Intraluminal medical device with evoked biopotential sensing capability

Abstract

An evoked response to electrical stimulation of a target tissue of a patient is sensed in conjunction with an intraluminal electrode. The intraluminal electrode may be implanted in a blood vessel or similar lumen proximate the target tissue, and the sensed signal and / or the delivered stimulation may pass through the blood vessel or other lumen, wall. In some examples, the evoked response may be an evoked compound action potential (ECAP), and the evoked response may also be an evoked resonant neural activity (ERNA). The electrical stimulation may elicit a measurable response indicative of a thinking pattern or neural state, which is otherwise undetectable using a non-evoked biopotential.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 369,810, filed on July 29, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present disclosure relates to sensing and stimulation within the lumen of anatomical structures. Background Art

[0003] The medical device may be external or implanted and may be used to sense bioelectric signals and deliver electrical stimulation therapy to various tissue sites of the patient to treat a variety of symptoms or conditions, such as chronic pain, tremor, Parkinson's disease, other movement disorders, epilepsy, urinary or fecal incontinence, sexual dysfunction, obesity or gastroparesis. The medical device delivery may sense the patient's electrical activity (such as local field potential (LFP) activity) and deliver electrical stimulation therapy via one or more leads, which include electrodes located near a target location associated with the patient's brain, spinal cord, pelvic nerves, peripheral nerves or gastrointestinal tract. For bipolar stimulation, the electrodes for stimulation may be on one or more leads. For monopolar stimulation, the electrodes may be on one or more leads, and the electrodes on the pulse generator housing are located away from the target site (e.g., near the clavicle). Leadless stimulation may be used using electrodes mounted on the pulse generator housing. Electrical stimulation and sensing may be used for different therapeutic applications, such as deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation or peripheral nerve field stimulation (PNFS). Summary of the invention

[0004] In general, the present disclosure describes techniques for sensing induced biosignals in conjunction with an intraluminal electrode system. In some examples, the induced biosignal may include an induced compound action potential (ECAP), an induced compound muscle action potential (ECMAP), or an induced resonant neural activity (ERNA). For example, an induced compound action potential (ECAP) is a synchronous activation of excitable tissues triggered by at least a single stimulus, although multiple stimuli may be delivered to enhance the effect in a neural matrix. The intraluminal electrode of the present disclosure is an electrode implantable in a vascular lumen or in any other lumen of an anatomical structure close to a target tissue (including neural tissue). The electrode may be connected to a sensing and / or electrical stimulation circuit of a medical device. The sensed signal and / or the delivered stimulus may pass through a vascular wall or other anatomical structure.

[0005] In some examples, due to the insulating effect of the body lumen wall, the biopotential signal amplitude can be attenuated and the stimulation coupled to the target tissue can be reduced. The medical system of the present disclosure can sense biopotentials such as ERNA with intraluminal electrodes to, for example, detect a measurable response indicating a thought pattern or a neural state, which is originally undetectable using non-induced biopotentials such as local field potentials. In other examples, the medical system can induce biopotentials (such as ECAP, ERNA, and ECMAP) as an auxiliary tool for determining the best position for sensing biopotentials, which indicates a thought pattern or a neural state. The medical system can also be configured to deliver a stimulation initiation signal that enhances the detectability of the relevant thought pattern or neural state and evaluates the patency of the intraluminal medical device. The patency of the intraluminal medical device may include the operational function of the intraluminal medical device at a known position and close contact with the anatomical target of interest.

[0006] In one example, the present disclosure describes a system comprising: an electrode configured to be positioned within a lumen of an anatomical structure and proximate to a target tissue of a patient; a medical device comprising: an electrical stimulation circuit configured to deliver electrical stimulation to the patient; a sensing circuit configured to detect bioelectrical signals from the patient via the electrode; and a processing circuit configured to: control the electrical stimulation circuit to deliver electrical stimulation to the patient; receive via the sensing circuit an indication of a biopotential induced by the delivered electrical stimulation, wherein the sensed biopotential is a measurable response indicative of at least one of: a thought pattern from the patient; or a neural state of the patient when the electrical stimulation is delivered.

[0007] In another example, the present disclosure describes a method comprising: delivering electrical stimulation to a target tissue of a patient; receiving, by a sensing circuit of a medical device, a bioelectric signal from the patient via one or more electrodes proximate to the target tissue, wherein at least one electrode is configured to be located within a lumen of an anatomical structure and proximate to the target tissue; receiving, by a processing circuit of the medical device and via the sensing circuit, an indication of a biopotential induced by the delivered electrical stimulation, wherein the sensed biopotential is a measurable response indicative of at least one of: a thought pattern from the patient; or a neurological state of the patient when the electrical stimulation is delivered.

[0008] In another example, the present disclosure describes a medical device comprising: an electrical stimulation circuit configured to deliver electrical stimulation to a patient via one or more electrodes, wherein at least one electrode is configured to be located within a lumen of an anatomical structure and proximate to a target tissue of the patient; a sensing circuit configured to detect bioelectrical signals from the patient via the electrode configured to be located within the lumen; and a processing circuit configured to: control the electrical stimulation circuit to deliver electrical stimulation to the patient; receive via the sensing circuit an indication of a biopotential induced by the delivered electrical stimulation, wherein the sensed biopotential is a measurable response indicative of at least one of: a thought pattern from the patient; or a neural state of the patient when the electrical stimulation is delivered.

[0009] The details of one or more examples of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the disclosure will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 is a conceptual diagram illustrating an example system including an implantable medical device (IMD) configured to deliver electrical stimulation to a patient and sense bioelectrical signals from the patient in accordance with an example of the presently disclosed technology.

[0011] Figure 2A is a conceptual diagram illustrating an example electrode configured to be positioned within a lumen and proximate to a target tissue of a patient, in accordance with one or more techniques of this disclosure.

[0012] Figure 2B is a conceptual illustration of an example device including one or more electrodes configured to be positioned within a lumen of an anatomical structure and proximate to a target tissue of a patient.

[0013] Figure 2C and Figure 2D is a conceptual illustration of an example device including one or more electrodes configured to spiral along a lumen of an anatomical structure and proximate to a target tissue of a patient.

[0014] Figure 3 It is used to deliver electrical stimulation and receive bioelectrical signals from target tissues of patients. Figure 1 Block diagram of an example IMD.

[0015] Figure 4 A method for controlling the sensing of bioelectric signals and the delivery of electrical stimulation according to an example of the disclosed technology Figure 1 Block diagram of an external programmer.

[0016] Figure 5Ais a temporal graph of example evoked compound action potentials (ECAPs) sensed for corresponding stimulation pulses, according to one or more techniques of the present disclosure.

[0017] Figure 5B is a time graph illustrating example evoked resonant neural activity (ERNA) received by an intraluminal medical device according to an example of the disclosed technology.

[0018] Fig. 6A is a temporal graph of example evoked compound action potentials (ECAPs) sensed for corresponding stimulation pulses, according to one or more techniques of the present disclosure.

[0019] Figure 6B is a time graph illustrating an example of a resonant bioelectric signal induced from electrical stimulation in accordance with one or more techniques of this disclosure.

[0020] Figure 7 is a flow chart illustrating one example operation of the system of the present disclosure. DETAILED DESCRIPTION

[0021] The present disclosure describes medical systems and techniques for sensing induced biopotentials (such as ECAP, ECMAP, and ERNA) with intraluminal electrode devices as part of the sensing system. In some examples, the intraluminal electrode device may include one or more electrodes. In some examples, the medical system may include one or more intraluminal electrode devices implanted in a patient and other implanted electrodes.

[0022] As described above, the sensed ECAP represents a synchronous response generated by a group of electrically activated nerve fibers. ECAP is a signal recorded from a nerve trunk composed of multiple axons. This is the result of the sum of many action potentials from a single axon in the nerve trunk. ECAP can be initiated on a peripheral nerve by applying an electrical stimulus to the nerve at a certain point at a certain distance from the recording site. The delay between the application of the stimulus and the start of the compound action potential is a function of the distance between the recording site and the stimulation site. The amplitude of the recorded compound action potential is the sum of the single action potentials from different axons. In some examples, the system can also sense and record an initial biphasic spike, which is a signal artifact from the stimulator. In the present disclosure, the sensing signal artifact may also be referred to as electric field imaging. When the induced response shows a resonant feature (e.g., resonating with the stimulation signal), the induced biopotential may be referred to as the induced resonant neural activity ERNA described herein. In some examples, the resonant feature of the response may occur at some locations of the patient's anatomical structure, but not at other locations. Compared with implanting other types of electrodes, implanting an intraluminal device is less invasive to the patient.

[0023] Figure 1is a conceptual diagram illustrating an example system 100 including an implantable medical device (IMD) 106 configured to deliver electrical stimulation to a patient 112 and sense bioelectrical signals from the patient, according to example techniques of the present disclosure. Figure 1 The examples depict an implantable neurostimulator (INS) configured to deliver deep brain stimulation (DBS) to a patient 112. However, the techniques of the present disclosure may be applied to other types of implantable or non-implantable electrical stimulation and sensing devices located in other areas (e.g., near the spine, pelvic area, ankles, neck, and other locations). Although some of the examples described in the present disclosure refer to patients 112 receiving electrical stimulation therapy, in some examples, the techniques described herein may be applied to patients who are not receiving electrical stimulation forms of therapy. For example, leads 114 may be implanted in a patient for simple sensing, including sensing induced responses.

[0024] The processing circuit of the system 100 ( Figure 1 106), including processing circuits within the IMD 106, an external computing device 104, and a server 102 in any combination, can perform the functions described in the present disclosure. The server 102 may include a remote server for a cloud computing infrastructure, such as, for example, a cloud or web interface.

[0025] In some examples, the delivered electrical stimulation (e.g., DBS) can be adaptive, i.e., processing circuitry of, for example, IMD 106 can adjust, increase, or decrease the magnitude of one or more parameters of DBS in response to changes in patient activity or movement, the severity of one or more symptoms of the patient's illness, the presence of one or more side effects due to DBS, or one or more sensed signals from the patient, e.g., via intraluminal electrode device 125.

[0026] For example, one example of system 100 is a bidirectional DBS system with the ability to both deliver stimulation and sense intrinsic neuronal signals. System 100 can provide a "closed loop" therapy, where IMD 106 can continuously monitor the state of certain biomarker signals and deliver stimulation according to a pre-programmed routine based on the biomarker signals.

[0027] The system 100 can be configured to treat a patient condition, such as a movement disorder, a neurodegenerative injury, a mood disorder, or an epilepsy in a patient 112. The patient 112 is typically a human patient. However, in some cases, the treatment system 100 can be applied to other mammals or non-mammalian, non-human patients. The treatment system 100 can provide treatment to manage symptoms of a patient condition, such as, but not limited to, a movement disorder and a neurodegenerative injury, an epilepsy (e.g., epilepsy), or a mood (or psychological) disorder (e.g., major depressive disorder (MDD), bipolar disorder, anxiety disorder, post-traumatic stress disorder, dysthymic disorder, and obsessive compulsive disorder (OCD), incontinence, pain, and other symptoms).

[0028] In other examples, system 100 may be configured to deliver electrical stimulation, and based on the response, processing circuitry may receive an indication of a biopotential induced based on the delivered electrical stimulation via sensing circuitry of IMD 110. The sensed biopotential may be a measurable response indicative of an indication from a patient's thought pattern, a patient's neurological state when the electrical stimulation was delivered, a function of an organ, muscle, or other tissue of the patient, and the sensed biopotential may be used as one or more biomarkers.

[0029] The example treatment system 100 includes an external computing device 104, an IMD 106, a lead extension 110, and leads 114A and 114B with respective electrode sets 116, 118 and a lead 114C with an intraluminal electrode 125. Figure 1 In the example shown, electrodes 116, 118, and 125 are positioned to deliver electrical stimulation to tissue sites within the brain 120, such as deep brain sites below the dura mater of the brain 120 of the patient 112. In some examples, delivering stimulation to one or more regions of the brain 120, such as the subthalamic nucleus, globus pallidus, or thalamus, can be an effective treatment for managing movement disorders, such as Parkinson's disease. Some or all of the electrodes 116, 118, and 125 may also be positioned to sense neural brain signals within the brain 120 of the patient 112. In some examples, some of the electrodes 116, 118, and 125 may be configured to sense neural brain signals, and other electrodes 116, 118, and 125 may be configured to deliver adaptive electrical stimulation to the brain 120. In other examples, all of the electrodes 116, 118, and 125 are configured to sense neural brain signals and deliver adaptive electrical stimulation to the brain 120. In some examples, IMD 106 may be configured to deliver monopolar stimulation using at least one electrode on a housing of IMD 106 .

[0030] IMD 106 includes a therapy module (e.g., which may include processing circuitry, signal generation circuitry, or other circuitry configured to perform the functions attributed to IMD 106, Figure 1 14A, 114B, and 114C (collectively referred to as leads 114) and a subset of any combination of electrodes 116, 118, and 125 that are used to deliver electrical stimulation to patient 112, and in some cases, the polarity of the subset of electrodes 116, 118, and 125 may be referred to as a stimulation electrode combination. As described in further detail below, a stimulation electrode combination may be selected (e.g., based on the patient's condition) for a particular patient 112 and target tissue site. Electrode groups 116, 118 include at least one electrode and may include multiple electrodes. In some examples, multiple electrodes 116 and / or 118 may have complex electrode geometries such that two or more electrodes are located at different locations around the periphery of the respective leads.

[0031] In some examples, the neural signals sensed within the brain 120 may reflect the current changes generated by the sum of the potential differences of the entire brain tissue. Examples of neural brain signals include, but are not limited to, bioelectric signals generated by local field potentials (LFPs) sensed in one or more regions of the brain 120. Electroencephalogram (EEG) signals or electrocorticogram (ECoG) signals are also examples of bioelectric signals. For example, neurons generate bioelectric signals; if measured at depth, it is an LFP signal; if measured on the cortex, it is an ECoG signal; and if measured on the scalp, it is an EEG signal. In the present disclosure, the term "oscillating signal source" may be used to describe an example of a signal source that generates a bioelectric signal. However, bioelectric signals are not limited to oscillating signals. For example, these techniques are intended to be described using oscillating bioelectric signals from an oscillating signal source.

[0032] In some examples, the neural brain signals for selecting the stimulation electrode combination can be sensed in the same area of ​​the brain 120 as the target tissue site for electrical stimulation. As described above, these tissue sites may include tissue sites within anatomical structures, such as the thalamus, subthalamic nucleus (STN), globus pallidus (GPi) or sinus veins, such as the superior sagittal sinus, inferior sagittal sinus, straight sinus, sigmoid sinus and transverse sinus of the brain 120, and other target tissue sites. Other example target sites may include the pedunculopontine nucleus (PPN), the posterior subthalamic area (PSA), the anterior nucleus of the thalamus (NT) and the hippocampus (HpC). Specific target tissue sites and / or regions within the brain 120 can be selected based on patient conditions (e.g., epilepsy, occipital neuralgia or other headaches and other patient conditions). Therefore, in some examples, the stimulation electrode combination and the sensing electrode combination can be selected from the same group of electrodes 116, 118 and 125. In other examples, the electrodes used to deliver electrical stimulation may be different from the electrodes used to sense the neural brain signals. In other examples, an IMD 106 configured for tibial nerve stimulation, spinal cord stimulation, vagus nerve stimulation, or other locations on the patient 112 can use electrodes in a similar manner. Intraluminal electrodes 125 can be located at any anatomical target, and particularly those anatomical targets accessed via the cerebral vasculature for DBS and other vasculature at other locations. In some examples, one or more intraluminal electrode devices can be located in multiple blood vessels proximate to the target tissue.

[0033] Other electrode locations may include vasculature or other accessible lumens, such as vasculature near the spinal cord and neck, lumens in one or more organs such as the liver, pancreas, and kidneys (for renal nerves), and other similar locations. In some examples, electrodes configured to be located within the lumen of an anatomical structure and near a target tissue of a patient may sense an ECMAP to confirm placement, such as for stimulation of the vagus nerve through the jugular vein. The intraluminal electrodes may provide signals from nearby muscle responses to a sensing circuit to confirm an optimal location for stimulation. For example, when the internal jugular vein (IJV) passes under the clavicle, the sternocleidomastoid and infrahyoid muscles cover the IJV. In the present disclosure, an ECMAP may also be referred to as an evoked electromyogram (EMG) response. An electromyogram measures muscle responses or electrical activity in response to muscle stimulation.

[0034] The electrical stimulation generated by IMD 106 may be configured to manage a variety of disorders and conditions and sense a variety of signals. In some examples, the stimulation generator of IMD 106 is configured to generate electrical stimulation via electrodes of a selected stimulation electrode combination and deliver the electrical stimulation as pulses to patient 112. However, in other examples, the stimulation generator of IMD 106 may be configured to generate and deliver a continuous wave signal, such as a sine wave or a triangle wave. The stimulation generation circuitry within IMD 106 ( Figure 1112 ) may generate electrical stimulation therapy according to the selected therapy program. In examples where IMD 106 delivers electrical stimulation in the form of stimulation pulses, the therapy program may include a set of therapy parameter values ​​(e.g., stimulation parameters), such as a stimulation electrode combination, a pulse frequency, a pulse width, and a current or voltage amplitude of the pulses used to deliver stimulation to patient 112. As previously described, the electrode combination may indicate specific electrodes 116, 118, and / or 125 and corresponding polarities selected to deliver stimulation signals to tissue of patient 112. In some examples, the electrical stimulation generated by IMD 106 may generate, for example, bursts of pulses, staggered pulses, or concurrent pulses.

[0035] In some examples, electrodes 116, 118 may be a radially segmented DBS array (rDBSA) of electrodes. A radially segmented DBS array refers to electrodes that are segmented radially along the lead. As an example, leads 114A and 114B may include a first set of electrodes arranged circumferentially around leads 114A and 114B, and these electrodes are at the same height level on leads 114A and 114B. Each electrode in the first set of electrodes is a separate segmented electrode and forms a layer of radially segmented electrode array. Leads 114A and 114B may include a second set of electrodes arranged circumferentially around leads 114A and 114B, and these electrodes are at the same height level on leads 114A and 114B. Each electrode in the first set of electrodes is a separate segmented electrode and forms a layer of radially segmented electrode array. rDBSA electrodes may facilitate directional stimulation and sensing.

[0036] The signal component in the beta band is described as an example, and the technique is applicable to other types of LFP activity. In addition, the example technique is not limited to examples where electrodes 116, 118 are rDBSA electrodes. The example using rDBSA electrodes is described as a way of directional stimulation and sensing. However, the example technique can also be used in examples where directional stimulation and sensing are not available or are not used. In addition, there may be other ways to perform directional stimulation and sensing that do not require the use of rDBSA electrodes.

[0037] In some examples, IMD 106 may generate and deliver electrical stimulation to induce ECAP and / or ERNA. As described above, when the induced response shows a resonant characteristic, such as resonating with the stimulation signal, the ECAP may be referred to as induced resonant neural activity ERNA. In some examples, the resonant characteristic of the response may occur at some locations of the patient's anatomy, but not at other locations. For example, when the sensing electrode is close to the STN, IMD 106 may sense a resonant induced response, and may not sense a resonant induced response in some other locations.

[0038] As described above, in some examples, IMD 106 may select some combination of electrodes 116 and 118 to deliver electrical stimulation and sense induced biopotentials using intraluminal electrode 125. In other examples, electrode 125 may both deliver electrical stimulation and sense induced responses. When used with an intraluminal device, the processing circuitry of system 100 may process induced biopotentials, such as ERNA, for any one or more of the following: eliciting a measurable response indicative of a thought pattern or neural state that would otherwise be undetectable using non-induced biopotentials such as local field potentials; an auxiliary tool for determining an optimal location and optimal stimulation parameters for sensing a biopotential indicative of a thought pattern or neural state; determining a location and parameters for delivering a stimulation-eliciting signal that enhances the detectability of the associated thought pattern or neural state; and assessing the patency of an intraluminal medical device; more specifically, that the medical device is operable, in a known location, and in close contact with an anatomical target of interest.

[0039] IMD 106 may be implanted in a subcutaneous pocket above the clavicle, or alternatively, on or in skull 122, or at any other suitable site in patient 112. Generally, IMD 106 is constructed of biocompatible materials that resist corrosion and degradation by body fluids. IMD 106 may include a hermetic housing to substantially enclose components, such as a processor, a therapy module, and a memory.

[0040] like Figure 1 As shown, implant lead extension 110 is coupled to IMD 106 via connector 108 (also referred to as a connector block or connector of IMD 106). Figure 1 In the example of FIG. 1 , lead extension 110 is passed from the implantation site of IMD 106 and along the neck of patient 112 to skull 122 of patient 112 to enter brain 120. Figure 1 In the example shown, the leads 114 are implanted in the right and left hemispheres of the patient 112, respectively (or in only one hemisphere in some examples), so as to deliver electrical stimulation to one or more regions of the brain 120, which may be selected based on a patient condition or disorder controlled by the treatment system 100 or by a desired sensing from the patient 112. However, a specific target tissue site and a stimulation electrode for delivering stimulation to the target tissue site may be selected, for example, based on the identified patient behavior and / or other sensed patient parameters. For example, the target tissue site may be the location of an oscillating signal source that generates a bioelectric signal having a signal component in the beta band. The stimulation electrodes for delivering stimulation to the target tissue site may be those stimulation electrodes that are closest to the oscillating signal source, such as those using the example techniques described in the present disclosure. In other examples, the IMD 106 may be implanted above the skull 122 or in some examples within the skull.

[0041] Other examples of lead sets may include axial leads carrying ring electrodes disposed at different axial positions and so-called "paddle" leads carrying planar electrode arrays. In some examples, more complex lead array geometries may be used.

[0042] Although lead 114 is Figure 1 108. The leads 114 are shown as being coupled to a common lead extension 110, but in other examples, the leads 114 may be coupled to the IMD 106 via separate lead extensions or directly to the connector 108. The leads 114 may be positioned to deliver electrical stimulation to one or more target tissue sites within the brain 120 or sense signals from the one or more target tissue sites. The leads 114 may be implanted to position the electrodes 116, 118 at desired locations in the brain 120 through corresponding holes in the skull 122. The leads 114 may be placed at any location within the brain 120 so that the electrodes 116, 118 are able to provide electrical stimulation to target tissue sites within the brain 120 during treatment. For example, the electrodes 116, 118 may be surgically implanted beneath the dura mater of the brain 120 or within the cerebral cortex of the brain 120 via a burr hole in the skull 122 of the patient 112 and electrically coupled to the IMD 106 via one or more leads 114. As described above, the electrode 125 may be implanted via the cerebral vasculature.

[0043] exist Figure 1 In the example shown, the electrodes 116, 118 of the lead 114 are shown as ring electrodes. Ring electrodes can be used in DBS applications because they are relatively easy to program and can deliver electric fields to any tissue adjacent to the electrodes 116, 118. In other examples, the electrodes 116, 118 may have different configurations. For example, at least some of the electrodes 116, 118 of the lead 114 may have a complex electrode array geometry that can generate a shaped electric field. The complex electrode array geometry may include multiple electrodes (e.g., partial rings or segmented electrodes) around the outer periphery of each lead 114, rather than a ring electrode. In this way, electrical stimulation can be guided from the lead 114 in a specific direction to enhance the efficacy of the treatment and reduce possible adverse side effects caused by stimulating a large amount of tissue.

[0044] IMD 106 may include a memory for storing a plurality of treatment programs ( Figure 1 ), each therapy program defines a set of therapy parameter values. In some examples, IMD 106 may select a therapy program from memory based on various parameters, such as sensed patient signals and identified characteristics of patient behavior. IMD 106 may generate electrical stimulation based on the parameters of the selected therapy program to manage patient symptoms or collect desired sensed signals.

[0045] The external computing device 104 (which may also be referred to as the external computing device 104 in this disclosure) can communicate wirelessly with the IMD 106 as needed to provide or retrieve information, such as sensed biopotential records. Users, such as clinicians and / or patients 112, can use the external computing device 104 to communicate with the IMD 106. For example, the external computing device 104 may be a clinician programmer, which the clinician uses to communicate with the IMD 106 and program one or more treatment programs for the IMD 106. Alternatively, the external computing device 104 may be a patient programmer that allows the patient 112 to select a program and / or view and modify treatment parameters. The clinician programmer may include more programming features than the patient programmer. In other words, only the clinician programmer can allow more complex or sensitive tasks to prevent untrained patients from making undesirable changes to the IMD 106.

[0046] When the external computing device 104 is configured for use by a clinician, the external computing device 104 may be used to transmit initial programming information to the IMD 106. The initial information may include hardware information, such as the type and electrode arrangement of the lead 114, the location of the lead 114 within the brain 120, the configuration of the electrode arrays 116, 118, an initial program defining the values ​​of the treatment parameters, and any other information that the clinician wishes to program into the IMD 106. The external computing device 104 may also be able to complete functional testing (e.g., measuring the impedance of the electrodes 116, 118, and 125 of the lead 114). However, in some examples, the IMD 106 or the external computing device 104 (alone or in combination) may include programming instructions that, when executed by the processing circuitry of the system 100, may automatically determine the electrode configuration and the treatment and sensing parameters. For example, the processing circuitry may determine which electrodes to use for stimulation based on which electrodes are closest to the source of the oscillating signal. In other examples, processing circuitry may determine which electrodes will elicit a desired biopotential (e.g., ERNA or ECAP), or provide stimulation initiation signals to target tissue of the patient that enhance detectability of thought patterns from patient 112. In some examples, external computing device 104 may output information indicative of the selected electrode configuration for stimulation and the determined stimulation amplitude or other treatment parameters for review and confirmation by a clinician or physician before IMD 106 delivers electrical stimulation via the selected electrode configuration with the determined stimulation amplitude, pulse width, and other parameters.

[0047] External computing device 104 may also be configured for use by patient 112. When configured as a patient programmer, external computing device 104 may have limited functionality (compared to a clinician programmer) to prevent patient 112 from altering critical functions of IMD 106 or applications that may be harmful to patient 112. Thus, external computing device 104 may only allow patient 112 to adjust values ​​of certain therapy parameters or set an available range of values ​​for a particular therapy parameter.

[0048] According to the techniques of the present disclosure, a medical device of system 100 (e.g., IMD 106 or external computing device 104, alone or in combination) may be configured to determine when patient 112 takes medication based on measured signals, such as LFP activity of patient 112. In some examples, the medical device of system 100 may be configured to determine the duration for which the medication is effective. External computing device 104 may display an indication on a display of external computing device 104 of when patient 112 takes the medication, the duration for which the medication is effective, and in some examples, a notification to take more medication to facilitate treatment of the patient.

[0049] Figure 2A 1 is a conceptual diagram illustrating an example electrode configured to be located within a lumen and proximate to a target tissue of a patient in accordance with one or more techniques of the present disclosure. Intraluminal device 152 may be configured to be connected to IMD 156 via lead 158 and / or lead extension. IMD 156 may also be connected to a device as described above with respect to Figure 1 Other leads and electrodes are described (not shown in FIG. 2 ). Intraluminal device 152 may be arranged as an electrode array and include one or more electrodes configured to be placed in the patient's brain 150 via the cerebral vasculature including blood vessel 154. Blood vessel 154 may be an example anatomical structure including a lumen, and may be a vein or an artery. As described above with respect to Figure 1 As described, the intraluminal device 152 may also be placed in other lumens of other anatomical structures at other locations within the patient's body. Example anatomical structures may include portions of the gastrointestinal tract such as the esophagus or small intestine, ducts within organs such as the pancreas or liver, or any other such anatomical structure that includes a lumen.

[0050] The electrodes of the intraluminal device 152 may be arranged such as Figure 2A In some examples, one or more electrodes may be in contact with a wall of the lumen. In some examples, one or more electrodes may be in contact with a fluid within the lumen. In some examples, electrodes closer to the vessel wall may provide improved sensing of signals generated outside the lumen. Similarly, electrodes closer to the vessel wall (e.g., in contact with the vessel wall) may provide improved conduction of electrical stimulation to nearby tissues, rather than the output signal being shunted by any fluid within the lumen (e.g., blood in the example of a blood vessel).

[0051] IMD 156 can be configured to deliver electrical stimulation and sense bioelectrical signals via intraluminal device 152. In some examples, an intraluminal sensing / stimulation system including intraluminal device 152 can be less invasive than a system with indwelling electrodes implanted via a craniotomy (such as described above with respect to Figure 1 In some examples, the amplitude of the biopotential signal sensed via the intraluminal device 152 may be attenuated and the stimulation coupled into the target tissue may be reduced due to the insulating effect of the body lumen wall. In other words, the signal to and from the target tissue must pass through the vasculature wall and may therefore be attenuated by the vasculature wall.

[0052] Figure 2B 1 is a conceptual diagram of an example device including one or more electrodes configured to be located within a lumen of an anatomical structure and proximate to a target tissue of a patient. Intraluminal device 162 may include a portion configured to connect to lead 168 and a portion configured to remain in place within a lumen including one or more electrodes 161.

[0053] Figure 2C and Figure 2D is a conceptual diagram of an example device including one or more electrodes configured to spiral along a lumen of an anatomical structure and proximate to a target tissue of a patient. As described above, Figure 2C The intraluminal device may include a portion configured to connect to the lead 178 and a portion configured to remain in place within a lumen including one or more electrodes 171. Figure 2D A side view of the same type of device with electrode 173 is illustrated. FIG. 2A to FIG. 2D The device is the above about Figure 1 An example of an intraluminal electrode device 125 is described.

[0054] Figure 3 It is used to deliver electrical stimulation and receive bioelectrical signals from target tissues of patients. Figure 1 A block diagram of an example IMD 106 is shown. Figure 3In the example shown, the IMD 106 includes a processing circuit 210, a memory 211, a stimulation generation circuit 202, a sensing circuit 204 and a telemetry circuit 208, a charging circuit 222, a sensor 224, and a power supply 220. Each of these circuits may be or include a circuit configured to perform the functions attributed to each corresponding circuit. The memory 211 may include any volatile or non-volatile medium, such as a random access memory (RAM), a read-only memory (ROM), a non-volatile RAM (NVRAM), an electrically erasable programmable ROM (EEPROM), a flash memory, a similar non-transitory computer-readable storage medium. The memory 211 may store computer-readable instructions that, when executed by the processing circuit 210, cause the IMD 106 to perform various functions. The memory 211 may also store data, including sensed bioelectric signals, information from an accelerometer, a temperature or other sensor included in the sensor 224, and temporary data for calculations or similar processing.

[0055] exist Figure 3 In the example shown, the memory 211 stores electrical stimulation information 214. The electrical stimulation information 214 may include program parameters (e.g., a set of treatment parameters), such as stimulation electrode combinations, electrode polarity, current or voltage amplitude, pulse width, and pulse rate. In some examples, individual treatment programs may be stored as a treatment group that defines a set of treatment programs that can be used to generate stimulation. The stimulation signals defined by the treatment programs of the treatment group may be delivered together on an overlapping or non-overlapping (e.g., time-interleaved) basis.

[0056] Stimulation generation circuit 202 generates stimulation signals under the control of processing circuit 210 for delivery to patient 112 via a selected combination of electrodes 116, 118, and 125. Leads 114 and electrodes 116, 118, and 125 are described above with respect to Figure 1 2 and have the same or similar functions and features.

[0057] Processing circuitry 210 may include fixed function processing circuitry and / or programmable processing circuitry, and may include, for example, one or more of the following: 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 configured to provide the functionality attributed to processing circuitry 210, which may be embodied herein as firmware, hardware, software, or any combination thereof. Processing circuitry 210 may control stimulation generation circuitry 202 according to programmed instructions stored in memory 211 to apply specific stimulation parameter values, such as voltage or current amplitude, pulse width, and / or pulse frequency, as specified by one or more of the programs.

[0058] exist Figure 3 In the example shown, the set of electrodes 116 includes electrodes 116A, 116B, 116C, and 116D, and the set of electrodes 118 includes electrodes 118A, 118B, 118C, and 118D. The processing circuit 210 controls the stimulation generation circuit 202 to generate stimulation signals and apply these stimulation signals to selected combinations of electrodes 116, 118, and 125. In some examples, the processing circuit 210 can control the switching circuit to apply the stimulation signals generated by the stimulation generation circuit 202 to the selected combination of electrodes 116, 118, and 125. In other examples, the stimulation generation circuit 202 includes multiple pairs of voltage sources, current sources, voltage sinks, or current sinks connected to each of the electrodes 116, 118, and 125, so that each pair of electrodes has a unique signal circuit. In other words, in these examples, each of electrodes 116, 118, and 125 is independently controlled via its own signal circuit (e.g., via a combination of a regulated voltage source and sink or a regulated current source and sink), as opposed to switching signals between electrodes 116, 118, and 125 and, in some examples, electrodes on the IMD 106 housing.

[0059] Despite Figure 3 Sensing circuit 204 is incorporated into a common housing with stimulation generation circuit 202 and processing circuit 210, but in other examples, sensing circuit 204 may be in a separate housing from IMD 106 and may communicate with processing circuit 210 via wired or wireless communication techniques. Example neural brain signals include, but are not limited to, signals generated by local field potentials (LFPs) within one or more regions of brain 120. EEG and ECoG signals are examples of local field potentials that can be measured within brain 120. LFP, EEG, and ECoG may be different measurements of the same bioelectrical signal in the brain.

[0060] As mentioned above about Figure 1 As described, in some examples, IMD 106 can stimulate a target tissue of a patient and sense an induced response, such as ERNA. In some examples, the stimulation generation circuit can output electrical stimulation via some combination of electrodes 116 and 118 and sense the response via intraluminal electrode 125. In other examples, intraluminal electrode 125 can provide electrical stimulation, such as source current or sink current, and also sense the induced response. As described above with respect to FIG. 2, in some examples, intraluminal electrode 125 can be arranged in an array and include a plurality of electrodes.

[0061] One application is that IMD 106 may be configured to deliver stimulation configured to elicit a measurable response indicative of a thought pattern or neural state that would otherwise be undetectable using non-evoked biopotentials such as local field potentials. Processing circuit 210 and / or Figure 1 Other processing circuitry of the system 100 depicted in may iteratively select electrodes to deliver stimulation while simultaneously recording evoked responses (such as ECAP or ERNA) from electrodes not used for stimulation.

[0062] Sensing circuit 204 can measure one or more characteristics of the biopotential, such as ERNA, both when the patient is engaged and when the patient is not engaged in a particular thought pattern. Some examples of the measured characteristics can include amplitude, delay, area under the curve, morphology, number of zero crossings, resonant frequency, decay constant (e.g., time for the ERNA signal to decay), or maximum and number of maximum values ​​within the signal. In some examples, IMD 106 can sense changes in biopotentials, such as changes in ERNA, during patient movement or lack of movement. In some examples, processing circuit 210 can associate signals from one or more accelerometers of sensor 224 of sensed position and / or movement with induced biopotentials.

[0063] In some examples, the processing circuitry may be trained for differences, which in some examples may be specific to a particular patient. For example, the training may include differences between a baseline and a specified thought pattern or a specified neural state. Other differences may include differences between a first neural state and a second neural state, or differences between two or more different thought patterns. Once trained, the processing circuitry may detect neural state changes and determine that a triggering event has occurred based on the neural state changes, such as activation / inhibition of an indicator, a system state change, a telemetry event, a closed-loop adjustment to an electrical stimulation therapy, or other actions.

[0064] In some examples, the processing circuit 210 may not be able to detect the desired thought pattern or neural state using a single local field potential. Active methods such as detecting evoked biopotentials (such as ECAP / ERNA) can induce a change in neural state that indicates a change in thought pattern. In some examples, the processing circuit 210 may first determine that the neural state change is not detectable with LFP, and then apply an active method to induce and measure ERNA. In other examples, the processing circuit 210 may use an accelerometer signal as a trigger to then apply an active method and induce an evoked biopotential.

[0065] The processing circuit (e.g., the processing circuit 210 of the IMD 106) may also analyze the sensed evoked biopotential as an auxiliary tool for determining the optimal position for sensing a biopotential that indicates a thought pattern or a neural state. In some examples, the amplitude of the LFP detectable in the body lumen that is manifested as a change in thought pattern or neural state may be very low and require a lot of signal processing or long periods of observation. However, due to the synchronous and compound activation of neural circuits associated with changes in neural state, the evoked biopotential may have a larger, more detectable amplitude. Therefore, the IMD 106 may output electrical stimulation to induce the evoked biopotential, and analyze the received sensed evoked biopotential to evaluate which electrodes and electrode positions may be most suitable for LFP detection. In some examples, the clinician may perform steps of this type of evaluation during device installation and training of the IMD 106 for the patient.

[0066] In some examples, the processing circuit may deliver a stimulation-inducing signal that enhances the detectability of the relevant thought pattern or neural state. As described above, LFPs associated with changes in thought patterns or neural states are generally difficult to detect within the body lumen. In some examples, IMD 106 may output neural stimulation via some combinations of electrodes 116, 118, and 125 to "trigger" neural circuits involved in changes in thought patterns or neural states. In some examples, neural stimulation (e.g., an electrical stimulation signal with certain parameters) may make a neural target more sensitive to activation and subsequently generate a larger LFP when a change in neural state occurs. In some examples, the output neural stimulation may be delivered as a burst, for example to save power or avoid undesirable effects such as neural habituation. IMD 106 may use the sensed induced biopotential to monitor the neural target and ensure that the triggering neural stimulation has been delivered. As described above, the selection of electrical stimulation parameters and electrode combinations may be set during installation and training.

[0067] In other examples, the IMD 106 may assess the patency of an intraluminal medical device (e.g., an intraluminal electrode 125). Some example criteria for patency may include that the electrode 125 is operable, in a known position, and in contact with an anatomical target of interest, such that the electrode 125 can deliver stimulation or sense signals from the target tissue. Because some of the biosignals of interest may be difficult to detect, as described above, it may be difficult to determine whether the signal is truly absent, or that the electrode 125 is not operating properly or is in an incorrect position. Unless otherwise noted, the terms "biosignal," biopotential, bioelectric signal, and similar terms may be used interchangeably. In the present disclosure, electrical stimulation delivered to induce a response may be different from electrical stimulation therapy delivered to manage patient symptoms (e.g., delivered with different parameters such as amplitude and pulse width).

[0068] IMD 106 can be configured to use the delivered electrical stimulation to induce a known neural response in the target tissue, such as an induced biopotential, such as ERNA. Degradation or absence of the induced response can indicate that the system is not operating correctly or that the electrode 135 is in an incorrect position. Conversely, the processing circuitry of IMD 106 can determine that the electrode 125 is operating properly and / or is in a desired position close to the target tissue based on sensing the induced biopotential (e.g., ECAP) in response to a control pulse configured to induce an ECAP.

[0069] The telemetry circuit 208 supports wireless communication between the IMD 106 and the external computing device 104 or another computing device under the control of the processing circuit 210. As an update to the program, the processing circuit 210 of the IMD 106 can receive values ​​of various stimulation parameters (such as amplitude and electrode combination) from the external computing device 104 via the telemetry circuit 208. Updates to the treatment program can be stored in the treatment program 214 portion of the memory 211. The telemetry circuit 208 in the IMD 106 and the telemetry modules (such as the external computing device 104) in other devices and systems described herein can communicate through radio frequency (RF) communication technology. In addition, the telemetry circuit 208 can communicate with the external medical device external computing device 104 via the proximal sensing interaction of the IMD 106 with the external computing device 104. Therefore, the telemetry circuit 208 can send information to the external computing device 104 on a continuous basis, at periodic intervals, or based on a request from the IMD 106 or the external computing device 104.

[0070] In some examples, processing circuit 210 can continuously measure one or more bioelectric signals in real time. In other examples, processing circuit 210 can periodically sample one or more bioelectric signals according to a predetermined frequency or after a predetermined amount of time. In some examples, processing circuit 210 can periodically sample the signals at a frequency of approximately 150 Hz.

[0071] Power supply 220 delivers operating power to various components of IMD 106. Power supply 220 may include a small rechargeable or non-rechargeable battery and a power generation circuit to generate operating power. Recharging may be accomplished through proximal inductive interaction between an external charger and an inductive charging coil (e.g., connected to charging circuit 222) within IMD 106. In some examples, the power requirements may be small enough to allow IMD 106 to utilize patient motion and implement a kinetic energy scavenging device to trickle charge the rechargeable battery. In other examples, conventional batteries may be used for a limited time.

[0072] Figure 4 yes Figure 11 is a block diagram of an external computing device 104. Although the external computing device 104 may be generally described as a handheld device, the external computing device 104 may be a larger portable device or a more fixed device. In addition, in other examples, the external computing device 104 may be included as part of an external charging device or include the functionality of an external charging device. Figure 4 As illustrated, external computing device 104 may include processing circuitry 410, memory 411, user interface 402, telemetry circuitry 408, and power source 420. Throughout this disclosure, memory 411 may store instructions that, when executed by processing circuitry 410, cause processing circuitry 410 and external computing device 104 to provide functionality attributed to external computing device 104. Each of these components or modules may include circuitry configured to perform some or all of the functionality described herein. In some examples, the external computing device 104 may include a processor 410, a memory 411, a user interface 402, a telemetry circuit 408, and a power source 420. Figure 3 The processing circuit 210 combined with the processing circuit 410 can execute the above-mentioned Figure 1 , Figure 2 and Figure 3 Some of the functions described, such as analyzing and responding to evoked responses sensed by the intraluminal electrode 125 .

[0073] In general, the external computing device 104 includes any suitable hardware arrangement that performs the techniques attributed to the external computing device 104 and the processor circuit 410, user interface 402, and telemetry circuit 408 of the external computing device 104, either alone or in combination with software and / or firmware. In various examples, the external computing device 104 may include one or more processors, which may include fixed-function processing circuits and / or programmable processing circuits, such as formed by, for example, one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuits, and any combination of such components. In various examples, the external computing device 104 may also include a memory 411, such as RAM, ROM, PROM, EPROM, EEPROM, flash memory, hard disk, CD-ROM, which includes executable instructions for causing one or more processors to perform the actions attributed to them. In addition, although the processing circuit 410 and the telemetry circuit 408 are described as separate modules, in some examples, the processing circuit 410 and the telemetry circuit 408 may be functionally integrated with each other. In some examples, processing circuit 410 and telemetry circuit 408 correspond to respective hardware units, such as an ASIC, DSP, FPGA, or other hardware units.

[0074] Memory 411 (e.g., a storage device) may store instructions that, when executed by processing circuit 410, cause processing circuit 410 and external computing device 104 to provide functionality attributed throughout this disclosure to external computing device 104. For example, memory 411 may include instructions that cause processing circuit 410 to retrieve a parameter set from memory or receive user input and send a corresponding command to IMD 106, or instructions for any other functionality. Furthermore, memory 411 may include a plurality of programs, where each program includes a parameter set that defines a stimulation therapy.

[0075] The user interface 402 may include buttons or a keypad, lights, a speaker for voice commands, a display such as a liquid crystal (LCD), a light emitting diode (LED), or an organic light emitting diode (OLED). In some examples, the display may be a touch screen. The user interface 402 may be configured to display any information related to the delivery of the stimulation therapy, the identified patient behavior, the sensed patient parameter values, the patient behavior criteria, displaying the detected thought patterns, the identified neural activity, the efficacy of the placed intraluminal electrode device, or any other such information. The user interface 402 may also receive user input. The input may be in the form of, for example, pressing a button on a keypad or selecting an icon from a touch screen.

[0076] Telemetry circuitry 408 may support wireless communication between IMD 106 and external computing device 104 under the control of processing circuitry 410. Telemetry circuitry 408 may also be configured to communicate with another computing device via wireless communication techniques, or directly with another computing device via a wired connection. In some examples, telemetry circuitry 408 provides wireless communication via RF or a proximal inductive medium. In some examples, telemetry circuitry 408 includes an antenna, which may take a variety of forms, such as an internal antenna or an external antenna.

[0077] Examples of local wireless communication technologies that may be used to facilitate communication between external computing device 104 and IMD 106 include RF communications according to the 802.11 or Bluetooth specification sets or other standard or proprietary telemetry protocols. In this way, other external devices may be able to communicate with external computing device 104 without establishing a secure wireless connection. In some examples, the external computing device may communicate with IMD 106 via an inductive coil (such as a RF transmitter connected to a power supply) during or interleaved with recharging IMD 106. Figure 3 The coil of the charging circuit 222 communicates.

[0078] In some examples, processing circuitry 410 of external computing device 104 defines parameters of the electrical stimulation therapy stored in memory 411 to deliver adaptive DBS to patient 112. In one example, processing circuitry 410 of external computing device 104 issues commands to IMD 106 via telemetry circuitry 408, causing IMD 106 to deliver electrical stimulation therapy via leads 114 via electrodes 116, 118, and 125, as described above with respect to Figures 1 to 3 as described.

[0079] External computing device 104 may also configure which electrodes IMD 106 uses to deliver electrical stimulation, e.g., to make a neural target more sensitive to activation and subsequently generate a larger LFP when a change in neural state occurs. Similarly, external computing device 104 may configure IMD 106 to elicit a measurable response indicative of a thought pattern or neural state that would otherwise be undetectable using non-evoked biopotentials.

[0080] According to the techniques of the present disclosure, external computing device 104 may be configured to determine when patient 112 takes medication, for example, based on LFP activity of patient 112. In some examples, external computing device 104 may be configured to determine the duration for which the medication is effective based on LFP activity of patient 112. External computing device 104 may be configured to determine when patient 112 takes medication and the duration for which the medication is effective based on LFP activity of patient 112. External computing device 104 may output an indication of when patient 112 takes medication and / or the duration for which the medication is effective to facilitate treatment of the patient.

[0081] Figure 5A is a time plot of an example evoked compound action potential (ECAP) sensed for a corresponding stimulation pulse according to one or more techniques of the present disclosure. Figure 4 As shown, graph 502 shows example ECAP signals 504 (dashed line) and ECAP signals 506 (solid line). In some examples, each of ECAP signals 504 and 506 is sensed by stimulation pulses (e.g., control pulses) delivered from a protected cathode, wherein the stimulation pulses are biphasic pulses that include an inter-phase interval between each positive and negative phase of the pulse. In some such examples, the protected cathode includes an 8-electrode lead (e.g., Figure 1 and Figure 3 The stimulating electrode at the end of the lead 114 of the 8-electrode may be located at the other end of the 8-electrode lead, while the two sensing electrodes may be located at the other end of the 8-electrode lead. The ECAP signal 504 illustrates the voltage amplitude sensed as a result of a sub-detection threshold stimulation pulse or a stimulation pulse that results in an undetectable ECAP. Figure 5AIn other examples not shown, the IMD may output single-phase, three-phase, or pulses having another number of phases to induce an evoked response.

[0082] IMD (e.g. Figure 1 and Figure 3 Sensing circuitry of the IMD 106 of the embodiment of the present invention can detect peak 508 of the ECAP signal 504. Peak 508 represents the stimulation signal of the delivered stimulation pulse. However, no propagation signal is detected after the stimulation signal in the ECAP signal 504 because the stimulation pulse has an intensity (e.g., amplitude and / or pulse width) that is "subthreshold" or below a detection threshold (e.g., sub-detection threshold) and / or below a propagation threshold (e.g., sub-propagation threshold).

[0083] Compared to ECAP signal 504, ECAP signal 506 represents the voltage amplitude detected from the super-detection stimulation threshold stimulation pulse. Peak 508 of ECAP signal 506 is detected, and the peak represents the stimulation signal of the delivered stimulation pulse. After peak 508, ECAP signal 506 also includes peaks P1, N1 and P2, which are three typical peaks representing the propagation action potential from ECAP. The example duration of the stimulation signal with peaks P1, N1 and P2 is about 1 millisecond (ms).

[0084] When the ECAP of the ECAP signal 506 is detected, different features can be identified. For example, the feature of the ECAP can be the amplitude between N1 and P2. Even if the stimulation signal is projected onto a relatively large signal P1, the N1-P2 amplitude may be detected, and the N1-P2 amplitude may be minimally affected by the electronic drift in the signal. In other examples, the feature of the ECAP for controlling subsequent stimulation pulses (e.g., control pulses and / or notification pulses) can be the amplitude of P1, N1 or P2 relative to the neutral voltage or zero voltage. In some examples, the feature of the ECAP for controlling subsequent stimulation pulses is the sum of two or more of the peaks P1, N1 or P2. In other examples, the feature of the ECAP signal 406 can be the area under one or more of the peaks P1, N1 and / or P2. In other examples, the feature of the ECAP can be the ratio of one of the peaks P1, N1 or P2 to another of these peaks. In some examples, the feature of the ECAP is the 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.

[0085] The time between delivering the stimulation pulse and a point in the ECAP signal can be referred to as the delay of the ECAP, and can indicate the type of fiber captured by the stimulation pulse (e.g., control pulse). An ECAP signal with a lower delay (i.e., a smaller delay value) indicates that the nerve fiber with a faster signal propagation has a higher percentage, while an ECAP signal with a higher delay (i.e., a larger delay value) indicates that the nerve fiber with a slower signal propagation has a higher percentage. Delay can also refer to the time between detecting an electrical feature at one electrode and then detecting the electrical feature again at a different electrode. The time (or delay) is inversely proportional to the conduction velocity of the nerve fiber. In other examples, other features of the ECAP signal can be used.

[0086] As long as the amplitude of the stimulation pulse is greater than the threshold, the amplitude of the ECAP signal increases as the pulse amplitude increases, causing the nerve to depolarize and propagate the signal. The target ECAP characteristic (e.g., target ECAP amplitude) can be determined based on the ECAP signal detected from the stimulation pulse (or control pulse) when determining that the notification pulse delivers effective treatment to the patient 105. Therefore, the ECAP signal represents the distance between the stimulation electrode and the nerve that is appropriate for the stimulation parameter value of the notification pulse delivered at that time. Therefore, Figure 1 The IMD 106 may attempt to use the detected changes in the measured ECAP characteristic values ​​to change therapy pulse parameter values ​​and maintain target ECAP characteristic values ​​during therapy pulse delivery.

[0087] Figure 5B is a time graph illustrating an example evoked resonant neural activity (ERNA) received by an intraluminal medical device according to an example of the disclosed technology. To induce an evoked response, the electrical stimulation generator outputs pulses with a frequency less than 60 Hz or bursts of pulses with a frequency greater than 60 Hz. Figure 5B The time zero in the example of is immediately after the delivered control pulse. For frequencies greater than 60 Hz, the time zero is after the last pulse of the pulse burst. Figure 5B An example pulse width is about 120 microseconds (μs).

[0088] In some examples, when the stimulation and sensing electrodes are closest to the STN target, the Figure 5B In some examples, such responses may also be sensed when the stimulation and sensing electrode contacts are the same (ie, the stimulation and sensing electrode contacts do not necessarily have to be different electrodes).

[0089] For lower frequencies, e.g., less than 40 Hz, the sensed evoked responses appear to be similar to ECAP, as discussed above with respect to Figure 5AIn some examples, evoked biopotentials may have different characteristics depending on electrode location. For example, differences in ECAPs in the brain may include time constants that differ from Figure 5A An example of SCS is shown in . Fig. 6A The response in may represent a DBS ECAP from a lower 20 Hz stimulation. As the frequency increases, Figure 5B The example of shows an increase in resonance in the sensed evoked response. In other words, the sensed evoked response may include additional peaks and troughs of resonance from the neural target connectivity. Thus, in order to induce a resonant evoked response, it may be desirable to stimulate the target tissue with a higher frequency of electrical stimulation.

[0090] Fig. 6A and Figure 6B is a time graph illustrating an example of a resonant bioelectric signal (eg, ERNA) induced from electrical stimulation in accordance with one or more techniques of the present disclosure. Fig. 6A 602 is a time plot of the sensed evoked response to a 20 Hz stimulus. The sensed evoked response of each pulse 602 includes peaks and troughs similar to the ECAP, as described above with respect to Figure 5A In some examples, the evoked biopotentials used for such electrical stimulation have characteristics similar to ECAPs induced by electrodes implanted proximal to the spinal cord (e.g., for spinal cord stimulation (SCS)).

[0091] Figure 6B607. FIG. 608 is a time graph illustrating the sensed evoked response to three consecutive bursts of 110 Hz stimulation. Each pulse 605 evokes a response 607, but because the period is approximately 90 milliseconds (ms), the sensing circuitry of the IMD may not have enough time to record the peaks and troughs of the resonant activity 609. Therefore, the processing circuitry of the IMD may be programmed to periodically pause the stimulation (e.g., stop the stimulation for a predetermined period of time) to measure and analyze the characteristics of the resonant response. Some examples of characteristics that the IMD may measure and analyze include, for example, the resonant frequency of the peaks and troughs or some subset of the peaks and troughs, the amplitude, the damping of the resonance, the delayed changes of the peaks and troughs, and other similar characteristics, the phase alignment of the evoked response with the base resonance. In some examples, the analysis of the sensed signal may include trends in one or more selected features of the sensed waveform, for example, the amplitude of the evoked response changes that indicate a change in the neural state, or the delay of the peak and trough shifts that may indicate a change in the neural state (thus changing the resonant frequency). In some examples, the number of pulses in a burst that induces resonant activity may depend on various factors, including individual patient physiology, neurological state, selected medications, deep sleep vs. wakefulness, disease progression electrode location, selected burst frequency, and other factors. In other examples, measured characteristics of the ERNA response may indicate the need to adjust stimulation parameters such as stimulation frequency, amplitude, pulse width, and other parameters. In some examples, Figure 3 The processing circuit 210 may adjust stimulation parameters in response to measured characteristics of the evoked biopotentials.

[0092] Figure 7 is a flow chart illustrating an example mode of operation of the system of the present disclosure. Figure 7 The system described includes the above Figure 1 System 100 is described.

[0093] Medical devices (such as Figure 1 The IMD 106 can deliver electrical stimulation (90) to a target tissue of the patient. The target tissue can include brain tissue, such as Figure 1 2, or other target tissues, such as spinal nerves, tibial nerves, internal organs, muscle tissue, and other patient tissues. The stimulation generation circuit 202 may be based on the Figure 3 The processing circuit 210 controls the signal to generate a stimulation electrical stimulus defined by one or more parameters.

[0094] Sensing circuits for medical devices (such as Figure 3 The sensing circuit 204 of the apparatus may receive bioelectrical signals (92) from the patient via one or more electrodes 116, 118 proximate to the target tissue. In some examples, at least one electrode 125 is configured to be located within the lumen of the anatomical structure and proximate to the target tissue, such as Figure 1 , Figure 2 and Figure 3as shown in .

[0095] Processing circuitry 210 of medical device 106 of FIG2 may receive an indication of a biopotential induced by the delivered electrical stimulation (94) via sensing circuitry 204. As described in detail above, the sensed biopotential may be a measurable response indicative of at least one of a thought pattern of the patient or a neural state of the patient at the time of the delivery of the electrical stimulation.

[0096] The technology of the present disclosure is described in the following examples.

[0097] Embodiment 1: A system comprising: an electrode configured to be located within a lumen of an anatomical structure and proximate to a target tissue of a patient; a medical device comprising: an electrical stimulation circuit configured to deliver electrical stimulation to the patient; a sensing circuit configured to detect bioelectric signals from the patient via the electrode; and a processing circuit configured to: control the electrical stimulation circuit to deliver electrical stimulation to the patient; receive via the sensing circuit an indication of a bioelectrical potential induced by the delivered electrical stimulation, wherein the sensed bioelectrical potential is a measurable response indicative of at least one of: a thought pattern from the patient; or a neural state of the patient when the electrical stimulation is delivered.

[0098] Example 2: According to the system of Example 1, the system includes a plurality of electrodes separate from the electrode configured to be located within the lumen of the anatomical structure, wherein the electrical stimulation circuit is configured to deliver electrical stimulation therapy via one or more of the plurality of electrodes.

[0099] Embodiment 3: The system of any one of embodiments 1 and 2, wherein the delivered electrical stimulation induces a biopotential comprising evoked resonant neural activity (ERNA) from the patient.

[0100] Example 4: The system of Example 3, wherein the target tissue of the patient comprises a location within the patient's subthalamic nucleus (STN).

[0101] Example 5: A system according to any of Examples 3 and 4, wherein the parameters that at least partially define the electrical stimulation include stimulation frequency, and wherein the ERNA induced from the patient exhibits one or more characteristics, wherein the one or more characteristics include the resonant frequencies of the peaks and troughs of the measured ERNA.

[0102] Embodiment 6: The system of any one of Embodiments 1 to 5, wherein the delivered electrical stimulation induces a biopotential comprising an evoked compound action potential (ECAP) from the patient.

[0103] Example 7: A system according to any one of Examples 1 to 6, wherein the delivered electrical stimulation is configured to provide a stimulation initiation signal to the target tissue of the patient, and the stimulation initiation signal enhances the detectability of at least one of: the thought pattern from the patient; or the neural state of the patient when the electrical stimulation is delivered.

[0104] Embodiment 8: A system according to any one of embodiments 1 to 7, wherein the processing circuit is configured to adjust one or more parameters that define the delivered electrical stimulation based on a received biopotential, wherein the received biopotential indicates the location of the patient's target tissue for sensing a biopotential indicative of a thought pattern or neural state.

[0105] Embodiment 9: A system according to any one of embodiments 1 to 8, wherein the processing circuit is configured to adjust one or more parameters that define the delivered electrical stimulation based on a received biopotential, wherein the received biopotential indicates the patency of the electrode located within the lumen of the anatomical structure.

[0106] Embodiment 10: A system according to any one of embodiments 1 to 9, wherein the processing circuit is configured to adjust one or more parameters that define the delivered electrical stimulation based on a received biopotential, wherein the received biopotential indicates one or more of the following: the electrode is operable, the electrode is in a known position, and the electrode is in contact with an anatomical target of interest of the patient.

[0107] Embodiment 11: The system of any one of Embodiments 1 to 10, wherein the anatomical structure is a blood vessel located in the brain.

[0108] Embodiment 12: The system of any one of Embodiments 1 to 11, wherein the electrical stimulation circuit is configured to deliver the electrical stimulation to the patient via the electrode configured to be positioned within the lumen of the anatomical structure.

[0109] Embodiment 13: A method, comprising: delivering electrical stimulation to a target tissue of a patient; receiving, by a sensing circuit of a medical device, a bioelectric signal from the patient via one or more electrodes proximate to the target tissue, wherein at least one electrode is configured to be located within a lumen of an anatomical structure and proximate to the target tissue; receiving, by a processing circuit and via the sensing circuit, an indication of a biopotential induced by the delivered electrical stimulation, wherein the sensed biopotential is a measurable response indicative of at least one of: a thought pattern from the patient; or a neurological state of the patient when the electrical stimulation is delivered.

[0110] Embodiment 14: The method of Embodiment 13, wherein the medical device is an implantable medical device.

[0111] Embodiment 15: The method according to any one of Embodiments 13 and 14, wherein the medical device comprises the processing circuit, the method further comprising controlling, by the processing circuit, an electrical stimulation circuit of the medical device to deliver the electrical stimulation to the patient.

[0112] Embodiment 16: The method according to Embodiment 15 further comprising controlling, by the processing circuit, the electrical stimulation circuit to deliver the electrical stimulation to the patient via the electrode configured to be located within the lumen of the anatomical structure.

[0113] Example 17: According to the method of any one of Examples 15 and 16, the method also includes controlling the electrical stimulation circuit by the processing circuit to deliver the electrical stimulation to the patient via a plurality of electrodes configured to be separated from the electrodes located within the lumen of the anatomical structure.

[0114] Embodiment 18: The method of any one of Embodiments 13 to 17, wherein the sensed biopotential is evoked resonant neural activity (ERNA) from the patient.

[0115] Embodiment 19: The method of Embodiment 18, wherein the induced ERNA from the patient exhibits one or more characteristics, and wherein the one or more characteristics include measured resonant frequencies of peaks and troughs of the ERNA.

[0116] Embodiment 20: A medical device, comprising: an electrical stimulation circuit configured to deliver electrical stimulation to a patient via one or more electrodes, wherein at least one electrode is configured to be located within a lumen of an anatomical structure and proximate to a target tissue of the patient; a sensing circuit configured to detect bioelectric signals from the patient via the electrode configured to be located within the lumen; and a processing circuit configured to: control the electrical stimulation circuit to deliver electrical stimulation to the patient; receive via the sensing circuit an indication of a bioelectrical potential induced by the delivered electrical stimulation, wherein the sensed biopotential is a measurable response indicative of at least one of: a thought pattern from the patient; or a neural state of the patient when the electrical stimulation is delivered.

[0117] In one or more examples, the above functions can be implemented in hardware, software, firmware, or any combination thereof. Figure 3 and Figure 4The various components (such as processing circuit 210, processing circuit 410, telemetry circuit 408, and charging circuit 222) may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored or transmitted as one or more instructions or codes on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include computer-readable storage media or communication media, which corresponds to tangible media such as data storage media, which includes any media that facilitates the transfer of a computer program from one place to another, for example, according to a communication protocol. As such, computer-readable media may generally correspond to: (1) non-transitory tangible computer-readable storage media or (2) communication media such as signals or carrier waves. Data storage media can be any available media that can be accessed by one or more computers or one or more processors to retrieve instructions, codes, and / or data structures for implementing the techniques described in the present disclosure. A computer program product may include a computer-readable medium.

[0118] The term "non-transitory" may indicate that the storage medium is not embodied in a carrier wave or propagating signal. In some examples, a non-transitory storage medium may store data that may change over time (e.g., in RAM or cache). By way of example and not limitation, such computer-readable storage media may include random access memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, hard disk, compact disk ROM (CD-ROM), floppy disk, cassette, magnetic media, optical media, or other computer system readable media. In some examples, an article of manufacture may include one or more computer-readable storage media.

[0119] In addition, any connection is properly referred to as a computer-readable medium. For example, if a coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technologies such as infrared, radio, and microwaves are used to transmit instructions from a website, server, or other remote source, the coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technologies such as infrared, radio, and microwaves are included in the definition of medium. However, it should be understood that the computer-readable storage medium and data storage medium do not include connections, carriers, signals, or other temporary media, but are actually directed to non-temporary tangible storage media. The above combination should also be included in the scope of computer-readable media.

[0120] The instructions may be executed by one or more processors, such as one or more DSPs, general-purpose microprocessors, ASICs, FPGAs, CPLDs, or other equivalent integrated or discrete logic circuits. Therefore, the terms "processor" and "processing circuitry" as used herein may refer to any of the aforementioned structures or any other structures suitable for implementing the techniques described herein. In addition, these techniques may be fully implemented in one or more circuits or logic elements.

[0121] The techniques of the present disclosure may be implemented in a variety of devices or apparatuses including integrated circuits (ICs) or sets of ICs (e.g., chipsets). Various components, modules, or units are described in this disclosure to emphasize the functional aspects of devices configured to perform the disclosed techniques, but do not necessarily need to be implemented by different hardware units. Instead, as described above, the various units may be combined in hardware units in conjunction with appropriate software and / or firmware, or provided by a collection of interoperable hardware units, the hardware units including one or more processors as described above.

[0122] The following examples are a non-limiting list of clauses in accordance with one or more techniques of the present disclosure.

[0123] Various examples of the disclosure have been described. These and other examples are within the scope of the following claims.

[0124] Embodiment 1. A system comprising: an electrode configured to be located within a lumen of an anatomical structure and proximate to a target tissue of a patient; a medical device comprising: an electrical stimulation circuit configured to deliver electrical stimulation to the patient; a sensing circuit configured to detect bioelectric signals from the patient via the electrode; and a processing circuit configured to: control the electrical stimulation circuit to deliver electrical stimulation to the patient; receive via the sensing circuit an indication of a bioelectrical potential induced by the delivered electrical stimulation, wherein the sensed bioelectrical potential is a measurable response indicative of at least one of: a thought pattern from the patient; or a neural state of the patient when the electrical stimulation is delivered.

[0125] Example 2. A system according to Example 1, comprising a plurality of electrodes separate from the electrode configured to be located within the lumen of the anatomical structure, wherein the electrical stimulation circuit is configured to deliver electrical stimulation therapy via one or more of the plurality of electrodes.

[0126] Embodiment 3. The system of embodiment 1, wherein the delivered electrical stimulation induces biopotentials comprising evoked resonant neural activity (ERNA) from the patient.

[0127] Example 4. The system of Example 3, wherein the target tissue of the patient comprises a location within the patient's subthalamic nucleus (STN).

[0128] Example 5. A system according to Example 3, wherein the parameters that at least partially define the electrical stimulation include stimulation frequency, and wherein the induced ERNA from the patient exhibits one or more characteristics, wherein the one or more characteristics include the resonant frequencies of the peaks and troughs of the measured ERNA.

[0129] Embodiment 6. The system of Embodiment 1, wherein the delivered electrical stimulation induces a biopotential comprising an evoked compound action potential (ECAP) from the patient.

[0130] Example 7. A system according to Example 1, wherein the delivered electrical stimulation is configured to provide a stimulation initiation signal to the target tissue of the patient, and the stimulation initiation signal enhances the detectability of at least one of: the thought pattern from the patient; or the neural state of the patient when the electrical stimulation is delivered.

[0131] Example 8. A system according to Example 1, wherein the processing circuit is configured to adjust one or more parameters that define the delivered electrical stimulation based on a received biopotential, wherein the received biopotential indicates the location of the patient's target tissue for sensing a biopotential indicative of a thought pattern or neural state.

[0132] Example 9. A system according to Example 1, wherein the processing circuit is configured to adjust one or more parameters that define the delivered electrical stimulation based on a received biopotential, wherein the received biopotential indicates the patency of the electrode located within the lumen of the anatomical structure.

[0133] Example 10. A system according to Example 1, wherein the processing circuit is configured to adjust one or more parameters that define the delivered electrical stimulation based on a received biopotential, wherein the received biopotential indicates one or more of the following: the electrode is operable, the electrode is in a known position, and the electrode is in contact with an anatomical target of interest of the patient.

[0134] Embodiment 11. The system of Embodiment 1, wherein the anatomical structure is a blood vessel located in the brain.

[0135] Example 12. The system of Example 1, wherein the electrical stimulation circuit is configured to deliver the electrical stimulation to the patient via the electrode configured to be positioned within the lumen of the anatomical structure.

[0136] Embodiment 13. A method, comprising: delivering electrical stimulation to a target tissue of a patient; receiving, by a sensing circuit of a medical device, a bioelectric signal from the patient via one or more electrodes proximate to the target tissue, wherein at least one electrode is configured to be located within a lumen of an anatomical structure and proximate to the target tissue; receiving, by a processing circuit of the medical device and via the sensing circuit, an indication of a biopotential induced by the delivered electrical stimulation, wherein the sensed biopotential is a measurable response indicative of at least one of: a thought pattern from the patient; or a neurological state of the patient when the electrical stimulation is delivered.

[0137] Embodiment 14. The method of Embodiment 13, wherein the medical device is an implantable medical device.

[0138] Embodiment 15. The method of embodiment 13, wherein the medical device comprises the processing circuit, the method further comprising controlling, by the processing circuit, an electrical stimulation circuit of the medical device to deliver the electrical stimulation to the patient.

[0139] Example 16. The method according to Example 15 further includes controlling, by the processing circuit, the electrical stimulation circuit to deliver the electrical stimulation to the patient via the electrode configured to be located within the lumen of the anatomical structure.

[0140] Example 17. The method according to Example 15 further includes controlling the electrical stimulation circuit by the processing circuit to deliver the electrical stimulation to the patient via a plurality of electrodes configured to be separate from the electrodes located within the lumen of the anatomical structure.

[0141] Embodiment 18. The method of embodiment 13, wherein the sensed biopotential is evoked resonant neural activity (ERNA) from the patient.

[0142] Embodiment 19. The method of embodiment 18, wherein the induced ERNA from the patient exhibits one or more characteristics, and wherein the one or more characteristics include measured resonant frequencies of peaks and troughs of the ERNA.

[0143] Embodiment 20. A medical device, comprising: an electrical stimulation circuit configured to deliver electrical stimulation to a patient via one or more electrodes, wherein at least one electrode is configured to be located within a lumen of an anatomical structure and proximate to a target tissue of the patient; a sensing circuit configured to detect bioelectric signals from the patient via the electrodes configured to be located within the lumen; and a processing circuit configured to: control the electrical stimulation circuit to deliver electrical stimulation to the patient; receive via the sensing circuit an indication of a bioelectrical potential induced by the delivered electrical stimulation, wherein the sensed biopotential is a measurable response indicative of at least one of: a thought pattern from the patient; or a neural state of the patient when the electrical stimulation is delivered.

Claims

1. A system, comprising: an electrode configured to be positioned within a lumen of an anatomical structure and proximate to a target tissue of a patient; A medical device, comprising: an electrical stimulation circuit configured to deliver electrical stimulation to the patient; a sensing circuit configured to detect a bioelectric signal from the patient via the electrodes; and A processing circuit, the processing circuit being configured to: controlling the electrical stimulation circuit to deliver electrical stimulation to the patient; receiving, via the sensing circuit, an indication of a biopotential induced by the delivered electrical stimulation, wherein the sensed biopotential is a measurable response indicative of at least one of: from the patient's thought patterns; or The neurological state of the patient at the time of delivery of the electrical stimulation.

2. A system according to claim 1, comprising a plurality of electrodes separated from the electrode configured to be located within the lumen of the anatomical structure, wherein the electrical stimulation circuit is configured to deliver electrical stimulation therapy via one or more of the plurality of electrodes.

3. The system of claim 1, wherein the delivered electrical stimulation induces biopotentials comprising evoked resonant neural activity (ERNA) from the patient.

4. The system of claim 3, wherein the target tissue of the patient comprises a location within the patient's subthalamic nucleus (STN).

5. The system according to claim 3, wherein the parameters defining at least in part the electrical stimulation include stimulation frequency, wherein the elicited ERNA from the patient exhibits one or more characteristics, The one or more characteristics include measured resonant frequencies of peaks and troughs of the ERNA.

6. The system of claim 1, wherein the delivered electrical stimulation induces a biopotential comprising an evoked compound action potential (ECAP) from the patient.

7. The system of claim 1 , wherein the delivered electrical stimulation is configured to provide a stimulation initiation signal to a target tissue of the patient, the stimulation initiation signal enhancing detectability of at least one of: said thought pattern from said patient; or The neurological state of the patient while delivering the electrical stimulation.

8. A system according to claim 1, wherein the processing circuit is configured to adjust one or more parameters that define the delivered electrical stimulation based on a received biopotential, wherein the received biopotential indicates the location of the patient's target tissue for sensing a biopotential indicative of a thought pattern or neural state.

9. A system according to claim 1, wherein the processing circuit is configured to adjust one or more parameters that define the delivered electrical stimulation based on a received biopotential, wherein the received biopotential indicates the patency of the electrode located within the lumen of the anatomical structure.

10. The system of claim 1, wherein the processing circuit is configured to adjust one or more parameters defining the delivered electrical stimulation based on the received biopotential, wherein the received biopotential is indicative of one or more of: The electrodes are capable of operating The electrodes are in known locations, and The electrodes are in contact with an anatomical target of interest of the patient.

11. The system of claim 1, wherein the anatomical structure is a blood vessel located in the brain.

12. The system of claim 1, wherein the electrical stimulation circuit is configured to deliver the electrical stimulation to the patient via the electrode configured to be positioned within the lumen of the anatomical structure.

13. A method comprising: delivering electrical stimulation to a target tissue of a patient; receiving, by sensing circuitry of a medical device, a bioelectrical signal from the patient via one or more electrodes proximate to the target tissue, wherein at least one electrode is configured to be positioned within a lumen of an anatomical structure and proximate to the target tissue; An indication of a biopotential induced by the delivered electrical stimulation is received by processing circuitry of the medical device and via the sensing circuitry, wherein the sensed biopotential is a measurable response indicative of at least one of: from the patient's thought patterns; or The neurological state of the patient at the time of delivery of the electrical stimulation.

14. The method of claim 13, wherein the medical device is an implantable medical device.

15. The method of claim 13, wherein the medical device comprises the processing circuit, the method further comprising controlling, by the processing circuit, an electrical stimulation circuit of the medical device to deliver the electrical stimulation to the patient.

16. The method of claim 15, further comprising controlling, by the processing circuit, the electrical stimulation circuit to deliver the electrical stimulation to the patient via the electrode configured to be positioned within the lumen of the anatomical structure.

17. The method of claim 15, further comprising controlling, by the processing circuit, the electrical stimulation circuit to deliver the electrical stimulation to the patient via a plurality of electrodes configured to be separate from the electrodes positioned within the lumen of the anatomical structure.

18. The method of claim 13, wherein the sensed biopotential is evoked resonant neural activity (ERNA) from the patient.

19. The method according to claim 18, wherein the elicited ERNA from the patient exhibits one or more characteristics, and The one or more characteristics include measured resonant frequencies of peaks and troughs of the ERNA.

20. A medical device, comprising: an electrical stimulation circuit configured to deliver electrical stimulation to a patient via one or more electrodes, wherein at least one electrode is configured to be positioned within a lumen of an anatomical structure and proximate to a target tissue of the patient; a sensing circuit configured to detect a bioelectric signal from the patient via the electrode configured to be located within the lumen; and A processing circuit, the processing circuit being configured to: controlling the electrical stimulation circuit to deliver electrical stimulation to the patient; receiving, via the sensing circuit, an indication of a biopotential induced by the delivered electrical stimulation, wherein the sensed biopotential is a measurable response indicative of at least one of: from the patient's thought patterns; or The neurological state of the patient at the time of delivery of the electrical stimulation.

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