Patent Application
20240057894
This document relates generally to medical systems, and more particularly to systems, devices, and methods for pain management using patient mobility information.
Pain is one of the most common and among the most personally compelling reasons for seeking medical attention, and consumes considerable healthcare resources each year. The relation between etiology, underlying mechanisms and the specific symptoms and signs related to painful disorders is complex. Pain in an individual patient may be produced by more than one mechanism.
Chronic pain, such as pain present most of the time for a period of six months or longer during the prior year, is a highly pervasive complaint and consistently associated with psychological illness. Chronic pain may originate with a trauma, injury or infection, or there may be an ongoing cause of pain. Chronic pain may also present in the absence of any past injury or evidence of body damage. Common chronic pain can include headache, low back pain, cancer pain, arthritis pain, neurogenic pain (pain resulting from damage to the peripheral nerves or to the central nervous system), or psychogenic pain (pain not due to past disease or injury or any visible sign of damage inside or outside the nervous system).
Chronic pain may be treated or alleviated using medications, acupuncture, surgery, and neuromodulation therapy such as local electrical stimulation or brain stimulation, among others. Examples of neuromodulation include Spinal Cord Stimulation (SCS), Deep Brain Stimulation (DBS), Peripheral Nerve Stimulation (PNS), and Functional Electrical Stimulation (FES). Implantable neuromodulation systems have been applied to deliver such a therapy. An implantable neuromodulation system may include an implantable neurostimulator, also referred to as an implantable pulse generator (IPG), which can electrically stimulate tissue or nerve centers to treat nervous or muscular disorders. In an example, an IPG can deliver electrical pulses to a specific region in a patient's spinal cord, such as particular spinal nerve roots or nerve bundles, to create an analgesic effect that masks pain sensation.
Patients with chronic pain usually have certain levels of mobility limitations or difficulty with daily tasks requiring adequate physical functions. Monitoring mobility can help assess chronic pain and efficacy of pain therapies such as neuromodulation therapy. This document discusses systems, devices, and methods for monitoring and managing patients with chronic pain. According to one example, a patient monitoring system comprises a sensor circuit to sense a physiological or functional signal indicative of or correlated to patient mobility, an electrostimulator to generate and deliver neuromodulation therapy to the patient, and a controller circuit to generate a mobility metric using the sensed physiological or functional signal. The mobility metric represents respective times spent in different activity intensity levels associated with one or more types of activities during a time period (e.g., a day). The controller circuit can trend the mobility metric over time and determine a progress toward a personalized mobility goal of the patient, and present the trended mobility metric or the progress on a user interface. In some examples, the physiological or functional signal can be sensed in response to a neuromodulation therapy for managing chronic pain, and the controller circuit can adjust the neuromodulation therapy based on the trended mobility metric or the progress toward the mobility goal.
Example 1 is a system for monitoring mobility of a patient treated with a neuromodulation therapy, the system comprising: a sensor circuit configured to sense a physiological or functional signal indicative of or correlated to patient mobility; an electrostimulator configured to generate and deliver the neuromodulation therapy to the patient; and a controller circuit configured to: generate a mobility metric using the sensed physiological or functional signal, the mobility metric representing mobility times spent in respective different activity intensities associated with one or more types of activities during a specific time period; trend the mobility metric over time and determine a progress toward a mobility goal of the patient; and generate a control signal to the electrostimulator to initiate or adjust the neuromodulation therapy in accordance with the trended mobility metric or the determined progress toward the mobility goal.
In Example 2, the subject matter of Example 1 optionally includes, wherein the controller circuit is configured to: based on the trended mobility metric or the determined progress toward the mobility goal, generate a recommendation for future activities or a modification of the mobility goal; and present the recommendation, and the trended mobility metric or the determined progress, on a user interface.
In Example 3, the subject matter of any one or more of Examples 1-2 optionally include, wherein the mobility metric includes an activity-specific mobility metric representing mobility times spent in the respective different activity intensities associated with a specific activity type or a specific activity context, wherein the controller circuit is further configured to: trend the activity-specific mobility metric over time and determine a progress toward an activity-specific mobility goal of the patient; and generate the control signal to the electrostimulator to initiate or adjust the neuromodulation therapy in accordance with the trended activity-specific mobility metric or the determined progress toward the activity-specific mobility goal when the patient engages in an activity of the specific activity type or under the specific activity context.
In Example 4, the subject matter of Example 3 optionally includes, wherein the controller circuit is further configured to: generate respective activity-specific mobility metrics for one or more activity types or activity contexts; and present on a user interface an association between (i) the one or more activity types or activity contexts and (ii) the respective activity-specific mobility metrics.
In Example 5, the subject matter of Example 4 optionally includes, wherein the controller circuit is configured to: receive from the user interface a user input of the one or more activity types or activity contexts during the specific time period; and correlate the user input to the respective activity-specific mobility metrics.
In Example 6, the subject matter of any one or more of Examples 1-5 optionally include, wherein the controller circuit is further configured to: generate (i) a first mobility metric from a first physiological or functional signal sensed in response to neurostimulation according to a first stimulation program, and (ii) a second mobility metric from a second physiological or functional signal sensed in response to neurostimulation according to a second stimulation program different than the first stimulation program; trend respectively the first mobility metric and the second mobility metric over time, and determine respective progresses toward the mobility goal of the patient; and generate the control signal to the electrostimulator to initiate or adjust the neuromodulation therapy using one of the first or the second stimulation program selected based on a comparison of the trended first mobility metric to the trended second mobility metric, or a comparison between the respective progresses toward the mobility goal.
In Example 7, the subject matter of Example 6 optionally includes, wherein the first and the second physiological or functional signals are sensed when the patient engages in a same type of activity or under a same activity context, wherein the controller circuit is configured to generate the control signal to the electrostimulator to initiate or adjust the neuromodulation therapy using the selected stimulation program when the patient engages in the same type of activity or under the same activity context.
In Example 8, the subject matter of any one or more of Examples 1-7 optionally include, wherein the controller circuit is configured to categorize the different activity intensities into a plurality of intensity bins, and to generate the mobility metric including an entropy of the mobility times across the plurality of intensity bins.
In Example 9, the subject matter of any one or more of Examples 1-8 optionally include, wherein: the sensor circuit includes a physiological sensor configured to sense a physiological signal correlated to patient mobility; and the controller circuit is configured to apply the sensed physiological signal to a trained estimation model to generate the mobility metric.
In Example 10, the subject matter of Example 9 optionally includes a model training circuit configured to: receive a training dataset comprising a set of activity signals sensed by accelerometers and a set of physiological signals sensed by physiological sensors different from the accelerometers, the set of activity signals and the set of physiological signals sensed substantially concurrently from the patient; determine accelerometer-based mobility metric values using the set of activity signals; and generate the trained estimation model using the training dataset and the accelerometer-based mobility metric values, the trained estimation model mapping the set of physiological signals to the accelerometer-based mobility metric values.
In Example 11, the subject matter of any one or more of Examples 1-10 optionally include, wherein the controller circuit is configured to: generate a population-based mobility metric using physiological or functional signals sensed from a number of patients having similar medical conditions or similar demographics to the patient; and determine, and present on a user interface, a relative position of the mobility metric of the patient with respect to the population-based mobility metric.
In Example 12, the subject matter of any one or more of Examples 1-11 optionally include, wherein the controller circuit is configured to determine the mobility goal based on at least one of: a baseline mobility metric of the patient during a baseline time period; or a population-based mobility metric generated from patients having similar medical conditions or similar demographics to the patient.
In Example 13, the subject matter of any one or more of Examples 1-12 optionally include, wherein the controller circuit is configured to: categorize the different activity intensities into a plurality of intensity bins; and present, on a user interface, a graphical comparison between (i) the mobility metric represented by a distribution of the mobility times across the plurality of intensity bins and (ii) the mobility goal represented by a target distribution of target mobility times across the plurality of intensity bins.
In Example 14, the subject matter of any one or more of Examples 1-13 optionally include, wherein the controller circuit is configured to: categorize the different activity intensities into a plurality of intensity bins; and present, on a user interface, a graphical comparison between (i) a first distribution of mobility times across the plurality of intensity bins during a first time period and (ii) a second distribution of mobility times across the plurality of intensity bins during a second time period prior to the first time period.
In Example 15, the subject matter of any one or more of Examples 1-14 optionally include, wherein the controller circuit is configured to: establish a correlation between the mobility metric and a patient-reported functional state of the patient; and predict a future functional state of the patient using the established correlation.
Example 16 is a method of monitoring mobility of a patient treated with a neuromodulation therapy, the method comprising: sensing, via a sensor circuit, a physiological or functional signal indicative of or correlated to patient mobility; generating, via a controller circuit, a mobility metric using the sensed physiological or functional signal, the mobility metric representing mobility times spent in respective different activity intensities associated with one or more types of activities during a specific time period; via the controller circuit, trending the mobility metric over time and determining a progress toward a mobility goal of the patient; and initiating or adjusting the neuromodulation therapy via a neuromodulator in accordance with the trended mobility metric or the determined progress toward the mobility goal.
In Example 17, the subject matter of Example 16 optionally includes, further comprising: based on the trended mobility metric or the determined progress toward the mobility goal, generating a recommendation for future activities or a modification of the mobility goal; and presenting the recommendation and the trended mobility metric or the determined progress on a user interface.
In Example 18, the subject matter of any one or more of Examples 16-17 optionally include, wherein the mobility metric includes an activity-specific mobility metric representing mobility times spent in the respective different activity intensities associated with a specific activity type or a specific activity context, the method comprising: trending the activity-specific mobility metric over time and determining a progress toward an activity-specific mobility goal of the patient; and initiating or adjusting the neuromodulation therapy in accordance with the trended activity-specific mobility metric or the determined progress toward the activity-specific mobility goal, the neuromodulation therapy being delivered to the patient when the patient engages in an activity of the specific activity type or under the specific activity context.
In Example 19, the subject matter of any one or more of Examples 16-18 optionally include, wherein: generating the mobility metric includes generating (i) a first mobility metric from a first physiological or functional signal sensed in response to neurostimulation according to a first stimulation program, and (ii) a second mobility metric from a second physiological or functional signal sensed in response to neurostimulation according to a second stimulation program different than the first stimulation program; trending the mobility metric include trending respectively the first mobility metric and the second mobility metric over time; determining the progress toward the mobility goal includes respective progresses toward the mobility goal of the patient; and initiating or adjusting the neuromodulation therapy is in accordance with one of the first or the second stimulation program selected based on a comparison of the trended first mobility metric to the trended second mobility metric trend, or a comparison between the respective progresses toward the mobility goal.
In Example 20, the subject matter of any one or more of Examples 16-19 optionally include, wherein the mobility metric includes at least one: a mobility score computed using a weighted combination of the mobility times spent in different activity intensities, the mobility times each scaled by respective weight factors proportional to the respective different activity intensities; or an entropy of the mobility times across a plurality of intensity bins representing categorized activity intensities.
In Example 21, the subject matter of any one or more of Examples 16-20 optionally include: generating a population-based mobility metric using physiological or functional signals sensed from a number of patients having similar medical conditions or similar demographics to the patient, the population-based mobility metric representing respective population-based mobility times spent in different activity intensities; and determining, and presenting on a user interface, a relative position of the mobility metric of the patient with respect to the population-based mobility metric.
In Example 22, the subject matter of any one or more of Examples 16-21 optionally include determining the mobility goal based on at least one of a baseline mobility metric of the patient during a baseline time period, or a population-based mobility metric generated from patients having similar medical conditions or similar demographics to the patient.
This summary is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the disclosure. The detailed description is included to provide further information about the present patent application. Other aspects of the disclosure will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which are not to be taken in a limiting sense.
Various embodiments are illustrated by way of example in the figures of the accompanying drawings. Such embodiments are demonstrative and not intended to be exhaustive or exclusive embodiments of the present subject matter.
By way of example, chronic pain management may involve monitoring patient pain symptoms and physical, functional, and emotional well-being, determining appropriate treatment options (e.g., neuromodulation therapies with an implantable device), and evaluating patient response to pain therapy. Effective monitoring and accurate pain assessment are important for managing patients with chronic pain. Such assessment may include a pain rating, such as on a numerical scale of 1 to 10 (with 10 being the worst pain) or similar descriptors of pain intensities. Such pain rating, however, may have several drawbacks. For one thing, chronic pain patients may have different tolerances to pain, making the pain ratings subjective and less comparable among patients. Additionally, the pain rating alone may not reflect patient physical and functional capacities. Although chronic pain may limit patient functional capacity and cause mobility issues, an improvement in pain sensation (e.g., a lower pain rating) may not always be accompanied by or synchronized with a progress in the patient's functional capacities, mobility status, and overall quality of life. For example, a chronic pain patient may report a sizable reduction in pain yet remains to be bedridden without gaining improvement in his/her physical or functional capacities. In another example, a chronic pain patient may not report substantial pain reduction, even though he/she has started walking, sleeping normally, and engaging in more activities.
Functional assessment has been performed clinically to optimize function-based strategy for treating chronic pain. A function-based strategy involves measuring a patient's progress not in pain relief (e.g., a decrease in pain rating), but in physical functions such as sleeping, walking, working, connecting with friends, or other behavioral and social activities in daily life. Such functional assessment can provide more objective insight into patient physical and social capacities and quality of life (QoL), and can be used to evaluation an efficacy of a pain therapy (e.g., neuromodulation therapy such as SCS) received by the patient or whether the pain therapy needs to be adjusted.
For patients with an implantable neuromodulation device for pain control, assessment of pain and mobility or functional capacities are typically performed in a clinic or other medical facilities. For some patients and on some occasions, such in-person assessment in a clinical setting may not always be feasible or practical. For example, some patients with chronic pain and under long-term treatment (e.g., via an implantable neuromodulator) may experience gradual physiological, functional, or emotional changes, which can get unnoticed for an extended period of time when the patient is outside a clinical setting until it becomes symptomatic and get managed during a clinic visit. Continuous or periodic monitoring of such patients would be desirable to timely detect pain progression and changes in patient functional abilities. On the other hand, some chronic-pain patients may experience sudden change in their pain sensation, and require immediate pain assessment, a therapy titration, or neuromodulation device check. However, geographic barriers to medical facilities and resources may prevent or delay the clinical evaluation and treatment titration.
The present inventors have recognized that a remotely-accessible patient monitoring and pain management platform can be more desirable and advantageous in certain situations than a conventional in-person visit at a clinic. Such a patient monitoring and pain management platform can monitor patient mobility continuously, periodically, or at any desired time between clinic visits. Disclosed herein are systems, devices, and methods for monitoring and managing patients with chronic pain. A patient monitoring system comprises a sensor circuit to sense a physiological or functional signal indicative of or correlated to patient mobility, and a controller circuit to generate a mobility metric using the sensed signal. The mobility metric represents respective times spent in different activity intensity levels in association with one or more types of activities during a time period. The controller circuit can trend the mobility metric over time and determine a progress toward a personalized mobility goal, and present the trended mobility metric or the progress to a user. In some examples, the physiological or functional signal can be sensed responsive to a neuromodulation therapy for managing chronic pain, and the controller circuit can adjust the neuromodulation therapy based on the trended mobility metric or the progress toward the mobility goal.
The patient monitoring and pain management system and methods of using the same, as described in this document, may improve the technology of device-based pain management. According to one aspect of the present subject matter, mobility metrics may be evaluated when a patient is engaging in daily activities such as grocery shopping, walking a dog, doing yardwork, working out in gym, cooking, among other activities. Such activity type or a context information may be “tagged” with the mobility metrics to produce activity type- or context-based mobility metrics, which can help improve interpretation of changes in mobility and optimize neuromodulation therapy when the patient engages in a particular activity. According to some embodiments, the mobility metric may be correlated to patient-reported physical functions, or used to generate a quality of life (QoL) score. The correlation and the QoL score enable more comprehensive and objective assessment of patient overall physical health and/or response to neuromodulation therapy. According to some embodiments, the mobility metric may be tracked against a personalized mobility goal of the patient. The mobility goal may be set based on patient baseline mobility characteristics, or population-based mobility data from patients with medical conditions or demographics similar to the patient being evaluated (the “similar” patients). The mobility goal thus established is not only tailored for individual patient health status, but also enables assessing patient improvement in mobility capacity relative to the group of “similar” patients. According to some embodiments, the mobility metric may be estimated by applying signals acquired by a variety of physiological sensors to respective trained mobility estimation models. Each model may be calibrated against a “standard” mobility metric determined using signals sensed by an accelerometer, such that the estimated mobility metric may be comparable to accelerometer-based mobility metric within a specified tolerance level. As the variety of physiological sensors may be included in different devices (e.g., an implantable medical device, a portable or wearable device such as a smartphone, a smart watch, etc.), the mobility estimation model enables “plug-and-play” capability of estimating a mobility metric from a range of existing devices with high estimation fidelity, yet without requiring device- or sensor-specific mobility algorithms. This can improve mobility assessment efficiency and reduce overall development and operation cost.
The patient monitoring and pain management system described herein can be implemented using a combination of hardware and software designed to provide a pain management regimen to increase therapeutic efficacy, increase patient satisfaction for neurostimulation therapies, reduce side effects, and/or increase device longevity. The present system may be applied in any neurostimulation (neuromodulation) therapies, including but not limited to SCS, DBS, PNS, FES, and Vagus Nerve Stimulation (VNS) therapies. In various examples, instead of providing closed-loop pain therapies, the systems, devices, and methods described herein may be used to monitor the patient and assess pain that either occurs intrinsically or is induced by nerve block procedures or radiofrequency ablation therapies, among others. The remote patient monitoring and pain management system may provide recommendations to the patient or a clinician regarding pain treatment.
In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural, logical and electrical changes may be made without departing from the spirit and scope of the present invention. References to “an”, “one”, or “various” embodiments in this disclosure are not necessarily to the same embodiment, and such references contemplate more than one embodiment. The following detailed description provides examples, and the scope of the present invention is defined by the appended claims and their legal equivalents.
The patient monitoring and pain management system 100 may include one or more of an implantable system 110 for implantation in the body 199 of the patient, a wearable electronic device 120 to be worn on the patient body 199 (such as on a wrist or an arm as shown), an external system 130, a mobile device 140 operable by a patient, a cloud-computing device 150, and one or more user terminals 160. The implantable system 110 may include an ambulatory medical device (AMD), such as an implantable pulse generator (IPG) 112, a lead system 114, and one or more electrodes 116. The IPG 112 may be configured for subcutaneous implant in a patient's chest, abdomen, or other parts of the body 199. The IPG 112 may include a hermetically sealed housing that houses sensing circuitry to sense physiological or functional signals from the patient via sensing electrodes or ambulatory sensors associated with the patient and in communication with the IPG 112. In some examples, the sensing electrodes or the ambulatory sensors may be included within the IPG 112. Physiological or functional signals may be sensed during a pain episode. The sensed physiological or functional signals may include at least one signal indicative of muscle electrical or mechanical activity at a specific body location. The IPG 112 may generate signal metrics indicative of muscle tension from the sensed muscle electrical or mechanical activity signal, and characterize and quantify the pain, such as to determine onset, intensity, severity, duration, or patterns of the pain experienced by the subject. The IPG 112 may generate an alert to indicate occurrence of a pain episode, pain exacerbation, or efficacy of pain therapy, and present the alert to a clinician.
The IPG 112 may provide neuromodulation therapy to the patient, such as therapies for treating or alleviating pain. The IPG 112 may generate electrical, magnetic, or other types of energy. In some examples, in addition or alternative to the IPG 112, a drug delivery system such as a drug infusion pump can be included to deliver pain medication to the patient, such as morphine sulfate or ziconotide, among others.
The IPG 112 may include electrostimulation circuitry that generates electrostimulation pulses to stimulate a neural target via the electrodes 116 operably connected to the IPG 112. In an example, the electrodes 116 may be positioned on or near a port of the spinal cord of the patient, and the electrostimulation circuitry may be configured to deliver SCS to alter or alleviate pain. In another example, the electrodes 116 may be surgically placed at other neural targets such as a brain or a peripheral neutral tissue, and the electrostimulation circuitry may be configured to deliver brain or peripheral stimulations. Examples of electrostimulation may include deep brain stimulation (DBS), trigeminal nerve stimulation, occipital nerve stimulation, vagus nerve stimulation (VNS), sacral nerve stimulation, sphenopalatine ganglion stimulation, sympathetic nerve modulation, adrenal gland modulation, baroreceptor stimulation, or transcranial magnetic stimulation, spinal cord stimulation (SCS), dorsal root ganglia (DRG) stimulation, motor cortex stimulation (MCS), transcranial direct current stimulation (tDCS), transcutaneous spinal direct current stimulation (tsDCS), pudendal nerve stimulation, multifidus muscle stimulation, transcutaneous electrical nerve stimulation (TENS), tibial nerve stimulation, among other peripheral nerve or organ stimulation. The IPG 112 may additionally or alternatively provide therapies such as radiofrequency ablation (RFA), pulsed radiofrequency ablation, ultrasound therapy, high-intensity focused ultrasound (HIFU), optical stimulation, optogenetic therapy, magnetic stimulation, other peripheral tissue stimulation therapies, other peripheral tissue denervation therapies, or nerve blocks or injections.
In various examples, the electrodes 116 may be disposed on one or more leads of the lead system 114 electrically coupled to the IPG 112. In an example, the lead system 114 may include a directional lead that includes at least some segmented electrodes circumferentially disposed about the directional lead. Two or more segmented electrodes may be distributed along a circumference of the lead. The actual number and shape of leads and electrodes may vary according to the intended application. Detailed description of construction and method of manufacturing percutaneous stimulation leads are disclosed in U.S. Pat. No. 8,019,439, entitled “Lead Assembly and Method of Making Same,” and U.S. Pat. No. 7,650,184, entitled “Cylindrical Multi-Contact Electrode Lead for Neural Stimulation and Method of Making Same,” the disclosures of which are incorporated herein by reference. The electrodes 116 may provide an electrically conductive contact providing for an electrical interface between the IPG 112 and tissue of the patient. The neurostimulation pulses are each delivered from the IPG 112 through a set of electrodes selected from the electrodes 116. In various examples, the neurostimulation pulses may include one or more individually defined pulses, and the set of electrodes may be individually definable by the user for each of the individually defined pulses.
Although the discussion herein with regard to pain management is focused on implantable devices such as the IPG 112, this is meant only by way of example and not limitation. The patient monitoring and pain management techniques discussed herein may also be applied to pain management via non-implantable devices, such as subcutaneous devices, wearable devices (e.g., wrist watch, patches, ring, necklace, garment- or shoe-mounted device, etc.), or other external medical devices, or a combination of implantable, wearable, or other external devices. The therapy, such as electrostimulation or medical therapies, may be used to treat various neurological disorders other than pain including, for example, epilepsy, obsessive compulsive disorder, tremor, Parkinson's disease, or dystonia, among other movement and affective disorders.
The external system 130 can be communicatively coupled to the IPG 112 via a communication link 170. The external system 130 may include a dedicated hardware/software system such as a programmer, a remote server-based patient management system, or alternatively a system defined predominantly by software running on a standard personal computer. The external system 130 may be configured to control the operation of the IPG 112, such as to program the IPG 112 for delivering neuromodulation therapy. The external system 130 may additionally receive via the communication link 170 information acquired by IPG 112, such as one or more sensor signals. In an example, a user may use the external system 130 to program the IPG 112 to deliver pain therapy in a closed-loop fashion based on the signals received from the IPG 112. The external system 130 may include a display that can display information including, for example, signal received by the IPG 112, a pain or paresthesia map indicating pain or paresthesia perception at various body locations of the patient, programming of pain therapy such as a stimulation setting including parameters and their values, among others. In some examples, the external system 130 may generate an alert notification. The alert notifications may include a Web page update, phone or pager call, E-mail, SMS, text or “Instant” message, as well as a message to the patient and a simultaneous direct notification to emergency services and to the clinician. Other alert notifications are possible.
The communication link 170 may include one or more communication channels and intermediate devices between the external system and the IPG 112. In an example, the communication link 170 may be a wired connection. In another example, the communication link 170 may be a wireless link, such as an inductive telemetry link, a capacitive telemetry link, a radio-frequency (RF) telemetry link, or wireless telemetry based on, for example, “strong” Bluetooth or IEEE 802.11 wireless fidelity “WiFi” interfacing standards. Other configurations and combinations of patient data source interfacing are possible. In an example where the external system 130 includes a remote server such as configured as a uni-, multi- or distributed computing and processing system, the communication link 170 may be based on the Transmission Control Protocol/Internet Protocol (TCP/IP) network communication specification, although other types or combinations of networking implementations are possible. Similarly, other network topologies and arrangements are possible.
The communication link 170 may provide for data transmission between the IPG 112 and the external system 130. The transmitted data may include, for example, real-time sensor signals acquired by and stored in the IPG 112, therapy history data, data indicating device operational status of the IPG 112, one or more programming instructions to the IPG 112 which may include configurations for sensing physiological signal or stimulation commands and stimulation parameters, or device self-diagnostic test, among others. In some examples, the IPG 112 may be coupled to the external system 130 further via an intermediate control device, such as a handheld external remote control device to remotely instruct the IPG 112 to generate electrical stimulation pulses in accordance with selected stimulation parameters produced by the external system 130.
The wearable electronic device 120 can include a smart watch, a smart wristband, or a smart ring, among other smart wearables. The wearable electronic device 120 can include a processor to execute a software application (a wearable “app”) to collect physiological and functional information from the patient, and process such information to generate one or more physiological or functional parameters. The wearable electronic device 120 can include, or be associated with, one or more sensors to sense physiological or functional information from the patient. Examples of the physiological information may include cardiac electrical activity, electrocardiograms (ECGs), heart rate, heart rate variability (HRV), a photoplethysmography (PPG) signal, blood oxygen saturation (SpO2) such as derived from the PPG signal, blood pressure, a respiration signal, respiratory rate, tidal volume, galvanic skin response, maximum rate of oxygen consumption (VO2max) during exercise, peripheral body temperatures, among others. Examples of the functional information may include motor activities such as posture, gait, balance, or physical activities, among others. The functional information may also include sleep or awakening state. Chronic pain patients may experience frequent disrupted sleep or change of sleep patterns. The functional information may be sensed using one or more motions sensors, such as an accelerometer (e.g., a three-axis accelerometer to measure and analyze separate orthogonal components of complex accelerations), a gyroscope (which may be a one-, two-, or three-axis gyroscope), a magnetometer (e.g., a compass), an inclinometer, a goniometer, an electromagnetic tracking system (ETS), or a global positioning system (GPS) sensor, among others. In some examples, the motion sensors may detect frequency or duration of sleep position switch, sleep incline, or other indicators of sleep quality. The wearable app on the wearable electronic device 120 can display the collected or processed physiological and functional information on a user interface, and receive patient input from a user interface.
The wearable electronic device 120 can be communicatively coupled to the mobile device 140 via the a short-range communication link 194, such as Wi-Fi, ZigBee, or Bluetooth, among other wireless communication modes. The physiological and functional information received and processed by the wearable electronic device 120 can be transmitted to the mobile device 140. The mobile device 140 can be a personal mobile electronic device operable by the patient, such as a smart phone, a tablet, or a laptop computer, among other mobile computing devices. The mobile device 140 can execute a software application (a mobile “app”) acting as a hub for patient data collection from various sources. For example, physiological and functional information collected and processed by the wearable electronic device 120 can be provided to the mobile device 140 via the short-range communication link 194. Data collected and processed by the IPG 112, including the physiological or functional data, device usage and diagnostic data, and therapy data (e.g., neuromodulation therapy such as SCS for pain relief), can be provided to the mobile device 140 via a short-range communication link 192, such as Wi-Fi, ZigBee, or Bluetooth, among other wireless communication modes.
The mobile app on the mobile device 140 can receive patient reported outcome (PRO). The PRO can be provided in various formats including, for example, textual, graphical, audio, video, among other or a mixture of formats. The PRO can include patient response to a questionnaire. Various questionnaires may be provided to the patient, such as displayed on a user interface of the mobile device 140. The patient response to such questionnaires may be valuable to the clinicians managing the patient. In an example, the mobile device 140 can present to the patient a questionnaire on pain sensation. The mobile app can receive patient description or pain or paresthesia sensation (e.g., intensity, severity, duration, body location, or pattern of pain or paresthesia). In an example, the PRO of pain sensation may include the patient's quantitative rating of pain level on a numerical scale (e.g., 0-10). In some examples, the PRO may include a pain drawing including the patient's depiction or identification of pain locations on the body and optionally pain quality description, or a paresthesia drawing including patient depiction or identification of body locations where paresthesia from stimulation is felt, and optionally paresthesia quality description. In some examples, the PRO may include a questionnaire about patient physical and functional capacities and mobility status, such as intensities, durations, qualities, types or contexts of physical activities the patient engages daily, sleep qualities, mood or emotional or mental health status, or general health status and quality of life reports, among others. In some examples, the PRO may include a patient report on their compliance with a daily routine or a clinical protocol.
In some examples, a questionnaire may additionally or alternatively be presented on the wearable electronic device 120, such as a smart watch. The wearable electronic device 120 can execute a wearable app to receive PRO, such as patient response to the questionnaire, via the user interface of the smart watch. For example, the patient may use the smart watch bezel to select and control a user-interface control element, and respond to the questionnaire. The patient may use the smart watch bezel to rotate a pain drawing at different viewing perspectives and displaying different body locations. In another example, the patient may use the smart watch bezel to select colors, or adjust one or more color properties (e.g., saturation, tone, brightness, or hue) to distinguish different pain levels or at different body locations on a pain drawing.
In some examples, physiological and functional information may be collected from the patient using one or more stationary sensors 125 in an environment of patient's daily life such as at a bedside, in a room at patient home, or in a testing room at a clinic or medical facility. In an example, a motion sensor may be mounted on a chair, a bed (e.g., under or attached to a mattress), or a fixture in a patient's environment. Unlike the wearable sensors which are ambulatory in nature, the stationary sensors 125 can detect one or more functional signals when the patient enters, or remains within, an environment within the scope of surveillance of the stationary sensors 125. Examples of the stationary sensors 125 may include a camera or a video recorder configured to capture an image, an image sequence, or a video of the patient at a specific physical state, such as sitting, standing, walking, or doing physical activities. In an example, the camera may be an infrared camera. In an example, the camera is a digital camera that may generate digital data representation of an image or a video sequence. Functional parameters such as patient posture, gait, balance, and range of motion can be generated from the image data image.
In an example, the stationary sensors 125 can include a weight sensor in a smart scale that can measure body weight of the patient. Chronic pain and obesity are common comorbidities. Reducing body weight may help reduce chronic pain levels. Monitoring patient body weight can be beneficial for managing chronic pain in a patient. In some examples, the stationary sensors 125 can measure or estimate body compositions including, for example, body fat percentage, body mass index (BMI), among others. Body fat percentage can be correlated to pain levels. A higher body fat levels could lead to deconditioning of pain pathways. Reliable body fat measurement at home can provide value to a monitoring physician, particularly if they are advising their patient to make necessary lifestyle changes to reduce weight. In an example, a body fat sensor can be an be incorporated into a smart scale. The smart scale includes an excitation signal generator that can sense electrical pulses towards the body. The body fat sensor can measure a responsive or reflected signal, and estimate a body fat percentage based at least on a relative change in electrical pulse strength.
The stationary sensors 125 can include or be associated with circuitry configured to communicate with the mobile device 140 via a short-range communication link 195, such as Wi-Fi, ZigBee, or Bluetooth, among other wireless communication modes. Measurements collected by the stationary sensors 125 (e.g., body weight or body fat percentage) can be transmitted to the mobile device 140 via the short-range communication link 195, and further be routed to the cloud-computing device 150 via the communication link 180.
In an example, the wearable electronic device 120 can access on-demand cloud-based services from a cloud-computing device 150, and process the collected physiological and functional information using the cloud-based services. Similarly, the mobile device 140 may include a communication module, such as a transceiver circuit, to establish data communication with the cloud-computing device 150. The mobile device 140 can securely route the data received from different sources (e.g., the IPG 112, the wearable electronic device 120, or the mobile device 140) to the cloud-computing device via a communication link 180. The mobile app on the mobile device 140, or the wearable app on the wearable electronic device 120, can interpret the PRO, and extract information such as patient subjective pain experience or feedback on pain therapy (e.g., pain characteristics extracted from the pain drawing). In some examples, the mobile app on the mobile device 140, the wearable app on the wearable electronic device 120, or the software system of the external system 130 can process the sensor information (e.g., physiological or functional signals acquired from the patient or from the stationary sensors 125) and optionally the PRO, and generate a mobility metric representing respective times spent in different activity intensity levels associated with a number of different activity types or contexts during a time period (e.g., a day). The mobile apps or the software system of said devices can trend the mobility metric over time, and determine a progress toward a personalized mobility goal of the patient. The trended mobility metric or the progress can be presented on a user interface of any of said devices, or be communicated to the cloud-computing device 150. In some examples, the sensor information and the PRO can be obtained responsive to a neuromodulation therapy delivered to the patient such as for managing chronic pain. The trended mobility metric or the progress toward the mobility goal may be indicative of an efficacy of the neuromodulation therapy. A user (e.g., a clinician or the patient) can adjust the neuromodulation therapy based on the trended mobility metric or the progress toward the mobility goal.
The cloud-computing device 150, also referred to simply as a “cloud”, can include a cloud server or a plurality of networked devices. The cloud-computing device 150 can include a cloud storage that can store data transmitted from networked devices such as the mobile device 140, and optionally the external system 130. The cloud-computing device 150 may include a suite of services (e.g., software as a service, platform as a service, infrastructure as a service) allowing for secured, on-demand access by multiple clients (or “tenants”), such as the wearable electronic device 120, the external system 130, the mobile device 140, or one or more user terminals 160 that can be operated by authorized users from different locations, such as clinicians, medical professionals, or device manufacturer representatives.
The cloud-based services may include data analysis services for analyzing data received from various sources (e.g., devices or user input), establishing a correspondence between one or more physiological or functional states and one or more pain levels, detecting a physiological or functional state of the patient, detecting or predicting a pain level for the detected patient physiological or functional state using the established correspondence, storing data in the cloud storage, making recommendations to the patient (e.g., making behavior changes to promote pain relief), or making therapy recommendations to the health care provider (e.g., adjusting neuromodulation device setting), performing regular or scheduled device integrity testing or trouble-shooting, making or recommending adjustment to device operations with regard to data acquisition, or formatting and presenting data such as on a display. For example, the patient may use the mobile app on the mobile device 140 to securely access the cloud storage to review the stored data, or to access one or more cloud-based services to aggregate and process patient physiological or functional data and review the data. An authorized user (e.g., a clinician) may use an application installed on one of the user terminals 160 to securely access one or more cloud-based services to review the data, and to modify a device parameter for the IPG 112 such as to adjust pain therapy. Examples of the cloud-based services are discussed below such as with reference to
Portions of the patient monitoring and pain management system 100 may be implemented using hardware, software, firmware, or combinations thereof. For example, portions of the IPG 112 or portions of the cloud-computing device 150 may be implemented using an application-specific circuit that may be constructed or configured to perform one or more particular functions, or may be implemented using a general-purpose circuit that may be programmed or otherwise configured to perform one or more particular functions. Such a general-purpose circuit may include a microprocessor or a portion thereof, a microcontroller or a portion thereof, or a programmable logic circuit, or a portion thereof. For example, a “comparator” may include, among other things, an electronic circuit comparator that may be constructed to perform the specific function of a comparison between two signals or the comparator may be implemented as a portion of a general-purpose circuit that may be driven by a code instructing a portion of the general-purpose circuit to perform a comparison between the two signals.
The ETM 229 may also be physically connected via the percutaneous lead extensions 232 and external cable 233 to the neuromodulation leads 225. The ETM 229 may have similar pulse generation circuitry as the IPG 226 to deliver electrical neuromodulation energy to the electrodes in accordance with a set of neuromodulation parameters. The ETM 229 is a non-implantable device that is used on a trial basis after the neuromodulation leads 225 have been implanted and prior to implantation of the IPG 226, to test the responsiveness of the neuromodulation that is to be provided. Functions described herein with respect to the IPG 226 can likewise be performed with respect to the ETM 229.
The RC 227 may be used to telemetrically control the ETM 229 via a bi-directional RF communications link 234. The RC 227 may be used to telemetrically control the IPG 226 via a bi-directional RF communications link 235. Such control allows the IPG 226 to be turned on or off and to be programmed with different neuromodulation parameter sets. The IPG 226 may also be operated to modify the programmed neuromodulation parameters to actively control the characteristics of the electrical neuromodulation energy output by the IPG 226. A clinician may use the CP 228 to program neuromodulation parameters into the IPG 226 and ETM 229 in the operating room and in follow-up sessions.
The CP 228 may indirectly communicate with the IPG 226 or ETM 229, through the RC 227, via an IR communications link 236 or another link. The CP 228 may directly communicate with the IPG 226 or ETM 229 via an RF communications link or other link (not shown). The clinician detailed neuromodulation parameters provided by the CP 228 may also be used to program the RC 227, so that the neuromodulation parameters can be subsequently modified by operation of the RC 227 in a stand-alone mode (i.e., without the assistance of the CP 228). Various devices may function as the CP 228. Such devices may include portable devices such as a lap-top personal computer, mini-computer, personal digital assistant (PDA), tablets, phones, or a remote control (RC) with expanded functionality. Thus, the programming methodologies can be performed by executing software instructions contained within the CP 228. Alternatively, such programming methodologies can be performed using firmware or hardware. In any event, the CP 228 may actively control the characteristics of the electrical neuromodulation generated by the IPG 226 to allow the desired parameters to be determined based on patient feedback or other feedback and for subsequently programming the IPG 226 with the desired neuromodulation parameters. To allow the user to perform these functions, the CP 228 may include a user input device (e.g., a mouse and a keyboard), and a programming display screen housed in a case. In addition to, or in lieu of, the mouse, other directional programming devices may be used, such as a trackball, touchpad, joystick, touch screens or directional keys included as part of the keys associated with the keyboard. An external device (e.g. CP) may be programmed to provide display screen(s) that allow the clinician to, among other functions, to select or enter patient profile information (e.g., name, birth date, patient identification, physician, diagnosis, and address), enter procedure information (e.g., programming/follow-up, implant trial system, implant IPG, implant IPG and lead(s), replace IPG, replace IPG and leads, replace or revise leads, explant, etc.), generate a pain map of the patient, define the configuration and orientation of the leads, initiate and control the electrical neuromodulation energy output by the neuromodulation leads, and select and program the IPG with neuromodulation parameters in a surgical or clinical setting.
An external charger 237 may be a portable device used to transcutaneously charge the IPG via a wireless link such as an inductive link 238. Once the IPG has been programmed, and its power source has been charged by the external charger or otherwise replenished, the IPG may function as programmed without the RC or CP being present.
The system 300 may include a controller circuit 350 and one or more devices communicatively coupled thereto, including, for example, an implantable device 310, a portable or wearable device 320, or a user interface device 330. The system 300 may also include a storage device 340 and an electrostimulator 360. The implantable device 310 can include, for example, the IPG 112. The portable or wearable device 320 can include, for example, the mobile device 140 and/or the wearable electronic device 120 (e.g., a smart watch). The user interface device 330 can include, for example, one or more of the clinician's programmer (CP) 228, the mobile device 140, the wearable electronic device 120, or the user terminal 160. Although the controller circuit 350 is shown to be separated from the implantable device 310, the portable or wearable device 320, and the user interface device 330, this is by way of example and not limitation. In some examples, the controller circuit 350 or a portion thereof can be implemented in at one of the implantable device 310, the portable or wearable device 320, or the user interface device 330.
The controller circuit 350 may be implemented as parts of a microprocessor circuit, which may be a dedicated processor such as a digital signal processor, application specific integrated circuit (ASIC), microprocessor, or other type of processor for processing information including physical activity information. Alternatively, the microprocessor circuit may be a general-purpose processor that may receive and execute a set of instructions of performing the functions, methods, or techniques described herein.
The controller circuit 350 may include circuit sets comprising one or more other circuits or sub-circuits, such as one or more of a mobility analyzer circuit 351, a stimulator controller 356, or a quality of life (QoL) estimator 357. The circuits or sub-circuits may, alone or in combination, perform the functions, methods, or techniques described herein. In an example, hardware of the circuit set may be immutably designed to carry out a specific operation (e.g., hardwired). In an example, the hardware of the circuit set may include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) including a computer readable medium physically modified (e.g., magnetically, electrically, moveable placement of invariant massed particles, etc.) to encode instructions of the specific operation. In connecting the physical components, the underlying electrical properties of a hardware constituent are changed, for example, from an insulator to a conductor or vice versa. The instructions enable embedded hardware (e.g., the execution units or a loading mechanism) to create members of the circuit set in hardware via the variable connections to carry out portions of the specific operation when in operation. Accordingly, the computer readable medium is communicatively coupled to the other components of the circuit set member when the device is operating. In an example, any of the physical components may be used in more than one member of more than one circuit set. For example, under operation, execution units may be used in a first circuit of a first circuit set at one point in time and reused by a second circuit in the first circuit set, or by a third circuit in a second circuit set at a different time.
The mobility analyzer circuit 351 can receive physiological or functional signals, optionally along with the patient reported outcome (PRO) as discussed above with reference to
The mobility metric generator 352 can assign a numerical intensity value for each of the intensity bins such that. In an example, a higher intensity value can be assigned to a higher intensity bin. The metric generator 352 can compute a mobility score (S(I)) using a weighted sum of the intensity values (I) each scaled by respective weight factors (w), across all (e.g., N) the intensity bins:
S(I)=Σi=1NwiIi (1)
The weight factors in Equation (1) above can be determined based on the respective mobility times (T) at corresponding intensity bins. In an example, the weight factors can be proportional to the mobility times, such that a longer mobility time corresponds to a larger weight factor, while a shorter mobility time corresponds to a smaller weight factor.
Alternatively, the mobility score (S(T)) may be computed using a weighted sum of the mobility times (T) each scaled by respective weight factors (w), across all (e.g., N) the intensity bins:
S(T)=Σi=1NwiTi (2)
The weight factors in Equation (2) above can be determined based on the respective mobility intensity values (I) at corresponding intensity bins. In an example, the weight factors can be proportional to the mobility intensity values, such that a higher intensity value corresponds to a larger weight factor, while a lower intensity value corresponds to a smaller weight factor. The mobility score (S) calculated according to Equation (1) or (2) indicates an overall mobility during the evaluation time period (e.g., a day). In an example, the mobility score (S) can be normalized or otherwise converted to a value between 0 and 1, where 1 indicates the highest possible mobility capacity and 0 indicates the lowest possible mobility capacity.
In some examples, the metric generator 352 can compute a dispersion metric of the mobility times (T) across the plurality of (e.g., N) intensity bins. An example of such dispersion metric is an entropy (H(T)) of the mobility times (T):
H(T)=−Σi=1NP(Ti)log P(Ti) (3)
where P(Ti) represents the probability of the Ti (corresponding to the i-th intensity bin), and can be estimated as a proportion of Ti over the entire observation period, that is, P(Ti)≈Ti/Σi=1NTi. The mobility time entropy (H(T)) indicates the randomness of distribution of mobility times across different intensity bins. For example, a higher entropy may result from mobility times that spread over all intensity bins than if the mobility times are skewed to one or more intensity bins. As will be discussed below, in some examples, a personalized mobile goal (such as generated by the mobility goal generator 355) may be characterized by mobility times more evenly distributed across all intensity bins, which corresponds to a high entropy goal (H*(T)). If the patient's daily mobility time entropy is less than the entropy goal H*(T), the metric generator 352 may determines that the mobility times are skewed towards certain intensity bins but not others. The patient may be recommended (e.g., via the portable or wearable devices 320 or the user interface device 330) to spread the mobility times across a wider range of mobility intensity bins.
Although the accelerometer-based activity signals can be used to provide a “standard” mobility metric of the patient, in some occasions or in some patients, such accelerometer-based mobility metric may be unavailable to use (e.g., devices lack a 3-axis accelerometer, or a device having the accelerometer is not worn or hold by the patient), or unreliable to use (e.g., due to interferences or noises). In such cases, it would be desirable to use other on-board physiological or functional sensors to derive a “surrogate” mobility metric comparable to the standard, accelerometer-based mobility metric. According to some embodiments, the metric generator 352 can estimate a mobility metric by applying a physiological or functional signal, acquired by a physiological or functional sensor other than an accelerometer, to at least one trained mobility metric estimation model 342. Examples of such physiological or functional signals may include electrocardiograms (ECGs), heart rate, heart rate variability, a photoplethysmography (PPG) signal, a blood oxygen saturation (SpO2) signal, a blood pressure signal, a respiration signal, respiratory rate, tidal volume, galvanic skin response, maximum rate of oxygen consumption (VO2max) during exercise, peripheral body temperatures, a posture, or a sleep signal, electrograms (e.g., cardiac electrophysiological signal sensed within the heart), heart sounds, among others. The estimation model 342 may be trained and calibrated against the accelerometer-based mobility metric values, such that the “surrogate” mobility metric estimated from various physiological or functional signal may be comparable to the standard, accelerometer-based mobility metric within a specified tolerance level (e.g., ±5% or ±10%). The mobility metric estimation model 342 may be trained using a training dataset comprising a set of activity signals sensed by accelerometers and a set of physiological signals sensed by physiological sensors different from the accelerometers. The set of activity signals and the set of physiological signals are sensed substantially concurrently from the patient (e.g., within an hour or within the same day). The training dataset may further comprise accelerometer-based mobility metric values that are determined from the set of activity signals and used as “labels” during training. Various training algorithms may be used train the mobility metric estimation model 342, such as Logistic Regression (LR), Naive-Bayes, Random Forest (RF), neural networks (NN), deep neural networks (DNN), matrix factorization, or Support Vector Machines (SVM), among other supervised learning or unsupervised learning. In an example, the mobility metric estimation model 342 can be trained using deep learning. The ML model has an architecture of a deep neural network Examples of DNN include a convolutional neural network (CNN), a recurrent neural network (RNN), a deep belief network (DBN), a long-term and short-term memory (LSTM) network, a transfer learning network, or a hybrid neural network comprising two or more neural network models of different types or different model configurations. The trained models can be stored in a storage device 340. As the variety of physiological sensors may be included in different devices (e.g., the IPG 112, the mobile device 140, or the wearable electronic device 120), using the trained mobility metric estimation model enables convenient, efficient, and high-fidelity mobility assessment through a common mobility estimation platform that enables a “plug-and-play” capability from a range of existing devices or sensors, yet without requiring dedicated, device- or sensor-specific mobility algorithms and software. This can improve mobility assessment efficiency the reduce overall development and operation cost.
The metric generator 352 may apply physiological or functional signals to the respective trained mobility metric estimation model 342 to generate, for example, heart rate-based mobility metric, SpO2-based mobility metric, respiration rate-based mobility metric, etc. In some examples, the metric generator 352 can identify subsets (e.g., minimal subsets) of physiological or functional signals that are sufficient to enable accurate estimation of the mobility metric, such that the “surrogate” mobility metric is comparable to the standard, accelerometer-based mobility metric within the specified tolerance level. Any future devices that can provide at least the physiological or functional signals from one of these minimal subsets (within predetermined accuracy ranges) can be used to calculate the “surrogate” mobility metric without new algorithm development effort.
In some examples, the mobility metric generator 352 can receive information about activities that the patient engages in during which the activity signal or other physiological or functional signals are collected. Examples of such activity information include activity intensity, activity timing information (e.g., start time and end time), activity type or context (e.g., brisk walk, gym workout, grocery shopping, doing yardwork, walking the dog, cooking a meal, washing dishes, morning jogging, hiking, etc.), among other information. In an example, such activity information may be received as user input via, for example, the portable or wearable device 320 or the user interface device 330. For example, when the patient is about to start a particular type of activity (e.g., gym workout), he/she may provide an input regarding the type or context of the activity, activity start time and end time, etc. The user input can be in various forms, such as textual or voice input. A natural language processing (NLP) system (which can be included in the portable or wearable device 320, the user interface device 330, or the controller circuit 350) can process the textual or voice input to determine an association or a correlation between the description of the activity (e.g., words and or their frequencies) and the mobility metric (e.g., time spent at different activity intensities, or mobility scores). The physiological or functional signals acquired during the activity and the mobility metric generated therefrom can be “tagged” with the activity type or context provided by the patient.
In addition or alternative to user provided activity information, in some examples, a device (e.g., the portable or wearable device 320, such as the mobile device 140, or the wearable electronic device 120) can automatically determine or infer the activity information based on a predetermined patient daily schedule. For example, in accordance with a patient's schedule of daily gym workout from 8:00 a.m. to 9:00 a.m., the device may automatically activate data collection (of physiological or functional signals) at the scheduled start time, and associate the collected data with the activity type or context per patient schedule. This feature is also referred to “mobility tracking.” The mobility tracking may be modified (e.g., allow certain activities to be tracked but not other activities) or turned off by the patient. The patient may provide a reason for the modification, such as being sick. In some examples, the device can automatically determine or infer the activity information (e.g., type or context of activities) based on patient locations (e.g., gym, park, grocery store) automatically (with user consent) detected by a GPS sensor in a mobile device or smart wearable device, or obtained from other location services. For example, when the device detects the patient is in a gym, the device may automatically activate data collection (of physiological or functional signals), and associate the collected data and the mobility metric generated therefrom with the activity type or context inferred from patient locations.
The mobility metric generator 352 can generate a patient-specific association model that establishes an association between the activity information (e.g., activity type or context either provided manually by the user or automatically determined or inferred by a device) and the mobility metric (e.g., mobility times spent at different activity intensity bins derived the physiological or functional signals acquired during the activity, or mobility scores). The association may be presented to the patient to signify different activity types or contexts and their relationships to the overall mobility status, and to encourage positive change in daily behavior (e.g., increase or decrease the amount of time spent in certain activities so as to have a more balanced mobility distribution across a broad spectrum of intensities, which may help alleviate pain and improve overall quality of life). Additionally or alternatively, the association may be presented to other patients to educate them on how to achieve desired mobility score or to reach a personalized mobility goal, aimed at improving their general health and/or pain outcomes.
In an example, as shown in
In some examples, the mobility metric generator 352 may generate respective mobility metrics for each of a number of different activity types or contexts.
In some examples, physiological or functional signals (and optionally the PRO information) can be collected in response to a neuromodulation therapy, such as SCS for chronic pain control. The neuromodulation therapy may be delivered in accordance with a stimulation setting, or one of a number of predetermined stimulation programs. The stimulation setting can be represented by one or more stimulation parameters taken respective values, including, for example, pulse amplitude, pulse width, pulse frequency, pulse waveform or shape, electrode configurations (electrodes designated as anode or cathode) and stimulation current or energy fractionalization across electrodes, etc. A stimulation program represents a collection of stimulation parameters with predetermined values. Examples of the stimulation programs can include I3D, Contour, FAST, or Micro Burst programs, among other programs.
In some examples, the stimulation setting or program-based mobility metric as described above with reference to
In some examples, the mobility metric generator 352 can compare the mobility metric to a population-based mobility metric to determine the patient's relative mobility and function capacity compared to other patients with similar medical conditions or similar demographics to the patient being evaluated (hereinafter referred to as “similar patients”). For example, a chronic pain patient may have a different expectation of mobility, or improvement in mobility capacity responsive to some neuromodulation therapy, than a non-pain patient or a patient with minor, acute pain. In an example, the relative mobility may be represented by a percentile rank in the group of similarly patients. For example, a 75th percentile indicates that the patient being evaluated has a mobility and functional capacity greater than 75% of the group of similar patients. A relative mobility with respect to a patient population allows for an objective assessment of patient mobility status and guided therapy optimization. The population-based mobility metric can be generated using aggregated physiological or functional data collected from a patient group having a common characteristic as the patient, such as a patient group with chronic pain, a patient group with similar diagnosis of underly diseases, a patient group with similar baseline pain, a patient group with similar time of implant of implantable devices (e.g., IPG 112), a patient group with similar demographics (e.g., age) subgroup, or a patient group with similar comorbidities. The aggregated physiological or functional data and the population-based mobility metrics can be stored in the storage device 340. In an example, the mobility metric generator 352 can determine a relative mobility metric represented by a percentile of the population-based mobility metric for a user-specified patient group. For example, a 75-percentile indicates that the patient has a mobility metric (e.g., a mobility score) higher than 75% of patients in that group. In some examples, the mobility score may be scaled by the aggregated, population-based data. For example, the patient raw mobility score may be normalized by the population-based mobility score aggregated over a patient population.
Referring back to
In some examples, the trending circuit 353 can trend the mobility metric since implantation of the implantable device 310, or since the patient received first neuromodulation therapy. The mobility trend can indicate how patient respond to the neurostimulation therapy, such as an improvement in overall mobility capacity (e.g., increase in mobility score over time), or an improvement in certain intensity levels (intensity bins) or certain types of activities over time.
The mobility analyzer circuit 351 can include a progress assessment circuit 354 to determine a progress toward a personalized mobility goal of the patient. The mobility analyzer circuit 351 can include a mobility goal generator 355 to determine the personalized mobility goal based at least in part on a baseline mobility metric of the patient during a baseline time period. The baseline mobility metric can be determined during a controlled baseline mobility test when the patient performs a number of activities of different types and intensities during a specified testing period (e.g., 2 weeks, 4 weeks, or other user-specified duration). The baseline mobility test can provide information on a normal range of mobility metric values for the patient, defined by a maximum metric value and a minimum metric value. In an example, the baseline mobility metric may include daily mobility metric values (e.g., daily mobility score S computed using Equation (1) or (2)) during a number of days, and the personalized mobility goal (Sg) may be determined to be the maximum daily mobility metric value (Smax) scaled by a weight factor (w), that is, Sg=w*Smax. The weight factor (w) can be a programmable value greater than one (e.g., w=1.25). In another example, the weight factor can be determined based on the patient's baseline pain score and a goal pain score (or the pain score reduction goal). For example, if the baseline pain score is 8, the goal pain score is 2 (or the reduction goal of 6), then the weight factor can be determined to be w=1+(8−2)/8=1.75.
In addition or alternative to the patient baseline mobility metric, other metrics may be relied upon to determine or adjust the personalized mobility goal. In an example, the mobility goal generator 355 may determine the personalized mobility goal based on a population-based mobility metric (Sop) generated from a group of patients having similar medical conditions or similar demographics to the patient being evaluated. The population-based mobility metric (Spop) may be determined as an average, median, or maximum mobility metric value across the group of such “similar” patients. In an example, the personalized mobility goal (Sg) may be determined to be the population-based mobility metric (Spop) scaled by a weight factor (w), that is, Sg=w*Spop.
The mobility goal generator 355 may determine or adjust the personalized mobility goal based on patient progress towards an existing mobility goal. For example, if the patient hits the existing mobility goal, the mobility goal may be updated (e.g., increased by a specific factor, e.g., 1.25). In another example, the mobility goal generator 355 may use the mobility trend generated by the trending circuit 353 to project a future goal-hitting time (e.g. in 2 weeks, or a month), and set a new goal or update the existing goal as approaching the projected goal-hitting time. If the mobility goal generator 355 determines that the patient is not progressing toward the existing goal as planned, the mobility goal generator 355 may reset the mobility goal (e.g., decrease by a specific factor, e.g., 1.25). The mobility goal thus established is not only tailored for individual patient health status, but also enables assessing patient improvement in mobility capacity relative to the group of “similar” patients.
The personalized mobility goal can be represented by a target mobility score, a target mobility time entropy, or a target mobility distribution. The progress assessment circuit 354 can determine patient progress toward the mobility goal based on, for example, a difference between the mobility score (e.g., calculated using Equation (1) or (2)) of the patient and the target mobility score, a difference between the mobility time entropy (e.g., calculated using Equation (3)) and the target mobility time entropy, or a comparison of the calculated mobility distribution (as illustrated in
The mobility trend (such as that shown in
The stimulation controller 356 can adjust stimulation settings based on the trended mobility metric provided by the trending circuit 353 or the progress toward the mobility goal provided by the progress assessment circuit 354. The stimulation controller 356 can generate the control signal to the electrostimulator 360 to deliver electrostimulation therapy in accordance with the adjusted stimulation setting. In an example, the neuromodulation therapy may include spinal cord stimulation (SCS) for controlling chronic pain. The stimulation controller 356 can adjust stimulation settings in accordance with the trended mobility metric or the progress toward the mobility goal. Examples of the stimulation settings may include, electrode selection and configuration, stimulation parameter values including, for example, amplitudes, pulse width, frequency, pulse waveform, active or passive recharge mode for FAST, ON time, OFF time, and therapy duration for BST, among others. In an example, the stimulation controller 356 can be implemented as a proportional integral (PI) controller, a proportional-integral-derivative (PID) controller, or other suitable controller that takes the trended mobility metric or the progress toward the mobility goal as a feedback on the adjustment of stimulation settings. As the selected signal feature is optimized to distinguish between different therapy states such as an optimal therapy state and an avoidance state, the closed-loop feedback control based on the optimal feature can achieve more reliable paresthesia-free effects and improved patient outcome comprising the therapeutic effects of sub-perception electrostimulation.
The electrostimulator 360 can be an implantable module, such as incorporated within the IPG 112. Alternatively, the electrostimulator 360 can be an external stimulation device, such as incorporated with the ETM 229. In some examples, the user can be notified of therapy reminder or prompted to adjust a stimulation setting, via the RC 227, the portable or wearable device 320, or the user interface device 330. The user can titrate the neuromodulation therapy, via the stimulation controller 356, in accordance with the trended mobility metric or the progress toward the mobility goal. Alternatively, electrostimulation therapy may be automatically delivered in accordance with the adjusted stimulation setting.
The quality of life (QoL) estimator 357 can generate a QoL score based at least in part on the mobility metric. Other information, such as patient reported outcome (PRO), may also be used to calculate the QoL score. The QoL score may be trended over time, and presented to the user along with the trended mobility metric (e.g., a mobility score trend) and optionally along with neurostimulation therapy information (e.g., SCS program usage information). In an example, the QoL estimator 357 may determine a correlation between a sensor-based mobility metric (such as based on the accelerometer or other physiological sensors for sensing heart rate, blood oxygen saturation (SpO2), respiration, posture, or sleep state) and patient-reported functional improvements. The patient-reported functional improvement may include activities of daily living (ADLs), pain interference, Patient-Reported Outcomes Measurement Information System (PROMIS) profile that assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. be quantified as functional improvement scores. The patient-reported functional improvement may be quantified by numerical physical function scores.
By way of example,
At 810, physiological or functional signals indicative of or correlated to patient mobility can be sensed from a patient using one or more implantable or external devices, such as the IPG 112, the wearable electronic device 120, or the mobile device 140. Examples of the received functional signals may include physical activity signals sensed by an activity sensor, such as an accelerometer (XL), a motor activity signal patient posture, gait, balance, or physical activity signals, a sleep state signal that contains information about sleep disturbance, among others. The functional signals may be collected by one or more sensors including, for example, an accelerometer, a gyroscope, a magnetometer (e.g., a compass), an inclinometer, a goniometers, an electromagnetic tracking system (ETS), or a global positioning system (GPS) sensor, among others. Examples of the received physiological signals can include electrocardiograms (ECGs), heart rate, heart rate variability, a photoplethysmography (PPG) signal, a blood oxygen saturation (SpO2) signal, blood pressure, a respiration signal, respiratory rate, tidal volume, galvanic skin response, maximum rate of oxygen consumption (VO2max) during exercise, peripheral body temperatures, a posture, or a sleep signal, among others. In some examples, patient reported outcome (PRO) may be received via a user interface of the wearable electronic device 120 or the mobile device 140. The PRO may include, for example, patient report on pain or paresthesia sensation (e.g., intensity, severity, duration, body location, or pattern of pain or paresthesia), effectiveness of pain therapy, patient report of activities, among others.
At 820, a mobility metric can be generated using the sensed physiological or function signal. The mobility metric may be represented by respective times spent in different activity intensity levels associated with one or more types of activities during a time period (e.g., a day, a number of days, a week, or other user-specified time period). The activity intensities may be categorized into one of a number of different mobility intensity bins, as illustrated in
The mobility metric may be generated using signals sensed by an accelerometer, such as a 3-axis accelerometer. Such mobility metrics are referred to as “standard” mobility metric. The mobility metric may alternatively be generated using one or more physiological or functional signals sensed by sensors other than an accelerometer. Such mobility metrics are referred to as “surrogate” mobility metric. One or more estimation models may be trained and calibrated against the accelerometer-based mobility metric values, such that the “surrogate” mobility metric estimated from various physiological or functional signals may be comparable to the standard, accelerometer-based mobility metric within a specified tolerance level (e.g., ±5% or +10%).
In some examples, the mobility metric may include an activity-specific mobility metric that represents mobility times spent in a number of different activity intensities associated with a specific activity type or a specific activity context. Activity type or activity context, along with other activity information such as activity intensity and timing information (e.g., start time and end time), may be received from the user via a user interface. The user input, which can be in forms of textual or voice input, can be processed using a natural language processing (NLP) system to determine an association or a correlation between the description of the activity (e.g., words and or their frequencies) and the mobility metric (e.g., time spent at different activity intensities, or mobility scores). The physiological or functional signals acquired during the activity and the mobility metric generated therefrom can be “tagged” with the activity type or context provided by the patient.
In some examples, physiological or functional signals (and optionally the PRO information) can be collected in response to a neuromodulation therapy, such as SCS for controlling chronic pain. The neuromodulation therapy may be delivered in accordance with a stimulation setting, or one of a number of predetermined stimulation programs. Mobility metrics (e.g., mobility time distribution or mobility score) may be evaluated respectively for a number of different stimulation settings or stimulation programs. Mobility distributions can be generated respectively for different stimulation settings or programs over a predetermined time period, such as a week or a month in this example. Such stimulation setting or program-based mobility metric can improve interpretation of the impact of stimulation settings or programs on patient mobility, and enable more efficient individualized optimization of neuromodulation therapy. In some examples, the stimulation setting or program-based mobility metric may be evaluated for a specific activity type or activity context.
In some examples, the mobility metric determined at 820 can be compared to a population-based mobility metric to determine a relative mobility compared to other patients with similar medical conditions or similar demographics to the patient being evaluated. The population-based mobility metric can be generated using aggregated physiological or functional data collected from a patient group having a common characteristic as the patient, such as a patient group with chronic pain, a patient group with similar diagnosis of underly diseases, a patient group with similar baseline pain, a patient group with similar time of implant of implantable devices (e.g., IPG 112), a patient group with similar demographics (e.g., age) subgroup, or a patient group with similar comorbidities. The relative mobility may be represented by a percentile rank in the group of similarly patients. In an example, the relative mobility metric may be represented by a percentile of the population-based mobility metric for a user-specified patient group.
At 830, the mobility metric may be trended over time, and the patient progress toward a personalized mobility goal may be determined, such as using the trending circuit 353 and the progress assessment circuit 354, respectively. The mobility trend can be computed as a trend of mobility score or a trend of mobility time entropies over a number of days, weeks, or months. Additionally or alternatively, the mobility trend can be represented by a change in mobility distribution over time, including differences in mobility times associated with respective one or more activity intensity bins. The personalized mobility goal can be represented by a target mobility score, a target mobility time entropy, or a target mobility distribution. The personalized mobility goal can be determined based on a baseline mobility metric of the patient during a baseline time period when the patient performs a number of activities of different types and intensities. The baseline mobility metric represents a normal range of values of the mobility metric for the patient. The personalized mobility goal may additionally or alternatively be determined based on a population-based mobility metric generated from a group of patients having similar medical conditions or similar demographics to the patient being evaluated. In some examples, the personalized mobility goal can be determined or adjusted based on patient progress towards an existing mobility goal.
At 842, a neuromodulation therapy (e.g., SCS for chronic pain control) can be initiated or adjusted based on the trended mobility metric or the progress toward the personalized mobility goal. In an example, stimulation settings may be adjusted in accordance with the trended mobility metric or the progress toward the mobility goal. The neuromodulation therapy may be automatically delivered in accordance with the adjusted stimulation setting. Alternatively, the user can titrate the neuromodulation therapy in accordance with the trended mobility metric or the progress toward the mobility goal. In some examples, the personalized mobility goal can be adjusted based on patient progress towards an existing mobility goal. For example, if the patient hits the existing mobility goal, the mobility goal may be updated (e.g., increased by a specific factor, e.g., 1.25). If the patient is not progressing toward the existing goal as planned, the mobility goal may be reset (e.g., decrease by a specific factor, e.g., 1.25).
At 844, mobility information, including the trended mobility metric or the determined progress, can be presented to the user. This may include daily mobility distribution, or mobility distribution over a number of days or weeks or other specified time periods, and trends of mobility scores as shown in
In alternative embodiments, the machine 900 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, the machine 900 may operate in the capacity of a server machine, a client machine, or both in server-client network environments. In an example, the machine 900 may act as a peer machine in peer-to-peer (P2P) (or other distributed) network environment. The machine 900 may be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine. Further, while only a single machine is illustrated, the term “machine” shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations.
Examples, as described herein, may include, or may operate by, logic or a number of components, or mechanisms. Circuit sets are a collection of circuits implemented in tangible entities that include hardware (e.g., simple circuits, gates, logic, etc.). Circuit set membership may be flexible over time and underlying hardware variability. Circuit sets include members that may, alone or in combination, perform specified operations when operating. In an example, hardware of the circuit set may be immutably designed to carry out a specific operation (e.g., hardwired). In an example, the hardware of the circuit set may include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) including a computer readable medium physically modified (e.g., magnetically, electrically, moveable placement of invariant massed particles, etc.) to encode instructions of the specific operation. In connecting the physical components, the underlying electrical properties of a hardware constituent are changed, for example, from an insulator to a conductor or vice versa. The instructions enable embedded hardware (e.g., the execution units or a loading mechanism) to create members of the circuit set in hardware via the variable connections to carry out portions of the specific operation when in operation. Accordingly, the computer readable medium is communicatively coupled to the other components of the circuit set member when the device is operating. In an example, any of the physical components may be used in more than one member of more than one circuit set. For example, under operation, execution units may be used in a first circuit of a first circuit set at one point in time and reused by a second circuit in the first circuit set, or by a third circuit in a second circuit set at a different time.
Machine (e.g., computer system) 900 may include a hardware processor 902 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 904 and a static memory 906, some or all of which may communicate with each other via an interlink (e.g., bus) 908. The machine 900 may further include a display unit 910 (e.g., a raster display, vector display, holographic display, etc.), an alphanumeric input device 912 (e.g., a keyboard), and a user interface (UI) navigation device 914 (e.g., a mouse). In an example, the display unit 910, input device 912 and UI navigation device 914 may be a touch screen display. The machine 900 may additionally include a storage device (e.g., drive unit) 916, a signal generation device 918 (e.g., a speaker), a network interface device 920, and one or more sensors 921, such as a global positioning system (GPS) sensor, compass, accelerometer, or other sensor. The machine 900 may include an output controller 928, such as a serial (e.g., universal serial bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.).
The storage device 916 may include a machine readable medium 922 on which is stored one or more sets of data structures or instructions 924 (e.g., software) embodying or utilized by any one or more of the techniques or functions described herein. The instructions 924 may also reside, completely or at least partially, within the main memory 904, within static memory 906, or within the hardware processor 902 during execution thereof by the machine 900. In an example, one or any combination of the hardware processor 902, the main memory 904, the static memory 906, or the storage device 916 may constitute machine readable media.
While the machine readable medium 922 is illustrated as a single medium, the term “machine readable medium” may include a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) configured to store the one or more instructions 924.
The term “machine readable medium” may include any medium that is capable of storing, encoding, or carrying instructions for execution by the machine 900 and that cause the machine 900 to perform any one or more of the techniques of the present disclosure, or that is capable of storing, encoding or carrying data structures used by or associated with such instructions. Non-limiting machine readable medium examples may include solid-state memories, and optical and magnetic media. In an example, a massed machine readable medium comprises a machine readable medium with a plurality of particles having invariant (e.g., rest) mass. Accordingly, massed machine-readable media are not transitory propagating signals. Specific examples of massed machine readable media may include: non-volatile memory, such as semiconductor memory devices (e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM)) and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.
The instructions 924 may further be transmitted or received over a communications network 926 using a transmission medium via the network interface device 920 utilizing any one of a number of transfer protocols (e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP), etc.). Example communication networks may include a local area network (LAN), a wide area network (WAN), a packet data network (e.g., the Internet), mobile telephone networks (e.g., cellular networks), Plain Old Telephone (POTS) networks, and wireless data networks (e.g., Institute of Electrical and Electronics Engineers (IEEE) 802.11 family of standards known as WiFi®, IEEE 802.16 family of standards known as WiMax®), IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, among others. In an example, the network interface device 920 may include one or more physical jacks (e.g., Ethernet, coaxial, or phone jacks) or one or more antennas to connect to the communications network 926. In an example, the network interface device 920 may include a plurality of antennas to wirelessly communicate using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) techniques. The term “transmission medium” shall be taken to include any intangible medium that is capable of storing, encoding or carrying instructions for execution by the machine 900, and includes digital or analog communications signals or other intangible medium to facilitate communication of such software.
Various embodiments are illustrated in the figures above. One or more features from one or more of these embodiments may be combined to form other embodiments.
The method examples described herein can be machine or computer-implemented at least in part. Some examples may include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device or system to perform methods as described in the above examples. An implementation of such methods may include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code may include computer readable instructions for performing various methods. The code can form portions of computer program products. Further, the code can be tangibly stored on one or more volatile or non-volatile computer-readable media during execution or at other times.
The above detailed description is intended to be illustrative, and not restrictive. The scope of the disclosure should, therefore, be determined with references to the appended claims, along with the full scope of equivalents to which such claims are entitled.
This application claims the benefit of U.S. Provisional Application No. 63/398,288, filed on Aug. 16, 2022, which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63398288 | Aug 2022 | US |
