Independent control of electrical stimulation amplitude for electrodes used to deliver electrical stimulation therapy

Abstract

This invention describes techniques for a medical device that delivers electrical stimulation using a current or voltage regulator with an adjustable principal amplitude. An exemplary method includes: receiving user input indicating a desired current amplitude via a programmer for an electrical stimulator; and selecting a first fractional adjustment or a second fractional adjustment as a target adjustment for achieving the desired current amplitude. A neural modulation system includes: a first electrode; a second electrode; a stimulation generator configured to deliver a first stimulation pulse to the first electrode and a second stimulation pulse to the second electrode, wherein a first current amplitude of the first stimulation pulse is a first fraction of the principal amplitude and a second current amplitude of the second stimulation pulse is a second fraction of the principal amplitude; and a processor configured to: generate initial instructions for the stimulation generator to perform: (i) deliver the first analog pulse based on the first fraction of the principal amplitude, and (ii) deliver the second stimulation pulse based on the second fraction of the principal amplitude, receiving user input including the desired current amplitude. The processor determines, based on the desired current amplitude, the adjustment of the first current amplitude of the first stimulation pulse to be required, and determines a target adjustment based at least in part on a comparison of the desired current amplitude with the main amplitude, wherein the processor is further configured to: (A) determine an adjustment to at least the first fraction as the target adjustment, or (B) determine the following as the target adjustment: (i) an adjustment to the main amplitude, and (ii) an adjustment to at least the second fraction relative to the main amplitude adjustment, and, based at least in part on the target adjustment, generate adjustment instructions for the stimulation generator to deliver the first stimulation pulse with the desired current amplitude and the second stimulation pulse with approximately the same second current amplitude.

Description

[0001] This application claims the benefit of U.S. Patent Application No. 16 / 694,549, filed November 25, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates to medical devices, and more specifically to medical devices for delivering electrical stimulation therapy. Background Technology

[0003] Medical devices can be used to treat a variety of medical conditions. For example, a medical electrical stimulation device can deliver electrical stimulation therapy to a patient via electrodes. Electrical stimulation therapy may include stimulating nerves, muscles, brain tissue, or other tissues within the patient's body. Electrical stimulation devices can be implanted entirely within the patient's body. For example, an electrical stimulation device may include an implantable electrical stimulation generator and one or more implantable leads with electrodes. Electrical stimulation devices may include leadless stimulators. In some cases, implantable electrodes may be coupled to an external electrical stimulation generator via one or more percutaneous leads or fully implantable leads.

[0004] Medical electrical stimulators can be used to deliver electrical stimulation to patients to relieve a variety of symptoms or conditions, such as chronic pain, tremor, Parkinson's disease, depression, epilepsy, urinary or fecal incontinence, pelvic pain, sexual dysfunction, obesity, or gastroparesis. The stimulator can be configured to deliver electrical stimulation via leads containing electrodes located near the patient's spinal cord, pelvic nerves, gastrointestinal organs, peripheral nerves, or within the patient's brain. Stimulation near the spinal cord and within the brain is commonly referred to as spinal cord stimulation (SCS) and deep brain stimulation (DBS), respectively. Summary of the Invention

[0005] Generally, this disclosure describes programming techniques for medical devices used to deliver electrical stimulation. Specifically, this disclosure describes a user interface capable of receiving, as user input, the desired amplitude of individual stimulation pulses to be delivered to specific electrodes in an electrical stimulation system. Additionally, this disclosure describes programming techniques for determining parameters of an electrical stimulator that achieve the desired amplitude using such user input defining the desired amplitude. According to various techniques of this disclosure, the electrical stimulator achieves the desired amplitude while maintaining the amplitude of other stimulation pulses delivered to one or more other electrodes.

[0006] For illustration, an exemplary electrical stimulator includes a main power supply with an adjustable master amplitude and a stimulation generator coupled to multiple electrodes. The stimulation generator delivers electrical stimulation pulses to the electrodes at various amplitudes specified by the user. In some examples, the main power supply may include a master voltage amplitude and / or master current amplitude for achieving individual amplitudes for each electrode. In examples involving master current amplitude, for each electrode, the stimulation generator includes a finite number of individually controllable current regulator branches. In this way, by selectively activating some or all of the current regulator branches, the stimulation generator can deliver electrical stimulation pulses with a current amplitude that is a fraction of the master current amplitude. In such examples, the fraction is defined as the specific number of regulator branches activated at a particular electrode at that time, compared to the total number of available regulator branches.

[0007] In an exemplary example, the stimulator may deliver a stimulation pulse with a first current amplitude to a first electrode, the first current amplitude being a first fraction of the main amplitude. Similarly, the stimulator may deliver a stimulation pulse with a second current amplitude to a second electrode, the second current amplitude being a second fraction of the main amplitude, which in some cases may be equal to the first fraction. In this example, the stimulator may increase or decrease the current amplitude delivered to the electrode being adjusted by activating a current regulator branch that more or less corresponds to the electrode being adjusted, by increasing the main amplitude, or some combination of both.

[0008] In some cases, where the desired current amplitude at a particular electrode exceeds the main current amplitude, the stimulator can adjust the main current amplitude up to the maximum current amplitude available from the main current source. However, in some examples, the user may only wish to affect the current amplitude of one electrode without affecting the current amplitudes of the others, which may occur by increasing the main current amplitude without changing the electrode fraction. Therefore, to maintain stimulation pulses delivered to the other electrodes with previously defined current amplitudes, the stimulator can adjust the fraction of electrodes not being targeted for adjustment. Additionally, the stimulator can adjust the main amplitude to the maximum amplitude available from a specific power source to provide sufficient main amplitude to support the desired current amplitude for each stimulation pulse. In any case, the user can request adjustments or initial settings from the electrical stimulation system to obtain a current amplitude controllable from the user interface. Therefore, the user interface receives the desired current amplitude of the electrode being targeted for adjustment as user input.

[0009] In this way, the processing circuitry of the electrical stimulator can cause an adjustment to the initial current amplitude while keeping the current amplitudes of the other electrodes close to the original current amplitude. That is, for a single user input of a desired current amplitude for a specific electrode targeted for adjustment, whether the amplitude is reset or adjusted from a previously set value, the desired current amplitude can be achieved. The desired current amplitude can be achieved regardless of whether it is greater than, less than, or equal to the main current amplitude, while simultaneously maintaining the current amplitude delivered to other electrodes not targeted for adjustment by adjusting the number of current regulator branches corresponding to electrodes not targeted for adjustment.

[0010] In one example, this disclosure relates to a neural modulation system comprising: a first electrode; a second electrode; and a stimulation generator configured to deliver a first stimulation pulse to the first electrode and a second stimulation pulse to the second electrode, wherein a first current amplitude of the first stimulation pulse is a first fraction of a principal amplitude and a second current amplitude of the second stimulation pulse is a second fraction of the principal amplitude. The neural modulation system further comprises a processor configured to: generate initial instructions for the stimulation generator to perform: (i) deliver the first analog pulse based on the first fraction of the principal amplitude, and (ii) deliver the second stimulation pulse based on the second fraction of the principal amplitude. The processor is further configured to: receive user input including a desired current amplitude; and determine, based on the desired current amplitude, an adjustment to the first current amplitude of the first stimulation pulse is required. The processor is further configured to determine a target adjustment at least in part based on a comparison of the desired current amplitude with the principal amplitude. The processor is further configured to: (A) determine an adjustment to at least the first fraction as the target adjustment, or (B) determine the following as the target adjustment: (i) an adjustment to the main amplitude, and (ii) an adjustment to at least the second fraction relative to the main amplitude. The processor is further configured to generate, at least in part, adjustment instructions for the stimulus generator to deliver the first stimulus pulse with the desired current amplitude and the second stimulus pulse with approximately the same second current amplitude, based on the target adjustment.

[0011] In another example, this disclosure relates to a method comprising: generating initial instructions for a stimulation generator to perform: (i) delivering a first analog pulse based on a first fraction of the principal amplitude, and (ii) delivering a second stimulation pulse based on a second fraction of the principal amplitude; and receiving user input including a desired current amplitude. The method further comprises determining, based on the desired current amplitude, an adjustment to the first current amplitude of the first stimulation pulse that needs to be performed. The method further comprises determining a target adjustment based at least in part on a comparison of the desired current amplitude with the principal amplitude. The method further comprises: (A) determining an adjustment to at least the first fraction as the target adjustment, or (B) determining, as the target adjustment, (i) an adjustment to the principal amplitude, and (ii) an adjustment to at least the second fraction relative to the principal amplitude. The method further comprises generating, at least in part, adjustment instructions for the stimulation generator to deliver the first stimulation pulse with the desired current amplitude and the second stimulation pulse with substantially the same second current amplitude, based at least in part on the target adjustment.

[0012] In another example, this disclosure relates to a computer-readable storage medium including instructions that, when executed, cause at least one processor to at least: generate initial instructions for the stimulus generator to: (i) deliver the first analog pulse based on the first fraction of the dominant amplitude, and (ii) deliver the second stimulus pulse based on the second fraction of the dominant amplitude; and receive user input including a desired current amplitude. The instructions, when executed, further cause at least one processor to at least: determine, based on the desired current amplitude, an adjustment to the first current amplitude of the first stimulus pulse that needs to be made. The instructions, when executed, further cause at least one processor to at least: determine, at least partially, a target adjustment based on a comparison of the desired current amplitude with the dominant amplitude, the target adjustment including (i) an adjustment to at least the first fraction, or (ii) an adjustment to the dominant amplitude and an adjustment to at least the second fraction relative to the adjustment to the dominant amplitude. When executed, the instruction further causes the at least one processor to at least: adjust, at least partially, based on the target, generate adjustment instructions for the stimulus generator to deliver the first stimulus pulse with the desired current amplitude and the second stimulus pulse with approximately the same second current amplitude.

[0013] Details of one or more aspects of this disclosure are set forth in the accompanying drawings and the following description. Other features, objectives, and advantages will be apparent from the specification, drawings, and claims. Attached Figure Description

[0014] Figure 1 This is a conceptual diagram illustrating an exemplary therapeutic system including an electrical stimulator coupled to stimulation leads, based on various techniques of this disclosure.

[0015] Figure 2This illustrates programmers (such as those used with electrical stimulators) according to various techniques disclosed herein. Figure 1 A block diagram of various exemplary components of a programmer.

[0016] Figure 3 An exemplary programmer screen according to this disclosure is shown.

[0017] Figure 4 This illustrates electrical stimulators (such as those based on various technologies according to this disclosure) Figure 1 A block diagram of various exemplary components of an electrical stimulator.

[0018] Figure 5 It is shown that it is used with electrical stimulators (such as...) Figure 1 and / or Figure 4 A block diagram of various components of an exemplary electrical stimulation generator used in conjunction with an electrical stimulator.

[0019] Figures 6 to 9 This is a flowchart illustrating an exemplary method for performing the techniques of this disclosure.

[0020] Figure 10 An exemplary programmer screen according to this disclosure is shown. Detailed Implementation

[0021] This disclosure describes various techniques for providing electrical stimulation therapy using electrodes and electrical stimulation pulses having a stimulation amplitude defined by a current amplitude in a medical device. The medical device can receive user input of the current amplitude from a programmer via a user interface. The user input can specify a variation in the current amplitude of the stimulation pulse delivered by electrodes with one or more leads. In response to the user input, the processing circuitry of the electrical stimulation generator can determine whether at least one of a first fractional adjustment or a second fractional adjustment is achieved as a target adjustment. That is, in examples involving at least two electrodes, according to various techniques of this disclosure, the target adjustment can be achieved by adjusting a first fraction of the adjusting electrode or adjusting the main current amplitude and adjusting at least one second fraction of the non-adjusting electrode to achieve the desired current amplitude.

[0022] Figure 1This is a conceptual diagram illustrating an exemplary system 2 that can be used to deliver stimulation therapy to a patient 6. The patient 6 is typically, but not necessarily, a person. Generally, the treatment system 2 includes an electrical stimulator 4 (e.g., an implantable medical device (IMD)) that delivers electrical stimulation to the patient 6 via one or more electrodes. The electrical stimulator 4 may include a main current and an array of current regulators that allow the electrical stimulator 4 to regulate the current generated or absorbed by the one or more electrodes 11. Thus, the electrical stimulator 4 may include multiple current regulator branches that can be used to implement current regulation for the one or more electrodes 11. For the purposes of description, the electrodes may be described as implantable electrodes. However, the example is not limited to implantable electrodes.

[0023] Electrodes may be deployed on one or more medical leads (such as implantable medical lead 10), and in some cases, on housing electrodes. Electrical stimulation may be in the form of controlled current pulses or voltage pulses, or substantially continuous current or voltage waveforms. The stimulation program may define various parameters of the pulses or waveforms. Pulses or waveforms may be delivered substantially continuously or burstily, segmentedly, or patterned, and may be delivered alone or in combination with pulses or waveforms defined by one or more other stimulation programs. In some examples, one or more electrodes may be located on the housing 14 of the electrical stimulator 4. Alternatively, implantable electrodes may be deployed on leadless stimulators.

[0024] In some examples, the electrical stimulator 4 can deliver, for example, deep brain stimulation (DBS) or cortical stimulation (CS) to the patient 6 via electrodes carried by lead segment 12. Although Figure 1 A specific stimulation environment (e.g., DBS) is shown, but the technology disclosed herein is not limited thereto, and the electrical stimulator 4 can deliver stimulation therapy to other sites of the patient 6 (such as the spinal cord of the patient 6), as described in U.S. Patent No. 8,560,080, entitled "Programming Techniques for Controlling Rate of Change of Electrical Stimulation Therapy" by Goetz et al., and U.S. Patent No. 8,996,123, entitled "Managing Electrical Stimulation Therapy Based on Variable Electrode Combinations" by Goetz et al., the entire contents of which are incorporated herein by reference. For example, other electrical stimulation systems can be configured to deliver electrical stimulation to gastrointestinal organs, pelvic nerves or muscles, peripheral nerves, or other stimulation sites. Additionally, although... Figure 1A fully implantable electrical stimulator 4 is shown, but the techniques described in this disclosure can be applied to external stimulators with electrodes deployed via percutaneous leads.

[0025] exist Figure 1 In the example shown, an electrical stimulator 4 is implanted in the clavicular region of a patient 6. The electrical stimulator 4 generates programmable electrical stimulation (e.g., current or voltage waveforms or current or voltage pulses) and delivers this stimulation via a medical lead 10 carrying an array of stimulating electrodes 11. Generally, for illustrative purposes, the delivery of electrical stimulation using controlled current pulses will be described in this disclosure. In some cases, the electrical stimulator may include multiple leads. Figure 1 In the example, the distal end of lead 10 is forked and includes two lead segments 12A and 12B (collectively referred to as "lead segment 12"). Lead segments 12A and 12B each include a set of electrodes forming part of the array of electrodes 11. In various examples, lead segments 12A and 12B may each carry four, eight, or sixteen electrodes. Figure 1 In this embodiment, each lead segment 12A, 12B carries four electrodes, which are configured as annular electrodes at different axial positions near the distal end of the lead segment 12. Throughout the remainder of this disclosure, for the purpose of brevity, the term "electrode" is generally used to refer to the electrode carried on the "lead," which may be a "lead segment" or the entire lead.

[0026] Figure 1 The housing electrode 13 is further depicted. The housing electrode 13 may be integrally formed with or otherwise coupled to the outer surface of the hermetically sealed housing 14 of the electrical stimulator 4. In one example, the housing electrode 13 is described as an active, non-removable electrode on the electrical stimulator 4. In some examples, the housing electrode 13 is defined by an uninsulated portion of the outward-facing part of the housing 14 of the electrical stimulator 4. Further partitions between the insulating and uninsulated portions of the housing 14 may be used to define two or more housing electrodes. In some examples, the housing electrode 13 may comprise substantially all of the housing 14, one side of the housing 14, a portion of the housing 14, or multiple portions of the housing 14. In an exemplary embodiment of the technology disclosed herein, for example, in an all-polar arrangement, one or more electrodes 11 may substantially transfer stimulation pulses from the lead 10 to the patient 6 while delivering stimulation pulses via the housing electrode 13.

[0027] In some examples, the electrical stimulator 4 may be coupled to one or more leads, which may be branched or unbranched. In such examples, the leads may be coupled to the electrical stimulator 4 via a common lead extension or via individual lead extensions. The proximal end of the lead 10 may be coupled to the head on the electrical stimulator 4. Conductors in the lead body electrically connect stimulation electrodes located on lead segment 12 to the electrical stimulator 4. The lead 10 extends from the implantation site of the electrical stimulator 4 along the neck of the patient 6 to the brain 16 of the patient 6. In some examples, lead segments 12A and 12B may be implanted in the right and left hemispheres of the brain, respectively, to deliver electrical stimulation to one or more regions of the brain 16.

[0028] Lead segments 12A and 12B can be implanted into the desired location in the brain 16 through corresponding holes in the skull of the patient 6. Lead segments 12A and 12B can be placed anywhere within the brain 16, such that electrodes on lead segments 12A and 12B can provide electrical stimulation to target tissue. The electrodes of lead segments 12A and 12B are shown as ring electrodes. In some examples, the electrodes of lead segments 12A and 12B can have different configurations. For example, the electrodes of lead segments 12A and 12B can have a complex electrode array geometry capable of generating a shaped electric field. The complex electrode array geometry may include multiple electrodes (e.g., partially ring or segmented electrodes) surrounding the periphery of each lead segment 12A and 12B. In some examples, lead segment 12 may have, in addition to... Figure 1 Other shapes besides the elongated cylinder shown. For example, lead segment 12 can be a paddle-shaped lead, a spherical lead, a flexible lead, or any other shape of lead that effectively treats patient 6. Additionally, the electrode can be an electrode pad of a paddle-shaped lead, a circular electrode surrounding the lead body, a conformal electrode, a cuff electrode, a segmented electrode, or any other type of electrode capable of forming monopolar, bipolar, multipolar, or other electrode configurations.

[0029] The treatment system 2 may include a programmer 40, such as an external programmer operated by a clinician or patient. In some examples, the programmer 40 may be a handheld computing device that allows a clinician to program the stimulation therapy for the patient 6 via a user interface. For example, using the programmer 40, the clinician can specify stimulation parameters for delivering the stimulation therapy. The programmer 40 may support telemetry of the electrostimulator 4, program downloading, and optionally, uploading operational or physiological data via the electrostimulator 4. The programmer 40 may also include a display and input keys to allow the patient 6 or clinician to interact with the programmer 40 and the electrostimulator 4. In this way, the programmer 40 provides the patient 6 with a user interface for controlling the stimulation therapy delivered by the electrostimulator 4. For example, the patient 6 can use the programmer 40 to start, stop, or adjust the electrical stimulation. In particular, the programmer 40 may allow the patient 6 to adjust the stimulation parameters of the program, such as duration, current or voltage amplitude, pulse width, pulse shape, and pulse rate. Patient 6 can also select a program (e.g., from multiple stored programs) as the current program to control the delivery of stimulation by the electrical stimulator 4.

[0030] In some cases, programmer 40 may be considered a physician or clinician programmer 40. For example, if programmer 40 is primarily intended for use by a physician or clinician, then programmer 40 may include a clinician programmer. In other cases, if programmer 40 is primarily intended for use by a patient, then programmer 40 may be considered a patient programmer. Typically, a physician or clinician programmer may support the selection and generation of programs by a clinician for use by stimulator 4, while a patient programmer may support the adjustment and selection of such programs by a patient during regular use.

[0031] Whether the programmer 40 is configured for use by a clinician or a patient, it can communicate wirelessly with the electrostimulator 4 or any other computing device. For example, the programmer 40 can communicate wirelessly with the electrostimulator 4 using RF telemetry techniques known in the art. The programmer 40 can also communicate with another programmer or computing device via a wired or wireless connection using any of a variety of local wireless communication technologies, such as radio frequency (RF) communication according to the 802.11 or Bluetooth specification set, infrared communication according to the Infrared Data Association (IrDA) specification set, or other standard or proprietary telemetry protocols. The programmer 40 can also communicate with another programmer or computing device via exchangeable removable media, such as a disk or optical disc or memory card or stick. Furthermore, the programmer 40 can communicate with the electrostimulator 4 and other programming devices via remote telemetry techniques known in the art, such as via a local area network (LAN), wide area network (WAN), public switched telephone network (PSTN), or cellular telephone network.

[0032] In some examples, the electrical stimulator 4 delivers stimulation according to a set of programs at a given time. Each program in such a set of programs may include a corresponding value for each of a plurality of therapeutic parameters, such as current or voltage amplitude, pulse width, pulse shape, pulse rate, and electrode configuration (e.g., electrode combination and polarity). The electrical stimulator 4 may generate pulses or other signals according to different programs in the set of programs. In such examples, a programmer 40 may be used to create programs and assemble these programs into a set of programs. In some examples, the programmer 40 may be used to adjust the stimulation parameters of one or more programs in the set of programs and select a set of programs as the current set of programs to control the delivery of stimulation by the electrical stimulator 4.

[0033] Generally, system 2 delivers stimulation therapy to patient 6 in the form of a constant current or voltage waveform or a constant current or voltage pulse. The shape of the pulse can vary depending on different design goals and can include ramp or trapezoidal pulses, sinusoidal or otherwise curved pulses, step pulses with two or more discrete amplitudes, closely spaced pulse pairs, and biphasic (a waveform with positive and negative directions in a single pulse) or monophasic (a waveform with only positive or only negative directions in a single pulse) waveform variations of any of the above. In the case of current-based stimulation, the electrical stimulator 4 modulates the current supplied or absorbed by one or more electrodes, which are called modulating electrodes. In some examples, one or more of the electrodes may be unmodified. In such configurations, the housing electrodes and / or lead electrodes may be unmodified electrodes.

[0034] Source current can refer to the positive current flowing out of the electrode (anode), while absorbent current can refer to the negative current flowing into the electrode (cathode). Regulated source currents can combine to produce a larger total source current (e.g., currents from multiple source currents combine to produce a total source current). Similarly, regulated absorbent currents can combine to produce a larger total absorbent current (e.g., currents from multiple absorbent currents combine to produce a total absorbent current). Regulated source currents and regulated absorbent currents can partially or completely cancel each other out, resulting in a net difference in the form of a net source current or a net absorbent current in the case of partial cancellation. In some examples, an unregulated current path can produce or absorb a current approximately equal to this net difference. In some examples, regulated source currents and regulated absorbent currents can be substantially balanced.

[0035] As described above, in some examples (e.g., an all-polar arrangement), one or more electrodes 11 can substantially transfer a stimulating current from the lead 10 to the tissue while delivering a stimulating current from the housing electrode 13 to the patient 6. In some examples (e.g., a bipolar / multipolar arrangement), one or more electrodes 11 can be configured to act as an anode and generate current, while one or more different electrodes 11 can be configured to act as a cathode and absorb current. In another example (e.g., a monopolar arrangement), the housing electrode 13 can be configured to act as an anode and generate current, while one or more electrodes 11 on one or more leads are configured to act as cathodes and absorb current. The techniques of this disclosure can be implemented using monopolar, bipolar / multipolar, and all-polar arrangements.

[0036] A user, such as a clinician or patient 6, can interact with the user interface of programmer 40 to program the electrical stimulator 4. According to various techniques described in this disclosure, programmer 40 receives user input via the user interface indicating a desired current amplitude. Programmer 40 can control the electrical stimulator 4 to deliver stimulation pulses to the electrodes with a desired current amplitude, as described in detail below, or otherwise program the stimulator 4. Programming the electrical stimulator 4 can generally refer to the generation and transfer of commands, programs, or other information to control the operation of the electrical stimulator 4. For example, programmer 40 can transfer programs, parameter adjustments, program selections, group selections, or other information to control the operation of the electrical stimulator 4. Furthermore, programming the stimulator 4 can include receiving user input via programmer 40 to indicate a target stimulation area and controlling the electrical stimulator to transmit electrical stimulation from an initial stimulation area through a series of one or more intermediate stimulation areas to the target stimulation area.

[0037] like Figure 1 As shown, the electrical stimulator 4 and the programmer 40 can communicate via wired or wireless communication. For example, the programmer 40 can communicate with the electrical stimulator 4 wirelessly using RF telemetry technology. The programmer 40 can also communicate with other programmers using any of a variety of local wireless communication technologies, such as those based on 802.11 or Bluetooth. TM The programmable controller 40 may include a transceiver that allows bidirectional communication with the electrostimulator 4, based on a set of RF communications, infrared communications (e.g., according to the IrDA standard), or other standard or proprietary telemetry protocols.

[0038] In some examples, the processing circuitry of programmer 40 may receive user input via a user interface, allowing a user (e.g., a clinician, physician, patient, etc.) to input a current amplitude value that defines the desired current amplitude of the electrical stimulation pulses delivered to one or more electrodes 11. In an exemplary example, the user interface may accept “1.2” mA (also milliamps) as input for the first electrode 11. In this example, the “1.2” input is a user command indicating that the first electrode is intended to deliver stimulation pulses with a current amplitude of 1.2 mA or close to 1.2 mA (e.g., 1.19 mA), and in any case, will be displayed as 1.2 mA on the user interface due to rounding of the actual current amplitude value. For example, the current amplitude of the stimulation pulses delivered to the first electrode 11 can be controlled by activating or deactivating multiple current regulator branches that regulate the main current. In an exemplary example, various adjustments can be made to the processing circuitry of the electrical stimulator 4 or the processing circuitry of the stimulation generator, such as by adjusting a fractional value of the number of current regulator branches relative to the total number of current regulator branches and / or by adjusting the main current amplitude to achieve a desired current amplitude of 1.2 mA.

[0039] The user interface of programmer 40 can display the current amplitude corresponding to each electrode. In some cases, the user interface of programmer 40 can also display the fraction associated with each current amplitude of one or more electrodes. In any case, the user can adjust the current amplitude corresponding to a specific electrode by increasing or decreasing the current amplitude value displayed on the user interface of programmer 40.

[0040] In an example involving user-adjusted fractional contribution, when attempting to adjust the current amplitude of a particular electrode, a clinician adjusts the electrode contribution by defining the degree to which a given electrode delivers the desired intensity relative to the main current. The clinician can set the contribution of a particular electrode within a range of 0.0 (0%) to 1.0 (100%), where the percentage or decimal value indicates the fraction of the total number of current regulator branches used by the stimulator to achieve the current regulator associated with the particular electrode.

[0041] In some examples, the user interface of programmer 40 may display the current amplitude corresponding to each electrode. The user interface may provide fillable fields or other adjustment input devices, such as increment or decrement input keys, which allow the user to input the desired current amplitude for a given electrode 11 or multiple electrodes 11 of the electrical stimulator 4 as adjustment targets. The processing circuitry system of the electrical stimulator 4 may receive the desired current amplitude or adjustments to the current amplitude as user input. The desired current amplitude may be input in amperes (e.g., milliamperes).

[0042] The desired current amplitude can be greater than, less than, or equal to the main current amplitude. That is, the value included in the user input can be directly compared to the main current amplitude. The main current amplitude defines the maximum current amplitude of any given electrode 11 in the stimulation system. The main current amplitude provides source power to the electrode 11 based on the number of current regulator branches activated for each electrode 11. In one example, the first electrode may activate 64 out of 64 branches (e.g., 64 / 64) and thus provide 100% of the main amplitude, while the second electrode may activate 32 out of 64 branches (e.g., 32 / 64) and thus provide 50% of the main amplitude. The main amplitude can be adjusted up or down as needed up to the maximum main amplitude, in which case the number of branches of the electrode may need to be adjusted based on whether the electrode is for adjustment or designed to maintain a constant current amplitude.

[0043] Based on the desired current amplitude or adjustments to the current amplitude, the processing circuitry of the electrical stimulator 4 can adjust various fractional and / or main current amplitudes. In an example including at least two electrodes, the processing circuitry of the electrical stimulator 4 can perform one of two fractional adjustments, including an adjustment of a first fraction of the electrode that is the target of amplitude adjustment (hereinafter referred to as "first fractional adjustment") or an adjustment of the main current amplitude and an adjustment of a second fraction corresponding to other electrodes that are not the target of amplitude adjustment (hereinafter referred to as "second fractional adjustment"). Although this disclosure refers to two or three electrodes in certain instances for illustrative purposes, the technology of this disclosure is not limited thereto, and fractional adjustments can be applied to any number of electrodes used to provide electrical stimulation using a main amplitude or a reference amplitude.

[0044] Figure 2 This is a functional block diagram showing the various components of the programmer 40 of the electrical stimulator 4. For example... Figure 2 As shown, the programmer 40 may include a processing circuitry 53, a memory 55, a telemetry circuitry 58, and a user interface 59. Typically, the processing circuitry 53 controls the user interface 59, stores data in and retrieves data from the memory 55, and controls data transmission with the electrostimulator 4 via the telemetry circuitry 58. The processing circuitry 53 may take the form of one or more microprocessors, controllers, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or equivalent discrete or integrated logic circuitry systems. The functions attributed herein to the processing circuitry 53 may be embodied in software, firmware, hardware, or any combination thereof.

[0045] Memory 55 may store various aspects that enable the processing circuitry system 53 to provide the functions attributed herein to programmer 40. Memory 55 may include any fixed or removable magnetic, optical, or electrical medium, such as random access memory (RAM), read-only memory (ROM), compact disc ROM (CD-ROM), magnetic storage, electronically erasable programmable ROM (EEPROM), non-volatile random access memory (NVRAM), flash memory, etc. Memory 55 may also include a removable memory portion that can be used to update the memory or increase its capacity. The removable memory may also allow patient data to be easily transferred from programmer 40 to another computing device. Memory 55 may also store operational information controlling the electrical stimulator 4.

[0046] Telemetry circuitry 58 allows data to be transferred to and from the electrostimulator 4. Telemetry circuitry 58 can automatically communicate with the electrostimulator 4 at a predetermined time or when it detects the proximity of the electrostimulator 4. Alternatively, telemetry circuitry 58 can communicate with the electrostimulator 4 when a user sends a signal notification via user interface 59. To support RF communication, telemetry circuitry 58 may include appropriate electronic components such as amplifiers, filters, mixers, encoders, decoders, etc.

[0047] In some examples, programmer 40 can wirelessly communicate with electrostimulator 4 using, for example, RF communication or near-field sensing interaction. This wireless communication is possible through the use of a telemetry circuitry system 58 that can be coupled to an antenna. Programmer 40 can also be configured to communicate with another computing device via wireless communication technology or directly with another computing device via a wired, such as network connection. Examples of local wireless communication technologies that can be used to facilitate communication between programmer 24 and another computing device include RF communication or infrared communication based on the 802.11 or Bluetooth specification sets.

[0048] Programmer 40 may include a user interface 59. As described above, a user (e.g., a clinician or patient 6) can interact with user interface 59 to, for example, manually select, change, or modify the voltage or current amplitude of stimulation pulses delivered by a specific electrode or multiple electrodes, or view stimulation data. User interface 59 may include a screen and one or more input buttons or input fields that allow programmer 40 to receive input from the user. The screen may be a liquid crystal display (LCD), a plasma display, a dot matrix display, or a touchscreen. Input buttons may include a touchpad, increase or decrease buttons / keys, and other input media required to control electrical stimulation. See below for further details. Figure 3 Example describing user interface 59.

[0049] User interface 59 may receive the desired current amplitude of the first electrode as user input. In some examples, the user may input the desired current amplitude value of electrode 11 via user interface 59. In some examples, the user input may include initial settings for one or more electrodes 11, or may include adjustments to electrodes that already have programmed current amplitude settings. Processing circuitry system 53 may receive user input of the desired current amplitude of a specific electrode in a multi-electrode system and may transmit instructions (e.g., adjustment instructions) to electrostimulator 4 to adjust electrostimulator 4 to deliver electrical stimulation according to the desired current amplitude. In another example, processing circuitry system 53 may transmit user input to electrostimulator 4 via telemetry circuitry system 58, wherein electrostimulator 4 may subsequently determine a target adjustment and generate an adjustment instruction. Thus, telemetry circuitry system 58 may transmit a milliampere value as an adjustment instruction to electrostimulator 4 based on user input defining a desired current value. In another example, telemetry circuitry system 58 may transmit a fractional value as an adjustment instruction to electrostimulator 4, wherein the adjustment instruction instructs electrostimulator 4 on the configuration of regulator branches based on user input defining a desired current value.

[0050] In some examples, programmer 40 may determine adjustments to the electrical stimulator based on user input, including the desired current amplitude. The adjustment may be selected from either a first fractional adjustment or a second fractional adjustment, depending on whether the desired current amplitude of the electrode is greater than, equal to, or less than the main current amplitude, and in some cases, whether the fraction of a particular electrode being adjusted is at its maximum value (such as in examples including segmented electrode loops).

[0051] When adjustments cause a change in the main current amplitude, in order to maintain the current amplitude of other electrodes that are not targeted for adjustment, it may be necessary to adjust the fraction of the other electrodes relative to the change in the main current amplitude. This is because a change in the main current amplitude causes a change in the current amplitude of other electrodes, unless more or less of the main current amplitude is used for electrodes that are not targeted for adjustment, as defined by the change in the number of active current regulator branches compared to the total number of available current regulator branches. As mentioned, the ratio of active current regulator branches to the sum of available current regulator branches is referred to throughout the text as a portion of the main amplitude used to obtain the individual amplitudes of the individual electrodes.

[0052] Figure 3 An exemplary screen of a user interface 59 presented on a programmer 40 is shown. The user interface 59 can be used to adjust the current value of one or more electrodes 48 of one or more leads 12. Electrodes 48 are... Figure 1 Example of electrode 11. Figure 3 A display window 240, depicting a user interface 59, is shown displaying an exemplary lead 12. In some examples, the user interface 59 may display multiple leads, each having one or more electrodes 48.

[0053] exist Figure 3 In the example, window 240 graphically depicts exemplary lead 12, which may correspond to Figure 1 One of leads 12A or 12B in the circuit. In an exemplary example, lead 12 includes four electrodes, namely electrodes 48A-48D (collectively referred to as "electrodes 48"). Depending on the specific lead configuration used, lead 12 may have more or fewer electrodes 48, and more than one lead may be displayed on screen 240, such as... Figure 1 Lead segments 12A and 12B are shown. For ease of illustration, according to various techniques of this disclosure, only four electrodes (or a portion of four electrodes) are depicted on lead 12, and only two electrodes are used to illustrate various current adjustment examples. Additionally, window 240 may depict stimulation regions, electric field regions, activation regions, etc. (not shown). For example, a region may be an anode region providing current generated by one or more electrodes 48 of lead 12. A second region may be a cathode region absorbing current generated by one or more electrodes 48 of lead 12.

[0054] exist Figure 3 In the example, adjacent to each of the four electrodes, display window 240 may indicate the current associated with each of the electrodes 48 or the electrode combination. Specifically, electrode 48A may include a fillable field or other adjustable field 214A, and electrode 48B may include another fillable field or other adjustable field 214B (hereinafter referred to as "field 214"). Field 214 may indicate how much current each of the electrodes 48 can provide or absorb (e.g., measured in milliamperes). Although only electrodes 48A and 48B (i.e., the exemplary first and second electrodes) are shown, field 214 may be equally applicable to all electrodes, including segmented electrodes in the case of segmented lead implementations.

[0055] In some examples, the display window 240 of the user interface 59 may include display windows 210 and 212, which indicate information about the main current amplitude and / or the maximum current amplitude. In some examples, the user interface 59 may provide the user with the option to hide information about the main current amplitude and / or the maximum current amplitude from the display window 240. In this way, the user interface allows the user to focus on adjusting the current amplitude of a single electrode 48 or a combination of electrodes 48. In any case, windows 210 or 212 provide the main current amplitude and the maximum current amplitude. In such examples, the user interface 59 may alert the user when the desired current amplitude is close to its maximum value. That is, the user interface 59 may be hidden from display windows 210 or 212 to facilitate the display of the current amplitude of the corresponding electrode or combination of electrodes.

[0056] In an illustrative example, user interface 59 allows the user to directly provide user input using field 214 to achieve the desired current amplitude for one or more electrodes 48. For example, user interface 59 may accept inputs of "1.1" in field 214A and "1.2" in field 214B. In some cases, one or both fields may be pre-filled with current amplitude values, in which case the user can adjust the pre-filled values ​​using adjustment values. In one example, user interface 59 may display "1.1mA" in field 214A, indicating that electrode 48A is programmed to have a stimulation amplitude of 1.1mA. Therefore, user interface 59 may accept adjustments to the first electrode 48A from "1.1" to higher or lower amplitude values ​​as input. For example, user interface 59 may accept adjustments to the first electrode 48A from "1.1" to "1.3". In an example where field 214B has a pre-filled current value indicating the current amplitude of electrode 48B, field 214B may display the same value before and after adjustments to the first electrode 48A.

[0057] In some examples, the user can adjust the current amplitude and other parameters using the user interface 59, but these changes may not take effect until the user provides an explicit command via the user interface 59. For example, the user can adjust electrode 48A from "1.1mA" to "1.3mA", but may want electrode 48B to remain at a current value of "1.2mA". According to various techniques of this disclosure, regardless of whether an explicit command is used, the user can use field 214B to adjust electrode 48A from "1.1mA" to "1.3mA", and field 214B can display "1.2mA" before and after the adjustment, indicating that the current amplitude of electrode 48B remains unchanged from "1.2mA". User input received via the user interface 59 can be transferred from programmer 40 to electrical stimulator 4. That is, electrical stimulator 4 can receive user input from programmer 40 and implement various programming requests accordingly.

[0058] Figure 4 This is a block diagram illustrating various components of an exemplary electrical stimulator 4, which in some examples can wirelessly communicate with a programmer 40 as indicated. In some examples, the electrical stimulator 4 includes a processing circuitry system 50, a memory 52, a telemetry circuitry system 56, an antenna 57, and a stimulation generator 60. The stimulation generator 60 is... Figure 5 The image also shows coupling to electrodes 48A-48Q (collectively referred to as "electrodes 48"). In some examples, electrodes 48A-48P may be implantable and deployable on one or more leads 12. Regarding... Figure 1Lead segments 12A and 12B can carry electrodes 48A-48H and electrodes 48I-48P, respectively. In some cases, one or more additional electrodes may be located on or within the housing of the electrical stimulator 4, for example, to provide a common or ground electrode or housing anode. In some examples, the leads or lead segments carry eight electrodes to provide a 2×8 electrode configuration (two leads, each with eight electrodes), providing a total of sixteen different electrodes.

[0059] In some examples, different electrode configurations, including single leads, two leads, three leads, or more, may be provided. Furthermore, the electrode counts on the leads may vary and may be the same or different between leads. Examples of other configurations include one lead with eight electrodes (1×8), one lead with twelve electrodes (1×12), one lead with sixteen electrodes (1×16), two leads each with four electrodes (2×4), three leads each with four electrodes (3×4), three leads each with eight electrodes (3×8), three leads with four, eight, and four electrodes respectively (4-8-4), two leads with twelve or sixteen electrodes (2×12, 2×16), two or more leads with eleven or thirteen electrodes, or other configurations. The processing circuit system 50 can select different electrodes to form various electrode combinations. In addition, the processing circuit system 50 can assign various polarities to the selected electrodes to designate the electrodes as anodes or cathodes, and form other electrode configurations from them.

[0060] Electrode 48Q represents one or more electrodes that can be carried on the housing of the electrostimulator 4. Electrode 48Q can also be a dedicated short lead extending from the housing, or a proximal portion of one of the electrodes 48A-48P. The proximal portion can be closely adjacent to the housing, for example, at or near the point where the lead couples to the housing. Electrode 48Q can be configured as an adjusted or unadjusted electrode for use in an electrode configuration having selected adjusted and / or unadjusted electrodes between electrodes 48A-48P, as described above, the electrode can be located on the lead body of one or more leads. Electrode 48Q can be formed together on the housing carrying the electrodes and accommodate components of the electrostimulator 4, such as the stimulation generator 60, processing circuitry 50, memory 52, and telemetry circuitry 56.

[0061] The housing electrode 48Q can be configured to serve as an electrode for a source current substantially simultaneously with one or more electrodes 48A-48P, which is configured to act as a cathode absorbing current in a unipolar arrangement. The housing electrode 48Q can also be configured to serve as an anode to provide current substantially simultaneously with current supplied by another electrode 48A-48P, which is configured to act as an anode in an all-polar arrangement. By specific example, electrodes 48A, 48B and the housing electrode 48Q can each be configured to serve as an anode. Electrodes 48A and 48B can deliver an electrical stimulation current substantially simultaneously with the electrical stimulation current delivered via the housing electrode 48Q. In this illustration, one or more cathodes can be formed from other electrodes on the leads (e.g., any one of electrodes 48C-48P) to absorb the current supplied by anodes 48A, 48B, and 48Q.

[0062] Memory 52 may store instructions for execution by processing circuitry system 50, stimulation therapy data, sensor data, and / or other information regarding the therapy of patient 6. Processing circuitry system 50 may control stimulation generator 60 to deliver stimulation according to one or more of a plurality of programs or groups of programs stored in memory 52. ​​Memory 52 may include any electronic data storage medium, such as RAM, ROM, EEPROM, NVRAM, flash memory, magnetic memory, etc. Memory 52 may store program instructions that, when executed by processing circuitry system 50, cause processing circuitry system to perform the various functions attributed to processing circuitry system 50 and electrostimulator 4 in this disclosure.

[0063] The processing circuitry system 50 may include one or more microprocessors, DSPs, ASICs, FPGAs, or other digital logic circuitry systems. The processing circuitry system 50 controls the operation of the electrical stimulator 4. For example, the processing circuitry system 50 may control the stimulation generator 60 to deliver stimulation therapy according to a selected program or set of programs retrieved from memory 52. ​​In some examples, the processing circuitry system 50 may control the stimulation generator 60 to deliver electrical signals, such as stimulation pulses or continuous waveforms, having a current amplitude, pulse width (if applicable), and rate specified by one or more stimulation programs. The processing circuitry system 50 may also control the stimulation generator 60 to selectively deliver stimulation via a subset of electrodes 48 (also referred to as electrode combinations) and having a polarity specified by one or more programs. The functionality attributed herein to the processing circuitry system 50 may be embodied in software, firmware, hardware, or any combination thereof.

[0064] When a specific program group is selected, the processing circuitry 50 can control the stimulus generator 60 to deliver stimulation according to the program in the group. If applicable, each program can specify a set of stimulation parameters, such as amplitude, pulse width, and pulse rate. For continuous waveforms, parameters can include amplitude and frequency. Additionally, each program can specify a specific electrode combination for stimulation delivery, and electrode configuration based on electrode polarity and regulated / unregulated state. Electrode combinations can specify specific electrodes in a single array or multiple arrays, and specific electrodes on a single lead or between multiple leads. Electrode combinations can include at least one anode (e.g., electrode 48Q) on the housing of the electrostimulator 4, at least one anode on a lead, and at least one cathode on a lead. If more than one lead is provided, the lead carrying the anode and cathode can be located on the same lead or on different leads. Programs can be defined by selecting parameters and electrodes, or directly through zone-based programming, where parameters and electrodes are automatically determined by the programmer in response to manipulation or positioning of the stimulation zone.

[0065] Stimulus generator 60 via corresponding leads (such as...) Figure 1 The conductor of lead 12) is electrically coupled to electrodes 48A-48P. The stimulator 60 may be electrically coupled to one or more housing electrodes 48Q via an electrical conductor disposed within the housing of the electrostimulator 4. Housing electrodes 48Q may be configured as adjusted or unadjusted electrodes to form an electrode configuration in conjunction with one or more of electrodes 48A-48P. Housing electrodes 48Q may be configured to function as anodes to substantially simultaneously supply current to one or more leads configured as anodes along with one or more electrodes (e.g., any of the electrodes 48A-48P).

[0066] The stimulation generator 60 may include a stimulation generation circuitry for generating stimulation pulses or waveforms and a circuitry for switching stimulation between different electrode combinations, for example, in response to control from the processing circuitry 50. The stimulation generator 60 generates electrical stimulation signals according to a program based on control signals from the processing circuitry 50.

[0067] In one exemplary embodiment (e.g., an all-polar arrangement), the stimulation generator 60 may be configured to deliver stimulation using one or more of electrodes 48A-48P as stimulation electrodes (e.g., anodes), while substantially simultaneously using housing electrode 48Q as a stimulation electrode (e.g., anode) to deliver stimulation. Anodes on the leads and housing may be used to deliver stimulation together with one or more cathodes on the leads. As an illustration, the electrode combination selected for delivering the stimulation current may include housing anodes and anodes on the leads, as well as cathodes on the same or different leads. In other examples, the electrode combination may include multiple anodes and / or multiple cathodes on one or more leads, and at least one anode on housing 14. In some examples, the electrode combination may include one or more anodes on one or more leads, and one or more cathodes on the same or different leads, such as a bipolar / multipolar arrangement. In other examples, the electrode combination may include an anode on the housing and one or more cathodes on one or more leads, such as an all-polar arrangement. In yet another example, the electrode assembly may include a cathode on the housing, and one or more additional cathodes on one or more leads, and one or more anodes on the leads, for example, a variation of the all-electrode arrangement.

[0068] The telemetry circuitry 56 may include an RF transceiver to allow bidirectional communication between the electrostimulator 4 and the programmer 40. The telemetry circuitry 56 may include an antenna 57, which may take various forms. For example, the antenna 57 may be formed from a conductive coil or wire embedded in a housing associated with the medical device 4. In some examples, the antenna 57 may be mounted on a circuit board carrying other components of the electrostimulator 4, or may take the form of circuit traces on a circuit board. In this way, the telemetry circuitry 56 may allow communication with… Figure 1 The programmer 40 communicates with the programmable circuitry 56 to receive, for example, new programs or program groups, or adjustments to programs or program groups. The telemetry circuitry 56 may be similar to the telemetry circuitry 58 of the programmer 40.

[0069] Figure 5 This is a block diagram illustrating various components of an exemplary stimulation generator 60. The stimulation generator 60 can be used with an electrical stimulator, for example, to perform the functions of the stimulation generator 60, as shown in the reference. Figure 4 As described. In Figure 4In one example, the stimulator 60 is selectively configured to deliver electrical stimulation pulses to the patient 6 via electrode 48. However, this disclosure is not limited to the example in which regulated current pulses are delivered. In other examples, the stimulator 60 may provide a continuous, regulated current waveform instead of regulated current pulses. In some examples, the stimulator 60 may deliver a combination of continuous waveforms and pulses, or selectively deliver either continuous waveforms or pulses. The stimulator 60 may generate stimulation based on a constant current or a constant voltage in the form of pulses or continuous waveforms. The stimulator 60 may also be controlled to provide constant power (current-voltage product) or controlled charge stimulation pulses.

[0070] exist Figure 5 In the example shown, the stimulus generator 60 includes a main current / voltage 64 and a current / voltage regulator array 68. In some examples, the stimulus generator 60 may further include a switch array 66. The main current / voltage 64 may provide operating power to the current / voltage regulator array 68 and may include a regulated current or a regulated voltage that sets the level of the main current (e.g., the amplitude of the main current) or the main voltage. Figure 5 As shown, the main current / voltage 64 can be coupled to provide operating power to the current / voltage regulator array 68 and, where appropriate, provide main current or main voltage to connect to the electrode 48. The maximum operating current level and the main current level provided for regulating the current regulator array 68 can be different at any given time. For example, the main current amplitude can be less than the maximum operating current level, such that the main current amplitude can be increased or decreased according to minimum and maximum operating conditions. In some examples, such as reference... Figure 3 As described, the user interface 59 can display such information for the user's reference, while adjusting the current amplitude of various electrodes.

[0071] The processing circuitry 50 can control (e.g., via a stimulation controller) the switch array 66 and the current / voltage regulator array 68 to deliver stimulation via the electrodes 48. In operation, the processing circuitry 50 can control the delivery of electrical stimulation according to one or more programs that specify stimulation parameters such as electrode combination, electrode polarity, stimulation current amplitude, pulse rate and / or pulse width, and the percentage of source current distributed in or distributed by one or more lead anodes on the housing anode and one or more leads, as well as the percentage absorbed by one or more cathodes. The programs can be defined and downloaded to the electrical stimulator 4 by a user via an external controller.

[0072] The current / voltage regulator array 68 includes a plurality of regulated current sources or current sinks. The current regulators can be used as current sources or current sinks, or selectively configured to operate as sources or sinks. In some examples, the current / voltage regulator array 68 can regulate voltage as a substitute for or supplement to current. For convenience, in some cases, the term "current regulator" may be used to refer to a source or sink. Thus, each current regulator in the current / voltage regulator array 68 can operate as a regulated current source or a regulated current sink that delivers stimulation via a corresponding electrode in electrode 48, and the regulated current sink receives current from a corresponding electrode in electrode 48, wherein electrode 48 may be disposed on leads, on a stimulator housing, on a leadless stimulator, or in other arrangements.

[0073] Each current regulator may correspond to multiple current regulator branches. In some examples, the current regulator branches may be implemented in parallel, such as having parallel current regulator branches. The number of current regulator branches defines the resolution of each current regulator. For example, in some examples, the number of current regulator branches may be 64, such that the current amplitude can be adjusted for a given electrode in 1 / 64 increments (i.e., resolution of 1 / 64). While 64 current branches are used, for example, throughout this disclosure, the technology of this disclosure is not limited thereto, and the number of current branches may be greater than or less than 64. For example, in some embodiments, 128 current branches may be used, such that the current regulator of a particular electrode can be adjusted in 1 / 128 increments (i.e., resolution of 1 / 128). In an exemplary embodiment with a resolution of 1 / 64, a full-output ring electrode may implement 64 branches (e.g., 64 / 64). Additionally, the stimulation generator 60 may be configured such that all 64 parallel current regulator branches are used for each of the highest contributing electrodes in the highest intensity active region.

[0074] In examples involving segmented leads (e.g., segmented electrodes), electrodes at various axial locations of lead 12 can have a fractional maximum value approximately equal to the number of available branches of the electrode divided by the number of electrode segments in the segmented electrode ring. For example, in an example involving 64 current regulator branches, the ring electrode can have a maximum fraction of 64 / 64, while each of the N segmented electrodes in the segmented electrode ring can have a maximum value of approximately 64 / N. In an exemplary example, in the case of three segmented electrodes in the ring, each electrode can have a fractional maximum value of 21 / 64. In some examples, the fractional maximum value for any given electrode (including the ring electrode) can reach an integer number of current regulator branches (e.g., 64 branches). That is, processing circuitry 53 or processing circuitry 50 can be configured to apply any fractional maximum value in use based on a specific stimulus generator 60 (e.g., the number of current regulator branches). For example, in the case of three segmented electrodes in the ring (as in the previous example), each electrode may have a maximum value of the X / X fraction (e.g., 64 / 64 fraction) or a fraction less than X / X, which has been predefined by the processing circuit system 53 or the processing circuit system 50.

[0075] In an example including switch array 66, each switch of switch array 66 couples a corresponding electrode in electrode 48 to a corresponding bidirectional current regulator or main current / voltage 64 of current / voltage regulator array 68. In some examples, processing circuitry system 50 selectively turns switches in switch array 66 on and off to configure one or more electrodes among housing electrodes (e.g., electrode 48Q) and electrodes 48A-48P on one or more leads as regulated electrodes by means of regulated current sources or current sinks connected to current / voltage regulator array 68. In some examples, processing circuitry system 50 may selectively turn switches in switch array 66 on and off to configure housing electrodes (e.g., electrode 48Q) or electrodes on leads as unregulated electrodes by means of main current / voltage 64. Additionally, processing circuitry system 50 may selectively control individual regulated current sources or current sinks in current / voltage regulator array 68 to deliver stimulation current pulses to selected electrodes. In an example where the switch array 66 is not used, the electrode 48 can still be coupled to the current / voltage regulator array 68 and / or the main current / voltage 64.

[0076] The main current / voltage 64 can be a high or low voltage supplied by a regulated power supply, depending on whether the electrodes are programmed as unregulated sources (high voltage rails) or unregulated slots (low voltage rails). Therefore, the main current / voltage 64 can generate high and low main currents or voltages as appropriate to selectively couple to the unregulated reference electrode as needed. The regulated power supply can generate one or more regulated voltage levels to serve as the main current / voltage 64 and as the power rails of the current / voltage regulator array 68. Although Figure 5 The same main current / voltage 64 is shown coupled to the current / voltage regulator array 68, but different current amplitudes can be used for the main current coupled to the switch array 66 and the maximum current amplitude provided to the current regulator array 68. In any case, the regulated power supply can generate the regulated current amplitude from the current provided by one or more power sources (such as one or more batteries (e.g., rechargeable batteries)).

[0077] The processing circuitry 50 controls the operation of the switch array 66 to produce electrode configurations defined by different stimulation programs. In some cases, the switches of the switch array 66 may be metal-oxide-semiconductor field-effect transistors (MOSFETs) or other circuit components for switching electronic signals. The switches of the switch array 66 may be designed to carry a certain amount of unregulated current, which can be coupled to the corresponding electrode through an unregulated current path associated with the main current / voltage 64. In some examples, two or more regulated electrodes 48 may be intentionally programmed to deliver different amounts of current, resulting in an unbalanced current distribution among the regulated electrodes. In other examples, the regulated source current and tank current may be balanced such that substantially all current can be supplied and absorbed via the corresponding regulated current source and current tank.

[0078] To provide individual control of electrode 48 as either a tunable electrode or an untuned reference electrode, processing circuitry 50 controls the operation of switch array 66 and current / voltage regulator array 68. When stimulation is delivered to patient 6 (e.g., a current pulse), processing circuitry 50 controls switch array 66 to couple selected stimulating electrodes of the desired electrode combination to the corresponding current regulator or main current / voltage 64 of current / voltage regulator array 68 as needed. Processing circuitry 50 controls tunable bidirectional current sources of current / voltage regulator array 68 coupled to tunable electrodes to provide or absorb a specified amount of current. For example, processing circuitry 50 may control selected current sources or current sinks on a pulse-by-pulse basis to deliver current pulses to the corresponding electrodes.

[0079] The processing circuitry 50 also disables the bidirectional current regulators of the current / voltage regulator array 68, which are connected to non-active electrodes, such as those acting as active regulating electrodes in a given electrode configuration. Each bidirectional current regulator of the current / voltage regulator array 68 may include an internal enable switch controlled by the processing circuitry 50, which disconnects the regulating power from the current regulator or otherwise disables the current source when the corresponding electrode is not used as a regulating electrode.

[0080] Figure 6 This illustrates various techniques according to the present disclosure for controlling neural modulation systems (such as...) Figure 1 A flowchart of an exemplary method of system 2) is provided. The neural modulation system may include at least two electrodes 48 and a stimulation generator 60. The stimulation generator 60 may be configured to deliver a first stimulation pulse to a first electrode 48A of the at least two electrodes 48, and to deliver a second stimulation pulse to a second electrode 48B. In such an example, the stimulation generator 60 may deliver the first stimulation pulse to the first electrode 48A with a first current amplitude, and may deliver the second stimulation pulse to the second electrode 48A with a second current amplitude. The first current amplitude may be implemented using a first fraction of the principal amplitude, and the second current amplitude of the second stimulation pulse may be implemented using a second fraction of the principal amplitude, as referenced above. Figure 5 As discussed. In some examples, the neural modulation system may include a third electrode to provide a return path for at least a portion of the stimulation pulse.

[0081] Although described as being performed by electrical stimulator 4, Figures 6 to 9 The example methods can also be performed by any or more of the programmer 40, the electrostimulator 4, an external device or server (e.g., a remote server), or a combination of one or more of these devices, for example, by the processing circuitry system of any one or more of these devices. In one example, the processing circuitry system 53 may determine adjustments to the fraction and amplitude based on user input via user interface 59. The programmer 40 may then transmit the determined adjustments to the electrostimulator 4, whereby the electrostimulator 4 can implement the adjustments. In another example, the processing circuitry system 53 may receive user input and transmit the user input to the electrostimulator 4, whereby the electrostimulator 4 can determine adjustments to the electrostimulator 4 according to various techniques of this disclosure.

[0082] In some examples, the electrical stimulator 4 can transmit information to the programmer 40 for display, such as the adjusted master amplitude value, the current amplitude value of the stimulation pulse, and / or the fractional value. The programmer 40 can store such information in memory 55, and in some examples, use this information to determine further adjustments to the electrical stimulator 4. Similarly, the electrical stimulator 4 can store adjustment requests received from the programmer 40 in memory 52 for later implementation. In some examples, the electrical stimulator 4 can perform adjustments based on input received from another device, such as a remote server or the programmer 40. Figures 6 to 9 One or more of the methods described herein. Then, the electrical stimulator 4 can adjust various parameters according to various techniques of this disclosure, and transmit an overview of the adjustment or a portion thereof (such as current value only) to the programmer 40 or another user interface device for display.

[0083] The processing circuitry system 50 of the electrical stimulator 4 can receive user input (602) including a desired current amplitude. For example, the processing circuitry system 50 can receive the desired current amplitude from the processing circuitry system 53 of the programmer 40. The processing circuitry system 53 can transfer the desired current amplitude provided by the user via fields 214A or 214B of the user interface 59 to the processing circuitry system 50. In some examples, the processing circuitry system 50 can first generate instructions for the stimulation generator 60 to deliver a first analog pulse based on a first fraction of the main amplitude and a second stimulation pulse based on a second fraction of the main amplitude, such as where the stimulation pulse has been achieved with a specific amplitude and the user wants to adjust the amplitude. In some examples, the user can reprogram the amplitude, in which case the initial instructions can be delivered with zero amplitude until the user sets the desired current amplitude.

[0084] In response to user input, the processing circuitry 50 can determine that the user input indicates a need for adjustment of the first current amplitude of the first stimulus pulse (604). For example, the original first current amplitude before adjustment may be 0 mA, or it may be a non-zero value, such as 1.1 mA. The user input may be a value greater than the original value, such as 1.2 mA, or in some cases less than the original value by 0.9 mA, indicating a request to reduce the current amplitude. In any case, the processing circuitry 50 can determine that the user input indicates a request to adjust the first current amplitude of the first stimulus pulse from its original value to an adjusted value greater than or less than the original value.

[0085] Based on user input including the desired current amplitude, processing circuitry 50 can compare the desired current amplitude with the principal amplitude, or otherwise determine whether the desired current amplitude is equal to, less than, or greater than the principal amplitude (606). For example, processing circuitry 50 can receive an indication from another device that the desired current amplitude is greater than, equal to, or less than the principal current amplitude. In some examples, processing circuitry 53 can transmit comparison information to processing circuitry 50 indicating that the desired current amplitude is equal to, less than, or greater than the principal amplitude.

[0086] The processing circuit system 50 can determine the target adjustment (608) at least in part based on a comparison between the desired current amplitude and the main amplitude. For example, the processing circuit system 50 can utilize a first fractional adjustment scheme as the first fractional target adjustment for the adjustment electrode 48A. The processing circuit system 50 can utilize a second fractional adjustment scheme as the second fractional target adjustment for the adjustment electrode 48B and for adjusting the main amplitude. (See reference) Figure 7 The first and second fraction adjustments are further illustrated.

[0087] Based on a specific fractional adjustment selected as the target adjustment, the processing circuitry 50 can generate instructions (e.g., adjustment instructions) for the stimulus generator 60 to deliver a first stimulus pulse with a desired current amplitude and a second stimulus pulse with approximately the same second current amplitude, the second stimulus pulse being delivered to the second electrode (610) before the first fractional adjustment. That is, the processing circuitry 50 can utilize the target adjustment to adjust the first current amplitude to achieve the desired current amplitude while maintaining the second stimulus pulse at the same or approximately the same amplitude. This approximation may be due to the limited resolution available for a specific number of current regulator branches. For example, the second fractional adjustment can result in an increase in the main amplitude and a decrease in the second fractional increase relative to the main amplitude, such that the second amplitude remains as close as possible to the original second amplitude.

[0088] As mentioned, an exact identical amplitude may not be possible, but due to specific rounding rules, the display on user interface 59 can show the same current amplitude. In the exemplary example involving a 64-branch regulator, the second current amplitude could be 1.1 mA, and the adjusted main amplitude could be 2 mA. Therefore, processing circuitry 50 can program the second fraction to 35 / 64, which is effectively equal to 1.09 mA, but the 35 / 64 fraction will keep the second current amplitude as close as possible to 1.1 mA. However, when displaying the current value, user interface 59 can round 1.09 mA to 1.1 mA, so for the user, the second current remains the same, despite the adjustment of the second fraction and the main amplitude.

[0089] In some examples, during the transition from the first current amplitude to the subsequent current amplitude, the electrical stimulator 4 continues to deliver electrical stimulation to the patient 6, thereby preventing the need for ramp-up intensity after the transition. Although in some examples the user may be limited to adjusting the current amplitude of one electrode at a time, some examples allow the user to adjust the current amplitude of multiple electrodes simultaneously. For example, the user may be able to input the desired current amplitude of multiple electrodes at once, and thus the processing circuitry system 50 can select specific fractional adjustments according to various techniques of this disclosure.

[0090] In an example involving processing circuitry 53 determining fraction and main amplitude adjustments based on user input, processing circuitry 53 may be configured to provide adjustment instructions to processing circuitry 50 via telemetry circuitry 53. Similarly, processing circuitry 50 may be configured to receive adjustment instructions from processing circuitry 53 via telemetry circuitry 58. In any case, adjustment instructions output to electrostimulator 4 (e.g., stimulation generator 60) may include fraction values, amplitude values, or combinations thereof. For example, programmer 40 may output adjustment instructions to electrostimulator 4 instructing stimulation generator 60 to adjust the fraction value of any of the electrodes 48 from a first fraction to an adjusted fraction to achieve the desired current amplitude defined by user input.

[0091] Figure 7 It shows relative to Figure 6 A flowchart illustrating the difference between the first and second fractional adjustments achieved by the method described above. Although described as being performed by the electrical stimulator 4, Figure 7 The exemplary method may also be performed by any one or more of the electrical stimulator 4, programmer 40, external device or server (e.g., remote server) or a combination of one or more of these devices, for example by the processing circuitry system of any one or more of these devices.

[0092] In an example involving adjustment of the current amplitude of the first electrode 48A, the processing circuit system 50 may determine whether to implement a first fractional adjustment scheme or a second fractional adjustment scheme (702). As described above, the processing circuit system 50 may utilize either the first fractional adjustment or the second fractional adjustment based at least in part on a comparison of the desired current amplitude of the first electrode and the main current amplitude.

[0093] When the first fraction adjustment is used, the processing circuit system 50 can adjust the first fraction (704) relative to the electrode 48A. It should be noted that when the first fraction adjustment is used as the target adjustment, the first fraction is adjusted, and the second fraction can also be adjusted.

[0094] When using the second fraction adjustment, the processing circuit system 50 can adjust the second fraction relative to electrode 48B (706). Additionally, the processing circuit system 50 can adjust the main amplitude (708). It should be noted that when using the second fraction adjustment as the target adjustment, adjusting the second fraction adjusts the main amplitude, and the first fraction can also be adjusted. However, in some cases, the first fraction may not be adjusted based on the desired change in current amplitude, current electrode configuration, and / or current main amplitude. The processing circuit system 50 can generate instructions (e.g., adjustment instructions) (710) for the stimulation generator 60 to deliver a first stimulation pulse via the first electrode 48A and a second stimulation pulse via the second electrode 48B based on the target adjustment.

[0095] While the first and second fractional adjustment schemes are described as potential target adjustments, the technology disclosed herein is not limited thereto. In some examples, the processing circuitry 50 may perform a combination of the first and second fractional adjustment schemes. For example, the processing circuitry 50 may switch between the first and second fractional adjustments to achieve a desired current amplitude. In one example, the processing circuitry 50 may perform a first fractional adjustment to adjust the fraction of the first electrode 48A. The processing circuitry 50 may determine that the adjustment of the fraction of the first electrode 48A causes the triggering of the main amplitude to be adjusted along with the main amplitude. For example, the first electrode 48A may be the electrode that drives the main amplitude, because the first electrode 48A delivers the highest amplitude beyond other electrodes, so the main amplitude may follow or be driven by the highest amplitude delivered to the electrode. However, the adjustment of the fraction of the first electrode 48A may include reducing the fraction of the first electrode 48A to achieve a desired current amplitude smaller than the main amplitude. Additionally, the reduction in the amplitude of the first electrode 48A may be smaller than the amplitude of the second electrode 48B. In such cases, the other electrode may become the driving electrode, and the main amplitude may not decrease below the current amplitude defined for the second electrode 48B. Therefore, a combination of a first fractional adjustment scheme and a second fractional adjustment scheme may be needed to continuously or iteratively adjust the main amplitude, the first fraction of the first electrode 48A, and the second fraction of the second electrode 48A. For example, the processing circuit system 50 may perform an iterative process between each of the first and second fractional adjustment schemes until all stimulation pulses reach the desired current amplitude.

[0096] It should be noted that in some cases, the principal amplitude can be adjusted before, simultaneously with, or after the adjustment of the second fraction. For example, if the target adjustment indicates an upward adjustment of the principal amplitude (e.g., increasing the principal amplitude), the fraction value can be changed first, and then the principal amplitude can be adjusted. In another example, if the target adjustment indicates a downward adjustment of the principal amplitude (e.g., decreasing the principal amplitude), the principal amplitude can be adjusted first, and then the fraction value can be adjusted. It should also be noted that although electrodes 48A and 48B are used to illustrate various electrodes in various examples of this disclosure, the technology of this disclosure is not limited thereto, and in accordance with the spirit of this disclosure, any electrode of the lead can be used as a first electrode or a second electrode.

[0097] Figure 8 This is a flowchart illustrating an exemplary method for adjusting the first current amplitude of the first electrode 48A while maintaining the current amplitude of the second electrode 48B, both electrodes having amplitudes defined by corresponding fractions of the adjustable main current amplitude. As described above, although described as being performed by an electrical stimulator 4, Figure 8 The exemplary method may also be performed by any one or more of the electrical stimulator 4, programmer 40, external device or server (e.g., remote server) or a combination of one or more of these devices, for example by the processing circuitry system of any one or more of these devices.

[0098] The processing circuit system 50 can receive user input (804) including a change in the amplitude of the first electrode 48A. In a non-limiting example, the user can provide user input requesting a change in the amplitude of the first electrode 48A to increase the electrical stimulation delivery from 1.0 mA to 1.1 mA, or from 1.0 mA to 0.9 mA. Therefore, the processing circuit system 50 can determine whether the adjustment of the amplitude of the first electrode 48A includes an increase or decrease in the amplitude of the first electrode 48A (806). If the user input indicates a request to increase the first current amplitude, the processing circuit system 50 can determine whether the desired current amplitude of the first electrode 48A includes an increase greater than the main current amplitude (808). If the desired current amplitude is greater than the main amplitude, the processing circuit system 50 can use a second fractional adjustment to achieve the desired current amplitude (812).

[0099] For example, if the principal amplitude is 1.0 mA and the user input includes a desired current amplitude of 1.0 mA to 1.1 mA, the principal amplitude can be increased to 1.1 mA to achieve the desired current amplitude of the first electrode 48A, so that the first fraction of the first electrode 48A remains unchanged. However, due to the increase in the principal amplitude, the second fraction can be adjusted relative to the adjustment of the principal amplitude in order to keep the second current amplitude at the same or approximately the same value before the user input. For example, the second current amplitude of the second electrode 48B may already be 0.5 mA before the processing circuit system 50 receives a user input requesting an increase in the first current amplitude of the first electrode 48A.

[0100] Therefore, in the example including 64 current regulator branches, the second fraction could be 32 / 64 before the change, so as to achieve 0.5mA on the second electrode 48B with a main amplitude of 1.0mA (i.e., 1.0mA*(32 / 64) = 0.5mA). As the main amplitude increases from 1.0mA to 1.1mA due to user input, in this example, the second fraction in this example can be reduced based on the fraction of the 1.1mA main amplitude to be as close as possible to 0.5mA. Specifically, the second fraction can be reduced to 29 / 64, or 29 of the 64 total current regulator branches, totaling approximately 0.498mA. Due to the specific rounding rules that the processing circuitry 50 may employ, 0.498mA on the user interface 59 can be rounded to 0.5mA, so for the user, the second amplitude will appear unaffected after the user requests a change to the first amplitude. That is, the second amplitude after adjusting to the second fraction can be approximately the same as the original second amplitude. In examples where the second fraction and the principal amplitude remain constant, the second amplitude can also remain the same. In any case, the second amplitude can be the same or approximately the same, meaning it is within a range that depends on the resolution available from the stimulus generator, or in other words, the total number of currently available modulator branches. This is because a single branch of the total number of branches can be fully realized to increase or decrease the fraction according to a finite step size (e.g., 1 / 64), and therefore, an approximation can be used to achieve an adjusted amplitude that is as close as possible to the original amplitude as a function of the principal amplitude.

[0101] If the desired current amplitude is less than the main amplitude, the processing circuit system 50 can determine whether the first fraction of the first electrode 48A is at its maximum value or at least greater than the second fraction of the second electrode 48B (810). If so, the processing circuit system 50 can use the second fraction adjustment (812). Otherwise, the processing circuit system 50 can use the first fraction adjustment (814). For example, the processing circuit system 50 can use the first fraction adjustment to increase the first fraction. In the case of using the second fraction adjustment, the processing circuit system 50 can use the second fraction adjustment to increase the main amplitude and decrease the second fraction of the electrode 48B in order to achieve the desired current amplitude of the first stimulation pulse of the first electrode 48A.

[0102] If the user inputs a request to reduce the amplitude of the first current, the processing circuit system 50 can automatically determine that if the main current amplitude does not decrease accordingly, the desired reduction in the first current amplitude will result in an amplitude smaller than the main current amplitude (806). In either case, the processing circuit system 50 can determine whether the first fraction is the only fraction at the maximum fraction value or a second fraction at least greater than the second electrode 48B (816). In some cases, to determine whether the first fraction is the only fraction at the maximum fraction value, the processing circuit system 50 can determine that the first fraction of the first electrode 48A is at the maximum fraction value defined for the first electrode 48A and the second fraction of the second electrode 48B is not at the maximum fraction value defined for the second electrode 48B. If so, the processing circuit system 50 can use the second fraction adjustment scheme as the target adjustment (812). Otherwise, the processing circuit system 50 can use the first fraction adjustment (814). For example, the processing circuit system 50 can use the first fraction adjustment to reduce the first fraction. When using the second fractional adjustment, the processing circuit system 50 can use the second fractional adjustment to reduce the main amplitude and increase the second fraction of the electrode 48B in order to achieve the desired current amplitude of the first stimulation pulse of the first electrode 48A.

[0103] Figure 9 This is a flowchart illustrating an exemplary method for performing the techniques of this disclosure relative to bipolar and monopolar arrangements. As described above, although described as being performed by an electrical stimulator 4, Figure 9 The exemplary method may also be performed by any one or more of the electrical stimulator 4, programmer 40, external device or server (e.g., remote server) or a combination of one or more of these devices, for example by the processing circuitry system of any one or more of these devices.

[0104] First, the processing circuit system 50 can receive a user input (902) that includes a desired increase in the current amplitude of the first electrode. For simplicity, the first electrode is... Figure 9The cathode electrode can be indicated by "C0". In this example, at least three cathode electrodes are described (e.g., C0-C2). However, the number of electrodes may be more or less than three, with three electrodes selected for illustrative purposes. Other electrodes including the suffix "A" may indicate the anode electrode. The processing circuitry 50 can determine, in a first case, whether the electrode configuration supports a bipolar arrangement with at least one adjusted anode or a bipolar arrangement with at least one unadjusted anode (904). The processing circuitry 50 can receive information about a particular arrangement before adjusting the current amplitude. For example, the processing circuitry 50 can store in memory 52 which type of electrode arrangement is used during the initial configuration phase.

[0105] A unipolar stimulation arrangement (e.g., monopolar) typically refers to the use of an anode that provides current on the housing and one or more cathodes that absorb current on one or more leads. A bipolar stimulation arrangement typically refers to the use of an anode that absorbs current on a lead and a cathode that absorbs current on the same lead and / or another lead. A multipolar stimulation arrangement typically refers to the use of one or more anodes (cathodes) that each provide (absorb) current on a lead and one or more electrodes (anodes) that absorb (provide) current on the same lead or another lead, or an anode that provides current on the same lead or another lead and multiple cathodes on a lead. A hybrid stimulation arrangement combining both unipolar and bipolar electrode relationships can be referred to as a holographic arrangement. The techniques disclosed herein can be implemented using unipolar, bipolar / multipolar, and holographic arrangements.

[0106] In an exemplary example, a bipolar stimulation device may include at least three electrodes, wherein a third electrode provides a return path for the other two electrodes. In a unipolar stimulation arrangement, a third electrode may be included, but in such a unipolar configuration, the third electrode may not be used to provide any return path.

[0107] In a unipolar configuration, the processing circuitry 50 can determine whether C0 is at its maximum fraction or at least greater than the second fraction of any of the second electrodes C1-C2 (920). If so, the processing circuitry 50 can use a second fraction adjustment (908). When using the second fraction adjustment, the processing circuitry 50 can use it to increase the main amplitude (910). The processing circuitry 50 can also decrease or reduce the second fraction of electrodes C1-C2 to achieve the desired current amplitude of the first stimulation pulse of the first electrode C1. If C0 is not at its maximum fraction, the processing circuitry 50 can use a first fraction adjustment (914). For example, the processing circuitry 50 can use the first fraction adjustment to increase the first fraction of C0 (916). Additionally, the processing circuitry 50 can maintain the C1-C2 fractions at their original values ​​before requesting adjustment of the current amplitude of the first stimulation pulse of the first electrode C1.

[0108] In a bipolar configuration, the processing circuit system 50 can determine whether C0 is at its maximum fraction or at least greater than the second fraction of any of the second electrodes C1-C2 (920). If so, the processing circuit system 50 can use a second fraction adjustment (922). When using the second fraction adjustment, the processing circuit system 50 can use it to increase the main amplitude (924). The processing circuit system 50 can also decrease the second fraction of electrodes C1-C2. Additionally, the processing circuit system 50 can increase the fraction associated with electrodes A0-A2. If C0 is not at its maximum fraction, the processing circuit system 50 can use a first fraction adjustment (914). For example, the processing circuit system 50 can use the first fraction adjustment to increase the first fraction of C0 (916). Furthermore, the processing circuit system 50 can maintain the C1-C2 fractions at their original values ​​before requesting adjustment of the current amplitude of the first stimulation pulse of the first electrode C1. Additionally, the processing circuit system 50 can increase the fraction associated with electrodes A0-A2. Figure 10 This is an example user interface screen for programmer 40. Figure 10 In this example, the user interface 59 of the programmer 40 can digitally display the stimulation amplitude associated with the electrode. In this example, Figure 10 Segmented leads are shown, wherein the segmented electrodes may have stimulation amplitudes that can be adjusted according to various techniques of this disclosure.

[0109] exist Figure 10 The diagram depicts adjacent electrodes 78A and 78B, showing two numbers. In some examples, the top number of field 214A may indicate the desired current amplitude to be provided or absorbed by the first electrode (e.g., electrode 78A). The bottom number of field 214B may indicate the stimulation amplitude to be provided or absorbed by the second electrode (e.g., electrode 78B), which is not used as an adjustment target in certain exemplary examples of this disclosure. However, in some examples, two or more electrodes 78A and 78B may be used as adjustment targets. For example, according to various techniques of this disclosure, lead 12 may include three electrodes, with two electrodes adjusted in parallel. Figure 10 A window 210 displaying the main current amplitude is also shown. In the example involving 64 current regulator branches, electrode 78B can achieve 64 / 64 branches, while electrode 78A can achieve 35 / 64 branches (e.g., 35 out of 64 branches), because 35 / 64 multiplied by the main current amplitude of 2.0 mA equals approximately 1.1 mA. As previously mentioned, the displayed current value can be rounded according to predefined rounding rules, but the actual amplitude may be greater or less than the displayed amplitude.

[0110] exist Figure 10In some examples, the user interface 59 also includes input devices (such as up / down arrows) to adjust the desired current amplitude. In some examples, the user interface 59 provides input devices and fillable fields, giving the user options on how they wish to provide input.

[0111] In some examples, the processing circuitry 50 may include a unit of measurement outputting a first current amplitude in milliampere units for display via a user interface, such as via user interface 59. For example, the processing circuitry 50 may provide a displayed value of electrode 78A of “1.09” (pre-rounded) or “1.1” (post-rounded) to a user interface device (such as user interface 59). The processing circuitry 50 may then receive user input from the user interface device 59 to define the desired current amplitude in milliampere units. For example, the user may require 2.2mA relative to electrode 78A. Therefore, the programmer 40 may transfer the desired current value to the processing circuitry 50. The processing circuitry 50 may perform adjustments according to various techniques of this disclosure. For example, the processing circuitry 50 may increase the main amplitude to 2.2 mA and decrease the fraction associated with electrode 78B from 64 / 64 to 58 / 64 to maintain the current amplitude of electrode 78B at 2.0 mA (or 1.99 mA pre-rounded), while also achieving the desired current amplitude of 2.2 A for electrode 78A by increasing the first fraction from 35 / 64 to 64 / 64. The processing circuitry 50 may then include a unit output of a milliampere measurement unit (i.e., 2.2 mA) to adjust the first current amplitude of the first stimulation pulse. For example, the processing circuitry 50 may output 2.2 mA to programmer 40 so that the milliampere value can be displayed via user interface 59.

[0112] In some examples, the processing circuitry 50 may also output a score corresponding to an adjustment to a first score or an adjustment to a second score for display via a user interface 59, wherein the score indicates a change in the contribution of a first or second electrode that defines the relative extent to which the corresponding electrode delivers the desired intensity to a particular region. The contribution of an electrode is the degree to which a given electrode delivers the desired intensity to a region. Electrode contributions may have values ​​between 0.0 and 1.0. A region may be a cathode (e.g., for stimulation) or an anode (e.g., for shielding / protection). The “contribution” of an electrode generally refers to the relative extent to which a given electrode delivers the desired intensity to a region of the recruiting electrode. Therefore, electrode contributions may have values ​​between 0.0 and 1.0. Electrode contributions are described in U.S. Patent No. 8,996,123 to Goetz et al., entitled “Managing Electrical Stimulation Therapy Based on Variable Electrode Combinations,” the entire contents of which are incorporated herein by reference. For example, Figure 10 The display window 240 may include a fractional, decimal, or percentage value indicating the level of contribution. However, since the user is adjusting the current amplitude, the display of fractional, decimal, or percentage values ​​may not provide information that the user can use when adjusting the current value using field 214 or its associated input device.

[0113] The following describes one or more exemplary techniques according to this disclosure. The exemplary techniques may be implemented together or in any combination.

[0114] Example 1: A neural modulation system comprising: a first electrode; a second electrode; a stimulation generator configured to deliver a first stimulation pulse to the first electrode and a second stimulation pulse to the second electrode, wherein a first current amplitude of the first stimulation pulse is a first fraction of a main amplitude and a second current amplitude of the second stimulation pulse is a second fraction of the main amplitude; and a processor configured to: generate initial instructions for the stimulation generator to perform the following operations: (i) deliver the first analog pulse based on the first fraction of the main amplitude, and (ii) deliver the second stimulation pulse based on the second fraction of the main amplitude; and receive a desired current. The processor is configured to: receive user input of amplitude; determine, based on the desired current amplitude, the required adjustment of the first current amplitude of the first stimulation pulse; and determine a target adjustment at least partially based on a comparison of the desired current amplitude with the main amplitude, wherein the processor is further configured to: (A) determine an adjustment to at least the first fraction as the target adjustment, or (B) determine the following as the target adjustment: (i) an adjustment to the main amplitude, and (ii) an adjustment to at least the second fraction relative to the main amplitude; and generate, at least partially based on the target adjustment, an adjustment instruction for the stimulation generator to deliver the first stimulation pulse with the desired current amplitude and the second stimulation pulse with approximately the same second current amplitude.

[0115] Example 2: According to the system of Example 1, wherein, in order to determine the adjustment required for the first current amplitude of the first stimulation pulse based on the desired current amplitude, the processor is configured to determine that the user input requires a reduction in the first current amplitude of the first stimulation pulse; and wherein, in order to determine the adjustment for at least the first fraction as the target adjustment, the processor is configured to determine that the adjustment for the first fraction includes increasing the first fraction when (i) the first fraction is not at its maximum value and (ii) the desired current amplitude is less than the main amplitude.

[0116] Example 3: According to the system of Example 1, wherein, in order to determine the adjustment required for the first current amplitude of the first stimulation pulse based on the desired current amplitude, the processor is configured to determine that the user input requires a reduction in the first current amplitude of the first stimulation pulse; and wherein, in order to determine the adjustment for at least the first score as the target adjustment, the processor is configured to determine that the adjustment for the first score includes reducing the first score when the first score is not at its maximum value.

[0117] Example 4: According to the system of Example 1, wherein, in order to determine the adjustment required for the first current amplitude of the first stimulation pulse based on the desired current amplitude, the processor is configured to determine that the user input requires an increase in the first current amplitude of the first stimulation pulse; and wherein, in order to determine the adjustment of the main amplitude and the adjustment of at least the second fraction as the target adjustment, the processor is configured to, when the desired current amplitude is greater than the main amplitude, determine that: the adjustment of the main amplitude includes increasing the main amplitude; and the adjustment of at least the second fraction includes decreasing the second fraction relative to the increase of the main amplitude.

[0118] Example 5: According to the system of Example 1, wherein, in order to determine the adjustment required for the first current amplitude of the first stimulation pulse based on the desired current amplitude, the processor is configured to determine that the user input requires a reduction in the first current amplitude of the first stimulation pulse; and wherein, in order to determine the adjustment of the main amplitude and the adjustment of at least the second fraction as the target adjustment, the processor is configured to determine, when the first fraction is at a maximum fraction value defined for the first electrode and the second fraction is not at a maximum fraction value defined for the second electrode: the adjustment of the main amplitude includes reducing the main amplitude; and the adjustment of at least the second fraction includes increasing the second fraction relative to the reduction of the main amplitude.

[0119] Example 6: The system according to Example 5, wherein the processor is further configured to: increase the second fraction by a first amount based on the reduction of the main amplitude, so as to keep the second current amplitude at approximately the same amplitude relative to the original second current amplitude.

[0120] Example 7: The system according to any one of Examples 1 to 6, wherein the processor is further configured to: output the first current amplitude in a measurement unit including milliampere units for display via a user interface; receive, via the user interface, the user input defining the desired current amplitude in a measurement unit including milliampere units; and output, in a measurement unit including milliampere units, the adjustment of the first current amplitude of the first stimulation pulse for display via the user interface.

[0121] Example 8: The system according to any one of Examples 1 to 7, wherein the processor is further configured to output a score value corresponding to the adjustment of the first score or the adjustment of the second score as part of the adjustment instruction to the stimulation generator, wherein the score value indicates a change in the contribution of the first electrode or the second electrode to the relative extent that the corresponding electrode delivers the desired intensity to a specific area.

[0122] Example 9: A method of performing neural modulation includes: generating initial instructions for the stimulation generator to perform: (i) delivering a first analog pulse based on a first fraction of the principal amplitude, and (ii) delivering a second stimulation pulse based on a second fraction of the principal amplitude; receiving user input including a desired current amplitude; determining, based on the desired current amplitude, an adjustment of the first current amplitude of the first stimulation pulse that needs to be performed; and determining a target adjustment based at least in part on a comparison of the desired current amplitude with the principal amplitude, wherein the method further includes: (A) determining an adjustment to at least the first fraction as the target adjustment, or (B) determining the following as the target adjustment: (i) an adjustment to the principal amplitude, and (ii) an adjustment to at least the second fraction relative to the principal amplitude; and generating, at least in part, adjustment instructions for the stimulation generator to deliver the first stimulation pulse with the desired current amplitude and the second stimulation pulse with a substantially similar second current amplitude based on the target adjustment.

[0123] Example 10: According to the method of Example 9, wherein determining the adjustment of the first current amplitude of the first stimulation pulse based on the desired current amplitude includes determining that the user input requires an increase in the first current amplitude of the first stimulation pulse; and wherein determining the adjustment of at least the first score as the target adjustment includes, when (i) the first score is not at the maximum score and (ii) the desired current amplitude is less than the main amplitude, determining that the adjustment of the first score includes increasing the first score.

[0124] Example 11: According to the method of Example 9, wherein determining the adjustment of the first current amplitude of the first stimulation pulse based on the desired current amplitude includes determining that the user input requires a reduction of the first current amplitude of the first stimulation pulse; and wherein determining the adjustment of at least the first score as the target adjustment includes, when the first score is not at its maximum value, determining that the adjustment of the first score includes reducing the first score.

[0125] Example 12: According to the method of Example 9, wherein determining the adjustment of the first current amplitude of the first stimulation pulse based on the desired current amplitude includes determining that the user input requires an increase in the first current amplitude of the first stimulation pulse; and wherein determining the adjustment of the main amplitude and the adjustment of at least the second fraction as the target adjustment includes, when the desired current amplitude is greater than the main amplitude, determining that: the adjustment of the main amplitude includes increasing the main amplitude; and the adjustment of the second fraction includes decreasing the second fraction relative to the increase of the main amplitude.

[0126] Example 13: According to the method of Example 9, wherein determining the adjustment of the first current amplitude of the first stimulation pulse based on the desired current amplitude includes determining that the user input requires a reduction in the first current amplitude of the first stimulation pulse; and wherein determining the adjustment of the main amplitude and the adjustment of at least the second fraction as the target adjustment includes, when the first fraction is at a maximum fraction value defined for the first electrode and the second fraction is not at a maximum fraction value defined for the second electrode, determining that: the adjustment of the main amplitude includes reducing the main amplitude; and the adjustment of the second fraction includes increasing the second fraction relative to the reduction of the main amplitude.

[0127] Example 14: According to the method of Example 13, the method further includes increasing the second fraction by a first amount based on the reduction of the main amplitude, so as to keep the second current amplitude at approximately the same amplitude relative to the original second current amplitude.

[0128] Example 15: The method according to any one of Examples 9 to 14, further comprising: outputting the first current amplitude in a measurement unit including milliampere units for display via a user interface; receiving, via the user interface, the user input defining the desired current amplitude in a measurement unit including milliampere units; and outputting, in a measurement unit including milliampere units, the adjustment of the first current amplitude of the first stimulation pulse for display via the user interface.

[0129] Example 16: The method according to any one of Examples 9 to 15, further comprising outputting a score value corresponding to the adjustment of the first score or the adjustment of the second score as part of the adjustment instruction to the stimulation generator, wherein the score value indicates a change in the contribution of the first electrode or the second electrode to the relative extent that the respective electrode delivers the desired intensity to a specific region.

[0130] Example 17: A computer-readable storage medium having instructions thereon that, when executed, cause one or more processors to at least: generate initial instructions for the stimulus generator to: (i) deliver the first analog pulse based on the first fraction of the main amplitude, and (ii) deliver the second stimulus pulse based on the second fraction of the main amplitude; receive user input including a desired current amplitude; determine, based on the desired current amplitude, that an adjustment of the first current amplitude of the first stimulus pulse is required; determine, at least in part, a target adjustment based on a comparison of the desired current amplitude with the main amplitude, the target adjustment including (i) an adjustment to at least the first fraction, or (ii) an adjustment to the main amplitude and an adjustment of at least the second fraction relative to the adjustment to the main amplitude; and generate, at least in part, adjustment instructions for the stimulus generator to deliver the first stimulus pulse with the desired current amplitude and the second stimulus pulse with a substantially similar second current amplitude, based on the target adjustment.

[0131] Example 18: According to the non-transitory computer-readable storage medium of Example 17, wherein, in order to determine the adjustment required for the first current amplitude of the first stimulus pulse based on the desired current amplitude, the instruction, when executed, causes the one or more processors to at least determine that the user input requires an increase in the first current amplitude of the first stimulus pulse; and wherein the adjustment for at least the first fraction includes increasing the first fraction when (i) the first fraction is not at the maximum value of the fraction, and (ii) the desired current amplitude is less than the dominant amplitude.

[0132] Example 19: According to the non-transitory computer-readable storage medium of Example 17, wherein, in order to determine the adjustment required for the first current amplitude of the first stimulus pulse based on the desired current amplitude, the instruction, when executed, causes the one or more processors to at least determine that the user input requires a reduction in the first current amplitude of the first stimulus pulse; and wherein the adjustment for at least the first fraction includes reducing the first fraction when the first fraction is not at its maximum value.

[0133] Example 20: According to the non-transitory computer-readable storage medium of Example 17, wherein, in order to determine the adjustment required for the first current amplitude of the first stimulation pulse based on the desired current amplitude, the instruction, when executed, causes the one or more processors to at least determine that the user input requires an increase in the first current amplitude of the first stimulation pulse; and wherein, when the desired current amplitude is greater than the principal amplitude, the adjustment of the principal amplitude and the adjustment of at least the second fraction include increasing the principal amplitude; and decreasing the second fraction relative to the increase of the principal amplitude.

[0134] The techniques described in this disclosure can be implemented, at least in part, in hardware, software, firmware, or any combination thereof. For example, aspects of these techniques can be implemented in one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuits, and any combination of these components, embodied in programmers such as doctor or patient programmers, stimulators, or other devices. The terms “processor,” “processing circuit system,” or “controller” generally refer to any of the aforementioned logic circuit systems (alone or in combination with other logic circuit systems) or any other equivalent circuit system (alone or in combination with other digital or analog circuit systems).

[0135] For the software-implemented aspects, at least some of the functions attributable to the systems and apparatus described in this disclosure can be embodied as instructions on a computer-readable storage medium such as RAM, ROM, NVRAM, EEPROM, flash memory, magnetic storage, optical media, etc. These instructions are executable to support one or more aspects of the functions described in this disclosure.

[0136] Various aspects of this disclosure have been described. These and other aspects are within the scope of the following claims.

Claims

1. A neural modulation system, the neural modulation system comprising: First electrode; Second electrode; A stimulation generator configured to deliver a first stimulation pulse to a first electrode and a second stimulation pulse to a second electrode, wherein a first current amplitude of the first stimulation pulse is a first fraction of a main amplitude and a second current amplitude of the second stimulation pulse is a second fraction of the main amplitude; and Processor, the processor being configured to: Generate initial instructions for the stimulation generator to perform the following operations: (i) deliver the first stimulation pulse based on the first fraction of the main amplitude, and (ii) deliver the second stimulation pulse based on the second fraction of the main amplitude; Receive user input including the desired current amplitude; Based on the desired current amplitude, determine the adjustment required for the first current amplitude of the first stimulation pulse; and The target adjustment is determined at least in part based on a comparison between the desired current amplitude and the principal amplitude. The processor is further configured as follows: (A) Determine an adjustment to at least the first score as the target adjustment, or (B) Determine the following as adjustments to the stated objectives: (i) Adjustment of the principal amplitude, and (ii) Adjustment of at least the second fraction relative to the principal amplitude; and Based at least in part on the target adjustment, adjustment instructions are generated for the stimulation generator to deliver the first stimulation pulse with the desired current amplitude and the second stimulation pulse with approximately the same second current amplitude.

2. The system according to claim 1, Wherein, to determine the required adjustment of the first current amplitude of the first stimulation pulse based on the desired current amplitude, the processor is configured to determine that the user input requires an increase in the first current amplitude of the first stimulation pulse; and In order to determine the adjustment of at least the first score as the target adjustment, the processor is configured to determine that the adjustment of the first score includes increasing the first score when (i) the first score is not at its maximum value and (ii) the desired current amplitude is less than the main amplitude.

3. The system according to claim 1, Wherein, to determine the required adjustment of the first current amplitude of the first stimulation pulse based on the desired current amplitude, the processor is configured to determine that the user input requires a reduction in the first current amplitude of the first stimulation pulse; and Wherein, in order to determine the adjustment for at least the first score as the target adjustment, the processor is configured to determine that the adjustment for the first score includes reducing the first score when the first score is not at the maximum score.

4. The system according to claim 1, Wherein, to determine the required adjustment of the first current amplitude of the first stimulation pulse based on the desired current amplitude, the processor is configured to determine that the user input requires an increase in the first current amplitude of the first stimulation pulse; and Wherein, to determine the adjustment to the principal amplitude and the adjustment to at least the second fraction as the target adjustment, the processor is configured to determine, when the desired current amplitude is greater than the principal amplitude: The adjustment to the principal amplitude includes increasing the principal amplitude; and The adjustment to at least the second fraction includes reducing the second fraction relative to the increase in the principal amplitude.

5. The system according to claim 1, Wherein, to determine the required adjustment of the first current amplitude of the first stimulation pulse based on the desired current amplitude, the processor is configured to determine that the user input requires a reduction in the first current amplitude of the first stimulation pulse; and Wherein, to determine the adjustment to the main amplitude and the adjustment to at least the second fraction as the target adjustment, the processor is configured to determine, when the first fraction is at a maximum fraction value defined for the first electrode and the second fraction is not at a maximum fraction value defined for the second electrode: The adjustment of the principal amplitude includes reducing the principal amplitude; and The adjustment to at least the second fraction includes increasing the second fraction relative to the reduction of the principal amplitude.

6. The system of claim 5, wherein the processor is further configured to: Based on the reduction of the main amplitude, the second fraction is increased by a first amount to keep the second current amplitude at approximately the same amplitude relative to the original second current amplitude.

7. The system according to any one of claims 1 to 6, wherein the processor is further configured to: The first current amplitude is output in a measurement unit including milliampere for display via a user interface; Receive, via the user interface, the user input defining the desired current amplitude in a measurement unit including milliampere units; and The adjustment of the first current amplitude of the first stimulation pulse is output in measurement units including milliampere units for display via the user interface.

8. The system according to any one of claims 1 to 6, wherein the processor is further configured to: The score value corresponding to the adjustment of the first score or the adjustment of the second score is output to the stimulus generator as part of the adjustment instruction, wherein the score value indicates the change in the contribution of the first electrode or the second electrode to the relative extent that the corresponding electrode delivers the desired intensity to a specific area.

9. A method for adjusting the amplitude of electrical stimulation, the method comprising: Generate initial instructions for the stimulus generator to perform the following operations: (i) deliver a first stimulus pulse based on a first fraction of the main amplitude, and (ii) deliver a second stimulus pulse based on a second fraction of the main amplitude; Receive user input including the desired current amplitude; Based on the desired current amplitude, the adjustment required for the first current amplitude of the first stimulation pulse is determined; as well as The target adjustment is determined at least in part based on a comparison between the desired current amplitude and the principal amplitude. The method further includes: (A) Determine an adjustment to at least the first score as the target adjustment, or (B) Determine the following as adjustments to the stated objectives: (i) Adjustment of the principal amplitude, and (ii) Adjustment of at least the second fraction relative to the principal amplitude; and Based at least in part on the target adjustment, adjustment instructions are generated for the stimulation generator to deliver the first stimulation pulse with the desired current amplitude and the second stimulation pulse with approximately the same second current amplitude.

10. The method according to claim 9, The determination of the required adjustment to the first current amplitude of the first stimulation pulse based on the desired current amplitude includes determining that the user input requires an increase in the first current amplitude of the first stimulation pulse; and The determination of the adjustment of at least the first fraction as the target adjustment includes, when (i) the first fraction is not at its maximum value and (ii) the desired current amplitude is less than the principal amplitude, determining the adjustment of the first fraction includes increasing the first fraction.

11. The method according to claim 9, The determination of the adjustment required for the first current amplitude of the first stimulation pulse based on the desired current amplitude includes determining that the user input requires a reduction in the first current amplitude of the first stimulation pulse; and The determination of the adjustment to at least the first score as the target adjustment includes, when the first score is not at the maximum score, determining the adjustment to the first score includes reducing the first score.

12. The method according to claim 9, The determination of the adjustment required for the first current amplitude of the first stimulation pulse based on the desired current amplitude includes determining that the user input requires an increase in the first current amplitude of the first stimulation pulse; And determining the adjustment to the principal amplitude and the adjustment to at least the second fraction as the target adjustment includes determining, when the desired current amplitude is greater than the principal amplitude: The adjustment to the principal amplitude includes increasing the principal amplitude; and The adjustment to the second fraction includes decreasing the second fraction relative to the increase in the principal amplitude.

13. The method according to claim 9, The determination of the adjustment required for the first current amplitude of the first stimulation pulse based on the desired current amplitude includes determining that the user input requires a reduction in the first current amplitude of the first stimulation pulse; And wherein determining the adjustment of the main amplitude and the adjustment of at least the second fraction as the target adjustment includes determining, when the first fraction is at a maximum fraction value defined for the first electrode and the second fraction is not at a maximum fraction value defined for the second electrode: The adjustment of the principal amplitude includes reducing the principal amplitude; and The adjustment to the second fraction includes increasing the second fraction relative to the reduction in the principal amplitude.

14. The method of claim 13, further comprising: Based on the reduction of the main amplitude, the second fraction is increased by a first amount to keep the second current amplitude at approximately the same amplitude relative to the original second current amplitude.

15. A computer-readable storage medium having instructions stored thereon, which, when executed, cause one or more processors to perform the method according to any one of claims 9 to 14.

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