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WO2025158350A1 - Systèmes et procédés de détermination de trajectoire d'implant de sonde et de placement final à l'aide de signaux d'activité neuronale résonante évoquée (erna) - Google Patents

Systèmes et procédés de détermination de trajectoire d'implant de sonde et de placement final à l'aide de signaux d'activité neuronale résonante évoquée (erna)

Info

Publication number
WO2025158350A1
WO2025158350A1 PCT/IB2025/050781 IB2025050781W WO2025158350A1 WO 2025158350 A1 WO2025158350 A1 WO 2025158350A1 IB 2025050781 W IB2025050781 W IB 2025050781W WO 2025158350 A1 WO2025158350 A1 WO 2025158350A1
Authority
WO
WIPO (PCT)
Prior art keywords
stimulation
evoked
signals
processor
lead
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2025/050781
Other languages
English (en)
Inventor
Kristin N. HAGEMAN
Todd D. Zenisek
Emily G. Klotsche
Nathan A. Torgerson
Rene A. MOLINA
Scott R. Stanslaski
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Inc
Original Assignee
Medtronic Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic Inc filed Critical Medtronic Inc
Publication of WO2025158350A1 publication Critical patent/WO2025158350A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36135—Control systems using physiological parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6868—Brain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • A61N1/0534—Electrodes for deep brain stimulation

Definitions

  • the present disclosure is generally directed to electrical stimulation therapy, and relates more particularly to using neurological responses in Deep Brain Stimulation (DBS) therapies.
  • DBS Deep Brain Stimulation
  • Medical devices may be external or implanted, and may be used to deliver electrical stimulation therapy to various tissue sites of a 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.
  • a medical device delivers electrical stimulation therapy via one or more leads that include electrodes located proximate to target locations associated with the brain, the spinal cord, pelvic nerves, peripheral nerves, or the gastrointestinal tract of a patient. Electrical stimulation is used in different therapeutic applications, such as DBS, spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, or peripheral nerve field stimulation (PNFS).
  • DBS spinal cord stimulation
  • SCS spinal cord stimulation
  • PNFS peripheral nerve field stimulation
  • Microelectrode recordings can be used to help define the trajectory and target location of DBS leads.
  • such recordings are muted when a patient is under the influence of one or more anesthetics (e.g., Propofol), analgesics, and/or the like, which muting may lead to subjective interpretation of the recordings.
  • Evoked Resonant Neural Activity (ERNA) responses to stimulation pulses occur when the patient is awake and even when the patient is under the influence of one or more anesthetics (e.g., Propofol), analgesics, or the like.
  • ERNA Evoked Resonant Neural Activity
  • ERNA responses may be used to plan the target location or trajectory of DBS lead implants, and may be further used to confirm the placement of the DBS lead once the DBS lead has been implanted.
  • the planning and confirmation of DBS lead placement may be utilized for patients who are awake, or alternatively on patients under the influence of one or more anesthetics, analgesics, and/or the like. Such use beneficially enhances accuracy of DBS lead placement and enables DBS implant procedures when the patient is under general anesthesia.
  • a system comprises: a processor; and a memory storing data thereon that, when processed by the processor, enable the processor to: receive, from a plurality of electrodes implanted along a first implant trajectory, a plurality of evoked neurological response signals; generate, based on the plurality of evoked neurological response signals, a multi-dimensional map including a target location of at least one anatomical structure for a stimulation implant; and determine, based on the target location, a second implant trajectory for the stimulation implant to arrive at the target location.
  • the memory comprises additional data that, when processed by the processor, further enable the processor to: receive a second plurality of evoked neurological response signals; and determine, based on the second plurality of evoked neurological response signals, that the stimulation implant that has been implanted at the target location has moved.
  • the memory comprises additional data that, when processed by the processor, further enable the processor to: render, to a display, the multidimensional map.
  • the stimulation implant is implanted along the second implant trajectory
  • the memory comprises additional data that, when processed by the processor, further enable the processor to: receive a second plurality of evoked neurological response signals; determine a second location of the at least one anatomical structure associated with an optimal evoked response signal of the second plurality of evoked neurological response signals; compare the target location with the second location; and provide, when a difference between the target location and the second location meets or exceeds a threshold value, one or more recommended adjustments to a pose of the stimulation implant.
  • the optimal evoked response signal comprises a maximum amplitude of the second plurality of evoked neurological response signals.
  • the stimulation implant comprises a deep brain stimulation (DBS) lead.
  • DBS deep brain stimulation
  • the at least one anatomical structure comprises a neural region.
  • the plurality of evoked neurological response signals comprises a plurality of Evoked Resonant Neural Activity (ERNA) signals.
  • ERNA Evoked Resonant Neural Activity
  • the memory comprises additional data that, when processed by the processor, further enable the processor to: generate, using a second plurality of electrodes of the stimulation lead, a second stimulation signal; receive a second plurality of evoked neurological response signals evoked in response to the second stimulation signal; and determine, based on the second plurality of evoked neurological response signals, that the stimulation lead implanted at the target location has moved.
  • the memory comprises additional data that, when processed by the processor, further enable the processor to: render, to a display, the multidimensional map.
  • the stimulation lead is implanted along the second implant trajectory
  • the memory comprises additional data that, when processed by the processor, further enable the processor to: generate, using a second plurality of electrodes of the stimulation lead, a second stimulation signal; receive a second plurality of evoked neurological response signals; determine a second location on the anatomical element associated with an optimal evoked response signal of the second plurality of evoked neurological response signals; compare the target location with the second location; and provide, when a difference between the target location and the second location meets or exceeds a threshold value, one or more recommended adjustments to a pose of the stimulation lead.
  • the optimal evoked response signal comprises a maximum amplitude of the second plurality of evoked neurological response signals.
  • the stimulation lead comprises a deep brain stimulation (DBS) lead.
  • DBS deep brain stimulation
  • anatomical element comprises a neural region.
  • the plurality of evoked neurological response signals comprises a plurality of Evoked Resonant Neural Activity (ERNA) signals.
  • ERNA Evoked Resonant Neural Activity
  • a system comprises: a processor; and a memory storing data thereon that, when processed by the processor, enable the processor to: generate, using a plurality of electrodes of a stimulation lead, a stimulation signal; receive a plurality of evoked neurological response signals; determine a first location on an anatomical element associated with an optimal evoked response signal of the plurality of evoked neurological response signals; compare the first location on the anatomical element with a second location of a stimulation electrode of the stimulation lead; and provide, when a distance between the first location and the second location meets or exceeds a threshold value, one or more recommended adjustments to a pose of the stimulation lead.
  • the optimal evoked response signal comprises a maximum amplitude of the plurality of evoked neurological response signals.
  • the stimulation lead comprises a deep brain stimulation (DBS) lead.
  • DBS deep brain stimulation
  • the plurality of evoked neurological response signals comprises a plurality of Evoked Resonant Neural Activity (ERNA) signals.
  • ERNA Evoked Resonant Neural Activity
  • anatomical element comprises a neuron
  • each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together.
  • each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as XI -Xn, Yl- Ym, and Zl-Zo
  • the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., XI and X2) as well as a combination of elements selected from two or more classes (e g., Y1 and Zo).
  • Fig. l is a diagram of a system according to at least one embodiment of the present disclosure.
  • Fig. 4A is a diagram of microelectrode devices (MERs) being inserted along an implant trajectory according to at least one embodiment of the present disclosure
  • Fig. 4B is a diagram of a stimulation lead being inserted along a second implant trajectory according to at least one embodiment of the present disclosure
  • Fig. 5 is a flowchart according to at least one embodiment of the present disclosure.
  • the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Alternatively or additionally, functions may be implemented using machine learning models, neural networks, artificial neural networks, or combinations thereof (alone or in combination with instructions).
  • Computer- readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).
  • Instructions may be executed by one or more processors or processing circuitry, such as one or more digital signal processors (DSPs), general purpose microprocessors (e.g., Intel Core i3, i5, i7, or i9 processors; Intel Celeron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Apple A10 or 10X Fusion processors; Apple Al l, A12, A12X, A12Z, or A13 Bionic processors; or any other general purpose microprocessors), graphics processing units (e.g., Nvidia GeForce RTX 2000-series processors, Nvidia GeForce RTX 3000-series processors, AMD Radeon RX 5000- series processors, AMD Radeon RX 6000-series processors, or any other graphics processing units), application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discretes (
  • Microelectrode recordings can be used to help define the trajectory and target location of Deep Brain Stimulation (DBS) leads in a patient, such as for DBS implants that are implanted while the patient is awake.
  • Mapping the target location includes placing one or more microelectrodes along an initial trajectory, and using auditory and visual feedback of the neural firing patterns to map out borders or outer boundaries of the target nuclei.
  • the DBS lead is then placed based on the feedback.
  • Interpretation of the firing patterns may be subjective, and health care provider (HCP) interpretation skills are highly varied, leading to variation in lead placement.
  • HCP health care provider
  • the MERs may beneficially enable a neurosurgeon to identify correct or accurate DBS targets based on physiological activity captured by the MERs.
  • the top and bottom of target nuclei, neural regions or subregions, and/or other anatomical elements may be identifiable or recognizable.
  • Magnetic Resonance Imaging (MRI) may not depict or otherwise enable visualization of the DBS target, so the MERs may be used to identify and confirm the best trajectory and target location for the DBS lead.
  • the target location may be or comprise a location at which the lead should sit in the target to optimize the number of DBS lead contacts for programming.
  • the microelectrodes may comprise single electrodes, or may comprise multipolar electrodes that enable spatial orientation determinations.
  • one or more microelectrodes may be placed for the purposes of generating a map.
  • the microelectrodes may be advanced to the target location along different trajectories, and may generate stimulation signals that evoke ERNA signals that are recorded by the microelectrodes around the target location (e.g., starting at 2 millimeters (mm) above the target and ending 2mm below the target).
  • the map may be based on the most distal electrode of the microelectrodes, but in other cases the map may be based on a different electrode.
  • the map may be based on the same microelectrode that was used to generate and deliver the stimulation signals, such as when the microelectrode is configured to both deliver the stimulation signal and then sense the evoked ERNA signal.
  • the microelectrode may comprise one or more electrodes that can be utilized to monitor ERNA signals and, if the electrode(s) are spatially placed, the microelectrode may also provide directionality information.
  • one or more algorithms or data models may be used to generate a three-dimensional (3D) view or heatmap of the active area (e.g., the target location of the lead within an anatomical structure), which may specify the target location in which to implant the DBS lead to achieve optimal ERNA response (e.g., the location that results in the greatest or a desired ERNA amplitude).
  • the location that achieves the optimal ERNA response may correspond to or be correlated with an improved or optimized therapy.
  • ERNA signals may be measured by electrodes on the DBS lead to confirm the placement of the DBS lead. After confirmation, the lead may be anchored.
  • the ERNA signals may additionally or alternatively be used to assist the HCP in placing the targeted DBS lead at a specific ERNA target.
  • the optimal ERNA response may correspond to or be correlated with the target location, such that the DBS lead records the optimal ERNA response at the target location, and records a less-than- optimal ERNA response when the DBS is not at the target location.
  • Such information may be used by the HCP to position or reposition the DBS lead (e.g., if the DBS records a less-than- optimal ERNA response, the HCP knows that the DBS lead is not positioned at the target location, and can adjust the position of the DBS lead).
  • one or more therapies or therapeutic windows may be defined. For example, based on the therapeutic windows of the DBS lead when the patient is asleep (e.g., based on the measured ERNA signals from the DBS lead), a therapy for when the patient would be awake may be defined. Additionally or alternatively, movement of the DBS lead may be determined or detected based on measurement of ERNA signals. For example, when ERNA signals taken from the DBS lead are different than those taken when the DBS lead was implanted and anchored, it may be determined that the DBS lead has rotated or shifted.
  • the ERNA signals may be used postoperatively (e.g., after the DBS lead has been implanted) to understand when the micro-lesioning effect has ended. For instance, the ERNA signals may change when the micro-lesioning effect has ended, enabling clinicians to identify when the micro-lesioning effect has ended. As another example, the ERNA response recorded during the initial DBS lead placement can be used to adjust the stimulation amplitude of the electrodes as micro-lesioning occurs to keep the ERNA response consistent even while under the effects of micro-lesioning. In some examples, the ERNA signals may be processed to determine how effective the DBS lead will be, such as by indicating when a patient is inside or outside the DBS window.
  • the ERNA signals measured for the patient may be ranked against other similar patients (e.g., patients with similar implants/implant locations/ailments for which the DBS lead is designed to treat/etc.) to predict the effectiveness of the DBS lead.
  • an implantable medical device (IMD) associated with the DBS lead can be programmed postoperatively before the patient is discharged
  • Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) inaccurate or sub-optimal DBS lead placement due to muted or reduced neurological responses from patients under anesthesia and (2) subjective and/or non-standardized approaches to DBS lead placement.
  • IMD implantable medical device
  • the DBS may be closed-loop in the sense that the IMD 106, as one example, may adjust, increase, or decrease the magnitude of one or more parameters of the DBS in response to changes in patient activity or movement, a severity of one or more symptoms of a disease of the patient, a presence of one or more side effects due to the DBS, and/or one or more sensed signals of the patient.
  • the system 100 comprises a bi-directional DBS system with capabilities to both deliver stimulation, sense intrinsic neuronal signals, and sense neural signals that are evoked in response to delivery of stimulation.
  • the system 100 may be configured to treat a patient condition, such as a movement disorder (e.g., ET, Parkinson’s, etc.), neurodegenerative impairment, a mood disorder, or a seizure disorder of the patient 112.
  • a movement disorder e.g., ET, Parkinson’s, etc.
  • the patient 112 is ordinarily a human patient.
  • the system 100 may be applied to other mammalian or non-mammalian, non-human patients.
  • the system 100 may provide therapy to manage symptoms of other patient conditions, such as, but not limited to, seizure disorders (e.g., epilepsy) or mood (or psychological) disorders (e.g., major depressive disorder (MDD), bipolar disorder, anxiety disorders, post-traumatic stress disorder, dysthymic disorder, and obsessive-compulsive disorder (OCD)). At least some of these disorders may be manifested in one or more patient movement behaviors.
  • seizure disorders e.g., epilepsy
  • mood (or psychological) disorders e.g., major depressive disorder (MDD), bipolar disorder, anxiety disorders, post-traumatic stress disorder, dysthymic disorder, and obsessive-compulsive disorder (OCD)
  • MMDD major depressive disorder
  • bipolar disorder e.g., anxiety disorders, post-traumatic stress disorder, dysthymic disorder, and obsessive-compulsive disorder (OCD)
  • OCD obsessive-compulsive disorder
  • a movement disorder or other neurodegenerative impairment may include symptoms such as, for example, muscle control impairment, motion impairment or other movement problems, such as rigidity, spasticity, bradykinesia, rhythmic hyperkinesia, nonrhythmic hyperkinesia, and akinesia.
  • the movement disorder may be a symptom of Parkinson’s disease or ET.
  • the movement disorder may be attributable to other conditions of the patient.
  • the system 100 comprises a programmer 104, the IMD 106, a lead extension 110, a lead 114A with a set of electrodes 116, and a lead 114B with a set of electrodes 118.
  • the electrodes 116, 118 of the leads 114A, 114B are positioned to deliver electrical stimulation to a tissue site within the brain 120 of the patient 112, such as a deep brain site under the dura mater of the brain 120 of the patient 112.
  • the IMD 106 may be implanted within a subcutaneous pocket above the clavicle, or, alternatively, on or within the cranium 122 or at any other suitable site within the patient 112.
  • the IMD 106 is constructed of a biocompatible material that resists corrosion and degradation from bodily fluids.
  • the IMD 106 may comprise a hermetic housing to substantially enclose components, such as a processor, therapy module, and memory.
  • delivery of stimulation to one or more regions of the brain 120 may be an effective treatment to manage disorders, such as Parkinson’s disease.
  • STN subthalamic nucleus
  • VIP ventralus intermediate
  • ANT anterior nucleus
  • VCVS ventral internal capsule/ventral striatum
  • AIC anterior insular cortex
  • Some or all of the electrodes 116, 118 also may be positioned to sense neurological brain signals within the brain 120 of the patient 112. In some examples, some of the electrodes 116, 118 may be configured to sense neurological brain signals and others of the electrodes 116, 118 may be configured to deliver electrical stimulation to the brain 120. In other examples, all of the electrodes 116, 118 are configured to both sense neurological brain signals and deliver electrical stimulation to the brain 120. In some examples, unipolar stimulation may be possible where one electrode is on the housing of the IMD 106. Although the IMD 106 is described as delivering electrical stimulation therapy to the brain 120, the IMD 106 may be configured to direct electrical stimulation to other anatomical regions of the patient 112.
  • an HMD may provide other electrical stimulation such as spinal cord stimulation to treat a movement disorder.
  • the IMD 106 includes a therapy module (e.g., which may include processing circuitry or other electrical circuitry configured to perform the functions attributed to the IMD 106) that includes stimulation generation circuitry configured to generate and deliver electrical stimulation therapy to the patient 112 via a subset of the electrodes 116, 118 of the leads 114A and 114B, respectively.
  • the subset of the electrodes 116, 118 that are used to deliver electrical stimulation to the patient 112, and, in some cases, the polarity of the subset of the electrodes 116, 118, may be referred to as a stimulation electrode combination.
  • the stimulation electrode combination can be selected for a particular patient and target tissue site (e.g., selected based on the patient condition).
  • the group of the electrodes 116, 118 includes at least one electrode and can include a plurality of electrodes.
  • the plurality of the electrodes 116 and/or 118 may have a complex electrode geometry such that two or more electrodes are located at different positions around the perimeter of the respective lead.
  • the neurological signals sensed within the brain 120 may reflect changes in electrical current produced by the sum of electrical potential differences across brain tissue
  • the electrodes 116, 118 may be configured to sense.
  • One example of a neurological brain signal is an ERNA signal, which may be evoked through delivery of electrical stimulation within the brain 120.
  • the electrical stimulation delivered within brain 120 to evoke the ERNA signal need not necessarily provide therapeutic benefit, but therapeutic benefit from the electrical stimulation used to evoke the ERNA signal is possible.
  • Electroencephalogram (EEG) signals, electrocorticogram (ECoG) signals, or local field potential (LFP) signals are also examples of neurological signals that may be sensed by the IMD 106.
  • neurons generate the neurological signals, and if measured at depth, it is LFP or ERNA (if evoked); if measured on the dura, it is ECoG; and if on scalp, it is EEG.
  • the neurological brain signals that are used to select a stimulation electrode combination may be sensed within the same region of the brain 120 as the target tissue site for the electrical stimulation.
  • the target tissue sites may include tissue sites within anatomical structures such as the thalamus, STN, or globus pallidus of the brain 120, as well as other target tissue sites.
  • the specific target tissue sites and/or regions within the brain 120 may be selected based on the patient condition.
  • both a stimulation electrode combination and sense electrode combinations may be selected from the same set of the electrodes 116, 118.
  • the electrodes used for delivering electrical stimulation may be different than the electrodes used for sensing neurological brain signals.
  • Therapeutic electrical stimulation generated by the IMD 106 may be configured to manage a variety of disorders and conditions.
  • the stimulation generation circuitry of the IMD 106 is configured to generate and deliver therapeutic electrical stimulation pulses to the patient 112 via electrodes of a selected stimulation electrode combination.
  • the stimulation generation circuitry of the IMD 106 may be configured to generate and deliver a continuous wave signal, e.g., a sine wave or triangle wave. In either case, stimulation generation circuitry within the IMD 106 may generate the electrical stimulation therapy for DBS according to a selected therapy program.
  • a therapy program may include a set of therapy parameter values (e.g., parameters), such as a stimulation electrode combination for delivering stimulation to the patient 112, pulse frequency, pulse width, and a current or voltage amplitude of the pulses.
  • the electrode combination may indicate the specific electrodes 116, 118 that are selected to deliver therapeutic stimulation signals to tissue of the patient 112 and the respective polarities of the selected electrodes.
  • the electrodes 116, 118 may be circumferentially-segmented DBS arrays of electrodes, and include some non-segmented electrodes as well, such as ring electrodes.
  • Circumferentially-segmented DBS arrays refer to electrodes that are segmented circumferentially along the lead.
  • the leads 114A and 114B may include a first set of electrodes arranged circumferentially around the leads 114A and 114B that are all at the same height level on the leads 114A and 114B. Each of the electrodes in the first set of electrodes is a separate segmented electrode and form a level of circumferentially-segmented array of electrodes.
  • the leads 114A and 114B may include a second set of electrodes arranged circumferentially around the leads 114A and 114B that are all at the same height level on the leads 114A and 114B.
  • Each of the electrodes in the first set of electrodes is a separate segmented electrode and form a level of circumferentially-segmented array of electrodes.
  • the electrodes may be beneficial by enabling directional stimulation and sensing.
  • the first and second sets of electrodes may evoke and measure ERNA signal responses from various anatomical tissues in the brain 120 of the patient 112, with such ERNA signal responses being used to plan and/or confirm the trajectory and target location of the leads 114A and 114B.
  • the IMD 106 may be configured to perform both directional stimulation and sensing, thereby enhancing the ability to target the source of the ERNA activities (also referred to as pathological neuronal activities).
  • the IMD 106 may be configured to perform directional sensing to determine a direction and/or orientation of the ERNA source (e.g., signal source that generates the ERNA).
  • the IMD 106 may direct the electrical stimulation toward the signal source to optimize the ERNA signal component produced by the signal source (e.g., amplitude, frequency, etc.), as one example.
  • the IMD 106 may determine a direction and/or orientation of the ERNA source, and may use such information along with information about the current pose of the leads 114A and 114B to determine whether the leads 114A and 114B are correctly placed at a target location. For instance, the IMD 106 may receive ERNA responses from surrounding anatomical tissue and, using processing circuitry, determine a location of target nuclei that are to receive directional stimulation.
  • the processing circuitry may further compare the location of the target nuclei to the location of the leads 114A and 114B (or the electrodes 116, 118) and, when a difference between the location of the target nuclei and the location of the leads 114A and 114B meet or exceed a threshold value, generate an alert indicating that the leads 114A and 114B have not been implanted in the correct location.
  • Such an alert may enable a physician, the patient 112, or the like to adjust the implant location of the leads 114A and 114B, adjust which electrodes of the electrodes 116, 118 are used to perform the stimulation, combinations thereof, and/or the like.
  • the example techniques discussed herein are not limited to examples where one or more of electrodes 116, 118 are circumferentially-segmented electrodes.
  • the example of using circumferentially-segmented electrodes is described as a way of directional stimulation and sensing.
  • the example techniques are also useable in examples where directional stimulation and sensing are not available or are not used.
  • the IMD 106 may be configured to deliver therapeutic electrical stimulation signals based on one or more parameters such as amplitude, pulse width, and frequency.
  • This disclosure describes example techniques for determining implant trajectories and placements using ERNA signals.
  • a clinician/ surgeon may use ERNA signals measured by one or more of the electrodes 116, 118 to determine that target location and/or surgical implant trajectory of the leads 114A, 114B.
  • the ERNA signals may be measured by a plurality of microelectrodes (which may be similar to or the same as the electrodes 116, 118) and used to generate a multi-dimensional (e g., two-dimensional (2D) or three-dimensional (3D)) maps of anatomical structures surrounding the leads 114A, 114B.
  • Such maps may be used to plan the surgical trajectory of the leads 114A, 114B.
  • the clinician/ surgeon may use ERNA signals measured by one or more of the electrodes 116, 118 to determine that the leads 114A, 114B have been implanted correctly.
  • the electrodes 116, 118 of the implanted leads may generate one or more stimulation signals that evoke one or more ERNA signals.
  • the ERNA signals may be recorded (e.g., by the IMD 106) and used to determine whether the leads 114A, 114B are in the correct position relative to the anatomical element or structure from which the ERNA signal was evoked (e.g., a neuron, a neural region or sub-region, etc.).
  • the processing circuitry may determine the ERNA signal of the respective ERNA signals having the highest peak-to-trough amplitude (e.g., constructive resonant state) came from a location 2 millimeters (mm) below the current position of a stimulation electrode of the stimulation lead (e.g., the lead 114A). The processing circuitry may then compare the 2mm difference to a threshold value and, when the difference meets or exceeds the threshold value, generate a signal indicative that the lead 114A should be adjusted to reduce the difference. For example, the processing circuity may indicate that the lead 114A should move 2mm further along the implant trajectory, such that the stimulation electrode is closer to the anatomical element.
  • the processing circuitry may indicate that the lead 114A should move 2mm further along the implant trajectory, such that the stimulation electrode is closer to the anatomical element.
  • the processing circuitry may evaluate the respective ERNA signals and use such evaluations in generating the multi-dimensional map, in processing the ERNA signals, in determining whether the leads 114A, 114B have been correctly implanted in the target location, combinations thereof, and/or the like. For instance, the processing circuitry may determine characteristics of the respective ERNA signals such as resonant activity. Examples of resonant activity include one or more of peak-to-trough amplitude, time between peak-to-peak, decay time constant, change in peak amplitudes (e.g., damping), amount of oscillations (e.g., number of peaks), rise or fall times, and frequency shift from early resonance to late resonance of the respective ERNA signals.
  • resonant activity include one or more of peak-to-trough amplitude, time between peak-to-peak, decay time constant, change in peak amplitudes (e.g., damping), amount of oscillations (e.g., number of peaks), rise or fall times, and frequency shift from early resonance to
  • the processing circuitry may determine the pose (e.g., position and orientation) of one or more anatomical elements from which the ERNA signals were evoked. Additionally or alternatively and based on such characteristics or properties of the ERNA signals, the processing circuitry may generate the multi-dimensional map depicting the active areas of anatomical structures (e.g., STN) relative to the electrodes used to evoke the ERNA signals, which may beneficially enable or enhance a physician’s ability to implant the leads 114A, 114B, patient satisfaction, clinical outcomes, etc.
  • the lead extension 110 is coupled to the IMD 106 via a connector 108 (also referred to as a connector block or a header of the IMD 106).
  • the lead extension 110 traverses from the implant site of the IMD 106 and along the neck of the patient 112 to the cranium 122 of the patient 112 to access the brain 120.
  • the leads 114A and 114B are implanted within the right and left hemispheres (or in just one hemisphere in some examples), respectively, of the patient 112 in order to deliver electrical stimulation to one or more regions of the brain 120, which may be selected based on the patient condition or disorder controlled by the system 100.
  • the specific target tissue site and the stimulation electrodes used to deliver stimulation to the target tissue site may be selected, e.g., according to the identified patient behaviors and/or other sensed patient parameters.
  • Other implant sites of the leads 114A, 114B and the IMD 106 are contemplated.
  • the IMD 106 may be implanted on or within the cranium 122, in some examples.
  • the leads 114A and 114B may be implanted within the same hemisphere or the IMD 106 may be coupled to a single lead implanted in a single hemisphere, in some examples.
  • Existing lead sets include axial leads carrying ring electrodes disposed at different axial positions and so-called "paddle" leads carrying planar arrays of electrodes. In some examples, more complex lead array geometries may be used.
  • the leads 114 are shown in FIG. 1 as being coupled to a common lead extension, in other examples, the leads 114 may be coupled to the HMD 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 to manage patient symptoms associated with, for example, a movement disorder of the patient 112.
  • the leads 114 may be implanted to position the electrodes 116, 118 at desired locations of the brain 120 through respective holes in the cranium 122.
  • the leads 114 may be placed at any location within the brain 120 such that the electrodes 116, 118 are capable of providing electrical stimulation to target tissue sites within the brain 120 during treatment.
  • the electrodes 116, 118 may be surgically implanted under the dura mater of the brain 120 or within the cerebral cortex of the brain 120 via a burr hole in the cranium 122 of the patient 112, and electrically coupled to the IMD 106 via one or more leads (e.g., the leads 114).
  • the electrodes 116, 118 of the leads 114 are shown as ring electrodes. Ring electrodes may be used in DBS applications because ring electrodes are relatively simple to program and are capable of delivering an electrical field 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 leads 114 may have a complex electrode array geometry that is capable of producing shaped electrical fields. The complex electrode array geometry may include multiple electrodes (e g., partial ring or segmented electrodes) around the outer perimeter of each lead 114, rather than one ring electrode.
  • one or more electrodes 116, 118 may be circumferentially- segmented DBS arrays of electrodes, and one or more electrodes 116, 118 may be nonsegmented electrodes such as ring electrodes, as described above.
  • electrodes 116, 118 may only be circumferentially-segmented DBS arrays of electrodes, and in some examples, electrodes 116, 118 may only be non-segmented electrodes, such as ring electrodes.
  • a housing of the IMD 106 may include one or more stimulation and/or sensing electrodes.
  • the leads 114 may have shapes other than elongated cylinders as shown in FIG. 1.
  • the leads 114 may be paddle leads, spherical leads, bendable leads, or any other type of shape effective in treating patient 112 and/or minimizing invasiveness of leads 114.
  • the IMD 106 includes a memory to store a plurality of therapy programs that each define a set of therapy parameter values. In some examples, the IMD 106 may select a therapy program from the memory based on various parameters, such as sensed patient parameters and the identified patient behaviors.
  • the stimulation generation circuitry of the HMD 106 may deliver a first set of one or more therapeutic electrical stimulation signals according to a first set of one or more parameters. Then, the processing circuitry may determine a second set of one or more parameters for a second set of one or more therapeutic electrical stimulation signals based on, for example, one or more ERNA signals and cause the stimulation generation circuitry to deliver the second set of the one or more therapeutic electrical stimulation signals.
  • the second set of one or more parameters may comprise changes to the first set of one or more parameters.
  • the programmer 104 wirelessly communicates with the IMD 106 as needed to provide or retrieve therapy information.
  • the programmer 104 is an external computing device that the user, (e.g., a clinician and/or the patient 112), may use to communicate with the IMD 106.
  • the programmer 104 may be a clinician programmer that the clinician uses to communicate with the IMD 106 and program one or more therapy programs for the IMD 106.
  • the programmer 104 may be a patient programmer that allows the patient 112 to select programs and/or view and modify therapy parameters.
  • the clinician programmer may include more programming features than the patient programmer. In other words, more complex and sensitive tasks may be reserved for the clinician programmer to prevent an untrained patient from making undesirable changes to the IMD 106.
  • the programmer 104 may be used to transmit initial programming information to the IMD 106.
  • This initial information may include hardware information, such as the type of leads and the electrode arrangement, the position of the leads 114 within the brain 120, the configuration of the electrodes 116, 118, initial programs defining therapy parameter values, and any other information the clinician desires to program into the IMD 106.
  • the programmer 104 may also be capable of completing functional tests (e.g., measuring the impedance of the electrodes 116, 118 of the leads 114).
  • the clinician may also store therapy programs within the IMD 106 with the aid of the programmer 104.
  • the clinician may determine one or more therapy programs that may provide efficacious therapy to the patient 112 to address symptoms associated with the patient condition, and, in some cases, specific to one or more different patient states, such as a sleep state, movement state or rest state.
  • the clinician may select one or more stimulation electrode combinations with which stimulation is delivered to the brain 120.
  • the clinician may evaluate the efficacy of the specific program being evaluated based on feedback provided by the patient 112 or based on one or more physiological parameters of the patient 112 (e.g., muscle activity, muscle tone, rigidity, tremor, etc.).
  • ERNA signals may be used to evaluate the efficacy of the specific program being evaluated (e.g., certain resonant activity in the ERNA signal may be indicative of efficacious therapy).
  • identified patient behavior from video information may be used as feedback during the initial and subsequent programming sessions.
  • the programmer 104 may assist the clinician in the creation/identification of therapy programs by providing a methodical system for identifying potentially beneficial therapy parameter values.
  • the programmer 104 may also be configured for use by the patient 112 When configured as a patient programmer, the programmer 104 may have limited functionality (compared to a clinician programmer) in order to prevent the patient 112 from altering critical functions of the IMD 106 or applications that may be detrimental to the patient 112. In this manner, the programmer 104 may only allow the patient 112 to adjust values for certain therapy parameters or set an available range of values for a particular therapy parameter. [0083] The programmer 104 may also provide an indication to the patient 112 when therapy is being delivered, when patient input has triggered a change in therapy or when the power source within the programmer 104 or the IMD 106 needs to be replaced or recharged.
  • the programmer 104 may include an alert LED, may flash a message to the patient 112 via a programmer display, generate an audible sound or somatosensory cue to confirm patient input was received (e.g., to indicate a patient state or to manually modify a therapy parameter).
  • an alert LED may flash a message to the patient 112 via a programmer display, generate an audible sound or somatosensory cue to confirm patient input was received (e.g., to indicate a patient state or to manually modify a therapy parameter).
  • the example techniques may be performed in the “cloud.”
  • the IMD 106 and/or the programmer 104 may upload the ERNA signals to one or more servers that form a cloud computing environment.
  • Processing circuitry of the cloud computing environment may perform the example techniques described in this disclosure.
  • the processing circuitry that is configured to perform the example techniques may be any one or combination of the processing circuitry of the IMD 106, the processing circuitry of programmer 104, and/or processing circuitry of a cloud computing environment.
  • the system 100 may be implemented to provide chronic stimulation therapy to the patient 112 over the course of several months or years. However, the system 100 may also be employed on a trial basis to evaluate therapy before committing to full implantation. If implemented temporarily, some components of the system 100 may not be implanted within the patient 112. For example, patient 112 may be fitted with an external medical device, such as a trial stimulator, rather than the IMD 106. The external medical device may be coupled to percutaneous leads or to implanted leads via a percutaneous extension. If the trial stimulator indicates the system 100 provides effective treatment to patient 112 (e.g., via DBS), the clinician may implant a chronic stimulator within the patient 112 for long-term treatment.
  • an external medical device such as a trial stimulator
  • Fig. 2 is a block diagram of the example IMD 106 of Fig. 1 for delivering DBS therapy.
  • the IMD 106 includes processing circuitry 210, a memory 212, stimulation generation circuitry 202, sensing circuitry 204, telemetry circuitry 208, and a power source 222.
  • Each of these circuits may be or include electrical circuitry configured to perform the functions attributed to each respective circuit.
  • the memory 212 may include any volatile or nonvolatile media, such as a random-access memory (RAM), read only memory (ROM), nonvolatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, any memory discussed herein, and/or the like.
  • RAM random-access memory
  • ROM read only memory
  • NVRAM nonvolatile RAM
  • EEPROM electrically erasable programmable ROM
  • flash memory any memory discussed herein, and/or the like.
  • the memory 212 may store computer-readable instructions that, when executed by the processing circuitry 210, cause the IMD 106 to perform various functions.
  • the memory 212 may be a storage device or other non-transitory medium.
  • the IMD 106 may include or may be referred to as a signal generator. [0087] In the example shown in Fig. 2, the memory 212 stores one or more multi-dimensional maps 214, one or more ERNA signals 216, one or more trajectories 218, and artificial intelligence (Al) 220.
  • one or more contents of the memory 212 may be absent or stored remotely (e.g., in a memory of the programmer 104), such that the memory 212 omits or does not include the multi-dimensional map 214, the ERNA signals 216, the trajectories 218, and/or the Al 220.
  • the multi-dimensional map 214 may be or comprise information associated with the pose (e.g., position and orientation) of one or more anatomical elements (e.g., neurons, neural regions or sub-regions), information about the areas in the brain 120 of the patient 112 experiencing or emitting the ERNA signals 216, combinations thereof, and/or the like.
  • the multi-dimensional map 214 may be capable of being rendered to a display (e.g., the user interface 302 discussed below), such that a user such as a clinician can view a visual representation of the ERNA signals 216 evoked by delivery of one or more stimulation signals from the stimulation electrodes of the electrodes 116, 118.
  • the ERNA signals 216 may be or comprise evoked neurological signals evoked in response to the one or more stimulation signals delivered from stimulation electrodes.
  • the trajectories 218 may be or comprise surgical information about the direction, depth, curvature, and/or any other information related to implanting the leads 114A, 114B.
  • the trajectories 218 may comprise information about an entry point through which the lead 114A is inserted into the brain 120 of the patient 112.
  • the trajectories 218 comprise information about the depth to which the lead 114A is to be inserted.
  • the trajectories 218 may be based on a surgical plan.
  • the trajectories 218 may be updatable or changeable, such as when the clinician uses the programmer 104 to send information, instructions, and/or the like to the IMD 106.
  • the trajectories 218 may be initially stored in the memory 212, but when the clinician goes to surgically implant the lead 114A, the clinician may desire an alternative trajectory to that stored in the trajectories 218. In this case, the clinician may update the trajectories 218 to reflect the alternative trajectory.
  • the trajectories 218 may be updated based on the processing circuitry 210 determining that the trajectories 218 do not result in the implanted leads stimulating the correct anatomical structures in the brain 120
  • the processing circuitry 210 may use measured ERNA signals (e.g., ERNA signals 216) to identify the location of the anatomical structures and, when the trajectories 218 do not result in the leads being placed correctly (e.g., the leads are in the incorrect location, the leads are too far away from the anatomical structures, etc ), the trajectories 218 may be updated.
  • the Al 220 may be or comprise one or more Al or machine learning (ML) models or methods.
  • the Al 220 may, in some embodiments, be organized into one or more applications, modules, packages, layers, or engines.
  • the memory 212 may store other types of content or data (e.g., machine learning models, artificial neural networks, deep neural networks, etc.) that can be processed by the processing circuitry 210 to carry out the method and features described herein.
  • content or data e.g., machine learning models, artificial neural networks, deep neural networks, etc.
  • functionality described herein can be achieved through use of instructions, algorithms, and/or machine learning models.
  • the data, algorithms, and/or instructions may cause the processing circuitry 210 to manipulate data stored in the memory 212 (e.g., the multi-dimensional map 214, the ERNA signals 216, the trajectories 218, combinations thereof, etc.) and/or received from or via the programmer 104 or other components of the IMD 106.
  • the Al or ML data models may be or comprise Convolutional Neural Networks (CNNs), Deep Neural Networks (DNNs), classification models, Support Vector Machines (SVMs), etc. that take the ERNA signals 216 as an input and output the multidimensional map 214.
  • the data models may be trained on historical data sets of similar anatomical elements or structures and/or similar surgeries or surgical procedures to generate the multi-dimensional map 214.
  • the generation of the multidimensional map 214 by the Al 220 may be semiautomatic, with the user capable of modifying the multi-dimensional map 214 manually.
  • the data model may generate the multidimensional map 214, and the user may be able to adjust the position or structure of one or more features depicted in the multi-dimensional map 214 (e.g., locations of anatomical structures) manually via input in a user interface (e g., a user interface of the programmer 104).
  • the stimulation generation circuitry 202 under the control of the processing circuitry 210, generates stimulation signals (e.g., electrical stimulation signals for evoking ERNA signals and/or therapeutic electrical stimulation signals for delivering therapy) for delivery to the patient 112 via the electrodes 116, 118.
  • stimulation signals e.g., electrical stimulation signals for evoking ERNA signals and/or therapeutic electrical stimulation signals for delivering therapy
  • An example range of electrical parameters believed to be effective in DBS to manage a movement disorder of patient include: a pulse rate (or frequency) between approximately 5 Hertz (Hz) and approximately 500Hz, such as between approximately 5 to 220Hz or such as approximately 130Hz; in examples with a voltage controlled system, a voltage amplitude between approximately 0.1 volts (V) and approximately 50V, such as between approximately 2V and approximately 3V; in examples with a current controlled system, a current amplitude between approximately 0.1 milliamps (mA) and approximately 3.5mA, such as between approximately 1.0mA and approximately 1.75mA; and/or a pulse width between approximately 20 microseconds (ps) and approximately 500ps, such as between approximately 50ps and approximately 200ps.
  • stimulation signals may be of any form, such as continuous-time signals (e.g., sine waves) or the like.
  • stimulation generation circuitry 202 may be configured to deliver electrical stimulation signals for evoking ERNA signals (e.g., where information indicative of the ERNA signals are stored as ERNA signals 216).
  • Example parameters of the electrical stimulation signals for evoking ERNA signals include amplitude within range of 0 to 7.5mA, such as 0 to 5mA, frequency within range of 5 to 250Hz, such as 80 to 220Hz, and pulse width in range of 20 to 450ps, such as 60 to 120ps.
  • the processing circuitry 210 may include fixed function processing circuitry and/or programmable processing circuitry, and may comprise, for example, any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), discrete logic circuitry, or any other processing circuitry configured to provide the functions attributed to the processing circuitry 210 herein may be embodied as firmware, hardware, software or any combination thereof.
  • the processing circuitry 210 may control the stimulation generation circuitry 202 according to therapy programs stored in the memory 212 to apply particular parameter values specified by one or more of programs, such as voltage amplitude or current amplitude, pulse width, and/or pulse rate.
  • the sensing circuitry 204 is configured to monitor signals from any combination of the electrodes 116, 118. Although the sensing circuitry 204 is incorporated into a common housing with the stimulation generation circuitry 202 and the processing circuitry 210 in Fig. 2, in other examples, the sensing circuitry 204 may be in a separate housing from the IMD 106 and may communicate with the processing circuitry 210 via wired or wireless communication techniques. [0094] In some examples, the sensing circuitry 204 includes one or more amplifiers, filters, and analog-to-digital converters. The sensing circuitry 204 may be used to sense physiological signals, such as ERNA signals. In some examples, sensing circuitry 204 measures ERNA signals from a particular combination of the electrodes 116, 118.
  • the particular combination of electrodes for sensing includes different electrodes than a set of electrodes 116, 118 used to deliver electrical stimulation signals (e.g., therapeutic electrical stimulation signals or electrical stimulation signals for evoking ERNA signals).
  • the particular combination of electrodes used for sensing includes at least one of the same electrodes as a set of electrodes used to deliver stimulation signals to the patient 112.
  • the sensing circuitry 204 may provide signals to an analog-to-digital converter, for conversion into a digital signal for processing, analysis, storage, or output by the processing circuitry 210.
  • the electrodes 116, 118 on the respective leads 114A, 114B may be constructed of a variety of different designs.
  • one or both of the leads 114 may include two or more electrodes at each longitudinal location along the length of the lead, such as multiple electrodes, e.g., arranged as segments, at different perimeter locations around the perimeter of the lead at each of the locations.
  • one or both of the leads 114 may include circumferentially-segmented DBS arrays of electrodes and non-segmented electrodes (e.g., ring electrodes).
  • Below the first ring electrode there may be three segmented electrodes of the electrodes 116 around the perimeter of lead 114A at a second longitudinal location on the lead 114A (e.g., location B).
  • the electrodes 118 may be similarly positioned along the lead 114B.
  • the example techniques should not be considered limited to such an example. There may be other configurations of electrodes for DBS. Moreover, the example techniques are not limited to DBS, and other electrode configurations are possible.
  • the electrodes 116, 118 may be electrically coupled to stimulation the stimulation generation circuitry 202 and the sensing circuitry 204 via respective wires that are straight or coiled within the housing of the lead and run to a connector at the proximal end of the lead.
  • each of the electrodes 116, 118 of the leads 114 may be electrodes deposited on a thin film.
  • the thin film may include an electrically conductive trace for each electrode that runs the length of the thin film to a proximal end connector.
  • the thin film may then be wrapped (e.g., a helical wrap) around an internal member to form the leads 114.
  • the telemetry circuitry 208 supports wireless communication between the IMD 106 and the programmer 104 or another computing device under the control of the processing circuitry 210.
  • the processing circuitry 210 of the IMD 106 may receive, as updates to programs, values for various parameters such as magnitude and electrode combination, from the programmer 104 via the telemetry circuitry 208.
  • the telemetry circuitry 208 in the IMD 106, as well as telemetry modules in other devices and systems described herein, such as the programmer 104 may accomplish communication by radiofrequency (RF) communication techniques.
  • the telemetry circuitry 208 may communicate with an external medical device programmer via proximal inductive interaction of the IMD 106 with the programmer 104. Accordingly, the telemetry circuitry 208 may send information to the programmer 104 on a continuous basis, at periodic intervals, or upon request from the IMD 106 or the programmer 104.
  • the power source 222 delivers operating power to various components of the HMD 106.
  • the power source 222 may include a small rechargeable or non-rechargeable battery and a power generation circuit to produce the operating power. Recharging may be accomplished through proximal inductive interaction between an external charger and an inductive charging coil within the IMD 106.
  • power requirements may be small enough to allow IMD 106 to utilize patient motion and implement a kinetic energy-scavenging device to trickle charge a rechargeable battery.
  • traditional batteries may be used for a limited period of time.
  • the DBS therapy is defined by one or more therapy programs having one or more parameters stored within the memory 212.
  • the one or more parameters include a current amplitude (for a current-controlled system) or a voltage amplitude (for a voltage- controlled system), a pulse rate or frequency, and a pulse width, or a number of pulses per cycle.
  • the electrical stimulation is delivered according to a “burst” of pulses, or a series of electrical pulses defined by an “on-time” and an “off-time”
  • the one or more parameters may further define one or more of a number of pulses per burst, an on-time, and an off-time.
  • the processing circuitry 210 via the electrodes 116, 118, delivers DBS to the patient 112 and may adjust one or more parameters defining the electrical stimulation.
  • Fig. 3 is a block diagram of the programmer 104 of Fig. 1.
  • the programmer 104 may generally be described as a hand-held device, the programmer 104 may be a larger portable device or a more stationary device.
  • the programmer 104 may be included as part of an external charging device or include the functionality of an external charging device.
  • the programmer 104 may include processing circuitry 310, a memory 312, a user interface 302, telemetry circuitry 308, and a power source 322.
  • the memory 312 may store instructions that, when executed by the processing circuitry 310, cause or enable the processing circuitry 310 and the programmer 104 to provide the functionality ascribed to the programmer 104 throughout this disclosure.
  • Each of these components, or modules, may include electrical circuitry that is configured to perform some or all of the functionality described herein.
  • the processing circuitry 310 may include processing circuitry configured to perform the processes discussed with respect to the processing circuitry 210 of the IMD 106 as described with reference to Fig. 2.
  • the programmer 104 may include or may be referred to as a signal generator (e.g., in combination with or separate from the IMD 106).
  • the programmer 104 comprises any suitable arrangement of hardware, alone or in combination with software and/or firmware, to perform the techniques attributed to the programmer 104, and the processing circuitry 310, the user interface 302, and the telemetry circuitry 308 of the programmer 104.
  • the programmer 104 may include one or more processors, which may include fixed function processing circuitry and/or programmable processing circuitry, as formed by, for example, one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components.
  • the programmer 104 also, in various examples, may include the memory 312, such as RAM, ROM, PROM, EPROM, EEPROM, flash memory, a hard disk, a CD-ROM, comprising executable instructions for causing the one or more processors to perform the actions attributed to them.
  • the processing circuitry 310 and the telemetry circuitry 308 are described as separate modules, in some examples, the processing circuitry 310 and the telemetry circuitry 308 may be functionally integrated with one another. In some examples, the processing circuitry 310 and the telemetry circuitry 308 correspond to individual hardware units, such as ASICs, DSPs, FPGAs, or other hardware units.
  • the memory 312 may store instructions or data that, when executed by the processing circuitry 310, cause or enable the processing circuitry 310 and the programmer 104 to provide the functionality ascribed to the programmer 104 throughout this disclosure.
  • the memory 312 may include instructions that cause the processing circuitry 310 to obtain a parameter set from memory or receive a user input and send a corresponding command to the IMD 106, or instructions for any other functionality.
  • the user interface 302 may be or comprise a keyboard, button, keypad, mouse, trackball, monitor, television, screen, touchscreen, lights, speaker for voice commands, display (e.g., a liquid crystal (LCD), light-emitting diode (LED), or organic light-emitting diode (OLED)) and/or any other device for receiving information from a user and/or for providing information to a user.
  • display e.g., a liquid crystal (LCD), light-emitting diode (LED), or organic light-emitting diode (OLED)
  • the user interface 302 may be configured to display any information related to the delivery of stimulation therapy, identified patient behaviors, sensed patient parameter values, patient behavior criteria, or any other such information.
  • the user interface 302 may also receive user input via the user interface 302. The input may be, for example, in the form of pressing a button on a keypad or selecting an icon from a touch screen.
  • the user interface 302 may be used, for example, to receive a user selection or other user input regarding any step of any method described herein. Notwithstanding the foregoing, any required input for any step of any method described herein may be generated automatically by the system 100 (e g., by a processor, processing circuitry, or another component of the system 100) or received by the system 100 from a source external to the system 100. In some embodiments, the user interface 302 may be useful to allow a physician, patient, or other user to modify instructions to be executed by the processing circuitry 310 according to one or more embodiments of the present disclosure, and/or to modify or adjust a setting of other information displayed on the user interface 302 or corresponding thereto. Although the user interface 302 is shown as part of the programmer 104, in some examples, the user interface 302 may be housed separately from one or more remaining components of the programmer 104.
  • the telemetry circuitry 308 may support wireless communication between the IMD 106 and the programmer 104 under the control of the processing circuitry 310.
  • the telemetry circuitry 308 may also be configured to communicate with another computing device via wireless communication techniques, or direct communication through a wired connection.
  • the telemetry circuitry 308 provides wireless communication via an RF or proximal inductive medium.
  • the telemetry circuitry 308 includes an antenna, which may take on a variety of forms, such as an internal or external antenna. Examples of local wireless communication techniques that may be employed to facilitate communication between the programmer 104 and the IMD 106 include RF communication according to the 802.11 or Bluetooth specification sets or other standard or proprietary telemetry protocols. In this manner, other external devices may be capable of communicating with the programmer 104 without needing to establish a secure wireless connection.
  • processing circuitry 310 of the programmer 104 defines the parameters of electrical stimulation therapy, stored in the memory 312, for delivering DBS to the patient 112.
  • the processing circuitry 310 of the programmer 104 via the telemetry circuitry 308, issues commands to the IMD 106 causing the IMD 106 to deliver electrical stimulation therapy via the electrodes 116, 118 via the leads 114.
  • the programmer 104 may be configured to perform one or more of the example techniques described in this disclosure.
  • the processing circuitry 310 may be configured to perform one or more of the example operations described above with respect to the processing circuitry 210.
  • the processing circuitry 310 may be configured to cause the stimulation generation circuitry 202 to deliver a first set of one or more therapeutic electrical stimulation signals according to a first set of one or more parameters.
  • microelectrodes 402 may be inserted into an anatomical structure 428 of the brain 120 of the patient 112.
  • the microelectrodes 402 may be similar in structure and function to, for example, the electrodes 116, 118, but may be smaller in dimension (e.g., thinner, shorter, etc ).
  • the microelectrodes 402 may be connected to the IMD 106 and/or any other stimulation generation circuitry such that the microelectrodes 402 can generate stimulation signals and/or record evoked neurological signals similar to the leads 114A, 114B.
  • the microelectrodes 402 may be inserted for the purposes of determining or confirming an optimized, preferred, or otherwise desired trajectory and/or target location for implanting the DBS lead(s) in the anatomical structure 428.
  • the microelectrodes 402 may be inserted along the same trajectories and/or to the same target location as planned for the lead 114A and/or the lead 114B.
  • the microelectrodes 402 may be inserted along the implant trajectory 404, an implant trajectory 424, and/or an implant trajectory 432, all of which may correspond to planned or available trajectories for implanting the lead 114A.
  • one or more electrodes of the microelectrodes 402 may emit stimulation signals.
  • the stimulation signals may be generated by the IMD 106 (e.g., by the stimulation generation circuitry 202) to which the microelectrodes 402 are electrically connected.
  • the stimulation signals may evoke one or more ERNA signals in surrounding anatomical tissues of the anatomical structure 428.
  • the ERNA signals may be measured by one or more electrodes of the microelectrodes 402.
  • the measured ERNA signals may include or otherwise reflect information about various characteristics of the ERNA signal (e.g., amplitude, latency, frequency, number of resonant peaks, etc.).
  • the microelectrodes 402 may generate and measure ERNA signals at a plurality of depths as the microelectrodes 402 are advanced along the implant trajectory 404. For instance, the microelectrodes 402 may generate and record ERNA signals at a first depth 408, a second depth 412, a third depth 416, and/or a fourth depth 420. Additionally or alternatively, the microelectrodes 402 may comprise an array of microelectrodes positioned at various locations along a length of the implanting device used to advance the microelectrodes 402 such that, at each depth, the microelectrodes 402 generate stimulation signals and record ERNA responses in a multi-dimensional plane.
  • the microelectrodes 402 may generate stimulation signals in a 2D plane (e.g., the 2D plane extending from the lefthand side to the righthand side of Fig. 4A in a first direction and out of the page in a second direction) extending through the anatomical structure 428.
  • the microelectrodes 402 may evoke ERNA signals along the non-depth dimensions of the anatomical structure 428.
  • the microelectrodes 402 may then measure the ERNA signals, such that the microelectrodes 402 gather ERNA signal information across a plane of the anatomical structure 428.
  • the microelectrodes 402 may record ERNA signals at a variety of depths, resulting in 3D ERNA signal information associated with the anatomical structure 428.
  • the ERNA signals may be stored in memory (e.g., memory 212 of the ZMD 106).
  • the method of inserting the microelectrodes 402 along a trajectory and recording ERNA signals at a plurality of depths may be repeated for additional or alternative trajectories.
  • the microelectrodes 402 may be first inserted along the implant trajectory 404 and generate ERNA signal information at a plurality of depths.
  • the microelectrodes 402 may then be extracted and inserted along the implant trajectory 424 and/or along the implant trajectory 432.
  • each trajectory (e.g., the implant trajectory 404, the implant trajectory 424, the implant trajectory 432, etc.) may have a different or unique entry point to the anatomical structure 428, may extend into the anatomical structure 428 at a different or unique angle or trajectory, may extend to a different or unique depth in the anatomical structure 428, etc.
  • the microelectrodes 402 may be implanted along the implant trajectory 404, while a different set of microelectrodes may be implanted along the implant trajectory 424 and/or the implant trajectory 432.
  • more than one set of microelectrodes 402 may be used during the course of generating and measuring ERNA signals evoked in the anatomical structure 428. Similar to when the microelectrodes 402 were implanted along the implant trajectory 404, the microelectrodes 402 may be used to generate and measure ERNA signals along the implant trajectory 424 and/or the implant trajectory 432.
  • the ERNA signals generated by the anatomical structure 428 and/or other anatomical elements/tissues/structures/etc. may be passed to the memory 212, where Al 220 may be used to generate the multi-dimensional map 214.
  • the Al 220 may be or comprise one or more data models that use one or more Al or ML techniques to generate the multi-dimensional map 214.
  • the Al 220 may be an algorithm configured to take the ERNA signals as input and, using transformations (e g., matrix multiplications), determine information about the location in 3D space from which the ERNA signals originated.
  • the multi-dimensional map 214 may reflect locations in the anatomical structure 428 from which ERNA signals were evoked, the strength (e.g., based on amplitude) of the ERNA signal, etc. Such information may be rendered to a display (e g., user interface 302) to enable a clinician or other user to understand the trajectories and/or depths at which the greatest ERNA signal response was measured.
  • a display e g., user interface 302
  • a target location, a depth, and/or a trajectory for placing the lead 114A may be chosen.
  • the target location may be designated as the location of the microelectrodes 402 at which the greatest ERNA amplitude or other characteristic (e.g., pulse width, resonant frequency, etc.) was measured.
  • the target location may be designated as the location where the greatest number or a threshold number of electrodes of the lead 114A can be used to evoke ERNA responses.
  • the clinician may designate the target location, the depth, and/or the trajectory based on the multi-dimensional map 214 (e.g., via input through the user interface 302), or alternatively the target location, the depth, and/or the trajectory may be automatically designated by the system 100 (e.g., the Al 220 identifies the target location, the depth, and/or the trajectory based on processing of the ERNA signals).
  • the trajectory may be chosen based on or from the trajectories along which the microelectrodes 402 were implanted. For example and as depicted in Fig. 4B, it may be determined that the target location is reached by implanting the lead 114A along the implant trajectory 424. The lead 114A may then be implanted along chosen trajectory (e.g., the implant trajectory 424) to the chosen depth to reach the target location.
  • the electrodes 116 may be used to generate one or more stimulation signals to evoke one or more ERNA responses. This may be done to ensure that the lead 114A has been correctly implanted at the target location. Similar to the evocation of ERNA signals with the microelectrodes 402, the electrodes 116 may emit stimulation signals and then record any ERNA responses to the stimulation signals.
  • the ERNA responses measured by the electrodes 116 may be different than the ERNA responses measured by the microelectrodes 402 when the microelectrodes 402 was at the target location.
  • the processing circuitry 210 may compare the ERNA responses measured by the lead 114A with the ERNA response measured by the microelectrodes 402 and, when the two are different (e.g., the difference between the two are equal to or greater than a threshold value), the processing circuitry 210 may generate an alert indicating that the lead 114A has moved from the target location or that the lead 114A has not been implanted at the target location.
  • the target location of the lead 114A may be used in defining, creating, or adjusting one or more therapies delivered by the IMD 106.
  • processing circuitry 210 may use the ERNA responses generated during implantation of the lead 114A to define therapeutic windows for when the patient is asleep.
  • the processing circuitry 210 may use the ERNA responses generated during implantation of the lead 114A to define which electrode of the electrodes 116 has the best ERNA response (and should thus be used for delivery of the therapy).
  • the processing circuitry 210 may use a transfer function (which may be stored in the memory 212) to map the therapeutic windows used when the patient is asleep to therapeutic windows that can be used while the patient is awake.
  • the ERNA responses may be used postoperatively (e.g., after the lead 114A has been implanted) to understand when the micro-lesioning effect has ended.
  • the ERNA signals may change when the micro-lesioning effect has ended, enabling clinicians to identify when the micro-lesioning effect has ended.
  • the ERNA response recorded during the initial DBS lead placement can be used to adjust the stimulation amplitude of the electrodes as micro-lesioning occurs to keep the ERNA response consistent even while under the effects of micro-lesioning.
  • the IMD 106 (and/or other components of the system 100) can be programmed postoperatively before the patient is discharged.
  • the ERNA signals may be processed to determine how effective the DBS lead will be, such as by indicating when a patient is inside or outside the DBS window.
  • the processing may be performed by the processing circuitry 210 (using, for example, the Al 220), the processing circuitry 310, combinations thereof, and/or the like.
  • the ERNA signals may be ranked against similar patients (e.g., patients with similar implants, patients with similar implant locations, patients with similar ailments for which the DBS lead is designed to treat, combinations thereof, and/or the like) to predict the effectiveness of the DBS lead.
  • the Al 220 may be used as a predictive model to predict the effectiveness of the DBS lead by comparing the ERNA signals associated with the lead 114A to ERNA signals in other patients.
  • Fig. 5 depicts a method 500 that may be used, for example, to plan a trajectory of an implantable lead and to confirm the location of the implantable lead using ERNA signals.
  • the method 500 (and/or one or more steps thereof) may be carried out or otherwise performed, for example, by at least one processor.
  • the at least one processor may be the same as or similar to the processor(s) of any system or device described herein.
  • the at least one processor may be part of the programmer 104 and/or the IMD 106 as described with reference to Figs. 1-3 (e.g., processing circuitry 210 and/or the processing circuitry 310) and/or may be part of a control unit (e.g., a computing device) in communication with the programmer 104 and/or the IMD 106.
  • a processor other than any processor described herein may also be used to execute the method 500.
  • the at least one processor may perform the method 500 by executing elements stored in a memory (such as a memory in the programmer 104 and/or the IMD 106 as described herein or a control unit, computing device, etc.).
  • the elements stored in the memory and executed by the processor may cause or enable the processor to execute one or more steps of a function as shown in the method 500.
  • One or more portions of the method 500 may be performed by the processor executing any of the content of memory, such as the multi-dimensional map 214, the ERNA signals 216, the trajectories 218, and/or the Al 220.
  • the method 500 comprises generating, using a plurality of electrodes implanted along a first implant trajectory, a stimulation signal (step 504).
  • the plurality of electrodes may be similar to or the same as the microelectrodes 402, which may be used to generate a stimulation signal sufficient to evoke one or more ERNA responses from anatomical tissues/elements/structures/etc. (e.g., the anatomical structure 428) into which the microelectrodes 402 have been implanted.
  • the first implant trajectory may be similar to or the same as the implant trajectory 404, the implant trajectory 424, the implant trajectory 432, or the like.
  • the microelectrodes 402 may be connected to an IMD (e.g., IMD 106) such that stimulation signals stimulation generation circuitry (e.g., stimulation generation circuitry 202) within the IMD are propagated via the microelectrodes 402 into the anatomical tissues/elements/structures/etc.
  • IMD e.g., IMD 106
  • stimulation signals stimulation generation circuitry e.g., stimulation generation circuitry 202
  • the method 500 also comprises receiving, from the plurality of electrodes, a plurality of evoked neurological response signals in response to the stimulation signal (step 508).
  • the evoked neurological response signals may be or comprise ERNA signals evoked by an anatomical structure (e.g., anatomical structure 428) in response to the stimulation signal.
  • the plurality of evoked neurological response signals may be measured using the microelectrodes 402.
  • the received evoked neurological responses signals may be stored in a database or memory (e.g., memory 212).
  • the method 500 also comprises generating, based on the plurality of evoked neurological response signals, a multi-dimensional map including a target location of at least one anatomical structure for a stimulation lead (step 512).
  • the multi-dimensional map may be similar to or the same as the multi-dimensional map 214.
  • the multi-dimensional map may be generated or output by one or more data models (e.g., Al 220), which may take the plurality of evoked neurological response signals as input and output the multi-dimensional map.
  • the target location of the at least one anatomical structure may correspond to ideal location for implanting the stimulation lead (e.g., lead 114A which may be configured to provide DBS therapy) based on the ERNA signal readings.
  • the target location may be designated as a location at which the microelectrodes were positioned when the greatest ERNA amplitude was measured and/or the location at which the microelectrodes were positioned when the ERNA response was evoked at a low stimulation amplitude. While amplitude is provided as an example, the target location may be designated based on any other characteristic of the ERNA responses (e g , resonant frequency, peak latency, etc ).
  • the multi-dimensional map may be rendered to a display (e.g., user interface 302) to enable a clinician to view the target location. When rendered, the multi-dimensional map may visually depict the target location.
  • the multidimensional map may highlight the target location, such as by visually depicting a border or outer boundary of the target location (e.g., the target location is visually outlined to indicate position of the target location within the anatomical structure 428).
  • the clinician may designate the target location (e.g., via the user interface 302), while in other embodiments the system 100 may identify the target location (e g., based on the location of the microelectrodes 402 when the ERNA response amplitude was greatest).
  • the method 500 also comprises determining, based on the target location, a second implant trajectory for a stimulation lead to arrive at the target location (step 516).
  • the second implant trajectory may be based on a clinician input (e.g., via the user interface 302) or determined by the processing circuitry 210 based on, for example, Al 220 receiving the target location as an input and outputting the second implant trajectory.
  • the second implant trajectory may correspond to an implant trajectory of the microelectrodes 402.
  • the microelectrodes 402 may be inserted along the implant trajectory 404, the implant trajectory 424, and the implant trajectory 432, and the second implant trajectory may be determined to be the implant trajectory 432.
  • the method 500 also comprises generating, using a second plurality of electrodes of the stimulation lead, a second stimulation signal (step 520).
  • the step 520 may be similar to the step 504 except that, instead of using microelectrodes such as microelectrodes 402 to generate the stimulation signal, the second stimulation signal is generated by the stimulation lead (e.g., lead 114A or 114B).
  • the stimulation lead e.g., lead 114A or 114B
  • the stimulation lead may be implanted along the second implant trajectory to reach the target location.
  • the electrodes e.g., electrodes 116 or 118
  • the electrodes may be used to generate the second stimulation signals to evoke neurological signal responses.
  • the method 500 also comprises receiving a second plurality of evoked neurological response signals (step 524).
  • the step 524 may be similar to the step 508 except that the second plurality of evoked neurological response signals are captured by electrodes of the stimulation lead instead of the microelectrodes.
  • the method 500 also comprises determining a second location of the at least one anatomical structure associated with an optimal evoked response signal of the second plurality of evoked neurological response signals (step 528).
  • the recorded evoked neurological response signals may be processed (e.g., by processing circuitry 210) to determine the evoked neurological response signal with one or more optimal features.
  • the optimal feature may be or comprise the maximum amplitude of all amplitudes of the second plurality of evoked neurological response signals, the lowest latency of all latencies of the second plurality of evoked neurological response signals, the greatest number of resonant peaks of all resonant peaks of the second plurality of evoked neurological response signals, the greatest frequency of all frequencies of the second plurality of evoked neurological response signals, combinations thereof, and/or the like.
  • the processing circuitry 210 may further determine the location from which the optimal evoked neurological response signal was emitted and/or the pose of the stimulation lead that led to the optimal evoked neurological response signal.
  • the processing circuitry 210 may use Al 220 to generate the second location and/or the pose of the stimulation lead.
  • information may be stored in a database or memory (e.g., memory 212) and/or rendered to a display (e.g., user interface 302).
  • the method 500 also comprises comparing the target location with the second location (step 532).
  • the processing circuitry 210 may compare the target location with the second location using the Al 220, which may take both the target location and the second location as inputs and outputting a difference (e.g., a percent difference, a distance and/or displacement between the two locations, etc.).
  • the processing circuitry 210 may compute the difference between the target location and the second location.
  • the difference between the target location and the second location may be stored in memory (e.g., memory 212) and/or a database.
  • the computed difference may be rendered to a display (e.g., user interface 302).
  • the method 500 also comprises providing, when a difference between the target location and the second location meets or exceeds a threshold value, one or more recommended adjustments to a pose of the stimulation lead (step 536).
  • the processing circuitry 210 may compare the difference determined in the step 532 to a threshold value and, when the difference meets or exceeds the threshold value, generate a recommendation to reduce the difference.
  • the threshold value may be based on a predetermined threshold stored in memory (e.g., memory 212) above which the therapy delivered by the stimulation lead may change. Stated differently, when the target location and the second location are too far apart, the stimulation lead may provide ineffective therapy or a therapy with reduced effect.
  • the difference between the target location and the second location may indicate that the stimulation lead should instead be implanted at the second location.
  • the processing circuitry 210 may determine a direction of movement (e g., a translation, a rotation, combinations thereof, etc.) of the stimulation lead to move the stimulation closer to the second location and/or to move the lead into a pose such that the maximum ERNA response can be evoked by the stimulation lead.
  • the one or more recommendations may be rendered to the display (e g., user interface 302).
  • the present disclosure encompasses embodiments of the method 500 that comprise more or fewer steps than those described above, and/or one or more steps that are different than the steps described above.
  • the present disclosure encompasses methods with fewer than all of the steps identified in Fig. 5 (and the corresponding description of the method 500), as well as methods that include additional steps beyond those identified in Fig. 5 (and the corresponding description of the method 500).
  • the present disclosure also encompasses methods that comprise one or more steps from one method described herein, and one or more steps from another method described herein. Any correlation described herein may be or comprise a registration or any other correlation.
  • a system comprising: a processor (210, 310); and a memory (212, 312) storing data thereon that, when processed by the processor (210, 310), enable the processor (210, 310) to: receive, from a plurality of electrodes (116, 118) implanted along a first implant trajectory, a plurality of evoked neurological response signals; generate, based on the plurality of evoked neurological response signals, a multi-dimensional map (214) including a target location of at least one anatomical structure for a stimulation implant; and determine, based on the target location, a second implant trajectory for the stimulation implant to arrive at the target location.
  • Statement 2 The system of Statement 1, wherein the memory (212, 312) comprises additional data that, when processed by the processor (210, 310), further enable the processor (210, 310) to: receive a second plurality of evoked neurological response signals; and determine, based on the second plurality of evoked neurological response signals, that the stimulation implant that has been implanted at the target location has moved.
  • Statement 3 The system of any of Statements 1-2, wherein the memory (212, 312) comprises additional data that, when processed by the processor (210, 310), further enable the processor (210, 310) to: render, to a display, the multi-dimensional map (214).
  • Statement 4 The system of Statement 3, wherein the multi-dimensional map (214), when rendered to the display, depicts information about an outer boundary of the target location.
  • Statement 5 The system of any of Statements 1-4, wherein the stimulation implant is implanted along the second implant trajectory, and wherein the memory (212, 312) comprises additional data that, when processed by the processor (210, 310), further enable the processor (210, 310) to: receive a second plurality of evoked neurological response signals; determine a second location of the at least one anatomical structure associated with an optimal evoked response signal of the second plurality of evoked neurological response signals; compare the target location with the second location; and provide, when a difference between the target location and the second location meets or exceeds a threshold value, one or more recommended adjustments to a pose of the stimulation implant.
  • Statement 6 The system of Statement 5, wherein the optimal evoked response signal comprises a maximum amplitude of the second plurality of evoked neurological response signals.
  • Statement 7 The system of any of Statements 1-6, wherein the stimulation implant comprises a deep brain stimulation (DBS) lead (114A, 114B).
  • DBS deep brain stimulation
  • Statement 8 The system of any of Statements 1-7, wherein the at least one anatomical structure comprises a neural region.
  • Statement 9 The system of any of Statements 1-8, wherein the plurality of evoked neurological response signals comprises a plurality of Evoked Resonant Neural Activity (ERNA) signals.
  • ERNA Evoked Resonant Neural Activity
  • a system comprising: a processor (210, 310); and a memory (212, 312) storing data thereon that, when processed by the processor (210, 310), enable the processor (210, 310) to: generate, using a plurality of electrodes (116, 118) implanted along a first implant trajectory, a stimulation signal; receive, from the plurality of electrodes (116, 118), a plurality of evoked neurological response signals evoked in response to the stimulation signal; generate, based on the plurality of evoked neurological response signals, a multi-dimensional map (214) that depicts a target location of an anatomical element for a stimulation lead (114A, 114B); and determine, based on the target location, a second implant trajectory for implanting a stimulation lead (114A, 114B) to arrive at the target location.
  • Statement 11 The system of Statement 10, wherein the memory (212, 312) comprises additional data that, when processed by the processor (210, 310), further enable the processor (210, 310) to: generate, using a second plurality of electrodes (116, 118) of the stimulation lead (114A, 114B), a second stimulation signal; receive a second plurality of evoked neurological response signals evoked in response to the second stimulation signal; and determine, based on the second plurality of evoked neurological response signals, that the stimulation lead (114A, 114B) implanted at the target location has moved.
  • the memory (212, 312) comprises additional data that, when processed by the processor (210, 310), further enable the processor (210, 310) to: generate, using a second plurality of electrodes (116, 118) of the stimulation lead (114A, 114B), a second stimulation signal; receive a second plurality of evoked neurological response signals evoked in response to the second stimulation signal; and determine, based on the second plurality of evoked neurological response signals
  • Statement 12 The system of any of Statements 10-11, wherein the memory (212, 312) comprises additional data that, when processed by the processor (210, 310), further enable the processor (210, 310) to: render, to a display, the multi-dimensional map (214).
  • Statement 13 The system of Statement 12, wherein the multi-dimensional map (214), when rendered to the display, depicts information about a border of the target location.
  • Statement 14 The system of any of Statements 10-13, wherein the stimulation lead (114A, 114B) is implanted along the second implant trajectory, and wherein the memory (212, 312) comprises additional data that, when processed by the processor (210, 310), further enable the processor (210, 310) to: generate, using a second plurality of electrodes (116, 118) of the stimulation lead (114A, 114B), a second stimulation signal; receive a second plurality of evoked neurological response signals; determine a second location on the anatomical element associated with an optimal evoked response signal of the second plurality of evoked neurological response signals; compare the target location with the second location; and provide, when a difference between the target location and the second location meets or exceeds a threshold value, one or more recommended adjustments to a pose of the stimulation lead (114A, 114B).
  • Statement 15 The system of Statements 14, wherein the optimal evoked response signal comprises a maximum amplitude of the second plurality of evoked neurological response signals.
  • Statement 16 The system of any of Statements 10-14, wherein the stimulation lead (114A, 114B) comprises a deep brain stimulation (DBS) lead (114A, 114B).
  • DBS deep brain stimulation
  • Statement 17 The system of any of Statements 10-16, wherein the anatomical element comprises a neural region.
  • Statement 18 The system of any of Statements 10-17, wherein the plurality of evoked neurological response signals comprises a plurality of Evoked Resonant Neural Activity (ERNA) signals.
  • ERNA Evoked Resonant Neural Activity
  • a system comprising: a processor (210, 310); and a memory (212, 312) storing data thereon that, when processed by the processor (210, 310), enable the processor (210, 310) to: generate, using a plurality of electrodes (116, 118) of a stimulation lead (114A, 114B), a stimulation signal; receive a plurality of evoked neurological response signals; determine a first location on an anatomical element associated with an optimal evoked response signal of the plurality of evoked neurological response signals; compare the first location on the anatomical element with a second location of a stimulation electrode of the stimulation lead (114A, 114B); and provide, when a distance between the first location and the second location meets or exceeds a threshold value, one or more recommended adjustments to a pose of the stimulation lead (114A, 114B).
  • Statement 20 The system of Statement 19, wherein the optimal evoked response signal comprises a maximum amplitude of the plurality of evoked neurological response signals.
  • Statement 21 The system of Statement 19, wherein the stimulation lead (114A, 114B) comprises a deep brain stimulation (DBS) lead (114A, 114B).
  • DBS deep brain stimulation
  • Statement 22 The system of any of Statements 19-21, wherein the plurality of evoked neurological response signals comprises a plurality of Evoked Resonant Neural Activity (ERNA) signals.
  • ERNA Evoked Resonant Neural Activity
  • Statement 23 The system of any of Statements 19-22, wherein the anatomical element comprises a neuron.

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Abstract

Un système selon au moins un mode de réalisation de la présente divulgation comprend : un processeur ; et une mémoire stockant des données sur celui-ci qui, lorsqu'elles sont traitées par le processeur, permettent au processeur de : recevoir, à partir d'une pluralité d'électrodes implantées le long d'une première trajectoire d'implant, une pluralité de signaux de réponse neurologique évoquée ; générer, sur la base de la pluralité de signaux de réponse neurologique évoquée, une carte multidimensionnelle comprenant un emplacement cible d'au moins une structure anatomique pour un implant de stimulation ; et déterminer, sur la base de l'emplacement cible, une seconde trajectoire d'implant pour que l'implant de stimulation arrive à l'emplacement cible.
PCT/IB2025/050781 2024-01-26 2025-01-24 Systèmes et procédés de détermination de trajectoire d'implant de sonde et de placement final à l'aide de signaux d'activité neuronale résonante évoquée (erna) Pending WO2025158350A1 (fr)

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