System for controlling treatment control parameter update

Abstract

An example of a system for delivering therapy can include a therapy output device that delivers therapy and a therapy control circuit that controls the delivery of therapy using sensed therapy control signals. The therapy control circuit can include a therapy controller that controls the delivery of therapy using therapy parameters, a therapy parameter adjuster that adjusts the therapy parameters using one or more sensed input parameters, a physiological condition detector that detects a physiological condition of the patient using one or more of the received sensed therapy control signals, a measurement system that measures one or more of the sensed therapy control signals at a sensed update rate and generates one or more sensed input parameters based on the measurements, and an update rate adjuster that adjusts the sensed update rate based on one or more rate adjustment parameters that include the sensed physiological condition.

Description

Technical Field

[0001] 〔Claim of Priority〕 This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 109,483, filed on November 4, 2020, which is hereby incorporated by reference in its entirety.

[0002] This document generally relates to medical devices, and more specifically, to medical devices that modify a parameter update rate with closed-loop control for efficient use of power and computing resources.

Background Art

[0003] Neural stimulation methods (also called neuromodulation methods) have been proposed as treatments for many diseases. Examples of neural stimulation methods include spinal cord stimulation (SCS), deep brain stimulation (DBS), peripheral nerve stimulation (PNS), and functional electrical stimulation (FES). To provide such treatments, implantable neural stimulation systems have been applied. An implantable neural stimulation system can include an implantable neural stimulator, also referred to as an implantable pulse generator (IPG), and one or more implantable leads, each including one or more electrodes. The implantable neural stimulator delivers neural stimulation energy through one or more electrodes disposed at or near a target site within the nervous system. An external programming device is used to program the stimulation parameters that control the delivery of neural stimulation energy to the implantable neural stimulator.

[0004] In one example, nerve stimulation energy is delivered in the form of an electrical signal. This delivery is controlled using stimulation parameters that specify the spatial aspect (where to stimulate), the temporal aspect (when to stimulate), and the informational aspect (the stimulation pattern that causes the nervous system to react as desired) of the electrical signal pattern. By determining these stimulation parameters according to the patient's condition and treatment purpose, the effectiveness and efficiency of a specific nerve stimulation treatment can be improved, and its side effects can be reduced. Modern electronics can meet the need to generate sophisticated signal patterns, but the ability of a nerve stimulation system depends on how the stimulation parameters that define such signal patterns can be determined and adjusted for a patient in order to ensure the effectiveness and efficiency of treatment using these stimulations when applying nerve stimulation to the patient. Summary of the Invention Means for Solving the Problems

[0005] An example of a system for providing treatment to a patient (e.g., "Example 1") can include a treatment output device and a treatment control circuit. The treatment output device can be configured to provide treatment to the patient. The treatment control circuit is configured to receive a detected treatment control signal and use the received detected treatment control signal to control the provision of treatment. The treatment control circuit can include a treatment controller, a treatment parameter adjuster, a physiological state detector, a measurement system, and an update rate adjuster. The treatment controller can be configured to control the provision of treatment using treatment parameters. The treatment parameter adjuster can be configured to adjust treatment parameters using one or more detected input parameters. The physiological state detector can be configured to detect the patient's physiological state using one or more physiological signals among the received detected treatment control signals. The measurement system can be configured to measure one or more signals among the received detected treatment control signals at a detection update rate and generate one or more detected input parameters based on the measurement. The update rate adjustment device can be configured to adjust the detection update rate based on one or more rate adjustment parameters including the detected physiological state.

[0006] In Example 2, optionally, the subject matter of Example 1 can be configured to include an implantable medical device including a treatment output device and a treatment control circuit.

[0007] In Example 3, optionally, the subject matter of either or any combination of Examples 1 and 2 can be configured such that the treatment output device includes a stimulation output circuit configured to deliver nerve stimulation to the patient, and the treatment control circuit includes a stimulation control circuit configured to receive a detected treatment control signal and use the received detected treatment control signal to control the delivery of nerve stimulation.

[0008] In Example 4, optionally, the subject matter of any one or any combination of Examples 1 to 3 can be configured such that the update rate adjuster adjusts the detection update rate based on the detected physiological state and one or more parameters that quantitatively indicate at least one of the energy or computing resources available to the treatment control circuit.

[0009] In Example 5, optionally, the subject matter of Example 4 can be configured such that the treatment control circuit includes a main processor and a coprocessor. The main processor includes a treatment controller and a treatment parameter adjuster. The coprocessor includes a physiological state detector, a measurement system, and an update rate adjuster.

[0010] In Example 6, optionally, the subject matter of Example 5 can be further configured to include a power source, and the update rate adjuster is configured to adjust the detection update rate based on the detected physiological state and at least one of the battery state, the main processor state, or the coprocessor state. The battery state is a measure of the remaining energy of the power source. The main processor state is a measure of the level of computing activity in the main processor. The coprocessor state is a measure of the level of computing activity in the coprocessor.

[0011] In Example 7, optionally, the subject matter of any one or any combination of Examples 1 to 6 can be configured such that the treatment parameter adjuster determines the treatment parameters using one or more detected input parameters at the treatment update rate, and the update rate adjuster adjusts the detection update rate and the treatment update rate based on one or more rate adjustment parameters including the detected physiological state.

[0012] In Example 8, optionally, the subject matter of Example 7 can be configured such that the detection update rate and the treatment update rate include a common rate.

[0013] In Example 9, optionally, the subject matter of Example 7 can be configured such that the detection update rate is different from the treatment update rate.

[0014] In Example 10, optionally, the subject matter of any one or any combination of Examples 1 to 9 can be configured such that the physiological state detector includes an activity level detector configured to detect an activity level as a physiological state using one or more activity signals among the received detected treatment control signals, and the update rate adjuster is configured to adjust the detection update rate based on one or more rate adjustment parameters including the detected activity level. The activity level is a measure of the patient's physical activity level.

[0015] In Example 11, optionally, the subject matter of Example 10 can be further configured to include a sensor communicably coupled to a treatment control circuit, the sensor including one or more activity sensors configured to detect one or more activity signals.

[0016] In Example 12, optionally, the subject matter of Example 11 can be configured such that the activity level detector is configured to detect the activity level using a single activity signal among the received detected treatment control signals.

[0017] In Example 13, optionally, the subject matter of Example 11 can be configured such that the activity level detector is configured to detect the activity level using a plurality of activity signals among the received detected treatment control signals.

[0018] In Example 14, optionally, the subject matter of any one or any combination of Examples 1 to 13 can be configured such that the update rate adjuster is configured to adjust the detection update rate according to a relationship associating the detection update rate with one or more rate adjustment parameters.

[0019] In Example 15, the subject matter of Example 14 can optionally be configured such that the update rate adjuster is configured to adjust the detected update rate using a look-up table representing the above relationship.

[0020] Examples of methods of providing treatment to a patient (e.g., “Example 16”) are also provided. The method can include providing treatment to the patient from a treatment output device and controlling the provision of treatment using a treatment control circuit using treatment parameters. Controlling can include receiving a detected treatment control signal, measuring one or more of the detected treatment control signals at a detection update rate, generating one or more detected input parameters based on the measurement, detecting the physiological state of the patient using one or more physiological signals of the received detected treatment control signals, adjusting the detection update rate based on one or more rate adjustment parameters including the detected physiological state, and adjusting the treatment parameters using one or more detected input parameters.

[0021] In Example 17, the subject matter of providing treatment from the treatment output device found in Example 16 can optionally include delivering nerve stimulation from the stimulation output circuit of an implantable nerve stimulator, and the subject matter of controlling the provision of treatment using a treatment control circuit using the treatment parameters found in Example 16 can optionally include controlling the delivery of nerve stimulation using a stimulation control circuit of an implantable nerve stimulator using stimulation parameters.

[0022] In Example 18, the subject matter of adjusting the detection update rate found in either or any combination of Examples 16 and 17 can optionally include adjusting the detection update rate based on the detected physiological state and one or more parameters quantitatively indicating at least one of the energy or computing resources available in the implantable nerve stimulator.

[0023] In Example 19, the subject of adjusting the treatment parameters found in any one or any combination of Examples 16 to 18 can optionally include determining the treatment parameters using one or more detected input parameters at a treatment update rate, and the subject of any one or any combination of Examples 16 to 18 can further optionally include adjusting the detection update rate and the treatment update rate based on one or more rate adjustment parameters including the detected physiological state.

[0024] In Example 20, the subject of Example 19 can optionally include that the detection update rate and the treatment update rate include a common rate.

[0025] In Example 21, the subject of any one or any combination of Examples 19 and 20 can further optionally include adjusting the detection update rate and the treatment update rate according to a relationship associating each of the detection update rate and the treatment update rate with one or more rate adjustment parameters.

[0026] In Example 22, the subject of detecting the physiological state of the patient found in any one or any combination of Examples 16 to 21 can optionally include detecting the activity level as the physiological state using one or more activity signals among the received detected treatment control signals, and the subject of adjusting the detection update rate found in any one or any combination of Examples 16 to 21 can optionally include adjusting the detection update rate based on one or more rate adjustment parameters including the detected activity level. The activity level is a measure of the patient's physical activity level.

[0027] In Example 23, the subject of the viewing modes found in Example 22 can further optionally include detecting one or more activity signals using one or more accelerometers.

[0028] In Example 24, the subject of detecting the physiological state of a patient found in any one or any combination of Examples 16 to 23 can optionally include detecting one or more of the electrophysiological signals among the detected treatment control signals.

[0029] Also provided is an example of a non - transitory computer - readable storage medium (e.g., "Example 25") that includes instructions to cause a system to execute a method for providing treatment to a patient when executed by the system. The method can include providing treatment to the patient from a treatment output device and controlling the provision of treatment using a treatment control circuit with treatment parameters. Controlling includes receiving the detected treatment control signal, measuring one or more of the detected treatment control signals at a detection update rate, generating one or more detection input parameters based on the measurement, detecting the physiological state of the patient using one or more physiological signals among the received detected treatment control signals, adjusting the detection update rate based on one or more rate adjustment parameters including the detected physiological state, and adjusting the treatment parameters using one or more detection input parameters.

[0030] In Example 26, the subject matter of Example 25 is configured such that detecting the physiological state of the patient includes detecting an activity level as a physiological state using one or more activity signals among the received detected treatment control signals, where the activity level is a measure of the patient's physical activity level, and the subject matter of adjusting the detection update rate found in Example 25 can further optionally include adjusting the detection update rate based on one or more rate adjustment parameters including the detected activity level.

[0031] This summary is a partial summary of the teachings of this application and is not intended to treat the subject matter exclusively or comprehensively. Further details regarding the subject matter can be found in the detailed description and the appended claims. Other aspects of the disclosure will become apparent to those skilled in the art upon reading the following detailed description and the accompanying drawings, which should not be construed in a limiting sense. The scope of the disclosure is defined by the appended claims and their legal equivalents.

[0032] The drawings generally illustrate various embodiments described herein by way of example. The drawings are for illustrative purposes only and may not be to scale. **Brief Description of the Drawings**

[0033]

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DETAILED DESCRIPTION OF THE INVENTION

[0034] In the following detailed description, reference is made to the accompanying drawings, which form a part of this specification and show specific embodiments in which the invention can be practiced. These embodiments are described in sufficient detail so that those skilled in the art can practice the invention, but it is understood that combinations of these embodiments or the use of other embodiments can be made and structural, logical, and electrical changes can be made without departing from the spirit and scope of the invention. References to "an," "one," or "various" embodiments in this disclosure are not necessarily to the same embodiment, and such references are intended to cover a plurality of embodiments. The following detailed description is exemplary, and the scope of the invention is defined by the appended claims and their legal equivalents.

[0035] In this document, among other things, an implantable medical device is described that dynamically adjusts the update frequency in a closed-loop therapy control operation for efficient use of power and computing resources. For example, the implantable medical device can include a battery-powered implantable pulse generator (IPG) that performs closed-loop operations with on-board sensing and stimulation updates. The rate (i.e., frequency) at which sensing and stimulation updates are performed is an important factor in determining the operating cost of the closed-loop therapy control, including the cost of energy and the cost of computing resources. The IPG can be battery-powered so that it can be placed subcutaneously in a patient for chronic use. The battery desirably has a long life and / or charge interval, and thus battery power savings are a design goal for the benefit of the patient. In an IPG including an implantable nerve stimulator, it can be sensed by one or more sensors within the IPG to provide therapy control responsive to changes in the patient's needs and / or condition, can be implanted in the patient and communicatively coupled to the IPG, and / or can be carried externally by the patient or placed near the patient and communicatively coupled to the IPG. A closed-loop sensing and stimulation system is used. The operation of such a closed-loop system requires energy and places a burden on the computing resources available from the IPG. Such requirements increase with the rate at which sensing and stimulation updates are performed. A faster sensing and stimulation update rate allows for quicker adjustment of therapy in response to changes in the patient's needs and / or condition, but consumes more energy and (which also means more energy) more computing resources. Therefore, there is a need for a sensing and stimulation update rate that enables sufficient performance of the closed-loop therapy control while minimizing the energy consumption required for the operation of the closed-loop therapy control.

[0036] The present subject matter controls the rate at which detection and stimulation updates are performed in a closed-loop therapy control system based on a detected metric of how fast one or more input signals change. A system for controlling the detection and stimulation update rates can be implemented as firmware in a processor of an IPG, such as an implantable nerve stimulator. The therapy update rate can be adjusted based on one or more detection signals that can detect the metric. The metric can include a patient activity level detected from any one or more signals indicative of patient activity that can be detected using implantable sensors and / or external sensors. The therapy update rate can be increased when needed, as indicated by a high patient activity level, and decreased when the patient activity level is low. Other factors can also be used to adjust the therapy update rate. For example, when the battery level is low, the therapy update rate can be decreased to maintain the operation of the IPG in a power-saving mode.

[0037] In one example embodiment, a system for controlling the detection and stimulation therapy update rates is implemented as firmware in a processor of the IPG that controls the operation of the IPG at a high level, and a coprocessor of the IPG provides the detected metric of how fast one or more input signals to the closed-loop therapy control system have changed to the main processor. Accordingly, the main processor of the IPG controls the therapy update rate of the closed-loop therapy control system, and the coprocessor can detect the patient activity level using signals from one or more sensors. The main processor tracks the power (battery) resources and computational resources available in the IPG, receives data indicative of the patient activity level from the coprocessor, and can adjust the therapy update rate at regular intervals or the like based on the patient activity level.

[0038] Determining the update rate of sensing and stimulation therapy can be an optimization process that balances the risk of inappropriate (e.g., insufficient or excessive) stimulation with the power consumption and amount of computing resources associated with the therapy update rate (e.g., from the main processor and coprocessors). The execution frequency of the closed-loop therapy control algorithm, the measurement of one or more input signals, and the adjustment of the therapy (e.g., stimulation) can be changed for each measurement. In various embodiments, the update rate of sensing and stimulation therapy can be the rate (frequency) at which one or more input signals are measured, or a function of this rate.

[0039] As an example, an IPG for nerve stimulation will be described, but the present subject matter can be applied to any closed-loop therapy control system, for example, to reduce power consumption and / or computing resource requirements. In various embodiments, the present subject matter provides flexibility in therapy adjustment based on one or more metrics regarding the need for ongoing or anticipated regular adjustments, such as the patient's activity level and the battery state of the IPG. As a result, a significant amount of power and / or computing resources can be saved when compared to existing devices that use a fixed sensing and stimulation therapy update rate determined, for example, to correspond to the highest patient activity level.

[0040] As used herein, "patient" includes a person receiving therapy provided using a therapy system including an IPG, such as a nerve stimulation system including an implantable nerve stimulator according to the present subject matter, and "user" includes a physician or other caregiver who uses the therapy system to treat the patient.

[0041] FIG. 1 shows an embodiment of a nerve stimulation system 100. The system 100 includes an electrode 106, a stimulation device 104, and a programming device 102. The electrode 106 is configured to be disposed at or near one or more nerve targets within a patient's body. The stimulation device 104 is electrically connected to the electrode 106 and is configured to deliver nerve stimulation energy, such as electrical pulses, to one or more nerve targets through the electrode 106. Delivery of the nerve stimulation is controlled using a plurality of stimulation parameters, such as an electrical pulse pattern and selection of the electrodes to deliver each electrical pulse. In various embodiments, at least some of the plurality of stimulation parameters are programmable by a user, such as a physician or other caregiver treating the patient using the system 100. The programming device 102 facilitates user access to the user-programmable parameters. In various embodiments, the programming device 102 is configured to communicatively couple to the stimulation device via a wired or wireless link.

[0042] As used herein, "user" includes a physician or other clinician or caregiver who treats a patient using the system 100, and "patient" includes a person who receives or is intended to receive nerve stimulation delivered using the system 100. In some embodiments, the patient can adjust his or her treatment to some extent using the system 100, such as by adjusting certain treatment parameters and entering feedback and clinical effect information.

[0043] In various embodiments, the programming device 102 can include a user interface 110 that enables a user to control the operation of the system 100 and monitor the performance of the system 100 and the patient's condition, including the response to the delivery of the nerve stimulation. The user can control the operation of the system 100 by setting and / or adjusting the values of the user-programmable parameters.

[0044] In various embodiments, the user interface 110 can include a graphical user interface (GUI) that enables a user to set and / or adjust values of user-programmable parameters by creating and / or editing graphical representations of various waveforms. Such waveforms can include, for example, waveforms representing patterns of nerve stimulation pulses to be delivered to a patient, and individual waveforms used as building blocks of a pattern of nerve stimulation pulses, such as the waveform of each pulse of the pattern of nerve stimulation pulses. The GUI can enable the user to set and / or adjust a stimulation field defined by each electrode set that enables delivery of one or more nerve stimulation pulses represented by the waveform to a patient. Each stimulation field can be further defined by the current distribution of each nerve stimulation pulse within the waveform. In various embodiments, nerve stimulation pulses can be delivered to multiple stimulation fields over a stimulation period (such as during a treatment session).

[0045] In various embodiments, the system 100 can be configured for nerve stimulation applications. The user interface 110 can be configured to enable a user to control the nerve stimulation operation of the system 100. For example, the system 100 and the user interface 100 can be configured for DBS applications. Such DBS configurations can include various features, such as those described in this document, that can simplify the user's task when programming the stimulation device 104 to deliver DBS to a patient.

[0046] FIG. 2 shows an embodiment of a stimulation device 204 and a lead system 208 that can be implemented in a nerve stimulation system 100. The stimulation device 204 represents an example of the stimulation device 104 and includes a stimulation output circuit 212 and a stimulation control circuit 214. The stimulation output circuit 212 generates and delivers nerve stimulation pulses. The stimulation control circuit 214 controls the delivery of nerve stimulation pulses from the stimulation output circuit 212 using a plurality of stimulation parameters that specify a nerve stimulation pulse pattern. The lead system 208 includes one or more leads configured to be electrically connected to the stimulation device 204, respectively, and a plurality of electrodes 206 distributed on the one or more leads. The plurality of electrodes 206 includes electrodes 206-1, electrodes 206-2, ··· electrodes 206-N, each of which is a single conductive contact that provides an electrical interface between the stimulation output circuit 212 and the patient's tissue, where N≧2 in this case. The nerve stimulation pulses are delivered from the stimulation output circuit 212 through a selected series of electrodes from the electrodes 206. In various embodiments, the nerve stimulation pulses can include one or more individually defined pulses, and the user can individually define an electrode set for each of the individually defined pulses or for each of a group of pulses intended to be delivered using the same combination of electrodes. In various embodiments, one or more additional electrodes 207 (each of which can be referred to as a reference electrode), such as one or more electrodes that are each part of the housing of the stimulation device 204 or otherwise incorporated into the housing of the stimulation device 204, can be electrically connected to the stimulation device 204. Monopolar stimulation uses a monopolar electrode configuration that includes one or more electrodes selected from the electrodes 206 and at least one electrode from the (single or multiple) electrodes 207. Bipolar stimulation uses a bipolar electrode configuration that includes two electrodes selected from the electrodes 206 and does not include the (single or multiple) electrodes 207. Multipolar stimulation uses a multipolar electrode configuration that includes a plurality (two or more) of electrodes selected from the electrodes 206 and does not include the (single or multiple) electrodes 207.

[0047] In various embodiments, the number of leads and the number of electrodes on each lead depend, for example, on the distribution of (single or multiple) nerve stimulation targets and the need to control the distribution of the electric field at each target. In one embodiment, the lead system 208 includes two leads, each having eight electrodes.

[0048] FIG. 3 shows an embodiment of a programming device 302 that can be implemented in the nerve stimulation system 100. The programming device 302 represents an example of the programming device 102 and includes a storage device 318, a programming control circuit 316, and a user interface 310. The programming control circuit 316 generates a plurality of stimulation parameters that control the delivery of nerve stimulation pulses according to a specified nerve stimulation program that can define, for example, the stimulation waveform and the electrode configuration. The user interface 310 represents an example of the user interface 110 and includes a stimulation control circuit 320. The storage device 318 stores information used by the programming control circuit 316 and the stimulation control circuit 320, such as information regarding the stimulation device that associates nerve stimulation programs with a plurality of stimulation parameters. In various embodiments, the stimulation control circuit 320 can be configured to support one or more functions that enable programming of a stimulation device, such as the stimulation device 104, including various embodiments as described in this document according to one or more selected nerve stimulation programs as described in this document.

[0049] In various embodiments, the user interface 310 can enable the definition of the pattern of nerve stimulation pulses delivered during a nerve stimulation therapy session by creating and / or adjusting one or more stimulation waveforms using a graphical method. This definition can also include the definition of one or more stimulation fields, each related to one or more pulses of the pattern of nerve stimulation pulses. As used in this document, a "nerve stimulation program" can include a pattern of nerve stimulation pulses including one or more stimulation fields, or at least various aspects or parameters of a pattern of nerve stimulation pulses including one or more stimulation fields. In various embodiments, the user interface 310 includes a GUI that enables the user to define a pattern of nerve stimulation pulses using a graphical method and perform other functions. "Nerve stimulation programming" as used in this document can include the definition of one or more stimulation waveforms including the definition of one or more stimulation fields.

[0050] In various embodiments, the circuitry of the nerve stimulation 100, including the various embodiments described in this document, can be implemented using a combination of hardware and software. For example, the circuitry of the user interface 100, the stimulation control circuit 214, the programming control circuit 316, and the stimulation control circuit 320, including the various embodiments described in this document, can be implemented using application-specific circuitry configured to perform one or more specific functions, or a general-purpose circuit programmed to perform such (single or multiple) functions. Such general-purpose circuits include, but are not limited to, a microprocessor or a portion thereof, a microcontroller or a portion thereof, and a programmable logic circuit or a portion thereof.

[0051] Figure 4 shows an embodiment of an implantable pulse generator (IPG) 404 and an implantable lead system 408. The IPG 404 represents an implementation example of the stimulation device 204. The lead system 408 represents an implementation example of the lead system 208. As shown in Figure 4, the IPG 404 can be coupled to each lead at the proximal ends of the implantable leads 408A and 408B. The distal end of each lead includes an electrical contact or electrode 406 that contacts a tissue site that is the target of electrical nerve stimulation. As shown in Figure 1, leads 408A and 408B each include eight electrodes 406 at their distal ends. The number and arrangement of leads 408A and 408B and electrodes 406 as shown in Figure 1 are merely illustrative, and other numbers and arrangements are possible. In various embodiments, the electrodes are ring electrodes. The implantable leads and electrodes can be configured in a shape and size such that they provide electrical nerve stimulation energy to nerve cell targets contained in the subject's brain or provide electrical nerve stimulation energy to nerve cell targets contained in the subject's spinal cord.

[0052] Figure 5 shows an implantable nerve stimulation system 500 and a portion of an environment in which the system 500 can be used. The system 500 includes an implantable system 521, an external system 502, and a telemetry link 540 that provides wireless communication between the implantable system 521 and the external system 502. Figure 5 shows the implantable system 521 implanted within the patient's body 599.

[0053] The implantable system 521 includes an implantable stimulator 504 (also referred to as an implantable pulse generator or IPG), a lead system 508, and electrodes 506, which represent an example of a stimulation device 204, a lead system 208, and electrodes 206, respectively. The external system 502 represents an example of a programming device 302. In various embodiments, the external system 502 includes one or more external (non-implantable) devices that each enable communication between the user and / or patient and the implantable system 521. In some embodiments, the external 502 includes a programming device intended for the user to initialize and adjust the settings of the implantable stimulator 504 and a remote control device intended for use by the patient. For example, the remote control device can enable the patient to turn the implantable stimulator 504 on and off and / or adjust specific patient-programmable parameters among a plurality of stimulation parameters.

[0054] The size and shape of the elements of the implantable system 521 and their positions within the body 599 are shown by way of example and not limitation. The implantable system is described as a particular application of programming according to various embodiments of the present subject matter. In various embodiments, the present subject matter can be applied in programming any type of stimulation device that uses electrical pulses as stimulation, whether or not the stimulation target is within the patient's body and whether or not the stimulation device is implantable.

[0055] Referring again to FIG. 4, the IPG 404 can include a sealed IPG case 422 that houses the electronic circuitry of the IPG 404. The IPG 404 can include electrodes 426 formed on the IPG case 422. The IPG 404 can include an IPG header 424 that couples the proximal ends of leads 408A and 408B. The IPG header 424 can optionally also include electrodes 428. Electrodes 426 and / or 428 represent embodiments of electrode 207 and can each be referred to as a reference electrode. Neural stimulation energy can be delivered in a monopolar mode (also referred to as unipolar) using electrode 426 or electrode 428 and one or more electrodes selected from electrodes 406. Neural stimulation energy can also be delivered in a bipolar mode using a pair of electrodes of the same lead (lead 408A or lead 408B). Neural stimulation energy can also be delivered in an extended bipolar mode using one or more electrodes of one lead (e.g., one or more electrodes of lead 408A) and one or more electrodes of a different lead (e.g., one or more electrodes of lead 408B).

[0056] The electronic circuit of the IPG404 can include a control circuit that controls the delivery of nerve stimulation energy. The control circuit can include a microprocessor, a digital signal processor, an application specific integrated circuit (ASIC), or other types of processors that interpret or execute instructions included in software or firmware. The nerve stimulation energy can be delivered according to specified (e.g., programmed) modulation parameters. Examples of modulation parameter settings include, among others, the selection of the electrodes or combinations of electrodes used in the stimulation, the setting of one or more electrodes as the anode or cathode for stimulation, the specification of the rate of nerve stimulation provided by the electrodes or combinations of electrodes, and the specification of the stimulation pulse parameters. Examples of pulse parameters include, among others, the amplitude of the pulse (specified in current or voltage), the pulse duration (e.g., in microseconds), the pulse rate (e.g., in pulses / second), and parameters related to the pulse train or pattern such as the burst rate (e.g., the “off” modulation time after the “on” modulation time), the amplitude of the pulses within the pulse train, and the polarity of the pulses.

[0057] Figure 6 shows some embodiments of a nerve stimulation system 600. The system 600 includes an IPG604, implantable nerve stimulation leads 608A and / or 608B, an external remote control device (RC) 632, a clinician programmer (CP) 630, and an external test stimulator (ETS) 634 (also referred to as an external test modulator or ETM). The IPG404 can be electrically coupled to the leads 608A and 608B directly or through a percutaneous extension lead 636. The ETS634 can be electrically connectable to the leads 608A and 608B via one or both of the percutaneous extension lead 636 and / or an external cable 638. The system 600 represents an example of the system 100, the IPG604 represents an embodiment of the stimulation device 104, the electrodes 606 of the leads 608A and 608B represent the electrodes 106, and the CP630, RC632, and ETS634 collectively represent the programming device 102.

[0058] The ETS634 can be either a stand-alone type or incorporated into the CP630. The ETS634 can have a pulse generation circuit similar to the IPG604 that supplies nerve stimulation energy according to the specified modulation parameters as described above. The ETS634 is typically used as a preliminary stimulation device after the leads 408A and 408B are implanted and is an external device used prior to stimulation with the IPG604 to test the patient's responsiveness to the stimulation provided by the IPG604. Since the ETS634 is external, it can be configured more easily than the IPG604.

[0059] The CP630 can configure the nerve stimulation provided by the ETS634. If the ETS634 is not integrated into the CP630, the CP630 can communicate with the ETS634 using a wired connection (e.g., via a USB link) or by a wireless communication link 640 using wireless telemetry. The CP630 also communicates with the IPG604 using the wireless communication link 640.

[0060] Examples of wireless telemetry are based on inductive coupling using the mutual inductance between two closely placed coils. This type of telemetry is often referred to as inductive telemetry or near-field telemetry because the coils must be in close proximity to normally achieve inductively coupled communication. The IPG604 can include a first coil and a communication circuit. The CP630 can include a second coil in the form of a wand or the like that can be placed near the IPG604 or can be otherwise electrically connected to such a second coil. Another example of wireless telemetry includes a far-field telemetry link, also referred to as a radio frequency (RF) telemetry link. The far field, also called the Fraunhofer zone, means a zone where the components of the electromagnetic field generated by a transmitting electromagnetic radiation source decay substantially proportionally to 1 / r, where r is the distance between the observation point and the radiation source. Thus, the far field means the zone outside the boundary of r = λ / 2π (λ is the wavelength of the transmitted electromagnetic wave), where λ is the wavelength of the transmitted electromagnetic energy. In one example, the communication distance of the RF telemetry link is at least 6 feet, but can be made as long as possible depending on the particular communication technology. For example, an RF antenna can be included in the header of the IPG604 and / or the housing of the CP630 to eliminate the need for a wand or other inductive coupling means. An example of such an RF telemetry link is a Bluetooth® wireless link.

[0061] The CP630 can be used to set the modulation parameters of the nerve stimulation after the IPG604 has been implanted. This allows the nerve stimulation to be adjusted if the requirements for nerve stimulation change after implantation. The CP630 can also upload information from the IPG604.

[0062] The RC632 also communicates with the IPG604 using the wireless link 340. The RC632 can be a communication device used by a user or provided to a patient. The RC632 may have lower programming capabilities compared to the CP630. As a result, while a user or patient can change the nerve stimulation treatment, the patient cannot fully control the treatment. For example, the patient can increase the amplitude of the nerve stimulation pulses or change the application time of a pre-programmed train of stimulation pulses. The RC632 can be programmed by the CP630. The CP630 can communicate with the RC632 using a wired or wireless communication link. In some embodiments, the CP630 can program the RC632 when located remotely from the RC632.

[0063] FIG. 7 shows an embodiment of an implantable stimulator 704 and one or more leads 708 of an implantable nerve stimulation system, such as the implantable system 600. The implantable stimulator 704 represents an example of the stimulation device 104 or 204 and can be implemented, for example, as the IPG604. The lead(s) 708 represents an example of the lead system 208 and can be implemented, for example, as the implantable leads 608A and 608B. The electrodes 706 included in the lead(s) 708 represent an example of the electrodes 106 or 206 and can be implemented as the electrodes 606.

[0064] The implanted stimulator 704 can include any detection circuit 742 that is necessary only when the stimulator requires detection capabilities, a stimulation output circuit 212, a stimulation control circuit 714, an implant memory device 746, an implant telemetry circuit 744, a power source 748, and one or more electrodes 707. When the detection circuit 742 is included and required, the detection circuit 742 detects one or more physiological signals for the purpose of patient monitoring and / or feedback control of nerve stimulation. Examples of one or more physiological signals include nerve signals and other signals that each indicate the state of the patient being treated by nerve stimulation and / or the patient's response to the delivery of nerve stimulation. The stimulation output circuit 212 is electrically connected to the electrode 706 through one or more leads 708, similar to the electrode 707, and delivers each of the nerve stimulation pulses through a selected set of electrodes from the electrode 706 and the electrode(s) 707. The stimulation control circuit 714 represents an example of the stimulation control circuit 214 and controls the delivery of nerve stimulation pulses using a plurality of stimulation parameters that specify the pattern of the nerve stimulation pulses. In one embodiment, the stimulation control circuit 714 controls the delivery of nerve stimulation pulses using one or more detected physiological signals. The implant telemetry circuit 744 provides wireless communication with another device, including receiving values of a plurality of stimulation parameters from another device such as the CP630 and the RC632 to the implanted stimulator 704. The implant memory device 746 can store one or more nerve stimulation programs and values of a plurality of stimulation parameters for each of the one or more nerve stimulation programs. The power source 748 supplies energy for operation to the implanted stimulator 704. In one embodiment, the power source 748 includes a battery. In one embodiment, the power source 748 includes a rechargeable battery and a battery charging circuit for charging the rechargeable battery. The implant telemetry circuit 744 can also function as a power receiver that receives power transmitted from an external device through inductive coupling. The electrode(s) 707 enables the delivery of nerve stimulation pulses in monopolar mode. Examples of the electrode(s) 707 include the electrode 426 and the electrode 418 within the IPG404 as shown in FIG. 4.

[0065] In one embodiment, the implantable stimulator 704 is used as a master database. Thus, a patient with an implanted implantable stimulator 704 (such as can be implemented as IPG604) can retain such information when the patient information necessary for their medical care cannot be otherwise accessed. The implant memory device 746 is configured to store such patient information. For example, a patient may be given a new RC632 and / or move to a new clinic where they can communicate with the device implanted in them using a new CP630. The new RC632 and / or CP630 can communicate with the implantable stimulator 704 to retrieve the patient information stored in the implant memory device 746 through the implant telemetry circuit 744 and the wireless communication link 640, and enable any necessary adjustment of the operation of the implantable stimulator 704 based on the retrieved patient information. In various embodiments, the patient information stored in the implant memory device 746 can include, for example, the position of the lead(s) 708 and electrode(s) 706 with respect to the patient's anatomy (conversion of a postoperative lead placement computed tomography (CT) fused to a magnetic resonance image (MRI) of the brain), clinical effect map data, objective measurements using quantitative assessment of symptoms (e.g., using microelectrode recordings, accelerometers, and / or other sensors), and / or any other information considered important or useful for providing appropriate care to the patient. In various embodiments, the patient information stored in the implant memory device 746 can include data transmitted to the implantable stimulator 704 for storage as part of the patient information, and data obtained by the implantable stimulator 704 using the sensing circuit 742 and the like.

[0066] In various embodiments, the sensing circuit 742 (if included), the stimulation output circuit 212, the stimulation control circuit 714, the implant telemetry circuit 744, the implant memory device 746, and the power source 748 are enclosed within a sealed implant housing or case, on which (single or multiple) electrodes 707 are formed or otherwise incorporated. In various embodiments, while one or more electrodes 706 are positioned over and / or around one or more targets to which a nerve stimulation pulse is to be delivered, an implantable stimulator 704 is implanted subcutaneously such that (single or multiple) leads 708 are implanted to be connected to the (single or multiple) leads 708 upon implantation.

[0067] FIG. 8 shows an embodiment of an external programming device 802 of an implantable nerve stimulation system such as system 600. The external programming device 802 represents an example of the programming device 102 or 302 and can be implemented, for example, as CP630 and / or RC632. The external programming device 802 includes an external telemetry circuit 852, an external memory device 818, a programming control circuit 816, and a user interface 810.

[0068] The external telemetry circuit 852 provides wireless communication of the external programming device 802 with another device such as the implantable stimulator 704 via a wireless communication link 640, including transmitting a plurality of stimulation parameters to the implantable stimulator 704 and receiving information including patient data from the implantable stimulator 704. In one embodiment, the external telemetry circuit 852 also transmits power to the implantable stimulator 704 through inductive coupling.

[0069] In various embodiments, the wireless communication link 640 can include an inductive telemetry link (near-field telemetry link) and / or a far-field telemetry link (RF telemetry link). For example, DBS is often used for movement disorders that are evaluated through a patient's activity, walking, balance, etc., so it can be useful to enable patient mobility during programming and evaluation. Thus, when the system 600 is intended for applications that include DBS, the wireless communication link 640 includes at least a far-field telemetry link that enables communication between an external programming device 802 and an implantable stimulator 704 over a relatively long distance, such as up to about 20 meters. Each of the external telemetry circuit 852 and the implant telemetry circuit 744 includes an antenna and an RF circuit configured to support such wireless telemetry.

[0070] The external memory device 818 stores one or more stimulation waveforms delivered during a nerve stimulation treatment session such as a DBS treatment session, as well as various parameters and building units that define the one or more waveforms. Each of the one or more stimulation waveforms is associated with one or more stimulation fields and can represent the pattern of nerve stimulation pulses to be delivered to the one or more stimulation fields during a nerve stimulation treatment session. In various embodiments, each of the one or more stimulation waveforms can be selected such that it can be modified by the user and / or used when programming a stimulation device such as the implantable stimulator 704 to provide treatment. In various embodiments, each waveform of the one or more stimulation waveforms is definable on a per-pulse basis, and the external memory device 818 can include a pulse library that stores one or more individually definable pulse waveforms, each of which defines one or more pulse types. The external memory device 818 also stores one or more individually definable stimulation fields. Each waveform 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 an electrode set that delivers nerve stimulation pulses. In various embodiments, each of the one or more individually definable stimulation fields is defined by an electrode set that delivers nerve stimulation pulses and the current distribution of the nerve stimulation pulses on the electrode set. In one embodiment, the current distribution is defined by allocating a portion of the overall pulse amplitude to each electrode of the electrode set. In this document, such a definition of the current distribution can be referred to as "fractionalization". In another embodiment, the current distribution is defined by assigning an amplitude value to each electrode of the electrode set. For example, the electrode set can include two electrodes used as anodes and an electrode used as a cathode to supply a nerve stimulation pulse having a pulse amplitude of 4 mA. It is necessary to define the current distribution across the two electrodes used as anodes. For example, a percentage of the pulse amplitude is assigned to each of the two electrodes, such as 75% to electrode 1 and 25% to electrode 2. In another embodiment, an amplitude value is assigned to each of the two electrodes, such as 3 mA to electrode 1 and 1 mA to electrode 2.By controlling the current in percentage units, the current between the electrodes can be accurately and consistently distributed even when the pulse amplitude is adjusted. This is suitable for considering the problem as the manipulation of the stimulation locus and changing the stimulation simultaneously on multiple contacts so as to move this locus while keeping the stimulation amount constant. By controlling and displaying the total current through each electrode in units of absolute value (e.g., mA), the current can be accurately administered through each specific electrode. This is suitable for (enabling the user to) changing the current on one contact simultaneously to shape the stimulation like a clay piece (pushing / pulling one part simultaneously).

[0071] The programming control circuit 816 represents an example of the programming control circuit 316 and generates a plurality of stimulation parameters to be transmitted to the implantable stimulator 704 based on a specified nerve stimulation program (e.g., a pattern of nerve stimulation pulses represented by one or more stimulation waveforms and one or more stimulation fields, or at least some aspects of the pattern). The nerve stimulation program can be created and / or adjusted by the user using the user interface 810 and stored in the external storage device 818. In various embodiments, the programming control circuit 816 can check the values of the plurality of stimulation parameters against safety rules and limit these values within the restricted range of the safety rules. In one embodiment, the safety rules are heuristic rules.

[0072] The user interface 810 represents an example of the user interface 310 and enables the user to define the pattern of nerve stimulation pulses and perform various other monitoring and programming tasks. The user interface 810 includes a display screen 856, a user input device 858, and an interface control circuit 854. The display screen 856 can include any type of interactive or non-interactive screen, and the user input device 858 can include any type of user input device that supports the various functions described in this document, such as a touch screen, keyboard, keypad, touch pad, trackball, joystick, mouse, etc. In one embodiment, the user interface 810 includes a GUI. The GUI can also enable the user to perform any function suitable for graphical presentation and / or editing as described in this document, as would be understood by those skilled in the art.

[0073] The interface control circuit 854 controls the operation of the user interface 810, including determining one or more stimulation waveforms in response to various inputs received by the user input device 858. The interface control circuit 854 includes a stimulation control circuit 320.

[0074] In various embodiments, the external programming device 802 can have operating modes including a configuration mode and a real-time programming mode. In the configuration mode (also called the pulse pattern configuration mode), the user interface 810 operates and the programming control circuit 816 does not operate. The programming control circuit 816 does not dynamically update the values of the plurality of stimulation parameters in response to any change in one or more stimulation waveforms. In the real-time programming mode, both the user interface 810 and the programming control circuit 816 operate. The programming control circuit 816 dynamically updates the values of the plurality of stimulation parameters in response to a change in one or more sets of stimulation waveforms and transmits the plurality of stimulation parameters with the updated values to the implantable stimulator 704.

[0075] Figure 9 shows an embodiment of a sensor 960 and a treatment device 904 that provide treatment to a patient and control the provision of treatment using the detected treatment control signal. The treatment device 904 can be implemented as a stimulation device 104 that delivers nerve stimulation energy and controls the delivery of nerve stimulation energy using the treatment control signal detected using the sensor 960, including but not limited to various embodiments of the stimulation device 104 described in this document. The treatment control signal can include an input signal of a closed-loop system that adjusts the provision of treatment based on the patient's condition and / or response to the treatment. The sensor 960 can include one or more implantable sensors 962 configured to be implanted in the patient, one or more external sensors 964 configured to be externally attached to or otherwise worn by the patient, and / or one or more remote sensors 966 configured to be disposed remotely from the patient. When the treatment device 904 is configured to be an implantable treatment device such as an implantable stimulator 704, the (single or plural) implantable sensors 962 can be included in the implantable treatment device respectively, and / or can be configured to be another implantable device communicably coupled to the implantable treatment device via a wired or wireless connection. The (single or plural) external sensors 964 and the (single or plural) remote sensors 966 can be configured to be communicably coupled to the implantable treatment device via a wireless connection respectively. In one embodiment, the sensor 960 includes only the implantable sensors 962. In other embodiments, the sensor 960 can include any combination of the (single or plural) implantable sensors 962, the (single or plural) external sensors 964, and the remote sensors 966.

[0076] Sensor 960 can include one or more physiological sensors that detect one or more physiological signals from a patient. The one or more physiological signals can include one or more electrophysiological signals such as one or more nerve signals. Examples of such one or more nerve signals can include signals indicative of local field potential (LFP, oscillatory signals from the brain) and / or evoked compound action potential (ECAP). Sensors that detect such nerve signals can include electrodes such as one or more implanted leads (e.g., electrodes 406 on leads 408A and 408B) and / or electrodes incorporated on an implanted medical device (e.g., IPG 404 including electrodes 426 on the IPG case 422 and / or electrodes 428 within the IPG header 424).

[0077] Sensor 960 can include one or more sensors that detect a physiological state of a patient. In various embodiments, the physiological state can be used as an indicator for how often these physiological signals should be measured in order to timely adjust the delivery of treatment based on how fast one or more detected physiological signals are changing and thus the change in the patient's needs indicated by the one or more detected physiological signals. In various embodiments, the physiological state includes an activity level, and sensor 960 includes one or more activity sensors that detect one or more activity signals indicative of the patient's activity level. The one or more activity sensors can include one or more accelerometers. When the treatment device 904 is configured to be an implanted treatment device such as IPG 404, each of the one or more accelerometers can be included in the IPG 404 or incorporated on the implanted lead 408A or 408B.

[0078] Sensor 960 can include one or more sensors that detect one or more environmental signals indicative of a patient's environment. Examples of the one or more environmental signals can include temperature, pressure, humidity, altitude, and other signals that can affect certain physiological functions such as the patient's nerve activity.

[0079] The treatment device 904 can include a treatment output device 912 and a treatment control circuit 914. The treatment output device 912 can provide treatment to a patient. The treatment control circuit 914 can control the provision of treatment using a treatment control signal detected using the sensor 960. In various embodiments, the treatment control circuit 914 controls the provision of treatment by executing a closed-loop control algorithm using one or more detected input parameters derived from the detected treatment control signal. The sensor 906 includes sensors that detect signals used to derive one or more detected input parameters.

[0080] The treatment device 904 can be configured to be an implantable medical device such as an IPG that provides treatment to a patient in the form of electrical stimulation pulses. In one embodiment, the treatment device 904 is implemented as an implantable stimulator such as the implantable stimulator 704 that delivers nerve stimulation to a patient. The nerve stimulation can be delivered, for example, as nerve stimulation pulses. The treatment device 912 can be implemented as 212, and the treatment control circuit 914 can be implemented as a stimulation control circuit 714. The treatment device 912 uses the detected treatment control signal to provide closed-loop control of the delivery of nerve stimulation from the stimulation output circuit to the stimulation control circuit 714.

[0081] FIG. 10 shows an embodiment of a system 1070 that includes a treatment output device 912 and a treatment control circuit 1014. The treatment control circuit 1014 can represent an example of the treatment device 914, receive the detected treatment control signal, and control the provision of treatment using the detected treatment control signal. In the illustrated embodiment, the treatment control circuit 1014 includes a treatment controller 1072, a treatment parameter adjuster 1074, a physiological state detector 1076, a measurement system 1078, and an update rate adjuster 1080.

[0082] The treatment controller 1072 can control the provision of treatment using treatment parameters. The provision of treatment can be controlled by executing a closed-loop control algorithm that uses treatment parameters. The treatment parameter adjuster 1074 can adjust the treatment parameters using one or more detected input parameters derived from the detected treatment control signal. In various embodiments, the treatment parameter adjuster 1074 adjusts the treatment parameters using one or more detected input parameters at a treatment update rate. The treatment update rate is the frequency at which the treatment parameters should be adjusted in response to changes in one or more detected input parameters. In other words, the treatment update rate is the frequency at which measurements of one or more detected input parameters can be used to adjust the stimulation parameters.

[0083] The physiological state detector 1076 can detect a patient's physiological state using one or more of the detected treatment control signals that are physiological signals. Examples of physiological states include during sleep, eating, sitting, exercising, showering, and walking. The physiological state of the patient to be detected can be determined by the need for treatment control and the design considerations regarding the detection and processing of the detected signals. In various embodiments, the physiological state detector 1076 can detect an activity level using one or more of the detected activity signals. The activity level is a measure of the patient's physical activity level. In one embodiment, the patient's physiological state is represented by the activity level only. In some other embodiments, the patient's physiological state can be determined by the activity level and one or more sensor signals. The measurement system 1078 can measure one or more of the detected treatment control signals at a sensing update rate and generate one or more detected input parameters based on this measurement. In various embodiments, the measurement system 1078 can be configured to perform various functions necessary to generate one or more detected input parameters by measuring one or more of the detected treatment control signals. The sensing update rate is the frequency at which one or more of the detected signals are measured to generate one or more detected input parameters. In various embodiments, the sensing update rate determines when the next measurement should be made, and the treatment update rate determines when the next adjustment of the stimulation parameters should be made. The update rate adjuster 1080 can adjust the sensing update rate based on one or more rate adjustment parameters including the detected physiological state of the patient. In various embodiments, the update rate adjuster 1080 can adjust the sensing update rate and the treatment update rate based on one or more rate adjustment parameters including the detected physiological state. The one or more other rate adjustment parameters can include one or more parameters that quantitatively indicate the energy and / or computational resources available for use by the system 1070.

[0084] System 1070 can be implemented in a treatment device (e.g., stimulation device 104, stimulation device 204, IPG 404, IPG 504, IPG 604, implantable stimulator 704, treatment device 904, and implantable medical device 1104) that includes the stimulation device described in this document. When closed-loop control is used in such a treatment device, the present subject matter prevents the treatment control circuit from always using the detection update rate and treatment update rate established based on the worst-case scenario that requires frequent updates, thereby extending battery life and / or charge cycles, freeing up computational resources that can be used to improve other functions of the implantable medical device, and / or saving energy used in calculations.

[0085] FIG. 11 shows an embodiment of an implantable medical device 1104. The implantable medical device 1104 can represent an example of a treatment device 904 and can be configured to be an implantable stimulator such as implantable stimulator 704. In the illustrated embodiment, the implantable medical device 1104 includes a treatment output device 912, a detection circuit 1142, an implant telemetry circuit 1144, an implant storage device 1146, a power supply 1148, and a treatment control circuit 1114. The implantable medical device 1104 can be configured to be an implantable stimulator 704 having a treatment output device 912 implemented in a stimulation output circuit 212, a detection circuit 1142 implemented in a detection circuit 742, an implant telemetry circuit 1144 implemented in an implant telemetry circuit 744, an implant storage device 1146 implemented in an implant storage device 746, a power supply 1148 implemented in a power supply 748, and a treatment control circuit 1114 implemented in a stimulation control circuit 714.

[0086] The detection circuit 1142 can receive a detection treatment control signal from a sensor such as sensor 960. In various embodiments, the detection circuit 1142 can condition one or more of the treatment control signals for measurement, such as by amplification and filtering.

[0087] The implant telemetry circuit 1144 can provide wireless bidirectional communication to the implantable medical device 1104. In various embodiments, wireless bidirectional communication can be performed using near-field magnetic telemetry and / or far-field electromagnetic telemetry. In one embodiment, the Bluetooth or Bluetooth Low Energy (BLE) protocol is used for wireless bidirectional communication.

[0088] The implant memory device 1146 can store information necessary for the operation of the implantable medical device 1104 and information acquired by the implantable medical device 1104. The information necessary for the operation of the implantable medical device 1104 includes one or more treatment programs, such as one or more nerve stimulation programs, and treatment parameters for each of the one or more treatment programs.

[0089] The power source 1148 can include one or more batteries. The amount of energy remaining in the one or more batteries can be indicated by the battery level. The battery level can be measured as a percentage of the energy capacity of the one or more batteries. In various embodiments, the one or more batteries can include rechargeable batteries.

[0090] The treatment control circuit 1114 can represent an example of the treatment control circuit 1014 implemented in an implantable medical device. In the illustrated embodiment, the treatment control circuit 1114 is implemented in the main processor 1182 and the coprocessor 1184. The main processor 1182 includes a treatment controller 1072 and a treatment parameter adjuster 1074. The coprocessor 1184 includes a physiological state detector 1076, a measurement system 1078, and an update rate adjuster 1080. In various embodiments, in addition to executing the closed-loop control algorithm as described above, the main processor 1182 can use one or more detected input parameters to execute one or more further detection-based algorithms (e.g., diagnostic algorithms and / or control algorithms for one or more further treatments). The main processor 1182 can also control wireless communication with the implantable medical device 1104 using the implant telemetry circuit 1144. The main processor 1182 and the coprocessor 1184 can include circuits implemented in a single processor or multiple processors. In one embodiment, a microcontroller is configured to be the main processor 1182 and another microcontroller is configured to be the coprocessor 1184. In some embodiments, a microcontroller is configured to be the main processor 1182 and additional microcontrollers are configured to be coprocessors each executing the functions of the treatment control circuit 1114.

[0091] The update rate adjuster 1080 can adjust at least the detection update rate based on one or more rate adjustment parameters according to a relationship associating the detection update rate with the one or more rate adjustment parameters. In various embodiments, the update rate adjuster 1080 can adjust the detection update rate and the treatment update rate according to a relationship associating each of the detection update rate and the treatment update rate with one or more rate adjustment parameters. The one or more rate adjustment parameters can include a detected physiological state of the patient (e.g., activity level), a battery state that is a measure of the remaining energy of the power supply 1148, a main processor state that is a measure of the computational activity level of the main processor 1182, a coprocessor state that is a measure of the computational activity level of the coprocessor 1184, and / or one or more other parameters indicating the computational resources and / or energy needs of the implantable medical device 1104. In one embodiment, the detection update rate is equal to the treatment update rate. In another embodiment, the detection update rate is higher than the treatment update rate (e.g., to enable multiple measurements of one or more detection signals to generate, by averaging, one or more detected input parameters). In another embodiment, the detection update rate is lower than the treatment update rate (e.g., to enable immediate treatment changes prior to the next detection update and scheduled treatment changes at a later time).

[0092] FIG. 12 shows an embodiment of one or more physiological state sensors 1286 and a physiological state detector 1276 that detect a physiological state of a patient. The physiological state detector 1276 can represent an example of the physiological state detector 1076 and can detect the physiological state of the patient using one or more physiological signals detected using the physiological state sensor(s) 1286. The physiological state sensor(s) 1286 can be one or more of the sensors 960. Examples of physiological states to be detected by the physiological state detector 1276 include during sleep, during grooming, while seated, during exercise, during a shower, and while walking.

[0093] In the illustrated embodiment, the (single or plural) physiological state sensor includes one or more activity sensors 1288 that can detect one or more activity signals. The (single or plural) activity sensors 1288 can include one or more accelerometers 1290 that each generate an accelerometer signal that is an activity signal. The physiological state detector 1276 includes an activity level detector 1292 that detects an activity level using one or more detected activity signals. The activity level is a measure of the patient's physical activity level. In various embodiments, the activity level can represent the patient's overall physical activity level and can be determined using a single activity signal or a combination of activity signals. In various embodiments, the activity level detector 1292 can generate discrete values of the activity level that each correspond to a range of the patient's physical activity level. Each discrete value can correspond to the patient's physiological state (e.g., during sleep, eating, sitting, exercising, showering, or walking), but additional information may be needed to verify whether the patient is actually in that physiological state. In various embodiments, only the activity level (e.g., representing the patient's overall physical activity level) is sufficient to be used as a rate adjustment parameter. The use of additional activity signals requires additional (single or plural) sensors and / or increases the computational activity, and thus the power consumption, of the implantable medical device 1104.

[0094] FIG. 13 shows an embodiment of an update rate adjuster 1380 that can represent an example of the update rate adjuster 1080. In the illustrated embodiment, the update rate adjuster 1080 includes a look-up table 1394 that represents a relationship associating a sensed update rate with one or more rate adjustment parameters, or a relationship associating each of the sensed update rate and the treatment update rate with one or more rate adjustment parameters. The update rate adjuster 1380 can use the look-up table 1394 to adjust at least the sensed update rate based on one or more rate adjustment parameters. In various embodiments, the update rate adjuster 1080 can use the look-up table 1394 to adjust the sensed update rate and the treatment update rate.

[0095] The relationship represented by the look-up table 1394 can be established using results from investigations and experiments. In various embodiments, this relationship can be established by balancing treatment and design considerations such as the risk of inappropriate treatment (e.g., excessive or insufficient nerve stimulation), battery management considerations regarding the detection update rate and / or treatment update rate, and the available computational resources of the implantable medical device 1104. In various embodiments, this relationship can be experimentally adjusted by updating the patient's look-up table 1394 based on aspects related to the performance of the implantable medical device 1104 after being implanted in the patient. In various embodiments, this relationship reflects the sensitivity of the detection update rate and treatment update rate to changes in the detected activity level (e.g., the number of discrete values). In various embodiments where the treatment involves delivery of nerve stimulation pulses, the detection update rate and treatment update rate can be determined based on the pulse frequency (e.g., to enable adjustment of the stimulation parameters on a per-pulse basis for the nerve stimulation pulses).

[0096] FIG. 14 shows an embodiment of a method 1400 for providing treatment to a patient. The method 1400 can be performed by any treatment device in which the system 1070 is implemented, including the system 1070 and treatment devices described in this document by way of non-limiting example (e.g., stimulation device 104, stimulation device 204, IPG 404, IPG 504, IPG 604, implantable stimulator 704, treatment device 904, and implantable medical device 1104).

[0097] At 1410, treatment is provided to the patient. In various embodiments, the treatment is provided from a treatment output device such as a stimulation output circuit capable of delivering nerve stimulation.

[0098] At 1420, the provision of treatment is controlled using treatment parameters. In various embodiments, the provision of treatment is controlled using a treatment control circuit, such as a stimulation control circuit that uses stimulation parameters to control the delivery of nerve stimulation. The stimulation output circuit and the stimulation control circuit can be part of an implantable nerve stimulator. The control of the provision of treatment at 1420 can include steps 1421-1426 as shown in FIG. 14.

[0099] At 1421, receive a treatment control signal detected from one or more sensors. The treatment control signal includes all detected signals used to control the provision of treatment, including an input signal to a closed-loop control algorithm. In various embodiments, the detected treatment control signal includes one or more electrophysiological signals detected from the patient. If the treatment includes nerve stimulation, the one or more electrophysiological signals can include one or more nerve signals indicative of the patient's nerve activity used to determine and adjust the stimulation parameters. At 1422, measure one or more of the received detected treatment control signals at a detection update rate. At 1423, generate one or more detected input parameters based on the measurement.

[0100] At 1424, detect the patient's physiological state using one or more of the received detected treatment control signals that are physiological signals. For example, using one or more activity signals that can be detected using one or more accelerometers, the activity level of the patient can be detected as a physiological state. The activity level is a measure of the patient's physical activity level. In various embodiments, the physiological state is represented by the detected activity level only. In various other embodiments, one or more additional rate adjustment parameters are used to determine the patient's physiological state such as during sleep, eating, sitting, exercising, showering, and walking. At 1425, adjust the detection update rate based on one or more rate adjustment parameters including the detected physiological state. In various embodiments, the detection update rate is adjusted using only the detected physiological state. In various other embodiments, the detection update rate is adjusted using the detected physiological state and one or more parameters that quantitatively indicate the energy and / or computing resources available in the treatment device. At 1426, adjust the treatment parameters using one or more of the detected input parameters. In various embodiments, the treatment parameters are adjusted at a treatment update rate that is also adjusted based on one or more rate adjustment parameters including the detected physiological state. In one embodiment, the detection update rate and the treatment update rate are a common rate. In another embodiment, the detection update rate is different from the treatment update rate. In various embodiments, each of the detection update rate and the treatment update rate is adjusted according to a relationship that associates each of the detection update rate and the treatment update rate with one or more rate adjustment parameters. This relationship is determined based on research and experimentation and can be stored so as to be used as a look-up table. This relationship (e.g., look-up table) can be adjusted experimentally for the patient as part of treatment adjustments that are performed periodically and / or in response to the patient's needs.

[0101] FIG. 15 shows an example of a parameter update rate as a function of rate adjustment parameters in an implantable treatment device 1104 configured as an implantable nerve stimulator. In this example, a plurality of rate adjustment parameters are used to adjust the parameter update rate according to the relationship between each parameter update rate and the rate adjustment parameters. The parameter update rate includes a detection update rate and a treatment update rate. The rate adjustment parameters include the patient's physiological state, the coprocessor state, the battery state, and the main processor state (as described above with respect to the implantable treatment device 1104). The illustrated example shows that the detection update rate and the treatment update rate increase when the physiological state corresponds to a high activity level and decrease when the physiological state corresponds to a low activity level. The treatment parameters are adjusted in response to changes in the patient's needs and / or state, and such changes occur at a rate corresponding to the patient's physiological state. Therefore, by using the physiological state to determine the parameter update rate, the use of energy and computing resources is reduced by reducing unnecessary parameter updates (which include little or no change in parameter values). The coprocessor state, the battery state, and the main processor state are also used to achieve a performance balance in controlling the provision of treatment between the available energy and computing resources and the rate of adjustment of treatment in response to changes in the patient's needs and / or state.

[0102] It should be understood that the above detailed description is intended to be illustrative rather than limiting. Other embodiments will be apparent to those skilled in the art upon reading and understanding the above description. Therefore, the scope of the present invention should be determined with reference to the appended claims and the full scope of equivalents to which such claims are entitled.

Description of Reference Numerals

[0103] 912 Treatment output device 1014 Treatment control circuit 1070 System 1072 Treatment controller 1074 Treatment parameter adjuster 1076 Physiological state detector 1078 Measurement system 1080 Update rate adjuster

Claims

1. A system including a plurality of sensors for providing treatment to a patient, a treatment output device configured to provide the treatment to the patient, a treatment control circuit configured to receive a treatment control signal and use the received treatment control signal to control the provision of the treatment, wherein the treatment control signal is detected using one or more physiological signals from the patient, the physiological state of the patient, and / or the plurality of sensors for detecting the environment of the patient, a treatment control circuit; comprising, wherein the treatment control circuit a physiological state detector configured to detect the physiological state of the patient using one or more physiological signals among the received treatment control signals; an update rate adjuster configured to adjust a detection update rate based on the detected physiological state and one or more parameters quantitatively indicating at least one of the energy or computing resources available to the treatment control circuit; a measurement system configured to generate one or more input parameters by measuring one or more signals selected from the received treatment control signals at the detection update rate; a treatment parameter adjuster configured to adjust treatment parameters using the one or more input parameters; a treatment controller configured to control the provision of the treatment using the treatment parameters; A system characterized by including.

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

3. The treatment output device includes a stimulation output circuit configured to deliver nerve stimulation to the patient, and the treatment control circuit includes a stimulation control circuit configured to receive the treatment control signal and use the received treatment control signal to control the delivery of the nerve stimulation. The system according to claim 1 or 2.

4. The treatment control circuit a main processor including the treatment controller and the treatment parameter adjuster; a coprocessor including the physiological state detector, the measurement system, and the update rate adjuster; The system according to any one of claims 1 to 3, including.

5. Further comprising a power supply, wherein the update rate adjuster the detected physiological state and, At least one of the battery state, which is a measure of the residual energy in the power supply, the main processor state, which is a measure of the level of computational activity in the main processor, or the coprocessor state, which is a measure of the level of computational activity in the coprocessor, and The system according to claim 4, configured to adjust the detection update rate based on

6. The treatment parameter adjuster is configured to determine the treatment parameters using the one or more input parameters at a treatment update rate, and the update rate adjuster is configured to adjust the detection update rate and the treatment update rate based at least on the detected physiological state. The system according to any one of claims 1 to 5.

7. The system according to claim 6, wherein the detection update rate and the treatment update rate comprise a common rate.

8. The system according to claim 6, wherein the detection update rate is different from the treatment update rate.

9. The physiological state detector includes an activity level detector configured to detect an activity level as the physiological state using one or more activity signals among the received treatment control signals, the activity level being the physical activity level of the patient, and the update rate adjuster is configured to adjust the detection update rate based at least on the detected activity level. The system according to any one of claims 1 to 8.

10. The system according to claim 9, further comprising a sensor configured to be communicably coupled to the treatment control circuit, the sensor including one or more activity sensors configured to detect one or more activity signals.

11. The system according to claim 10, wherein the activity level detector is configured to detect the activity level using a single activity signal among the received treatment control signals.

12. The system according to claim 10, wherein the activity level detector is configured to detect the activity level using a plurality of activity signals among the received treatment control signals.

13. The system according to any one of claims 1 to 12, wherein the update rate adjuster is configured to adjust the detection update rate according to a relationship that associates the detection update rate with at least the detected physiological state.

14. The system according to claim 13, wherein the update rate adjuster is configured to adjust the detected update rate using a look-up table representing the relationship.

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