Control pulses and posture for ECAPs

Systems, devices, and techniques for adjusting electrical stimulation based on a posture state of a patient are described. For example, processing circuitry is configured to control delivery of a first informed stimulation pulse defined by at least a first value of an informed stimulation parameter, control delivery of a control stimulation pulse to a patient, the control stimulation pulse defined by at least a first value of a control stimulation parameter, determine a characteristic value of the ECAP signal elicited from the control stimulation pulse, receive, from a sensor, a posture state signal representing a posture state of the patient, and adjust, based on the characteristic value of the ECAP signal and the posture state signal, the first value of the informed stimulation parameter to a second value of the informed stimulation parameter.

TECHNICAL FIELD

This disclosure generally relates to electrical stimulation, and more specifically, control of electrical stimulation.

BACKGROUND

Medical devices may be external or implanted and may be used to deliver electrical stimulation to patients via various tissue sites to treat a variety of symptoms or conditions such as chronic pain, tremor, Parkinson's disease, epilepsy, urinary or fecal incontinence, sexual dysfunction, obesity, or gastroparesis. A medical device may deliver electrical stimulation therapy via one or more leads that include electrodes located proximate to target locations associated with the brain, the spinal cord, pelvic nerves, peripheral nerves, or the gastrointestinal tract of a patient. Stimulation proximate the spinal cord, proximate the sacral nerve, within the brain, and proximate peripheral nerves are often referred to as spinal cord stimulation (SCS), sacral neuromodulation (SNM), deep brain stimulation (DBS), and peripheral nerve stimulation (PNS), respectively. Electrical stimulation may be delivered by the medical device as a train of pulses, and the values of the parameters defining the pulses may be altered.

SUMMARY

In general, systems, devices, and techniques are described for managing the delivery of electrical stimulation based on evoked compound action potential (ECAP) signals sensed from a patient. When a patient moves, the distance between implanted electrodes and target nerves changes. For example, electrodes implanted along the spinal column are closer to the spinal cord when a subject lies in a supine posture state as compared to a standing posture state. Similarly, the implanted electrodes may move closer to the spinal cord when a subject coughs or sneezes. This changing distance between the electrodes and target tissue affects neural recruitment for a given intensity of delivered stimulation and can cause the patient's perception and/or therapeutic benefit to also change. Therefore, a characteristic value of the ECAP signal can represent the change in distance, and a system can modulate electrical stimulation using the characteristic value as feedback.

When in different posture states (e.g., sitting as compared to laying in the supine position), the different distances between the electrodes and target tissue cause the patient to have different levels of sensitivity to changes in stimulation parameters that define electrical stimulation. In this manner, a growth curve of the ECAP signal (e.g., the relationship between the characteristic value of the ECAP and amplitude of the stimulation pulse) can depend on at least in part on a posture state of the patient. In one examples, the closer the distance between the electrodes and the target tissue, the greater the sensitivity and slope of the growth curve. As described herein, a system may use detected posture state of the patient to inform how the system uses the ECAP signal in a control policy that defines changes to stimulation parameter values for subsequent pulses, such as a frequency, an amplitude, a pulse width, and a pulse shape. Generally, informed stimulation pulses may be configured to contribute to a therapeutic effect of the patient, but ECAP signals may not be detectable from these informed stimulation pulses. Therefore, control stimulation pulses having a pulse width shorter than the informed stimulation pulses may be delivered to the patient in order to detect elicited ECAP signals. The control stimulation pulses may or may not contribute to a therapeutic effect for the patient. In one example, the system may select a gain value associated with a detected posture state for adjusting a parameter values for one or both of the control stimulation pulses and the informed stimulation pulses. The gain value may be associated with the respective growth curve of that detected posture state. In addition, or alternatively, the system may select a target ECAP characteristic value according to the detected posture state of the patient.

In one example, a system includes sensing circuitry configured to sense an evoked compound action potential (ECAP) signal elicited by a control stimulation pulse of a plurality of control stimulation pulses and processing circuitry configured to control delivery of a first informed stimulation pulse defined by at least a first value of an informed stimulation parameter, the informed stimulation pulse being one informed stimulation pulse of a plurality of informed stimulation pulse, control delivery of the control stimulation pulse to a patient, the control stimulation pulse defined by at least a first value of a control stimulation parameter, determine a characteristic value of the ECAP signal elicited from the control stimulation pulse, receive, from a sensor, a posture state signal representing a posture state of the patient, adjust, based on the characteristic value of the ECAP signal and the posture state signal, the first value of the informed stimulation parameter to a second value of the informed stimulation parameter; and control delivery of a second informed stimulation pulse of the plurality of informed stimulation pulses that is defined at least by the second value of the informed stimulation parameter.

In another example, a method includes controlling, by processing circuitry, delivery of a first informed stimulation pulse defined by at least a first value of an informed stimulation parameter, the informed stimulation pulse being one informed stimulation pulse of a plurality of informed stimulation pulse, controlling, by the processing circuitry, delivery of a control stimulation pulse of a plurality of control stimulation pulses to a patient, the control stimulation pulse defined by at least a first value of a control stimulation parameter, sensing, by sensing circuitry, an evoked compound action potential (ECAP) signal elicited by the control stimulation pulse, determining, by the processing circuitry, a characteristic value of the ECAP signal elicited from the control stimulation pulse, receiving, by the processing circuitry and from a sensor, a posture state signal representing a posture state of the patient, adjusting, by the processing circuitry and based on the characteristic value of the ECAP signal and the posture state signal, the first value of the informed stimulation parameter to a second value of the informed stimulation parameter, and controlling, by the processing circuitry, delivery of a second informed stimulation pulse of the plurality of informed stimulation pulses that is defined at least by the second value of the informed stimulation parameter.

In another example, a computer-readable storage medium including instructions that, when executed by processing circuitry, cause the processing circuitry to control delivery of a first informed stimulation pulse defined by at least a first value of an informed stimulation parameter, the informed stimulation pulse being one informed stimulation pulse of a plurality of informed stimulation pulse, control delivery of a control stimulation pulse of a plurality of control stimulation pulses to a patient, the control stimulation pulse defined by at least a first value of a control stimulation parameter, control sensing circuitry to sense an evoked compound action potential (ECAP) signal elicited by the control stimulation pulse, determine a characteristic value of the ECAP signal elicited from the control stimulation pulse, receive, from a sensor, a posture state signal representing a posture state of the patient, adjust, based on the characteristic value of the ECAP signal and the posture state signal, the first value of the informed stimulation parameter to a second value of the informed stimulation parameter, and control delivery of a second informed stimulation pulse of the plurality of informed stimulation pulses that is defined at least by the second value of the informed stimulation parameter

The 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, device, and methods described in detail within the accompanying drawings and description below. Further details of one or more examples of this disclosure are set forth in the accompanying drawings and in the description below. Other features, objects, and advantages of the techniques will be apparent from the description and drawings, and from the claims.

Like reference characters denote like elements throughout the description and figures.

DETAILED DESCRIPTION

The disclosure describes examples of medical devices, systems, and techniques for adjusting electrical stimulation delivered to a patient based on a posture state of the patient and one or more characteristics of ECAP signals. Electrical stimulation therapy is typically delivered to a target tissue (e.g., nerves of the spinal cord or muscle) of a patient via two or more electrodes. Parameters of the electrical stimulation therapy (e.g., electrode combination, voltage or current amplitude, pulse width, pulse frequency, etc.) are selected by a clinician and/or the patient to provide relief from various symptoms, such as pain, nervous system disorders, muscle disorders, etc. However, as the patient moves, the distance between the electrodes and the target tissues changes. Since neural recruitment at the nerves is a function of stimulation intensity (e.g., amplitude and/or pulse frequency) and distance between the target tissue and the electrodes, movement of the electrode closer to the target tissue may result in increased neural recruitment (e.g., possible painful sensations or adverse motor function), and movement of the electrode further from the target tissue may result in decreased efficacy of the therapy for the patient. Certain patient postures (which may or may not include patient activity) may be representative of respective distances (or changes in distance) between electrodes and nerves and thus be an informative feedback variable for modulating stimulation therapy.

In some examples, a patient may experience discomfort or pain caused by transient patient conditions, which is referred to herein as transient overstimulation. The electrodes can move closer to the target tissue for a number of reasons including coughing, sneezing, laughing, valsalva maneuvers, leg lifting, cervical motions, deep breathing, or another transient patient movement. If a system is delivering stimulation during these movements, the patient may perceive the stimulation as stronger (and possibly uncomfortable) due to the decreased distance between electrodes and target tissue in a short amount of time. Although a patient may anticipate such movements and preemptively reduce stimulation intensity in an attempt to avoid these uncomfortable sensations, these patient actions interfere with normal activities and may not be sufficient to avoid uncomfortable stimulation at all times.

ECAPs are a measure of neural recruitment because each ECAP signal represents the superposition of electrical potentials generated from a population of axons firing in response to an electrical stimulus (e.g., a stimulation pulse). Changes in a characteristic (e.g., an amplitude of a portion of the signal or area under the curve of the signal) of an ECAP signals occur as a function of how many axons have been activated by the delivered stimulation pulse. For a given set of parameter values that define the stimulation pulse and a given distance between the electrodes and target nerve, the detected ECAP signal may have a certain characteristic value (e.g., amplitude, or area under a curve). Therefore, a system can determine that the distance between electrodes and nerves has increased or decreased in response to determining that the measured ECAP characteristic value has increased or decreased. For example, if the set of parameter values stays the same and the ECAP characteristic value of amplitude increases, the system can determine that the distance between electrodes and the nerve has decreased.

In some examples, effective stimulation therapy may rely on a certain level of neural recruitment at a target nerve. This effective stimulation therapy may provide relief from one or more conditions (e.g., patient perceived pain) without an unacceptable level of side effects (e.g., overwhelming perception of stimulation). However, if the patient changes posture or otherwise engages in physical activity, the distance between the electrodes and the nerve changes as well. This change in distance can cause loss of effective therapy and/or side effects if the parameter values that define stimulation are not adjusted to compensate for the change in distance. Moreover, the different distance between electrodes and the target nerve (e.g., caused by a shift from one posture state to another) may also result in different sensitivities to stimulation intensity (e.g., smaller distances may result in greater sensitivities to changes in stimulation intensity). If a system does not adjust the control policy for these changes, adjustments to stimulation parameter values may not be sufficient to maintain effective therapy or may provide stimulation that is too strong at that posture state. Therefore, it may be beneficial to maintain effective therapy by the system adjusting how stimulation intensity is changed within a given posture state and/or changing target ECAP characteristic values when a posture state of the patient has changed.

As described herein, systems, devices, and techniques provide solutions to one or more of the above-referenced problems by adjusting electrical stimulation therapy delivered to a patient based on a posture state of the patient and one or more characteristics of ECAP signals. As discussed above, when a patient moves, the distance between implanted electrodes and target nerves changes. For example, electrodes implanted along the spinal column move to a position closer to the spinal cord when a subject lies in a supine posture state as compared to a position farther from the spinal cord when the subject assumes a standing posture state. Since the posture state can affect the distance between the electrodes and target nerve, the system may detect or otherwise obtain the current posture state of the patient and adjust one or more aspects of the control policy employed by the system to modulate stimulation therapy in response to detected ECAP signals. A posture state may refer to a patient posture, an activity level, or a combination of patient posture and activity level. In some examples, the system may select a therapy program or set of stimulation parameter values according to the detected posture state of the patient.

The system may store or otherwise obtain gain values, growth curves, target ECAP characteristic values, or other factors that affect modulation of stimulation associated with respective posture states. Electrical stimulation may be delivered to a patient by the medical device in a train of stimulation pulses, and parameters that define the stimulation pulses may include pulse amplitude (current and/or voltage), pulse frequency, pulse width, pulse shape, and/or electrode combination. The system may alter, adjust, change, or otherwise modulate one or more parameters of the stimulation pulses over time in order to maintain a desired level of stimulation efficacy for the patient.

Nerve impulses detectable as the ECAP signal travel quickly along the nerve fiber after the delivered stimulation pulse first depolarizes the nerve. If the stimulation pulse that elicits the ECAP signal is delivered by first electrodes has a pulse width that is too long, different electrodes configured to sense the ECAP will sense the stimulation pulse itself as an artifact that obscures the lower amplitude ECAP signal. Although sensing electrodes could be positioned farther away from where the stimulation pulse is delivered to avoid this artifact, the ECAP signal loses fidelity as the electrical potentials propagate from the electrical stimulus because different nerve fibers propagate electrical potentials at different speeds. Therefore, sensing the ECAP at a far distance from the stimulating electrodes may avoid the artifact caused by a stimulation pulse with a long pulse width, but the ECAP signal may lose fidelity needed to detect changes to the ECAP signal that occur when the electrode to target tissue distance changes. In other words, the system may not be able to identify, at any distance from the stimulation electrodes, ECAPs elicited by certain stimulation pulses having relatively long pulse widths that interfere with detection of ECAP signals (e.g., stimulation pulses that may be configured to provide a therapeutic effect for the patient).

To avoid this ECAP detection problem with some stimulation pulses, a medical device may be configured to deliver a plurality of control pulses and a plurality of informed pulses in some examples. Informed pulses may be configured to contribute to a therapeutic effect for the patient, but the informed pulses may have a stimulation parameter, such as a pulse width, that overlaps with the ECAP signal and prevents the system from detecting the ECAP signal or otherwise using the ECAP signal for feedback for modulating parameter values of the informed pulses. The plurality of control pulses, on the other hand, may be configured to elicit detectable ECAP signals. For example, the control pulses may have a pulse width that is short enough to avoid interfering with the ECAP signal detection. The control pulses may or may not contribute to a therapeutic effect for the patient. In this manner, the system may be configured to adjust one or more parameters that define the informed pulses based on the detectable ECAP signals elicited by one or more control pulses.

In one example described herein, a medical device can deliver a plurality of informed pulses to provide a therapy to the patient and a plurality of control pulses. At least some of the control pulses may elicit a detectable ECAP signal without the primary purpose of providing a therapy to the patient. The control pulses may be interleaved with the delivery of the informed pulses. For example, the medical device may alternate the delivery of informed pulses with control pulses such that a control pulse is delivered, and an ECAP signal is sensed, between consecutive informed pulses. In some examples, multiple control pulses are delivered, and respective ECAP signals sensed, between the delivery of consecutive informed pulses. In some examples, multiple informed pulses will be delivered between consecutive control pulses. In any case, the informed pulses may be delivered according to a predetermined pulse frequency selected so that the informed pulses can produce a therapeutic result for the patient. One or more control pulses are then delivered, and the respective ECAP signals sensed, within one or more time windows between consecutive informed pulses delivered according to the predetermined pulse frequency. In this manner, a medical device can administer informed pulses from the medical device uninterrupted while ECAPs are sensed from control pulses delivered during times at which the informed pulses are not being delivered. In other examples described herein, ECAPs are sensed by the medical device in response to the informed pulses delivered by the medical device, and control pulses are not used to elicit ECAPs.

The system may monitor one or more characteristic values that represent detected ECAP signals and adjust a stimulation parameter value in an attempt to achieve a target ECAP characteristic value. The system may adjust an informed parameter that at least partially defines subsequent informed pulses and may adjust a control parameter that at least partially defines subsequent control pulses. When adjusting the informed parameter value and/or the control parameter value in response to determining that the sensed characteristic value of the ECAP signal is below or above the target ECAP characteristic value, the system may employ a gain value that represents the magnitude, or rate, of change applied to a stimulation parameter in order to achieve the target ECAP characteristic value. The gain value may be the same or different for informed pulses and control pulses. In some examples, the system may apply a scaling factor or otherwise adjust the gain value so that it is appropriate for informed pulses and control pulses that may have different amplitudes or other parameters. For example, if the control pulse has a higher amplitude value than the informed pulse, the system may effectively reduce the gain value, or reduce the effect of the gain value, on the change to the informed pulse amplitude because the lower amplitude value of the informed pulse may not need to be changes as much as the control pulse amplitude. The system can thus increase or decrease a stimulation parameter according to the gain value in order to maintain the target ECAP characteristic value.

In some examples, the gain value may be a multiplier applied to a difference between a target ECAP characteristic value and a detected ECAP characteristic value. If the gain value is constant, the result is a stimulation parameter value that changes linearly. For example, the system may select one gain value for any detected ECAP characteristic value that is less than the target ECAP characteristic value, and the system may select a different gain value for any detected ECAP characteristic value that is greater than the target ECAP characteristic value. In other examples, the gain value may be calculated using a function that may be linear or non-linear. Put another way, for a given input or set of inputs (e.g., the detected ECAP characteristic value and/or posture state may be an input that affects the calculated gain value) the system may calculate different gain values for increasing stimulation intensity and/or decreasing stimulation intensity.

In one example, the system may determine a gain value that changes for different sensed ECAP characteristic values or different differences between the sensed ECAP characteristic value and a target ECAP characteristic value. A changing gain value (via a linear or non-linear function) would result in a non-linear function that determines the adjusted stimulation parameter (e.g., the output of the non-linear function). For example, the system may adjust the stimulation parameter value exponentially or logarithmically according to the difference between the sensed ECAP characteristic value and the threshold ECAP amplitude. In one example, the gain value is calculated by multiplying the difference between the sensed ECAP characteristic value and the threshold ECAP amplitude to a multiplier (e.g., a linear function) such that the gain value changes according to that difference between the sensed ECAP characteristic value and the threshold ECAP amplitude. In some examples, the gain value may represent a value selected from a table that stores gain values for respective difference values between the sensed ECAP characteristic value and the threshold ECAP amplitude. The table may result in a linear or non-linear function for determining the next stimulation parameter value.

For example, a larger gain value will cause the system to make a larger adjustment to a stimulation parameter (e.g., informed parameter or control parameter) for the same stimulation pulse than the adjustment resulting from a smaller gain value. For a non-linear function this comparison in gain value can be made relative to the same value for the difference between the sensed ECAP characteristic value and the threshold ECAP amplitude (e.g., the value difference representing an input value to the gain function). Thus, for a given input value of the gain function (or set of input values) the corresponding gain value (or set of gain values) is changed. For ease of discussion, various examples discuss the change in gain value relative to a linear function. It is understood that a non-linear function may also be used in such embodiments, where the relative change in gain value is thereby relative to the same value for the difference between the sensed ECAP characteristic value and the threshold ECAP amplitude.

Without different gain values for different posture states, a system may respond too slowly or too quickly with adjustments to stimulation parameter values. If the gain value is too large for the posture state, the system may overcorrect a stimulation parameter value (e.g., cause an uncomfortable sensation or reduce therapy efficacy). If the gain value is too small for the posture state, the system may require many iterations of adjustments to the stimulation parameter before the appropriate stimulation intensity is provided (e.g., also causing a prolonged uncomfortable sensation or a prolonged period of ineffective therapy). Generally, posture states associated with farther distances between the electrodes and target nerve may generally have larger gain values than posture states associated with closer distances between the electrodes and target nerve. In this manner, smaller gain values may be associated with smaller distances between electrodes and the target nerve (e.g., posture states more sensitive to changes in stimulation intensity such as a supine posture state). Conversely, larger gain values may be associated with larger distances between electrodes and the target nerve (e.g., posture states less sensitive to changes in stimulation intensity such as a prone posture state). A gain value may be inversely proportional to a growth curve for a particular posture state, wherein the growth curve may be a best fit curve or line of ECAP characteristic values (e.g., voltage amplitude) for given stimulation parameter values (e.g., a current amplitude of the respective pulses that elicited respective ECAP signals). In some examples, the target ECAP characteristic value may be the same for some or all posture states, but the target ECAP characteristic value may be different between posture states in other examples. In this manner, the system may select the target ECAP characteristic value associated with the detected posture state.

In another type of control policy (e.g., type of closed-loop feedback scheme), the system may employ a threshold ECAP characteristic value instead of a target ECAP characteristic value. The system may monitor characteristic values for sensed ECAP signals and reduce one or more stimulation parameter values (e.g., informed parameter values and/or control parameter values) from a predetermined value only in response to the characteristic value exceeding the threshold ECAP characteristic value. In other words, the system may be configured to attempt to keep characteristic values of sensed ECAP signals below the threshold ECAP characteristic value and only increase the stimulation parameter back up to the predetermined value in response to the characteristic value dropping back below the threshold ECAP characteristic value. In some examples, the system may select the gain value used for adjusting the stimulation parameter according to the current posture state of the patient. In addition, or alternatively, the system may select the threshold ECAP characteristic value according to the detected posture state of the patient.

In some examples, stimulation parameter values may be predetermined and/or automatically adjusted by the system based on characteristic values of ECAP signals, posture states, and other types of feedback. An external programmer for an IMD may provide a variety of features to support association of stimulation parameter values and/or characteristic values of ECAP signals with different posture states. As one example, the programmer may receive user input indicating the posture state that the patient is occupying and associated ECAP signals, and/or corresponding characteristic values, with that posture state. As another example, a patient may indicate a value for a previously undefined stimulation parameter value for a defined posture state while the patient is in the posture state or transitioning to the posture state. The indicated value may be defined for the posture state. As another example, a user may link multiple posture states and select a set of stimulation parameter values for delivery of therapy for each of the linked posture states. In this manner, it may not be necessary to specify separate sets of stimulation parameter values for each individual posture state.

In some examples, a medical device, e.g., an implantable medical device (IMD), that delivers electrical stimulation may also employ a posture state detector (e.g., one or more sensors) that detects the patient posture state. In other examples, the IMD may receive data from one or more a separate devices that sense the posture state of the patient. The IMD may then adjust one or more stimulation parameters in response to different posture states as indicated by the posture state detector.

Informed pulses and control pulses are generally described herein as different stimulation pulses reflective of different types of electrical stimulation. However, the different types of electrical stimulation, and their respective pulses, may be described with different attributes. For example, a first type of electrical stimulation may include first pulses (such as informed pulses) configured to primarily contribute to a therapy for a patient. The first pulses of this first type of electrical stimulation may also have one or more characteristics (e.g., a pulse width) that prevent or reduce the ability of the system to detect ECAP signals elicited from the first pulses of the first type of electrical stimulation because an artifact representative of the first pulses themselves overlaps with and obscures at least a portion of the respective elicited ECAP signal. A second type of electrical stimulation may include second pulses (such as control pulses) defined by one or more parameter values selected to elicit ECAP signals that are sensed and detectable by the system. The second pulses may thus be referred to as “sense pulses” or “test pulses” since the second pulses are configured to elicit a detectable ECAP signal. For example, the second pulses of the second type of electrical stimulation may improve the detectability of the ECAP signal such as not to generate an artifact that obscures the ECAP signals or otherwise prevents or reduces the ability of the system to detect the ECAP signal from each of the second pulses. In addition, the second pulses may be defined by parameter values selected to elicit an ECAP signal that is used to at least modify one or more parameter values of the first pulses of the first type of electrical stimulation. The first pulses may thus differ from the second pulses by at least one parameter (e.g., current and/or voltage amplitude, pulse width, and/or frequency). The first pulses may be at least partially interleaved with at least some of the second pulses. For example, the system may alternate delivery of one first pulse with delivery of one second pulse. In another example, the number of first pulses may differ from the number of second pulses by a ratio or percentage. The ratio could be 1:1 when the first and second pulses are fully interleaved. The ratio could be 10:1 first pulses to second pulses in examples in which the second pulses are delivered less frequently than the first pulses. In other examples, the ratio could be 1:4 first pulses to second pulses when the second pulses, and respective sensed ECAP signals) occur more frequently than the first pulses. The second pulses may or may not contribute to a therapy and/or sensation perceived by the patient, but the primary purpose of the second pulses is to elicit respective ECAP signals that are detectable by the system separate from any sensed artifacts representative of the second pulses themselves.

Although electrical stimulation is generally described herein in the form of electrical stimulation pulses, electrical stimulation may be delivered in non-pulse form in other examples. For example, electrical stimulation may be delivered as a signal having various waveform shapes, frequencies, and amplitudes. Therefore, electrical stimulation in the form of a non-pulse signal may be a continuous signal than may have a sinusoidal waveform or other continuous waveform.

FIG.1is a conceptual diagram illustrating example system100that includes implantable medical device (IMD)110to deliver electrical stimulation therapy to patient102. Although the techniques described in this disclosure are generally applicable to a variety of medical devices including external devices and IMDs, application of such techniques to IMDs and, more particularly, implantable electrical stimulators (e.g., neurostimulators) will be described for purposes of illustration. More particularly, the disclosure will refer to an implantable SCS system for purposes of illustration, but without limitation as to other types of medical devices or other therapeutic applications of medical devices.

As shown inFIG.1, system100includes an IMD110, leads108A and108B, and external programmer104shown in conjunction with a patient102, who is ordinarily a human patient. In the example ofFIG.1, IMD110is an implantable electrical stimulator that is configured to generate and deliver electrical stimulation therapy to patient102via one or more electrodes of electrodes of leads108A and/or108B (collectively, “leads108”), e.g., for relief of chronic pain or other symptoms. In other examples, IMD110may be coupled to a single lead carrying multiple electrodes or more than two leads each carrying multiple electrodes. In some examples, the stimulation signals, or pulses (e.g., control pulses), may be configured to elicit detectable ECAP signals that IMD110may use to determine the posture state occupied by patient102and/or determine how to adjust one or more parameters that define stimulation therapy. IMD110may be a chronic electrical stimulator that remains implanted within patient102for weeks, months, or even years. In other examples, IMD110may be a temporary, or trial, stimulator used to screen or evaluate the efficacy of electrical stimulation for chronic therapy. In one example, IMD110is implanted within patient102, while in another example, IMD110is an external device coupled to percutaneously implanted leads. In some examples, IMD110uses one or more leads, while in other examples, IMD110is leadless.

IMD110may be constructed of any polymer, metal, or composite material sufficient to house the components of IMD110(e.g., components illustrated inFIG.2) within patient102. In this example, IMD110may be constructed with a biocompatible housing, such as titanium or stainless steel, or a polymeric material such as silicone, polyurethane, or a liquid crystal polymer, and surgically implanted at a site in patient102near the pelvis, abdomen, or buttocks. In other examples, IMD110may be implanted within other suitable sites within patient102, which may depend, for example, on the target site within patient102for the delivery of electrical stimulation therapy. The outer housing of IMD110may be configured to provide a hermetic seal for components, such as a rechargeable or non-rechargeable power source. In addition, in some examples, the outer housing of IMD110is selected from a material that facilitates receiving energy to charge the rechargeable power source.

Electrical stimulation energy, which may be constant current or constant voltage-based pulses, for example, is delivered from IMD110to one or more target tissue sites of patient102via one or more electrodes (not shown) of implantable leads108. In the example ofFIG.1, leads108carry electrodes that are placed adjacent to the target tissue of spinal cord106. One or more of the electrodes may be disposed at a distal tip of a lead108and/or at other positions at intermediate points along the lead. Leads108may be implanted and coupled to IMD110. The electrodes may transfer electrical stimulation generated by an electrical stimulation generator in IMD110to tissue of patient102. Although leads108may each be a single lead, lead108may include a lead extension or other segments that may aid in implantation or positioning of lead108. In some other examples, IMD110may be a leadless stimulator with one or more arrays of electrodes arranged on a housing of the stimulator rather than leads that extend from the housing. In addition, in some other examples, system100may include one lead or more than two leads, each coupled to IMD110and directed to similar or different target tissue sites.

The electrodes of leads108may be electrode pads on a paddle lead, circular (e.g., ring) electrodes surrounding the body of the lead, conformable electrodes, cuff electrodes, segmented electrodes (e.g., electrodes disposed at different circumferential positions around the lead instead of a continuous ring electrode), any combination thereof (e.g., ring electrodes and segmented electrodes) or any other type of electrodes capable of forming unipolar, bipolar or multipolar electrode combinations for therapy. Ring electrodes arranged at different axial positions at the distal ends of lead108will be described for purposes of illustration.

The deployment of electrodes via leads108is described for purposes of illustration, but arrays of electrodes may be deployed in different ways. For example, a housing associated with a leadless stimulator may carry arrays of electrodes, e.g., rows and/or columns (or other patterns), to which shifting operations may be applied. Such electrodes may be arranged as surface electrodes, ring electrodes, or protrusions. As a further alternative, electrode arrays may be formed by rows and/or columns of electrodes on one or more paddle leads. In some examples, electrode arrays include electrode segments, which are arranged at respective positions around a periphery of a lead, e.g., arranged in the form of one or more segmented rings around a circumference of a cylindrical lead. In other examples, one or more of leads108are linear leads having 8 ring electrodes along the axial length of the lead. In another example, the electrodes are segmented rings arranged in a linear fashion along the axial length of the lead and at the periphery of the lead.

The stimulation parameter set of a stimulation program that defines the stimulation pulses of electrical stimulation therapy by IMD110through the electrodes of leads108may include information identifying which electrodes have been selected for delivery of stimulation according to a stimulation program, the polarities of the selected electrodes, i.e., the electrode combination for the program, voltage or current amplitude, pulse frequency, pulse width, pulse shape of stimulation delivered by the electrodes. These stimulation parameters values that make up the stimulation parameter set that defines pulses may be predetermined parameter values defined by a user and/or automatically determined by system100based on one or more factors or user input. Informed pulses may be defined by a set of informed stimulation parameter values and control pulses may be defined by a set of control stimulation parameter values.

AlthoughFIG.1is directed to SCS therapy, e.g., used to treat pain, in other examples system100may be configured to treat any other condition that may benefit from electrical stimulation therapy. For example, system100may be used to treat tremor, Parkinson's disease, epilepsy, a pelvic floor disorder (e.g., urinary incontinence or other bladder dysfunction, fecal incontinence, pelvic pain, bowel dysfunction, or sexual dysfunction), obesity, gastroparesis, or psychiatric disorders (e.g., depression, mania, obsessive compulsive disorder, anxiety disorders, and the like). In this manner, system100may be configured to provide therapy taking the form of deep brain stimulation (DBS), peripheral nerve stimulation (PNS), peripheral nerve field stimulation (PNFS), cortical stimulation (CS), pelvic floor stimulation, gastrointestinal stimulation, or any other stimulation therapy capable of treating a condition of patient102.

In some examples, lead108includes one or more sensors configured to allow IMD110to monitor one or more parameters of patient102, such as patient activity, pressure, temperature, or other characteristics. The one or more sensors may be provided in addition to, or in place of, therapy delivery by lead108.

IMD110is generally configured to deliver electrical stimulation therapy (e.g., informed pulses and/or control pulses) to patient102via selected combinations of electrodes carried by one or both of leads108, alone or in combination with an electrode carried by or defined by an outer housing of IMD110. The target tissue for the electrical stimulation therapy may be any tissue affected by electrical stimulation, which may be in the form of electrical stimulation pulses or continuous waveforms. In some examples, the target tissue includes nerves, smooth muscle or skeletal muscle. In the example illustrated byFIG.1, the target tissue is tissue proximate spinal cord106, such as within an intrathecal space or epidural space of spinal cord106, or, in some examples, adjacent nerves that branch off spinal cord106. Leads108may be introduced into spinal cord106in via any suitable region, such as the thoracic, cervical or lumbar regions. Stimulation of spinal cord106may, for example, prevent pain signals from traveling through spinal cord106and to the brain of patient102. Patient102may perceive the interruption of pain signals as a reduction in pain and, therefore, efficacious therapy results. In other examples, stimulation of spinal cord106may produce paresthesia which may be reduce the perception of pain by patient102, and thus, provide efficacious therapy results.

IMD110is configured to generate and deliver electrical stimulation therapy to a target stimulation site within patient102via the electrodes of leads108to patient102according to one or more therapy stimulation programs. A therapy stimulation program may generally define informed pulses, but may also define control pulses if the control pulses also contribute to a therapeutic effect). A therapy stimulation program defines values for one or more parameters (e.g., a parameter set) that define an aspect of the therapy delivered by IMD110according to that program. For example, a therapy stimulation program that controls delivery of stimulation by IMD110in the form of pulses may define values for voltage or current pulse amplitude, pulse width, pulse rate (e.g., pulse frequency), electrode combination, pulse shape, etc. for stimulation pulses delivered by IMD110according to that program.

A user, such as a clinician or patient102, may interact with a user interface of an external programmer104to program IMD110. Programming of IMD110may refer generally to the generation and transfer of commands, programs, or other information to control the operation of IMD110. In this manner, IMD110may receive the transferred commands and programs from external programmer104to control stimulation, such as stimulation pulses that provide electrical stimulation therapy. For example, external programmer104may transmit therapy stimulation programs, stimulation parameter adjustments, therapy stimulation program selections, posture states, user input, or other information to control the operation of IMD110, e.g., by wireless telemetry or wired connection.

In some cases, external programmer104may be characterized as a physician or clinician programmer if it is primarily intended for use by a physician or clinician. In other cases, external programmer104may be characterized as a patient programmer if it is primarily intended for use by a patient. A patient programmer may be generally accessible to patient102and, in many cases, may be a portable device that may accompany patient102throughout the patient's daily routine. For example, a patient programmer may receive input from patient102when the patient wishes to terminate or change electrical stimulation therapy, or when a patient perceives stimulation being delivered. In general, a physician or clinician programmer may support selection and generation of programs by a clinician for use by IMD110, whereas a patient programmer may support adjustment and selection of such programs by a patient during ordinary use. In other examples, external programmer104may include, or be part of, an external charging device that recharges a power source of IMD110. In this manner, a user may program and charge IMD110using one device, or multiple devices.

As described herein, information may be transmitted between external programmer104and IMD110. Therefore, IMD110and external programmer104may communicate via wireless communication using any techniques known in the art. Examples of communication techniques may include, for example, radiofrequency (RF) telemetry and inductive coupling, but other techniques are also contemplated. In some examples, external programmer104includes a communication head that may be placed proximate to the patient's body near the IMD110implant site to improve the quality or security of communication between IMD110and external programmer104. Communication between external programmer104and IMD110may occur during power transmission or separate from power transmission.

In some examples, IMD110, in response to commands from external programmer104, delivers electrical stimulation therapy (e.g., informed pulses and/or control pulses) according to a plurality of therapy stimulation programs to a target tissue site of the spinal cord106of patient102via electrodes (not depicted) on leads108. In some examples, IMD110modifies therapy stimulation programs as therapy needs of patient102evolve over time. For example, the modification of the therapy stimulation programs may cause the adjustment of at least one parameter of the plurality of stimulation pulses. When patient102receives the same therapy for an extended period, the efficacy of the therapy may be reduced. In some cases, parameters of the plurality of stimulation pulses may be automatically updated.

As described herein, IMD110may be configured to detect ECAP signals which are representative of the number of nerve fibers activated by a delivered stimulation signal (e.g., a control pulse). Since the distance between electrodes and the target nerve changes for different posture states (e.g., a static posture and/or activity component), a characteristic value of one or more ECAP signals can be indicative of the posture state currently occupied when the one or more ECAP signals were detected by IMD110. In one example, IMD110may deliver a plurality of control pulses defined by different parameter values and detect the respective ECAP signal elicited by each pulse. IMD110may determine a relationship between characteristic values from each ECAP signal and the different parameter values of the control pulses, and this relationship may be different for each different posture state. In one example, the relationship may be a curve of the characteristic values of the ECAP (e.g., an amplitude of the ECAP signal) vs. values of a stimulation parameter (e.g., the current amplitude of the respective control pulses) that elicited each ECAP signal from which the characteristic values were derived. Each posture state may have a respective curve that varies in slope and/or intercept. In some examples, a gain value may be determined from the slope of the growth curve, wherein the gain value may be inversely proportional to the slope.

In this disclosure, efficacy of electrical stimulation therapy may be indicated by one or more characteristics (e.g. an amplitude of or between one or more peaks or an area under the curve of one or more peaks) of an action potential that is evoked by a control pulse delivered by IMD110(i.e., a characteristic value of the ECAP signal). Electrical stimulation therapy delivery by leads108of IMD110may cause neurons within the target tissue to evoke a compound action potential that travels up and down the target tissue, eventually arriving at sensing electrodes of IMD110. Furthermore, stimulation may also elicit at least one ECAP signal, and ECAPs responsive to stimulation may also be a surrogate for the effectiveness of the therapy. The amount of action potentials (e.g., number of neurons propagating action potential signals) that are evoked may be based on the various parameters of electrical stimulation pulses such as amplitude, pulse width, frequency, pulse shape (e.g., slew rate at the beginning and/or end of the pulse), etc. The slew rate may define the rate of change of the voltage and/or current amplitude of the control pulse at the beginning and/or end of each control pulse or each phase within the pulse. For example, a very high slew rate indicates a steep or even near vertical edge of the pulse, and a low slew rate indicates a longer ramp up (or ramp down) in the amplitude of the control pulse. In some examples, these parameters contribute to an intensity of the electrical stimulation. In addition, a characteristic of the ECAP signal (e.g., an amplitude) may change based on the distance between the stimulation electrodes and the nerves subject to the electrical field produced by the delivered control pulses.

Some example techniques for adjusting stimulation parameter values for stimulation pulses (e.g., informed pulses and/or control pulses that may or may not contribute to therapy for the patient) are based on comparing the value of a characteristic of a measured ECAP signal to a target ECAP characteristic value. In response to delivering a control pulse defined by a set of stimulation parameter values, IMD110, via two or more electrodes interposed on leads108, senses electrical potentials of tissue of the spinal cord106of patient102to measure the electrical activity of the tissue. IMD110senses ECAPs from the target tissue of patient102, e.g., with electrodes on one or more leads108and associated sense circuitry. In some examples, IMD110receives a signal indicative of the ECAP from one or more sensors, e.g., one or more electrodes and circuitry, internal or external to patient102. Such an example signal may include a signal indicating an ECAP of the tissue of patient102. Examples of the one or more sensors include one or more sensors configured to measure a compound action potential of patient102, or a physiological effect indicative of a compound action potential. For example, to measure a physiological effect of a compound action potential, the one or more sensors may be an accelerometer, a pressure sensor, a bending sensor, a sensor configured to detect a posture of patient102, or a sensor configured to detect a respiratory function of patient102. However, in other examples, external programmer104receives a signal indicating a compound action potential in the target tissue of patient102and transmits a notification to IMD110.

In the example ofFIG.1, IMD110is described as performing a plurality of processing and computing functions. However, external programmer104instead may perform one, several, or all of these functions. In this alternative example, IMD110functions to relay sensed signals to external programmer104for analysis, and external programmer104transmits instructions to IMD110to adjust the one or more parameters defining the electrical stimulation therapy based on analysis of the sensed signals. For example, IMD110may relay the sensed signal indicative of an ECAP to external programmer104. External programmer104may compare the parameter value of the ECAP to the target ECAP characteristic value, and in response to the comparison, external programmer104may instruct IMD110to adjust one or more stimulation parameter that defines the electrical stimulation informed pulses and, in some examples, control pulses, delivered to patient102.

In some examples, the system changes the target ECAP characteristic value and/or growth rate(s) over a period of time, such as according to a change to a stimulation threshold (e.g., a perception threshold or detection threshold specific for the patient). The system may be programmed to change the target ECAP characteristic in order to adjust the intensity of informed pulses to provide varying sensations to the patient (e.g., increase or decrease the volume of neural activation). Although the system may change the target ECAP characteristic value, received ECAP signals may still be used by the system to adjust one or more parameter values of the informed pulses and/or control pulses in order to meet the target ECAP characteristic value.

One or more devices within system100, such as IMD110and/or external programmer104, may perform various functions as described herein. For example, IMD110may include stimulation circuitry configured to deliver electrical stimulation, sensing circuitry configured to sense a plurality ECAP signals, and processing circuitry. The processing circuitry may be configured to control the stimulation circuitry to deliver a plurality of electrical stimulation pulses (e.g., control pulses) having different amplitude values and control the sensing circuitry to detect, after delivery of each electrical stimulation pulse of the plurality of electrical stimulation pulses, a respective ECAP signal of the plurality of ECAP signals. The processing circuitry of IMD110may then determine, based on the plurality of ECAP signals, a posture state of the patient.

As described herein, IMD110may modulate or adjust one or more stimulation parameters that at least partially define electrical stimulation based on a detected posture state of the patient102. IMD110may use the detected posture state to determine how to employ ECAP signals in a closed-loop feedback system for adjusting stimulation parameters that define informed pulses and/or control pulses. In one example, IMD110includes stimulation generation circuitry configured to generate and deliver electrical stimulation to patient102according one or more sets of stimulation parameters (e.g., informed parameters and/or control parameters) that at least partially define the respective informed pulses and/or control pulses of the electrical stimulation. Each set of stimulation parameters may include at least one of an amplitude, a pulse width, a pulse frequency, or a pulse shape.

IMD110may also include sensing circuitry configured to sense an ECAP signal elicited by delivered electrical stimulation, such as a control pulse. IMD110may also include processing circuitry configured to control delivery of an informed pulses to patient102according to a first value of an informed stimulation parameter and determine a characteristic value of the ECAP signal detected from the control pulse. IMD110may also receive, from a sensor, a posture state signal representing a posture state of the patient. In some examples, IMD110may then determine, based on the posture state signal, a gain value for the stimulation parameter and adjust, based on the characteristic value of the ECAP signal and the gain value, the first value of the informed stimulation parameter to a second value of the informed stimulation parameter. In other examples, IMD110may additionally, or alternatively, adjust a target ECAP characteristic value or a threshold ECAP characteristic value based on the posture state signal. IMD110may then control subsequent delivery of one or more informed stimulation pulses according to the second value of the informed stimulation parameter. In this manner, an informed parameter value that defines the next informed pulse was “informed” by the ECAP signal elicited by a control pulse.

In some examples, the processing circuitry of IMD110may be configured to adjust the first value of the informed parameter to the second value of the informed parameter by one of increasing or decreasing the informed parameter of the informed pulses based on a growth curve associated with the posture state of the patient. In addition, the processing circuitry may be configured to adjust a control parameter value for subsequent control pulses based on the growth curve. As discussed herein, the growth curve may represent a relationship between one or more parameters of delivered control pulses and a characteristic of ECAP signals. For example, the characteristic may be an amplitude of the ECAP signals (e.g., an amplitude between an N1 peak and a P2 peak of the ECAP signal), an area under one or more peaks of the ECAP signal, or some other metric indicative of the nerve activation that resulted in the ECAP signal. In some examples, the gain value may be inversely proportional to a slope of the growth curve.

When IMD110is configured to modulate stimulation pulses in order to maintain consistent nerve activation, such as increasing and decreasing a stimulation parameter to maintain a target ECAP characteristic value, IMD110may perform an example process. For example, IMD110may monitor an amplitude that is the characteristic value of the detected ECAP signal. IMD110may adjust the first value to the second value of the informed stimulation parameter by subtracting the amplitude from a target ECAP amplitude value for the patient to generate a differential amplitude. The differential amplitude is the difference between the detected amplitude from the ECAP signal and the target ECAP amplitude value. IMD110may then multiply the differential amplitude by the gain value that at least partially defines the control pulses to generate a differential value. The gain value may be a multiplier or fraction selected based on the detected posture state. A larger gain value may be associated with posture states at which the distance between electrodes and the target nerve is larger because the distance causes less sensitivity for changes in stimulation pulse intensity. IMD110may then add the differential value to a previous amplitude value (e.g., the amplitude value of the last control pulse that was delivered and elicited the ECAP signal) to generate the second value that at least partially defines the next control pulse to be delivered to patient102. IMD110may then multiple the differential value by a scaling factor to generate an informed differential value representing how much the amplitude of the informed pulses needs to change. The scaling factor may be greater than one when the informed pulse amplitude is greater than the control pulse amplitude, and conversely, the scaling factor may be less than one when the informed pulse amplitude is less than the control pulse amplitude. IMD110can then add the informed differential value to the previous amplitude value of the informed pulses to generate a second value of the informed pulses for subsequent delivery to the patient.

In other examples, IMD110may not attempt to maintain consistent nerve activation by modulating stimulation pulses to achieve a target ECAP characteristic value. Instead, IMD110may monitor characteristic values of ECAP signals and only take action when the characteristic value exceeds a threshold ECAP characteristic value. Characteristic values exceeding the threshold ECAP characteristic values may be indicative of increased stimulation perception that may be above an uncomfortable threshold or pain threshold for the patient. Therefore, reducing stimulation pulse intensity when the characteristic value exceeds this level of stimulation may reduce the likelihood that patient102experiences any uncomfortable sensations that may occur as a result of posture state changes or any transient movement. For example, IMD110may be configured to compare the characteristic value of the ECAP signal to a threshold ECAP characteristic value and determine that the characteristic value of the ECAP signal is greater than the threshold ECAP characteristic value. Responsive to determining that the characteristic value of the ECAP signal is greater than the threshold ECAP characteristic value, IMD110may be configured to decrease the first value of the informed stimulation parameter to the second value of the informed stimulation parameter for subsequent informed pulses to be delivered. Similarly, IMD110may be configured to decrease the value of a control stimulation parameter that defines subsequent control pulses to be delivered.

The detected posture state may be one posture state of a plurality of posture states. In some examples, each posture state may be associated with a respective growth curve representing the relationship between the ECAP values and control stimulation parameter values when the patient occupies that particular posture state. In some examples, IMD110may select, based on the posture state signal, the gain value from a plurality of gain values associated with respective posture states. The gain value may represent at least one of an increment rate (e.g., how fast IMD110should increase the stimulation parameter value) or a decrement rate (e.g., how slow IMD110should decrease the stimulation parameter value) for the control stimulation parameter (or the informed stimulation parameter in some examples) that at least partially defines the control stimulation pulses. In other examples, the gain value may represent a particular magnitude that IMD110should increment or decrement a previous parameter value of control pulses and/or informed pulses each time IMD110increases or decrease the parameter value. This particular magnitude may effectively result in a rate of change at which IMD110can adjust a stimulation parameter value. In addition, or alternatively, IMD110may select the target ECAP characteristic value or the threshold ECAP characteristic value according to the detected posture state. A patient may or may not benefit from posture state specific target or threshold ECAP characteristic values.

IMD110may sense the posture state of patient102at predetermined intervals or during predetermined periods of time. In some examples, IMD110may sense the posture state in response to a trigger event, such as a patient-requested change in stimulation therapy, a sensed event representative of a patient condition such as pain, or any other triggers. In some examples, IMD110may modulate posture state sensing frequency based on whether or not posture state changes are detected. For example, IMD110may determine, from at least the signal representing the posture state of the patient, that the posture state of the patient has changed. Responsive to determining that the posture state has changed, IMD110may change at least one of an ECAP sensing frequency. IMD110may increase posture state sensing frequency when more posture state changes are expected and decrease posture state sensing frequency when fewer posture state changes are expected. Sensing frequency may refer to sensor sampling frequency and/or frequency at which processing circuitry analyzes data obtained from one or more sensors. In this manner, IMD110may modulate sensing frequency to conserve power consumption or otherwise reduce processing tasks.

As discussed herein, some example techniques for adjusting informed stimulation parameter values and/or control stimulation parameter values for electrical stimulation signals are based on comparing the value of a characteristic of a measured ECAP signal to a target ECAP characteristic value or using control parameter values at a determined target ECAP characteristic to inform adjustment of one or more control parameter values and/or informed parameter values to maintain the target ECAP according to known relationships between parameters. For example, during delivery of an electrical stimulation signal, IMD110, via two or more electrodes interposed on leads108, senses electrical potentials of tissue of the spinal cord106of patient102to measure the electrical activity of the tissue. IMD110senses ECAPs from the target tissue of patient102, e.g., with electrodes on one or more leads108and associated sensing circuitry. In some examples, IMD110receives a signal indicative of the ECAP from one or more sensors, e.g., one or more electrodes and circuitry, internal or external to patient102. Such an example signal may include a signal indicating an ECAP of the tissue of the patient102. Examples of the one or more sensors include one or more sensors can measure a compound action potential of the patient102, or a physiological effect indicative of a compound action potential. For example, to measure a physiological effect of a compound action potential, the one or more sensors may be an accelerometer, a pressure sensor, a bending sensor, a sensor can detect a posture of patient102, or a sensor can detect a respiratory function of patient102. However, in other examples, external programmer104receives a signal indicating a compound action potential in the target tissue of patient102and transmits a notification to IMD110.

In the example ofFIG.1, IMD110described as performing a plurality of processing and computing functions. However, external programmer104instead may perform one, several, or all of these functions. In this alternative example, IMD110functions to relay sensed signals to external programmer104for analysis, and external programmer104transmits instructions to IMD110to adjust the one or more parameters defining the electrical stimulation signal based on analysis of the sensed signals. For example, IMD110may relay the sensed signal indicative of an ECAP to external programmer104. External programmer104may compare the parameter value of the ECAP to the target ECAP characteristic value, and in response to the comparison, external programmer104may instruct IMD110to adjust one or more parameters that define the electrical stimulation signal.

In some examples, the system may change the target ECAP characteristic value over a period of time (e.g., based on a sensed posture state or change in patient conditions). The system may be programmed to change the target ECAP characteristic in order to adjust the intensity of the informed pulses and/or control pulses to provide varying sensations to the patient (e.g., increase or decrease the volume of neural activation). In one example, a system may be programmed to oscillate a target ECAP characteristic value between a maximum target ECAP characteristic value and a minimum target ECAP characteristic value at a predetermined frequency to provide a sensation to the patient that may be perceived as a wave or other sensation that may provide therapeutic relief for the patient. The maximum target ECAP characteristic value, the minimum target ECAP characteristic value, and the predetermined frequency may be stored in the memory of IMD110and may be updated in response to a signal from external programmer104(e.g., a user request to change the values stored in the memory of IMD110). In other examples, the target ECAP characteristic value may be programed to steadily increase or steadily decrease to a baseline target ECAP characteristic value over a period of time. In other examples, external programmer104may program the target ECAP characteristic value to automatically change over time according to other predetermined functions or patterns. In other words, the target ECAP characteristic value may be programmed to change incrementally by a predetermined amount or predetermined percentage, the predetermined amount or percentage being selected according to a predetermined function (e.g., sinusoid function, ramp function, exponential function, logarithmic function, or the like). Increments in which the target ECAP characteristic value is changed may be changed for every certain number of pulses or a certain unit of time. Although the system may change the target ECAP characteristic value, received ECAP signals may still be used by the system to adjust one or more informed and/or control parameter values of the electrical stimulation signal in order to meet the target ECAP characteristic value.

Although in one example IMD110takes the form of an SCS device, in other examples, IMD110takes the form of any combination of deep brain stimulation (DBS) devices, implantable cardioverter defibrillators (ICDs), pacemakers, cardiac resynchronization therapy devices (CRT-Ds), left ventricular assist devices (LVADs), implantable sensors, orthopedic devices, or drug pumps, as examples.

FIG.2is a block diagram of IMD200. IMD200may be an example of IMD110ofFIG.1. In the example shown inFIG.2, IMD200includes switch circuitry202, stimulation generation circuitry204, sensing circuitry206, processing circuitry208, sensor210, telemetry circuitry212, power source214, and memory216. Each of these circuits may be or include programmable or fixed function circuitry can perform the functions attributed to respective circuitry. For example, processing circuitry208may include fixed-function or programmable circuitry, stimulation generation circuitry204may include circuitry can generate electrical stimulation signals such as pulses or continuous waveforms on one or more channels, sensing circuitry206may include sensing circuitry for sensing signals, and telemetry circuitry212may include telemetry circuitry for transmission and reception of signals. Memory216may store computer-readable instructions that, when executed by processing circuitry208, cause IMD200to perform various functions described herein. Memory216may be a storage device or other non-transitory medium.

In the example shown inFIG.2, memory216stores patient posture state data218, which may include one or more patient postures, an activity level, or a combination of patient posture and activity level. A set of pre-established posture state definitions for a patient may be stored in patient posture state data218. A posture state definition may be modified based on user therapy adjustments and/or posture state information. In some cases, the posture state may be expanded and split, or instead, may be reduced in size based on posture state information. The posture state definitions can be automatically updated or updated by a patient, including creating new posture states. Posture states may include, for example, a supine posture, a prone posture, a lying left and/or lying right, a sitting posture, a reclining posture, a standing posture, and/or activities such as running or riding in an automobile.

Memory216may store stimulation parameter settings220within memory216or separate areas within memory216. Each stored stimulation parameter setting220defines values for one or more sets of electrical stimulation parameters (e.g., an informed stimulation parameter set and a control stimulation parameter set), such as pulse amplitude, pulse width, pulse frequency, electrode combination, pulse burst rate, pulse burst duration, and/or waveform shape. Stimulation parameter settings220may also include additional information such as instructions regarding delivery of electrical stimulation signals based on stimulation parameter relationship data, which can include relationships between two or more stimulation parameters based upon data from electrical stimulation signals delivered to patient102or data transmitted from external programmer104. The stimulation parameter relationship data may include measurable aspects associated with stimulation, such as an ECAP characteristic value. Stimulation parameter settings220, or another portion of memory216, may include instructions on how processing circuitry208can modulate informed stimulation parameters and/or control stimulation parameters based on the detected posture state and/or at least one of a target ECAP characteristic value or a threshold ECAP characteristic value, as described herein.

Memory216also stores patient ECAP characteristics222which may include target ECAP characteristics and/or threshold ECAP characteristic values determined for the patient and/or a history of measured ECAP characteristic values for the patient. Memory216may also store growth curve data224in separate areas from or as part of patient stimulation parameter settings. Instead of, or in addition to growth curve data224, memory216may include gain values that processing circuitry208may use to modulate informed and/or control stimulation pulses as described herein. In other examples, growth curve data224may include information regarding relationships between ECAP characteristics and control stimulation parameters for one or more posture states.

Accordingly, in some examples, stimulation generation circuitry204generates electrical stimulation signals (e.g., informed pulses and control pulses) in accordance with the electrical stimulation parameters noted above. Other ranges of stimulation parameter values may also be useful and may depend on the target stimulation site within patient102. While stimulation pulses are described, stimulation signals may be of any form, such as continuous-time signals (e.g., sine waves) or the like. Switch circuitry202may include one or more switch arrays, one or more multiplexers, one or more switches (e.g., a switch matrix or other collection of switches), or other electrical circuitry configured to direct stimulation signals from stimulation generation circuitry204to one or more of electrodes232,234, or directed sensed signals from one or more of electrodes232,234to sensing circuitry206. In other examples, stimulation generation circuitry204and/or sensing circuitry206may include sensing circuitry to direct signals to and/or from one or more of electrodes232,234, which may or may not also include switch circuitry202.

Sensing circuitry206may be configured to monitor signals from any combination of electrodes232,234. In some examples, sensing circuitry206includes one or more amplifiers, filters, and analog-to-digital converters. Sensing circuitry206may be used to sense physiological signals, such as ECAPs. In some examples, sensing circuitry206detects ECAPs from a particular combination of electrodes232,234. In some cases, the particular combination of electrodes for sensing ECAPs includes different electrodes than a set of electrodes232,234used to deliver control stimulation pulses and/or informed stimulation pulses. Alternatively, in other cases, the particular combination of electrodes used for sensing ECAPs includes at least one of the same electrodes as a set of electrodes used to deliver informed and/or control stimulation pulses to patient102. Sensing circuitry206may provide signals to an analog-to-digital converter, for conversion into a digital signal for processing, analysis, storage, or output by processing circuitry208.

Processing circuitry208may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), discrete logic circuitry, or any other processing circuitry can provide the functions attributed to processing circuitry208herein may be embodied as firmware, hardware, software or any combination thereof. Processing circuitry208controls stimulation generation circuitry204to generate electrical stimulation signals according to stimulation parameter settings220stored in memory216to apply stimulation parameter values, such as pulse amplitude, pulse width, pulse frequency, and waveform shape of each of the electrical stimulation signals.

In the example shown inFIG.2, the set of electrodes232includes electrodes232A,232B,232C, and232D, and the set of electrodes234includes electrodes234A,234B,234C, and234D. In other examples, a single lead may include all eight electrodes232and234along a single axial length of the lead. Processing circuitry208also controls stimulation generation circuitry204to generate and apply the electrical stimulation signals to selected combinations of electrodes232,234. In some examples, stimulation generation circuitry204includes a switch circuit (instead of, or in addition to, switch circuitry202) that may couple stimulation signals to selected conductors within leads230, which, in turn, deliver the stimulation signals across selected electrodes232,234. Such a switch circuit may be a switch array, switch matrix, multiplexer, or any other type of switch circuitry can selectively couple stimulation energy to selected electrodes232,234and to selectively sense bioelectrical neural signals of a spinal cord of the patient (not shown inFIG.2) with selected electrodes232,234.

In other examples, however, stimulation generation circuitry204does not include a switch circuit and switch circuitry202does not interface between stimulation generation circuitry204and electrodes232,234. In these examples, stimulation generation circuitry204comprises a plurality of pairs of voltage sources, current sources, voltage sinks, or current sinks connected to each of electrodes232,234such that each pair of electrodes has a unique signal circuit. In other words, in these examples, each of electrodes232,234is independently controlled via its own signal circuit (e.g., via a combination of a regulated voltage source and sink or regulated current source and sink), as opposed to switching signals between electrodes232,234.

Electrodes232,234on respective leads230may be constructed of a variety of different designs. For example, one or both of leads230may include one or more electrodes at each longitudinal location along the length of the lead, such as one electrode at different perimeter locations around the perimeter of the lead at each of the locations A, B, C, and D. In one example, the electrodes may be electrically coupled to stimulation generation circuitry204, e.g., via switch circuitry202and/or switch circuitry of the stimulation generation circuitry204, via respective wires that are straight or coiled within the housing of the lead and run to a connector at the proximal end of the lead. In another example, each of the electrodes of the lead may be electrodes deposited on a thin film. The thin film may include an electrically conductive trace for each electrode that runs the length of the thin film to a proximal end connector. The thin film may then be wrapped (e.g., a helical wrap) around an internal member to form the lead230. These and other constructions may be used to create a lead with a complex electrode geometry.

Although sensing circuitry206is incorporated into a common housing with stimulation generation circuitry204and processing circuitry208inFIG.2, in other examples, sensing circuitry206may be in a separate housing from IMD200and may communicate with processing circuitry208via wired or wireless communication techniques.

In some examples, one or more of electrodes232and234may be suitable for sensing ECAPs. For instance, electrodes232and234may sense the voltage amplitude of a portion of the ECAP signals, where the sensed voltage amplitude is a characteristic the ECAP signal.

Memory216may be configured to store information within IMD200during operation. Memory216may include a computer-readable storage medium or computer-readable storage device. In some examples, memory216includes one or more of a short-term memory or a long-term memory. Memory216may include, for example, random access memories (RAM), dynamic random access memories (DRAM), static random access memories (SRAM), magnetic discs, optical discs, flash memories, or forms of electrically programmable memories (EPROM) or electrically erasable and programmable memories (EEPROM). In some examples, memory216is used to store data indicative of instructions for execution by processing circuitry208. As discussed herein, memory216can store patient posture state data218, stimulation parameter settings220, patient ECAP characteristics222, and growth curve data224.

Sensor210may include one or more sensing elements that sense values of a respective patient parameter. As described, electrodes232and234may be the electrodes that sense, via sensing circuitry206, a value of the ECAP indicative of a target stimulation intensity at least partially caused by a set of control stimulation parameter values. Sensor210may include one or more accelerometers, optical sensors, chemical sensors, temperature sensors, pressure sensors, or any other types of sensors. Sensor210may output patient parameter values that may be used as feedback to control delivery of electrical stimulation signals. IMD200may include additional sensors within the housing of IMD200and/or coupled via one of leads108or other leads. In addition, IMD200may receive sensor signals wirelessly from remote sensors via telemetry circuitry212, for example. In some examples, one or more of these remote sensors may be external to patient (e.g., carried on the external surface of the skin, attached to clothing, or otherwise positioned external to the patient). In some examples, signals from sensor210may indicate a posture state (e.g., sleeping, awake, sitting, standing, or the like), and processing circuitry208may select target and/or threshold ECAP characteristic values according to the indicated posture state. In this manner, processing circuitry208may be configured to determine the currently occupied posture state of patient102.

Telemetry circuitry212supports wireless communication between IMD200and an external programmer (not shown inFIG.2) or another computing device under the control of processing circuitry208. Processing circuitry208of IMD200may receive, as updates to programs, values for various stimulation parameters such as amplitude and electrode combination (e.g., for informed and/or control pulses), from the external programmer via telemetry circuitry212. Updates to stimulation parameter settings220and input efficacy threshold settings226may be stored within memory216. Telemetry circuitry212in IMD200, as well as telemetry circuits in other devices and systems described herein, such as the external programmer, may accomplish communication by radiofrequency (RF) communication techniques. In addition, telemetry circuitry212may communicate with an external medical device programmer (not shown inFIG.2) via proximal inductive interaction of IMD200with the external programmer. The external programmer may be one example of external programmer104ofFIG.1. Accordingly, telemetry circuitry212may send information to the external programmer on a continuous basis, at periodic intervals, or upon request from IMD110or the external programmer.

Power source214delivers operating power to various components of IMD200. Power source214may include a rechargeable or non-rechargeable battery and a power generation circuit to produce the operating power. Recharging may be accomplished through proximal inductive interaction between an external charger and an inductive charging coil within IMD200. In other examples, traditional primary cell batteries may be used. In some examples, processing circuitry208may monitor the remaining charge (e.g., voltage) of power source214and select stimulation parameter values that may deliver similarly effective therapy at lower power consumption levels when needed to extend the operating time of power source214. For example, power source214may switch to a lower pulse frequency based on the relationships of parameters that may provide similar ECAP characteristic values.

According to the techniques of the disclosure, stimulation generation circuitry204of IMD200receives, via telemetry circuitry212, instructions to deliver electrical stimulation according to stimulation parameter settings220to a target tissue site of the spinal cord of the patient via a plurality of electrode combinations of electrodes232,234of leads230and/or a housing of IMD200. Each electrical stimulation signal may elicit an ECAP that is sensed by sensing circuitry206via electrodes232and234. Processing circuitry208may receive, via an electrical signal sensed by sensing circuitry206, information indicative of an ECAP signal (e.g., a numerical value indicating a characteristic of the ECAP in electrical units such as voltage or power) produced in response to the electrical stimulation signal(s). Stimulation parameter settings220may be updated according to the ECAPs recorded at sensing circuitry206according to the following techniques.

Generally, the pulse width of informed pulses are greater than the pulse width of control pulses. This difference in pulse width may allow ECAPs elicited from the control pulses to be detectable by the system when the longer pulse widths of the informed pulses prevent elicited ECAPs, or at least some portion of the elicited ECAPs, from being detectable. In some examples, the plurality of informed stimulation pulses are defined by an informed pulse width greater than approximately 300 microseconds and less than approximately 1000 microseconds, while the plurality of control stimulation pulses are defined by a control pulse width less than approximately 300 microseconds. In one example, the plurality of informed pulses each have a pulse width of greater than approximately 300 μs and less than approximately 2000 μs (i.e., 2 milliseconds). In some examples, the informed pulse width is greater than approximately 300 μs and less than approximately 900 μs. In another example, the informed pulse width is greater than approximately 300 μs and less than approximately 500 μs. In one example, the informed pulses have a pulse width of approximately 450 μs and a pulse frequency of approximately 60 Hertz. Amplitude (current and/or voltage) for the pulses may be between approximately 0.5 mA (or volts) and approximately 10 mA (or volts), although amplitude may be lower or greater in other examples.

In one example, the predetermined pulse frequency of the plurality of informed pulses may be less than approximately 400 Hertz. In some examples, the predetermined pulse frequency of the plurality of pulses may be between approximately 50 Hertz and 70 Hertz. In one example, the predetermined pulse frequency of the plurality of pulses may be approximately 60 Hertz. However, the informed pulses may have frequencies greater than 400 Hertz or less than 50 Hertz in other examples. In addition, the informed pulses may be delivered in bursts of pulses, with interburst frequencies of the informed pulses being low enough such that a sensed ECAP elicited by a control pulse can still fit within the window between consecutive pulses delivered within the burst of pulses. In any example, processing circuitry208may be configured to detect ECAPs elicited from respective control stimulation pulses.

The pulse width of the control pulses may be shorter than the pulse width of the informed pulses to reduce or prevent a sensed electrical artifact from control pulses from obscuring the ECAP signals (put another way, the pulse width of the informed pulses may be longer than the pulse width of the control pulses). For example, the control pulses may be less than approximately 300 microseconds (μs). In one example, the control pulse may be a bi-phasic pulse having a positive phase of approximately 100 μs and a negative phase of approximately 100 μs separated by an interphase interval of approximately 30 μs. In this manner, stimulation electrodes at one end of a lead may deliver the control pulse and electrodes at the other end of the same lead may sense the ECAP signal without, or with minimal, interference from the control pulse itself. In general, the term “pulse width” herein refers to the collective duration of every phase, and interphase interval when appropriate, of a single pulse. A single pulse may include a single phase in some examples (i.e., a monophasic pulse) or two or more phases in other examples (e.g., a bi-phasic pulse or a tri-phasic pulse). The pulse width defines a period of time beginning with a start time of a first phase of the pulse and concluding with an end time of a last phase of the pulse (e.g., a biphasic pulse having a positive phase lasting 100 μs, a negative phase lasting 100 μs, and an interphase interval lasting 30 μs defines a pulse width of 230 μs).

Processing circuitry208may be configured to compare one or more characteristics of ECAPs sensed by sensing circuitry206with target ECAP characteristics stored in memory216(e.g., patient ECAP characteristics222). For example, processing circuitry208can determine the amplitude of each ECAP signal received at sensing circuitry206, and processing circuitry208can determine the representative amplitude of at least one respective ECAP signal and compare the representative amplitude of a series of ECAP signals to a target ECAP characteristic value.

In other examples, processing circuitry208may use the representative amplitude of the at least one respective ECAP to change other parameters of stimulation pulses (e.g., informed pulses and/or control pulses) to be delivered, such as pulse width, pulse frequency, and pulse shape. All of these parameters may contribute to the intensity of the stimulation pulses, and changing one or more of these parameter values may effectively adjust the stimulation pulse intensity to compensate for the changed distance between the stimulation electrodes and the nerves indicated by the characteristic (e.g., a representative amplitude) of the ECAP signals.

In some examples, leads230may be linear 8-electrode leads (not pictured); sensing and stimulation delivery may each be performed using a different set of electrodes. In a linear 8-electrode lead, each electrode may be numbered consecutively from 0 through 7. For instance, a pulse may be generated using electrode 1 as a cathode and electrodes 0 and 2 as anodes (e.g., a guarded cathode), and a respective ECAP signal may be sensed using electrodes 6 and 7, which are located on the opposite end of the electrode array. This strategy may minimize the interference of the stimulation pulse with the sensing of the respective ECAP. Other electrode combinations may be implemented, and the electrode combinations may be changed using the patient programmer via telemetry circuitry212. For example, stimulation electrodes and sensing electrodes may be positioned closer together. Shorter pulse widths for the nontherapeutic pulses may allow the sensing electrodes to be closer to the stimulation electrodes.

In one example, sensor210may detect a change in posture state, including activity or a change in posture of the patient. Processing circuitry208may receive an indication from sensor210that the activity level or posture of the patient is changed, and processing circuitry208can initiate or change the delivery of the plurality of pulses according to stimulation parameter settings220. For example, processing circuitry208may increase the frequency of pulse delivery and respective ECAP sensing in response to receiving an indication that the patient activity has increased, which may indicate that the distance between electrodes and nerves will likely change. Alternatively, processing circuitry208may decrease the frequency of pulse delivery and respective ECAP sensing in response to receiving an indication that the patient activity has decreased. In some examples, one or more therapy parameters (e.g., frequency, amplitude, slew rate, pulse width, or the like) may be adjusted (e.g., increased or decreased) in response to receiving an indication that the patient posture state has changed. Processing circuitry208can update patient posture state data218and growth curve data224according to the signal received from sensor210.

FIG.3is a block diagram of the example external programmer300. External programmer300may be an example of external programmer104ofFIG.1. Although programmer300may generally be described as a hand-held device, external programmer300may be a larger portable device or a more stationary device. In addition, in some examples, external programmer300may be included as part of an external charging device or include the functionality of an external charging device. As illustrated inFIG.3, external programmer300may include a processing circuitry302, memory304, user interface306, telemetry circuitry308, and power source310. Storage device304may store instructions that, when executed by processing circuitry302, cause processing circuitry302and external programmer300to provide the functionality ascribed to external programmer300throughout this disclosure. Each of these components, circuitry, or modules, may include electrical circuitry that can perform some, or all of the functionality described herein. For example, processing circuitry302may include processing circuitry to perform the processes discussed with respect to processing circuitry302.

In general, programmer300comprises any suitable arrangement of hardware, alone or in combination with software and/or firmware, to perform the techniques attributed to programmer300, and processing circuitry302, user interface306, and telemetry circuitry308of programmer300. In various examples, programmer300may include one or more processors, such as one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components. Programmer300also, in various examples, may include a memory304, such as RAM, ROM, PROM, EPROM, EEPROM, flash memory, a hard disk, a CD-ROM, comprising executable instructions for causing the one or more processors to perform the actions attributed to them. Moreover, although processing circuitry302and telemetry circuitry308are described as separate, in some examples, processing circuitry302and telemetry circuitry308are functionally integrated. In some examples, processing circuitry302and telemetry circuitry308correspond to individual hardware units, such as ASICs, DSPs, FPGAs, or other hardware units.

Memory304(e.g., a storage device) may store instructions that, when executed by processing circuitry302, cause processing circuitry302and programmer300to provide the functionality ascribed to programmer300throughout this disclosure. For example, memory304may include instructions that cause processing circuitry302to obtain a stimulation parameter setting from memory, select a spatial electrode movement pattern, or receive a user input and send a corresponding command to programmer300, or instructions for any other functionality. In addition, memory304may include a plurality of stimulation parameter settings, where each setting includes a parameter set that defines electrical stimulation. Memory304may also store data received from a medical device (e.g., IMD110). For example, memory304may store ECAP related data recorded at a sensing circuitry of the medical device, and memory304may also store data from one or more sensors of the medical device.

User interface306may include a button or keypad, lights, a speaker for voice commands, a display, such as a liquid crystal (LCD), light-emitting diode (LED), or organic light-emitting diode (OLED). In some examples the display may be a touch screen. User interface306can display any information related to the delivery of electrical stimulation, identified patient behaviors, sensed patient parameter values, patient behavior criteria, or any other such information. External programmer300may receive user input (e.g., indication of when the patient changes posture states) via user interface306. The input may be, for example, in the form of pressing a button on a keypad or selecting an icon from a touch screen. The input may request starting or stopping electrical stimulation, the input may request a new spatial electrode movement pattern or a change to an existing spatial electrode movement pattern, of the input may request some other change to the delivery of electrical stimulation. In other examples, user interface306may receive input from the patient and/or clinician regarding efficacy of the therapy, such as binary feedback, numerical ratings, textual input, etc. In some examples, processing circuitry302may interpret patient requests to change therapy as negative feedback regarding the current parameter values used to define therapy.

Telemetry circuitry308may support wireless communication between the medical device and programmer300under the control of processing circuitry302. Telemetry circuitry308can communicate with another computing device via wireless communication techniques, or direct communication through a wired connection. In some examples, telemetry circuitry308provides wireless communication via an RF or proximal inductive medium. In some examples, telemetry circuitry308includes an antenna, which may take on a variety of forms, such as an internal or external antenna.

Examples of local wireless communication techniques that may be employed to facilitate communication between programmer300and IMD110include RF communication according to the 902.11 or Bluetooth specification sets or other standard or proprietary telemetry protocols. In this manner, other external devices may be capable of communicating with programmer300without needing to establish a secure wireless connection. As described herein, telemetry circuitry308can transmit a spatial electrode movement pattern or other stimulation parameter values to IMD110for delivery of electrical stimulation.

According to the techniques of the disclosure, user interface306of external programmer300receives an indication from a clinician instructing a processor of the medical device to update one or more patient posture state settings, gain values, growth curve settings, or stimulation parameter settings. Updating the posture state settings, gain values, growth curve settings may cause the stimulation parameter settings to update as well, including changing one or more parameter values of the informed stimulation pulses delivered by the medical device according to the settings, such as pulse amplitude, pulse width, pulse frequency, electrode combination, and/or waveform shape. Gain values and/or growth curve settings may be based upon sensed ECAP signals, posture state data, and stimulation parameter data, in some examples. User interface306may also receive instructions from the clinician commanding any electrical stimulation.

Power source310can deliver operating power to various components of programmer300. Power source310may be the same as or substantially similar to power source214. Power source310may include a battery and a power generation circuit to produce the operating power. In some examples, the battery is rechargeable to allow extended operation. Recharging may be accomplished by electrically coupling power source310to a cradle or plug that is connected to an alternating current (AC) outlet. In addition, recharging may be accomplished through proximal inductive interaction between an external charger and an inductive charging coil within external programmer300. In other examples, traditional batteries (e.g., nickel cadmium or lithium ion batteries) may be used. In addition, external programmer300may be directly coupled to an alternating current outlet to operate.

The architecture of external programmer300illustrated inFIG.3is shown as an example. The techniques as set forth in this disclosure may be implemented in the example external programmer300ofFIG.3, as well as other types of systems not described specifically herein. Nothing in this disclosure should be construed so as to limit the techniques of this disclosure to the example architecture illustrated byFIG.3.

FIG.4is a graph400of an example ECAP signals sensed for respective stimulation pulses (e.g., a control pulse). As shown inFIG.3, graph400shows example ECAP signal402(dotted line) and ECAP signal404(solid line). Each of ECAP signals402and404may be sensed from control pulses that were delivered from a guarded cathode and bi-phasic pulses including an interphase interval between each positive and negative phase of the pulse. The guarded cathode of the stimulation electrodes is located at the end of an 8-electrode lead while two sensing electrodes are provided at the other end of the 8-electrode lead. ECAP signal402illustrates the voltage amplitude sensed as a result from a sub-threshold stimulation pulse. Peaks406of ECAP signal402are detected and represent the artifact of the delivered pulse. However, no propagating signal is detected after the artifact in ECAP signal404because the pulse was sub-threshold.

In contrast to ECAP signal402, ECAP signal404represents the voltage amplitude detected from a supra-threshold stimulation pulse. Peaks406of ECAP signal404are detected and represent the artifact of the delivered pulse. After peaks406, ECAP signal404also includes peaks P1, N1, and P2, which are three peaks representative of propagating action potentials from an ECAP. The example duration of the artifact and peaks P1, N1, and P2 is approximately 1 millisecond (ms). When detecting the ECAP of ECAP signal404, different characteristics may be identified. For example, the characteristic of the ECAP may be the amplitude between N1 and P2. This N1-P2 amplitude can be detected even if the artifact impinges on P1, a relatively large signal, and the N1-P2 amplitude may be minimally affected by electronic drift in the signal. In other examples, the characteristic of the ECAP used to control pulses may be an amplitude of P1, N1, or P2 with respect to neutral or zero voltage. In some examples, the characteristic of the ECAP used to control pulses may be a sum of two or more of peaks P1, N1, or P2. In other examples, the characteristic of ECAP signal404may be the area under one or more of peaks P1, N1, and/or P2. In other examples, the characteristic of the ECAP may be a ratio of one of peaks P1, N1, or P2 to another one of the peaks. In some examples, the characteristic of the ECAP may be a slope between two points in the ECAP signal, such as the slope between N1 and P2. In other examples, the characteristic of the ECAP may be the time between two points of the ECAP, such as the time between N1 and P2. The time between two points in the ECAP signal may be referred to as a latency of the ECAP and may indicate the types of fibers being captured by the pulse. ECAP signals with lower latency (i.e., smaller latency values) indicate a higher percentage of nerve fibers that have faster propagation of signals, whereas ECAP signals with higher latency (i.e., larger latency values) indicate a higher percentage of nerve fibers that have slower propagation of signals. Other characteristics of the ECAP signal may be used in other examples.

The amplitude of the ECAP signal increases with increased amplitude of the pulse, as long as the pulse amplitude is greater than the threshold such that nerves depolarize and propagate the signal. The target ECAP characteristic (e.g., the target ECAP amplitude) may be determined from the ECAP signal detected from a pulse when pulses are determined to deliver effective therapy to the patient. The ECAP signal thus is representative of the distance between the stimulation electrodes and the nerves appropriate for the stimulation parameter values of the pulses delivered at that time. Therefore, IMD110may attempt to use detected changes to the measured ECAP characteristic value to change stimulation pulse parameter values and maintain the target ECAP characteristic value during stimulation pulse delivery (e.g., informed pulses and/or control pulses). Alternatively, IMD110may attempt to prevent undesirable stimulation intensity by decreasing stimulation pulse intensity in response to the ECAP characteristic value exceeding a threshold ECAP characteristic value.

FIG.5Ais a timing diagram500A illustrating one example of electrical stimulation pulses (e.g., control pulses) and respective sensed ECAPs, in accordance with one or more techniques of this disclosure. For convenience,FIG.5Ais described with reference to IMD200ofFIG.2. As illustrated, timing diagram500A includes first channel502, a plurality of control pulses504A-504N (collectively “control pulses504”), second channel506, a plurality of respective ECAPs508A-508N (collectively “ECAPs508”), and a plurality of stimulation interference signals509A-509N (collectively “stimulation interference signals509”). In the example ofFIG.5A, control pulses504may or may not contribute to therapy for the patient. In any case, control pulses504may elicit respective ECAPs508for the purpose of determining relative neural recruitment due to the control pulses504, which may be reflective as a growth curve specific to the posture state of the patient that was assumed with the ECAPs508were sensed.

First channel502is a time/voltage (and/or current) graph indicating the voltage (or current) of at least one electrode of electrodes232,234. In one example, the stimulation electrodes of first channel502may be located on the opposite side of the lead as the sensing electrodes of second channel506. Control pulses504may be electrical pulses delivered to the spinal cord of the patient by at least one of electrodes232,234, and control pulses504may be balanced biphasic square pulses with an interphase interval. In other words, each of control pulses504are shown with a negative phase and a positive phase separated by an interphase interval. For example, a control pulse504may have a negative voltage for the same amount of time and amplitude that it has a positive voltage. It is noted that the negative voltage phase may be before or after the positive voltage phase. Control pulses504may be delivered according to instructions stored in storage device212of IMD200.

In some examples, each of control pulses504may be a part of a sweep of pulses configured to determine a relationship between the stimulation parameter values of the pulses and a characteristic value of the resulting respective ECAPs508. For example, the relationship may be a growth curve of ECAP voltage amplitude versus pulse current amplitude. In this manner, each of control pulses504may differ from each other by a parameter value, such as an iteratively increasing current amplitude. Such sweeps may be performed for each posture state of a plurality of posture states in order to determine the growth curve, gain value, or some characteristic related to ECAPs for that posture state. In one example, control pulses504may have a pulse width of less than approximately 300 microseconds (e.g., the total time of the positive phase, the negative phase, and the interphase interval is less than 300 microseconds). In another example, control pulses504may have a pulse width of approximately 100 microseconds for each phase of the bi-phasic pulse. In some examples, the pulse width of control pulses504may be longer than 300 microseconds, as long as the pulse width does not interfere with the detection of the desired one or more features of the elicited ECAPs508. As illustrated inFIG.5A, control pulses504may be delivered via channel502. Delivery of control pulses504may be delivered by leads230in a guarded cathode electrode combination. For example, if leads230are linear 8-electrode leads, a guarded cathode combination is a central cathodic electrode with anodic electrodes immediately adjacent to the cathodic electrode.

Second channel506is a time/voltage (and/or current) graph indicating the voltage (or current) of at least one electrode of electrodes232,234. In one example, the electrodes of second channel506may be located on the opposite side of the lead as the electrodes of first channel502. ECAPs508may be sensed at electrodes232,234from the spinal cord of the patient in response to control pulses504. ECAPs508are electrical signals which may propagate along a nerve away from the origination of control pulses504. In one example, ECAPs508are sensed by different electrodes than the electrodes used to deliver control pulses504. As illustrated inFIG.5A, ECAPs508may be recorded on second channel506. In some examples, ECAPs508may not be sensed after each control pulse504.

Stimulation interference signals509A,509B, and509N (e.g., the artifact of the control pulses) may be sensed by leads230and may be sensed during the same period of time as the delivery of control pulses504. Since the interference signals may have a greater amplitude and intensity than ECAPs508, any ECAPs arriving at IMD200during the occurrence of stimulation interference signals509may not be adequately sensed by sensing circuitry206of IMD200. However, ECAPs508may be sufficiently sensed by sensing circuitry206because each ECAP508, or at least a portion of ECAP508that includes one or more desired features of ECAP508that is used to detect the posture state and/or as feedback for control pulses504, falls after the completion of each a control pulse504. As illustrated inFIG.5A, stimulation interference signals509and ECAPs508may be recorded on channel506.

In some examples, IMD200, for example, may deliver the entire group of control pulses504(e.g., a sweep) consecutively and without any other intervening pulses in order to detect ECAPs508from which respective characteristic values are determined. IMD200may then determine the relationship between the characteristic values from ECAPs508and the different parameter values of control pulses504. In one example, the sweep of pulses504may be delivered by IMD200during a break in delivery of other types of control pulses.

FIG.5Bis a timing diagram500B illustrating another example of electrical stimulation pulses and respective sensed ECAPs, in accordance with one or more techniques of this disclosure. For convenience,FIG.5Bis described with reference to IMD200ofFIG.2. As illustrated, timing diagram500B includes first channel510, a plurality of control pulses512A-512N (collectively “control pulses512”), second channel520, a plurality of informed pulses524A-524N (collectively “informed pulses524”) including passive recharge phases526A-526N (collectively “passive recharge phases526”), third channel530, a plurality of respective ECAPs536A-536N (collectively “ECAPs536”), and a plurality of stimulation interference signals538A-538N (collectively “stimulation interference signals538”).

First channel510is a time/voltage (and/or current) graph indicating the voltage (or current) of at least one electrode of electrodes232,234. In one example, the stimulation electrodes of first channel510may be located on the opposite side of the lead as the sensing electrodes of third channel530. Control pulses512may be electrical pulses delivered to the spinal cord of the patient by at least one of electrodes232,234, and control pulses512may be balanced biphasic square pulses with an interphase interval. In other words, each of control pulses512are shown with a negative phase and a positive phase separated by an interphase interval. For example, control pulse512may have a negative voltage for the same amount of time and amplitude that it has a positive voltage. It is noted that the negative voltage phase may be before or after the positive voltage phase. Control pulses512may be delivered according to control stimulation parameters stored in memory216of IMD200, and the control stimulation parameters may be updated according to user input via an external programmer and/or may be updated according to a signal from sensor(s)210. In one example, control pulses512may have a pulse width of less than approximately 300 microseconds (e.g., the total time of the positive phase, the negative phase, and the interphase interval is less than 300 microseconds). In another example, control pulses512may have a pulse width of approximately 100 microseconds for each phase of the bi-phasic pulse. As illustrated inFIG.5B, control pulses512may be delivered via channel510. Delivery of control pulses512may be delivered by leads230in a guarded cathode electrode combination. For example, if leads230are linear 8-electrode leads, a guarded cathode combination is a central cathodic electrode with anodic electrodes immediately adjacent to the cathodic electrode.

Second channel520is a time/voltage (and/or current) graph indicating the voltage (or current) of at least one electrode of electrodes232,234for the informed pulses. In one example, the electrodes of second channel520may partially or fully share common electrodes with the electrodes of first channel510and third channel530. Informed pulses524may also be delivered by the same leads230that are configured to deliver control pulses512. Informed pulses524may be interleaved with control pulses512, such that the two types of pulses are not delivered during overlapping periods of time. However, informed pulses524may or may not be delivered by exactly the same electrodes that deliver control pulses512. Informed pulses524may be monophasic pulses with pulse widths of greater than approximately 300 microseconds and less than approximately 1000 microseconds. In fact, informed pulses524may be configured to have longer pulse widths than control pulses512. As illustrated inFIG.6B, informed pulses524may be delivered on channel520.

Informed pulses524may be configured for passive recharge. For example, each informed pulse524may be followed by a passive recharge phase526to equalize charge on the stimulation electrodes. Unlike a pulse configured for active recharge, wherein remaining charge on the tissue following a stimulation pulse is instantly removed from the tissue by an opposite applied charge, passive recharge allows tissue to naturally discharge to some reference voltage (e.g., ground or a rail voltage) following the termination of informed pulse524. In some examples, the electrodes of the medical device may be grounded at the medical device body. In this case, following the termination of informed pulse524, the charge on the tissue surrounding the electrodes may dissipate to the medical device, creating a rapid decay of the remaining charge at the tissue following the termination of the pulse. This rapid decay is illustrated in passive recharge phases526. Passive recharge phase526may have a duration in addition to the pulse width of the preceding informed pulse524. In other examples (not pictured inFIG.5B), informed pulses524may be bi-phasic pulses having a positive and negative phase (and, in some examples, an interphase interval between each phase) which may be referred to as pulses including active recharge. Informed pulse524that is a bi-phasic pulse may or may not have a following passive recharge phase.

Third channel530is a time/voltage (and/or current) graph indicating the voltage (or current) of at least one electrode of electrodes232,234. In one example, the electrodes of third channel530may be located on the opposite side of the lead as the electrodes of first channel510. ECAPs536may be sensed at electrodes232,234from the spinal cord of the patient in response to control pulses512. ECAPs536are electrical signals which may propagate along a nerve away from the origination of control pulses512. In one example, ECAPs536are sensed by different electrodes than the electrodes used to deliver control pulses512. As illustrated inFIG.5B, ECAPs536may be recorded on third channel530.

Stimulation interference signals538A,538B, and538N (e.g., the artifact of the stimulation pulses) may be sensed by leads230and may be sensed during the same period of time as the delivery of control pulses512and informed pulses524. Since the interference signals may have a greater amplitude and intensity than ECAPs536, any ECAPs arriving at IMD200during the occurrence of stimulation interference signals538may not be adequately sensed by sensing circuitry206of IMD200. However, ECAPs536may be sufficiently sensed by sensing circuitry206because each ECAP536falls after the completion of each control pulse512and before the delivery of the next informed pulse524. As illustrated inFIG.5B, stimulation interference signals538and ECAPs536may be recorded on channel530.

Two or more control pulses512may be delivered during each time event (e.g., window) of a plurality of time events, and each time event represents a time between two consecutive informed pulses524. For example, during each time event, a first control pulse may be directly followed by a first respective ECAP, and subsequent to the completion of the first respective ECAP, a second control pulse may be directly followed by a second respective ECAP. Informed pulses may commence following the second respective ECAP.

Consecutive informed pulses524may be delivered without intervening control pulse512. For example, control pulses512may not be delivered during each time event (or window) of the plurality of time events, wherein each time event represents a time between two consecutive informed pulses524. In any case, informed pulses524can be delivered according to a predetermined frequency, and control pulses512may be delivered at any time between the informed pulses.

FIG.5Cis a timing diagram500C illustrating another example of electrical stimulation pulses and respective ECAPs according to the techniques of the disclosure. For convenience,FIG.5Cis described with reference to IMD200ofFIG.2A. As illustrated, timing diagram500C includes first channel540, a plurality of control pulses542A-542N (collectively “control pulses542”), second channel550, a plurality of informed pulses554A-554N (collectively “informed pulses554”) including passive recharge phases556A-556N (collectively “passive recharge phases556”), third channel560, a plurality of respective ECAPs564A-564N (collectively “ECAPs564”), and a plurality of stimulation interference signals562A-562N (collectively “stimulation interference signals562”).FIG.5Cmay be substantially similar toFIG.5B, except for the differences detailed below.

Two or more (e.g. two) control pulses542may be delivered during each time event (e.g., window) of a plurality of time events, and each time event represents a time between two consecutive informed pulses554. For example, during each time event, a first control pulse of control pulses542A may be directly followed by a first respective ECAP of ECAPs564A, and subsequent to the completion of the first respective ECAP, a second control pulse of control pulses542A may be directly followed by a second respective ECAP of ECAPs564A. Informed pulses554may commence following the second respective ECAP. In other examples not illustrated here, three or more control pulses542may be delivered, and respective ECAP signals sensed, during each time event of the plurality of time events.

FIG.5Dis a timing diagram500D illustrating another example of electrical stimulation pulses and respective ECAPs according to the techniques of the disclosure. For convenience,FIG.5Dis described with reference to IMD200ofFIG.2A. As illustrated, timing diagram500D includes first channel570, a plurality of control pulses572A-572N (collectively “control pulses572”), second channel580, a plurality of informed pulses582A-582N (collectively “informed pulses582”) including passive recharge phases584A-584N (collectively “passive recharge phases584”), third channel590, a plurality of respective ECAPs594A-594N (collectively “ECAPs594”), and a plurality of stimulation interference signals592A-592N (collectively “stimulation interference signals592”).FIG.6may be substantially similar toFIGS.5B and5C, except for the differences detailed below.

In previous examples illustrated inFIG.5BandFIG.5C, at least one control pulse was delivered and interleaved between each pair of consecutive informed pulses. However, in some examples, control pulses572are not delivered during each time event (or window) of the plurality of time events, wherein each time event represents a time between two consecutive informed pulses582. As illustrated in the example ofFIG.5D, a control pulse572is not delivered following informed pulse582A and preceding informed pulse582B. In other words, consecutive informed pulses582A and582B may be delivered without an intervening control pulse. In any case, informed pulses are delivered according to a predetermined frequency, and control pulses may be delivered at any time between the informed pulses. In some examples, the parameter values of both informed pulse582A and informed pulse582B may be the same because they are defined by the same stimulation program. In other examples, informed pulse582A and informed pulse582B may have at least one stimulation parameter that differs in value, such as a different amplitude, pulse width, pulse frequency, or electrode combination. In this manner, informed pulse582A may be a part of a first stimulation program while informed pulse582B may be part of a second stimulation program that is different than the first stimulation program. Processing circuitry214may thus delivery informed pulses from two or more different stimulation programs, where processing circuitry214uses the detected ECAP signal from the same control pulse (e.g., control pulse572A) to “inform” or otherwise adjust one or more parameter values of the informed pulses in multiple stimulation programs (e.g., both of informed pulses582A and582B). This concept of multiple stimulation programs may be applied to any informed pulses described herein.

Control pulses572may be administered according to control stimulation parameters stored in memory216. Processing circuitry214may be configured to update the control pulse delivery instructions according to user input via telemetry circuitry213, and also by a signal from sensor216. For example, a clinician may operate a patient programmer and send a signal to telemetry circuitry213including instructions for updating the control pulse parameters. The clinician may set control stimulation to any of the examples illustrated inFIGS.5A-5D, and the clinician also may customize control stimulation to a configuration not illustrated inFIGS.5A-5D. The clinician may elect to cease control stimulation or commence control stimulation at any time. In some examples, a detection that the patient's posture or activity level has changed will initiate control stimulation.

FIG.6is a graph600of example growth curves602,604, and606of sensed ECAPs from respective stimulation pulse amplitudes. Graph600illustrates example ECAPs shown as dots (growth curve602), squares (growth curve604), and triangles (growth curve606) for respective different current amplitudes of stimulation pulses. ECAPs will sometimes not be generated until the control stimulation pulse amplitude reaches a threshold, approximately at 4.5 mA current in the example ofFIG.6. Then, as the current amplitude is increased, the ECAP amplitude also increases approximately linearly. This linear relationship is shown by growth curves602,604,606. Besides growth curves varying based on the posture state of the patient, the slope may vary for each patient based on the type of electrodes implanted, where the electrodes are implanted, the sensitivity of the patient's neurons to stimulation, neurological dysfunction, or other factors.

While a patient is in a given posture state, sensed ECAPs may be detected for control stimulation pulses with different current amplitudes. For example, each growth curve602,604, and606may be for a single posture state, e.g., supine, prone, sitting, standing, or lying on the right side or left side. If a patient changes posture states, the growth curve can also change. When a patient changes posture states, e.g., supine to standing and standing to running, the corresponding growth curve can change as well. For example, growth curve602may be associated with a supine posture state, growth curve604may be associated with a sitting posture state, and growth curve606may be associated with a prone posture state. In some examples, a patient may change posture states, but the same growth curve, or gain value, may apply to the different posture state.

The slope of the growth curves602,604, and606that linearly increase may indicate the relationship between sensed ECAP amplitudes and control pulse amplitudes. In some examples, the gain value used to increase or decrease control stimulation parameter values and/or informed stimulation pulse values may be inversely proportional to the slope of the growth curve of values of the characteristic of ECAP signals (e.g., an amplitude such as the N1-P2 amplitude or the amplitude of any peak of the ECAP signal) elicited from respective control stimulation pulses delivered to the patient and at least partially defined by different values of a control stimulation parameter (e.g., current amplitude, voltage amplitude, or pulse width). For example, the gain value for a patient may be used to dynamically adjust pulse amplitude based on the sensed ECAP amplitudes. In some examples, the gain may be approximated for a patient based on historical data for similar patients. In other examples, the system may generate a custom growth curve and gain specific to the patient before starting therapy with the system.

FIG.7is a flowchart illustrating an example operation700for informed delivery according to the techniques of this disclosure. For convenience,FIG.7is described with respect to processing circuitry208of IMD200ofFIG.2. However, the techniques ofFIG.7may be performed by different components of IMD200or by additional or alternative medical devices in some examples.

In the example ofFIG.7, IMD200delivers electrical stimulation therapy to patient102, the electrical stimulation therapy comprising a plurality of informed pulses at a predetermined pulse frequency over a period of time (702). Furthermore, IMD200delivers, over the period of time, a plurality of control pulses interleaved with at least some informed pulses of the plurality of informed pulses (704). For example, one or more control pulses may be delivered between consecutive informed pulses. As another example, one or more informed pulses may be delivered between consecutive control pulses. IMD200may sense, after each control pulse and prior to an immediately subsequent informed pulse of the plurality of informed pulses, a respective ECAP (706). Subsequent to the sensing, IMD200may adjust, based on at least one respective ECAP and a selected growth curve, one or more informed parameter values that at least partially define the plurality of informed pulses of the electrical stimulation therapy (708). IMD200may also determine the current posture state of the patient and select the growth curve associated with the determined posture state. IMD200may compare a value of a characteristic of the sensed ECAP to a target ECAP characteristic value and adjust the informed pulses and, in some examples, the control pulses to maintain the target ECAP characteristic value. As discussed herein, IMD200may update the growth curve, continuously or non-continuously, to adjust for different posture states of patient102. IMD200then delivers, via electrodes108, the electrical stimulation therapy to spinal cord106of patient102according to the adjusted one or more informed parameter values (710).

FIG.8is a diagram illustrating an example technique800for adjusting stimulation therapy. As shown in the example ofFIG.8, the system, such as IMD200or any other device or system described herein, may dynamically adjust pulse amplitude (or other parameter) based on the gain value representing the patient sensitivity to stimulation. Processing circuitry208of IMD200may control stimulation generator204to deliver a stimulation pulses, such as informed pulses and control pulses, to a patient. Processing circuitry208may then control sensing circuitry206to sense an ECAP signal elicited by the control pulse and then identify a characteristic of the ECAP signal (e.g., an amplitude of the ECAP signal). Processing circuitry208may then determine, based on the characteristic of the ECAP signal and a gain value associated with a growth curve, a parameter value (e.g., an amplitude, pulse width value, pulse frequency value, and/or slew rate value) that at least partially defines stimulation pulses, such as control pulses and informed pulses. Processing circuitry208may then control stimulation generator204to deliver the informed pulses and control pulses according to the determined stimulation parameters.

As shown inFIG.8, control pulse812is delivered to the patient via electrode combination814, shown as a guarded cathode of three electrodes. The resulting ECAP is sensed by the two electrodes at the opposing end of the lead of electrode combination816fed to a differential amplifier818. For each sensed ECAP, processing circuitry208may measure an amplitude of a portion of the ECAP signal, such as the N1-P2 voltage amplitude from the portion of the ECAP signal. Processing circuitry208may average the recently measured ECAP amplitudes, such as averaging the most recent, and consecutive, 2, 3, 4, 5, 6, or more ECAP amplitudes. In some examples, the average may be a mean or median value. In some examples, one or more ECAP amplitudes may be ignored from the calculations if the amplitude value is determined to be an error. The measured amplitude (or average measured amplitude) is then subtracted from the selected target ECAP amplitude802to generate a differential amplitude. The selected target ECAP amplitude802may be determined from an ECAP sensed when the physician or patient initially discovers effective therapy from the informed pulses and/or control pulses. This target ECAP amplitude802may essentially represent a reference distance between the stimulation electrodes and the target neurons (e.g., the spinal cord for the case of SCS).

The differential amplitude is then multiplied by the gain value for the patient to generate a differential value808. Processing circuitry208may detecting patient posture state804at varying intervals including, e.g., periodic time intervals, at certain steps of the technique800, in response to a trigger event, or continuously. For example, processing circuitry208may be continuously detecting posture state804of the patient in order to select a growth curve806that is associated with the detected posture state. Once the growth curve is selected806, a gain value can be determined to generate the differential value808. In other examples, processing circuitry208may select the gain value directly from the detected posture state instead of first selecting the associated growth curve. Processing circuitry208may add the differential value to the ECAP pulse amplitude to generate the new, or adjusted, control pulse amplitude810that at least partially defines the next pulse812.

The following formulas may represent the function used to calculate the pulse amplitude of the next pulse812. Equation 1 below represents an equation for calculating the new current amplitude using a linear function, wherein ACis the current pulse amplitude, D is the differential amplitude by subtracting the measured amplitude from the target ECAP amplitude, G is a real number for the gain value, and ANis the new pulse amplitude:
AN=AC+(D×G)  (1)

In this manner, the gain value G may not change for a given input. Alternatively, processing circuitry208may calculate the gain value G such that the gain value varies according to one or more inputs or factors, such as posture state. In this manner, for a given input or set of inputs, processing circuitry208may change the gain value G. Equation 2 below represents an example linear function for calculating the gain value, wherein M is a multiplier, D is the differential amplitude by subtracting the measured amplitude from the target ECAP amplitude, and G is the gain value:
G=M×D(2)

Processing circuitry208may use the gain value G calculated in Equation 2 in Equation 1. This would result in Equation 1 being a non-linear function for determining the new current amplitude. According to Equation 2 above, the gain value G may be greater for larger differences between the measured amplitude and the target ECAP amplitude. Thus, gain value G will cause non-linear changes to the current amplitude. In this manner, the rate of change in the current amplitude will be higher for larger differences between the measured amplitude and the target ECAP amplitude and lower for smaller differences between the measured amplitude and the target ECAP amplitude. In other examples, a non-linear function may be used to calculate the gain value G.

To adjust the informed pulse amplitude, the differential value808is multiplied by a scaling factor822to generate the informed differential value. For example, the scaling factor may be the ratio of the previously delivered informed pulse amplitude to the previously delivered control pulse amplitude. The informed differential value is then added to the previously delivered informed pulse amplitude824to generate the new, or adjusted, informed pulse amplitude that at least partially defines the next informed pulse826. The next informed pulse826is then delivered, interleaved with control pulse812, to the patient via electrode combination815. In some examples, at least two control pulses may be delivered, and at least two respective ECAP signals sensed, between consecutive informed pulses. This increased frequency of nontherapeutic pulses may allow the system to quickly adjust informed pulse amplitudes for any changes in the distance between electrodes and neurons. Although electrode combination815is different than electrode combinations814and816, electrode combination815can be any set of electrodes on the lead as desired for therapy because the informed pulse is delivered in a non-overlapping fashion with control pulses and sensed ECAP signals.

The pulse width of the informed pulse may be greater than approximately 300 μs and less than approximately 1000 μs. In other examples, the pulse width of the informed pulse may be less than approximately 300 μs or greater than 1000 μs. The stimulation pulse may be a monophasic pulse followed a passive recharge phase. However, in other examples, the pulse may be a bi-phasic pulse that includes a positive phase and a negative phase. In some examples, a pulse may be less than 300 μs, but the following passive recharge phase or even an active recharge phase (of a bi-phasic pulse) may still obscure the detectable ECAP signal from that pulse.

In some examples, depending upon, at least in part, pulse width of the control pulse, IMD200may not sufficiently detect an ECAP signal because the stimulation pulse is also detected as an artifact that obscures the ECAP signal. If ECAPs are not adequately recorded, then ECAPs arriving at IMD200cannot be used to determine the efficacy of stimulation parameter settings, and electrical stimulation signals cannot be altered according to responsive ECAPs. In some examples, pulse widths of the control pulses may be less than approximately 300 μs, which may increase the number of ECAP signals detected. Similarly, high pulse frequencies may interfere with IMD110sufficiently detecting ECAP signals. For example, at pulse frequency values (e.g., greater than 1 kHz) that cause IMD110to deliver another control pulse before an ECAP from the previous pulse can be detected, IMD110may not be capable to detecting the ECAP.

FIG.9is a flowchart illustrating an example operation900for adjusting stimulation parameters, such as informed parameters and control parameters. IMD200and processing circuitry208will be described in the example ofFIG.9, but other IMDs such as IMD110or other devices or systems may perform, or partially perform, operation900. Operation900may be similar to the diagram and discussion related toFIG.8.

In the example ofFIG.9, processing circuitry208determines the target ECAP amplitude (902). The target ECAP amplitude may be determined based on sample stimulation initially delivered to the patient. The target ECAP amplitude may be the N1-P2 amplitude of the ECAP signal, but other measures of amplitude, such as amplitude of one or more different peaks in the ECAP signal may be used instead. Alternatively, the target ECAP amplitude may instead be a different characteristic of the ECAP signal such as the area under one or more peaks of the ECAP signal. In some examples, processing circuitry208is configured to automatically change the target ECAP amplitude over a period of time according to a predetermined function (e.g., a sinusoid function) in order to change the volume of neuron activation and, in some examples, the perceived sensation of the informed pulses.

Processing circuitry208receives a measured amplitude from the previously sensed ECAP signal. In order to use the ECAP signal as feedback to control the informed pulses of electrical stimulation therapy for the patient, processing circuitry208subtracts the measured amplitude from the target ECAP amplitude to generate a differential amplitude (904). In some examples, or as additional measured amplitudes are available from the process, processing circuitry208may average a certain number of recent measured amplitudes (e.g., two or more) to create a rolling average of measured ECAP amplitudes and subtract the average measured amplitudes from the target ECAP amplitude to smooth out variations between ECAP signals. The differential amplitude is thus a representation of how far of a distance the electrodes have moved relative to the neurons and can be used to adjust the amplitudes of the informed pulses and the control pulses to maintain consistent volume of neural activation of the neurons that provide relief to the patient.

Processing circuitry208can select a growth curve based on a posture state of the patient (906). Detecting patient posture state may be conducted at varying intervals including, e.g., periodic time intervals, at certain predetermined steps of method800, or continuously. For example, processing circuitry208may continuously detect the posture state of the patient in order to select a growth curve for the currently occupied posture state of the patient. The patient posture state data can be stored in memory216continuously or non-continuously, including at set time intervals. Once the growth curve is selected, processing circuitry208can use the relationship between sensed and target parameter values to select new parameter values. In some examples, the processing circuitry208may determine the gain value from the growth curve. In other examples, processing circuitry208may select the gain value as directly associated with the identified posture state without first identifying a growth curve.

Processing circuitry208then multiplies the differential amplitude from block904by a gain value for the posture state of the patient to generate a preliminary differential value (908). The gain value may represent the slope of the growth curve for the patient. Processing circuitry208then uses the preliminary differential value to adjust the amplitudes of both subsequent informed pulses and control pulses (e.g., ECAP test pulses). Processing circuitry208adds the preliminary differential value to the control pulse amplitude to generate a new control pulse amplitude (910). Processing circuitry208then controls stimulation generation circuitry208to deliver a subsequent control pulse defined by the new control pulse amplitude at a scheduled time, such as according to the frequency of the control pulses or according to the next available window between informed pulses (912). Processing circuitry208also controls sensing circuitry206to measure the amplitude of the sensed ECAP elicited by the recently delivered control pulse (914) to use again as feedback in block904.

In addition to adjusting the amplitude of the control pulses, processing circuitry208uses the preliminary amplitude to adjust the informed pulse amplitude. Processing circuitry208multiplies the differential value by a scaling factor to generate a new informed differential value (916). The scaling factor may be determined as the ratio between the amplitude of the most recently delivered informed pulse and the amplitude of the most recently delivered control pulse that elicited the ECAP signal used to generate the measured amplitude used in block904. The scaling factor may scale up, or scale down, the differential amplitude for the informed pulses because the differential amplitude was generated based on amplitudes of control pulses. Processing circuitry208then adds the therapy differential value to the most recent informed pulse amplitude to generate a new informed pulse amplitude (918). Processing circuitry208then controls stimulation generator204to deliver the next informed pulse with the newly adjusted informed pulse amplitude at the scheduled time according to the predetermined pulse frequency of the informed pulses (920).

Although operation900is described for adjusting the amplitude of informed pulses and control pulses, a similar operation may be used to adjust other stimulation parameters in other examples. For example, parameters that contribute to the intensity of the informed pulses and control pulses may affect the volume of neural activation, such parameters as pulse width, pulse frequency, or even pulse shape (e.g., the amount of charge per pulse). Therefore, processing circuitry208can adjust a different parameter instead of, or in addition to, amplitude using the sensed ECAP signal elicited from the control pulses. For example, processing circuitry208may increase the pulse width of the informed pulses and control pulses in response to detecting a decreased ECAP amplitude. In addition, processing circuitry208can adjust parameters based on a change of patient posture state as well as a different growth curve being selected.

FIG.10illustrates a graph1000which plots control pulse current amplitude1002, informed pulse current amplitude1004, a threshold ECAP amplitude1006, and an ECAP voltage amplitude1008as a function of time, in accordance with one or more techniques of this disclosure. For convenience,FIG.10is described with respect to IMD200ofFIG.2. However, the techniques ofFIG.10may be performed by different components of IMD200or by additional or alternative medical devices.

Graph1000illustrates a relationship between sensed ECAP voltage amplitude1008and stimulation current amplitude. For example, control pulse current amplitude1002and informed pulse current amplitude1004are plotted alongside ECAP voltage amplitude1008as a function of time, thus showing how processing circuitry208of IMD200can change stimulation current amplitudes relative to ECAP voltage amplitude1008. In some examples, IMD200delivers a plurality of control pulses and a plurality of informed pulses at control pulse current amplitude1002and informed pulse current amplitude1004, respectively. Initially, IMD200may deliver a first set of control pulses, where IMD200delivers the first set of control pulses at current amplitude I2. Additionally, IMD200may deliver a first set of informed pulses, where IMD200delivers the first set of informed pulses at current amplitude I2. I1 and I2 may be referred to as a predetermined value for the amplitude of respective control and informed pulses, respectfully. This predetermined value may be a programmed value or otherwise selected value that a stimulation program has selected to at least partially define stimulation pulses to the patient in the absence of transient conditions (e.g., when the ECAP amplitude is below a threshold ECAP value). The first set of control pulses and the first set of informed pulses may be delivered prior to time T1. In some examples, I1 is 8 milliamps (mA) and I2 is 4 mA. Although control pulse current amplitude1002is shown as greater than informed pulse current amplitude1004, control pulse current amplitude1002may be less than or the same as informed pulse current amplitude1004in other examples. In some examples, current amplitudes I1 and I2 may be less than 25 milliamps (mA) and can be between about 2 mA and about 18 mA. However, current amplitudes I1 and I2 may be any current amplitudes that IMD200can deliver to the patient and appropriate for eliciting ECAP signals and/or effective stimulation therapy for the patient.

While delivering the first set of control pulses and the first set of informed pulses, IMD200may record ECAP voltage amplitude1008, which is a characteristic value derived from ECAP signals elicited from respective control pulses. During dynamic and transient conditions which occur in patient102such as coughing, sneezing, laughing, Valsalva maneuvers, leg lifting, cervical motions, or deep breathing, ECAP voltage amplitude1008may increase if control pulse current amplitude1002and informed pulse current amplitude1004are held constant. This increase in ECAP voltage amplitude1008may be caused by a reduction in the distance between the electrodes and nerves. For example, as illustrated inFIG.10, ECAP voltage amplitude1008may increase prior to time T1 while stimulation current amplitude is held constant. An increasing ECAP voltage amplitude1008may indicate that patient102is at risk of experiencing transient overstimulation due to the control pulses and the informed pulses delivered by IMD200. To prevent patient102from experiencing transient overstimulation, IMD200may decrease control pulse current amplitude1002and informed pulse current amplitude1004in response to ECAP voltage amplitude1008exceeding the threshold ECAP amplitude1006. For example, if IMD200senses an ECAP having an ECAP voltage amplitude1008meeting or exceeding threshold ECAP amplitude1006, as illustrated inFIG.10at time T1, IMD200may enter a decrement mode where control pulse current amplitude1002and informed pulse current amplitude1004are decreased. In some examples, the threshold ECAP amplitude1006is selected from a range of approximately 10 microvolts (μV) to approximately 100 μV, or from a range of approximately 15 microvolts (μV) to approximately 40 μV. For example, the threshold ECAP amplitude1006is 30 μV. In other examples, the threshold ECAP amplitude1006is less than or equal to 10 μV or greater than or equal to 100 μV. The exact value of threshold ECAP amplitude1006may depend on the patient's perception of the delivered stimulation, as well as the spacing between the sensing/stimulation electrodes and the neural tissue, whether or not stimulation intensity is increasing or decreasing, or other factors.

IMD200may respond relatively quickly to the ECAP voltage amplitude1008exceeding the threshold ECAP amplitude1006. For example, IMD may be configured to detect threshold exceeding ECAP amplitudes within 20 milliseconds (ms). If IMD200delivers control pulses at a frequency of 50 Hz, the period of time for a single sample that includes delivering the control pulse and detecting the resulting ECAP signal may be 20 ms or less. However, since an ECAP signal may occur within one or two ms of delivery of the control pulse, IMD200may be configured to detect an ECAP signal exceeding the threshold ECAP amplitude in less than 10 ms. For transient conditions, such as a patient coughing or sneezing, these sampling periods would be sufficient to identify ECAP amplitudes exceeding the threshold and a responsive reduction in subsequent pulse amplitudes before the ECAP amplitude would have reached higher levels that may have been uncomfortable for the patient.

The decrement mode may, in some cases, be stored in storage device216of IMD200. In the example illustrated inFIG.10, the decrement mode is executed by IMD200over a second set of control pulses and a second set of informed pulses which occur between time T1 and time T2. In some examples, to execute the decrement mode, IMD200decreases the control pulse current amplitude1002of each control pulse of the second set of control pulses according to a first function with respect to time. In other words, IMD200decreases each consecutive control pulse of the second set of control pulses proportionally to an amount of time elapsed since a previous control pulse. Additionally, during the decrement mode, IMD200may decrease the informed pulse current amplitude1004of each informed pulse of the second set of informed pulses according to a second function with respect to time. Although linear first and second functions are shown, the first and/or second function may be non-linear, such as logarithmic (e.g., the rate of change decreases over time), exponential (e.g., the rate of change increases over time), parabolic, step-wise, multiple different functions, etc., in other examples. In some examples, processing circuitry208may select the first function or second function that defines the magnitude of each step in pulse amplitude change, or the rate of change, according to the detected posture state of the patient. For example, the first function or second function may represent a gain value or other function controlling the rate at which current amplitudes are changed. These functions selected according to the posture state may be used for the decrement and/or increment modes described herein. In some examples, processing circuitry208may select threshold ECAP amplitude1006based on the detected posture state of the patient. During a period of time in which IMD200is operating in the decrement mode (e.g., time interval T2-T1), ECAP voltage amplitude1008of ECAPs sensed by IMD200may be greater than or equal to threshold ECAP amplitude1006.

In the example illustrated inFIG.10, IMD200may sense an ECAP at time T2, where the ECAP has an ECAP voltage amplitude1008that falls back below the threshold ECAP amplitude1006. The ECAP sensed at time T2 may, in some cases, be the first ECAP sensed by IMD200with a below-threshold amplitude since IMD200began the decrement mode at time T1. Based on sensing the ECAP at time T2, IMD200may deactivate the decrement mode and activate an increment mode. The increment mode may, in some cases, be stored in storage device216of IMD200. IMD200may execute the increment mode over a third set of control pulses and a third set of informed pulses which occur between time T2 and time T3. In some examples, to execute the increment mode, IMD200increases the control pulse current amplitude1002of each control pulse of the third set of control pulses according to a third function with respect to time, which may be selected based on the detected posture state of the patient. In other words, IMD200increases each consecutive control pulse of the third set of control pulses proportionally to an amount of time elapsed since a previous control pulse. Additionally, during the increment mode, IMD200may increase the informed pulse current amplitude1004of each informed pulse of the third set of informed pulses according to a fourth function with respect to time.

As shown inFIG.10, IMD200is configured to decrease amplitude at a faster rate than increasing amplitude after ECAP voltage amplitude1008falls below threshold ECAP amplitude1006. In other examples, the rate of change during the decrement mode and increment mode may be similar. In other examples, IMD200may be configured to increase amplitude of informed and control pulses at a faster rate than when decreasing amplitude. The rate of change in amplitude of the pulses may be relatively instantaneously (e.g., a very fast rate) in other examples. As discussed above, the rate may be associated with a gain value for the detected posture state, such that the rate of increase or decrease in amplitude is faster for posture states having a shallower growth curve, or larger distance between the electrodes and target nerve. In one example, in response to ECAP voltage amplitude1008exceeding threshold ECAP amplitude1006, IMD200may immediately drop the amplitude of one or both of control pulse current amplitude1002or informed pulse current amplitude1004to a predetermined or calculated value. Then, in response to ECAP voltage amplitude1008dropping back below threshold ECAP amplitude1006, IMD200may enter increment mode as described above.

When control pulse current amplitude1002and informed pulse current amplitude1004return to current amplitude12and current amplitude I1, respectively, IMD200may deactivate the increment mode and deliver stimulation pulses at constant current amplitudes. By decreasing stimulation in response to ECAP amplitudes exceeding a threshold and subsequently increasing stimulation in response to ECAP amplitudes falling below the threshold, IMD200may prevent patient105from experiencing transient overstimulation or decrease a severity of transient overstimulation experienced by patient105, whether the decrease is in terms of the length of the experience, the relative intensity, or both.

In other examples, processing circuitry208may only adjust stimulation parameters when the ECAP voltage amplitude1008is above an upper threshold or below a lower threshold. In this manner, when the ECAP voltage amplitude1008is between the upper ECAP amplitude threshold and the lower ECAP amplitude threshold, processing circuitry208does not increase the stimulation amplitude values back to the predetermined value or decrease the stimulation amplitude values. This “buffer” zone may reduce oscillating amplitude values when the ECAP amplitudes are similar to the ECAP amplitude threshold. These oscillating amplitude values may be perceived as uncomfortable or unwanted by the patient. However, once the ECAP amplitude drops below the lower ECAP amplitude threshold, processing circuitry210can return the amplitude value back to the predetermined amplitude value intended for therapy.

Although IMD200may increase and decrease the amplitudes by linear functions in some examples, IMD200may employ non-linear functions in other examples. For example, the gain value may represent a non-linear function in which the increment or decrement changes exponentially or logarithmically according to the difference between the sensed ECAP characteristic value and the threshold ECAP amplitude1006.FIG.10is described in the situation in which IMD200delivers both control pulse and informed pulses. However, IMD200may apply the technique ofFIG.10to the situation in which only control pulses are delivered to provide therapy to the patient. In this manner, IMD200would similarly enter a decrement mode or increment mode for control pulse current amplitude1002based on the detected ECAP voltage amplitude1008without adjusting the amplitude or other parameter of any other type of stimulation pulse.

FIG.11is a flow diagram illustrating an example operation for controlling stimulation based on one or more sensed ECAPs, in accordance with one or more techniques of this disclosure. For convenience,FIG.11is described with respect to IMD200ofFIG.2. However, the techniques ofFIG.11may be performed by different components of IMD200or by additional or alternative medical devices. The technique ofFIG.11is associated with graph1000ofFIG.10.

Stimulation generation circuitry204of IMD200may deliver electrical stimulation therapy to a patient (e.g., patient102). In order to control the electrical stimulation therapy, processing circuitry208may direct the delivery of at least some stimulation pulses, where the electrical stimulation therapy may include a plurality of control pulses and/or informed pulses. Informed pulses may, in some cases, produce ECAPs detectable by IMD200. However, in other cases, an electrical polarization of an informed pulse may interfere with sensing of an ECAP responsive to the informed pulse. In some examples, to evoke ECAPs which are detectable by IMD200, stimulation generation circuitry204delivers a plurality of control pulses, the plurality of control pulses being interleaved with at least some informed pulses of the plurality of informed pulses. Processing circuitry208may control the delivery of control pulses according to instructions stored in memory216. Since the control pulses may be interleaved with the informed pulses, sensing circuitry206of IMD200may detect a plurality of ECAPs, where sensing circuitry206is configured to detect each ECAP of the plurality of ECAPs after a control pulse of the plurality of control pulses and prior to a subsequent informed pulse of the plurality of informed pulses. In this way, IMD200may evoke the plurality of ECAPs in target tissue by delivering control pulses without the informed pulses obstructing IMD200from sensing the ECAPs.

As illustrated inFIG.11, processing circuitry208directs stimulation generation circuitry204to deliver a control pulse (1102). Stimulation generation circuitry204may deliver the control pulse to target tissue of patient102via any combination of electrodes232,234of leads230. In some examples, the control pulse may include a balanced, bi-phasic square pulse that employs an active recharge phase. However, in other examples, the control pulse may include a monophasic pulse followed by a passive recharge phase. In other examples, the control pulse may include an imbalanced bi-phasic portion and a passive recharge portion. Although not necessary, a bi-phasic control pulse may include an interphase interval between the positive and negative phase to promote propagation of the nerve impulse in response to the first phase of the bi-phasic pulse. The control pulse may have a pulse width of less than approximately 300 μs, such as a bi-phasic pulse with each phase having a duration of approximately 100 μs.

After delivering the control pulse, IMD200attempts to detect an ECAP (1104). For example, sensing circuitry206may monitor signals from any combination of electrodes232,234of leads230. In some examples, sensing circuitry206detects ECAPs from a particular combination of electrodes232,234. In some cases, the particular combination of electrodes for sensing ECAPs includes different electrodes than a set of electrodes232,234used to deliver stimulation pulses. Alternatively, in other cases, the particular combination of electrodes used for sensing ECAPs includes at least one of the same electrodes as a set of electrodes used to deliver stimulation pulses to patient102. In some examples, the particular combination of electrodes used for sensing ECAPs may be located on an opposite side of leads230from the particular combination of electrodes used to deliver stimulation pulses. IMD200may detect an ECAP responsive to the control pulse. IMD200may measure one or more characteristics of the responsive ECAP, such as ECAP amplitude, ECAP duration, peak-to-peak durations, or any combination thereof. For example, to measure an amplitude of the ECAP, IMD200may determine a voltage difference between an N1 ECAP peak and a P2 ECAP peak.

At block1106, processing circuitry208determines if the ECAP amplitude of the responsive ECAP is greater than an ECAP amplitude threshold. If the ECAP amplitude is greater than the ECAP amplitude threshold (“YES” branch of block1106), processing circuitry208activates/continues a decrement mode (1108) in IMD200. For example, if the decrement mode is already “turned on” in IMD200when processing circuitry determines that the ECAP amplitude is greater than the ECAP amplitude threshold, then processing circuitry208maintains IMD200in the decrement mode. If the decrement mode is “turned off” in IMD200when processing circuitry determines that the ECAP amplitude is greater than the ECAP amplitude threshold, then processing circuitry208activates the decrement mode. In some examples, processing circuitry208may adjust the pulse amplitude according to a gain value or other factor selected according to the current posture state of the patient as determined by processing circuitry208. The decrement mode may be a set of instructions which causes IMD200to decrease one or more parameter values of each consecutive informed pulse from a respective predetermined value (e.g., a value determined by a stimulation program and/or posture state) and decrease one or more parameter values of each consecutive control pulse from a respective predetermined value (e.g., a value determined by a stimulation program and/or posture state). In other words, the parameter values may be reduced from the values that IMD200would use to define respective pulses in the absence of the ECAP amplitude exceeding the threshold ECAP amplitude. For example, when the decrement mode is activated, processing circuitry208may decrease an electric current amplitude of each consecutive informed pulse delivered by IMD200and decrease an electric current amplitude of each consecutive control pulse delivered by IMD200. After processing circuitry208activates/continues the decrement mode, the example operation may return to block1102and IMD200may deliver another control pulse.

If the ECAP amplitude is not greater than the ECAP amplitude threshold (“NO” branch of block1106), processing circuitry208determines whether the decrement mode is activated in IMD200(1110). If the decrement mode is activated in IMD200(“YES” branch of block1110), processing circuitry208deactivates the decrement mode and activates an increment mode (1112) in IMD200. The increment mode may be a set of instructions which causes IMD200to increase one or more parameter values of each consecutive informed pulse and increase one or more parameter values of each consecutive control pulse. For example, when the increment mode is activated, processing circuitry208may increase an electric current amplitude of each consecutive informed pulse delivered by IMD200and increase an electric current amplitude of each consecutive control pulse delivered by IMD200. In some examples, processing circuitry208may adjust the pulse amplitude according to a gain value or other factor selected according to the current posture state of the patient as determined by processing circuitry208. After processing circuitry208deactivates the decrement mode and activates the increment mode, the example operation may return to block1102and IMD200may deliver another control pulse.

When the example operation ofFIG.11arrives at block1110and the decrement mode is not activated in IMD200(“NO” branch of block1110), processing circuitry208determines whether the increment mode is activated (1114) in IMD200. If the increment mode is activated in IMD200(“YES” branch of block1114), processing circuitry208may complete the increment mode (1116) in IMD200. In some examples, to complete the increment mode, processing circuitry208may increase the electric current amplitude of each consecutive informed pulse delivered by IMD200and increase the electric current amplitude of each consecutive control pulse delivered by IMD200until the pulse amplitude of the stimulation pulses reach an electric current amplitude (e.g., a predetermined value that may be set by the stimulation program selected for therapy) of the stimulation pulses delivered by IMD200prior to the activation of the decrement mode. In this manner, the process may not be referred to as a fully closed-loop system. Put another way, IMD200may monitor the high end (ECAP amplitude threshold) for adjusting stimulation pulses instead of monitoring any low end of the sensed ECAP amplitude. For example, IMD20may continue to increase the current amplitude of consecutive informed pulses without any feedback from the sensed ECAP, unless the sensed ECAP value again exceeds the ECAP amplitude threshold. After processing circuitry208completes the increment mode, the example operation may return to block1102and IMD200may deliver another control pulse. When the example operation ofFIG.11arrives at block1114and the increment mode is not activated in IMD200(“NO” branch of block1114), processing circuitry208maintains stimulation (1118) in IMD200. AlthoughFIG.11describes adjusting both informed pulses and control pulses, the technique ofFIG.11may also apply when IMD200is delivering only control pulses (e.g., without informed pulses) to the patient for therapy.

The following examples are described herein. Example 1: a system comprising: sensing circuitry configured to sense an evoked compound action potential (ECAP) signal elicited by a control stimulation pulse of a plurality of control stimulation pulses; and processing circuitry configured to: control delivery of a first informed stimulation pulse defined by at least a first value of an informed stimulation parameter, the informed stimulation pulse being one informed stimulation pulse of a plurality of informed stimulation pulse; control delivery of the control stimulation pulse to a patient, the control stimulation pulse defined by at least a first value of a control stimulation parameter; determine a characteristic value of the ECAP signal elicited from the control stimulation pulse; receive, from a sensor, a posture state signal representing a posture state of the patient; adjust, based on the characteristic value of the ECAP signal and the posture state signal, the first value of the informed stimulation parameter to a second value of the informed stimulation parameter; and control delivery of a second informed stimulation pulse of the plurality of informed stimulation pulses that is defined at least by the second value of the informed stimulation parameter.

Example 2: the system of example 1, further comprising stimulation generation circuitry configured to deliver the plurality of control stimulation pulses and the plurality of informed stimulation pulses to the patient, and wherein the processing circuitry is configured to control the stimulation generation circuitry to deliver the plurality of control stimulation pulses and the plurality of informed stimulation pulses.

Example 3: the system of any of examples 1 or 2, wherein the informed stimulation parameter and the control stimulation parameter comprises one of an amplitude, a pulse width, or a pulse shape.

Example 4: the system of any of examples 1 through 3, wherein the processing circuitry is configured to: determine, based on the posture state signal, a gain value for the posture state; and adjust the first value of the informed stimulation pulse to the second value of the informed stimulation pulse by one of increasing or decreasing the stimulation parameter of the electrical stimulation based on the gain value associated with the posture state of the patient.

Example 5: the system of example 4, wherein the characteristic value is an amplitude of a portion of the ECAP signal, wherein the informed stimulation parameter comprises an informed amplitude, wherein the control stimulation parameter comprises a control amplitude, and wherein the processing circuitry is configured to adjust the first value of the informed stimulation pulse to the second value of the informed stimulation pulse by: subtracting the amplitude from a target ECAP amplitude value for the patient to generate a differential amplitude; multiplying the differential amplitude by the gain value to generate a preliminary differential value; multiplying the preliminary differential value by a scaling factor to generate an informed differential value, wherein the scaling factor represents a ratio of the first value of the informed amplitude that defines the first informed stimulation pulse delivered prior to the control stimulation pulse to a control amplitude defining the control stimulation pulse; adding the informed differential value to the first value of the informed amplitude to generate the second value of the informed amplitude that at least partially defines the electrical stimulation to be delivered to the patient; and adding the preliminary differential value to the first value of the control stimulation parameter to generate a second value of the control stimulation parameter for a subsequent control stimulation pulse of the plurality of control stimulation pulses.

Example 6: the system of example 5, wherein the amplitude of the portion of the ECAP signal comprises a voltage amplitude between an N1 peak and a P2 peak of the ECAP signal.

Example 7: the system of any of examples 4 through 6, wherein the gain value is inversely proportional to a slope of a growth curve defining a relationship of ECAP values to values of the control stimulation parameter for the patient.

Example 8: the system of example 7, wherein the posture state is one posture state of a plurality of posture states, and wherein each posture state comprises a respective growth curve representing the relationship between the ECAP values and the values of the control parameter when the patient occupies that posture state.

Example 9: the system of any of examples 1 through 8, wherein the processing circuitry is configured to adjust the first value of the informed stimulation parameter to the second value of the informed stimulation parameter by: comparing the characteristic value of the ECAP signal to a threshold ECAP characteristic value; determining that the characteristic value of the ECAP signal is greater than the threshold ECAP characteristic value; and responsive to determining that the characteristic value of the ECAP signal is greater than the threshold ECAP characteristic value, decreasing the first value of the informed stimulation parameter to the second value of the informed stimulation parameter.

Example 10: the system of example 9, wherein the ECAP signal is a first ECAP signal and the characteristic value is a first characteristic value, wherein the control stimulation pulse is a first control stimulation pulse, and wherein the processing circuitry is configured to: determine a second characteristic value of a second ECAP signal elicited from a second stimulation pulse delivered after sensing the first ECAP signal; determine that the second characteristic value of the second ECAP signal subsequently decreased below the threshold ECAP characteristic value; and responsive to determining that the second characteristic value of the second ECAP signal decreases below the threshold ECAP characteristic value, increase the second value of the informed stimulation parameter to a third value of the informed stimulation parameter, the third value of the informed stimulation parameter being limited to be less than or equal to the first value.

Example 11: the system of example 10, wherein the processing circuitry is configured to increase the second value of the informed stimulation parameter at a slower rate than the first value of the informed stimulation parameter was decreased to the second value of the informed stimulation parameter.

Example 12: the system of any of examples 1 through 11, wherein the processing circuitry is configured to select, based on the posture state signal, the gain value from a plurality of gain values associated with respective posture states, and wherein the gain value represents at least one of an increment rate or a decrement rate for at least one of the informed stimulation parameter or the control stimulation parameter.

Example 13: the system of any of examples 1 through 12, wherein the processing circuitry is configured to: select, based on the posture state signal, a target ECAP characteristic value; compare the characteristic value of the ECAP signal to the threshold ECAP characteristic value; adjust, based on the comparison of the characteristic value of the ECAP signal to the threshold ECAP characteristic value and a gain value, the first value of the informed stimulation parameter to the second value of the informed stimulation parameter.

Example 14: the system of any of examples 1 through 13, wherein the processing circuitry is configured to: determine, from at least the posture state signal representing the posture state of the patient, that the posture state of the patient has changed; and responsive to determining that the posture state has changed, change an ECAP sensing frequency.

Example 15: the system of any of examples 1 through 14, further comprising an implantable medical device comprising the sensing circuitry and the processing circuitry.

Example 16: the system of any of examples 1 through 15, wherein the plurality of informed stimulation pulses are defined by an informed pulse width greater than approximately 300 microseconds and less than approximately 1000 microseconds, and wherein the plurality of control stimulation pulses are defined by a control pulse width less than approximately 300 microseconds.

Example 17: a method comprising: controlling, by processing circuitry, delivery of a first informed stimulation pulse defined by at least a first value of an informed stimulation parameter, the informed stimulation pulse being one informed stimulation pulse of a plurality of informed stimulation pulse; controlling, by the processing circuitry, delivery of a control stimulation pulse of a plurality of control stimulation pulses to a patient, the control stimulation pulse defined by at least a first value of a control stimulation parameter; sensing, by sensing circuitry, an evoked compound action potential (ECAP) signal elicited by the control stimulation pulse; determining, by the processing circuitry, a characteristic value of the ECAP signal elicited from the control stimulation pulse; receiving, by the processing circuitry and from a sensor, a posture state signal representing a posture state of the patient; adjusting, by the processing circuitry and based on the characteristic value of the ECAP signal and the posture state signal, the first value of the informed stimulation parameter to a second value of the informed stimulation parameter; and controlling, by the processing circuitry, delivery of a second informed stimulation pulse of the plurality of informed stimulation pulses that is defined at least by the second value of the informed stimulation parameter.

Example 18: the method of example 17, further comprising delivering, by stimulation generation circuitry, the plurality of control stimulation pulses and the plurality of informed stimulation pulses to the patient.

Example 19: the method of any of examples 17 and 18, wherein the informed stimulation parameter and the control stimulation parameter comprises one of an amplitude, a pulse width, or a pulse shape.

Example 20: the method of any of examples 17 through 19, further comprising determining, based on the posture state signal, a gain value for the posture state, wherein adjusting the first value of the informed stimulation pulse to the second value of the informed stimulation pulse comprises one of increasing or decreasing the stimulation parameter of the electrical stimulation based on the gain value associated with the posture state of the patient.

Example 21: the method of example 20, wherein the characteristic value is an amplitude of a portion of the ECAP signal, wherein the informed stimulation parameter comprises an informed amplitude, wherein the control stimulation parameter comprises a control amplitude, and wherein adjusting the first value of the informed stimulation pulse to the second value of the informed stimulation pulse comprises: subtracting the amplitude from a target ECAP amplitude value for the patient to generate a differential amplitude; multiplying the differential amplitude by the gain value to generate a preliminary differential value; multiplying the preliminary differential value by a scaling factor to generate an informed differential value, wherein the scaling factor represents a ratio of the first value of the informed amplitude that defines the first informed stimulation pulse delivered prior to the control stimulation pulse to a control amplitude defining the control stimulation pulse; adding the informed differential value to the first value of the informed amplitude to generate the second value of the informed amplitude that at least partially defines the electrical stimulation to be delivered to the patient; and adding the preliminary differential value to the first value of the control stimulation parameter to generate a second value of the control stimulation parameter for a subsequent control stimulation pulse of the plurality of control stimulation pulses.

Example 22: the method of example 21, wherein the amplitude of the portion of the ECAP signal comprises a voltage amplitude between an N1 peak and a P2 peak of the ECAP signal.

Example 23: the method of any of examples 20 through 22, wherein the gain value is inversely proportional to a slope of a growth curve defining a relationship of ECAP values to values of the control stimulation parameter for the patient.

Example 24: the method of example 23, wherein the posture state is one posture state of a plurality of posture states, and wherein each posture state comprises a respective growth curve representing the relationship between the ECAP values and the values of the control parameter when the patient occupies that posture state.

Example 25: the method of any of examples 17 through 24, wherein adjusting the first value of the informed stimulation parameter to the second value of the informed stimulation parameter comprises: comparing the characteristic value of the ECAP signal to a threshold ECAP characteristic value; determining that the characteristic value of the ECAP signal is greater than the threshold ECAP characteristic value; and responsive to determining that the characteristic value of the ECAP signal is greater than the threshold ECAP characteristic value, decreasing the first value of the informed stimulation parameter to the second value of the informed stimulation parameter.

Example 26: the method of example 25, wherein the ECAP signal is a first ECAP signal and the characteristic value is a first characteristic value, wherein the control stimulation pulse is a first control stimulation pulse, and wherein the method further comprises: determining a second characteristic value of a second ECAP signal elicited from a second stimulation pulse delivered after sensing the first ECAP signal; determining that the second characteristic value of the second ECAP signal subsequently decreased below the threshold ECAP characteristic value; and responsive to determining that the second characteristic value of the second ECAP signal decreases below the threshold ECAP characteristic value, increasing the second value of the informed stimulation parameter to a third value of the informed stimulation parameter, the third value of the informed stimulation parameter being limited to be less than or equal to the first value.

Example 27: the method of example 26, further comprising increasing the second value of the informed stimulation parameter at a slower rate than the first value of the informed stimulation parameter was decreased to the second value of the informed stimulation parameter.

Example 28: the method of any of examples 17 through 27, further comprising selecting, based on the posture state signal, the gain value from a plurality of gain values associated with respective posture states, and wherein the gain value represents at least one of an increment rate or a decrement rate for at least one of the informed stimulation parameter or the control stimulation parameter.

Example 29: the method of any of examples 17 through 28, further comprising: selecting, based on the posture state signal, a target ECAP characteristic value; comparing the characteristic value of the ECAP signal to the threshold ECAP characteristic value; and adjusting, based on the comparison of the characteristic value of the ECAP signal to the threshold ECAP characteristic value and a gain value, the first value of the informed stimulation parameter to the second value of the informed stimulation parameter.

Example 30: the method of any of examples 17 through 29, further comprising: determining, from at least the posture state signal representing the posture state of the patient, that the posture state of the patient has changed; and responsive to determining that the posture state has changed, changing an ECAP sensing frequency.

Example 31: the method of any of examples 17 through 30, wherein an implantable medical device comprises the sensing circuitry and the processing circuitry.

Example 32: the method of any of examples 17 through 31, wherein the plurality of informed stimulation pulses are defined by an informed pulse width greater than approximately 300 microseconds and less than approximately 1000 microseconds, and wherein the plurality of control stimulation pulses are defined by a control pulse width less than approximately 300 microseconds.

Example 33: a computer-readable storage medium comprising instructions that, when executed by processing circuitry, cause the processing circuitry to: control delivery of a first informed stimulation pulse defined by at least a first value of an informed stimulation parameter, the informed stimulation pulse being one informed stimulation pulse of a plurality of informed stimulation pulse; control delivery of a control stimulation pulse of a plurality of control stimulation pulses to a patient, the control stimulation pulse defined by at least a first value of a control stimulation parameter; control sensing circuitry to sense an evoked compound action potential (ECAP) signal elicited by the control stimulation pulse; determine a characteristic value of the ECAP signal elicited from the control stimulation pulse; receive, from a sensor, a posture state signal representing a posture state of the patient; adjust, based on the characteristic value of the ECAP signal and the posture state signal, the first value of the informed stimulation parameter to a second value of the informed stimulation parameter; and control delivery of a second informed stimulation pulse of the plurality of informed stimulation pulses that is defined at least by the second value of the informed stimulation parameter.

Such hardware, software, and firmware may be implemented within the same device or within separate devices to support the various operations and functions described in this disclosure. In addition, any of the described units, circuits or components may be implemented together or separately as discrete but interoperable logic devices. Depiction of 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 realized by separate hardware or software components. Rather, functionality associated with one or more circuits or units may be performed by separate hardware or software components or integrated within common or separate hardware or software components.