System for sequencing sensing blocks for neuromodulation

Abstract

An example of a system for delivering a neural stimulus to a patient and controlling delivery of the neural stimulus using a sensor can include a stimulus output circuit, a sensing circuit, and a control circuit. The stimulus output circuit can be configured to deliver the neural stimulus. The sensing circuit can be configured to receive a sensed signal from the sensor and process the sensed signal. The sensing circuit has adjustable settings that control processing of the sensed signal. The control circuit can be configured to control delivery of the neural stimulus using the processed sensed signal and to control the settings of the sensing circuit according to a sequence of sensing blocks, each of the sensing blocks including a set of sensing parameters.

Description

[0001] Priority requirements

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 183,459, filed May 3, 2021, which is incorporated herein by reference in its entirety. Technical Field

[0003] This document generally relates to neural stimulation, and more specifically to a neural stimulation system that uses a programmable sequence of sensing blocks to control signal sensing spatially and temporally. Background Technology

[0004] Neurostimulation, also known as neuromodulation, has been proposed as a treatment for a variety of conditions. Examples of neurostimulation include spinal cord stimulation (SCS), deep brain stimulation (DBS), peripheral nerve stimulation (PNS), and functional electrical stimulation (FES). Implantable neurostimulation systems have been used to deliver such treatments. An implantable neurostimulation system may include an implantable neurostimulator (also known as an implantable pulse generator (IPG)) and one or more implantable leads, each containing one or more electrodes. The implantable neurostimulator delivers neurostimulation energy through one or more electrodes placed on or near a target site in the nervous system. An external programming device is used to program the implantable neurostimulator with stimulation parameters that control the delivery of neurostimulation energy.

[0005] In one example, neural stimulation energy is delivered in the form of electrical pulses. Delivery is controlled using stimulation parameters that specify the spatial (where to stimulate), temporal (when to stimulate), and informational (patterns of pulses that guide the nervous system to respond as needed) aspects of the electrical pulse pattern. Various signals can be sensed from the patient and / or the patient's environment to set and adjust the stimulation parameters. For example, signals indicating changes in the patient's condition can be sensed to start, stop, or adjust the delivery of neural stimulation therapy, and signals indicating the patient's response to neural stimulation therapy can be sensed to allow for closed-loop control of its delivery. The effectiveness and safety of this neural stimulation therapy can depend on the appropriate sensing of signals controlled using sensing parameters that specify the spatial (where to sense), temporal (when to sense), and informational (signal modulation and processing) aspects of the sensing. Summary of the Invention

[0006] An example of a system for delivering neural stimulation to a patient and controlling the delivery of the neural stimulation using sensors (e.g., "Example 1") may include a stimulation output circuit, a sensing circuit, and a control circuit. The stimulation output circuit may be configured to deliver the neural stimulation. The sensing circuit may be configured to receive and process sensed signals from the sensors. The sensing circuit has adjustable settings for controlling the processing of the sensed signals. The control circuit may be configured to control the delivery of the neural stimulation using the processed sensed signals and to control the settings of the sensing circuit according to a sequence of sensing blocks, each sensing block including a set of sensing parameters.

[0007] In Example 2, the subject of Example 1 may optionally be configured to include an implantable medical device comprising the stimulation output circuit, the sensing circuit, and the control circuit.

[0008] In Example 3, the subject matter of Example 2 may optionally be configured such that the implantable medical device includes at least one internal sensor among the sensors.

[0009] In Example 4, the subject matter of any one or any combination of Examples 2 and 3 may optionally be configured to include at least one external sensor among the sensors. The at least one external sensor is external to the implantable medical device and communicatively coupled to the implantable medical device.

[0010] In Example 5, the subject of Example 4 may optionally be configured such that the at least one external sensor includes an implantable sensor configured to be placed inside the patient's body.

[0011] In Example 6, the subject matter of any one or any combination of Examples 4 and 5 may optionally be configured such that the at least one external sensor includes a sensor configured to be worn externally by the patient or placed away from the patient.

[0012] In Example 7, the subject matter of any one or any combination of Examples 2 to 6 may optionally be configured to further include a programming device configured to program the implantable medical device. The programming control circuitry includes programming control circuitry and a user interface. The programming control circuitry is configured to generate parameters for programming the implantable medical device to control the delivery of the neural stimulation pulses according to a pattern of the neural stimulation pulses and to control the settings of the sensing circuitry according to a sequence of the sensing blocks. The user interface is coupled to the programming control circuitry and includes a presentation device, a user input device, and interface control circuitry. The interface control circuitry includes a stimulation programming circuitry configured to generate a pattern of the neural stimulation pulses and a sensing programming circuitry configured to generate a sequence of the sensing blocks.

[0013] In Example 8, the subject of Example 7 may optionally be configured to include a sensor writer implemented using the presentation device, the user input device, and the sensor programming circuitry, the sensor writer being configured to allow the writing of sequences of the sensor blocks to customize the settings of the sensor circuitry for at least one of the patient or treatment using the neural stimulation.

[0014] In Example 9, the subject matter of any one or any combination of Examples 2 to 8 may optionally be configured to also include an external device configured to communicatively couple to the implantable medical device, store the processed sensed signals, and use the processed sensed signals to adjust the settings of the sensing circuitry.

[0015] In Example 10, the subject matter of any one or any combination of Examples 1 to 9 may optionally be configured such that the sensing circuit includes a plurality of individually controllable sensing channels configured to simultaneously receive and process two or more of the sensed signals.

[0016] In Example 11, the subject matter of any one or any combination of Examples 1 to 10 may optionally be configured such that the control circuit is configured to store one or more sensing algorithms and sensing parameters used by each of the one or more sensing algorithms, and to control the settings of the sensing circuit by executing a sensing algorithm selected from the stored one or more algorithms.

[0017] In Example 12, the subject matter of Example 11 may optionally be configured such that the control circuitry includes a microcontroller unit (MCU) that includes firmware that controls the settings of the sensing circuitry and stores the one or more sensing algorithms as independent images.

[0018] In Example 13, the subject of Example 12 may optionally be configured such that the control circuitry further includes a register storing parameters that define the settings of the sensing circuitry, and is configured to adjust the settings of the sensing circuitry without changing the firmware.

[0019] In Example 14, the subject matter of any one or any combination of Examples 1 to 13 may optionally be configured such that the control circuitry is configured to adjust one or more of the sensing parameters using one or more of the processed sensed signals.

[0020] In Example 15, the subject matter of any one or any combination of Examples 1 to 14 may optionally be configured such that the control circuit is configured to store adjustable parameters used by the one or more sensing algorithms, and dynamically adjust the adjustable parameters during the delivery of the neural stimulus and the sensing of the signal.

[0021] Examples of methods for delivering neural stimulation are also provided (e.g., "Example 16"). The method may include: delivering neural stimulation from a stimulation device; receiving a sensed signal from a sensor and processing the sensed signal using a sensing circuit having adjustable settings for controlling the processing of the sensed signal; using a control circuit to control the delivery of the neural stimulation using the processed sensed signal; and using the control circuit to control the settings of the sensing circuit according to a sequence of sensing blocks, each sensing block including a set of sensing parameters.

[0022] In Example 17, the subject matter of Embodiment 16 may optionally also include a sequence of at least one customized sensing block for a patient or treatment.

[0023] In Example 18, the subject of the sequence of custom sensing blocks, as found in Example 17, may optionally include each of one or more blocks in the sequence of custom sensing blocks.

[0024] In Example 19, the subject matter of any one or any combination of Examples 16 to 18 may optionally also include adjusting at least one of the sensing parameters in the group of sensing parameters according to at least one of a schedule or a specified event.

[0025] In Example 20, the subject matter of any one or any combination of Examples 16 to 19 may optionally also include using one or more of the processed sensed signals to adjust at least one sensed parameter in the set of sensed parameters.

[0026] In Example 21, the subject matter of any one or any combination of Examples 16 to 20 may optionally also include dynamically adjusting at least one sensing parameter in the set of sensing parameters during the delivery of neural stimulation and the sensing of the signal.

[0027] In Example 22, the subject of receiving sensed signals from a sensor and processing sensed signals using sensing circuitry, as found in any one or any combination of Examples 16 to 21, may optionally include simultaneously receiving and processing two or more sensed signals using multiple individually controllable sensing channels of sensing circuitry.

[0028] In Example 23, the subject matter of any one or any combination of Examples 16 to 22 may optionally include storing one or more sensing algorithms in the control circuit, and the subject matter of controlling the settings of the sensing circuit as found in any one or any combination of Examples 16 to 22 may optionally include executing a sensing algorithm selected from the stored one or more algorithms.

[0029] In Example 24, the subject of Example 23 may optionally include using the firmware of a microcontroller with control circuitry to execute a sensing algorithm and storing the set of sensing parameters in the microcontroller and one or more registers coupled to the microcontroller to allow adjustment of the sensing circuitry settings without changing the firmware.

[0030] Examples of non-transitory computer-readable storage media are also provided (e.g., "Example 25"). The non-transitory computer-readable storage medium includes instructions that, when executed by a system, cause the system to perform a method for delivering neural stimulation. The method may include: delivering neural stimulation from a stimulation device; receiving sensed signals from a sensor and processing the sensed signals using sensing circuitry having adjustable settings for controlling the processing of the sensed signals; controlling the delivery of neural stimulation using the processed sensed signals with control circuitry; and controlling the settings of the sensing circuitry according to a sequence of sensing blocks, each sensing block including a set of sensing parameters.

[0031] This invention is a summary of some of the teachings of this application and is not intended to be exclusive or exhaustive of the subject matter. Further details regarding the subject matter can be found in the detailed description and the appended claims. Other aspects of this disclosure will be apparent to those skilled in the art upon reading and understanding the following detailed description and viewing the accompanying drawings, which form a part thereof, wherein each drawing is not limiting. The scope of this disclosure is defined by the appended claims and their legal equivalents. Attached Figure Description

[0032] The accompanying drawings illustrate, by way of example, various embodiments discussed in this document. The drawings are for illustrative purposes only and may not be drawn to scale.

[0033] Figure 1 An example of a neural stimulation system is shown.

[0034] Figure 2 Showing things like can be Figure 1 Examples of stimulation devices and lead systems implemented in a neural stimulation system.

[0035] Figure 3 Showing things like can be Figure 1 An example of a programming device implemented in a neural stimulation system.

[0036] Figure 4 Examples of implantable pulse generators (IPGs) and implantable lead systems are shown, such as... Figure 2 Example implementation of the stimulation device and lead system.

[0037] Figure 5 IPG and implantable lead systems (such as) arranged to provide neurostimulation to a patient are shown. Figure 4 Examples of IPG and wire systems.

[0038] Figure 6 An embodiment of the various parts of a neural stimulation system is shown.

[0039] Figure 7 Showing neural stimulation systems (such as Figure 6 An embodiment of an implantable stimulator, one or more leads, and one or more sensors for a neurostimulation system.

[0040] Figure 8 Showing neural stimulation systems (such as Figure 6 An example of an external programming device for a neural stimulation system.

[0041] Figure 9 An embodiment of a system for delivering neural stimulation and using sensors to control the delivery of neural stimulation is shown.

[0042] Figure 10 This demonstrates that it can be stimulated by neural stimulation systems (such as...) Figure 9 Examples of sensors used in the system.

[0043] Figure 11 This demonstrates that it can be used in neural stimulation systems (such as...) Figure 9 An example of a sensing block sequence used in a system.

[0044] Figure 12 Showing neural stimulation systems (such as Figure 9 An example of the control circuit of the system.

[0045] Figure 13 Show Figure 12 An example of the firmware architecture for the control circuit.

[0046] Figure 14 Examples of methods for delivering neural stimulation and controlling the delivery of neural stimulation using sensors are shown.

[0047] Figure 15 Examples of methods for data storage associated with sorted sensor blocks and for adjusting stimuli and / or sensing settings are shown. Detailed Implementation

[0048] In the following detailed description, the accompanying drawings, which form part of the invention, illustrate specific embodiments in which the invention can be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it should be understood that these embodiments may be combined, other embodiments may be utilized, and structural, logical, and electrical changes may be made without departing from the spirit and scope of the invention. References to “a,” “an,” or “various” embodiments in this disclosure do not necessarily refer to the same embodiment, and such references contemplate more than one embodiment. The following detailed description provides examples, and the scope of the invention is defined by the appended claims and their legal equivalents.

[0049] This document specifically discusses a neurostimulation system capable of sensing various signals, delivering neural stimulation, and using the sensed signals to control the delivery of neural stimulation. The system can spatially and temporally control the sensing of various signals using a programmable sequence of sensing blocks, and can use the sensed signals to determine and adjust the settings of neural stimulation and sensing. In various embodiments, the neural modulation system may include: an implantable device configured to deliver neural stimulation (also known as neural modulation) therapy, such as deep brain stimulation (DBS), spinal cord stimulation (SCS), peripheral nerve stimulation (PNS), and vagus nerve stimulation (VNS); and one or more external devices configured to program the operation of the implantable device and monitor the performance of the implantable device.

[0050] Neurostimulation systems can sense signals using various types of sensors, such as implantable leads with stimulation and sensing electrodes, other implantable sensors, patient-worn external sensors, external sensors placed near the patient, and percutaneous sensors. The characteristics of the signal and the features of interest that can be extracted from the signal to indicate the patient's condition and / or response to neurostimulation determine when to sense the signal and how to modulate (e.g., amplify and / or filter) and sample the signal. When used in certain applications, it is crucial for the neurostimulation system to sense from different spatial locations at different times. For example, in DBS, to avoid adverse side effects and ensure the desired clinical outcome, it may be necessary to sense different spatial locations within internal brain structures in the limbic system to assess local field potentials (LFP), different spatial locations within the basal ganglia to assess evoked potentials (EP) or evoked resident neural activity (ERNA) features, or different spatial locations within the neocortex of the brain to assess motor EP or motor LFP features. Furthermore, different signals have different frequency characteristics, and / or the frequency ranges of interest for different signals may differ, thus requiring different cutoff frequencies for filtering and therefore different sampling frequencies. For example, spinal cord EP (exposure probe) can have a frequency range of 300Hz-5kHz, while bed sensors used to sense patient movement on the bed can have frequencies below 10Hz. Therefore, sensing from different sites needs to be performed at different times and / or using different cutoff frequencies and sampling rates.

[0051] This invention provides control over the sensing of various signals using a sequence of sensing settings called sensing blocks, each sensing setting including sensing parameters that define, for example, when and where each signal is sensed and how they are modulated for further processing prior to controlling neural stimulation. A user interface is provided to allow a user to program the sequence of sensing blocks based on the signal being sensed and features of interest to be extracted from the sensed signal. Although a neural stimulation system is discussed as an example in which a sequence of sensing blocks can be used, this invention can be applied to provide spatial and temporal control of sensing settings in any diagnostic and / or therapeutic system.

[0052] In this document, unless otherwise stated, “patient” includes a person who receives treatment delivered from a neurostimulation system according to this subject and / or uses the neurostimulation system for monitoring, and “user” includes a physician or other caregiver who uses the neurostimulation system to examine and / or treat a patient.

[0053] Figure 1An embodiment of a neurostimulation system 100 is illustrated. System 100 includes electrodes 106, a stimulation device 104, and a programming device 102. Electrodes 106 are configured to be placed on or near one or more neural targets of a patient. Stimulation device 104 is configured to be electrically connected to electrodes 106 and to deliver neurostimulation energy to one or more neural targets, such as in the form of electrical pulses, through electrodes 106. The delivery of neurostimulation is controlled by using multiple stimulation parameters, such as stimulation parameters specifying the pattern of electrical pulses and the selection of electrodes through which each electrical pulse is delivered. In various embodiments, stimulation device 104 senses one or more signals and / or receives one or more sensed signals from sensors, and may also use the sensed signals(s) to control the delivery of neurostimulation. In various embodiments, at least some of the multiple stimulation parameters can be programmed by a user, such as a physician or other caregiver using system 100 to treat a patient. Programming device 102 provides the user with access to user-programmable parameters. In various embodiments, programming device 102 is configured to be communicatively coupled to stimulation device via a wired or wireless link. In various embodiments, the system 100 may allow a patient to adjust his or her treatment to some extent, such as by adjusting certain treatment parameters and recording feedback and clinical effect information.

[0054] In various embodiments, the programming device 102 may include a user interface 110 that allows a user to control the operation of the system 100 and monitor the performance of the system 100 and the patient's condition (including response to the delivery of neural stimulation). The user can control the operation of the system 100 by setting and / or adjusting the values ​​of user-programmable parameters.

[0055] In various embodiments, the user interface 110 may include a graphical user interface (GUI) that allows a user to set and / or adjust values ​​of user-programmable parameters by creating and / or editing graphical representations of various waveforms. Such waveforms may include, for example, waveforms representing patterns of neural stimulation pulses to be delivered to a patient, and individual waveforms serving as building blocks of the neural stimulation pulse pattern, such as the waveform of each pulse in the pattern. The GUI may also allow a user to set and / or adjust stimulation fields, each defined by a set of electrodes through which one or more neural stimulation pulses, represented by the waveform, are delivered to the patient. Each stimulation field may be further defined by the distribution of current in each neural stimulation pulse within the waveform. In various embodiments, neural stimulation pulses for a stimulation period (such as the duration of a treatment session) may be delivered to multiple stimulation fields.

[0056] In various embodiments, system 100 can be configured for neurostimulation applications. User interface 110 can be configured to allow a user to control the operation of system 100 for neurostimulation. For example, system 100 and user interface 110 can be configured for SCS applications. Although the SCS system is shown and discussed as an example, this subject matter applies to any neurostimulation system in which electrodes are placed at a location suitable for sensing one or more neural signals from which indicators of degenerative and / or other neurological disorders can be detected and monitored.

[0057] Figure 2 An embodiment of a stimulation device 204 and a lead system 208, such as those that can be implemented in a neurostimulation system 100, is shown. The stimulation device 204 represents an example of the stimulation device 104 and includes a stimulation output circuit 212 and a control circuit 214. The stimulation output circuit 212 generates and delivers neural stimulation pulses. The control circuit 214 controls the delivery of neural stimulation pulses from the stimulation output circuit 212 using a plurality of stimulation parameters specifying the pattern of the neural stimulation pulses. The lead system 208 includes one or more leads, each configured to be electrically connected to the stimulation device 204, and a plurality of electrodes 206 distributed among said one or more leads. The plurality of electrodes 206 includes electrodes 206-1, 206-2, ..., 206-N, each electrode 206-N providing a single conductive contact for an electrical interface between the stimulation output circuit 212 and patient tissue, where N ≥ 1. Neural stimulation pulses are each delivered from the stimulation output circuit 212 through a set of electrodes selected from the electrodes 206. In various embodiments, the neural stimulation pulses may include one or more individually defined pulses, and the set of electrodes may be individually defined by the user for each individually defined pulse or for each set of pulses intended to be delivered using the same combination of electrodes. In various embodiments, one or more additional electrodes 207 (each electrode may be referred to as a reference electrode) may be electrically connected to the stimulation device 204, such as one or more electrodes, each of which is part of the housing of the stimulation device 204 or otherwise incorporated into the housing of the stimulation device 204. Monopolar stimulation uses a monopolar electrode configuration having one or more electrodes selected from electrode 206 and at least one electrode selected from electrode(s) 207. Bipolar stimulation uses a bipolar electrode configuration having two electrodes selected from electrode 206 and no electrode selected from electrode(s) 207. Multipolar stimulation uses a multipolar electrode configuration having multiple (two or more) electrodes selected from electrode 206 and optional electrode(s) 207.

[0058] In various embodiments, the number of leads and the number of electrodes on each lead depend on, for example, the distribution of the targets(s) to be stimulated and the need to control the electric field distribution at each target. In various embodiments, the lead system 208 may include two leads each having eight electrodes, four leads each having eight electrodes, two leads each having sixteen electrodes, or any other number of leads and electrodes required to deliver neural stimulation to the targets(s). Lead and electrode configurations are illustrated in this document by way of example and not limitation. For example, various embodiments may use paddle electrodes, cuff electrodes, and other electrodes suitable for delivering neural stimulation.

[0059] Figure 3 An embodiment of a programming device 302, such as that which can be implemented in a neurostimulation system 100, is illustrated. Programming device 302 represents an example of programming device 102 and includes a storage device 318, programming control circuitry 316, and a user interface 310. Programming control circuitry 316 generates a plurality of stimulation parameters controlling the delivery of neurostimulation pulses according to a specified neurostimulation program that can define, for example, stimulation waveforms and electrode configurations. User interface 310 represents an example of user interface 110 and includes stimulation programming circuitry 320 and sensing programming circuitry 360. Storage device 318 stores information used by programming control circuitry 316, stimulation programming circuitry 320, and sensing programming circuitry 360, such as information about the stimulation device that associates the neurostimulation program with the plurality of stimulation parameters. In various embodiments, stimulation programming circuitry 320 and sensing programming circuitry 360 may be configured to support stimulation- and sensing-related functions, respectively, that allow programming of stimulation devices (such as stimulation device 104, including various embodiments thereof, as discussed herein) according to one or more selected neurostimulation programs as discussed herein.

[0060] In various embodiments, the user interface 310 may allow defining a pattern of neural stimulation pulses to be delivered during a neural stimulation therapy session by creating and / or adjusting one or more stimulation waveforms using graphical methods. This definition may also include the definition of one or more stimulation fields, each associated with one or more pulses in the neural stimulation pulse pattern. As used herein, "neurostimulation programming" may include a pattern of neural stimulation pulses containing the one or more stimulation fields, or may include at least various aspects or parameters of a pattern of neural stimulation pulses containing the one or more stimulation fields. In various embodiments, the user interface 310 includes a GUI that allows a user to define patterns of neural stimulation pulses using graphical methods and perform other functions, including the writing of sequences of sense blocks. In this document, "neurostimulation programming" may include the definition of the one or more stimulation waveforms, including the definition of one or more stimulation fields.

[0061] In various embodiments, the circuitry of the neurostimulation system 100 can be implemented using a combination of hardware and software, including the various embodiments discussed herein. For example, the circuitry of the user interface 110, control circuitry 214, programming control circuitry 316, stimulation programming circuitry 320, and sensing programming circuitry 360 (including various embodiments of them discussed herein) can be implemented using dedicated circuitry configured to perform one or more specific functions and / or general-purpose circuitry programmed to perform such functions(s). Such general-purpose circuitry may include, but is not limited to, a microprocessor or a portion thereof, a microcontroller or a portion thereof, and / or programmable logic circuitry or a portion thereof.

[0062] Figure 4 An embodiment of an implantable pulse generator (IPG) 404 and an implantable lead system 408 is shown. IPG 404 represents an example embodiment of the stimulation device 204. Lead system 408 represents an example embodiment of the lead system 208. Figure 4 As shown, IPG 404 can be coupled to implantable leads 408A and 408B at the proximal end of each lead. The distal end of each lead includes an electrical contact or electrode 406 for contacting a tissue site intended for electrical nerve stimulation. Figure 4 As shown, wires 408A and 408B each include eight electrodes 406 at their distal ends. (As...) Figure 4 The number and arrangement of the leads 408A and 408B and the electrode 406 shown are merely examples; other numbers and arrangements are possible. In various embodiments, the electrodes are loop electrodes. In various embodiments where DBS or SCS is applied, the implanted leads and electrodes can be configured in shape and size to deliver electrical nerve stimulation energy to neuronal targets included in the patient's brain, or to deliver electrical nerve stimulation energy to target nerve cells in the patient's spinal cord.

[0063] Figure 5 This diagram illustrates an implantable neurostimulation system 500 and a portion of the environment in which the system 500 can be used. System 500 includes an implantable system 521, an external system 502, and a telemetry link 540 providing wireless communication between the implantable system 521 and the external system 502. The implantable system 521... Figure 5 The image shows 599 implanted in the patient's body.

[0064] The implantable system 521 includes an implantable stimulator (also referred to as an implantable pulse generator or IPG) 504, a lead system 508, and an electrode 506, which respectively represent examples of stimulation device 204, lead system 208, and electrode 206. The external system 502 represents an example of programming device 302. In various embodiments, the external system 502 includes one or more external (non-implantable) devices, each allowing a user and / or patient to communicate with the implantable system 521. In some embodiments, the external system 502 includes programming devices designed for user initialization and adjustment of settings for the implantable stimulator 504, and remote control devices designed for patient use. For example, the remote control device may allow the patient to turn the implantable stimulator 504 on and off and / or adjust certain patient-programmable parameters among the plurality of stimulation parameters.

[0065] The dimensions and shapes of the elements of the implantable system 521 and their positions within the body 599 are shown by way of example rather than limitation. The implantable system is discussed as a specific application of programming, according to various embodiments of this subject matter. In various embodiments, this subject matter can be applied to programming any type of stimulation device that uses electrical pulses as stimulation, regardless of the stimulation target within the patient or whether the stimulation device is implantable.

[0066] return Figure 4 IPG 404 may include a hermetically sealed IPG housing 422 to house the electronic circuitry within IPG 404. IPG 404 may include electrodes 426 formed on the IPG housing 422. IPG 404 may include an IPG head 424 for coupling the proximal ends of leads 408A and 408B. IPG head 424 may also optionally include electrodes 428. Electrodes 426 and / or 428 represent embodiments of electrodes 207(s), and each electrode may be referred to as a reference electrode. Neurostimulation energy may be delivered in a unipolar (also known as monopolar) mode using electrodes 426 or 428 and one or more electrodes selected from electrode 406. Neurostimulation energy may be delivered in a bipolar mode using a pair of electrodes from the same lead (lead 408A or lead 408B). Neurostimulation energy may be delivered in an extended bipolar mode using one or more electrodes from one lead (e.g., one or more electrodes from lead 408A) and one or more electrodes from different leads (e.g., one or more electrodes from lead 408B).

[0067] The electronic circuitry of the IPG 404 may include control circuitry for controlling the delivery of neural stimulation energy. The control circuitry may include a microprocessor, digital signal processor, application-specific integrated circuit (ASIC), or other type of processor that interprets or executes instructions included in software or firmware. Neural stimulation energy may be delivered according to specified (e.g., programmed) modulation parameters. Examples of setting modulation parameters may include, in particular, selecting an electrode or electrode combination to be used in the stimulation, configuring one or more electrodes as an anode or cathode for stimulation, specifying the percentage of neural stimulation provided by the electrode or electrode combination, and specifying stimulation pulse parameters. Examples of pulse parameters may include, in particular, the pulse amplitude (specified in current or voltage), pulse duration (e.g., in microseconds), pulse rate (e.g., pulses per second), and parameters associated with a pulse train or pattern, such as burst rate (e.g., an "on" modulation time followed by an "off" modulation time), the amplitude of pulses in the pulse train, the polarity of the pulses, etc.

[0068] Figure 6 An embodiment of the various parts of a neurostimulation system 600 is shown. System 600 includes an IPG 604, implantable neurostimulation leads 608A and 608B, an external remote controller (RC) 632, a clinician programmer (CP) 630, and an external trial stimulator (ETS, also known as an external trial modulator or ETM) 634. The IPG 604 may be electrically coupled to leads 608A and 608B directly or via percutaneous extension leads 636. The ETS 634 may be electrically connected to leads 608A and 608B via one or both of the percutaneous extension leads 636 and / or an external cable 638. System 600 represents an example of system 100, where IPG 604 represents an embodiment of stimulation device 104, electrodes 606 of leads 608A and 608B represent electrodes 106, and CP 630, RC 632, and ETS 634 collectively represent programming device 102.

[0069] The ETS 634 can be standalone or incorporated into the CP 630. The ETS 634 may have a pulse generation circuitry similar to that of the IPG 604 to deliver neural stimulation energy according to the modulation parameters specified as described above. The ETS 634 is an external device configured for portable use, serving as a preliminary stimulator after leads 408A and 408B have been implanted and for testing patient responsiveness to stimulation to be provided by the IPG 604 prior to IPG stimulation. The ETS 634 may include a cable connector for easy proximal docking with external leads intended for long-term use and may include a replaceable battery.

[0070] The CP 630 can be configured to provide neural stimulation via the ETS 634. If the ETS 634 is not integrated into the CP 630, the CP 630 can communicate with the ETS 634 via a wired connection (e.g., via a USB link) or via wireless telemetry using wireless communication link 640. The CP 630 also communicates with the IPG 604 using wireless communication link 640.

[0071] One example of wireless telemetry is inductive coupling based on the mutual inductance between two closely placed coils. This type of telemetry is called inductive telemetry or near-field telemetry because the coils must typically be placed close together to achieve inductively coupled communication. The IPG 604 may include a first coil and communication circuitry. The CP 630 may include or otherwise be electrically connected to a second coil, such as in the form of a rod that can be placed near the IPG 604. Another example of wireless telemetry includes far-field telemetry links, also known as radio frequency (RF) telemetry links. The far field, also known as the Fraunhofer zone, refers to the region in which the electromagnetic field component generated by a source of emitting electromagnetic radiation decays substantially in proportion to 1 / r, where r is the distance between the observation point and the radiation source. Thus, the far field refers to the region beyond the boundary r = λ / 2π, where λ is the wavelength of the emitted electromagnetic energy. In one example, the communication range of an RF telemetry link is at least six feet, but can be as long as allowed by a particular communication technology. The RF antenna can be included in, for example, the head of the IPG 604 and the housing of the CP 630, thus eliminating the need for rods or other inductive coupling tools. For example, such an RF telemetry link is... Wireless link.

[0072] The CP 630 can be used to set modulation parameters for neural stimulation after the IPG 604 has been implanted. This allows for adjustment of neural stimulation if the requirements change after implantation. The CP 630 can also transmit information from the IPG 604.

[0073] The RC 632 also communicates with the IPG 604 via a wireless link 640. The RC 632 can be a communication device used by a user or given to a patient. Compared to the CP 630, the RC 632 may have reduced programmability. This allows the user or patient to change the neurostimulation therapy, but does not allow the patient complete control over the therapy. For example, the patient may be able to increase the amplitude of the neurostimulation pulses or change the timing of the application of a pre-programmed stimulation pulse train. The RC 632 can be programmed by the CP 630. The CP 630 can communicate with the RC 632 using a wired or wireless communication link. In some embodiments, the CP 630 can program the RC 632 when it is located at a distance from the RC 632.

[0074] Figure 7An embodiment of a neurostimulation system such as system 600 is shown, including an implantable stimulator 704, one or more leads 708, and one or more sensors 750. The implantable stimulator 704 represents an example of stimulation device 104 or 204 and can be implemented, for example, as IPG 604. The leads 708 represent an example of lead system 208 and can be implemented, for example, as implantable leads 608A and 608B. The leads 708 include electrodes 706, which represent examples of electrodes 106 or 206 and can be implemented as electrode 606.

[0075] The implantable stimulator 704 may include sensing circuitry 742, stimulation output circuitry 212, control circuitry 714, implantable storage device 746, implantable telemetry circuitry 744, power supply 748, and one or more electrodes 707. Sensing circuitry 742 is optional and required only when the stimulator needs sensing capabilities. Sensing circuitry 742 senses one or more physiological signals for the purpose of patient monitoring and / or feedback control of neural stimulation. Examples of one or more physiological signals include neural signals and other signals, each indicating the patient's condition treated by neural stimulation and / or the patient's response to the delivery of neural stimulation (e.g., see below). Figure 10 (Signals discussed). In various embodiments, sensing circuitry 742 senses one or more neural signals using at least electrode 706 and receives one or more signals sensed by sensor(s) ... In one embodiment, power source 748 includes a battery. In another embodiment, power source 748 includes a rechargeable battery and battery charging circuitry for charging the rechargeable battery. Implantable telemetry circuitry 744 can also function as a power receiver, receiving power transmitted from an external device via inductive coupling. Multiple electrodes 707 allow for the delivery of neural stimulation pulses in a unipolar mode. Examples of multiple electrodes 707 include electrodes 426 and 418 in IPG 404, such as... Figure 4 As shown. Multiple sensors 750 sense one or more signals for controlling neural stimulation. In various embodiments, the multiple sensors 750 may be included in an implantable stimulator 704, may be implantable separately from the implantable stimulator 704 in a patient, may be worn externally by the patient, and / or located away from the patient, as referred to below. Figure 10 Further discussion is needed.

[0076] In one embodiment, the implantable stimulator 704 serves as a master database. Therefore, a patient with the implantable stimulator 704 (such as an IPG 604) can carry this information when the patient information required for his or her medical care is unavailable. The implantable storage device 746 is configured to store such patient information. For example, a new RC 632 can be given to the patient (e.g., by installing a new application in a smart device such as a smartphone), and / or the patient can travel to a new clinic where a new CP 630 can be used to communicate with the device implanted in his or her body. The new RC 632 and / or CP 630 can communicate with the implantable stimulator 704 to retrieve the patient information stored in the implantable storage device 746 via the implantable telemetry circuitry 744 and the wireless communication link 640, and allow any necessary adjustments to the operation of the implantable stimulator 704 based on the retrieved patient information. In various embodiments, for example, patient information to be stored in the implantable storage device 746 may include: the position of (multiple) leads 708 and electrodes 706 relative to the patient's anatomy (for conversion of computed tomography (CT) images of postoperative lead placement to magnetic resonance imaging (MRI) of the brain), clinical outcome data, objective measurements of quantitative assessment of symptoms (e.g., using microelectrode recordings, accelerometers, and / or other sensors), any physiological sensing data or features extracted from sensing data, and / or any other information deemed important or useful for providing adequate care to the patient. In various embodiments, patient information to be stored in the implantable storage device 746 may include data transmitted to the implantable stimulator 704 for storage as part of the patient information and data acquired by the implantable stimulator 704 (e.g., through the use of sensing circuitry 742).

[0077] In various embodiments, sensing circuitry 742 (if included), stimulation output circuitry 212, control circuitry 714, implantable telemetry circuitry 744, implantable storage device 746, and power supply 748 are encapsulated in a sealed implantable housing or enclosure, and electrodes(multiple) 707 are formed or otherwise incorporated into the enclosure. In various embodiments, leads(multiple) 708 are implanted such that electrodes 706 are placed on and / or around one or more targets to which nerve stimulation pulses will be delivered, while the implantable stimulator 704 is subcutaneously implanted and connected to the leads(multiple) 708 upon implantation.

[0078] Figure 8 An embodiment of an external programming device 802 for a neurostimulation system such as system 600 is shown. External programming device 802 represents an example of programming device 102 or 302 and may be implemented, for example, as CP 630 and / or RC 632. External programming device 802 includes external telemetry circuitry 852, external storage device 818, programming control circuitry 816, and user interface 810.

[0079] External telemetry circuitry 852 provides wireless communication with another device, such as implantable stimulator 704, to external programming device 802 via wireless communication link 640, including transmitting multiple stimulation parameters to and from implantable stimulator 704 and receiving information including patient data. In one embodiment, external telemetry circuitry 852 also transmits power to implantable stimulator 704 via inductive coupling.

[0080] In various embodiments, the wireless communication link 640 may include an inductive telemetry link (near-field telemetry link) and / or a far-field telemetry link (RF telemetry link). For example, since DBS is generally applicable to movement disorders assessed through patient activity, gait, balance, etc., it is useful to allow patient activity during programming and assessment. Therefore, when system 600 is intended for use in applications including DBS, the wireless communication link 640 includes at least a far-field telemetry link, which allows communication between the external programming device 802 and the implanted stimulator 704 over relatively long distances (such as up to about 20 meters). The external telemetry circuitry 852 and the implanted telemetry circuitry 744 each include an antenna and an RF circuitry system configured to support such wireless telemetry.

[0081] External storage device 818 stores one or more stimulation waveforms for delivery during a neurostimulation therapy session (such as a DBS or SCS therapy session), as well as various parameters and building blocks for defining the one or more waveforms. Each of the one or more stimulation waveforms may be associated with one or more stimulation fields and represents a pattern of neurostimulation pulses to be delivered to the one or more stimulation fields during the neurostimulation therapy session. In various embodiments, each of the one or more stimulation waveforms may be selectable for user modification and / or for programming a stimulation device (e.g., implantable stimulator 704) to deliver therapy. In various embodiments, each of the one or more stimulation waveforms may be defined on a pulse-by-pulse basis, and external storage device 818 may include a pulse library storing one or more individually definable pulse waveforms, each pulse waveform defining a pulse type of one or more pulse types. External storage device 818 also stores one or more individually definable stimulation fields. Each of the one or more stimulation waveforms is associated with at least one of the one or more individually definable stimulation fields. Each of the one or more individually definable stimulation fields is defined by a set of electrodes through which neurostimulation pulses are delivered. In various embodiments, each of the one or more individually definable fields is defined by the set of electrodes through which the neural stimulation pulses are delivered and the current distribution of the neural stimulation pulses on the set of electrodes. In one embodiment, the current distribution is defined by allocating a small fraction of the total pulse amplitude to each of the electrodes in the set. This definition of the current distribution may be referred to herein as “fractionalization.” In another embodiment, the current distribution is defined by allocating amplitude values ​​to each of the electrodes in the set. For example, the electrode set may include two electrodes serving as anodes and one electrode serving as cathodes for delivering neural stimulation pulses with a pulse amplitude of 4 mA. The current distribution on the two electrodes serving as anodes needs to be defined. In one embodiment, a percentage of the pulse amplitude is allocated to each of the two electrodes, such as 75% to electrode 1 and 25% to electrode 2. In another embodiment, an amplitude value is allocated to each of the two electrodes, such as 3 mA to electrode 1 and 1 mA to electrode 2. Even when adjusting the pulse amplitude, controlling the current by percentage allows for precise and consistently distributed current between the electrodes. This approach is suitable for treating the problem as manipulating a stimulus trajectory, where the stimulus is simultaneously changed at multiple contacts to move the trajectory while keeping the stimulus intensity constant. Controlling and displaying the total current through each electrode in absolute values ​​(e.g., mA) enables precise dosing of the current through each specific electrode. It allows for changing the current one contact at a time (and allows the user to do so), shaping the stimulus like a block of clay (pushing / pulling one point at a time).

[0082] Programmable control circuitry 816 represents an example of programmable control circuitry 316. Programmable control circuitry 816 generates multiple stimulation parameters to be transmitted to implantable stimulator 704 based on a specified neurostimulation program (e.g., a pattern of neurostimulation pulses represented by one or more stimulation waveforms and one or more stimulation fields, or at least some aspects of that pattern). Programmable control circuitry 816 also generates multiple sensing parameters to be transmitted to implantable stimulator 704 based on a sensing configuration (such as a sequence of sensing blocks). The neurostimulation program and sensing configuration can be created and / or adjusted by a user using user interface 810 and stored in external storage device 818. In various embodiments, programmable control circuitry 816 can check the values ​​of the multiple stimulation parameters and / or multiple sensing parameters against safety rules to restrict these values ​​to the constraints of the safety rules. In one embodiment, the safety rules are heuristic rules.

[0083] User interface 810 represents an example of user interface 310 and allows a user to define patterns of neural stimulation impulses and perform various other monitoring and programming tasks. User interface 810 includes a display screen 856, a user input device 858, and interface control circuitry 854. The display screen 856 may include any type of interactive or non-interactive screen, and the user input device 858 may include any type of user input device supporting the various functions discussed herein, such as a touchscreen, keyboard, keypad, touchpad, trackball, joystick, and mouse. In one embodiment, user interface 810 includes a GUI. The GUI may also allow the user to perform any functions discussed herein that are suitable for graphical presentation and / or editing as will be understood by those skilled in the art.

[0084] Interface control circuit 854 controls the operation of user interface 810, including responding to various inputs received by user input device 858 and defining one or more stimulation waveforms. Interface control circuit 854 may include stimulation programming circuit 820 and sensing programming circuit 860. Stimulation programming circuit 820 allows the writing of a neural stimulation program or neural stimulation pulse pattern according to which neural stimulation is delivered. Sensing programming circuit 860 allows the writing of a sensing configuration (such as a sequence of sensing blocks) according to which signals are sensed for controlling the delivery of neural stimulation, as described below. Figures 9-15 Further discussion is needed.

[0085] In various embodiments, the external programming device 802 may have operating modes including a writing mode (a mode in which a sequence of sense blocks and / or neural stimulation pulses is written during the writing mode) and a real-time programming mode. In the writing mode, the user interface 810 is activated, while the programming control circuit 816 is temporarily deactivated. The programming control circuit 816 dynamically updates the values ​​of multiple stimulation parameters without responding to any changes in one or more stimulation waveforms. In the real-time programming mode, both the user interface 810 and the programming control circuit 816 are activated. The programming control circuit 816 dynamically updates the values ​​of multiple stimulation parameters in response to changes in the set of one or more stimulation waveforms and transmits the multiple stimulation parameters with updated values ​​to the implantable stimulator 704. In various embodiments, a closed-loop system with the programming control circuit 816 operating in real-time programming mode is used to control the delivery of neural stimulation, with both the user interface 810 and the programming control circuit 816 activated in real-time programming mode. The programming control circuit 816 dynamically updates the values ​​of multiple stimulation parameters in response to changes in one or more sensing algorithms (e.g., programmed in control circuit 714) that follow the sequence of the sensing block, and transmits the multiple stimulation parameters with updated values ​​to the implantable stimulator 704.

[0086] Figure 9 An embodiment of a system 970 for delivering neural stimulation and controlling the delivery of neural stimulation using sensors is shown. System 970 includes a stimulation output circuit 912, a sensing circuit 942, and a control circuit 914. The stimulation output circuit 912 can deliver neural stimulation. The sensing circuit 942 can receive and process sensed signals from sensors. The settings of the sensing circuit 942, which controls the processing of the sensed signals, are adjustable. The control circuit 914 can use the processed sensed signals to control the delivery of neural stimulation and controls the settings of the sensing circuit 942 according to a sequence of sensing blocks (each including a set of sensing parameters).

[0087] System 970 can be implemented in neurostimulation systems such as systems 100, 500, and 600. In various embodiments, system 970 is implemented in an implantable medical device, such as IPG 404, IPG or implantable stimulator 504, IPG 604, or implantable stimulator 704 discussed herein. For example, when system 970 is implemented in implantable stimulator 704, stimulation output circuitry 212 can be configured to include stimulation circuitry 912, sensing circuitry 742 can be configured to include sensing circuitry 942, and control circuitry 714 can be configured to include control circuitry 914. Sensors can include any combination of sensors(multiple) 750, electrodes 706, and electrodes(multiple) 707.

[0088] In various embodiments, neural stimulation is delivered in the form of electrical stimulation pulses (referred to as neural stimulation pulses in this document), and system 970 is configured to deliver neural stimulation pulses and control the delivery of neural stimulation pulses using signals sensed by sensors. Stimulation output circuitry 912 (also referred to as “stimulation hardware”) can deliver neural stimulation pulses. Sensing circuitry 942 (also referred to as “sensing hardware”) can receive sensed signals from sensors and process the sensed signals for controlling the delivery of neural stimulation pulses in various direct and / or indirect ways (e.g., directly by automatically adjusting the delivery of neural stimulation pulses in response to changes in the sensed signals detected, or indirectly by notifying the user of changes in patient control detected from the sensed signals to allow the user to decide whether the delivery of neural stimulation pulses should be adjusted). Sensing circuitry 942 includes multiple sensing channels that allow simultaneous reception and processing of multiple signals. Sensing circuitry 942 has adjustable settings for controlling the processing of sensed signals. Processing of each received sensed signal may include one or more of, for example, the following:

[0089] • Amplify the sensed signal;

[0090] • Filter the sensed signal;

[0091] • Digitize the sensed signals;

[0092] • Averaging the sensed signal;

[0093] • Extract one or more features from the sensed signal.

[0094] In some embodiments, the settings of the sensing circuit 942 can also be adjusted to control the operation of one or more sensors, such as activating and deactivating sensors and / or adjusting sensor parameters of the sensors according to when and how the sensors are used. The control circuit 914 can control the delivery of neural stimulation pulses based on the pattern of the stimulation pulses and using sensed signals received and processed by the sensing circuit 942. In various embodiments, the control circuit 914 controls the delivery of neural stimulation pulses that execute a stimulation algorithm using stimulation parameters and adjusts the stimulation parameters using sensed signals received and processed by the sensing circuit 942. The control circuit 914 can also control the settings of the sensing circuit 942 based on a sequence of sensing blocks (each including a set of sensing parameters). In various embodiments, the control circuit 914 controls the settings of the sensing circuit 942 by executing a sensing algorithm that uses sensing parameters defined for the sensing blocks. The control circuit 914 can store one or more sensing algorithms and the sensing parameters used by each of the one or more sensing algorithms.

[0095] Figure 10An embodiment of a sensor 1050, which can be used by a neurostimulation system such as system 970, is shown. In various embodiments, sensing circuitry 942 can receive signals from sensor 1050.

[0096] Sensor 1050 may include one or more internal sensors 1072 and / or one or more external sensors 1074. The internal sensors 1072 are included in the implantable medical device 1004. Examples of implantable stimulators 1004 include IPG 404, IPG or implantable stimulator 504, IPG 604, or implantable stimulator 704 discussed herein. The external sensors 1074 are external to and communicatively coupled to the implantable stimulator 1004. In various embodiments, the external sensors 1074 may include one or more implantable sensors 1076, one or more percutaneous sensors 1078, one or more wearable sensors 1080, and / or one or more remote sensors 1082. Each of the external sensors 1074 is communicatively coupled to the implantable stimulator 1004 via a wired or wireless connection. The implantable sensors 1076 may be placed within a patient in which the implantable stimulator 1004 is placed. Multiple percutaneous sensors 1078 may be partially inserted into the patient's body. Multiple wearable sensors 1080 may be worn externally by the patient, such as attached to the patient's skin or otherwise carried by the patient to move with the patient. Multiple remote sensors 1082 may sense signals from the patient or the environment without being carried by the patient or moving with the patient. The choice of the type of external sensor used to sense the desired signal may depend on the nature of the signal and the available sensor technology. Examples of sensors 1050 include:

[0097] • Electrodes for sensing neural electrical signals (e.g., electrodes coupled to one or more implantable leads of an implantable medical device and electrodes incorporated into the implantable medical device, such as electrode 706 and(a plurality of) electrodes 707);

[0098] • Motion sensors used to sense motion signals in different parts of the patient's body;

[0099] • An electrocardiogram (ECG) sensor used to sense ECG signals;

[0100] • A heart rate sensor used to sense signals from which the patient's heart rate can be detected;

[0101] • A blood pressure sensor used to sense signals that indicate a patient's blood pressure;

[0102] Impedance sensors used to sense skin impedance;

[0103] • Sleep sensors are used to sense signals that indicate a patient’s sleep state (e.g., sleep stage) or the total time spent resting or sleeping;

[0104] • Chemical sensors used to sense levels of sugar or other substances, such as those in a patient's blood vessels;

[0105] • A pulse oximeter used to sense a patient's oxygen saturation;

[0106] • Screen writing sensor: Patients use this sensor to follow graphics or letters on the screen to detect hand tremors, slow movements, or muscle twitching (micrographia) while writing.

[0107] • A respiratory sensor used to sense signals that indicate a patient's respiratory cycle;

[0108] • Acoustic sensors for sensing acoustic signals (e.g., echo Doppler sensors for sensing blood flow in a patient);

[0109] • An eye sensor used to detect pupil dilation in patients;

[0110] • Bed sensors (e.g., mattress sensors) used to sense patient movement on the bed.

[0111] • A step counter that counts the number of steps a patient takes; and

[0112] • Activity sensors used to sense a patient's activity level.

[0113] Each of these sensors can be configured as an implantable, percutaneous, wearable, or remote sensor, depending on physiological and design considerations (e.g., the optimal site for sensing the desired signal, the least invasive or most convenient method for placing the sensor, and the type of sensor already available for sensing the desired signal). In various embodiments, sensor 1050 may include any sensor selected from these examples, as well as other sensors that can be used to control neural stimulation.

[0114] Figure 11An embodiment of a sequence of sensing blocks is shown, according to which the setup of sensing circuitry in a neurostimulation system, such as sensing circuitry 942 in system 970, can be controlled. The sequence of sensing blocks may include two or more sensing blocks, each including a set of sensing parameters. In the illustrated embodiment, the sequence of sensing blocks includes sensing block 1 (including sensing parameter set 1), sensing block 2 (including sensing parameter set 2), ..., sensing block N (including sensing parameter set N). In various embodiments, the sequence of sensing blocks is customizable for treatment and / or patient. Customization may include customizing a set of sensing parameters for each block in the sequence and / or customizing the order of the sensing blocks in the sequence. Each sensing parameter may have a value that varies across different sensing blocks and / or varies within a sensing block. The sequence of sensing blocks may include one or more non-sensing blocks, for which signal sensing is paused. In various embodiments, the sensing circuitry may continuously and periodically cycle through sensing blocks 1 to N according to a specified schedule while neurostimulation is being delivered or in response to a specific event or condition.

[0115] The sensing parameters for each sensing block in the sequence of sensing blocks can be specified as one or more of the following, for example:

[0116] • One or more sensors activated for the sensing block (i.e., the signals to be sensed);

[0117] • One or more sensing channels activated for the sensing block;

[0118] • Sensing electrodes for each sensing channel;

[0119] • The sampling frequency of each sensed signal (depending on the type of signal);

[0120] • The filter type and cutoff frequency for each sensed signal (depending on the signal type);

[0121] • Sensing time window for each sensed signal (the duration of sensing, depending on the signal and the signal features of interest, such as the response after the stimulus);

[0122] • Whether each sensed signal is averaged (e.g., the response averaged for multiple stimuli);

[0123] • Whether to store each sensed signal or one or more signal features extracted from that signal (e.g., whether to store neural signals including ECAP, EP (evoked potential), ERNA (evoked resonant neural activity) and / or LFP (local field potential), and / or whether to store the amplitude(s) of ECAP, EP, ERNA and / or LFP);

[0124] • The types of signal features(s) to be extracted from each sensed signal (e.g., range, curve length (CL), area under the curve (AUC), and / or frequency domain features, such as LFP associated with a specific frequency band); • The stimulus delivered for sensing purposes;

[0125] • Default settings for different signals such as EP, ERNA, and / or LFP;

[0126] • Closed-loop sensing algorithm;

[0127] • One or more closed-loop parameters used within the algorithm (each adjusted using closed-loop sense control); and

[0128] • Logic blocks for scheduled sensing (e.g., sensing parameters adjusted according to a schedule) and / or conditional sensing (e.g., sensing parameters adjusted in response to conditions or events).

[0129] Different parameters can be specified to handle different types of signals sensed during each sensing block. Examples of controlling various settings of the sensing circuitry by specifying sensing parameters in each sensing block include:

[0130] • Programming analog and / or digital filters;

[0131] • Decompose the sensed signal into frequency components (f or s domain) or another type of signal (e.g., wavelet); • For wavelet-type analysis, program the system to use conventional groups or allow users to specify patterns to associate signals with desired patterns;

[0132] • Allows users to define and apply filters to sensed signals in the time domain or other domains (e.g., frequency domain or wavelet domain) for phase decomposition, cross-correlation across different channels, and phase-amplitude coherence analysis across channels;

[0133] • Define the signal features to be extracted from the sensed signal by means of power, changes in baseline characteristics, and information-theoretic features (such as entropy, spectral entropy, mutual information, fractal dimension, etc.);

[0134] • Program the sensed signal to modulate it with another sensed signal (e.g., by addition, subtraction, or multiplication);

[0135] • Use signal characteristics on the sensed signal to control the processing of another sensed signal (e.g., parameters measured from the sensed signal can trigger sampling and / or filtering of the other sensed signal, or can be used to set a cutoff frequency for filtering the other sensed signal);

[0136] • One or more sensing parameters of the sensing block are set based on one or more sensing parameters of the preceding sensing block. In various embodiments, the type of sensing parameters that can be specified in each sensing block depends on which settings of the sensing circuit are adjustable, and the type of sensing parameters actually specified depends on the type of signal to be sensed and the type of information to be obtained from the sensed signal.

[0137] Figure 12 An embodiment of control circuitry 1214 for a neurostimulation system such as system 970 is shown. Control circuitry 1214 may represent an example of control circuitry 914. In the illustrated embodiment, control circuitry 1214 includes a microcontroller unit (MCU) 1286 and registers 1288. MCU 1286 includes one or more central processing units (CPUs), memory, and programmable input / output peripherals.

[0138] When the system 970 with control circuitry 1214 is implemented in an implantable medical device such as IPG 404, IPG or implantable stimulator 504, IPG 604, or implantable stimulator 704, the MCU 1286 includes firmware that controls the operation of the implantable medical device, including settings for sensing circuitry 942. The MCU 1286 can be configured for neurostimulation, including the delivery of neurostimulation pulses and the settings for sensing circuitry 942. The memory of the MCU 1286 can store one or more stimulation algorithms that control the delivery of neurostimulation and one or more sensing algorithms that control the settings for sensing circuitry 942. These one or more sensing algorithms can each be loaded as an independent image into memory and can also each be stored as an independent image in external flash memory (e.g., for transfer and programming purposes). These one or more sensing algorithms can each be loaded without requiring a full firmware upgrade of the MCU 1286 (e.g., by updating a specific firmware image instead of the entire firmware). The memory of the MCU 1286 can also store adjustable parameters used by the one or more stimulation algorithms and the one or more sensing algorithms. In various embodiments, the adjustable parameters are dynamically adjustable during the delivery of neural stimulation and the sensing of signals (using an external programming device such as CP 630, RC 632, or external programming device 802). In various embodiments, the adjustable parameters are adjustable to allow changes to the closed-loop behavior of the stored sensing algorithm without updating the firmware or loading a new sensing algorithm. The settings of the sensing circuit 942 can be adjusted during signal sensing by adjusting parameters without changing the firmware. In various embodiments, the use of ordered sensing blocks according to the subject matter of the invention encourages the development of generalizable closed-loop sensing algorithms for maximum flexibility, wherein logic blocks for scheduled sensing and / or conditional sensing can be executed in the MCU 1286.

[0139] Register 1288 may store additional information used by the one or more sensing algorithms stored and executable in MCU 1286. In one embodiment, register 1288 is implemented in an application-specific integrated circuit (ASIC) and is referred to as an ASIC register. In one embodiment, hardware-specific sensing configuration is written to register 1288. Examples of hardware-specific sensing configuration include settings for: analog control (e.g., which electrodes to use), digital measurement (e.g., when to trigger sensing, sampling frequency), digital processing (i.e., how to process raw data, e.g., filtering / averaging), and feature extraction (e.g., which(s) features(s) to extract and how to detect each feature).

[0140] Figure 13 An embodiment of the firmware architecture for control circuitry 1214 is shown. The hardware architecture allows for upgrading the firmware image, rather than the entire firmware, to add or modify sensing algorithms. Sensing parameters used by each sensing algorithm can be adjusted during signal sensing without changing the firmware. In various embodiments, a software-level sensing programmer can be used to program the sequence of sensing blocks without altering the firmware. When control circuitry 1214 is part of an implantable medical device, an external device for programming the implantable medical device can be configured to include a sensing programmer.

[0141] The firmware architecture shown by way of example and not limitation includes the following blocks for controlling the settings of sensing circuits such as sensing circuit 942:

[0142] • Establish registers: Registers are established for analog control (e.g., which electrodes to use), digital measurement (e.g., when to trigger sensing), digital processing (e.g., how to filter the sensed signal), and feature extraction (e.g., which feature(s) to extract from the sensed signal).

[0143] • Establish logic: Select a sensing algorithm and perform sensing based on conditions (e.g., Cond0: select an algorithm, Cond1: repeat M times, Cond3: the scheduled time for running the algorithm, ...).

[0144] • Control algorithm: The firmware jumps to the starting address of the hard-coded algorithm and uses the algorithm's parameters via pointers.

[0145] Algorithm parameters: The parameters are unknown to the algorithm being executed, but the algorithm knows which parameters to use.

[0146] Return to reference Figure 8In one embodiment, the external programming device 802 is configured to allow the writing of sensing algorithms for sequencing sense blocks. Programming control circuitry 816 can be configured to generate parameters for programming an implantable medical device (such as an implantable stimulator 704) to control the delivery of neural stimulation pulses according to a pattern of neural stimulation pulses and to control the setup of sensing circuitry (such as sensing circuitry 742) according to a sequence of sense blocks. User interface 810 can be configured to generate the sequence of sense blocks. In one embodiment, a sense writer is implemented in the external programming device 802 using a display screen 856, a user input device 858, and sense programming circuitry 860. The sense writer allows the writing of each sense block and the use of the sense blocks to create patient- and / or treatment-specific settings for the sense circuitry. The sense programming circuitry 860 can display a sense writing window or field on the display screen 856 and receive user input related to the writing using the user input device 858. User interface 810 may include a GUI configured as part of a sensor writer to allow a user to graphically create and / or edit sequences of sensor blocks, including creating and / or editing each sensor block individually. In various embodiments, the sensor writer may, for example, allow the user to program the following:

[0147] • Logic: Signal conditioning and sensing scheduling capabilities;

[0148] • Analog control: Electrodes used for sensing;

[0149] • Digital measurement: The event or condition that triggers signal sensing;

[0150] • Digital filtering: Filtering parameters used for each sensed signal;

[0151] • Feature extraction: The extraction of signal features from each sensed signal; and

[0152] • Control algorithm: The sensing algorithm to be selected.

[0153] Figure 14 An embodiment of a method 1400 for delivering neural stimulation and controlling the delivery of neural stimulation using sensors is shown. In one embodiment, method 1400 is performed using system 970.

[0154] At 1401, neural stimulation is delivered from the stimulation device. The neural stimulation may be in the form of electrical pulses. The stimulation device may be an implantable neurostimulator.

[0155] At 1402, a sensing circuit is used to receive and process the sensed signals. The sensing circuit has adjustable settings to control the processing of the sensed signals. In various embodiments, multiple individually controllable sensing channels of the sensing circuit are used to simultaneously receive and process two or more sensed signals.

[0156] In 1403, a control circuit is used to control the delivery of neural stimulation using processed sensed signals. In various embodiments, the processed sensed signals are used as input to the control circuit to execute a closed-loop control algorithm.

[0157] At 1404, control circuitry is used to control the settings of the sensing circuitry according to the sequence of sensing blocks. Each sensing module includes a set of sensing parameters. In various embodiments, the sequence of sensing blocks is customized for the patient and / or treatment. Customization of the sensing block sequence may include customizing each of one or more blocks in the sequence. In various embodiments, one or more sensing parameters of each sensing block may be adjusted according to a schedule and / or events or conditions. In various embodiments, one or more signals from the processed sensed signals may be used to adjust one or more sensing parameters of each sensing block. In various embodiments, one or more sensing parameters of each sensing block may be dynamically adjusted during the delivery of neural stimulation and / or the sensing of signals. In various embodiments, one or more sensing algorithms are stored in the control circuitry, and the settings of the sensing circuitry are controlled by executing a sensing algorithm selected from the stored one or more algorithms. The sensing algorithms may be executed using the firmware of the microcontroller of the control circuitry. The sensing parameters may be stored in the microcontroller and one or more registers coupled to the microcontroller to allow adjustment of the sensing circuitry settings without changing the firmware.

[0158] Figure 15 An embodiment of method 1500 for data storage associated with sorted sensor blocks and for adjusting stimulation and / or sensing settings is illustrated. In one embodiment, method 1500 is performed using system 970 when system 970 is implemented in an implantable medical device (e.g., such as IPG 404, IPG or implantable stimulator 504, IPG 604, or implantable stimulator 704) that is communicatively coupled to an external device (e.g., CP630, RC 632, external programming device 802, or a general-purpose device with a neurostimulation application) and communicatively coupled to a network server. The general-purpose device may be a smartphone, tablet computer, laptop computer, or any device that can be configured to store sensing data representing signals of processed sensing and to control settings of sensing circuitry (including adjusting settings using the sensing data). In various embodiments, the implantable medical device, external device, and network server may each store a portion of the sensing data.

[0159] At 1501, signal sensing is performed by iteratively traversing a sequence of sensing blocks, including sensing blocks 1 to N, where N ≥ 2. Depending on the sequence of sensing blocks, signal sensing is performed at 1501-1 using sensing parameter group 1, at 1501-2 using sensing parameter group 2, ..., and at 1501-N using sensing parameter group N. In some embodiments, one or more parameters of each sensing parameter group can be determined based on one or more parameters of another sensing parameter group (e.g., one or more parameters of sensing parameter group N can be expressed as a function of one or more parameters of sensing parameter group N-1, i.e., sensing parameter group N = f(sensing parameter group N-1), N = 1, 2, ...). At 1502, while processing the sensed signal, sensing data is collected and stored. A portion of the sensing data may be stored in the implantable medical device at 1503, transmitted to and stored in a web server, and / or transmitted to and stored in an external device at 1504. At 1505, the sensing data can be used to adjust stimulation and / or sensing settings. In various embodiments, adjustments can be determined within implantable medical devices, web servers, and / or external devices, depending on how each of these devices is configured for sensing control. This allows for closed-loop control of the delivery of neural stimulation and / or closed-loop control of signal sensing.

[0160] It should be understood that the above detailed description is intended to be illustrative and not restrictive. Other embodiments will be apparent to those skilled in the art upon reading and understanding the above description. Therefore, the scope of the invention should be determined by reference to the appended claims and the full scope of their authorized equivalents.

Claims

1. A system for delivering neural stimulation to a patient and using sensors to control the delivery of neural stimulation, the system comprising: A stimulation output circuit configured to deliver the neural stimulation; A sensing circuit configured to receive and process a sensed signal from the sensor, the sensing circuit having adjustable settings for controlling the operation of one or more of the sensors and the processing of the sensed signal; as well as A control circuit is configured to control the delivery of the neural stimulation using processed sensed signals, and to control adjustable settings of the sensing circuitry cyclically through a sequence of sensing blocks, each sensing block including a set of sensing parameters. The system uses a sequence of the sensing blocks to control the sensing of the sensed signals spatially and temporally.

2. The system according to claim 1, comprising an implantable medical device, the implantable medical device comprising the stimulation output circuit, the sensing circuit, and the control circuit.

3. The system of claim 2, wherein the implantable medical device comprises at least one internal sensor among the sensors.

4. The system according to any one of claims 2 and 3, comprising at least one external sensor of the sensors, the at least one external sensor being external to the implantable medical device and communicatively coupled to the implantable medical device.

5. The system of claim 4, wherein the at least one external sensor comprises an implantable sensor configured to be placed within the patient's body.

6. The system according to any one of claims 4 and 5, wherein the at least one external sensor comprises a sensor configured to be worn by the patient externally or placed away from the patient.

7. The system according to any one of claims 2 to 6, further comprising a programming means configured to program the implantable medical device, the programming means comprising: A programming control circuit is configured to generate parameters for programming the implantable medical device to control the delivery of the nerve stimulation pulses according to the pattern of the nerve stimulation pulses, and to control the settings of the sensing circuit according to the sequence of the sensing blocks. as well as A user interface, coupled to the programming control circuit, includes: Presentation device; User input device; and The interface control circuit includes a stimulation programming circuit configured to generate a pattern of the neural stimulation pulses and a sensing programming circuit configured to generate a sequence of the sensing blocks.

8. The system of claim 7, comprising: A sensor writer implemented using the presentation device, the user input device, and the sensor programming circuitry is configured to allow the writing of sequences of the sensor blocks to customize the settings of the sensor circuitry for at least one of the patient or treatment using the neural stimulation.

9. The system according to any one of claims 2 to 8 further includes an external device configured to communicatively couple to the implantable medical device, store the processed sensed signals, and use the processed sensed signals to adjust settings of the sensing circuitry.

10. The system according to any one of the preceding claims, wherein the sensing circuit comprises a plurality of individually controllable sensing channels configured to simultaneously receive and process two or more of the sensed signals.

11. The system according to any one of the preceding claims, wherein the control circuit is configured to store one or more sensing algorithms and sensing parameters used by each of the one or more sensing algorithms, and to control the settings of the sensing circuit by executing a sensing algorithm selected from the stored one or more algorithms.

12. The system of claim 11, wherein the control circuitry includes a microcontroller unit (MCU) comprising firmware that controls the settings of the sensing circuitry and stores the one or more sensing algorithms as independent images.

13. The system according to claim 12, wherein, The control circuit also includes a register that stores parameters that define the settings of the sensing circuit, and is configured to adjust the settings of the sensing circuit without changing the firmware.

14. The system according to any one of the preceding claims, wherein the control circuitry is configured to adjust one or more of the sensing parameters using one or more of the processed sensed signals.

15. The system according to any one of the preceding claims, wherein the control circuitry is configured to store adjustable parameters used by the one or more sensing algorithms, and to dynamically adjust the adjustable parameters during the delivery of the neural stimulation and the sensing of the signal.

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