented to a clinician by clinician programmer22. User interface screen180presents a calendar view of the patient event information. Dropdown box182allows the clinician to select the desired time window to view. In the example shown inFIG. 8C, the time window is on the order of one month. However, other time windows are contemplated, such as days, weeks or more than one month. In the example shown inFIG. 8C, the month selected for viewing by the user may be shown in a calendar view, with the dates194of the month located at the tops of respective boxes. The location, color, and text of the dates and other displayed information is for illustrative purposes only, and is to be understood to be non-limiting. Each day may indicate event information, or the lack thereof, through the use of multiple elements. For example, in the illustrated example, the number of activations of event indication button58, i.e., the number of event markers, is indicated for each day by a simple numeral188in approximately the center of the box corresponding to the day. A clinician may select a particular day and review the time stamp for each event marker.

When IMD16is able to provide therapy according to different therapy programs, an indication184of the date when the therapy program implemented by IMD16was changed may be given in symbolic form, as illustrated, or may be presented in textual form. Additionally, an indication190that more than one seizure actually occurred on a single day may be provided in symbolic or text form. The actual seizure detection may be based on physiological parameter data and/or input from patient14. An indication186that stimulation was turned on or off, e.g., by patient14either purposefully or inadvertently, may also be provided in the calendar view.

The calendar view may also provide a summary192of the information presented. For example, in the illustrated example, the summary192includes the total number of activations of event indication button58in the month of August, the number of therapy program mode changes in the month of August, and the total time the therapy device was in an off state. A user may select the month or other time frame displayed via dropdown box182, in which case summary192may provide the event information relevant to the selected time frame. In other examples, other summary data may be provided by calendar view180, such as, for example, the number of each type of seizure, the average number of seizures per amount of time, a summary of event information from a previous time period to enable comparison between more than one time period, a rating from patient14as to the efficacy of therapy and the like.

Clinician programmer22may also permit the clinician to program patient programmer24, configure IMD16, and perform tests on IMD16. In one example, a clinician may use clinician programmer22to program patient programmer24and IMD16to operate in a placebo mode. In some cases, a clinician may wish to evaluate whether patient programmer24including an event indication button58that allows patient14some control over therapy delivery by IMD16is a useful feature. As previously described, activation of event indication button58by patient14may result in a shift between therapy programs or program groups implemented by IMD16or a change in a therapy cycle. A therapy cycle may include at least one “on-cycle,” during which stimulation is turned on, and at least one “off cycle,” during which stimulation is not delivered to patient14. During the “on-cycle,” stimulation may be turned on and, off, for example, if stimulation is provided as pulses or bursts of pulses.

Patient14may test patient programmer24during a trial stage, which may be, for example, a few days, weeks, months or any other time period that provides sufficient time to evaluate patient programmer24in view of any fluctuations in the patient's condition. The clinician may determine whether to implement patient programmer24or another patient programmer that does not include the functionality of event indication button58(e.g., a modified patient programmer24) based on the frequency of usage of indication button58by patient14and feedback indicating the efficacy of indication button58.

In the placebo mode, processor40of patient programmer24may generate a placebo indication to patient14each time event indication button58is activated. Processor40, however, does not implement control of IMD16or otherwise take action to modify therapy delivered by IMD16. The placebo indication may be presented, e.g., via display60of patient programmer24, via an audible sound generated by patient programmer24or another sensory cue. The placebo indication provides feedback to patient14to indicate that the activation of event indication button58was received, and in some cases, may even indicate that the therapy delivered by IMD16was adjusted in response to the activation of event indication button58.

The clinician may not inform patient14that event indication button58is merely a placebo and does not directly affect IMD16. Thus, patient14may believe that therapy was triggered, a therapy cycle was restarted or therapy was otherwise modified after event indication button58was activated. In some cases, receiving the placebo indication may cause the placebo effect, in which patient14feels therapeutic effects, although IMD16functionality was not changed. During this trial stage, IMD16may be set to deliver stimulation at regular intervals, substantially continuously or deliver no stimulation at all. If a clinician may wish to evaluate whether patient14requires therapy in order to control a condition, such as seizures, IMD16may be configured to withhold stimulation during the trial stage.

The clinician may determine whether to implement the patient programmer24including a functional event indication button58based on the frequency of usage of the event indication button58by patient14and feedback indicating the efficacy of the event indication button58during the trial stage. The clinician may evaluate whether patient14believed event indication button58had any effect on therapy based on the patient feedback reflected in the event information. If the patient feedback indicated that activating event indication button58provided efficacious therapy when event indication button58merely resulted in the placebo indication, the clinician may discern that patient14does not need patient programmer24that includes a functional event indication button58. On the other hand, if the feedback from patient14indicated that activating event indication button58did not provide efficacious therapy, the clinician may wish to provide patient14with a patient programmer24that includes a functioning event indication button58that allows patient14to better control therapy delivery by IMD16.

FIG. 8Dillustrates another example user interface screen200clinician programmer22may present to a user. User interface screen200illustrates a tabular arrangement of patient event information for the period of a month, where each row includes information from one day. Column202displays the number of events per day and other ancillary information including, for example, days when the therapy was turned off, turned on, or modified. Column204displays a cumulative total of the number of events for the displayed period, and column206displays a cumulative average of events per day over the time period displayed. In some cases, the average number of event markers per day may provide more meaningful information to a clinician when determining whether therapy system10is providing effective therapy to patient14.

Although a time period of a month is shown inFIG. 8D, in other examples, user interface screen200may display any suitable time period, such as one week, two weeks, three weeks or more than a month.

FIG. 8Eshows yet another example user interface screen210clinician programmer22may present to a user. System Activity212window illustrates a first dropdown box214and a second dropdown box216for selecting the type of information displayed and the timeframe displayed, respectively. The illustrated example shows the number of events per unit time in graphical form, but any other type of patient event information described herein may be displayed in any suitable format described herein.

User interface screen210may be useful for displaying event information for a large range of time. For example, the x-axis of each of graphs218and220may represent time (e.g., measured in days, weeks or months), while the y-axis represents the number of event markers, which may be indicative of the number of seizures. Alternatively, processor40of clinician programmer22may discern the actual number of seizure occurrences based on patient feedback and the y-axis may represent the number of seizures.

FIG. 8Fillustrates another example user interface screen230that may be presented to a clinician by clinician programmer22. Screen230presents a table of selected event information for each of three therapy programs: program A232, program B234and program C236, and an off setting238of IMD16. In other examples, each row may indicate a therapy program group instead of a therapy program. Column240lists the percentage of time IMD16spent in each therapy program, e.g., during a time period selected by a user, column242lists the number of event markers that are associated with each therapy program, and column244lists the maximum number of event markers that were generated in one day while IMD16was delivering therapy in accordance with the respective therapy program. Screen230may also show a warning246indicating that data may be inaccurate because the date and time set in IMD16have been changed.

FIG. 8Gillustrates a table250of event information that may be generated and presented by clinician programmer22. The therapy program groups are listed in column252. The amount of time that IMD16delivered therapy in accordance with each therapy group (i.e., the “active time”) during a time period selected by a user or in the time period since the last interaction between clinician programmer22and patient programmer24may be provided in column254in both days and hours. The average number of activations of the particular therapy group per week may be listed in column256, the minimum and maximum number of activations per week of the particular therapy group may be listed in column258, the number of changes to therapy program settings (e.g., therapy parameter values)may be listed in column260, and the last programmed settings, including the pulse width, frequency, and voltage may be listed in column262. Again, the particular event information shown inFIG. 8Gis one example, and any of the event information described herein may be added, substituted or removed from the table inFIG. 8G. Additionally, the event information may be grouped differently than shown inFIG. 8G, and may be grouped in any manner desired by the clinician or other user. The clinician may annotate the data displayed inFIG. 8Gwith any comments provided by patient14or any observations made by the clinician. Clinician programmer22may allow the clinician to enter typed or written notes, or may accept oral notes. Other illustrated user interface screens may also allow a clinician to annotate the data or screens presented.

The table of event information shown inFIG. 8Gmay be useful for evaluating which therapy groups provided the most effective therapy to patient14relative to the other therapy groups. If patient programmer24is set such that patient14has the freedom to select the program group, the table of event information shown inFIG. 8Gmay also be useful for determining which program group patient14preferred (e.g., based on the active time for each program group). The clinician may take this information into consideration when selecting a chronic therapy group for patient14or for generating additional therapy program groups to trial on patient14.

FIG. 8Hshows an exemplary table270similar toFIG. 8G. However,FIG. 8Hshows event information from the current session272, the previous session274, and two sessions ago276. The information listed for each session is similar to that described inFIG. 8G, and again, may include any of the event information described herein.

Other user interface screens are also contemplated. For example, clinician programmer22may present a user interface that allows a clinician to modify the therapy parameter values stored within IMD16or patient programmer24. As another example, clinician programmer22may present a user interface that allows a clinician to make changes to the operating software used by patient programmer24. Still other user interface screens may allow a clinician to modify the lists presented to patient14by user interface44of patient programmer24. For example, the clinician may add, delete or modify the type of event information patient14may provide via user interface44of patient programmer24, or the presentation for receiving the event information.

FIGS. 9A-9Gillustrate example data formats (e.g., graphs and tables) that processor70of clinician programmer22or a processor of another device may generate and present in order to display event information to a user. While the description ofFIGS. 9A-9Gprimarily refers to clinician programmer22, in other examples, another computing device may generate the data formats and displays described herein. Displaying patient event information in graphic or tabular form may allow a user, such as a clinician, to more easily identify subtle or significant trends in the event information, or identify any relationships between occurrences of different types of information. Thus, clinician programmer22may store the necessary software, firmware, hardware or combinations thereof to generate one or more types of graphical or tabular displays.

FIG. 9Aillustrates a pie chart280. In this example, pie chart280represents the number of events associated with five different types of medications or combination of medications during a particular time period, which the user may specify or which clinician programmer22may automatically select. In other examples, pie chart280may represent the number of events associated with different therapy programs or program groups (e.g., stimulation programs). For example, slice282may indicate that eighteen event markers were generated (i.e., patient14activated event indication button5818 times) while patient14was ingesting medication A or was otherwise under the influence of medication A (e.g., a fluid delivery device may automatically deliver medication A to patient14or deliver medication A to patient14at the direction of patient14). Slice284of pie chart280may indicate that thirty-eight event markers were generated while patient14was ingesting medication A or otherwise under the influence of medical A. Similarly, slice286may represent the total number of event markers associated with medication C, slice288may represent the total number of event markers associated with medication D, and slice190may represent the total number of event markers associated with medication E.

Pie chart280may facilitate the clear and concise presentation of certain types of information, and may enable a clinician to quickly determine the relative effectiveness of a medication. Furthermore, in some examples, pie chart180may be interactive. A user may select one slice282,284,286,288, and290in order to ascertain more information about the event markers associated with the slice. For example, if pie chart280is presented on a display60of clinician programmer22, the user may select one slice of pie chart280with a peripheral pointing device (e.g., a mouse or a stylet). In response, processor70of clinician programmer24may generate another display that presents the requested information, such as the date stamp for the event markers associated with the selected slice of pie chart280, as well as event information (e.g., patient feedback) associated with the event markers (e.g., type of seizure, severity of seizure, and/or duration of seizure).

AlthoughFIG. 9Ais directed to a number of events per drug use, other types of information may be advantageously displayed as pie charts. For example, the relative number of events per therapy program or program group, the relative number of seizures per time of day or other time period, and the like may be easily displayed and ascertained via pie charts.

FIG. 9Billustrates an example of a Venn diagram300that may be useful for representing event information. In the example shown inFIG. 9B, circle302represents the number of times patient14activated event indication button58of patient programmer24and reset a therapy cycle, and circle304represents the number of times a certain type of seizure, such as a tonic-clonic seizure, was experienced by patient14. Section306between circle302and circle304represents the number of times the patient14activated the event indication button58and the event resulted in the selected type of seizure. A clinician may view a Venn diagram300and quickly ascertain the effectiveness of a therapy, e.g., based on the relative size of the overlapping section306or the patient event indication button58activations associated with section306. In the example shown inFIG. 9B, a larger overlapping section306may represent a less effective therapy. Once again, other types of event information may be displayed in a Venn diagram300, and the desired data may be indicated by the clinician using user interface74of clinician programmer22.

Examples of Venn diagrams for display of patient data, such as event information, as well as other types of useful displays of information are described in commonly-assigned U.S. patent application Ser. No. 11/789,690, entitled, ‘GRAPHICAL DISPLAY OF PATIENT DATA,” which is incorporated herein by reference in its entirety. As described in U.S. patent application Ser. No. 11/789,690, each section of Venn diagram300(e.g., circles302,304, overlapping section306and the portions of circles302,304that do not overlap) may provide a dynamic link. The clinician may select one or more portions of Venn diagram300in order to access more detailed information about the event information associated with the selected section of Venn diagram300.

FIG. 9Cillustrates an example of a bar graph310, which includes the number of event markers on the y-axis, and the severity/efficacy rating on the x-axis. In this example the severity is ranked as E1, which indicates patient14did not experience a seizure, E2, which indicates patient14experienced a relatively minimal/non-consequential seizure, E3, which indicates patient14experienced a relatively minor seizure, and E4, which indicated patient14experienced a relatively more intense seizure than E3.

Severity/efficacy rating E5 may represent the number of times that patient14provided information to patient programmer24indicating that the activation of event indication button58had little to no effect on the severity of a seizure. In examples in which activating event indication button58results in a therapy adjustment, e.g., an adjustment of the therapy program used by IMD16to deliver therapy or a restarting of a therapy cycle, rating E5 may be useful for determining whether the therapy adjustment is sufficient. For example, the clinician may find that the threshold for determining whether to shift therapy programs should be lowered in order to provide more efficacious adjustment of therapy in response to activation of event indication button58. In examples in which patient programmer24is operating in a placebo mode and activating event indication button58does not result in any therapy adjustment, but patient14is led to believe it results in a therapy adjustment, rating E5 may be useful for determining whether a functional event indication button58may be useful for patient14.

Bar314represents the number of times (18) patient14did not experience a seizure after an event marker was generated, i.e., after activating event indication button58. Similarly, bar312represents the number of times (26) patient14did not experience a minimal seizure after an event marker was generated. Bar316represents the number of times (13) patient14experienced a relatively minor seizure after activating event indication button58, bar318represents the number of times (5) patient14experienced a relatively severe seizure after activating event indication button56, and bar320represents the number of times (22) activating event indication button56did not affect the occurrence of a seizure.

Bar graphs or histograms may allow the concise and clear presentation of a variety of event information, including, for example, the number of seizures occurring in a given time period, the relatively number of different types of seizures, the number of seizures experienced in each therapy parameter set, the seizure frequency for each type for each therapy parameter set, drug concentrations for each drug administered, the severity of seizure for each of a number of activities, the duration of stimulation therapy for each of a number of drug types, the number of seizures of each type, severity, or duration, and the like. In some examples, three-dimensional bar graphs may be used to represent data on three axes. This may be desired in certain examples, such as displaying the frequency of each type of seizure for a number of therapy parameter sets. Other three-dimensional may be useful including, for example, surface maps and the like.

Just as with the other types of displays shown inFIGS. 9A and 9B, a clinician may more quickly ascertain relevant trends or relationships between the types of event information from bar graph310compared to a linear presentation of information (e.g., a table listing all event markers and associated event information).

FIG. 9Dillustrates an example of a histogram330representing of the effectiveness of therapy on the patient's condition. In the example of the histogram330shown inFIG. 9D, a ranking of “1” indicates little to no effect, and a ranking of “5” indicates a strong effect. For example, in the case of epilepsy, the y-axis represents the number of seizures corresponding to each ranking. Each of bars332,334,336,338,340represent the number of seizures that were affected by the therapy to the extent indicated by the category label.

FIG. 9Eillustrates an example of a line graph350representing the number of event markers generated per day, thereby representing the number of times patient14activated event indication button58. In this example, the x-axis includes a plurality of dates. However, in other examples, the x-axis may be scaled to represent any desired time period, including, for example, a period of hours, a week, a month, and the like. Line graphs may enable a clinician to quickly ascertain any trends in the event occurrence data. Other types of event information may be represented as line graphs, including any of the event information described above. Event information that varies with time may be particularly suited for display using a line graph.

FIG. 9Fillustrates a relatively large amount of event information presented in tabular format360. Table format360may allow a clinician to view detailed information about a single event or a small number of events, or may allow aggregation of many events into a single grouping (e.g., a week or a month). A tabular format may be particularly useful when viewing the notes entered by patient14regarding the events and related therapy, and may also be preferred when viewing summary data, such as the total number of event since the last office visit, or the average number of events per time period.

In each of the examples described above, certain tasks performed by processor40of patient programmer24may be performed by a processor of another computing device, such as clinician programmer22or by a clinician. For example, inFIG. 5, a clinician or a processor of another computing device may associate event information with an event marker, e.g., based on the date and time the event marker was generated and the event information was received. Furthermore, each of the features described herein may be performed via hardware, software, firmware, or any combination thereof.

Various examples have been described in the disclosure. These and other examples are within the scope of the disclosure. For example, while the examples described herein are primarily directed toward therapy system10that includes an implanted medical device to deliver DBS, the disclosure is not so limited. In other examples, for example, therapy system10may include an external DBS device, an implanted or external electrical stimulator configured to deliver therapy to treat other patient conditions, a fluid delivery device configured to deliver pharmaceutical agents, insulin, pain relieving agents, gene therapy agents, or the like to patient14, one or more microstimulators or other therapy devices.

The systems and methods described herein are also useful with therapy systems that provide an electrical stimulator, fluid (e.g., drug) delivery device or another therapy device that provides therapy to patient14to manage a patient condition other than a seizure disorder. For example, the systems and methods described herein are also useful with therapy systems that provide therapy for neurological disorders, psychiatric disorders, pain mitigation, peripheral neuropathy or post-operative pain mitigation, ilioinguinal nerve stimulation, intercostal nerve stimulation, gastric stimulation for the treatment of gastric mobility disorders and obesity, muscle stimulation (e.g., functional electrical stimulation (FES) of muscles), for mitigation of other peripheral and localized pain (e.g., leg pain or back pain) or sacral nerve stimulation to influence the behavior of the relevant structures, such as the bladder, sphincter and pelvic floor muscles. For example, the systems and methods described herein may also be useful with spinal cord stimulation, gastric stimulation, pelvic floor stimulation, peripheral nerve stimulation, peripheral nerve field stimulation, and the like.

In addition, while the examples described herein are primarily directed toward receiving an indication of a patient event that is related to a seizure and receiving event information related to the seizure or seizure symptom, in other examples, a patient programmer may include an event indication button that generates a log of patient events related to other patient conditions. For example, a patient may activate the event indication button to indicate the occurrence of a headache (e.g., migraine headache, cluster headache, tension headache, cervicogenic headache or occipital neuralgia), which may be useful if the patient is afflicted with chronic pain or migraines. The patient may then provide information relating to the headache, such as the efficacy of therapy. Efficacy of therapy may include, for example, a type of headache, a severity of the headache, a duration of the headache, or a comparison of severity and/or duration of the headache to a baseline condition (e.g., a headache when therapy is not applied or a headache before a therapy system was implanted). Efficacy of therapy may also include an indication of the absence of a headache or the reduction in a severity of a headache compared to a baseline after the patient perceived an imminent headache and activated event indication button58of patient programmer24.

As another example, a patient may activate event indication button58to indicate the occurrence of psychiatric disorder event, which may include a symptom or a mood state related to a psychiatric disorder. Psychiatric disorders may include, for example, major depressive disorder (MDD), bipolar disorder, anxiety disorders, post-traumatic stress disorder, dysthymic disorder, and obsessive-compulsive disorder (OCD). For example, as patient may activate the event indication button to indicate the occurrence of an anxiety event (e.g., an anxiety or panic attack) or the occurrence of a compulsion or obsessive thought (i.e., an obsessive-compulsive event), which may be useful if the patient is afflicted with OCD.

A patient also may activate the event indication button to indicate the occurrence of a depression event (or episode), which may be useful if the patient is afflicted with major depressive disorder, anxiety disorder, bipolar disorder, or another psychological disorder. A depression event may include a symptom of depression, such as fatigue, anhedonia, depressed mood, loss of energy, diminished ability to think or concentrate, indecisiveness, or recurrent thoughts of death or suicidal ideation, insomnia or hypersomnia. As an example, the patient symptoms may be defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), which is a book, published by the American Psychiatric Association, which defines criteria used to diagnose various mental disorders, including depression.

As another example, a patient may activate the event indication button to indicate the occurrence of a manic event (or episode), which may be useful if the patient is afflicted with bipolar disorder. Examples of manic events include inflated self-esteem or grandiosity and a decreased need for sleep.

The patient may also provide information relating to the psychiatric disorder, such as the efficacy of therapy. Efficacy of therapy with respect to a psychiatric disorder may include, for example, an improvement in mood or function, an absence or reduction in severity of an anxiety attack or obsessive compulsive act after the patient perceives an imminent attack, the overall reduction in frequency of the psychiatric disorder symptom or mood state, or the like.

Patients afflicted with physical or psychological dependency (i.e., addiction), e.g., to a drug, alcohol, eating, gambling, or other activities or substances, may provide patient input to indicate the occurrence of withdrawal symptoms or cravings. The patient may also provide information relating to efficacy of therapy delivery for treating the dependency.

With respect to patients afflicted with urinary or fecal incontinence, the patient event indications may indicate the occurrence of a urinary or fecal voiding event or an urge to void felt by the patient. For example, the patient may provide input indicating the occurrence of the urinary or fecal voiding event or the voiding event may automatically be detected, e.g., with the aid of sensors. The sensors may be carried external to the patient, e.g., included within an undergarment worn by the patient as described in U.S. patent application Ser. No. 11/414,626, which was filed on Apr. 28, 2006 and is entitled, “EXTERNAL VOIDING SENSOR SYSTEM,” which is incorporated herein by reference in its entirety. In other examples, the sensors may be implanted within the patient and sense physiological parameters associated with the voiding, such as electrical activity of the pelvic floor muscles, movement of fluid through the patient's body, and the like.

As another example, a patient may activate the event indication button to indicate the occurrence of a tremor episode or another symptom of a movement disorder, such as rigidity, bradykinesia, rhythmic hyperkinesia, nonrhythmic hyperkinesia, dystonia, and akinesia, which may be useful if the patient is afflicted with a movement disorder (e.g., Parkinson's disease or Huntington's disease). The patient may also provide information relating to the movement disorder, such as the efficacy of therapy. Efficacy of therapy with respect to a movement disorder may include, for example, an improvement in motion or motor function, an absence of motion reduction, or the like. Use of a patient programmer including an event indication button may also be useful with other patient events and conditions.

In each of the other examples of event indication buttons described above, patient programmer24may generate a signal that causes IMD16to adjust therapy in response to the generation of the event marker. For example, IMD16may change therapy programs if a certain threshold number of event markers are associated with the current therapy program, adjust a therapy parameter (e.g., increasing intensity of stimulation or a concentration or size of a drug bolus), or restart a therapy cycle.