Patient-specific optimization algorithm

Abstract

A system can receive first information about a patient, collected during a baseline period prior to the patient receiving stimulation. The system can also receive second information about the patient, collected during an initial therapy specification period. This second information may include test data generated by delivering stimulation during the implantation procedure. The system can determine an initial stimulation protocol setting based on the first information, the second information, and group informed information, which may be about other patients. The system can deliver therapy based on this initial stimulation protocol setting during a training period.

Description

[0001] This application claims priority to U.S. Application No. 17 / 215,685, filed March 29, 2021, which claims the benefit of U.S. Provisional Patent Application No. 63 / 009,710, filed April 14, 2020, the entire contents of each of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates to determining the settings of a medical device and more specifically to determining the settings of a medical device used to deliver therapy to a patient. Background Technology

[0003] Illness, aging, and injury can impair a patient's physiological functions. In some cases, physiological functions are completely impaired. In other examples, physiological functions may function adequately at some times or under certain conditions, but not at other times or under other conditions. Some examples of impaired physiological functions include overactive bladder, non-obstructive urinary retention, fecal incontinence, constipation, pelvic pain, and sexual dysfunction. In one example, bladder disorders such as overactive bladder, urinary urgency, or urinary incontinence are problems that can affect people of all ages, sexes, and ethnicities. Various muscles, nerves, organs, and ducts within the pelvic floor work together to collect, store, and release urine. Many disorders can impair urinary tract function and cause overactive bladder, urinary urgency, or urinary incontinence, which interfere with normal physiological function. Many of these disorders may be related to aging, injury, or illness.

[0004] Urinary incontinence can include urge incontinence and stress incontinence. In some cases, urge incontinence may be caused by dysregulation of the peripheral or central nervous system that controls the bladder's urination reflex. Some patients may also suffer from neurological disorders that prevent the normal triggering and functioning of the bladder and sphincter, or neurological disorders that lead to overactive bladder activity or urge incontinence. In some cases, urinary incontinence may be attributed to inadequate sphincter function in the internal or external urethral sphincter.

[0005] Electrical nerve stimulation can be used for several therapeutic and diagnostic purposes, including the treatment of urinary incontinence. It can be provided by devices with a limited power source, such as battery-powered implantable devices. Energy consumption may be a limiting factor in the effectiveness and durability of such devices. Additionally, the body may adapt to continuous stimulation. Summary of the Invention

[0006] In general, this disclosure relates to devices, systems, and techniques for identifying, maintaining, and re-acquiring stimulation therapy settings that are effective for a patient. Example techniques are described with respect to neurostimulation, but they can be extended to other types of stimulation. Typically, when evaluating a patient for a potential neurostimulation implant, the patient can be connected to a testing system under the supervision of a healthcare professional, who can then test various stimulation program settings on the patient. For example, the healthcare professional can test different stimulation program settings, such as neurostimulation programs, neurostimulation parameters (e.g., at least one of the following: the amplitude of the current or voltage of the stimulation signal, the frequency or pulse rate of the stimulation signal, the shape of the stimulation signal waveform, the duty cycle of the stimulation signal, the pulse width of the stimulation signal, the duty cycle of the stimulation on / off period, etc.), and / or combinations of electrodes used to deliver the stimulation and the corresponding polarities of the electrodes. If the patient responds to neurostimulation therapy, the patient can undergo the implantation procedure. After implantation, the healthcare professional can test various stimulation program settings again. Testing of stimulation program settings may be conducted during multiple medical visits, during which the healthcare professional attempts to find a stimulation program setting that is therapeutically effective for the patient. A therapeutic stimulation protocol is typically determined through a trial-and-error process with specific patients. One patient may find a particular stimulation protocol relieves their symptoms, while another may not. In some cases, a stimulation protocol that relieves symptoms for one patient may even be uncomfortable for another.

[0007] Patients may suffer from different diseases, different disease states, and different medical histories. Patients may take different medications and have different lifestyles. These differences between patients may necessitate tailoring stimulation therapy to a given patient by determining stimulation procedural settings, such as neurostimulation procedures, neurostimulation parameters, and / or combinations of active electrodes, that may be effective for that specific patient. This disclosure provides timing and parameters for initially and longitudinally (e.g., over time) customizing neurostimulation therapy delivery at the level of specific patient cohorts (e.g., treatment) and / or individual patients (personalized medicine) throughout the therapy and patient management lifecycle. These techniques can reduce the administrative burden on patients and physicians. For example, the techniques disclosed herein can reduce the time required to find a neurostimulation treatment effective for a patient, thereby reducing the duration or frequency of uncomfortable symptoms or reducing the number of visits required to find an effective neurostimulation treatment. Additionally, these techniques can allow for more efficient use of implantable medical devices (IMDs). For example, by reducing the time required to find a neurostimulation treatment effective for a patient, the stimulation procedural settings of the IMD can be optimized faster than with other stimulation procedural settings, potentially leading to more efficient energy use or reduced communication with the IMD. In addition, some patients may lose the effectiveness of the therapy as they become accustomed to it or due to other environmental factors such as aging or new medications. The techniques described in this article can assist these patients.

[0008] While many of the techniques disclosed herein are described as being implemented on servers in a cloud computing environment, it should be noted that these techniques can be implemented on implantable medical devices (IMDs), external devices, servers, or any combination thereof. According to the techniques disclosed herein, a system can collect information about a patient and group informed consent information, and determine a stimulation protocol setting based on the patient information and the group informed consent information. The system can guide a patient through multiple periods using different stimulation protocol settings (such as neurostimulation procedures, neurostimulation parameters, and / or electrode combinations). The system can receive information about the effectiveness of the stimulation protocol settings. The system can determine an initial stimulation protocol setting and a maintenance stimulation protocol setting based on the collected information and the group informed consent information.

[0009] In one example, this disclosure relates to a system for determining a neurostimulation therapy, the system comprising: a group-informed memory configured to store first information about a patient, wherein the first information is acquired during a baseline period prior to the patient receiving stimulation; and processor circuitry coupled to the memory, the processor circuitry configured to receive the first information about the patient; receive second information about the patient, wherein the second information is acquired during an initial therapy designation period and includes test data generated by providing stimulation during the implantation process; determine an initial stimulation procedure setting based on the first information, the second information, and group-informed information about other patients; and deliver therapy based on the initial stimulation procedure setting during a training period.

[0010] In another example, this disclosure relates to a method comprising: receiving first information about a patient, wherein the first information is acquired during a baseline period prior to the patient receiving stimulation; receiving second information about the patient, wherein the second information is acquired during an initial therapy designation period and the second information includes test data generated by providing stimulation during the implantation process; determining an initial stimulation procedure setting based on the first information, the second information, and group-informed information about other patients; and delivering therapy based on the initial stimulation procedure setting during a training period.

[0011] In another aspect, this disclosure relates to a non-transient storage medium comprising instructions that, when executed by one or more processors, cause the one or more processors to: receive first information about a patient, wherein the first information is acquired during a baseline period prior to the patient receiving stimulation; receive second information about the patient, wherein the second information is acquired during an initial therapy specification period and includes test data generated by providing stimulation during the implantation process; determine an initial stimulation procedure setting based on the first information, the second information, and group informed information about other patients; and deliver therapy based on the initial stimulation procedure setting during a training period.

[0012] In another aspect, this disclosure relates to an implantable medical device comprising: a memory configured to store an initial stimulation program setting, wherein the initial stimulation program setting is determined based on first information, second information, and group-informed information, the first information being information about the patient collected during a baseline period prior to the patient receiving stimulation, the second information being information collected during an initial therapy specification period including test data generated during the delivery of stimulation during the implantation process of the IMD, and the group-informed information being information about other patients; and processor circuitry configured to cause a stimulation generator to deliver therapy based on the initial stimulation program setting during a training period.

[0013] Details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objectives, and advantages of this disclosure will become apparent from the specification, drawings, and claims.

[0014] The above summary is not intended to describe every example or implementation shown in this disclosure. Attached Figure Description

[0015] Figure 1 This is a conceptual diagram illustrating an example system for managing the delivery of neural stimulation to a patient in order to manage bladder disorders such as overactive bladder, urinary urgency, or urinary incontinence.

[0016] Figure 2A and Figure 2B It demonstrates what can be used in Figure 1 A block diagram of an example configuration of an implantable medical device (IMD) in a system.

[0017] Figure 3 It demonstrates what can be used in Figure 1 A block diagram illustrating an example configuration of external devices in the system.

[0018] Figure 4 This is a block diagram of an example system that can be configured to perform the techniques disclosed herein.

[0019] Figure 5 This is a conceptual state diagram of the various stages of the patient management lifecycle based on the technology disclosed herein.

[0020] Figure 6 This is a flowchart illustrating the example technology disclosed herein.

[0021] Figure 7 This is a conceptual diagram illustrating an example of the technology disclosed herein. Detailed Implementation

[0022] This disclosure relates to devices, systems, and techniques for determining stimulation settings for a patient's stimulation therapy. This disclosure covers techniques for integrating patient data to create and maintain customized, distributed, and closed-loop algorithms for determining stimulation program settings for therapy delivery of neuromodulation (such as sacral nerve modulation). Patient data may include individual and group data. Patient data may be self-reported and / or automatically measured / recorded, for example, via sensors external to or inside the patient (e.g., attached to an implantable medical device (IMD), such as a neurostimulation device). In some examples, self-reported patient data may include demographic information and the patient's medical history. In some examples, sensor data may include data indicating physiological markers (such as bladder filling phases or expiratory events), which may indicate the utility of the stimulation program settings. The techniques disclosed may include applying various algorithms within defined, specific phases of the therapy and patient management lifecycle to achieve adaptive and customized timing and (multiple) stimulation settings for therapy delivery.

[0023] These techniques can be used to tailor treatments for a variety of disorders, conditions, or dysregulations. For illustrative purposes, but not limited to, the use of these techniques will be described below with reference to bladder disorders. Bladder disorders generally refer to conditions of abnormal functioning of the bladder or urethra and may include, for example, overactive bladder, urgency, or incontinence. Overactive bladder (OAB) is a patient condition that may include symptoms such as urgency, with or without incontinence. Urgency is a sudden, uncontrollable urge to urinate and may usually, though not always, be associated with incontinence. Incontinence is the condition of unintentionally urinating and may include urge incontinence, stress incontinence, or both (which may be referred to as mixed incontinence). As used in this disclosure, the term “incontinence” includes disorders of urinating when one does not want to urinate, such as stress incontinence or urge incontinence. Other bladder disorders may include disorders such as non-obstructive urinary retention.

[0024] One class of therapies for treating bladder disorders involves delivering electrical stimulation to a target tissue site within the patient's body, thereby producing a therapeutic effect during the delivery of the stimulation. The delivery of the stimulation can be continuous, cyclically switched on and off, or can be turned on and off for specific periods of time. The therapeutic effect can even be maintained for multiple periods when the stimulation is off. For example, delivering electrical stimulation from the IMD to a target treatment site (e.g., related to modulating spinal nerves (e.g., the sacral nerve), pudendal nerve, dorsal clitoral nerve, tibial nerve, saphenous nerve, inferior rectal nerve, perineal nerve, branches of any of the aforementioned nerves, roots of any of the aforementioned nerves, ganglia of any of the aforementioned nerves, or plexuses of any of the aforementioned nerves) can provide a direct therapeutic effect on bladder disorders, such as a desired reduction in bladder contraction frequency. In some cases, electrical stimulation of the sacral nerve can modulate afferent nerve activity to restore urinary function during the electrical stimulation.

[0025] For example, a medical device such as an IMD can be configured to use electrical stimulation directed at the sacral nerve (sacral nerve modulation (SNM)). Stimulation of the sacral nerve can provide therapy for various pelvic disorders, particularly pelvic floor dysfunction. Examples of pelvic disorders include, but are not limited to, overactive bladder, non-obstructive urinary retention, fecal incontinence, constipation, pelvic pain, and sexual dysfunction. The medical device can deliver therapy to at least one nerve (e.g., a spinal nerve or pelvic floor nerve) to modulate nerve activity via at least one electrode electrically connected to the medical device. The electrical stimulation can be configured to modulate the contraction of the patient's detrusor muscle, thereby reducing the frequency of bladder contractions (to reduce incontinence) or increasing the frequency of bladder contractions (to facilitate emptying). Reducing the frequency of bladder contractions can reduce the urgency of emptying and can reduce urinary urgency and / or incontinence, thereby at least partially alleviating bladder disorders.

[0026] The neural stimulation described herein can be targeted to manage bladder disorders such as overactive bladder, urinary urgency, urinary incontinence, or even non-obstructive urinary retention. For example, stimulation can be delivered to target tissue sites typically used to alleviate these types of disorders. While these techniques are primarily described in this disclosure for managing bladder disorders, they can also be applied to manage other pelvic floor disorders or disorders of other organs, tissues, or nerves in a patient. For example, alternatively or additionally, the devices, systems, and techniques described herein can be used to manage sexual disorders, pelvic pain, fecal urgency, or fecal incontinence. Example nerves that can be targeted for therapy include the sacral nerve, pudendal nerve, dorsal nerve of the penis or clitoris, tibial nerve, saphenous nerve, sural nerve, sciatic nerve, inferior rectal nerve, and peroneal or perineal nerve. Example organ systems that can be treated include the small and large intestines, stomach and / or intestines, liver, and spleen, which can be modulated by delivering neural stimulation directly to the organ, to one or more nerves innervating the organ, and / or through blood supply to the organ. In some examples, the methods described in this disclosure may be used for spinal nerve stimulation (e.g., for pain therapy) or for deep brain stimulation (DBS) (e.g., for neurological disorders such as Parkinson's disease).

[0027] Different examples of one or more stimulation devices are discussed. It is recognized that these stimulation devices may include features and functions other than electrical stimulation. Many of these additional features are explicitly discussed herein. Some example features include, but are not limited to, different types of sensing capabilities and different types of wireless communication capabilities. For ease of discussion, this disclosure does not explicitly reference every conceivable combination of these additional features (as each feature is repeated each time a different example and use of the stimulation device is discussed).

[0028] Figure 1 This is a conceptual diagram illustrating an example system 10 that defines (multiple) stimulus settings and manages the delivery of neural stimulation to patient 14 in order to manage bladder disorders such as overactive bladder, urinary urgency, or urinary incontinence. (See also...) Figure 1 As shown in the example, the therapy system 10 includes an implantable medical device (IMD) 16 (e.g., the example medical device) coupled to wires 18, 20, and 28 and sensor 22. System 10 also includes an external device 24 configured to communicate with the IMD 16 via wireless communication. System 10 also includes a server 26, which may be one or more servers in a cloud computing environment. Server 26 may be configured to communicate via a network access point (in... Figure 1(Not shown) Communicates wirelessly with external device 24 and / or IMD 16, and can cooperate with external device 24 or be located elsewhere, such as within a cloud computing data center. IMD 16 generally functions as a therapeutic device that delivers nerve stimulation to target tissue sites, such as those near spinal nerves, sacral nerves, pudendal nerves, dorsal clitoral nerves, tibial nerves, saphenous nerves, inferior rectal nerves, perineal nerves, or other pelvic nerves, branches of any of the aforementioned nerves, roots of any of the aforementioned nerves, ganglia of any of the aforementioned nerves, or plexuses of any of the aforementioned nerves. Figure 1 (For example, electrical stimulation). The IMD 16 provides electrical stimulation to the patient 14 by generating and delivering programmable electrical stimulation signals (e.g., in the form of electrical pulses or waveforms) to the target therapeutic site near the lead 28 and more specifically near the distal end of the lead 28, to the electrodes 29A-29D (collectively referred to as “electrodes 29”).

[0029] The IMD 16 can be surgically implanted into the patient 14 at any suitable location within the body, such as near the pelvis. In some examples, the IMD 16 can be implanted subcutaneously in the lower lateral abdomen, lower back, or upper buttock. The IMD 16 has a biocompatible housing, which can be formed of titanium, stainless steel, liquid crystal polymer, etc. The proximal ends of leads 18, 20, and 28 are electrically and mechanically coupled to the IMD 16, directly or indirectly, for example, via corresponding lead extensions. Electrical conductors placed within the lead bodies of leads 18, 20, and 28 electrically connect sensing electrodes (e.g., electrodes 19A, 19B, 21A, 21B, 29A, 29B, 29C, and 29D) and stimulating electrodes (e.g., electrode 29) to sensing and stimulation circuitry (e.g., a stimulation generator) within the IMD 16. Figure 1In the example, leads 18 and 20 carry electrodes 19A and 19B (collectively referred to as “electrode 19”) and electrodes 21A and 21B (collectively referred to as “electrode 21”), respectively. As further detailed below, electrodes 19 and 21 can be positioned to sense the impedance of bladder 12, which increases with increasing urine volume within bladder 12. In some examples, system 10 may include electrodes (such as electrodes 19 and 21), strain gauges, one or more accelerometers, ultrasonic sensors, optical sensors, or any other sensors. In some examples, these sensors can be configured to collect information about the patient, such as detecting bladder 12 contractions, bladder 12 pressure or volume, or any other indication of bladder 12 filling cycles and / or possible bladder dysfunction. In some examples, system 10 may use sensors different from electrodes 19 and 21 to sense information about the patient, such as bladder volume. System 10 can use the sensed data to determine stimulation procedure settings for a given patient, as described below. IMD 16 can transmit the sensed data to server 26. In some examples, IMD 16 can send sensor data via external device 24. In some examples, IMD 16 can send sensor data to server 26 without sending sensor data via external device 24.

[0030] In some examples, system 10 may not use any sensors. For example, external device 24 may collect user input identifying a discharge event, perceived level of fullness, or any other indication of a patient-related event. User input may be in the form of a discharge log analyzed by external device 24, IMD 16, or server 26, or in the form of a single user input associated with the corresponding discharge event, leakage, or any other patient-related event. External device 24 may provide this user input to server 26.

[0031] One or more medical leads, such as leads 18, 20, and 28, may be connected to IMD 16 and surgically or percutaneously perforated to place one or more electrodes carried by the distal ends of the respective leads at desired nerve or muscle sites, such as one of the previously listed target therapy sites, such as tissue sites near spinal (e.g., sacral) nerves or pudendal nerves. For example, lead 28 may be positioned such that electrode 29 delivers electrical stimulation to the spinal, sacral, or pudendal nerves to reduce the contraction frequency and / or amplitude of bladder 12. Additional electrodes of lead 28 and / or electrodes of another lead may also provide additional stimulation therapy to other nerves or tissues. Figure 1In this embodiment, leads 18 and 20 are positioned at a first location and a second location, respectively, near the outer surface of the wall of the bladder 12. In other examples of the therapy system 10, the IMD 16 may be coupled to more than one lead, which includes electrodes for delivering electrical stimulation to different stimulation sites within the patient 14, such as electrodes pointing to different nerves.

[0032] exist Figure 1 In the examples shown, leads 18, 20, and 28 are columnar. Electrodes 19, 20, and 29 of leads 18, 20, and 28 can be loop electrodes, segmented electrodes, partially loop electrodes, or any suitable electrode configuration, respectively. Segmented and partially loop electrodes each extend around the periphery of the respective lead 18, 20, and 28 along an arc of less than 360 degrees (e.g., 90–120 degrees). In some examples, the segmented electrode 29 of lead 28 can be used to target different fibers of the same or different nerves to produce different physiological effects (e.g., therapeutic effects). In the examples, one or more of leads 18, 20, and 28 can be at least partially paddle-shaped (e.g., “paddle-shaped” leads) and can include an electrode array on a common surface, which may or may not be substantially flat.

[0033] In some examples, one or more of electrodes 19, 20, and 29 may be clasp electrodes configured to extend at least partially around the nerve (e.g., axially around the outer surface of the nerve). Delivering electrical stimulation via one or more clasp electrodes and / or segmented electrodes can help achieve a more uniform distribution of the electric field or activation field relative to the nerve, which can help minimize discomfort to patient 14 caused by the delivery of electrical stimulation. The electric field can define the volume of tissue affected when electrodes 19, 20, and 29 are activated. The activation field represents neurons in the neural tissue near the activated electrodes that will be activated by the electric field.

[0034] The wires 18, 20, and 28 shown, as well as the number and configuration of electrodes carried by them, are merely exemplary. Other configurations, such as the number and location, of the wires and electrodes are also envisioned. For example, in other implementations, the IMD 16 may be coupled to additional wires or wire segments having one or more electrodes located near the spinal cord of the patient 14 or at different locations in the pelvic region. The additional wires may be used to deliver different stimulation therapies or to provide additional electrical stimulation to corresponding stimulation sites within the patient 14, or to monitor at least one physiological marker of the patient 14.

[0035] According to some examples in this disclosure, the IMD 16 delivers electrical stimulation to spinal nerves (e.g., sacral nerves), pudendal nerves, dorsal clitoral nerves, tibial nerves, saphenous nerves, inferior rectal nerves, or perineal nerves to provide a therapeutic effect of reducing or eliminating obstructive conditions such as overactive bladder. The desired therapeutic effect may be an inhibitory physiological response to bladder discharge in the patient 14, such as reducing the frequency of bladder contractions by a desired level or extent (e.g., percentage).

[0036] Stimulation procedures can define various parameters of the stimulation waveform and electrode configuration, resulting in the delivery of a predetermined stimulation intensity to the target nerve or tissue. In some examples, stimulation procedures define parameters for at least one of the following: the current or voltage amplitude of the stimulation signal, the frequency or pulse rate of the stimulation, the shape of the stimulation waveform, the duty cycle of the stimulation, the pulse width of the stimulation, the duty cycle of the stimulation on / off period, and / or a combination of the corresponding polarities of the electrodes 29 and subsets of electrodes 29 used to deliver the stimulation. These stimulation parameter values ​​can be used together to define the stimulation intensity (also referred to herein as the stimulation intensity level). In some examples, if the stimulation pulse is delivered in bursts, the burst duty cycle can also contribute to the stimulation intensity. Regardless of intensity, specific pulse widths and / or pulse rates can also be selected from a range suitable for producing the desired therapeutic effect, both after stimulation has ceased and optionally during stimulation. Additionally, as illustrated herein, the periods of stimulation delivery can include on and off periods (e.g., duty cycle or pulse bursts), where even shorter inter-pulse durations (when no pulse is delivered) are still considered part of stimulation delivery. The period during which System 10 blocks stimulus delivery is a period during which there is no active stimulation program for IMD 16 (e.g., IMD 16 does not track pulse duration or inter-pulse duration as part of an electrical stimulation delivery protocol). In addition to the stimulation parameters mentioned above, stimulation can also be defined by other characteristics, such as the timing of stimulus delivery, the timing of stimulus termination, and the timing of stimulus blocking.

[0037] System 10 may also include external devices 24, such as Figure 1 As shown in the figure. External device 24 can be an example of a computing device (such as...) Figure 4The computing devices 230A-230N shown are illustrated. In some examples, the external device 24 may be a clinician programmer or a patient programmer. In some examples, the external device 24 may be a device for inputting information about the patient. In some examples, the external device 24 may be a wearable communication device with a therapy request input integrated into a key fob or wristwatch, handheld computing device, smartphone, computer workstation, or networked computing device. The external device 24 may include a user interface configured to receive input from a user (e.g., patient 14, patient caregiver, or clinician). In some examples, the user interface includes, for example, a keypad and a display, which may be, for example, a liquid crystal display (LCD) or a light-emitting diode (LED) display. In some examples, the user interface may include a knob or a representation of a knob. The keypad may take the form of an alphanumeric keypad or a reduced set of keys associated with a specific function. The external device 24 may additionally or alternatively include a peripheral pointing device, such as a mouse, via which the user can interact with the user interface. In some examples, the display of external device 24 may include a touchscreen display, and the user can interact with external device 24 via the display. It should be noted that the user can also remotely interact with external device 24, server 26, and / or IMD 16 via a networked computing device.

[0038] Users, such as physicians, technicians, surgeons, electrophysiologists, or other clinicians, may also interact with external device 24 or another separate programmer (not shown), such as a clinician programmer, to communicate with IMD 16 and / or server 26. Such users can interact with external device 24 to retrieve physiological or diagnostic information from IMD 16. Users can also interact with external device 24 to program IMD 16, for example, by selecting stimulation parameter values ​​for stimulation generated and delivered by IMD 16 and / or other operating parameters of IMD 16, such as stimulation energy amplitude, user-requested stimulation or prevention of stimulation periods, or any other user-defined therapy options. In some examples, stimulation parameter values ​​may be proposed by system 10, such as server 26, and the user may be able to accept or reject these stimulation parameter values. In other examples, stimulation parameter values ​​may be set by system 10, such as server 26. As discussed herein, users may also provide input to external device 24 indicating physiological events, such as bladder fullness level sensations and discharge events.

[0039] In some examples, users, such as clinicians or patients, can input patient information into external device 24, and external device 24 can collect initial information about the patient and provide that information to server 26. Initial patient information may include: 1) demographic information, such as gender, age, etc.; 2) medical history, such as BMI, diagnosis, comorbidities, medications, etc.; and 3) baseline symptom data over a predetermined period, such as a period ranging from three days to two weeks. Baseline symptom data may include symptoms of the illness the patient is experiencing. For example, baseline symptom data may include the number or duration of incontinence problems or feelings of urinary urgency. Baseline symptom data may also include the volume of urinary events or other measures indicating symptoms the patient may be experiencing, such as information about bowel motility, pain, etc. In some examples, external device 24 may prompt the patient to answer questions about their medications, lifestyle, and quality of life. These questions may include questions about sleep length and quality, fluid intake, food intake, food choices, daily activities, activity levels (e.g., steps), exercise, pain, discomfort, etc. In some examples, these questions may be asked periodically over a period of several days, such as three to four days. In some examples, the user can provide initial information about the patient during a baseline period before treatment begins. In other examples, initial information about the patient's medications, lifestyle, and quality of life can be collected in a different way, such as by a clinician typing it into external device 24. In one example, the user can provide further information about the patient during other periods. For example, external device 24 can prompt the patient 14 to answer questions about their symptoms or the effectiveness of treatment during other periods. For example, external device 24 can prompt the patient 14 to enter whether the patient 14 experienced bladder incontinence on that day or the number of times the patient 14 experienced bladder incontinence on that day. External device 24 can collect information about the patient and provide this information, including the answers to questions, to server 26.

[0040] In some examples, caregivers can use sensors, such as wearable sensor 15 or existing implantable sensors, to collect additional targeted patient data about sleep, activity, or disease symptoms. For example, wearable sensor 15 could be a heart rate sensor, an accelerometer, and / or other sensors used to collect patient data (e.g., disease symptoms or lifestyle). Patient data collected by sensors, such as wearable sensor 15, can be provided to server 26. In some examples, sensors, such as wearable sensor 15, can be configured to communicate with external devices, such as external device 24, via a wireless link. In some examples, external device 24 can collect patient data generated by the sensors and send the patient data to server 26. In other examples, another device can collect patient data generated by the sensors and send the patient data to server 26.

[0041] For example, a user can use external device 24 to retrieve information from IMD 16 regarding the frequency of bladder 12 contractions and / or discharge events. As another example, a user can use external device 24 to retrieve information from IMD 16 regarding the performance or integrity of IMD 16 or other components of system 10 (such as leads 18, 20, and 28, or the power supply to IMD 16). In some examples, this information can be presented to the user as a warning if a systemic condition that may affect therapeutic efficacy is detected.

[0042] The user of external device 24 can also communicate with server 26. For example, the user of external device 24 can provide server 26 with information about the patient, such as demographic information, medical history, lifestyle information, bladder events, satisfaction level with treatment, or sensor data.

[0043] If patient 14 senses that urinary incontinence may be imminent, or if discontinuing the urination-inducing therapy may facilitate an upcoming expulsion, patient 14 may use, for example, a keypad or the touchscreen of external device 24 to request IMD 16 to deliver or terminate electrical stimulation. In this way, patient 14 can use external device 24 to make therapy requests to control the delivery of electrical stimulation "on demand," such as when patient 14 feels a desire for a second stimulation therapy. This request could be a therapy-triggered event for terminating electrical stimulation. Patient 14 can also use external device 24 to provide IMD 16 with other information, such as information indicating the stage of the physiological cycle (e.g., the occurrence of an expulsion event).

[0044] While electrical stimulation is being delivered, the external device 24 can provide notification to the patient 14, or inform the patient 14 that the electrical stimulation is about to terminate. Additionally, termination notifications can help inform the patient 14 that a more likely bladder emptying event and / or the end of the filling cycle is approaching, requiring the bladder to be emptied (e.g., the patient should go to the toilet). In such examples, the external device 24 can display a visible message, emit an audible alarm signal, or provide a somatosensory alarm (e.g., by vibrating the casing of the external device 24). In other examples, the notification can indicate when the therapy is available during the physiological cycle (e.g., a countdown in minutes or an indication that the therapy is ready). In this way, the external device 24 can await input from the patient 14 before terminating electrical stimulation that reduces bladder contractions or otherwise promotes urination. The patient 14 can type in input confirming termination of electrical stimulation to pause the therapy for bladder emptying purposes, confirming that the system should maintain therapy delivery until the patient 14 can empty, and / or confirming that the patient 14 is ready for another different stimulation therapy to promote bladder emptying during the bladder emptying event.

[0045] When an out-of-control event is predicted, in the event that no input is received within a specific time frame, the external device 24 can wirelessly transmit a signal to the IMD 16 indicating the absence of patient input. The IMD 16 can then, based on its programming, choose to continue stimulation until patient input is received or to terminate stimulation. In some examples, electrical stimulation can be terminated or continued in response to other physiological markers.

[0046] The IMD 16 and external device 24 can communicate wirelessly using any technology known in the art. Examples of communication technologies may include, for example, low-frequency or radio-frequency (RF) telemetry, but other technologies are also contemplated. In some examples, external device 24 may include a programmed lead that can be placed near the patient's body close to the IMD 16 implantation site to improve the quality or security of communication between the IMD 16 and external device 24.

[0047] exist Figure 1 In Example 4 of the wire arrangement, electrodes 19A and 21A, and electrodes 19B and 21B, can be positioned substantially opposite to each other relative to the center of bladder 12. For example, electrodes 19A and 21A can be placed on opposite sides of bladder 12, either front-back or side-to-side. Figure 1 In the diagram, electrodes 19 and 21 are shown placed near the outer surface of the wall of bladder 12. In some examples, electrodes 19 and 21 may be sutured or otherwise attached to the bladder wall. In other examples, electrodes 19 and 21 may be implanted into the bladder wall. To measure the impedance of bladder 12, IMD 16 may initiate an electrical signal, such as a current, to electrode 19A via wire 18, and electrode 21A may collect this electrical signal via wire 20. IMD 16 may then determine the voltage between electrodes 19B and 21B via wires 18 and 20, respectively. IMD 16 uses the known value of the initiated electrical signal of the determined voltage to determine the impedance of bladder 12.

[0048] In other examples, electrodes 19 and 21 can be used to detect electromyography (EMG) of the detrusor muscle. This EMG can be used to determine the frequency of bladder contractions and physiological markers of patient 14. In some examples, the EMG can also be used to detect the intensity of bladder contractions. Alternatively, or in addition to the EMG, strain gauges or other devices can be used to detect the state of bladder 12, for example, by sensing the force indicating bladder contractions.

[0049] exist Figure 1In some examples, IMD 16 may also include a sensor 22 for detecting changes in bladder 12 contraction. Sensor 22 may include, for example, a pressure sensor for detecting changes in bladder pressure, electrodes for sensing pudendal or sacral nerve signals, electrodes for sensing urethral sphincter EMG signals (or, in an example where system 10 provides a therapy for managing urgency or fecal incontinence, an anal sphincter EMG signal), or any combination thereof. In examples where sensor 22 is a pressure sensor, the pressure sensor may be a remote sensor that wirelessly transmits signals to IMD 16 or may be carried on wires 18, 20, or 28 or on additional wires coupled to IMD 16. In some examples, IMD 16 may determine whether a contraction frequency of bladder 12 has occurred based on the pressure signal generated by sensor 22.

[0050] In an example where sensor 22 includes one or more electrodes for sensing afferent nerve signals, the sensing electrodes may be carried on leads 18, 20, or 28 or coupled to additional leads of IMD 16. In an example where sensor 22 includes one or more sensing electrodes for generating urethral sphincter EMG, the sensing electrodes may be carried on leads 18, 20, or 28 or coupled to additional leads of IMD 16. In any case, in some embodiments, IMD 16 may control the timing of electrical stimulation delivery based on input received from sensor 22.

[0051] Sensor 22 may include a patient motion sensor that generates signals indicative of the patient's activity level or postural state. In some examples, based on signals from the motion sensor, IMD 16 may terminate the delivery of electrical stimulation to patient 14 when a patient activity level is detected to exceed a specific threshold. In other examples, IMD 16 may use sensor 22 to identify postural states known to require the desired therapeutic effect. For example, when patient 14 is in an upright posture, compared to a lying posture, patient 14 may be more likely to perform an unintentional discharge event. In any event, electrodes 19 and 21, as well as sensor 22, may be configured to detect the discharge event and / or detect the magnitude of the bladder 12's filling level during a filling cycle.

[0052] As discussed above, system 10 can monitor the filling cycle of bladder 12 by detecting subsequent discharges over time. In some examples, system 10 can detect a discharge event by receiving an indication representing user input (e.g., via external device 24) that indicates a discharge event has occurred. In other words, external device 24 can receive input from the user identifying the occurrence of a discharge event, the start of the discharge event, and / or the end of the discharge event. In other examples, system 10 can automatically detect a discharge event without receiving user input via external device 24. Instead, system 10 can detect a discharge event by detecting at least one of the following: bladder pressure, urine flow from the bladder, moisture of external patient garments, bladder volume, EMG signals, neural recordings, postural changes, the patient's physical location within a structure (such as a house or care facility), or toilet use events. Some sensors external to patient 14 can communicate with external device 24 and / or IMD 16 to provide information indicating possible discharge events. For example, moisture levels can be detected by a humidity sensor (e.g., an impedance or chemical sensor) embedded in the patient's underwear and transmitted to the IMD 16 or external device 24. Similarly, the toilet may include a presence sensor (e.g., an infrared sensor, a thermal sensor, or a pressure sensor) that detects the patient's use and transmits a signal indicating the patient's presence to the IMD 16 or external device 24. In this way, data acquired non-invasively can provide information indicating a discharge event without implanted sensors. This information indicating a discharge event can be provided to the server 26 by the external device 24 or the IMD 16. Figure 1 System 10 can implement the technology disclosed herein.

[0053] For example, system 10 may include a memory configured to store first information about a patient, wherein the first information is acquired during a baseline period prior to the patient receiving stimulation, and processor circuitry coupled to the memory, the processor circuitry being configured to receive the first information about the patient, receive second information about the patient, wherein the second information is acquired during an initial therapy specification period, and the second information includes test data generated by providing stimulation during the implantation process, determining an initial stimulation procedure setting based on the first information, the second information, and group informed information about other patients, and delivering therapy based on the initial stimulation procedure setting during a training period.

[0054] Figure 2A It's a block diagram showing what can be used in... Figure 1 Example configuration of IMD in the system. For example... Figure 2AAs shown, IMD 16 includes sensor 22, processor circuitry 53, therapy delivery circuitry 52, impedance circuitry 54, memory 56, telemetry circuitry 58, and power supply 60. In other examples, IMD 16 may include more or fewer components. For example, in some examples, such as those where IMD 16 delivers electrical stimulation in an open-loop manner, IMD 16 may not include sensor 22 (e.g., a pressure sensor or an electrical signal sensor) and / or impedance circuitry 54. In some examples, if IMD 16 does not include sensors (e.g., sensor 22 and / or impedance circuitry 54), physiological markers may be provided via patient input on an external device.

[0055] According to some examples, processor circuitry 53 identifies changes in a patient's physiological state in relation to a desired change in neural stimulation. For example, bladder emptying may indicate a period of time or that stimulation is not required until a sensor input indicates that stimulation is needed. The system may include one or more sensors that sense biomarkers indicating relevant physiological state changes, such as sensors external to sensor 22 and / or IMD 16. For example, a pressure sensor may detect the amount of bladder pressure. Thus, processor circuitry 53 may be configured to classify certain changes in bladder pressure as corresponding to emptying (e.g., when the sensed signal matches one or more sets of parameters). Processor circuitry 53 may also classify the relative fullness of the bladder from subsequently detected pressure levels.

[0056] Specific parameters of the bladder pressure signal can be used to notify the processor circuit 53 when a discharge event has occurred. For example, and without limitation, the processor circuit 53 can monitor one or more of the following: bladder pressure, the magnitude of bladder pressure change, the duration of bladder pressure change, and the rate of bladder pressure change. This data can be used to identify discharge events. It should be noted that other neural targets may alter urinary function in a manner similar to that of sacral nerves such as the tibial nerve, saphenous nerve, pudendal nerve, dorsal nerve of the penis, and dorsal nerve of the clitoris.

[0057] Generally, IMD 16 may include any suitable hardware arrangement, alone or in combination with software and / or firmware, to perform techniques attributable to IMD 16 and its processor circuitry 53, therapy delivery circuitry 52, impedance circuitry 54, and telemetry circuitry 58. In various examples, IMD 16 may include one or more processors, such as one or more microprocessors, digital signal processors (DPS), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, and any combination of such components. In various examples, IMD 16 may also include memory 56, such as random access memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, containing executable instructions to cause the one or more processors to perform actions therein. Furthermore, although the processor circuit 53, therapy delivery circuit 52, impedance circuit 54, and telemetry circuit 58 are described as separate circuits, in some examples, they are functionally integrated. In some examples, the processor circuit 53, therapy delivery circuit 52, impedance circuit 54, and telemetry circuit 58 correspond to individual hardware units, such as microprocessors, ASICs, DSPs, FPGAs, or other hardware units. In other examples, any one of the processor circuit 53, therapy delivery circuit 52, impedance circuit 54, and telemetry circuit 58 may correspond to multiple individual hardware units, such as microprocessors, ASICs, DSPs, FPGAs, or other hardware units.

[0058] Memory 56 stores a therapy program 66 that specifies stimulation parameter values ​​for electrical stimulation provided by IMD 16. Therapy program 66 may also store information about identifying and using physiological markers, information about physiological cycles and / or disorder states, or any other information. In some examples, IMD 16 may deliver stimulation therapy based on one or more physiological markers. In other examples, IMD 16 may deliver stimulation therapy not based on one or more physiological markers. In some examples, memory 56 also stores bladder data 69, which processor circuitry 53 can use to control the timing of delivering electrical stimulation (e.g., defining when to deliver and block stimulation during physiological cycle phases). For example, bladder data 69 may include bladder impedance, bladder pressure, sacral or pudendal nerve signals, bladder contraction frequency, or threshold or baseline values ​​of the external urethral sphincter EMG template for use as physiological markers of associated physiological cycles. Bladder data 69 may also include timing information and physiological markers related to physiological events such as evacuation events. IMD 16 may provide some or all of the bladder data 69 to external device 24 or server 26.

[0059] Information regarding sensed bladder contractions, bladder impedance, and / or the patient 14's posture can be recorded for long-term storage and retrieval by the user, for use by the processor circuitry 53 to adjust stimulation parameters (e.g., amplitude, pulse width, pulse rate, duty cycle, etc.) or as physiological markers, or for transmission to the server 24. In some examples, the memory 56 includes separate memories for storing instructions, electrical signal information, stimulation programs 66, and bladder data 69.

[0060] Generally, the therapy delivery circuit 52 generates and delivers electrical stimulation under the control of the processor circuit 53. In some examples, the processor circuit 53 controls the therapy delivery circuit 52 by accessing the memory 56 to selectively access at least one of the stimulation programs 66 and load it into the therapy delivery circuit 52. For example, during operation, the processor circuit 53 may access the memory 56 to load one of the stimulation programs 66 into the therapy delivery circuit 52. In other examples, the therapy delivery circuit 52 may access the memory 56 and load one of the stimulation programs 66.

[0061] For example, processor circuitry 53 can access memory 56 to load one of stimulation programs 66 into therapy delivery circuitry 52 for delivering electrical stimulation to patient 14. Clinician or patient 14 can select a specific stimulation program 66 from a list using a programming device (such as external device 24 or a clinician programmer). Processor circuitry 53 can receive the selection via telemetry circuitry 58. Therapy delivery circuitry 52 delivers electrical stimulation to patient 14 according to the selected program for an extended period (such as minutes, hours, days, weeks, or until patient 14 or clinician manually stops or changes the program).

[0062] The therapy delivery circuit 52 delivers electrical stimulation according to stimulation parameters. In some examples, the therapy delivery circuit 52 delivers electrical stimulation in the form of electrical pulses. In such examples, the relevant stimulation parameters may include voltage amplitude, current amplitude, pulse rate, pulse width, duty cycle, duty cycle of the stimulation on / off period, or a combination of electrodes 29 used by the therapy delivery circuit 52 to deliver the stimulation signal. In other examples, the therapy delivery circuit 52 delivers electrical stimulation in the form of a continuous waveform. In such examples, the relevant stimulation parameters may include voltage or current amplitude, frequency, shape of the stimulation signal, duty cycle of the stimulation signal, or a combination of electrodes 29 used by the therapy delivery circuit 52 to deliver the stimulation signal.

[0063] In some examples, the stimulation parameters used for stimulation procedure 66 can be selected to relax bladder 12 after electrical stimulation is terminated, for example, by reducing the contraction frequency of bladder 12. Examples of stimulation parameters that may be effective in treating bladder disorders, such as when applied to spinal nerves, sacral nerves, pudendal nerves, tibial nerves, saphenous nerves, dorsal clitoral nerves, inferior rectal nerves, or perineal nerves, are as follows: 1. Frequency or pulse rate: Between approximately 0.5 Hz and approximately 500 Hz, such as between approximately 1 Hz and approximately 250 Hz, between approximately 1 Hz and approximately 20 Hz, or approximately 10 Hz. 2. Amplitude: Between approximately 0.1 volts and approximately 50 volts, such as between approximately 0.5 volts and approximately 20 volts, or between approximately 1 volt and approximately 10 volts. Alternatively, the amplitude may be between approximately 0.1 milliamperes (mA) and approximately 50 mA, such as between approximately 0.5 mA and approximately 20 mA, or between approximately 1 mA and approximately 10 mA. 3. Pulse width: Between approximately 10 microseconds (μs) and approximately 5000 μs, such as between approximately 100 μs and approximately 1000 μs, or between approximately 100 μs and approximately 200 μs.

[0064] While IMD 16 is monitoring bladder filling levels to determine the state of the bladder filling cycle, processor circuitry 53 can monitor the impedance of bladder 12 for a predetermined duration to detect bladder 12 contractions and determine the baseline contraction frequency of bladder 12 by determining the number of contractions of bladder 12 during that predetermined duration. In other examples, electrodes 19 or 21 can be used to detect EMG of the detrusor muscle to identify bladder contraction frequency. Alternatively, strain gauge sensor signal output or other measures of bladder contraction variation can be used to detect physiological markers of bladder 12. These alternative methods for monitoring bladder 12 filling levels and / or emptying events can be used in some examples.

[0065] exist Figure 2A In the example shown, the impedance circuit 54 includes a voltage measurement circuit 62 and a current source 64, and may include an oscillator (not shown) to generate an alternating signal. In some examples, such as those mentioned above... Figure 1 As illustrated, impedance circuit 54 can use a four-wire arrangement or a Kelvin arrangement. As an example, processor circuit 53 can periodically control current source 64 to initiate a current signal, for example, via motor 19A and collect that current signal via motor 21A. In some examples, to collect impedance measurements, current source 64 can deliver a current signal, such as a signal below a threshold, which does not deliver stimulation therapy to bladder 12 due to, for example, the amplitude or width of such a signal and / or the timing of its delivery. Impedance circuit 54 may also include switching circuitry (not shown) for selectively coupling electrodes 19A, 19B, 21A, and 21B to current source 64 and voltage measurement circuit 62. Voltage measurement circuit 62 can measure the voltage between electrodes 19B and 21B. Voltage measurement circuit 62 may include sampling and holding circuitry or other suitable circuitry for measuring the voltage amplitude. Processor circuit 53 determines the impedance value from the measured voltage value received by voltage measurement circuit 52.

[0066] In other examples, processor circuitry 53 may monitor signals received from sensor 22 to detect contractions of bladder 12 and determine a baseline contraction frequency. In some examples, sensor 22 may be a pressure sensor for detecting pressure changes in bladder 12, which processor circuitry 53 may associate with contractions of bladder 12. Processor circuitry 53 may determine a pressure value based on signals received from sensor 22 and compare the determined pressure value with a threshold stored in bladder data 69 to determine whether the signal indicates a contraction of bladder 12. In some implementations, processor circuitry 53 monitors the pressure of bladder 12 for a predetermined duration to detect contractions of bladder 12 and determines the contraction frequency of bladder 12 by counting the number of contractions of bladder 12 during that predetermined duration.

[0067] In some examples, processor circuitry 53 can store contraction frequency information as bladder data 69 in memory 56, and can utilize changes in contraction frequency to track the filling level of the bladder filling cycle or otherwise track the phase of the filling cycle. In some implementations, processor circuitry 53 can determine the contraction frequency on the filling cycle automatically or under user control. Processor circuitry 53 can determine that an increase in contraction frequency indicates a later phase of the filling cycle. In some examples, processor circuitry 53 can use EMG signals from patient 14 to track bladder contractions. In some implementations, sensor 22 can include an EMG sensor, and processor circuitry 53 can generate EMG from received signals generated by sensor 22. Sensor 22 can be implanted near muscles active when bladder 12 contracts, such as the detrusor muscle. Processor circuitry 53 can compare EMG acquired during a second period with an EMG template stored as bladder data 69 (e.g., a short-term moving average) to determine whether bladder contraction indicates a specific phase of the bladder filling cycle.

[0068] In other examples, sensor 22 may be a pressure sensor, and processor circuitry 53 may monitor signals received from sensor 22 during at least a portion of the second period to detect bladder 12 contractions. In some examples, processor circuitry 53 monitors the pressure of bladder 12 substantially continuously during at least the second period to detect bladder 12 contractions, and determines the contraction frequency of bladder 12 by determining the number of contractions of bladder 12 during a given period. Sensor 22 may also provide long-term pressure changes to track bladder filling status (e.g., increased bladder volume may correspond to increased bladder pressure).

[0069] exist Figure 2AIn one example, the therapy delivery circuit 52 drives electrodes on a single lead 28. Specifically, the therapy delivery circuit 52 delivers electrical stimulation to the tissues of the patient 14 via selected electrodes 29A-29D carried by the lead 28. The proximal end of the lead 28 extends from the housing of the IMD 16 and the distal end extends to a target therapy site, such as a spinal nerve (e.g., the S3 nerve), or a therapy site within the pelvic floor, such as a tissue site near the sacral nerve, pudendal nerve, tibial nerve, saphenous nerve, dorsal clitoral nerve, inferior rectal nerve, perineal nerve, hypogastric nerve, urinary sphincter, or any combination thereof. In other examples, the therapy delivery circuit 52 may deliver electrical stimulation with electrodes on more than one lead, and each of these leads may carry one or more electrodes. These leads may be configured as axial leads with loop electrodes or segmented electrodes and / or paddle-shaped leads with electrode pads arranged in a two-dimensional array. These electrodes can operate in a bipolar or multipolar configuration with other electrodes, or in a unipolar configuration with reference to the electrodes carried by the device housing or the "can" of the IMD 16.

[0070] As previously described, sensor 22 may include a pressure sensor configured to detect changes in bladder pressure, electrodes for sensing pudendal or sacral nerve signals, or electrodes for sensing external urethral sphincter EMG signals (or, in the example where IMD 16 provides treatment for urgency or fecal incontinence, an anal sphincter signal), or any combination thereof. Additionally or alternatively, sensor 22 may include motion sensors such as a biaxial accelerometer, a triaxial accelerometer, one or more gyroscopes, a pressure transducer, a piezoelectric crystal, or other sensors that generate signals that alter the patient's level of activity or postural state. Processor circuitry 53 may detect physiological markers indicating points during bladder filling cycles. Sensor 22 may also be a motion sensor that responds to (e.g., by the patient 14) tapping the skin above IMD 16. Processor circuitry 53 may be configured to record patient input using this tapping method (e.g., a tap may indicate that a discharge event is occurring). Alternatively or additionally, processor circuitry 53 may control therapeutic circuitry 52 to deliver or terminate electrical stimulation delivery in response to a tap or some tapping pattern.

[0071] In an example where sensor 22 includes a motion sensor, processor circuitry 53 can determine the patient's activity level or postural state based on signals generated by sensor 22. This patient activity level can be, for example, sleeping, sitting, exercising, working, running, walking, or any other activity of patient 14. For example, processor circuitry 53 can determine the patient's activity level by sampling signals from sensor 22 and determining the number of activity counts during a sample period, where each of a plurality of activity levels is associated with a corresponding activity count. In one example, processor circuitry 53 compares the signals generated by sensor 22 with one or more amplitude thresholds stored in memory 56 and identifies each crossing of a threshold as an activity count. Physical activity can indicate bladder filling levels, expiratory events, or any other physiological markers associated with the bladder filling cycle.

[0072] In some embodiments, processor circuitry 53 can control therapy delivery circuitry 52 to deliver or terminate electrical stimulation based on patient input received via telemetry circuitry 58. Telemetry circuitry 58 includes any suitable hardware, firmware, software, or any combination thereof for use with other devices, such as external device 24. Figure 1 Communication. Under the control of processor circuit 53, telemetry circuit 58 can receive downlink telemetry, such as patient input, from external device 24 via an antenna, and can send uplink telemetry to external device, the antenna being internal and / or external. Processor circuit 53 can provide data to be uplinked to external device 24 and control signals for the telemetry loop within telemetry circuit 58, and receive data from telemetry circuit 58.

[0073] Generally, processor circuitry 53 can control telemetry circuitry 58 to exchange information with external device 24 or other devices outside the IMD 16, such as server 26. Processor circuitry 53 can transmit operational information and bladder data 69 via telemetry circuitry 58 and receive stimulation programs or stimulation program adjustment values. In some examples, the IMD 16 can also communicate with other implantable devices such as stimulators, control devices, or sensors via telemetry circuitry 58.

[0074] Power supply 60 delivers operating power to components of IMD 16. Power supply 60 may include a battery and power generation circuitry to generate operating power. In some examples, the battery may be rechargeable to allow for extended operation. Recharging can be accomplished via adjacent inductive interaction between an external charger and an inductive charging coil within IMD 16. In other examples, the external inductive supply may power IMD 16 percutaneously whenever electrical stimulation occurs. IMD 16 may be configured to implement the techniques disclosed herein. For example, IMD 16 may include: a memory, such as memory 56, configured to store initial stimulation program settings, such as therapy program 66, wherein the initial stimulation program settings are determined based on first information, second information, and group-informed information, the first information being information about the patient collected during a baseline period prior to the patient receiving stimulation, the second information being information collected during the initial therapy specification period including test data generated during the delivery of stimulation during the implantation process of the IMD, and the group-informed information being information about other patients; and processor circuitry, such as processor circuitry 53, configured to cause the stimulation generator to deliver therapy based on the initial stimulation program settings during a training period. Figure 2B As shown, IMD 70 is similar to Figure 2A The IMD 16 is used, but the IMD 70 delivers neural stimulation to the patient 14 in the form of medication rather than electrical stimulation. The IMD 70 includes processor circuitry 73 (e.g., similar to processor circuitry 53), a therapy delivery module 74 coupled to a guide tube 75, and a sensor 76 (e.g., similar to...). Figure 2A The sensor 22 is a pressure sensor; telemetry circuit 78 (e.g., similar to telemetry circuit 58); memory 80 (e.g., similar to memory 56); and power supply 86 (e.g., similar to power supply 60). Although IMD 70 does not include impedance circuit 54, such impedance circuit or other circuits may be provided in some examples.

[0075] The therapy delivery module 74 may include a drug reservoir and a drug pump that directs the drug from the reservoir through a guide tube 75 and out to the patient 14. In some examples, the IMD 70 may include both the drug pump and an electrical stimulation generator. The memory 80 may include a therapy program 82 and bladder data 84. The therapy program 82 may include instructions for drug delivery. In some examples, the instructions for drug delivery may be based on one or more physiological markers stored as bladder data 84. The IMD 70 may deliver a single dose of drug to the patient 14 based on the therapy program. In some examples, the processor circuitry 73 may predict when to deliver a single dose of drug to the patient 14 based on physiological cycles such as the phases of a bladder filling cycle, for example, in a manner similar to... Figure 2A The processor circuit 53 relates to the manner of delivering stimuli.

[0076] Figure 3 This is a block diagram illustrating an example configuration of external device 24. While external device 24 can generally be described as a handheld computing device, it can be, for example, a laptop computer, smartphone, workstation, remote key, or wearable device. Figure 3 As shown, external device 24 may include processor circuitry 90, memory 92, user interface 94, telemetry circuitry 96, and power supply 98. Memory 92 may store program instructions that, when executed by processor circuitry 90, enable processor circuitry 90 and external device 24 to provide the functionality attributed to external device 24 throughout this disclosure.

[0077] Generally, external device 24 includes any suitable hardware arrangement, either individually or in combination with software and / or firmware, to perform techniques attributed to external device 24 and its processor circuitry 90, user interface 94, and telemetry circuitry 96. In various examples, external device 24 may include one or more processors, such as one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, and any combination of such components. In various examples, external device 24 may also include memory 92, such as RAM, ROM, PROM, EPROM, EEPROM, flash memory, hard disk, CD-ROM, containing executable instructions to cause the one or more processors to perform actions caused thereby. Additionally, while processor circuitry 90 and telemetry circuitry 96 are described as separate circuits, in some examples, processor circuitry 90 and telemetry circuitry 96 are functionally integrated. In some examples, processor circuitry 90 and telemetry circuitry 96 and telemetry circuitry 58 correspond to separate hardware units, such as microprocessors, ASICs, DSPs, FPGAs, or other hardware units. In other examples, any one of the processor circuit 90 and the telemetry circuits 96 and 58 may correspond to multiple separate hardware units, such as microprocessors, ASICs, DSPs, FPGAs, or other hardware units.

[0078] Memory 92 may store program instructions that, when executed by processor circuitry 90, enable processor circuitry 90 and external device 24 to provide the functionality attributed to external device 24 throughout this disclosure. In some examples, memory 92 may also include program information, such as a stimulation program defining neural stimulation, similar to those stored in memory 56 of IMD 16. The stimulation program stored in memory 92 may be downloaded to memory 56 of IMD 16.

[0079] In some examples, external device 24 includes a user interface 94 that allows the patient to provide input. Clinician or patient 14 can provide information about patient 14 to external device 24 through user interface 94. For example, as described above, during the baseline period, patient 14 or clinician can input demographic information, medical history, and baseline symptom data. During other periods, such as when patient 14 can provide information about symptoms or treatment efficacy, external device 24 can prompt patient 14 through user interface 94 to input whether patient 14 experienced bladder incontinence on that day or the number of times patient 14 experienced bladder incontinence on that day.

[0080] Additionally or alternatively, patient 14 may request changes to the stimulation program or settings via user interface 94. IMD 16 may respond to patient-provided data from the user interface by providing the data to server 26 or by changing the therapy. In some examples, patient 14 may use external device 24 (e.g., a handheld device) to record physiological events of interest (by pressing a button). Processor circuitry 53 of IMD 16 may respond by turning the therapy on or off, by adjusting the therapy (e.g., stimulation intensity), or by changing the therapy program. Processor circuitry 53 may store physiological events of interest in memory 92 for later transmission to server 26 via telemetry circuitry 96. Regarding the urological applications discussed herein, patient 14 may press a button on external device 24 (e.g., their smartphone) when the bladder is empty. Pressing the button in this way causes telemetry circuitry 96 of external device 24 to signal IMD 16 to shut down for a period of time. Alternatively, patient 14 may press the button when they feel an impending discharge is urgent. This will alert IMD 16 to turn on, increase its therapy level, or activate a specific program consistent with the pre-discharge timing scenario. Consistent with the various examples disclosed herein, patient-provided data regarding physiological events of interest can be used by server 26 as information about the patient to determine the stimulation procedure settings for patient 14.

[0081] User interface 94 may include buttons or a keypad, lights, a speaker for voice commands, knobs, and a display such as a liquid crystal display (LCD), a light-emitting diode (LED), or a cathode ray tube (CRT). In some examples, the display may be a touchscreen. As discussed in this disclosure, processor circuitry 90 may present and receive information about electrical stimulation and the resulting therapeutic effects via user interface 94. For example, processor circuitry 90 may receive patient input via user interface 94. Input may, for example, be in the form of pressing a key on a keypad or selecting an icon from a touchscreen.

[0082] The processor circuitry 90 can also present information to the patient or family caregiver via the user interface 94 in the form of an alarm regarding the delivery of electrical stimulation to the patient 14. Although not shown, the external device 24 may additionally or alternatively include a data or network interface to another computing device to facilitate communication with other devices and to present information about the effects of the electrical stimulation and therapy via other devices after the electrical stimulation has been terminated.

[0083] Under the control of processor circuitry 90, telemetry circuitry 96 supports communication between IMD 16 and external device 24, as well as between server 26 and external device 24. Telemetry circuitry 96 can also be configured to communicate with other computing devices via wireless communication technology or directly via a wired connection. In some examples, telemetry circuitry 96 may be substantially similar to telemetry circuitry 58 of IMD 16 described above, thereby providing wireless communication via RF or adjacent inductive media. In some examples, telemetry circuitry 96 may include an antenna, which may take various forms, such as an internal antenna or an external antenna.

[0084] Examples of local wireless communication technologies that can be used to facilitate communication between external device 24 and other computing devices include RF communication according to the 802.11 or Bluetooth specification set, infrared communication (e.g., according to the IrDA standard or other standards), or proprietary telemetry protocols. In this way, other external devices may be able to communicate with programmer 24 without establishing a secure wireless connection.

[0085] Power supply 98 delivers operating power to the components of programmer 24. Power supply 98 may include a battery and power generation circuitry to generate operating power. In some examples, the battery may be rechargeable to allow for extended operation.

[0086] Figure 4 This is a functional block diagram illustrating an example system including an external computing device such as a server 26 and one or more other computing devices 230A-230N coupled to an IMD 16 and an external device 24 via a network 222. In this example, the IMD 16 can use its telemetry circuitry 58 to communicate with the external device 24 via a first wireless connection and with the access point 220 via a second wireless connection, for example, at different times and / or in different locations or settings. Figure 4 In the example, access point 220, external device 24, server 26 and computing devices 230A-230N are interconnected and can communicate with each other via network 222.

[0087] Access point 220 may include a device connected to network 222 via any of a variety of connections, such as dial-up, digital subscriber line (DSL), or cable modem connections. In other examples, access point 220 may be coupled to network 222 via different connection methods, including wired and wireless connections. In some examples, access point 220 may be co-located with patient 14. Access point 220 may, for example, periodically or in response to commands from patient 14 or network 222, pollute IMD 16 to retrieve physiological signals acquired by sensor 22. Access point 220 may provide the retrieved data to server 26 via network 222.

[0088] In some cases, server 26 can be configured to provide a secure storage location for data already collected by IMD 16 and / or external device 24. In some cases, server 26 can compile data from web pages or other documents for viewing by trained professionals such as clinicians via computing devices 230A-230N. Figure 4 The system demonstrated can be implemented in some aspects using general networking technologies and functions, similar to the Medtronic system developed by Medtronic plc in Dublin, Ireland. Provided online.

[0089] This disclosure describes techniques relating to processor circuitry. While examples may be described relating to processor circuitry 53 of IMD 16, processor circuitry 90 of external device 24, and processor circuitry 228 of server 26, the techniques disclosed herein can be implemented by any one or more processor circuits of any computing device of IMD 16, external device 24, server 26, access point 220, or computing devices 230A-230N. In some examples, the techniques disclosed herein can be implemented in a distributed manner, wherein one of a plurality of techniques is implemented by processor circuitry of any computing device of IMD 16, external device 24, server 26, access point 220, or computing devices 230A-230N, and one or more techniques are implemented by one or more processor circuits of any computing device of IMD 16, external device 24, server 26, access point 220, or computing devices 230A-230N. For example, in some examples, processor circuitry 53 of IMD 16 can determine an initial program setting and, based on the initial stimulation program setting, cause IMD 16 to deliver therapy. In some examples, the processor circuitry 228 of server 26 can determine an initial program setting and, based on the initial stimulation program setting, enable the IMD 16 to deliver therapy. In other examples, the processor circuitry of a computing device such as external device 24 or any computing device 230A-230N can determine the initial program setting and, based on the initial stimulation program setting, enable the IMD 16 to deliver therapy. In still other examples, any combination of the IMD 16, external device 24, server 26, or any computing device 230A-230N can determine the initial program setting and, based on the initial stimulation program setting, enable the IMD 16 to deliver therapy.

[0090] exist Figure 4 In this example, server 26 includes storage 226 for storing information about the patient and group informed information. In some examples, information about the patient may be stored in an electronic record of care (EHR) 232 within storage 226. In some examples, group informed information may be stored in a database 234 within storage 226. In some examples, as shown, the electronic record of care 232 may be located outside of database 234. In other examples, as shown, the electronic record of care 232 may be located within database 234. Group informed information may include anonymized data about other patients. In some examples, information about patient 14 or group informed information may be stored elsewhere.

[0091] Figure 5 It is a conceptual state diagram that shows the different stages of a patient's treatment lifecycle. Figure 5Five states are shown: baseline period 200, initial therapy designation 202, induction period 204, training period 206, and maintenance period 208. In baseline period 200, before the patient has been exposed to neuromodulation such as sacral or tibial modulation, the patient or caregiver can digitally enter initial information on, for example, an external device 24. Initial information may include basic demographic information and the patient's medical history. For example, the patient or caregiver may enter gender, age, BMI, diagnosis, comorbidities, medications, and other information on the external device 24. In some examples, the external device 24 may collect initial information by asking the patient or caregiver a few questions on the external device 24. In some examples, the external device 24 may present the patient or caregiver with a form to fill out for collecting initial information. In this way, the external device 24 can collect initial information by providing the patient or caregiver with a direct interface to the electronic care record 232. Initial information may also include baseline symptom data. As discussed above, baseline symptom data may include indications, symptoms of a disease the patient is experiencing, or physiological parameters. In some examples, patients can provide baseline symptom data to external device 24 for a minimum number of days. In some examples, the minimum number of days can be in the range of 3-14 days. External device 24 can collect baseline symptom data by asking questions digitally about the patient's disease symptoms (e.g., urinary urgency, incontinence, discharge, etc.) and about the patient's medications, lifestyle, and quality of life (including sleep, fluid intake, food choices, activities of daily living, activity levels, exercise, pain, etc.).

[0092] In some examples, the initial information may also include sensor data. For instance, a patient may wear wearable sensors such as wearable sensor 15 or other sensors to collect more targeted data about sleep and activity. For example, a heart rate sensor, accelerometer, hygrometer, electromyography sensor, or other sensors may be used to collect data about disease symptoms or other patient data. An external device 24 may collect sensor data from the wearable sensors.

[0093] The telemetry circuitry 96 of external device 24 can provide the acquired first information to server 26. In some examples, the processor circuitry 228 of server 26 determines whether patient 14 is a candidate for neurostimulation based on the first information. For example, processor circuitry 228 can compare the patient's first information with the first information of other patients in the group informed information in database 234 in memory 226, and determine whether other patients with similar first information were successfully treated as they moved along the treatment path from baseline to trial to implantation. If other patients with similar first information to the patient have been successfully treated with neurostimulation, this may mean that the patient is a good candidate for neurostimulation. For simplicity, these techniques are illustrated with reference to processor circuitry 228; however, it should be understood that the processor circuitry performing the example techniques can be distributed across one or more computing devices 230A-230N and server 26. In this way, server 26 can utilize the first information as a tool for patient selection. Server 26 can utilize the first information to determine recommended therapeutic approaches, including implantation targets, initial programming characteristics, and behavioral recommendations. For example, processor circuitry 228 can determine recommended therapeutic approaches based on the patient's diagnosis and indications. For example, processor circuit 228 may recommend stimulating a patient with overactive bladder once or twice an hour, while processor circuit 228 may recommend stimulating a patient with fecal incontinence once or twice a day.

[0094] Once the patient has received the neuromodulation system (fully implanted or experimental), the patient can proceed to initial therapy designation 202. During initial therapy designation 202, data from three sources can be acquired (e.g., by external device 24 or IMD 16) and processed (e.g., by server 24) to determine the initial stimulation program settings. These three sources may include, for example, first information acquired at baseline, physiological data including information on motor and sensory tests that can be performed during the implantation process, and group-informed data collected from other patients with similar profiles. For example, a series of simple tests for determining motor and sensory thresholds may be collected during or after implantation in clinic programming. Typically, motor threshold information is collected during the implantation process, and sensory threshold information is collected post-operatively in the clinic because patients can report the stimuli they feel. Second information may also include the location of motor and sensory information (e.g., where the patient feels or where sensation is visible on their body). Additionally, second information may include electromyography (EMG) data, such as the amplitude, shape, and location of EMG signals collected during implantation.

[0095] In some examples, the group-informed data may be stored in database 234 on server 26 or anonymized data accessible by server 26. For example, server 26 may determine different initial stimulation program settings for patients with a specific condition, such as fecal incontinence, and for patients with different indications, such as urinary incontinence. These differences may be based on group-informed data, patient-specific data, or both. Server 26 may determine different initial stimulation program settings for patients with more severe symptoms and patients with milder symptoms. For most patients affected by nocturia during sleep, server 26 may determine an initial stimulation program that includes only therapy during sleep or additional therapy during sleep. In some examples, the initial therapy program settings may include more than one stimulation program, for example, in case the initial program used does not provide symptom relief.

[0096] Following the initial therapy designation 202 is the induction period 204. During the induction period 204 (which may exist during the trial period or post-implantation), the initial stimulation procedure setting can be tested for a minimum number of days. In the trial (pre-implantation) case, this minimum number of days can be on the order of two to four days. In the post-implantation case, this minimum number of days can be on the order of two to four weeks or longer. The number of days in the induction period 204 can be limited based on changes in symptoms or, for example, by a physician or caregiver when registration is required. The induction period 204 can also be adjusted based on group informed information. For example, the processor circuitry 228 of server 26 can determine that another patient with the same or similar demographic data, medical history, activity level, symptoms, disease, disease state, or other characteristics has a certain length of induction period and adjust the length of the induction period to be closer to that of the other patient or to match the length of the induction period of patient 14 to that of the other patient. During the induction period 204, the processor circuitry 228 of server 26 can continue to integrate data (e.g., input from caregivers, patients on external device 24, sensors, IMD 16). In some examples, the acquired data is similar to the initial information acquired during the baseline period. For example, external device 24 can provide patient 14 or caregivers with a set of questions to assess the effectiveness of the therapy to date. For example, external device 24 can prompt patient 14 to answer questions about their symptoms or the efficacy of the treatment. The processor circuitry 228 of server 26 can analyze the performance and determine whether to provide a recommendation to modify or maintain the initial stimulation program settings. For example, if the therapy does not affect the patient's symptoms, the processor circuitry 228 of server 26 can recommend switching programs or performing a quick test of the patient's sensory threshold to adjust the amplitude level or other parameters of the initial stimulation program settings.

[0097] Following the induction period 204 is the training period 206. The training period 206 can last, for example, from a few days (during the trial) to several weeks or even several months (post-implantation). During the training period 206, the processor circuitry 228 of the server 26 attempts to determine the optimal treatment procedure or treatment procedure schedule (maintenance stimulation program settings). The processor circuitry 228 can determine the maintenance stimulation program settings over a period of time. The length of the training period can be limited by the physician or caregiver. During the training period 206, in some examples, less data may be collected from the patient than during earlier periods. In some examples, the patient 14 may be able to continue providing data via the external device 24 regarding the patient's most bothersome symptoms, how they feel, etc. The processor circuitry 228 can determine some personalization and improvement of the initial stimulation program settings based on the initial stimulation program settings. The length of the training period 206 can be extended or shortened based on the therapeutic efficacy and the patient 14's satisfaction with the therapy.

[0098] Additionally, if the therapy is less effective, a self-reprogramming process can be triggered. This process can include tests similar to those typically performed during programming by a clinician, where various configurations are programmed and stimulation is increased until the patient feels and indicates that they feel, for example, by pressing a button on external device 24. For example, server 26 can notify external device 24 that a self-reprogramming process should be initiated. Server 26 can guide patient 14 through a series of steps via external device 24 to test the self-reprogramming process. External device 24 can communicate with IMD 16 to initiate the self-reprogramming process. During the self-reprogramming process, IMD 16 can utilize different stimulation programs and electrode configurations during this time, and external device 24 can collect self-reprogramming process information from patient 14, IMD 16, and / or sensors. Example tests may include providing stimulation with: 1) an electrode configuration at a higher amplitude than the initial stimulation program setting; 2) the same electrode configuration at a lower amplitude than the initial stimulation program setting; 3) the same electrode configuration at a higher frequency than the initial stimulation program setting; 4) the same electrode configuration with different pulse widths; 5) the same electrode configuration at an on / off period different from the initial stimulation program setting; and 6) any combination of electrode configurations. Server 26 may ask patient 14 questions about symptom relief or comfort during these tests via external device 24 and collect answers from patient 14. During the training period, external device 24 or IMD 16 may collect third information about patient 14. This third information may include information indicating the utility of the initial stimulation program setting and may include data from self-reprogrammed tests. The third information may include data typed by patient 14 on external device 24 or sensor data, such as data from wearable sensor 15 or sensor 22.

[0099] Once training period 206 is complete, maintenance period 208 begins. During maintenance period 208, patient 14 may be able to switch programs and adjust the amplitude of stimulation signals, for example, by interacting with external device 24. External device 24 may also automatically prompt patient 14 to make changes based on data provided and recorded by patient 14 (such as symptoms, activity levels, and sleep quality). Settings within each program can vary, and new programs can be created or rotated over time based on patient status and data collected over time. However, interaction with server 26 can be minimized during maintenance period 208, as the optimal therapy may have already been determined during training period 206. In many cases, patient 14 does not need to change or adjust settings. In some examples, if therapy effectiveness or satisfaction decreases, the user interface 94 of external device 24 can provide simple "knobs" more intuitively labeled "intensity," "volume," or "amount" for patient 14 to adjust. In some examples, for instance, if patient 14 feels the therapy effectiveness or patient satisfaction is unacceptable, patient 14 can use external device 24 to return to training period 206. In some cases, if the efficacy of the therapy and patient satisfaction are unacceptable, physicians or caregivers may also recommend returning to the training period 206.

[0100] Figure 6 This is a flowchart illustrating example technologies according to this disclosure. Figure 6 The technology can be implemented on server 26, external device 24, IMD 16, computing device 230A-230N, or any combination thereof. For simplicity, ... Figure 6 The discussion of examples focuses on server 26. Server 26 can receive first information (300) about patient 14 via network 222, for example, from external device 24, through telemetry circuit 224. The first information about patient 14 may be acquired by external device 24, for example, during a baseline period prior to patient 14 receiving stimulation. The first information about patient 14 may include, for example, basic demographic information, patient 14's medical history, or basic symptom data. In some examples, the first information includes at least one of the following: symptom data acquired over a predetermined period, medical history data, demographic data, lifestyle data, quality of life data, or sensor data.

[0101] Server 26 may store initial information about patient 14 in electronic care records 232 in memory 226. In some examples, processor circuitry 228 of server 26 may determine, based on the initial information, whether patient 14 is a candidate for neurostimulation (302). For example, processor circuitry 228 may compare the patient's initial information with initial information of other patients in group informed information in database 234 in memory 226 and determine whether other patients with similar initial information were successfully treated as they moved along the treatment pathway from baseline to trial to implantation. If other patients with similar initial information to this patient have been successfully treated with neurostimulation, this may mean that the patient is a good candidate for neurostimulation.

[0102] Server 26 can receive second information (304) about patient 14 via network 222, for example, from external device 24, through telemetry circuit 224. The second information about patient 14 can be acquired, for example, by external device 24 or IMD 16 during initial therapy designation or during clinician testing prior to initial therapy designation, and can include test data generated by delivering stimulation during the implantation procedure. Server 26 can store the second information about patient 14 in electronic care record 232 in memory 226.

[0103] The processor circuitry 228 of server 26 can determine the initial stimulation program settings (306) based on first information about patient 14, second information about patient 14, and group-informed information. For example, processor circuitry 228 can determine that patient 14's demographic data, medical history, activity level, symptoms, disease, and disease state most closely match another patient and set the initial stimulation program settings to be based on the current stimulation program settings of the other most closely matched patient. The initial stimulation program settings may include (multiple) stimulation programs, stimulation parameters (such as the current or voltage amplitude of the stimulation signal, the frequency or pulse rate of the stimulation signal, the shape of the stimulation signal waveform, the duty cycle of the stimulation signal, the pulse width of the stimulation signal, the duty cycle of the stimulation on / off period, etc.) and / or combinations of electrodes used to deliver stimulation and the corresponding polarities of the electrodes. Group-informed information may include anonymized data about other patients. For example, group-informed information may be stored in a database 234 in memory 226. Telemetry circuitry 224 of server 26 may provide the initial stimulation program settings to external device 24 or to IMD 16, for example, via network 222. When the initial stimulation program settings are provided to the external device 24, the telemetry circuitry 96 of the external device 24 can provide the initial stimulation program settings to the IMD 16. The IMD can then deliver the therapy to the patient 14 based on the initial stimulation program settings. In this way, the server 26 can deliver the therapy to the patient 14 (308) based on the initial stimulation program settings during the induction period.

[0104] In some examples, server 26 may communicate with external device 24 during the training period to guide patient 14 through tests (310) of at least one of the stimulation procedure, stimulation parameters, or electrode configuration. For example, server 26 may enable external device 24 to initiate the self-reprogramming process of IMD 16 (a series of tests described above) and collect patient feedback on the self-reprogramming process.

[0105] Server 26 can receive third information (312) about patient 14 via telemetry circuit 224 through network 222, for example, from external device 24. This third information about patient 14 can be collected during the training period, for example, by external device 24 or IMD 16, and indicates the effectiveness of the initial stimulation program settings. For example, patient 14 can input the third information on external device 24, or the sensor 22 of IMD 16 can sense the third information. Server 26 can store the third information about patient 14 in electronic care record 232 in memory 226.

[0106] The processor circuitry 228 of server 26 can determine the maintenance stimulation program settings (314) based on third information about patient 14. The maintenance stimulation program settings may include (one or more) stimulation programs, stimulation parameters (such as the current or voltage amplitude of the stimulation signal, the frequency or pulse rate of the stimulation signal, the shape of the stimulation signal waveform, the duty cycle of the stimulation signal, the pulse width of the stimulation signal, the duty cycle of the stimulation on / off periods, etc.), and / or combinations of electrodes used to deliver stimulation and their corresponding polarities. The maintenance stimulation program settings may include a range for each parameter. Sensor data or patient input may be used to gradually increase or decrease the parameters within their range or to turn them on and off for certain periods.

[0107] In some examples, maintenance stimulation program settings may include more than one therapeutic program. For example, processor circuitry 228 may determine that an initial stimulation program setting is effective and set the initial stimulation program setting as a maintenance stimulation program setting. For example, processor circuitry 228 may determine that an initial stimulation program setting is ineffective or unsuitable for patient 14 and may determine that a maintenance stimulation program setting is one or more settings different from the initial stimulation program setting. In some examples, processor circuitry 228 may use group-informed data to determine the maintenance stimulation program setting. For example, if another patient has a similar initial stimulation program setting to patient 14 and has experienced similar utility to patient 14 and is now in the maintenance phase of the same disease as patient 14, processor 228 may base patient 14's maintenance stimulation program setting on that other patient's maintenance stimulation program setting.

[0108] The telemetry circuit 224 of server 26 can provide maintenance stimulation program settings, for example, to external device 24 or to IMD 16 via gateway 222. When providing maintenance stimulation program settings to external device 24, the telemetry circuit 96 of external device 24 can provide the maintenance stimulation program settings to IMD 16. IMD can then deliver therapy to patient 14 based on the maintenance stimulation program settings. In this way, server 26 can deliver therapy to patient 14 (316) during the maintenance period based on the maintenance stimulation program settings.

[0109] Figure 7 This is a conceptual diagram illustrating the timeline of the example technologies disclosed herein. Figure 7 The technology can be implemented on server 26, external device 24, IMD 16, computing device 230A-230N, or any combination thereof. For simplicity, ... Figure 7 The discussion of examples focuses on server 26. Although Figure 7 The periods shown (400, 406, 412, 420, and 426) are depicted as being separated from each other by a period, but in some examples these periods (400, 406, 412, 420, and 426) can be back-to-back, such that there is no time between one period and the next. For example, training period 420 can transition to maintenance period 426 without any time in between.

[0110] During the baseline period 400, server 26 can receive initial information about patient 402, such as information about... Figure 6 The first information about patient 402 may include basic demographic information, indications, physiological parameters, symptoms, medical history, lifestyle data, quality of life data, and sensor data. Server 26 may store the first information about patient 402, for example, in electronic care record 232 in memory 226. Before initial treatment designation 406, server 26 may receive physiological data 404 (which may be second information about the patient), such as the patient's motor and sensory thresholds, the location of motor and sensory information, and EMG signal data. For example, a clinician may test the patient to determine motor and sensory thresholds and provide physiological data 404 to server 26 across network 222 via, for example, an external device 24. Server 26 may store physiological data 404 in electronic care record 232 for patient 10 in memory 226.

[0111] Server 26 can determine initial stimulation program settings, including a fixed parameter set 410, based on first information 402, physiological data 404 (which may be second information), and group informed information, and can provide the fixed parameter set 410 across network 222 to IMD 16 or external device 24 (which can provide the parameter set to IMD 16), as per [reference to...]. Figure 6 The subject of discussion. Figure 7 In the example, the initial treatment specification 406 can begin at the start of the trial period 408.

[0112] exist Figure 7 In the example, the induction period 412 may overlap with the trial period 408 and the post-implantation period 418. The IMD 16 can deliver therapy to the patient 10 during the induction period 412 based on the initial stimulation procedure settings. Parameters can be fine-tuned during the induction period 412. Figure 7 In this example, during the implantation procedure, the clinician can determine physiological data 416, which may include motor and sensory thresholds, the location of motor and sensory information, and EMG data. The clinician can provide the physiological data 416 to the server 26 across network 222 via, for example, an external device 24. The server 26 can store the physiological data 416 in the patient 10's electronic care record 232 in memory 226.

[0113] Following the induction period 412 may be a training period 420. During the training period 420, third information 422 may be collected by the IMD 16 or external device 24. This third information may include data on patient symptoms and sensor data during neurostimulation therapy with different parameters. For example, the server 26 may communicate with the external device 24 to guide the patient 14 through tests of at least one of the stimulation procedures, stimulation parameters, or electrode configurations, as discussed above, or to prompt the patient 14 to answer questions about the patient 14's symptoms or the efficacy of the treatment. The IMD 16 or external device 24 may collect the third information 422. The IMD 16 or external device 24 may transmit the third information 422 to the server 26, for example, via network 222. The server 26 may store the third information 422 in the patient 10's electronic care record 232 in memory 226. During the training period 420, clinicians may test the patient to collect physiological data 424 (which may be second information), which may include motor and sensory thresholds, the location of motor and sensory information, and EMG data. Clinicians can collect physiological data 424 on external device 24, and external device 24 can provide physiological data 424 to server 26, for example, via network 222. Server 26 can store physiological data 424 in patient 10's electronic care record 232 in memory 228.

[0114] The processor circuitry 228 of server 26 can determine a treatment plan 428, including maintenance stimulation program settings, based on third information about patient 14. Server 26 can provide the maintenance stimulation program settings to IMD 16 or external device 24, for example, via network 222 (the external device can provide the maintenance stimulation program settings to IMD 16). A maintenance period 426 may follow the training period 420, during which IMD 16 employs relatively optimized neurostimulation parameters compared to the initial stimulation program settings. During maintenance period 426, IMD 16 can automatically change the stimulation program, or patient 10 can change the stimulation program, for example, via external device 24. During maintenance period 426, clinicians can test patient 10 to collect physiological data 430 (which may be second information), for example, on external device 24. External device 24 can provide the physiological data 430 to server 26, for example, via network 222, and server 26 can record the physiological data 430 in patient 10's electronic care record 232. If sensor data provided to server 26 by IMD16 or external device 24, or patient input on external device 24, indicates that patient 10’s symptoms have worsened, server 26 can return patient 10 to training period 420, as discussed above, for example by initiating its own reprogramming process.

[0115] It should be noted that System 10 and the techniques described herein are not limited to treating or monitoring human patients. In alternative examples, System 10 can be implemented in non-human patients, such as primates, canines, equines, suidae, and felines. These other animals may be subjected to clinical or research therapies that may benefit from the subject matter of this disclosure.

[0116] The techniques disclosed herein can be implemented in a wide variety of computing devices, medical devices, or any combination thereof. Any of the illustrated units, circuits, or components can be implemented together or separately as discrete but interoperable logic devices. Describing different features as circuits or units is intended to highlight different functional aspects and does not necessarily imply that such circuits or units must be implemented by separate hardware or software components. Rather, the functionality associated with one or more circuits or units can be performed by separate hardware or software components, or integrated within shared or separate hardware or software components.

[0117] This disclosure contemplates a computer-readable storage medium containing instructions that cause a processor to perform any of the functions and techniques described herein. The computer-readable storage medium may take the form of any volatile, non-volatile, magnetic, optical, or electrical medium, such as RAM, ROM, NVRAM, EEPROM, or tangible flash memory. The computer-readable storage medium may be referred to as non-transient. Server, client computing devices, or any other computing devices may also include more portable removable memory types to allow for easy data transfer or offline data analysis.

[0118] The technologies described in this disclosure, including those attributable to various circuits and components, can be implemented at least in part in hardware, software, firmware, or any combination thereof. For example, aspects of these technologies can be implemented in one or more processors, including one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, or other processor circuitry, and any combination of such components, remote servers, remote client devices, or other devices. The term "processor circuitry" or "processor circuit" can generally refer to any of the aforementioned logic circuitry, alone or in combination with other logic circuitry, or any other equivalent circuitry.

[0119] Such hardware, software, and firmware may be implemented in the same device or in separate devices to support the various operations and functions described in this disclosure. Furthermore, any of the described units, circuits, or components may be implemented together or separately as discrete but interoperable logical devices. Describing different features as circuits or units is intended to highlight different functional aspects and does not necessarily imply that such circuits or units must be implemented by separate hardware or software components. Rather, the functionality associated with one or more circuits or units may be performed by separate hardware or software components or integrated within shared or separate hardware or software components. For example, any circuit described herein may include electrical circuitry configured to perform features attributed to that particular circuit, such as fixed-function processor circuitry, programmable processor circuitry, or combinations thereof.

[0120] The techniques described in this disclosure can also be implemented or encoded in an article of manufacture including a computer-readable storage medium with encoded instructions. When the instructions included or encoded in the computer-readable storage medium are executed by one or more processors, the instructions implemented or encoded in the article of manufacture including the encoded computer-readable storage medium can cause one or more programmable processors, or other processors, to implement one or more of the techniques described herein. Example computer-readable storage media may include random access memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electronically erasable programmable read-only memory (EEPROM), flash memory, hard disk, optical disk read-only memory (CD-ROM), floppy disk, magnetic tape, magnetic media, optical media, or any other computer-readable storage device or tangible computer-readable medium. The computer-readable storage medium may also be referred to as a storage device.

[0121] In some examples, computer-readable storage media include non-transient media. The term "non-transient" can indicate that the storage medium is not implemented with a carrier wave or a propagated signal. In some examples, non-transient storage media can store data that may change over time (e.g., in RAM or cache).

[0122] This disclosure includes the following non-limiting examples.

[0123] Example 1. A system for determining a neurostimulation therapy, the system comprising: a memory configured to store first information about a patient, wherein the first information is acquired during a baseline period prior to the patient receiving stimulation; and processor circuitry coupled to the memory, the processor circuitry configured to: receive the first information about the patient; receive second information about the patient, wherein the second information is acquired during an initial therapy designation period and includes test data generated by providing stimulation during the implantation process; determine an initial stimulation procedure setting based on the first information, the second information, and group-informed information about other patients; and deliver the therapy based on the initial stimulation procedure setting during a training period.

[0124] Example 2. The system as described in Example 1, wherein the processor circuitry is further configured to: receive third information about the patient, wherein the third information is acquired during the training period, the third information indicating the utility of the initial stimulation program setting; determine a maintenance stimulation program setting based on the third information; and deliver therapy based on the maintenance stimulation program setting during the maintenance period.

[0125] Example 3. A system as described in any combination of Examples 1-2, wherein the first information includes symptom data collected over a predetermined period.

[0126] Example 4. A system as described in any combination of Examples 1-3, wherein the first information includes medical history data.

[0127] Example 5. A system as described in any combination of Examples 1-4, wherein the first information includes population data.

[0128] Example 6. A system as described in any combination of Examples 1-5, wherein the first information includes lifestyle data.

[0129] Example 7. A system as described in any combination of Examples 1-6, wherein the first information includes quality of life data.

[0130] Example 8. A system as described in any combination of Examples 1-7, wherein the first information includes sensor data.

[0131] Example 9. A system as described in any combination of Examples 1-8, wherein the processor circuitry is further configured to determine, based on the first information, whether the patient is a candidate for neural stimulation.

[0132] Example 10. A system as described in any combination of Examples 1-9, wherein the informed information for the group includes data on the treatment of other patients with the same disease or characteristics.

[0133] Example 11. A system as described in any combination of Examples 1-10, wherein the second information includes physiological data.

[0134] Example 12. A system as described in any combination of Examples 1-11, wherein the processor circuitry is further configured to guide the patient through a test of at least one of a stimulation procedure, stimulation parameters, or electrode configuration during the testing period.

[0135] Example 13. A system as described in any combination of Examples 1-12, wherein the system further includes an implantable medical device (IMD) implanted as part of the implantation process, wherein the processor circuitry is configured to provide an initial stimulation program setting to the IMD in order to deliver the therapy based on the initial stimulation program setting.

[0136] Example 14. A system as described in any combination of Examples 1-13, wherein the system further includes an IMD implanted as part of the implantation procedure, wherein the IMD includes processor circuitry configured to determine an initial stimulation procedure setting, and the processor circuitry is further configured to cause the IMD to deliver the therapy based on the initial stimulation procedure setting.

[0137] Example 15. A system as described in any combination of Examples 1-14, wherein the system further includes a server, wherein the server includes processor circuitry configured to determine an initial stimulation procedure setting, and the server is also configured to provide the initial stimulation procedure setting to an IMD implanted as part of the implantation process.

[0138] Example 16. A system as described in any combination of Examples 1-15, wherein the system further includes a computing device, wherein the computing device includes processor circuitry configured to determine an initial stimulation procedure setting, and the computing device is further configured to provide the initial stimulation procedure setting to an IMD implanted as part of the implantation procedure.

[0139] Example 17. A method comprising: receiving first information about a patient, wherein the first information is acquired during a baseline period prior to the patient receiving stimulation; receiving second information about the patient, wherein the second information is acquired during an initial therapy designation period and the second information includes test data generated by providing stimulation during the implantation process; determining an initial stimulation procedure setting based on the first information, the second information, and group informed information about other patients; and delivering therapy based on the initial stimulation procedure setting during a training period.

[0140] Example 18. The method of Example 17 further includes: receiving third information about the patient, wherein the third information is acquired during the training period, the third information indicating the utility of the initial stimulation program setting; determining a maintenance stimulation program setting based on the third information; and delivering therapy based on the maintenance stimulation program setting during the maintenance period.

[0141] Example 19. The method as described in any combination of Examples 17-18, wherein the first information includes symptom data over a predetermined period.

[0142] Example 20. The method described in any combination of Examples 17-19, wherein the first information includes medical history data.

[0143] Example 21. The method as described in any combination of Examples 17-20, wherein the first information includes population data.

[0144] Example 22. The method as described in any combination of Examples 17-21, wherein the first information includes lifestyle data.

[0145] Example 23. The method as described in any combination of Examples 17-22, wherein the first information includes quality of life data.

[0146] Example 24. The method as described in any combination of Examples 17-23, wherein the first information includes sensor data.

[0147] Example 25. The method as described in any combination of Examples 17-24, further comprising determining, based on the first information, whether the patient is a candidate for neural stimulation.

[0148] Example 26. The method as described in any combination of Examples 17-25, wherein the informed information for the group includes data on the treatment of other patients with the same disease or characteristic.

[0149] Example 27. The method as described in any combination of Examples 17-26, wherein the second information includes physiological data.

[0150] Example 28. The method as described in any combination of Examples 17-27, further comprising guiding the patient through a test of at least one of a stimulation procedure, stimulation parameters, or electrode configuration during the testing period.

[0151] Example 29. The method described in any combination of Examples 17-28, further comprising providing an initial stimulus procedure setting to the IMD.

[0152] Example 30. The method as described in any combination of Examples 17-29, wherein the initial stimulation procedure setting is determined by the IMD.

[0153] Example 31. The method as described in any combination of Examples 17-30, wherein the initial stimulus procedure is determined by the server.

[0154] Example 32. The method as described in any combination of Examples 17-31, wherein the initial stimulation procedure setting is determined by a computing device.

[0155] Example 33. A non-transient computer-readable storage medium encoded with instructions that, when executed, cause the processor circuitry of a device to perform the methods described in any combination of Examples 17-32.

[0156] Example 34. An implantable medical device includes: a memory configured to store an initial stimulation program setting, wherein the initial stimulation program setting is determined based on first information, second information, and group-informed information, the first information being information about the patient collected during a baseline period prior to the patient receiving stimulation, the second information being information collected during the initial therapy specification period including test data generated during the delivery of stimulation during the implantation process of the IMD, and the group-informed information being information about other patients; and The processor circuit is configured to enable the stimulation generator to deliver therapy based on the initial stimulation program settings during the training period.

[0157] Various examples have been illustrated herein. Any combination of the illustrated operations or functions is contemplated. These and other examples are within the scope of the claims below. Based on the foregoing discussion and illustrations, it is recognized that different modifications and alterations can be made to the disclosed examples without strictly adhering to the examples and applications shown and illustrated herein. Such modifications do not depart from the true spirit and scope of all aspects of this disclosure, including those set forth in the claims.

Claims

1. A system for determining a neurostimulation therapy, the system comprising: A memory configured to store first information about the patient, wherein the first information was acquired during a baseline period prior to the patient receiving stimulation; as well as A processor circuit coupled to the memory, the processor circuit being configured to: Receive the first information about the patient; Receive second information about the patient, wherein the second information is collected during the initial therapy specification period, and the second information includes test data generated by providing stimulation during the implantation process; The initial stimulus procedure is determined based on the first information, the second information, and group informed information concerning other patients; and Therapy is delivered based on the initial stimulation program settings during the training period.

2. The system as claimed in claim 1, wherein, The processor circuit is also configured to: Receive third information about the patient, wherein the third information is acquired during the training period and indicates the utility set by the initial stimulation program; The maintenance stimulus procedure setting is determined based on the aforementioned third information; as well as Therapy is delivered during the maintenance period based on the maintenance stimulation program settings.

3. The system as described in claim 1, wherein, The first information includes at least one of the following: symptom data, medical history data, population data, lifestyle data, quality of life data, or sensor data collected over a predetermined period.

4. The system as claimed in claim 1, wherein, The processor circuitry is also configured to determine, based on the first information, whether the patient is a candidate for neurostimulation.

5. The system as claimed in claim 1, wherein, The group informed information includes data on the treatment of other patients with the same disease or characteristics.

6. The system as claimed in claim 1, wherein, The second information includes physiological data.

7. The system as claimed in claim 1, wherein, The processor circuitry is also configured to guide the patient through a test of at least one of a stimulation procedure, stimulation parameters, or electrode configuration during the testing period.

8. The system of claim 1, further comprising an implantable medical device (IMD) implanted as part of the implantation process, wherein the processor circuitry is configured to provide an initial stimulation program setting to the IMD in order to deliver the therapy based on the initial stimulation program setting.

9. The system of claim 1, further comprising an IMD implanted as part of the implantation process, wherein the IMD includes processor circuitry configured to determine an initial stimulation program setting, and the processor circuitry is further configured to cause the IMD to deliver the therapy based on the initial stimulation program setting.

10. The system of claim 1, further comprising a server, wherein the server includes processor circuitry configured to determine an initial stimulation procedure setting, and the server is further configured to provide the initial stimulation procedure setting to an IMD implanted as part of the implantation process.

11. The system of claim 1, further comprising a computing device, wherein the computing device includes processor circuitry configured to determine an initial stimulation procedure setting, and the computing device is further configured to provide the initial stimulation procedure setting to an IMD implanted as part of the implantation procedure.

12. A non-transient computer-readable storage medium, the non-transient computer-readable storage medium comprising instructions that cause a processor to perform a method, the method comprising: Receive first information about the patient, wherein the first information is acquired during a baseline period prior to the patient receiving stimulation; Receive second information about the patient, wherein the second information is acquired during the initial therapy specification period, and the second information includes test data generated by providing stimulation during the implantation process; The initial stimulation procedure setting is determined based on the first information, the second information, and group informed information, which is about other patients; as well as Therapy is delivered based on the initial stimulation program settings during the training period.

13. The non-transient computer-readable storage medium of claim 12, wherein the method further comprises: Receive third information about the patient, wherein the third information is acquired during the training period and indicates the utility set by the initial stimulation program; The maintenance stimulus procedure setting is determined based on the aforementioned third information; as well as Therapy is delivered during the maintenance period based on the maintenance stimulation program settings.

14. The non-transient computer-readable storage medium of claim 12, wherein the first information includes at least one of the following: symptom data, medical history data, population data, lifestyle data, quality of life data, or sensor data over a predetermined period.

15. The non-transient computer-readable storage medium of claim 12, the method further comprising determining, based on the first information, whether the patient is a candidate for neural stimulation.

16. The non-transient computer-readable storage medium of claim 12, wherein the group-informed information includes data on the treatment of other patients with the same disease or characteristics.

17. The non-transient computer-readable storage medium of claim 12, wherein the second information includes physiological data.

18. The non-transient computer-readable storage medium of claim 12, the method further comprising guiding the patient through a test of at least one of a stimulation procedure, stimulation parameters, or electrode configuration during the test period.

19. The non-transient computer-readable storage medium of claim 12, the method further comprising providing an initial stimulus program setting to the IMD.

20. The non-transient computer-readable storage medium of claim 12, wherein the initial stimulus program setting is determined by the IMD.

21. The non-transient computer-readable storage medium of claim 12, wherein the initial stimulus program settings are determined by a server.

22. The non-transient computer-readable storage medium of claim 12, wherein the initial stimulus program setting is determined by a computing device.

23. A non-transient computer-readable storage medium, the storage medium being encoded with instructions that, when executed, cause the processor circuitry of a device to: Receive the first information about the patient; Receive second information about the patient, wherein, The second information is collected during the initial therapy period and includes test data generated by providing stimulation during the implantation process; The initial stimulation procedure setting is determined based on the first information, the second information, and group informed information, which is about other patients; as well as Therapy is delivered based on the initial stimulation program settings during the training period.

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