Stimulation evoked signal type determination for stimulation therapy

Abstract

One example method includes determining, for a patient, a characteristic of one or more different signal types received in response to using at least one setting selected from the group of one or more electrical stimulation settings, one or more sensing settings, or a combination thereof. The example method further includes programming the neurostimulation system based on the characteristic, the programming including at least one of: an electrical stimulation setting to deliver subsequent electrical stimulation to the patient to induce at least one of the signal types; or a sensing setting for sensing at least one of the signal types in response to a stimulus of the patient.

Description

[0001] This application claims priority to U.S. Provisional Patent Application 63 / 498,226, filed April 25, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates generally to medical devices, and more specifically to electrical stimulation. Background Technology

[0003] Electrical stimulation devices, sometimes referred to as neurostimulators or neurostimulatory devices, can be external to the patient or implanted within the patient and are configured to deliver electrical stimulation to various tissue sites to treat a wide range of conditions or symptoms, such as chronic pain, tremor, Parkinson's disease, epilepsy or other neurological disorders, bladder dysfunction such as urinary retention, overactive bladder, urgency, frequency, incontinence, bladder incontinence, bowel incontinence, fecal incontinence, sexual dysfunction, obesity, or gastroparesis. Electrical stimulation devices deliver electrical stimulation via electrodes, which are carried, for example, by one or more leads, and are positioned close to target locations associated with nerves in the brain, spinal cord, pelvis and pelvic floor, tibial nerves, peripheral nerves, gastrointestinal tract, or other locations within the patient's body. Stimulation near the spinal cord, near the sacral nerves, within the brain, and near peripheral nerves are commonly referred to as spinal cord stimulation (SCS), sacral nerve modulation (SNM), deep brain stimulation (DBS), and peripheral nerve stimulation (PNS), respectively.

[0004] Physicians or clinicians can select values ​​for multiple programmable stimulation parameters to define the electrical stimulation therapy to be delivered to a patient by an implantable stimulator. For example, a physician or clinician can select one or more electrodes, the polarity of the selected electrodes, the voltage or current amplitude, pulse width, pulse frequency, cycle, and stimulation duration as stimulation parameters. A set of therapeutic stimulation parameters (such as a group including electrode combinations or configurations, electrode polarity, amplitude, pulse width, pulse shape, pulse frequency or pulse rate, cycle or biphasic recharge parameters, or pulse pattern (e.g., masked detection)) can be referred to as a treatment procedure in the sense that they define the electrical stimulation therapy to be delivered to the patient. Summary of the Invention

[0005] Medical devices can sense stimulus-evoked signals and use these signals as feedback to control the delivery of therapeutic electrical stimulation. However, the characteristics (e.g., content) of the stimulus-evoked signals may differ for different patients (e.g., based on patient physiology or lead placement). For example, different types of stimulus-evoked signals exist, and the characteristics of these different signal types can indicate which type will be used to control therapeutic electrical stimulation for different patients. The characteristics of different stimulus-evoked signal types can be attributed to patient characteristics (e.g., some stimulus-evoked signal types are better evoked than others), to lead placement and / or electrode type (e.g., some stimulus-evoked signal types are better sensed than others), or to stimulation parameters (e.g., characteristics can vary with electrode configuration, electrode polarity, stimulus signal amplitude, frequency, pulse width, pulse shape, pulse rate, cyclic or biphasic recharge parameters, or pulse pattern (e.g., masked detection)).

[0006] This disclosure describes example techniques for determining one or more types of sensed stimulus-evoked signals from one or more sensed stimulus-evoked signals evoked by delivery of electrical stimulation (e.g., by scanning a stimulus signal intended to elicit a stimulus-evoked signal). In some examples, the techniques may include characteristics for determining two or more types of sensed stimulus-evoked signals from one or more sensed stimulus-evoked signals evoked by delivery of electrical stimulation. A medical device can then utilize these characteristics to determine a stimulus signal for eliciting a subsequent stimulus-evoked signal or a device configuration for sensing a subsequent stimulus-evoked signal. In this way, the example techniques facilitate a more accurate way of using stimulus-evoked signals to determine parameters for therapeutic electrical stimulation.

[0007] In one example, this disclosure describes a method comprising: determining, for a patient, characteristics of one or more different signal types received in response to at least one setting selected from the group consisting of one or more electrical stimulation settings, one or more sensing settings, or combinations thereof; and programming a neural stimulation system based on the characteristics, the programming comprising at least one of: an electrical stimulation setting for delivering subsequent electrical stimulation to the patient to induce at least one of the signal types; or a sensing setting for sensing at least one of the signal types in response to stimulation by the patient.

[0008] In another example, this disclosure describes a system comprising: at least one electrode configured to deliver the electrical stimulation to a patient; and a device including processing circuitry configured to: determine, for the patient, a characteristic of one or more different signal types received in response to the use of at least two settings selected from one or more electrical stimulation settings, one or more sensing settings, or combinations thereof; and to program a neurostimulation system based on the characteristic, the programming comprising at least one of: an electrical stimulation setting for delivering subsequent electrical stimulation to the patient to induce at least one of the signal types; or a sensing setting for sensing at least one of the signal types in response to stimulation by the patient.

[0009] In another example, this disclosure describes a computer-readable medium including instructions that, when executed, cause one or more processors to: determine, for a patient, a characteristic of receiving one or more different signal types in response to the use of at least two settings selected from one or more electrical stimulation settings, one or more sensing settings, or combinations thereof; and to program a neurostimulation system based on the characteristic, the programming including at least one of: an electrical stimulation setting for delivering subsequent electrical stimulation to the patient to induce at least one of the signal types; or a sensing setting for sensing at least one of the signal types in response to stimulation by the patient.

[0010] This summary is intended to provide an overview of the subject matter described in this disclosure. It is not intended to provide an exclusive or exhaustive explanation of the systems, apparatus, and methods described in detail in the following drawings and specification. Further details of one or more examples of this disclosure are set forth in the following drawings and specification. Other features, objectives, and advantages will be apparent from the specification, drawings, and claims. Attached Figure Description

[0011] Figure 1 The present invention is a conceptual diagram illustrating an example system according to one or more technologies of the present disclosure, the example system comprising an implantable medical device (IMD) in the form of a neurostimulation device configured to deliver sacral nerve modulation (SNM), an external programmer, and one or more sensing devices.

[0012] Figure 2 This is a block diagram illustrating an example of an IMD in the form of a neurostimulation device according to one or more technologies of this disclosure.

[0013] Figure 3 This is a block diagram illustrating an example of an IMD in the form of a neurostimulation device according to one or more technologies of this disclosure.

[0014] Figure 4 This illustrates the suitability of one or more technologies according to this disclosure. Figure 2 or Figure 3 A block diagram of an example of an external programmer used with IMD.

[0015] Figure 5 It is a graph of example stimulus-evoked signals according to one or more techniques of this disclosure.

[0016] Figure 6 This is another example of a stimulus-evoked signal curve according to one or more techniques of this disclosure.

[0017] Figure 7 This is another example of a stimulus-evoked signal curve according to one or more techniques of this disclosure.

[0018] Figure 8 This is another example of a stimulus-evoked signal curve according to one or more techniques of this disclosure.

[0019] Figure 9 It is a graph of an example of a compound stimulus-evoked signal according to one or more techniques of this disclosure.

[0020] Figure 10 It is a graph of the combined stimulus-evoked signal according to one or more other examples of the techniques of this disclosure.

[0021] Figure 11 This is another example of a composite stimulus-evoked signal curve according to one or more techniques of this disclosure.

[0022] Figure 12 This is a flowchart illustrating an example method for delivering controlled electrical stimulation therapy according to one or more techniques of this disclosure.

[0023] Figure 13 This is a flowchart illustrating another example method of delivering controlled electrical stimulation therapy according to one or more techniques of this disclosure.

[0024] Figure 14 This is a flowchart illustrating an example method for delivering controlled electrical stimulation therapy according to one or more techniques of this disclosure.

[0025] Figure 15 This is a flowchart illustrating an example method for delivering controlled electrical stimulation therapy according to one or more techniques of this disclosure.

[0026] Figure 16 It is a series of diagrams of example electrical stimulation pulses based on one or more techniques according to the present disclosure and masked detection techniques.

[0027] Figure 17It is based on one or more technologies of this disclosure. Figure 16 A series of graphs showing the example sensed stimulus-evoked signals generated by the pulse. Detailed Implementation

[0028] Electrical stimulation therapy (e.g., sacral nerve stimulation, tibial nerve stimulation, pudendal nerve stimulation, and / or other types of invasive or non-invasive neuromodulation) can provide treatment for bladder dysfunction, pain relief, and / or other therapeutic benefits. Electrical stimulation can elicit responses (e.g., signals), such as neural responses in one or more nerves and contractions in one or more muscles. For example, stimulation of the sacral nerve via an electrical lead implanted near the sacral nerve (e.g., in the third sacral foramen) may elicit neural responses in adjacent nerves, muscle contractions in the pelvic floor, and distal contractions in the foot. The neural responses in the nerves and the activation / contraction of the muscles evoked by electrical stimulation can be captured (e.g., detected, sensed, measured, etc.) as stimulation-evoked signals, for example, via the implanted electrical lead. In some examples, the captured stimulation-evoked signals can be composite signals generated from multiple signal sources, such as a composite of evoked neural signals from nerves (e.g., evoked compound action potential (ECAP) signals, neural reflex responses, etc.) and electromyographic (EMG) signals from one or more muscles.

[0029] Stimulation-evoked signals may include one or more features that indicate and / or guide one or more aspects of electrical stimulation therapy delivery, such as guided positioning of electrical leads to provide effective treatment, or guided stimulation programming, or providing feedback in a chronic closed-loop electrical stimulation therapy system. However, the challenge lies in the fact that the stimulation parameter settings used to deliver electrical stimulation to evoke the stimulation-evoked signal and the sensing settings used to sense the stimulation-evoked signal may differ for different signal types (e.g., ECAP, EMG). For example, electrode configuration, recharging, blanking, and the techniques used to evoke and sense ECAP signals may differ from those used for EMG signals.

[0030] According to one or more techniques of this disclosure, example electrical stimulation systems and techniques can induce and sense different types of stimulation-evoked signals, and determine the operating mode of the medical device based on the characteristics of the sensed stimulation-evoked signals (including composite stimulation-evoked signals). For example, the electrical stimulation system can be configured to stimulate and sense ECAP signals, or alternatively stimulate and sense EMG signals, or stimulate and sense alternately (e.g., temporally continuous) ECAP signals followed by EMG signals, or stimulate and sense composite ECAP and EMG signals, for example, simultaneously or synchronously stimulating and sensing ECAP and EMG signals.

[0031] As an example, patients without strong EMG signals can be programmed into ECAP mode to focus sensing parameters for optimal ECAP signal sensing. For instance, the characteristics of the stimulation-evoked EMG signal type can indicate that the EMG signal type should not be used to control the therapeutic electrical stimulation signal. Alternatively, patients with both EMG and ECAP signal types can be programmed using an alternating mode to optimally sense both EMG and ECAP signals. For instance, the characteristics of the stimulation-evoked EMG and ECAP signal types can indicate that both EMG and ECAP signal types are used to control the therapeutic electrical stimulation signal.

[0032] The systems and techniques disclosed herein offer numerous advantages. For example, the disclosed systems and techniques can provide improved electrical stimulation therapy by improving the quantity and quality of characteristics that determine one or more aspects indicative of electrical stimulation therapy. This can be accomplished by improving and / or optimizing the sensing of stimulation-evoked signals, which can be tailored to the patient and / or patient-specific factors.

[0033] For example, if a specific lead placement in or within a patient results in relatively good ECAP signal sensing and relatively poor EMG signal sensing (e.g., the patient is a good "ECAP responder"), the system can customize the electrical stimulation delivery parameter settings and / or sensing settings to optimally induce and / or sense the ECAP signal, for example, to improve signal quality and feature recognition. In some examples, the system can use the ECAP signal to customize the electrical stimulation delivery parameter settings for delivering therapeutic electrical stimulation. Conversely, if a specific lead placement in or within a patient results in relatively poor ECAP signal sensing and relatively good EMG signal sensing (e.g., the patient is a good "EMG responder"), the system can customize the electrical stimulation delivery parameter settings and / or sensing settings to optimally induce and / or sense the EMG signal, for example, to improve signal quality and feature recognition. In some examples, the system can use the EMG signal to customize the electrical stimulation delivery parameter settings for delivering therapeutic electrical stimulation.

[0034] In some examples, if a specific lead placement in the patient or within the patient results in relatively good ECAP and EMG signals (e.g., the patient is a good "ECAP responder" and a good "EMG responder"), the system can customize the electrical stimulation delivery parameter settings and / or sensing settings to optimally induce and / or sense ECAP and EMG signals alternately (e.g., continuously) or simultaneously (e.g., to sense composite ECAP / EMG signals), for example, to sense additional and / or different signal types, thereby increasing the number and / or quality of features identified from the signals. In some examples, the system can use ECAP and EMG signals to customize the electrical stimulation delivery parameter settings for delivering therapeutic electrical stimulation.

[0035] There can be various ways to determine whether a patient is an ECAP responder, an EMG responder, or both. As an example, a medical device can be configured to perform calibration. Calibration can be performed at the time of implantation or periodically as the patient's physiological functions may change.

[0036] During calibration, the medical device can scan different stimulation parameters for the stimulation signal intended to elicit a stimulus-evoked signal, and scan different sensing parameters to sense the stimulus-evoked signal. Different stimulation parameters can be different amplitudes, pulse widths, frequencies, and electrode configurations. Furthermore, in some examples, the medical device can sense such a stimulus-evoked signal on different electrode pairs to sense the stimulus-evoked signal. Based on the stimulation parameters used and the sensing from different electrode pairs, the medical device, or possibly some other device, can determine how the electrical stimulation therapy should be “tuned” (e.g., tuning parameters), such as stimulating and sensing both EMG signals, ECAP signals, ECAP signals and EMG signals, or alternating between ECAP signals and EMG signals.

[0037] The medical device can then use stimulation parameters determined during the scan and sensing electrode configuration determined during the scan to deliver subsequent stimulation signals to subsequently evoked stimulation-evoked signals (e.g., based on one or both of EMG and ECAP, where the patient is a responder type). The medical device can use the subsequently evoked stimulation-evoked signals as feedback to control the delivery of therapeutic electrical stimulation.

[0038] In some examples, the stimulus signal used to induce the stimulus-evoking signal may provide therapeutic benefits, but the technology is not limited thereto. In some examples, therapeutic electrical stimulation may induce the stimulus-evoking signal, but the technology is not limited thereto. The medical device may be configured to control therapeutic electrical stimulation using a stimulus-evoking signal induced from the delivery of the stimulus signal intended to induce the stimulus-evoking signal. In some examples, the medical device may be configured to control therapeutic electrical stimulation using a stimulus-evoking signal induced from the delivery of the stimulus signal intended to induce the stimulus-evoking signal and / or a stimulus-evoking signal induced from the delivery of therapeutic electrical stimulation.

[0039] In the examples above, EMG and ECAP are described as examples of stimulus-evoked signal types. However, these example techniques should not be considered limited to EMG and ECAP as stimulus-evoked signal types. Other examples of stimulus-evoked signal types may exist.

[0040] Figure 1This is a conceptual diagram illustrating an example system 10 according to one or more technologies of the present disclosure. The example system includes an implantable medical device (IMD 16) in the form of a neurostimulation device configured to deliver sacral nerve modulation (SNM), an external programmer, and one or more sensing devices. In some examples, system 10 can determine one or more stimulation settings and manage the delivery of neurostimulation to a patient 14, for example, to manage bladder dysfunction such as urinary retention, overactive bladder, urinary urgency, urinary frequency, urinary incontinence, bladder incontinence, bowel incontinence, and fecal incontinence.

[0041] like Figure 1 As illustrated in the example, the treatment system 10 includes an implantable medical device (IMD) 16 (e.g., an example medical device) coupled to leads 18, 20, and 28 and a sensor 22. System 10 also includes an external device 24 configured to communicate with the IMD 16 wirelessly. System 10 further 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 (…). Figure 1 (Not shown) Communicates wirelessly with external device 24 and / or IMD 16, and may be located in the same location as external device 24 or elsewhere, such as in a cloud computing data center. IMD 16 is typically used as a therapeutic device that delivers nerve stimulation (e.g.,) to target tissue sites near, for example, spinal nerves, sacral nerves, pudendal nerves, dorsal genital 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 any of the aforementioned nerve plexuses. Figure 1 (Electrical stimulation in the example). The IMD 16 provides electrical stimulation to the patient 14 by generating a programmable electrical stimulation signal (e.g., in the form of an electrical pulse or electrical signal) and delivering it to a target treatment site near the lead 28 and more specifically near the electrodes 29A to 29D (collectively, “electrodes 29”) positioned near the distal end of the lead 28.

[0042] The IMD 16 can be surgically implanted in any suitable location within the patient 14, such as near the pelvis. In some examples, the IMD 16 can be implanted in a subcutaneous location in the lower abdomen, lower back, or upper hip. The IMD 16 has a biocompatible housing, which may 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, for example, directly or indirectly, via corresponding lead extensions. Electrical conductors disposed 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 (such as electrode 29) to sensing circuitry and stimulation delivery circuitry (e.g., a stimulation generator) within the IMD 16. Figure 1 In 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.

[0043] In some examples, external device 24 may collect user input that identifies an excretion event, perceived fullness, activity, or any other indication of an event associated with the patient. The user input may be in the form of an excretion log analyzed by external device 24, IMD 16, or server 26, or it may be separate user input associated with the corresponding excretion event, leak, or any other event related to the patient. External device 24 may provide this user input to server 26.

[0044] One or more medical leads (e.g., leads 18, 20, and 28) may be connected to the IMD 16 and, via surgical or transdermal tunneling, place one or more electrodes carried by the distal end of the respective lead at desired nerve or muscle sites, such as a site of the previously listed target treatment sites (e.g., tissue sites near spinal nerves (e.g., sacral nerves) or pudendal nerves). For example, lead 28 may be positioned such that electrode 29 delivers electrical stimulation to the spinal nerve, sacral nerve, or pudendal nerve to reduce the contraction frequency and / or magnitude of bladder 12. Additional electrodes of lead 28 and / or electrodes of another lead may also provide additional stimulation to other nerves or tissues. Figure 1 In this configuration, leads 18 and 20 are positioned at a first position and a second position, respectively, close to the outer surface of the wall of the bladder 12. In other examples of the treatment system 10, the IMD 16 may be coupled to more than one lead, which includes electrodes for delivering electrical stimulation to different stimulation sites (e.g., to target different nerves) within the patient 14.

[0045] exist Figure 1In the examples shown, leads 18, 20, and 28 are cylindrical. Electrodes 19, 21, and 29 of leads 18, 20, and 28 may be loop electrodes, segmented electrodes, partially loop electrodes, or any suitable electrode configuration, respectively. Segmented electrodes and partially loop electrodes each extend around the outer 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, segmented electrode 29 of lead 28 may 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 leads 18, 20, and 28 may be at least partially paddle-shaped (e.g., “paddle-shaped” leads) and may include an array of electrodes on a common surface, which may or may not be substantially flat.

[0046] In some examples, one or more of electrodes 19, 21, 29 may be scaphoid 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 scaphoid 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 in patient 14 caused by the delivery of electrical stimulation. The electric field can define the volume of tissue affected when electrodes 19, 21, 29 are activated. The activation field represents neurons in the neural tissue near the activating electrode that will be activated by the electric field.

[0047] The illustrated number and configuration of leads 18, 20, and 28, and the electrodes carried by leads 18, 20, and 28, are merely exemplary. Other configurations of leads and electrodes, such as number and location, are also contemplated. For example, in other implementations, IMD 16 may be coupled to additional leads or lead segments having one or more electrodes located at different locations near the spinal cord or pelvic region of patient 14, and in some examples, IMD 16 may be an electrode; for example, the shell or “canister” of IMD 16 may serve as an electrode (e.g., to deliver “monopolar” stimulation). Additional leads may be used to deliver different stimulation therapies or other electrical stimulation to corresponding stimulation sites within patient 14, or to monitor at least one physiological marker of patient 14.

[0048] In some examples, the IMD 16 delivers electrical stimulation to at least one of the spinal nerves (e.g., the sacral nerve), pudendal nerve, dorsal genital nerve, tibial nerve, saphenous nerve, inferior rectal nerve, or perineal nerve to provide a therapeutic effect that reduces or eliminates a functional disorder such as overactive bladder. The desired therapeutic effect may be an inhibitory physiological response related to the patient's bladder excretion, such as a decrease in the desired level or extent (e.g., percentage) of bladder contraction frequency, a decrease in bladder afferent discharge, or alterations in pelvic floor muscle / nerve responses and / or states (such as the external urethral sphincter (EUS), levator ani nerve, external anal sphincter), etc.

[0049] The stimulation procedure can define various parameters of the stimulation signal and electrode configuration that result in the delivery of a predetermined stimulation intensity to the target nerve or tissue. In some examples, the stimulation procedure defines parameters of 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 signal, the duty cycle of the stimulation, the pulse width of the stimulation, the duty cycle of the stimulation on / off period, biphasic recharge parameters or pulse patterns (e.g., masked detection) and / or the combination of electrodes 29 used to deliver the stimulation and the corresponding polarity of a subset of electrodes 29. These stimulation parameter values ​​(e.g., stimulation parameter settings) can be used together to define the stimulation intensity (also referred to herein as the stimulation intensity level). In some examples, if the stimulation pulses are delivered in the form of a pulse train, the pulse train duty cycle can also contribute to the stimulation intensity. Moreover, regardless of intensity, a particular pulse width and / or pulse rate can be selected from a range suitable for eliciting the desired therapeutic effect after the stimulation is terminated and optionally during stimulation.

[0050] Furthermore, as described herein, the periods during which stimulation is delivered may include on-time and off-time (e.g., pulse duty cycle or pulse train), wherein even short inter-pulse durations when no pulses are delivered are still considered part of stimulation delivery. The periods during which system 10 inhibits stimulation delivery are those during which there is no stimulation procedure activity for IMD 16 (e.g., IMD 16 does not track pulse durations or inter-pulse durations that occur as part of the electrical stimulation delivery scheme). In addition to the stimulation parameters described above, stimulation may also be defined by other characteristics, such as the time of stimulation delivery, the time of stimulation termination, and the time of stimulation inhibition.

[0051] System 10 may also include external devices 24, such as Figure 1As shown. External device 24 can be an example of a computing device. In some examples, external device 24 can be a clinician programmer or a patient programmer, such as the patient programmer 300 described below. In some examples, external device 24 can be a device for inputting patient-related information. In some examples, external device 24 can be a wearable communication device, where treatment request input is integrated into a keychain or wristwatch, handheld computing device, smartphone, computer workstation, or networked computing device. 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. The keypad may take the form of an alphanumeric keypad associated with a specific function or a reduced set of keys. External device 24 may additionally or alternatively include a peripheral pointing device, such as a mouse, through which the user can interact with the user interface. In some examples, the display of external device 24 may include a touchscreen display, through which the user can interact with external device 24. It should be noted that users can also interact remotely with external devices 24, server 26 and / or IMD 16 via networked computing devices.

[0052] Users such as device manufacturer representatives (e.g., sales representatives, technical experts, etc.), 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. This user may interact with external device 24 to retrieve physiological or diagnostic information from IMD 16. The user may also interact with external device 24 to program IMD 16, for example, selecting settings (e.g., alternatively referred to as values) of stimulation parameter settings (or values) used by IMD 16 to generate and deliver stimuli, and / or other operational parameters of IMD 16 (such as the magnitude of stimulation energy, the user-requested stimulation period or the period of preventing stimulation, or any other such user-customized treatment). In some examples, stimulation parameter settings may be suggested by system 10, such as by IMD 16, and the user may be able to accept or reject the stimulation parameter settings. In other examples, stimulation parameter settings may be set by system 10, such as by IMD 16. As discussed herein, the user may also provide input to the external device 24 indicating physiological events such as bladder fullness level perception and excretion events.

[0053] In some examples, healthcare providers may utilize sensor 15 (such as wearable sensors or existing implanted sensors) to collect patient data related to sleep, activity, or disease symptoms. For example, sensor 15 may be a heart rate sensor or monitor, blood pressure and / or blood flow sensors, as well as EMG sensors, skin conductance sensors, accelerometers, environmental sensors, such as microphones, thermometers, hygrometers, pedometers, GPS sensors, and / or other sensors used to collect patient data (e.g., data about disease symptoms or lifestyle).

[0054] In some examples, the user can use external device 24 to retrieve information from IMD 16 related to the contraction frequency and / or excretion events of bladder 12. As another example, the 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, if a systemic condition that could affect therapeutic efficacy is detected, this information can be presented to the user as an alert.

[0055] 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 patient-related information, such as demographic information, medical history, lifestyle information, bladder events, treatment level satisfaction, or sensor data.

[0056] Patient 14 can, for example, use the keypad or touchscreen of external device 24 to request IMD 16 to deliver or terminate electrical stimulation, such as when patient 14 senses that a leakage event may be imminent or when an upcoming urination could benefit from terminating treatment to promote urinary retention. Thus, patient 14 can use external device 24 “on demand” (e.g., when patient 14 deems a second stimulation treatment necessary) to make treatment requests to control the delivery of electrical stimulation. This request can be a treatment trigger 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 menstrual cycle, such as the occurrence of a urination event.

[0057] 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... However, other technologies are also conceivable. In some examples, the external device 24 may include a programming lead that can be placed close to the patient's body near the IMD 16 implantation site to improve the quality or security of communication between the IMD 16 and the external device 24.

[0058] In response to a command from external device 24, IMD 16 can deliver electrical stimulation therapy to the target tissue site of patient 14 via any of electrodes 29A to 29D, 19A to 19B, and 21A to 21B according to one or more stimulation programs. In some examples, IMD 16 automatically modifies the treatment stimulation program as the treatment needs of patient 14 evolve over time. For example, modification of the treatment stimulation program can cause adjustment of at least one parameter of multiple stimulation pulses based on received information.

[0059] 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 and physiological markers of bladder contractions in patient 14. In some examples, EMG can also be used to detect the intensity of bladder contractions. As an alternative to or supplement to EMG, strain gauges or other devices can be used, for example, to detect the state of bladder 12 by sensing the force indicating bladder contractions.

[0060] exist Figure 1 In 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 (e.g., afferent and / or efferent), electrodes for sensing urethral sphincter EMG signals (or anal sphincter EMG signals in examples where system 10 provides treatment to manage fecal urgency or fecal incontinence), 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 it may be carried on leads 18, 20, or 28 or on additional leads 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. In some examples, IMD 16 may control the timing of delivering electrical stimulation based on input received from sensor 22.

[0061] In some examples, the IMD 16 and / or external device 24 may be configured to control one or more electrical stimulation parameters based on stimulation-evoked signals and / or compound stimulation-evoked signals. For example, the IMD 16 and / or external device 24 may be configured to control treatment parameters, such as stimulation amplitude, frequency, pulse width, and cycles, based on sensed stimulation-evoked signals. In some examples, the IMD 16 and / or external device 24 may be configured to provide feedback to the user and / or clinician, for example, via a display screen, and the user and / or clinician may adjust treatment parameters, lead placement and / or positioning, and timing of treatment delivery. In some examples, the IMD 16 and / or external device 24 may be configured to bypass changes to the treatment, for example, based on determining that the treatment is effective (e.g., based on compound stimulation-evoked signals).

[0062] In some examples, one or more stimulus-evoked signal sources (or simply signal sources) (such as one or more nerves, one or more muscles, or at least one muscle and at least one nerve) may respond to electrical stimulation, for example, via a neural response, muscle contraction and / or activation, or any other response. In some examples, the response of one or more sources may be electrical, such as ECAP, EMG, or surface EMG. In some examples, the response may be mechanical and converted into an electrical signal by a sensor or detector (e.g., by a piezoresistive sensor or other sensors configured to measure muscle contraction and myocardiography (MMG), etc. In some examples, nerves may include any sacral nerve, such as the dorsal and ventral branches of the sacral nerves, the pudendal nerve, the sciatic nerve, the tibial nerve, the saphenous nerve, nerves in the sacral plexus, pelvic nerves, pelvic plexus nerves, pelvic visceral nerves, the hypogastric plexus, the lumbosacral trunk (e.g., where the lumbosacral trunk connects to the sacral nerves), or any sympathetic nerve fiber in the sympathetic chain of any of the aforementioned nerves or other nerves. In some examples, one or more muscles may include the external anal sphincter, coccygeus, levator ani muscle group, bulbospongiosus and / or bulbospongiosus muscles, gluteal muscles (e.g., gluteus maximus, gluteus medius and gluteus minimus), perineum, ischiocavernosus, puborectalis, piriformis or any other muscle.

[0063] In some examples, the composite stimulus-evoked signal sensed by one or more sensors and / or electrodes can be any and / or a combination of various signal sources. For example, an electrical stimulation signal may elicit a response in nerves and / or muscles near the stimulation signal, and other nerves or muscles not necessarily near the stimulation signal may also elicit a response. The composite stimulus-evoked signal can be a combination of signals from any of a plurality of signal sources. In some examples, the composite stimulus-evoked signal may include one or more different stimulus-evoked signal types (e.g., ECAP and EMG are examples of stimulus-evoked signal types). For example, the composite stimulus-evoked signal may include EMG signals from two different sources (a combination of signals of the same type). In other examples, the composite stimulus-evoked signal may include two or more different stimulus-evoked signal types, such as EMG signals and ECAP signals.

[0064] One or more sensors and / or electrodes (such as sensor 15, sensor 22, and / or electrodes 19, 21, and 29) may receive and / or sense signals from two or more signal sources. In some examples, the received signals may be composite; for example, sensor 15, sensor 22, and / or electrodes 19, 21, and 29 may simultaneously receive and / or sense signals from one or more signal sources as a single composite stimulus-evoked signal over a period of time. For example, two or more signals may simultaneously “arrive” at a sensor (or multiple sensors or electrodes) and may be added together to form the sensed composite signal. For example, the two or more signals may be electrical signals that may be added incoherently, coherently, constructively, destructively, etc., to form the sensed electrical signal. In other examples, two or more signals may be sensed individually, and then these signals may be added and / or combined to form a composite stimulus-evoked signal. For example, electrode 29 may sense an electric field caused by neural activity of a nerve, and sensor 15 may sense an EMG signal caused by muscle contraction, both in response to delivered electrical stimulation. The IMD16 and / or external device 24 can receive each stimulus-evoked signal from two or more sources and then combine these signals to form a composite stimulus-evoked signal.

[0065] In some examples, two or more signal sources may be positioned relatively far from the sensors / electrodes (e.g., sensors 15, 22, and / or electrodes 19, 21, and 29) and / or relatively far from each other, for example, at least 1 mm away from the sensors and / or electrodes and / or each other, at least 10 mm away from the sensors and / or electrodes and / or each other, at least 100 mm away from the sensors and / or electrodes and / or each other, at least 200 mm away from the sensors and / or electrodes and / or each other, or at least 1 meter away from the sensors and / or electrodes and / or each other. For example, two or more signal sources may include the tibial nerve that responds to sacral nerve stimulation.

[0066] In some examples, the compound stimulus-evoked signal can have a relatively long duration, such as greater than 1 millisecond (ms), greater than 5 ms, greater than 10 ms, greater than 20 ms, etc. For example, because the compound stimulus-evoked signal can originate from multiple signal sources located at distances from one or more of the sensor and / or electrodes, and because different signal sources can have different response times, signals from the signal sources can arrive at and be captured by the sensor and / or electrodes at different times. In some examples, the sensor and / or electrodes can sense the signal from the signal source after the delivery of each electrical stimulation signal, or the sensor and / or electrodes can sense the signal from the signal source a certain amount of time after the delivery of the electrical stimulation signal.

[0067] As described above, in some examples, a composite stimulus-evoked signal may include signals of different signal types from different signal sources. For example, a composite stimulus-evoked signal may include an ECAP signal generated relatively rapidly (e.g., within approximately 10 ms) after the delivery of the electrical stimulation signal, and an EMG signal generated relatively slowly (e.g., after approximately 1 ms) after the delivery of the electrical stimulation signal. In some examples, a composite stimulus-evoked signal may include signals from multiple signal sources that do not overlap in time. For example, a composite stimulus-evoked signal may include an ECAP signal from a signal source relatively close to the sensor and / or electrode, followed by an EMG signal or another ECAP signal from a different signal source that may be relatively far from the sensor and / or electrode, for example, such that the ECAP from the nearby signal source is no longer present, while the EMG signal and / or ECAP from the more distant signal source are received by the sensor and / or electrode.

[0068] According to one or more aspects of this disclosure, electrodes 19, 21, and 29 and / or sensor 15 may be configured to sense one or more different types of stimulus-evoked signals received in response to at least two settings selected from electrical stimulation settings, sensing settings, or combinations thereof, and IMD 16 and / or external device 24 may be configured to capture such one or more different types of stimulus-evoked signals. In some examples, electrodes 19, 21, and 29 and / or sensor 15 may be configured to sense two or more different types of stimulus-evoked signals received in response to at least two settings selected from electrical stimulation settings, sensing settings, or combinations thereof, and IMD 16 and / or external device 24 may be configured to capture such two or more different types of stimulus-evoked signals. For example, electrodes 19, 21, and 29 and / or sensor 15 may be configured to sense an ECAP signal generated (or evoked) by a first stimulation-evoked signal source, an EMG signal generated (or evoked) by a second stimulation-evoked signal source different from the first signal source, an EMG signal from a second source following an ECAP signal from the first source, or a composite ECAP and EMG stimulation-evoked signal comprising a composite of ECAP and EMG signals generated by two or more signal sources, for example, in response to one or more electrical stimulation signals. In some examples, IMD 16 and / or external device 24 may be configured to control the delivery of electrical stimulation signals and / or treatment based on the composite stimulation-evoked signal. For example, IMD 16 and / or external device 24 may be configured to cause one or more electrodes 19, 21, and 29 to deliver one or more electrical stimulation signals to patient 14. In some examples, IMD 16 and / or external device 24 may cause one or more electrodes 19, 21, and 29 to deliver one or more electrical stimulation signals having non-isopulse amplitude, non-isopulse duration, and / or non-isopulse frequency. In some examples, the IMD16 and / or external device may be configured to deliver one or more electrical stimulation signals to the sacral nerve (e.g., for SNM treatment), the brain (e.g., for DBS treatment), peripheral nerves (e.g., for PNS and / or PNFS), saphenous nerve, tibial nerve, pudendal nerve, sciatic nerve, or any other suitable nerve, muscle, and / or tissue of the patient 14.

[0069] Stimulation-evoked signals can be used to control electrical stimulation therapy. For example, stimulation-evoked signals can indicate the efficacy of electrical stimulation therapy and can provide feedback based on which the electrical stimulation settings can be verified and / or modified. As described herein, stimulation-evoked signals can be of different types, for example, derived from different signal sources, such as neural sources for ECAP and muscle sources for EMG, and can be a combination of several different stimulation-evoked signal types. For some patients, the content of the stimulation-evoked signals and / or the type of signals evoked by electrical stimulation can vary, for example, based on patient characteristics, environment and / or patient posture characteristics, lead placement, etc.

[0070] In some examples, the systems and techniques disclosed herein can determine which stimulus-evoked signal types may be most suitable or most effective for eliciting and sensing, for example, for a particular patient. For example, stimulus-evoked signal types may be, but are not limited to, ECAP signal types (typically faster signals with lower delay and smaller amplitude) and EMG signal types (typically slower signals with higher delay and larger amplitude), composite signal types including both ECAP and EMG signals (which may be sequential (temporally separate) or simultaneous (temporally at least partially overlapping)), non-ECAP signal types (e.g., lack of an ECAP signal, such as when an ECAP signal would normally be expected to be evoked), or non-EMG signal types (e.g., lack of an EMG signal, such as when an EMG signal would normally be expected to be evoked). Due to patient characteristics, lead placement, environmental characteristics, etc., patients may preferentially elicit some signal types, or some signal types may be more easily sensed than others.

[0071] To determine a patient's response, electrical stimulation may be provided with stimulation and sensing settings optimized to generate and sense a specific type of stimulus-evoked signal. The subsequently sensed stimulus-evoked signal may include the specific stimulus-evoked signal type, or alternatively or additionally, other stimulus-evoked signal types. In some examples, this may optionally be repeated for other signal types; for example, electrical stimulation may be provided with stimulation and sensing settings optimized to generate different specific stimulus-evoked signal types, and the resulting stimulus-evoked signals may be subsequently sensed. Based on the subsequently sensed stimulus-evoked signals, characteristics of two or more sensed stimulus-evoked signal types can be determined, and based on these characteristics, the stimulation and sensing settings for delivering therapeutic electrical stimulation can be determined.

[0072] According to one or more aspects of this disclosure, the systems and techniques disclosed herein can enable the control, improvement, and / or optimization of electrical stimulation based on the content and / or type of stimulus-evoked signals. In some examples, the systems and techniques disclosed herein can enable the improvement and / or optimization of electrical stimulation for a specific patient, for example, based on the specific stimulus-evoked signals of the patient. In some examples, IMD 16 and / or external device 24 can be configured to determine and control the delivery of electrical stimulation according to operating modes (e.g., operating modes of one or more sensors and / or electrodes (such as sensor 15, sensor 22, and / or electrodes 19, 21, and 29)).

[0073] In some examples, the IMD 16 and / or external device 24 can be configured to determine an operating mode and control the delivery of electrical stimulation according to the operating mode based on the stimulation-evoked signal, and the operating mode can be customized for a specific patient and / or patient-specific stimulation therapy parameters (e.g., lead placement, environment, etc.). For example, if electrical stimulation does not evoke a strong EMG signal from the patient, the IMD 16 and / or external device 24 can be configured to operate in an ECAP mode, in which the electrical stimulation settings and sensing settings can be optimized for evoking and sensing an ECAP signal. Conversely, if electrical stimulation does not evoke a strong ECAP signal from the patient, the IMD 16 and / or external device 24 can be configured to operate in an EMG mode, in which the electrical stimulation settings and sensing settings can be optimized for evoking and sensing an EMG signal. In some examples, if electrical stimulation induces strong ECAP and EMG signals from the patient, the IMD 16 and / or external device 24 can be configured to operate in an alternating mode or a simultaneous mode, in which the electrical stimulation settings and sensing settings are optimized for inducing and sensing ECAP signals, followed by EMG signals, and in the simultaneous mode, the electrical stimulation settings and sensing settings are optimized for inducing and sensing composite ECAP and EMG signals.

[0074] In some examples, IMD 16 and / or external device 24 can be configured to perform (or run) calibration sequences and determine which mode is best suited for a particular patient. For example, IMD 16 and / or external device 24 can perform calibration sequences in response to a physician calibration request, a patient calibration request, or IMD 16 and / or external device 24 can determine that calibration or calibration update is required. For calibration, IMD 16 and / or external device 24 can scan (e.g., electrodes 19, 21, and / or 29) electrode configurations, evaluate the capture of ECAP, EMG, and / or combined ECAP / EMG stimulation-evoked signals, determine operating modes based on the captured stimulation-evoked signals and / or one or more characteristics of the captured stimulation-evoked signals, and store the stimulation-evoked signals and / or determined stimulation-evoked signal characteristics (e.g., for multiple pulse widths).

[0075] In some examples, the IMD 16 and / or external device 24 can be configured to automatically or on-demand update or recalibrate the calibration. For example, the IMD 16 and / or external device 24 can be configured to record stimulus-evoked signals and / or signal characteristics in a previously selected configuration and / or operating mode, and to compare the newly recorded (or captured) stimulus-evoked signals and / or signal characteristics with the previously recorded (or captured) stimulus-evoked signals and / or signal characteristics. If the new stimulus-evoked signals and / or signal characteristics are within acceptable limits, the IMD 16 and / or external device 24 can be configured to keep the electrical stimulation settings and sensing settings unchanged. If the new stimulus-evoked signals and / or signal characteristics are outside acceptable limits (e.g., indicating a change in the received signal), the IMD 16 and / or external device 24 can be configured to recalibrate and determine new electrical stimulation settings and / or sensing parameter settings and / or a new operating mode.

[0076] In some examples, the IMD 16 and / or external device 24 may be configured to determine characteristics of two or more sensed stimulus-evoked signal types (e.g., ECAP, EMG) from one or more sensed stimulus-evoked signals evoked by the delivery of electrical stimulation (e.g., a single stimulus-evoked signal of a specific stimulus-evoked signal type, consecutive stimulus-evoked signals of different stimulus-evoked signal types, or one or more composite stimulus-evoked signals including multiple different stimulus-evoked signal types) for the patient. The IMD 16 and / or external device 24 may be configured to determine, based on these characteristics, at least one of an electrical stimulation setup for delivering subsequent electrical stimulation to the patient to evoke one or more subsequent stimulus-evoked signals, or a sensing setup for sensing one or more subsequent stimulus-evoked signals from the patient. The IMD 16 and / or external device 24 may be configured to deliver subsequent electrical stimulation to the patient according to the determined electrical stimulation setup to evoke one or more subsequent stimulus-evoked signals from the patient. Additionally or alternatively, the IMD 16 and / or external device 24 may be configured to sense one or more subsequent stimulation evoked signals from the patient in response to subsequent electrical stimulation, according to determined sensing settings.

[0077] In some examples, IMD 16 and / or external device 24 may be configured to determine one or more characteristics of sensed stimulus evoked signals, (e.g., alternating stimulus evoked signal type) alternating stimulus evoked signals and / or compound stimulus evoked signals. For example, IMD 16 and / or external device 24 may be configured to determine signal peaks, signal peak amplitudes, the number of signal peaks, the area below the signal peaks, the width of the signal peaks, the time between signal peaks, the ratio of signal peak amplitudes, the ratio of signal peak widths, the ratio of the area below the signal peaks, the delay of the signal peaks, signal valleys, signal valley amplitudes, the number of signal valleys, the area above the signal valleys, the width of the signal valleys, the time between signal valleys, the ratio of signal valley amplitudes, the ratio of signal valley widths, the ratio of the area above the signal valleys, valley delay, root mean square signal value, signal skew, signal kurtosis, signal frequency, signal spectral content, Hjorth feature, signal amplitude growth curve threshold, signal amplitude growth curve inflection point amplitude, signal amplitude growth curve inflection point delay, signal amplitude growth curve saturation point, signal strength duration curve time value, signal strength duration curve base strength or another signal strength duration curve feature, signal maximum rate of change feature (e.g., the maximum value of the derivative of the signal) or signal minimum rate of change feature (e.g., the minimum value of the derivative of the signal) or any other suitable signal feature. In some examples, the IMD 16 and / or external device 24 may be configured to determine the amplitude of one or more peaks of a composite stimulus-evoked signal greater than 1 millivolt (mV), or greater than 0.1 mV, or greater than 0.01 mV. Additionally, the signal can be measured at multiple amplitudes, and a growth curve having one of the aforementioned characteristics can be used to estimate the signal's growth rate, or neural threshold, or EMG threshold or inflection point.

[0078] although Figure 1The examples involve the management of bladder dysfunction, but in other examples, System 10 can also be configured to treat other conditions that may benefit from neurostimulation therapy. For example, System 10 can be used to treat urinary retention, overactive bladder, urgency, frequency, urinary incontinence, bladder incontinence, stress urinary incontinence, nocturia, fecal incontinence, sexual dysfunction, obesity, gastroparesis, intractable constipation, pelvic pain, chronic pain, irritable bowel syndrome, inflammatory bowel disease, interstitial cystitis, neurogenic bowel / bladder, neurological disorders such as tremor, Parkinson's disease, epilepsy, multiple sclerosis, stroke, spinal cord injury, neuropathy, etc., or mental illnesses such as depression, mania, obsessive-compulsive disorder, or anxiety. Therefore, in some examples, system 10 may be configured to deliver sacral nerve modulation (SNM), sacral nerve stimulation (SNS), deep brain stimulation (DBS), peripheral nerve stimulation (PNS), or other stimulations such as peripheral nerve field stimulation (PNFS), cortical stimulation (CS), gastrointestinal stimulation, or any other stimulation therapy capable of treating the condition of patient 14. In some examples, where the electrical stimulation includes stimulation parameters for delivering therapy, system 10 may be configured to address one or more of the following conditions: painful diabetic neuropathy (PDN), peripheral vascular disease (PVD), peripheral artery disease (PAD), complex regional pain syndrome (CRPS), angina pectoris (AP), leg pain, back pain, or pelvic pain.

[0079] Figure 2 and Figure 3 This is a block diagram illustrating an example configuration of components of IMD 200A and IMD 200B according to one or more technologies of this disclosure. IMD 200A and / or IMD 200B may be Figure 1 An example of IMD 16. In Figure 2 and Figure 3 In the example shown, IMD 200A and IMD 200B each include a stimulus generation circuit 202, a switching circuit 204, a sensing circuit 206, a telemetry circuit 208, a sensor 222, a power supply 224, and a lead 230A carrying an electrode 232A (which may correspond to...). Figure 1 (one of leads 18, 20, 28 and electrodes 19, 21, 29) and lead 230B carrying electrode 232B (which may correspond to Figure 1 (One of leads 18, 20, 28 and electrodes 19, 21, 29). In Figure 2 In the example shown, IMD 200A includes processing circuitry 210A and storage device 212A, and... Figure 3In the example shown, IMD 200B includes processing circuitry 210B and storage device 212B. Processing circuitry 210A and / or 210B may include one or more processors configured to perform various operations of IMD 200A and / or IMD 200B.

[0080] exist Figure 2 and Figure 3 In the example shown, storage devices 212A and 212B store stimulus parameter settings 242. Additionally, as... Figure 2 As shown, storage device 212A can store data from one or more electrodes 232 and / or sensors 222, or electrodes 19, 21, 29 and / or sensors 15, 22 (…). Figure 1 ) Stimulus-evoked signal data obtained directly or indirectly 254. In this case, Figure 2 The IMD200A can process stimulus-evoked signal data 254 and select or adjust stimulus parameter settings 242 based on the stimulus-evoked signal data 254.

[0081] Stimulus-evoked signal data 254 may include signals sensed from one or more signal sources (e.g., which may be stimulus-evoked and referred to as stimulus-evoked signals) and / or sensed composite stimulus-evoked signals, such as those described herein. In some examples, stimulus-evoked signal data 254 may include raw sensed signals from sensor 222 and / or signals amplified, filtered, and / or analog-to-digital converted, for example, via sensing circuitry 206. For example, stimulus-evoked signal data 254 may include time-varying signals indicating one or more responses of one or more signal sources (e.g., nerves and / or muscles) to electrical stimulation, such as those referenced below. Figures 5 to 9 As shown and described. In some examples, stimulus-evoked signal data 254 may include an average signal and / or one or more signal characteristics determined via signal processing, such as peak / valley detection, peak / valley amplitude, width and / or area, frequency analysis, digital signal processing, signal delay, etc. In some examples, stimulus-evoked signal data 254 may include additional information, such as sensor 222 settings during the sensing of the stimulus-evoked signal; a timestamp indicating the date and / or time of sensing one or more stimulus-evoked signals; patient information including the current physiological state of patient 14; physiological measurements of patient 14 at or near the time of sensing one or more stimulus-evoked signals, such as heart rate, body temperature, blood pressure, patient activity, movement and / or posture (e.g., patient input and / or measurements, such as from, for example, a patient's smartphone, wearable device, external device 24 or 300 or other devices); or patient input, such as excretion and / or excretion frequency, pain level and / or pain score; patient medical history; patient age or other demographic information; or any other suitable patient input information.

[0082] In one or more examples, such as Figure 3 As shown, the IMD 200B may not store or receive stimulus-evoked signal data 254. Instead, an external device 24 or another device may directly or indirectly select or adjust stimulus parameter settings based on the stimulus-evoked signal data 254, and transmit the selected settings or adjustments to... Figure 3 IMD 200B.

[0083] In some examples, stimulation parameter settings 242 may include electrical stimulation parameter settings (sometimes referred to as "therapeutic stimulation parameter sets") and / or sensing settings. In some examples, stimulation parameter settings 242 may include settings for different stimulation procedures that can be selected by a clinician or patient for treatment, or for automatically determining stimulation procedures and / or operating modes. In some examples, stimulation parameter settings 242 may include one or more recommended parameter settings. In this way, each stored therapeutic stimulation procedure or stimulation parameter set of stimulation parameter settings 242 defines a set of values ​​for electrical stimulation parameters (e.g., stimulation parameter sets), such as electrode combinations (selected electrodes and polarity), stimulation current or voltage amplitude, stimulation pulse width, and pulse frequency.

[0084] The stimulation generation circuit 202 includes an electrical stimulation circuit configured to generate electrical stimulation and generate electrical stimulation pulses selected to alleviate symptoms of one or more diseases, disorders, or syndromes. Although stimulation pulses are described, the stimulation signal may take other forms, such as continuous-time signals (e.g., sine waves). The electrical stimulation circuit may reside in an implantable housing, such as an IMD. Each of the leads 230A, 230B may include any number of electrodes 232A, 232B. The electrodes are configured to deliver electrical stimulation to the patient. Figure 2 and Figure 3In some examples, each group of electrodes 232A, 232B includes eight electrodes A through H. In some examples, the electrodes are arranged in a monopolar combination. In some examples, the electrodes are arranged in a bipolar combination and / or a tripolar combination. A bipolar or tripolar electrode combination may use electrodes carried by the same leads 230A, 230B or different leads. For example, electrode A of electrode 232A may be a cathode, and electrode B of electrode 232A may be an anode, thereby forming a bipolar combination. Switching circuit 204 may include: one or more switch arrays, one or more multiplexers, one or more switches (e.g., a switch matrix or other set of switches), or other circuitry configured to direct stimulation signals from stimulation generation circuit 202 to one or more electrodes of electrodes 232A, 232B or to direct directional sensing signals from one or more electrodes of electrodes 232A, 232B to sensing circuit 206. In some examples, each of the electrodes 232A, 232B may be associated with a corresponding current source and absorption circuitry to selectively and independently configure the electrode as a cathode or anode. The stimulation generation circuitry 202 and / or the sensing circuitry 206 may also include sensing circuitry to guide electrical signals sensed at one or more of the electrodes 232A, 232B.

[0085] Sensing circuit 206 can be configured to monitor signals from any combination of electrodes 232A, 232B and / or sensor 222. In some examples, sensing circuit 206 includes one or more amplifiers, filters, averagers, and analog-to-digital converters. Sensing circuit 206 can be used to sense stimulus-evoked and / or physiological signals, such as ECAP signals, EMG signals, etc. In some examples, sensing circuit 206 detects ECAP and / or EMG signals from a specific combination of electrodes 232A, 232B. In some cases, the specific combination of electrodes used to sense ECAP and / or EMG signals includes electrodes different from the set of electrodes 232A, 232B used to deliver stimulation pulses. Alternatively, in other cases, the specific combination of electrodes used to sense ECAP and / or EMG signals includes at least one electrode from the same set of electrodes used to deliver stimulation pulses to patient 14. Sensing circuit 206 can provide signals to analog-to-digital converters for conversion into digital signals for processing, analysis, storage, feature extraction, classification, and / or output by processing circuit 210. In some examples, sensing circuit 206 can sense and / or detect stimulus-evoked signals and / or compound stimulus-evoked signals, which include one or more of the following: ECAP, EMG or surface EMG, MMG, network excitability, and / or multiple signals of different signal types evoked by one or more signal sources such as sacral nerves (e.g., dorsal and ventral branches of the sacral nerves), pudendal nerve, sciatic nerve, tibial nerve, saphenous nerve, nerves in the sacral plexus, pelvic nerves, pelvic plexus nerves, pelvic visceral nerves, hypogastric plexus nerves, lumbosacral trunk nerves (e.g., the lumbosacral trunk connecting to the sacral nerves), any sympathetic nerve fiber in the sympathetic chain of any of the above nerves or other nerves, muscles (such as the external anal sphincter, coccygeus muscle, levator ani muscle group, bulbospongiosus muscle and / or bulbospongiosus muscle), gluteal muscles (e.g., gluteus maximus, gluteus medius and gluteus minimus), perineal muscles, ischiocavernosus muscle, puborectalis muscle, piriformis muscle, or any other muscle.

[0086] Sensor 222 may be configured to sense one or more physiological responses of a patient (e.g., patient 14). In some examples, sensor 222 may be referenced above. Figure 1 The described sensors 15 and 22 are substantially the same. In some examples, sensor 222 may be located at one or more other locations on the patient 14, at or near one or more muscles and / or nerves, or at other locations on the patient 14 that may be relatively far from the signal source (e.g., nerves or muscles).

[0087] Telemetry circuit 208, under the control of processing circuit 210, supports wireless communication between IMD 200A and / or IMD 200B and an external programmer or another computing device. As updates to the program, processing circuits 210A and / or 210B of IMD 200A and / or IMD 200B can receive values ​​of various stimulation parameters (such as amplitude and electrode combinations) from the external programmer via telemetry circuit 208. Processing circuits 210A and / or 210B of IMD 200A and / or IMD 200B can store updates to stimulation parameter settings 242 or any other data in storage device 212. Telemetry circuit 208 in IMD 200A and / or IMD 200B, as well as telemetry circuits in other devices and systems described herein (such as external programmers and patient feedback sensing systems), can communicate via radio frequency (RF) communication technology. Additionally, the telemetry circuit 208 can communicate with the external medical device programmer via IMD 200A and / or IMD 200B through proximal sensor interaction, wherein the external programmer can be... Figure 1 An example of external device 24. Thus, telemetry circuit 208 can continuously, periodically, or upon request from IMD 16 and / or external device 24 to send information to an external programmer.

[0088] Processing circuits 210A and / or 210B may include one or more processors, such as one or more of the following: microprocessor, controller, digital signal processor (DSP), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), discrete logic circuit, or any other processing circuit configured to provide functionality attributable to processing circuits 210A and / or 210B as may be embodied herein as firmware, hardware, software, or any combination thereof. Processing circuits 210A and / or 210B control stimulus generation circuit 202 to generate stimulus signals according to stimulus parameter settings 242. In some examples, processing circuits 210A and / or 210B may respectively execute additional instructions stored in storage devices 212A and / or 212B to apply stimulus parameters specified by one or more programs, such as electrode combination or configuration, electrode polarity, amplitude, pulse width, pulse shape, pulse frequency or pulse rate, cyclic or biphasic recharge parameters, or the pulse pattern (e.g., masked detection) of each of these stimulus signals.

[0089] exist Figure 2In the example shown, processing circuitry 210A includes signal unit 216 for processing stimulus-evoked signals and / or complex stimulus-evoked signals. Signal unit 216 may represent an example of a portion of processing circuitry configured to process stimulus-evoked signals and / or complex stimulus-evoked signals received from sensors (such as sensor 222 and / or sensors 15, 22) and / or patient input devices (such as external device 24) or patient devices (such as the patient's telephone and / or computing device). Figure 3 In the example, the processing of stimulus-evoked signals and / or compound stimulus-evoked signals occurs in a device other than the IMD 200B.

[0090] Refer again Figure 2 As discussed further below, signal unit 216 receives information about stimulus-evoked signals and / or compound stimulus-evoked signals, such as information about sensed and / or received stimulus-evoked signals and / or compound stimulus-evoked signals associated with the efficacy of electrical stimulation therapy, and controls electrical stimulation circuit 202 to deliver electrical stimulation to the patient based on the received stimulus-evoked signals and / or compound stimulus-evoked signals, wherein indications of the received stimulus-evoked signals and / or compound stimulus-evoked signals can be stored in a storage device. Processing circuits 210A and / or 210B also control stimulation generation circuit 202 to generate stimulation signals and apply them to selected combinations of electrodes 232A, 232B.

[0091] In some examples, the stimulation generation circuit 202 includes a switching circuit (alternative to or supplementing the switching circuit 204) that couples a stimulation signal to a selected conductor within lead 230, which then delivers the stimulation signal across selected electrodes 232A, 232B. This switching circuit selectively couples stimulation energy to selected electrodes 232A, 232B and selectively senses bioelectrical signals of the patient's sacral nerve or muscles using the selected electrodes 232A, 232B. However, in other examples, the stimulation generation circuit 202 does not include a switching circuit, and the switching circuit 204 is not interposed between the stimulation generation circuit 202 and electrodes 232A, 232B. In these examples, the stimulation generation circuit 202 may include multiple pairs of current sources and current absorbers, each pair connected to a corresponding electrode of electrodes 232A, 232B. In other words, in these examples, instead of switching stimulation signals between different electrodes of electrodes 232A and 232B, each electrode in electrodes 232A and 232B is independently controlled via its own stimulation circuitry (e.g., via a combination of a regulated current source and a current absorber).

[0092] Storage devices 212A and / or 212B may be configured to store information, respectively, within IMD 200A and / or 200B during operation. Storage devices 212A and / or 212B may include a computer-readable storage medium or a computer-readable storage device. In some examples, storage devices 212A and / or 212B include one or more of short-term or long-term memory. Storage devices 212A and / or 212B may include, for example, random access memory (RAM), dynamic random access memory (DRAM), static random access memory (SRAM), magnetic disk, optical disk, flash memory, or various forms of electrically programmable memory (EPROM) or electrically erasable programmable memory (EEPROM). In some examples, storage devices 212A and / or 212B are used to store data indicating instructions, for example, executed by processing circuits 210A and / or 210B, respectively. As discussed above, storage devices 212A and / or 212B are configured to store stimulus parameter settings 242.

[0093] Power source 224 is configured to deliver operating power to components of IMD 200A and / or 200B. Power source 224 may include a battery and power generation circuitry for generating operating power. In some examples, the battery is rechargeable to allow for extended operation. In some examples, recharging is achieved via near-side inductive interaction between an external charger and an inductive charging coil within IMD 200A and / or 200B. Power source 224 may include any one or more of a variety of different battery types, such as nickel-cadmium batteries and lithium-ion batteries.

[0094] In such Figure 2 In some of the examples shown, the processing circuits 210A of IMD 200A and 210B of IMD 200B control and / or guide the delivery of electrical stimulation to the electrodes 232A and 232B of leads 230A and 230B, receive stimulation-evoked signal data and / or information from sensor 222, and generate an output based on the received data and / or information.

[0095] Processing circuits 210A and / or 210B control stimulation circuit 202 to deliver stimulation energy having stimulation parameters specified by one or more stimulation parameter settings 242 stored in storage devices 212A and / or 212B, and in Figure 2In this example, stimulation-evoked signals related to the stored stimulation parameter setting 242 are collected. Processing circuits 210A and / or 210B collect this information by receiving stimulation-evoked signal information and / or combined stimulation-evoked signal information via sensing circuit 206 and / or sensor 222. Processing circuit 210A can also control stimulation circuit 202 to test different parameter settings and record one or more corresponding stimulation-evoked signals for each selected combination, and test different parameter settings by comparing them with one or more sensed stimulation-evoked signals.

[0096] According to the apparatus and techniques disclosed herein, processing circuits 210A and / or 210B may be configured to determine characteristics of two or more sensed stimulus-evoked signal types from one or more sensed stimulus-evoked signals evoked by delivery of electrical stimulation (e.g., by scanning a stimulus signal intended to evoked a stimulus-evoked signal). Processing circuits 210A and / or 210B may then utilize these characteristics to determine a stimulus signal to evoke a subsequent stimulus-evoked signal or to sense a subsequent stimulus-evoked signal.

[0097] For example, processing circuit 210A guides stimulation circuit 202 to deliver stimulation via electrical stimulation settings, and signal unit 216 collects corresponding stimulation-evoked signal data 254 from sensing circuit 206 via sensing settings. In some examples, processing circuit 210A may guide stimulation circuit 202 to deliver electrical stimulation by scanning multiple electrical stimulation settings, and processing circuit 210A may guide sensing circuit 206 to sense stimulation-evoked signals evoked by the delivered electrical stimulation by scanning multiple sensing settings or parameters (e.g., electrode configurations such as monopolar, bipolar, tripolar, etc., alternating sensing polarity, blanking parameters, or any other suitable sensing parameters). In some examples, the electrical stimulation delivered by processing circuit 210A guiding stimulation circuit 202 may additionally provide therapeutic electrical stimulation.

[0098] Processing circuitry 210A can determine the characteristics of one or more different signal types (e.g., stimulus-evoked signal types) received in response to the use of one or more settings selected from electrical stimulation settings, sensing settings, or combinations thereof, and program the electrical stimulation system (e.g., IMD 200A) based on these characteristics. For example, based on the determined characteristics, processing circuitry 210A can program IMD 200A to include at least one of the following: an electrical stimulation setting for delivering subsequent electrical stimulation to the patient to evoke at least one signal type; or a sensing setting for sensing at least one signal type in response to stimulation by the patient. Processing circuitry 210A can then direct stimulation circuitry 202 to deliver subsequent electrical stimulation to the patient according to the determined electrical stimulation setting to evoke one or more subsequent stimulus-evoked signals from the patient. Additionally or alternatively, processing circuitry 210A can direct sensing circuitry 206 to sense one or more subsequent stimulus-evoked signals from the patient in response to subsequent electrical stimulation according to the determined sensing setting.

[0099] For example, processing circuitry 210A can be configured to determine the most suitable operating mode for a particular patient. For instance, processing circuitry 210A can capture stimulus-evoked signals and subsequent stimulus-evoked signals via a calibration process, and determine the operating mode based on the determined type of stimulus-evoked signal and the electrical stimulation settings and sensing settings corresponding to the generation and subsequent stimulation-evoked signals. For example, processing circuitry 210A can determine an ECAP mode, an EMG mode, an alternating ECAP then EMG mode, a simultaneous ECAP and EMG mode, or any other operating mode suitable for improving and / or optimizing the evoked and sensed stimulus-evoked signals, which provide information indicating the efficacy of delivering therapeutic electrical stimulation to the patient.

[0100] In some examples, processing circuitry 210A may deliver therapeutic electrical stimulation based on one or more subsequent stimulus-evoked signals. For example, processing circuitry 210A may run calibration, determine an operating mode, and deliver therapeutic electrical stimulation according to electrical stimulation settings and sensing settings optimized for the operating mode. In some examples, processing circuitry 210A may direct sensing circuitry 206 to sense stimulus-evoked signals delivered from the therapeutic stimulation. In some examples, processing circuitry 210A may direct sensing circuitry 206 not to sense stimulus-evoked signals from the therapeutic stimulation, for example, to sense only stimulus-evoked signals from electrical stimulation delivered according to calibration or parameter scans. For example, processing circuitry 210A may determine electrical stimulation settings and sensing settings based solely on stimulus-evoked signals evoked by electrical stimulation designed to elicit stimulus-evoked signals and / or a specific type of stimulus-evoked signal.

[0101] Figure 4This is a block diagram illustrating an example configuration of components of an example external programmer 300. The external programmer 300 can be... Figure 1 Examples of external devices 24. While external programmer 300 may generally be described as a handheld device, such as a tablet computer or a smartphone-like device, external programmer 300 may be a larger portable device, such as a laptop computer, or a more fixed device, such as a desktop computer. Additionally, in other examples, programmer 300 may be included as part of an external charging device, or include the functionality of an external charging device, such as for recharging one or more batteries associated with IMD 200. Figure 4 As shown, the external programmer 300 may include processing circuitry 352, storage device 354, user interface 356, telemetry circuitry 358, and power supply 360. In some examples, throughout this disclosure, storage device 354 may store instructions that, when executed by processing circuitry 352, enable processing circuitry 352 and external programmer 300 to provide functionality attributable to external programmer 300. Each of these components, circuits, or modules may include circuitry configured to perform some or all of the functions described herein. For example, processing circuitry 352 may include processing circuitry configured to perform the processes discussed relative to processing circuitry 352.

[0102] Typically, the external programmer 300 includes any suitable hardware arrangement that executes, individually or in combination with software and / or firmware, the techniques belonging to the external programmer 300 and its processing circuitry 352, user interface 356, and telemetry circuitry 358. In various examples, the processing circuitry 352, telemetry circuitry 358, or other circuitry of the external programmer 300 may include: one or more processors, such as one or more microprocessors; DSP; ASIC; FPGA; or any other equivalent integrated or discrete logic circuitry; and any combination of such components. In various examples, the external programmer 300 may also include a storage device 354, such as RAM, ROM, PROM, EPROM, EEPROM, flash memory, hard disk, CD-ROM, containing executable instructions for causing the one or more processors to perform actions belonging to those instructions. Furthermore, although the processing circuitry 352 and telemetry circuitry 358 are described as separate modules, in some examples, the processing circuitry 352 and telemetry circuitry 358 are functionally integrated. In some examples, the processing circuitry 352, telemetry circuitry 358, or other circuitry of the external programmer 300 may correspond to a separate hardware unit, such as an ASIC, DSP, FPGA, or other hardware unit.

[0103] Processing circuitry 352 is configured to guide the delivery of electrical stimulation and receive information associated with one or more stimulus-evoked signals. In some examples, processing circuitry 352 is configured to control the electrical stimulation circuitry to deliver electrical stimulation based on stimulus-evoked signal information received in a closed-loop manner by guiding the IMD to use specific stimulation parameters.

[0104] In some examples, storage device 354 may include instructions that cause processing circuitry 352 to retrieve a parameter set from memory, or to receive user input and send a corresponding command to IMD 200; or instructions for any other functionality. Additionally, storage device 354 may include multiple programs, each including a parameter set defining a therapeutic or control stimulus. Storage device 354 may also store data received from a medical device (e.g., IMD 16) and / or remote sensing devices. For example, storage device 354 may store data recorded at the sensing module of the medical device, and storage device 354 may also store data from one or more sensors of the medical device. In examples, storage device 354 may store data recorded at remote sensing devices, such as one or more stimulus-evoked signals sensed by one or more sensors.

[0105] User interface 356 may include buttons or a keypad, lights, a speaker for voice commands, and a display (such as a liquid crystal (LCD), a light-emitting diode (LED), or an organic light-emitting diode (OLED)). In some examples, the display includes a touchscreen. User interface 356 may be configured to display any information related to the delivery of electrical stimulation, including, for example, output information based on one or more stimulation-evoked signals. User interface 356 may also receive user input (e.g., an indication of when the patient perceives stimulation, or a pain score perceived by the patient at the time of stimulation delivery). User input may be in the form of, for example, pressing a button on a keypad or selecting an icon from a touchscreen. Input may request the start or stop of electrical stimulation, input may request a new electrode combination or a change in an existing electrode combination, or input may request some other change to the delivery of electrical stimulation, such as changes in electrode combination or configuration, electrode polarity, amplitude, pulse width, pulse shape, pulse frequency or pulse rate, cyclic or biphasic recharge parameters, or pulse pattern (e.g., masked detection). In some examples, input may induce or trigger a sensing or calibration sequence, for example, as follows: Figures 13 to 15 As described in the description.

[0106] Telemetry circuit 358 can support wireless communication between the medical device and external programmer 300 under the control of processing circuit 352. Telemetry circuit 358 can also be configured to communicate with another computing device via wireless communication technology, or directly with another computing device via a wired connection. In some examples, telemetry circuit 358 provides wireless communication via RF or a near-side sensing medium. In some examples, telemetry circuit 358 includes an antenna, which can take various forms, such as an internal antenna or an external antenna.

[0107] Examples of local wireless communication technologies that can be used to facilitate communication between the external programmer 300 and the IMD 16 include, according to RF communication via the 802.11 specification set or other standards or proprietary telemetry protocols. In this way, other external devices can be able to communicate with the external programmer 300 without establishing a secure wireless connection. As described herein, the telemetry circuitry 358 can be configured to transmit spatial electrode motion patterns or other stimulation parameter values ​​to the IMD 16 for delivery of electrical stimulation therapy.

[0108] Power supply 360 is configured to deliver operating power to components of external programmer 300. Power supply 360 may include a battery and a power generation circuit for generating operating power. In some examples, the battery is rechargeable to allow for extended operation. Recharging can be achieved by electrically coupling power supply 360 to a bracket or plug connected to an alternating current (AC) outlet. Alternatively, recharging can be achieved through near-side inductive interaction between an external charger and an inductive charging coil within external programmer 300. In other examples, conventional batteries (e.g., nickel-cadmium or lithium-ion batteries) can be used. Alternatively, external programmer 300 can be directly coupled to an AC outlet for operation.

[0109] In some examples, the external programmer 300 guides the delivery of electrical stimulation to the IMD, receives information related to stimulation-evoked signals and / or compound stimulation-evoked signals, and generates outputs based on the received information. These outputs may be used to assess the efficacy of stimulation parameters and / or to recommend or assist the user in programming the stimulation parameters used for delivery of electrical stimulation, or as part of a closed-loop control scheme to automatically adjust stimulation parameters using stimulation-evoked signal information and / or compound stimulation-evoked signal information. In one or more examples, the external programmer 300 generates outputs based on stimulation-evoked signal information, such as outputs that can be used as part of closed-loop control, outputs that can be displayed and used by the external programmer 300 to manually control treatment delivery, outputs that can be used to maintain the same treatment delivery, outputs that can be recorded and tracked, or outputs that are suitable for any other purpose related to the delivery of electrical stimulation therapy.

[0110] Programmer 300 can be a patient programmer or a clinician programmer, and receives stimulus-evoked signal information and / or compound stimulus-evoked signal information, such as stimulus-evoked signal data 364. Programmer 300 receives stimulus-evoked signal information and allows the user to interact with processing circuitry 352 via user interface 356 to identify parameter settings, such as loops and / or one or more other stimulus parameters, using the stimulus-evoked signal information. Programmer 300 further assists the user in programming the neurostimulation device by using the stimulus-evoked signal information displayed on user interface 356. Furthermore, programmer 300 can be used as part of a closed-loop control scheme to automatically adjust stimulus parameters, at least based on stimulus-evoked signal information. In some examples, programmer 300 receives stimulus-evoked signal information and / or compound stimulus-evoked signal information (such as stimulus-evoked signal data 364) from one or more sensor devices and stores stimulus-evoked signal data 364 in storage device 354. In some examples, the programmer 300 may be a device specifically designed to communicate with an IMD (e.g., IMD 16, IMD 200A, IMD 200B, etc.) as part of an electrical stimulation system. In other examples, the programmer 300 may be a device configured to interact with an IMD or other devices of the electrical stimulation system, such as a computing device and / or mobile phone configured to run suitable application software for the electrical stimulation system and configured to communicate with one or more devices (e.g., IMDs) of the electrical stimulation system.

[0111] Programmer 300 can be used to determine the efficacy of a specific parameter setting of the IMD by testing parameter settings and recording one or more stimulus-evoked signals for each parameter setting. For example, programmer 300 can be used to enable the IMD to automatically scan multiple electrode combinations or parameter combinations. Processing circuitry 352 enables the IMD to automatically scan each of the multiple parameter combinations, including electrode combinations and parameter combinations. For each combination, programmer 300 acquires and records one or more corresponding stimulus-evoked signals and / or compound stimulus-evoked signals. In some examples, programmer 300 can be used to enable the IMD to automatically scan multiple electrode combinations or parameter combinations at one or more times (e.g., periodically hourly, daily, weekly, monthly, yearly, and / or non-periodicly) according to a schedule or other determination of when to repeat scanning, and acquires and records one or more corresponding stimulus-evoked signals and / or compound stimulus-evoked signals for each scan. In some examples, programmer 300 or another device (e.g., IMD 16, external device 24, server 26, or other device) can compare the recorded stimulus-evoked signals and / or compound stimulus-evoked signals over time.

[0112] As an alternative to or supplement to the automated scanning process, the user can, for example, manually advance the scan using arrow buttons on the user interface 356 via electrode pairs and / or parameter combinations. In some examples, the user scans electrode pairs or parameter combinations to test and record one or more stimulus-evoked signals for each combination.

[0113] Processing circuit 352 controls stimulation circuit 202 to deliver stimulation energy having stimulation parameters specified by one or more stimulation parameter settings 366 stored in storage device 354, and collects stimulation-evoked signal information related to the stored stimulation parameter settings 366. For example, processing circuit 352 may be substantially similar to processing circuits 210A and / or 210B described above, except that it is located in external programmer 300.

[0114] Figure 4 The architecture of the external programmer 300 shown is illustrated as an example. The techniques described in this disclosure can be used in... Figure 4 This includes implementations of the example external programmer 300 and other types of systems not specifically described herein. Nothing in this disclosure should be construed as limiting the technology of this disclosure to... Figure 4 The example architecture shown.

[0115] Figures 5 to 8 It is a graph of the stimulus-evoked signal, and Figures 9 to 11 This is an example of a compound stimulus-evoked signal, and it is described together below. Figures 5 to 11 In a specific example, each plotted signal represents the voltage amplitude of a circuit including electrode 232, which varies over time in proportion to a time-varying electric field sensed by electrode 232. In the illustrated example, the time-varying field is caused by one or more signal sources from the patient (e.g., nerves, muscles, or other tissues) in response to electrical stimulation. However, Figures 5 to 11Typically, it can represent one or more other quantities. In some examples, each signal graph can represent the amplitude of the sensed quantity as a time function of time, which varies proportionally to the physiological response of the signal source. In some examples, the quantity is the amplitude measured by a sensor. For example, the amplitude can be a voltage and / or current that varies over time based on the amplitude of the electric field and / or potential emitted and / or sensed by the signal source. In some examples, the amplitude can be, for example, displacement, pressure, accelerometer data, sound, such as an MMG signal. In some examples, the composite stimulus-evoked signal 902 described below can be a composite of quantities sensed by multiple sensors from multiple sources, for example, a combined amplitude as a time function from two or more different sensors that sense two or more different quantities from one or more different signal sources that respond to the same electrical stimulus at or near the same time or within a time period (e.g., a sensing "time window"). In some examples, two sensors can sense two different quantities from the same signal source, for example, EMG and MMG of a muscle response. In other examples, the composite stimulus-evoked signal 902 may be a composite of sensed measurements (e.g., electric fields and / or potentials) from multiple signal sources sensed by the same sensor. For example, electrode 232 senses a changing electric field that is a superposition of multiple electric fields caused by multiple signal sources responding to electrical stimuli within a sensing time window.

[0116] Figure 5 This is a graph 500 of an example stimulus-evoked signal 502 according to one or more techniques of this disclosure. In the illustrated example, signal 502 is a voltage amplitude that varies over time proportional to a time-varying electric field sensed by electrode 232, induced by a signal source in response to electrical stimulation. In the illustrated example, time T0 corresponds to the time when electrical stimulation of a nerve or muscle ceases (e.g., is turned off), and time T1 corresponds to the end time of a sensing time window, e.g., the difference between T0 and T1. In some examples, signal 502 may have a signal duration equal to the time window, e.g., a detectable quantity (e.g., electric field) of the duration of a physiological response emission from the signal source. In other examples, the signal length of signal 502 may be less than the time window. Generally, the time window may be selected based on the signal length; for example, time T0 may be selected as the time when electrical stimulation ceases, and time T1 may be selected based on the duration of the sensed signal (e.g., any one of 502, 602, 702, 802, and / or 902). Figures 5 to 9In the examples, T1 is selected based on the exemplary duration of signal 902 and is shown on each graph in graphs 500 to 900 for reference. In some examples, the lengths of stimulus-evoked signals 502-902 may be relatively long, such as 1 ms, 5 ms, 10 ms, 15 ms, 20 ms, 30 ms, or longer. In some examples, the shape, length, and position along the time axis of one or more features of stimulus-evoked signals 502-802 may differ.

[0117] In the example shown, signal 502 includes a trough 504 at time 506 (which can be considered a “peak” with a negative amplitude and may be simply referred to as a “peak” herein) and a peak 508 at time 510. In the example shown, signal 502 may be a stimulus-evoked signal of an EMG response of muscle to electrical stimulation.

[0118] Figure 6 This is a graph 600 of a stimulus-evoked signal 602 according to one or more techniques of this disclosure. In the example shown, signal 602 is a voltage amplitude that varies over time proportionally to a time-varying electric field sensed by electrode 232, which is induced by a signal source in response to electrical stimulation. In the example shown, signal 602 includes a peak 604 at time 606. In the example shown, signal 602 may be a stimulus-evoked signal of the EMG of a muscle in response to electrical stimulation.

[0119] Figure 7 This is a graph 700 of a stimulus-evoked signal 702 according to one or more techniques of this disclosure. In the example shown, signal 702 is a voltage amplitude that varies over time proportionally to a time-varying electric field sensed by electrode 232, which is induced by a signal source in response to electrical stimulation. In the example shown, signal 702 includes a valley 704 at time 706. In the example shown, signal 702 may be a stimulus-evoked signal of a neural response of a nerve fiber to electrical stimulation.

[0120] Figure 8 This is a graph 800 of a stimulus-evoked signal 802 according to one or more techniques of this disclosure. In the illustrated example, signal 802 is a voltage amplitude that varies over time proportionally to a time-varying electric field sensed by electrode 232, which is induced by a signal source in response to electrical stimulation. In the illustrated example, signal 802 includes a peak 804 at time 806. In the illustrated example, signal 802 may be a stimulus-evoked signal of a neural response of one or more fibers of a nerve or muscle to electrical stimulation via EMG.

[0121] Figure 9This is a graph illustrating an example of a composite stimulus-evoked signal according to one or more techniques of this disclosure. In the example shown, signal 902 is a voltage amplitude that varies over time proportional to a time-varying electric field sensed by electrode 232, which is induced by multiple signal sources in response to electrical stimulation. For example, signal 902 may be a composite of signals 502-802. Although not shown, signal 902 may include other peaks, features, artifacts, and / or noise. For example, electrode 232 may sense signal 902 but not signals 502-802, which are shown as individual components of the composite signal 902 for clarity.

[0122] In the example shown, the compound stimulus-evoked signal 902 includes peaks 504, 508, 604, 704, 804, and 904 and 908, occurring at times 506, 510, 606, 706, 806, and 906 and 910, respectively. In the example shown, peak 904 may correspond to a combination of two or more signal sources. In other words, peak 904 may not be a peak caused by a single signal source, but rather a result of a combination of signals 502 and 702. Peak 908 may be a stimulus-evoked signal of the EMG of a muscle in response to electrical stimulation, for example, a second contraction of the same muscle or a different muscle, as seen in peak 604.

[0123] In some examples, multiple characteristics of signal 902 can be described, for example, according to the reference above. Figure 4 B is shown and described in the method (406) for determination. For example, IMD 200A, external programmer 300 or another device such as a computing device may determine and receive signal 902 and determine one or more peaks 504, 508, 604, 704, 804, 904 and 908, the corresponding time of the peaks, the delay between one or more peaks (such as ΔT between peaks 508 and 604), the width and area of ​​any of the above peaks, the frequency and / or spectral content of signal 902, or any other signal characteristics, for example, that may be derived via signal processing and / or digital signal processing.

[0124] In some examples, one or more specific features may correspond to and be associated with the efficacy of the stimulation therapy. For example, peak 504 may relate to the electrical stimulation response of certain nerve fibers to electrical stimulation, peak 604 may relate to the EMG of muscles, and peak 704 may relate to the electrical stimulation response of nerve fibers, for example, the electrical stimulation response may relate to sensory and motor information. In some examples, improved and / or optimal electrical stimulation therapy may be electrical stimulation that excites certain nerve fibers while reducing / minimizing the excitation of certain other nerve fibers, for example, causing peak 508 to increase and peak 704 to decrease. For example, the system may determine movable lead 230 and / or adjustable stimulation parameter settings 242 to increase peak 508 (e.g., increase stimulation of certain nerve fibers) while also reducing peak 704 (e.g., reduce valley 704 or make the negative value of peak 704 smaller, indicating a reduction in the excitation of certain other nerve fibers).

[0125] As another example, improved and / or optimal electrical stimulation therapy could be electrical stimulation that reduces / minimizes the firing of some fibers while increasing the firing of other nerve fibers and muscle contraction (e.g., the EMG response of the muscle). For example, the system could determine movable lead 230 and / or adjustable stimulation parameter settings 242 to increase peak 704 (e.g., increase trough 704 or make the negative value of peak 704 larger, indicating an increase in firing of certain fibers of the nerve), while increasing peak 604 (e.g., increasing muscle response and corresponding EMG) and decreasing peak 508 (e.g., decreasing firing of other fibers of the nerve).

[0126] Figure 10 This is a graph of stimulus-evoked signals according to one or more other examples of techniques according to this disclosure. In the illustrated example, signals 1002, 1004, and 1006 are voltage amplitudes that vary over time in proportion to a time-varying electric field sensed by electrode 232, which is induced by one or more signal sources in response to electrical stimulation. In the illustrated example, signals 1002-1006 are stimulus-evoked signals sensed from a sacral nerve modulation lead. Signal 1002 is a baseline composite stimulus-evoked signal, signal 1004 is a stimulus-evoked signal without a muscle response, and signal 1006 is a stimulus-evoked signal without a neural or muscular response. In the illustrated example, peaks 1012 and 1014 (e.g., they may be “negative peaks” or troughs) include features from multiple sources in the composite signal 1002, for example, peak 1012 is a signal feature indicating a neural response (e.g., ECAP), and peak 1014 is a signal feature indicating a muscle response (e.g., EMG or compound muscle action potential (CMAP)). In the example shown, signal 1004 includes peak 1012, such as an ECAP signal, but does not include peak 1014. Signal 1006 does not include ECAP or EMG signal characteristics.

[0127] Figure 11 This is a graph of a composite stimulus-evoked signal according to one or more techniques of this disclosure. In the illustrated example, signal 1102 is a voltage amplitude that varies over time in proportion to a time-varying electric field sensed by electrode 232, which is induced by one or more signal sources in response to electrical stimulation. In the illustrated example, signal 1102 is a composite stimulus-evoked signal sensed from sacral nerve modulation. In the illustrated example, peaks 1112 and 1114 comprise features from multiple sources in the composite signal 1102, for example, peak 1112 is a signal feature indicating a neural response (e.g., ECAP), and peak 1114 is a signal feature indicating a muscle response (e.g., EMG or CMAP).

[0128] Figure 12 This is a flowchart illustrating an example method for delivering controlled electrical stimulation therapy according to one or more techniques of this disclosure. Although using Figure 2 The IMD 200A and Figure 4 Let's discuss the external programmer 300. Figure 12 However, it should be understood that in other examples, the methods discussed herein may include and / or utilize other systems and methods. In some examples, the IMD 200A can perform... Figure 12 The method determines the characteristics of two or more sensed stimulus-evoked signal types from one or more sensed stimulus-evoked signals evoked from the delivery of electrical stimulation (e.g., by scanning a stimulus signal intended to elicit a stimulus-evoked signal), and then uses those characteristics to determine the stimulus signal to elicit a subsequent stimulus-evoked signal or to sense a subsequent stimulus-evoked signal.

[0129] Physicians or clinicians may place electrical stimulation leads (12020). For example, a physician or clinician may implant one or more leads 18, 20 or 28 into the patient 14 to deliver electrical stimulation to the target tissue.

[0130] The IMD 200A can run calibration sequences (1204). For example, the IMD 200A can run calibrations to customize operating modes for a specific patient, such as ECAP mode, EMG mode, alternating ECAP then EMG mode, simultaneous ECAP and EMG mode, etc. For example, the IMD 200A can determine that calibration is needed, or that a physician, clinician, or patient may request calibration. The IMD 200A can run calibration sequences by delivering electrical stimulation according to multiple sets of electrical stimulation settings (e.g., varying electrode configuration and polarity, varying amplitude, varying frequency, and / or varying frequency) (e.g., electrodes via leads 18, 20, or 28). The IMD 200A can sense and record (e.g., capture, detect, process, and / or store) stimulation-evoked signals in response to electrical stimulation delivered according to multiple sets of sensing settings.

[0131] The IMD 200A can determine the operating mode (1206) of a treatment system (e.g., treatment system 10). For example, based on one or more stimulus-evoked signals recorded for known electrical stimulation settings and sensing settings, the IMD 200A can determine one or more characteristics of the stimulus-evoked signal type (e.g., ECAP signal, EMG signal, or any suitable stimulus-evoked signal type). In some examples, the IMD 200A can determine one or more characteristics of one or more recorded stimulus-evoked signals, and determine the signal type of one or more stimulus-evoked signals and / or one or more characteristics of one or more stimulus-evoked signals and signal types.

[0132] The IMD 200A can then determine an operating mode based on defined characteristics. For example, the IMD 200A can determine an ECAP operating mode in which electrical stimulation and sensing settings are selected to optimize the evoked and sensed ECAP signal (e.g., compared to an EMG signal). Alternatively, the IMD 200A can determine an EMG operating mode in which electrical stimulation and sensing settings are selected to optimize the evoked and sensed EMG signal (e.g., compared to an ECAP signal). In some examples, the IMD 200A can determine an operating mode that includes a stimulation / sensing scheme compatible with a specific type of stimulus-evoked signal. For example, if the IMD 200A determines an ECAP operating mode, the ECAP operating mode may include masking detection techniques configured to reduce stimulus artifacts from the recording of the ECAP. Figure 16 and Figure 17 If the IMD 200A determines an EMG operating mode, the EMG operating mode may include an alternating polarity technique configured to change the pulse polarity every other pulse and average the pulses. Alternatively, the IMD 200A may determine an alternating operating mode in which electrical stimulation settings and sensing settings are selected to optimize the induction and sensing of a first stimulus-evoked signal type (e.g., ECAP), and then electrical stimulation settings and sensing settings are selected to optimize the induction and sensing of a second stimulus-evoked signal type (e.g., an EMG signal). Additionally, the IMD 200A may determine a simultaneous operating mode in which electrical stimulation settings and sensing settings are selected to optimize the induction and sensing of multiple stimulus-evoked signal types, such as a composite stimulus-evoked signal including ECAP and EMG signals.

[0133] The IMD 200A can deliver treatment based on a defined pattern (1208). For example, the IMD 200A can determine the electrical stimulation settings and sensing settings based on a defined pattern, and deliver subsequent electrical stimulation and sense subsequent stimulation evoked signals according to the defined electrical stimulation settings and sensing settings, for example, to deliver a one-time or chronic electrical stimulation treatment.

[0134] In some examples, the IMD 200A can operate in a closed-loop manner within a selected operating mode. For example, the IMD 200A can determine an operating mode that provides improved and / or optimized stimulation-evoked signals, and determine the efficacy of electrical stimulation therapy based on that operating mode. The IMD 200A can change the electrical stimulation settings and / or sensing settings to alter or improve the efficacy of electrical stimulation therapy based on one or more types of stimulation-evoked signals in the selected mode (e.g., based on the characteristics and / or features of one or more types of sensed stimulation-evoked signals in the selected mode). For example, within an operating mode, the IMD 200A can update the electrical stimulation settings and / or sensing settings to change or improve the efficacy of electrical stimulation over time. In some examples, the IMD 200A can recalibrate or update the calibration to determine whether selecting the same or different operating modes at future times is advantageous, for example, whether the stimulation-evoked signals drift or change over time, as referenced below. Figure 15 Further details are provided.

[0135] Figure 13 This is a flowchart illustrating an example method for delivering controlled electrical stimulation therapy according to one or more techniques of this disclosure. Although using Figure 2 The IMD 200A and Figure 4 Let's discuss the external programmer 300. Figure 13 However, it should be understood that in other examples, the methods discussed herein may include and / or utilize other systems and methods.

[0136] The IMD 200A can be configured to determine for a patient the characteristics of receiving two or more types of sensed stimulus-evoked signals in response to the use of at least two settings selected from electrical stimulation settings, sensing settings, or combinations thereof (1302). For example, the IMD 200A can run the calibration sequence described above at (1204), or as referred to below. Figure 14 and Figure 15The calibration sequence further described in one or both of these. For example, the IMD 200A can deliver electrical stimulation by scanning (or scanning the electrodes of leads 18, 20, or 28) the delivery of multiple electrical stimulation pulses (e.g., via the electrodes of leads 18, 20, or 28), wherein each electrical stimulation pulse is characterized at least by electrode configuration, pulse width, polarity, frequency, amplitude, recharge parameters (e.g., duration and / or amplitude of active recharge or duration and / or amplitude of passive recharge) or pulse pattern (e.g., such as a masked detection sequence). For example, the IMD 200A can deliver electrical stimulation by scanning a plurality of pulses in one or more monopolar and / or bipolar electrode configurations, the plurality of pulses including at least one of 20 microsecond pulses, 40 microsecond pulses, 60 microsecond pulses, 80 microsecond pulses, 100 microsecond pulses, 180 microsecond pulses, 190 microsecond pulses, 200 microsecond pulses, 210 microsecond pulses, 220 microsecond pulses, 300 microsecond pulses, or 450 microsecond pulses. In some examples, the IMD 200A can deliver electrical stimulation by scanning a plurality of pulses, the plurality of pulses including pulses of at least 20 microseconds and less than or equal to 450 microseconds. In some examples, the IMD 200A can deliver electrical pulses with alternating polarities.

[0137] The IMD 200A can sense and record (e.g., capture, detect, process, and / or store) stimulus-evoked signals after corresponding electrical stimulation pulses in a plurality of electrical stimulation pulses. For example, the IMD 200A can sense and record a set of multiple stimulus-evoked signals, each corresponding to a pulse delivered in a pulse scan. The IMD 200A can characterize one or more stimulus-evoked signals in this set, with each characteristic including one or more signal features. In some examples, the IMD 200A can sense and record stimulus-evoked signals by scanning sensing parameters to sense the stimulus-evoked signals, such as scanning electrode configurations (monopolar, bipolar, tripolar, etc.), alternating sensing polarity, or scanning blanking parameters.

[0138] In some examples, the IMD 200A can determine signal characteristics that include at least one of the following: signal peaks (e.g., peaks 508, 604, 804, 908, 1012, 1014, 1112, or 1114), signal peak amplitude, number of signal peaks, area under a signal peak, signal peak width, time between signal peaks, ratio of signal peak amplitudes, ratio of signal peak widths, ratio of area under a signal peak, delay of signal peaks, signal valleys (e.g., valleys 504, 704, 1012, 1014, 1112, or 1114), and valley amplitude. The following parameters are considered: degree, number of signal valleys, area above signal valleys, width of signal valleys, time between signal valleys, ratio of signal valley amplitude, ratio of signal valley width, ratio of area above signal valleys, valley delay, root mean square signal value, signal skewness, signal kurtosis, signal frequency, signal spectrum content, Hjorth feature, threshold of signal amplitude growth curve, amplitude of signal amplitude growth curve inflection point, delay of signal amplitude growth curve inflection point, saturation point of signal amplitude growth curve, characteristic of signal intensity duration curve, characteristic of maximum rate of change of signal or characteristic of minimum rate of change of signal.

[0139] The IMD 200A can determine the characteristics of ECAP stimulus-evoked signal type (e.g., based on the characteristic that at least one of the sources indicating stimulus-evoked signals is an ECAP source) and non-EMG stimulus-evoked signal type (e.g., based on the characteristic that indicates an EMG source may not be a source of stimulus-evoked signals) based on these characteristics, or the IMD 200A can determine the characteristics of EMG stimulus-evoked signal type (e.g., based on the characteristic that at least one of the sources indicating stimulus-evoked signals is an EMG source) and non-ECAP stimulus-evoked signal type (e.g., based on the characteristic that indicates an ECAP source may not be a source of stimulus-evoked signals) based on these characteristics, or the IMD 200A can determine the characteristics of ECAP stimulus-evoked signal type and EMG stimulus-evoked signal type based on these characteristics (e.g., based on the characteristic that at least one of the sources indicating stimulus-evoked signals is an ECAP source and at least one of the sources of stimulus-evoked signals is an EMG source). In other words, the IMD 200A can determine the characteristics of a composite stimulus-evoked signal based on these features, such as whether the ECAP and EMG signals are simultaneous (and at least partially overlap in time) or whether the ECAP and EMG signals are continuous (and substantially non-overlap in time).

[0140] The IMD 200A can be programmed and / or configured based on characteristics to include at least one of the following: an electrical stimulation setting for delivering subsequent electrical stimulation to a patient to evoke at least one signal type of signal type; or a sensing setting for sensing at least one signal type of signal type in response to stimulation by the patient (1304). In some examples, the IMD 200A can determine an electrical stimulation setting for delivering subsequent electrical stimulation configured to evoke a stimulus-evoked signal of one or more stimulus-evoked signal types. For example, the IMD 200A can determine an electrical stimulation setting for delivering subsequent electrical stimulation configured to evoke an ECAP signal, evoke an EMG signal, evoke a combined ECAP and EMG signal, or evoke an ECAP signal followed by an EMG signal (or evoke an ECAP signal followed by an ECAP signal). In some examples, subsequent electrical stimulation may include electrical stimulation according to one or more modes, such as an ECAP mode, an EMG mode, a combined ECAP and EMG mode, or an alternating ECAP followed by an EMG mode. In some examples, subsequent electrical stimulation may include a portion of the calibration or may include a portion of therapeutic electrical stimulation (e.g., after calibration and during normal chronic electrical stimulation therapy delivery).

[0141] In some examples, the IMD 200A may determine the electrical stimulation setting and / or sensing setting based on one or more thresholds. For example, the IMD 200A may determine the electrical stimulation setting and / or sensing setting based on defined characteristics that evoke one or more stimulation-evoked signal types (e.g., ECAP, EMG, composite) that have a minimum threshold signal strength, minimum signal-to-noise ratio, minimum power, etc., but also a maximum threshold electrical stimulation strength, amplitude, energy, etc. For example, the IMD 200A may determine the electrical stimulation setting and / or sensing setting based on defined characteristics that balance the power and / or quality of the stimulation-evoked signal of the sensing stimulation-evoked signal type (ECAP, EMG, composite) with respect to the amount of electrical stimulation delivered to evoke the stimulation-evoked signal and provide effective electrical stimulation to the patient.

[0142] The IMD 200A can deliver subsequent electrical stimulation to a patient according to a determined electrical stimulation setting to evoke one or more subsequent stimulation evoked signals from the patient and / or sense one or more subsequent stimulation evoked signals from the patient in response to subsequent electrical stimulation according to a determined sensing setting (1306). For example, the IMD 200A can deliver subsequent electrical stimulation and sense subsequent stimulation evoked signals for further calibration or refinement of calibration, or deliver therapeutic electrical stimulation. In some examples, the IMD 200A can then deliver therapeutic electrical stimulation based on one or more subsequent stimulation evoked signals, for example, after refining, confirming, etc., the calibration and / or electrical stimulation settings and / or sensing settings.

[0143] Figure 14 This is a flowchart illustrating an example method for delivering controlled electrical stimulation therapy according to one or more techniques of this disclosure. Although using Figure 2 The IMD 200A and Figure 4 Let's discuss the external programmer 300. Figure 14 However, it should be understood that in other examples, the methods discussed herein may include and / or utilize other systems and methods. In some examples, Figure 14 Example methods could be used to determine the characteristics of stimulus-evoked signals and / or signal types, for example, Figure 13 Method step 1302.

[0144] The IMD 200A can be configured to scan (or scan the electrodes of leads 18, 20, and / or 28) at multiple amplitudes with alternating polarities and specific pulse widths (1402). For example, the IMD 200A can deliver or scan multiple electrical pulses by applying 20 pulses of 210 microseconds each with alternating polarities (e.g., a total of 40 pulses), starting with an amplitude of zero or near zero, and increasing the amplitude of each alternating polarity pair to a maximum signal threshold that the IMD 200A can output, or to a maximum amplitude less than the maximum capability of the IMD 200A, for example, selected by a clinician, physician, and / or the IMD 200A based on previous patient responses or other input information. The IMD 200A can sense or capture one and / or multiple stimulus-evoked signals corresponding to one or more pulses in the pulses. For example, the IMD 200A can sense or capture ECAP, EMG, or composite signals including consecutive or simultaneous ECAP and EMG signals after each individual pulse (e.g., a stimulus-evoked signal is evoked by a pulse) or after two or more pulses (e.g., a stimulus-evoked signal is evoked by two or more pulses). In some examples, the IMD 200A can repeat the scan at method step 1402 at multiple frequencies.

[0145] In some examples, the IMD 200A can optionally be configured to scan with alternating polarities and specific pulse widths (or to scan the electrodes of leads 18, 20 and / or 28) multiple amplitudes, for example, in addition to or as an alternative to bipolar scanning.

[0146] The IMD 200A can determine an electrode configuration (1404) having an optimal (e.g., “highest quality”) stimulus-evoked signal and / or one or more optimal (e.g., “highest quality”) stimulus-evoked signal characteristics. In some examples, the optimal (e.g., “highest quality”) stimulus-evoked signal is a signal with the largest amplitude, such as a maximum signal, and one or more optimal stimulus-evoked signal characteristics may be based on predetermined criteria (e.g., maximum amplitude, maximum or minimum area under a peak, minimum or maximum delay, shortest or longest time between peaks, specific spectral content, etc.), thresholds, comparisons, etc. In some examples, the optimal stimulus-evoked signal is a “highest quality” signal, such as a signal with the largest signal-to-noise ratio, the largest number of signal characteristics, the clearest and / or most distinguishable signal characteristics, or any suitable signal quality metric indicating an “optimal” or “highest quality” signal. In some examples, the IMD 200A can determine a monopolar electrode configuration, a bipolar electrode configuration, a tripolar electrode configuration, or any other electrode configuration, as corresponding to the optimal stimulus-evoked signal and / or signal characteristics at method step 1406.

[0147] The IMD 200A can scan (or make the electrodes of leads 18, 20 and / or 28 scan) multiple pulse widths (1406) under a determined electrode configuration. For example, the IMD 200A can scan 20 pulses for each pulse width of 20 microsecond pulse width, 40 microsecond pulse width, 60 microsecond pulse width, 80 microsecond pulse width, 100 microsecond pulse width, 200 microsecond pulse width and 450 microsecond pulse width, wherein the electrode configuration (e.g. bipolar, monopolar, tripolar or other) and amplitude are determined, and in some examples, the frequency is determined from method step 1402.

[0148] The IMD 200A can scan (or make the electrodes of leads 18, 20 and / or 28 scan) one or more additional electrical stimulation settings and / or sensing settings, or repeat any previous scan (1408). For example, if the sensed stimulation-evoked signal is weak or has low stability or low signal-to-noise ratio or does not contain signal characteristics, or if the IMD 200A determines that sensing additional stimulation-evoked signals increases the confidence of determining the pattern or electrical stimulation setting or sensing parameter sensing setting, for example, to deliver therapeutic electrical stimulation, then the IMD 200A can repeat any scan of method steps 1402, 1404 or 1406.

[0149] In some examples, the IMD 200A may store sensed stimulus-evoked signals in a database, such as as a "lookup table". In some examples, the IMD 200A may store stimulus-evoked signals and / or quantities derived from sensed stimulus-evoked signals, such as features and / or characteristics that may be associated with and / or related to patient and / or stimulus parameter settings and / or sensing settings.

[0150] The IMD 200A can determine, for a patient, the characteristics of one or more sensed stimulus-evoked signal types from one or more sensed stimulus-evoked signals evoked via scan delivery of electrical stimulation (1410). For example, the IMD 200A can determine the characteristics as described above at method step 1302, wherein one or more sensed stimulus-evoked signals are sensed, recorded, detected, and / or captured via the aforementioned scan. In some examples, the IMD 200A can determine, for a patient, the characteristics of two or more sensed stimulus-evoked signal types from one or more sensed stimulus-evoked signals evoked via scan delivery of electrical stimulation (1410). For example, the IMD 200A can determine the ECAP signal type and non-EMG signal type, or EMG signal type and non-ECAP signal type, or composite signal type, such as EMG signal type and ECAP signal type, among the sensed stimulus-evoked signals.

[0151] Figure 15 This is a flowchart illustrating an example method for delivering controlled electrical stimulation therapy according to one or more techniques of this disclosure. Although using Figure 2 The IMD 200A and Figure 4 Let's discuss the external programmer 300. Figure 15 However, it should be understood that in other examples, the methods discussed herein may include and / or utilize other systems and methods. In some examples, Figure 15 Example methods could be recalibrating based, for example, on changes such as lead migration, changes in patient response, environmental changes, disease progression, or any changes that cause changes in the stimulus-evoked signals sensed after previous calibration and determination of operating modes.

[0152] The IMD 200A can determine changes in the sensed stimulus-evoked signal, such as signal quality (1502). In some examples, the IMD 200A can determine changes in the sensed stimulus-evoked signal that indicate lead migration, such as a decrease in signal amplitude, a change in characteristics or feature shape, etc.

[0153] The IMD 200A can be recalibrated (1504). For example, the IMD 200A can be recalibrated according to... Figures 12 to 14 Calibration or modified calibration can be performed using any or all of the methods mentioned above (e.g., fewer scans across a smaller range of parameter settings).

[0154] The IMD 200A can determine, for a patient, the characteristics of one or more sensed stimulus-evoked signal types from one or more sensed stimulus-evoked signals evoked via recalibrated delivery of electrical stimulation (1506). In some examples, the IMD 200A can determine, for a patient, the characteristics of two or more sensed stimulus-evoked signal types from one or more sensed stimulus-evoked signals evoked via recalibrated delivery of electrical stimulation. In some examples, the IMD 200A can determine the characteristics as described above at method steps 1302 and / or 1412, wherein one or more sensed stimulus-evoked signals are sensed, recorded, detected, and / or captured via the recalibration scan of method step 1502.

[0155] For example, the IMD 200A can determine a second characteristic (at a later time than the previously determined characteristic) of two or more types of sensed stimulus-evoked signals from one or more sensed stimulus-evoked signals delivered by a recalibrated or recalibrated scan for a patient.

[0156] The IMD 200A may determine, based on this characteristic, at least one of the following: a second electrical stimulation setting for delivering subsequent electrical stimulation to the patient to induce one or more subsequent stimulation evoked signals; or a second sensing setting for sensing one or more subsequent stimulation evoked signals from the patient (1508). In some examples, the IMD 200A may determine the second electrical stimulation and / or sensing setting as described above at method step 1304, wherein the characteristic is a second characteristic determined via method step 1506.

[0157] In some examples, the IMD 200A can identify one or more different stimulation and / or sensing settings that compensate for variations in sensed stimulus-evoked signals, or improve the sensing of stimulus-evoked signals or determine the effectiveness of stimulus-evoked signal types (e.g., ECAP, non-ECAP, EMG, non-EMG, composite). For example, the IMD 200A can identify different electrode combinations for delivering electrical stimulation to compensate for drift and / or lead migration, for example, to improve or optimize the delivery of electrical stimulation to different locations or the sensing of stimulus-evoked signals from different locations.

[0158] The IMD 200A may deliver subsequent electrical stimulation to a patient according to a determined second electrical stimulation setting to evoke one or more subsequent stimulation evoked signals from the patient and / or sense one or more subsequent stimulation evoked signals from the patient in response to subsequent electrical stimulation according to a determined second sensing setting (1510). In some examples, the IMD 200A may deliver electrical stimulation and sense stimulation evoked signals according to a second electrical setting and / or sensing setting as described above at method step 1306, wherein the second electrical setting and / or sensing setting is determined via method step 1508.

[0159] Figure 16 These are a series of graphs of example electrical stimulation pulses used to perform masking detection techniques, and Figure 17 It is by Figure 16 A series of graphs showing example sensed stimulus-evoked signals generated by pulses. In the example shown, each sensed stimulus-evoked signal 1702-1706 corresponds to each delivered pulse 1602-1606; for example, pulse 1602 evokes signal 1702, pulse 1604 evokes signal 1704, and pulse 1606 evokes signal 1706. Signal 1708 is mathematically calculated from signals 1702, 1704, and 1706.

[0160] In some examples, masking probe techniques can be used to reduce one or more stimulus artifacts from the recording of the ECAP. For example, the IMD 200A can deliver (or enable electrodes of leads 18, 20, and / or 28 to deliver) three pulse sequences: a probe-only pulse 1602, a masking pulse 1604, and a masking and probe pulse 1606. The IMD 200A can then sense and record the stimulus-evoked signal from each pulse (e.g., 1702, 1704, and 1706) and process the recorded signal (e.g., probe - (mask + probe) + mask) to obtain the resulting ECAP (e.g., 1708) with artifacts removed. For the mask + probe sequence, when the pulses are close together, the activated neurons may be in a relative refractory period after the probe pulse, resulting in a small ECAP (or no ECAP), while the artifacts remain, thus allowing the artifacts to be subtracted from the recorded probe-only ECAP.

[0161] The following numbered embodiments illustrate one or more aspects of this disclosure:

[0162] Example 1: A method comprising: determining, for a patient, a characteristic of receiving one or more different signal types in response to using at least one setting selected from the group consisting of one or more electrical stimulation settings, one or more sensing settings, or combinations thereof; and programming a neurostimulation system based on the characteristic, the programming comprising at least one of: an electrical stimulation setting for delivering subsequent electrical stimulation to the patient to induce at least one of the signal types; or a sensing setting for sensing at least one of the signal types in response to stimulation by the patient.

[0163] Example 2: According to the method of Example 1, the method further includes at least one of the following: delivering the subsequent electrical stimulation to the patient according to the determined electrical stimulation settings to induce one or more subsequent stimulation evoked signals from the patient according to the determined sensing settings.

[0164] Example 3: The method according to Example 1 or Example 2, the method further includes delivering therapeutic electrical stimulation based on the one or more subsequent stimulation evoked signals.

[0165] Example 4: The method according to any one of Examples 1 to 3, wherein the one or more different signal types include at least one of the following: evoked nerve signal type, electromyography (EMG) signal type, or a combination of evoked nerve signal type and EMG signal type.

[0166] Example 5: The method according to any one of Examples 1 to 4, wherein the characteristic includes one or more signal features, the one or more signal features including at least one of the following: signal peak, signal peak amplitude, number of signal peaks, area below signal peak, signal peak width, time between signal peaks, ratio of signal peak amplitude, ratio of signal peak width, ratio of area below signal peak, signal peak delay, signal valley, signal valley amplitude, number of signal valleys, area above signal valley, signal valley width, time between signal valleys, ratio of signal valley amplitude, ratio of signal valley width, ratio of area above signal valley, valley delay, root mean square signal value, signal skew, signal kurtosis, signal frequency, signal spectral content, Hjorth feature, signal amplitude growth curve threshold, signal amplitude growth curve inflection point amplitude, signal amplitude growth curve inflection point delay, signal amplitude growth curve saturation point, signal intensity duration curve feature, maximum rate of change of signal, or minimum rate of change of signal.

[0167] Example 6: The method according to any one of Examples 1 to 5, wherein the electrical stimulation setting includes a setting for delivering subsequent electrical stimulation, the subsequent electrical stimulation being configured to at least one of the following: evoking an ECAP signal, evoking an EMG signal, evoking a combined ECAP and EMG signal, evoking an ECAP signal followed by an EMG signal, or evoking an EMG signal followed by an ECAP signal.

[0168] Example 7: According to the method of Example 6, determining the characteristics of the one or more different signal types includes: scanning the delivery of a plurality of electrical stimulation pulses, wherein each electrical stimulation pulse is characterized by at least electrode configuration, pulse width, polarity, frequency, amplitude, recharge parameter or pulse pattern; and scanning sensing parameters to sense one or more stimulation-evoked signals, wherein the one or more sensing parameters include electrode configuration or blanking parameters.

[0169] Example 8: According to the method described in Example 7, each sensed stimulus-evoked signal of one or more different signal types is sensed after a corresponding electrical stimulation pulse or a set of corresponding stimulation pulses in the plurality of electrical stimulation pulses.

[0170] Example 9: The method according to Example 7 or Example 8, wherein the plurality of electrode configurations includes at least one of a unipolar configuration, a bipolar configuration, or a tripolar configuration, and wherein the plurality of pulses includes pulses of at least 20 microseconds and less than or equal to 450 microseconds.

[0171] Example 10: The method according to any one of Examples 1 to 9, wherein the electrical stimulation setup for delivering subsequent electrical stimulation to the patient to induce at least one of the signal types includes a masked probe pulse sequence.

[0172] Example 11: The method according to any one of Examples 1 to 10, wherein the electrical stimulation setup for delivering subsequent electrical stimulation to the patient to induce at least one of the signal types includes the polarity of alternating continuous pulses.

[0173] Example 12: The method according to any one of Examples 1 to 11, wherein the characteristic is a first characteristic, wherein the electrical stimulation setting is a first electrical stimulation setting, and wherein the sensing setting is a first sensing setting, the method further comprising: determining for the patient a second characteristic of one or more different signal types received in response to using at least two settings selected from the group consisting of one or more electrical stimulation settings, one or more sensing settings, or combinations thereof; programming the neurostimulation system based on the second characteristic to include at least one of: a second electrical stimulation setting for delivering subsequent electrical stimulation to the patient to induce at least one signal type of the signal type; or a second sensing setting for sensing at least one signal type of the signal type in response to stimulation by the patient; and performing at least one of: delivering the subsequent electrical stimulation to the patient according to the determined second electrical stimulation setting to induce the one or more subsequent stimulation evoked signals from the patient; or sensing the one or more subsequent stimulation evoked signals from the patient in response to the subsequent electrical stimulation according to the second signal sensing setting.

[0174] Example 13: A system comprising: at least one electrode configured to deliver electrical stimulation to a patient; and means comprising processing circuitry configured to: determine, for the patient, a characteristic of one or more different signal types received in response to the use of at least two settings selected from one or more electrical stimulation settings, one or more sensing settings, or combinations thereof; and to program a neurostimulation system based on the characteristic, the programming comprising at least one of: an electrical stimulation setting for delivering subsequent electrical stimulation to the patient to induce at least one signal type of the signal type; or a sensing setting for sensing at least one signal type of the signal type in response to stimulation by the patient.

[0175] Example 14: The system according to Example 13, wherein the processing circuit is further configured to perform at least one of the following: delivering the subsequent electrical stimulation to the patient according to a determined electrical stimulation setting to induce one or more subsequent stimulation evoked signals from the patient according to a determined sensing setting.

[0176] Example 15: The system according to Example 13 or Example 14, wherein the processing circuit is further configured to deliver therapeutic electrical stimulation based on the one or more subsequent stimulus evoked signals.

[0177] Example 16: The system according to any one of Examples 13 to 15, wherein the one or more different signal types include at least one of the following: evoked nerve signal type, electromyography (EMG) signal type, or a combination of evoked nerve signal type and EMG signal type.

[0178] Example 17: The system according to any one of Examples 13 to 16, wherein the characteristic includes one or more signal features, the one or more signal features including at least one of the following: signal peak, signal peak amplitude, number of signal peaks, area below signal peak, signal peak width, time between signal peaks, ratio of signal peak amplitude, ratio of signal peak width, ratio of area below signal peak, signal peak delay, signal valley, signal valley amplitude, number of signal valleys, area above signal valley, signal valley width, time between signal valleys, ratio of signal valley amplitude, ratio of signal valley width, ratio of area above signal valley, valley delay, root mean square signal value, signal skew, signal kurtosis, signal frequency, signal spectral content, Hjorth feature, signal amplitude growth curve threshold, signal amplitude growth curve inflection point amplitude, signal amplitude growth curve inflection point delay, signal amplitude growth curve saturation point, signal strength duration curve feature, maximum rate of change of signal or minimum rate of change of signal.

[0179] Example 18: The system according to any one of Examples 13 to 17, wherein the electrical stimulation setting includes a setting for delivering subsequent electrical stimulation, the subsequent electrical stimulation being configured to at least one of the following: evoking an ECAP signal, evoking an EMG signal, evoking a combined ECAP and EMG signal, evoking an ECAP signal followed by an EMG signal, or evoking an EMG signal followed by an ECAP signal.

[0180] Example 19: The system according to Example 18, wherein the processing circuit is configured to determine the characteristics of the two or more different signal types by: scanning the delivery of a plurality of electrical stimulation pulses, wherein each electrical stimulation pulse is characterized at least by electrode configuration, pulse width, polarity, frequency, amplitude, recharge parameter or pulse mode; and scanning sensing parameters to sense one or more stimulation-evoked signals, wherein the one or more sensing parameters include electrode configuration or blanking parameters.

[0181] Example 20: According to the system of Example 19, each sensed stimulus-evoked signal of the two or more different signal types is sensed after a corresponding electrical stimulation pulse or a set of corresponding stimulation pulses in the plurality of electrical stimulation pulses.

[0182] Example 21: The system according to Example 19 or Example 20, wherein the plurality of electrode configurations includes at least one of a monopolar configuration, a bipolar configuration, or a tripolar configuration, and wherein the plurality of pulses includes pulses of at least 20 microseconds and less than or equal to 450 microseconds.

[0183] Example 22: The system according to any one of Examples 13 to 21, wherein the electrical stimulation setup for delivering subsequent electrical stimulation to the patient to induce at least one of the signal types includes a masked probe pulse sequence.

[0184] Example 23: The system according to any one of Examples 13 to 22, wherein the electrical stimulation setting for delivering subsequent electrical stimulation to the patient to induce at least one of the signal types includes the polarity of alternating continuous pulses.

[0185] Example 24: A system according to any one of Examples 13 to 23, wherein the characteristic is a first characteristic, wherein the electrical stimulation setting is a first electrical stimulation setting, wherein the sensing setting is a first sensing setting, wherein the processing circuitry is further configured to: determine for the patient a second characteristic of two or more different signal types received in response to the use of at least two settings selected from the group consisting of one or more electrical stimulation settings, one or more sensing settings, or combinations thereof; program the neurostimulation system based on the second characteristic to include at least one of: a second electrical stimulation setting for delivering subsequent electrical stimulation to the patient to induce at least one signal type of the signal type; or a second sensing setting for sensing at least one signal type of the signal type in response to stimulation by the patient; and perform at least one of: delivering the subsequent electrical stimulation to the patient according to the determined second electrical stimulation setting to induce the one or more subsequent stimulation evoked signals from the patient; or sensing the one or more subsequent stimulation evoked signals from the patient in response to the subsequent electrical stimulation according to the second signal sensing setting.

[0186] Example 25: A computer-readable medium comprising instructions that, when executed, cause one or more processors to: determine, for a patient, a characteristic of one or more different signal types received in response to the use of at least two settings selected from one or more electrical stimulation settings, one or more sensing settings, or combinations thereof; and to program a neurostimulation system based on the characteristic, the programming including at least one of: an electrical stimulation setting for delivering subsequent electrical stimulation to the patient to induce at least one of the signal types; or a sensing setting for sensing at least one of the signal types in response to stimulation by the patient.

[0187] The techniques described in this disclosure can be implemented, at least in part, in hardware, software, firmware, or any combination thereof. For example, aspects of the described techniques can be implemented within a processing circuit that may include one or more processors, including one or more microprocessors, digital signal processors (DSPs), 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. The terms "processor" or "processing circuitry" can generally refer to any of the aforementioned logic circuitry, alone or in combination with other logic circuitry, or any other equivalent circuitry. A control unit, including hardware, may also form one or more processors or processing circuitry configured to execute one or more techniques of this disclosure.

[0188] Such hardware, software, and firmware can be implemented and can perform various operations on a coordinated basis within the same device, within a single device, and / or within, between, or across multiple devices to support the various operations and functions described in this disclosure. Furthermore, any described unit, circuit, or component can be implemented together or independently 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 common or separate hardware or software components. The processing circuitry including one or more processors described in this disclosure can be implemented in various examples as fixed-function circuitry, programmable circuitry, or combinations thereof. Fixed-function circuitry refers to circuitry that provides specific functionality using preset operations. Programmable circuitry refers to circuitry that can be programmed to perform various tasks and provide flexible functionality in executable operations. For example, programmable circuitry can execute software or firmware that causes the programmable circuitry to operate in a manner defined by the instructions of the software or firmware. Fixed-function circuits can execute software instructions (e.g., to receive or output stimulus parameters), but the type of operation performed by the fixed-function circuit is typically immutable. In some examples, one or more of these units may be different circuit blocks (fixed-function or programmable), and in some examples, one or more of these units may be integrated circuits.

[0189] The techniques described in this disclosure may also be embodied or encoded in a computer-readable medium (such as a computer-readable storage medium) containing instructions, which may be described as a non-transitory medium. Instructions embedded or encoded in a computer-readable storage medium may cause a programmable processor or other processor to perform the method, for example, when executing those instructions. 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), electrically erasable programmable read-only memory (EEPROM), flash memory, hard disk, CD-ROM, floppy disk, magnetic tape cassette, magnetic media, optical media, or other computer-readable media.

Claims

1. A system comprising: At least one electrode, the at least one electrode being configured to deliver electrical stimulation to a patient; and The device includes a processing circuit configured to: The characteristics of a patient receiving one or more different signal types in response to the use of at least two settings selected from one or more electrical stimulation settings, one or more sensing settings, or combinations thereof; as well as The neural stimulation system is programmed based on the aforementioned characteristics, and the programming includes at least one of the following: An electrical stimulation setup for delivering subsequent electrical stimulation to a patient to induce at least one of the signal types, or A sensing setting for sensing at least one of the signal types in response to stimulation by the patient.

2. The system according to claim 1, wherein the processing circuit is further configured to: Perform at least one of the following: deliver the subsequent electrical stimulation to the patient according to a determined electrical stimulation setting to induce one or more subsequent stimulation evoked signals from the patient, or sense the one or more subsequent stimulation evoked signals from the patient in response to the subsequent electrical stimulation according to a determined sensing setting.

3. The system of claim 1 or claim 2, wherein the processing circuitry is further configured to deliver therapeutic electrical stimulation based on the one or more subsequent stimulus-evoked signals.

4. The system according to any one of claims 1 to 3, wherein the one or more different signal types include at least one of the following: evoked nerve signal type, electromyography (EMG) signal type, or a combination of evoked nerve signal type and EMG signal type.

5. The system according to any one of claims 1 to 4, wherein the characteristic comprises one or more signal features, the one or more signal features comprising at least one of the following: signal peak, signal peak amplitude, number of signal peaks, area below signal peak, signal peak width, time between signal peaks, ratio of signal peak amplitude, ratio of signal peak width, ratio of area below signal peak, signal peak delay, signal valley, signal valley amplitude, number of signal valleys, area above signal valley, signal valley width, time between signal valleys, ratio of signal valley amplitude, ratio of signal valley width, ratio of area above signal valley, valley delay, root mean square signal value, signal skew, signal kurtosis, signal frequency, signal spectral content, Hjorth feature, signal amplitude growth curve threshold, signal amplitude growth curve inflection point amplitude, signal amplitude growth curve inflection point delay, signal amplitude growth curve saturation point, signal intensity duration curve feature, maximum rate of change of signal, or minimum rate of change of signal.

6. The system according to any one of claims 1 to 5, wherein the electrical stimulation setup includes a configuration for delivering subsequent electrical stimulation, the subsequent electrical stimulation being configured to be at least one of the following: Inducing ECAP signal, Induce EMG signals, Inducing combined ECAP and EMG signals, ECAP signal is followed by EMG signal, or The ECAP signal is induced after the EMG signal.

7. The system of claim 6, wherein the processing circuitry is configured to determine the characteristics of two or more different signal types by: The delivery of multiple electrical stimulation pulses is scanned, wherein each electrical stimulation pulse is characterized at least by electrode configuration, pulse width, polarity, frequency, amplitude, recharge parameters, or pulse mode; and Scanning sensing parameters to sense one or more stimulus-evoked signals, wherein the one or more sensing parameters include electrode configuration or blanking parameters.

8. The system of claim 7, wherein after a corresponding electrical stimulation pulse or a set of corresponding stimulation pulses in the plurality of electrical stimulation pulses, each sensed stimulation-evoked signal of the two or more different signal types is sensed.

9. The system of claim 7 or claim 8, wherein the plurality of electrode configurations comprises at least one of a unipolar configuration, a bipolar configuration, or a tripolar configuration, and The plurality of pulses includes pulses of at least 20 microseconds and less than or equal to 450 microseconds.

10. The system according to any one of claims 1 to 9, wherein the electrical stimulation setup for delivering subsequent electrical stimulation to the patient to induce at least one of the signal types comprises a masked probe pulse sequence.

11. The system of claims 2 to 10, wherein the electrical stimulation setup for delivering subsequent electrical stimulation to the patient to induce at least one of the signal types comprises the polarity of alternating continuous pulses.

12. The system according to any one of claims 2 to 11, wherein the characteristic is a first characteristic, the electrical stimulation setting is a first electrical stimulation setting, the sensing setting is a first sensing setting, and the processing circuitry is further configured to: For the patient, a second characteristic is defined as the two or more different signal types received in response to the use of at least two settings selected from the group consisting of one or more electrical stimulation settings, one or more sensing settings, or combinations thereof; The neural stimulation system is programmed based on the second characteristic to include at least one of the following: A second electrical stimulation setting, configured to deliver subsequent electrical stimulation to the patient to induce at least one of the signal types; or a second sensing setting, configured to sense at least one of the signal types in response to stimulation by the patient; and Perform at least one of the following: deliver the subsequent electrical stimulation to the patient according to a determined second electrical stimulation setting to induce one or more subsequent stimulation evoked signals from the patient; or sense one or more subsequent stimulation evoked signals from the patient in response to the subsequent electrical stimulation according to a second signal sensing setting.

13. A computer-readable medium comprising instructions that, when executed, cause one or more processors to: The characteristics of a patient receiving one or more different signal types in response to the use of at least two settings selected from one or more electrical stimulation settings, one or more sensing settings, or combinations thereof; and The neural stimulation system is programmed based on the aforementioned characteristics, and the programming includes at least one of the following: An electrical stimulation setup for delivering subsequent electrical stimulation to a patient to induce at least one of the signal types, or A sensing setting for sensing at least one of the signal types in response to stimulation by the patient.

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