This document relates generally to medical devices and more particularly to a user interface for neurostimulation programming including composition of stimulation waveforms.
Neurostimulation, also referred to as neuromodulation, has been proposed as a therapy for a number of conditions. Examples of neurostimulation include Spinal Cord Stimulation (SCS), Deep Brain Stimulation (DBS), Peripheral Nerve Stimulation (PNS), and Functional Electrical Stimulation (FES). Implantable neurostimulation systems have been applied to deliver such a therapy. An implantable neurostimulation system may include an implantable neurostimulator, also referred to as an implantable pulse generator (IPG), and one or more implantable leads each including one or more electrodes. The implantable neurostimulator delivers neurostimulation energy through one or more electrodes placed on or near a target site in the nervous system. An external programming device is used to program the implantable neurostimulator with stimulation parameters controlling the delivery of the neurostimulation energy.
In one example, the neurostimulation energy is delivered in the form of electrical neurostimulation pulses. The delivery is controlled using stimulation parameters that specify spatial (where to stimulate), temporal (when to stimulate), and informational (patterns of pulses directing the nervous system to respond as desired) aspects of a pattern of neurostimulation pulses. Many current neurostimulation systems are programmed to deliver periodic pulses with one or a few uniform waveforms continuously or in bursts. However, the human nervous systems use neural signals having much more sophisticated patterns to communicate various types of information, including sensations of pain, pressure, temperature, etc. The nervous system may interpret an artificial stimulation with a simple pattern of stimuli as an unnatural phenomenon, and respond with an unintended and undesirable sensation and/or movement. For example, some neurostimulation therapies are known to cause paresthesia and/or vibration of non-targeted tissue or organ.
Recent research has shown that the efficacy and efficiency of certain neurostimulation therapies can be improved, and their side-effects can be reduced, by using patterns of neurostimulation pulses that emulate natural patterns of neural signals observed in the human body. While modern electronics can accommodate the need for generating such sophisticated pulse patterns, the capability of a neurostimulation system depends on its post-manufacturing programmability to a great extent. For example, a sophisticated pulse pattern may only benefit a patient when it is customized for that patient, and stimulation patterns predetermined at the time of manufacturing may substantially limit the potential for the customization. Such customization may be performed at least in part by a user such as a physician or other caregiver with the patient in a clinical setting.
An example (e.g., “Example 1”) of a system for use by a user to program a neurostimulator configured to deliver neurostimulation to a patient may include a first storage device and a first user interface. The first storage device may be configured to store waveform building blocks. The first user interface may include a first display screen, a first user input device, and a first interface control circuit coupled to the first display screen and the first user input device. The first interface control circuit may include a waveform composer configured to allow for composition of one of more building blocks of the waveform building blocks and composition of a pattern of the neurostimulation pulses using one of more building blocks selected from the waveform building blocks. The waveform composer may include a library controller and a plurality of waveform building block editors. The library controller may be configured to display a library management area on the screen. The displayed library management area allows the user to manage the waveform building blocks stored in the storage device. The waveform building block editors may each be configured to allow the user to compose a type of the waveform building blocks of a plurality of types of the waveform building blocks.
In Example 2, the subject matter of Example 1 may optionally be configured to further include a programming control circuit configured to generate a plurality of stimulation parameters controlling delivery of neurostimulation pulses from the neurostimulator according to the pattern of the neurostimulation pulses.
In Example 3, the subject matter of Example 2 may optionally be configured to further include a remote device and an external programming device. The remote device includes the first storage device and the first user interface. The external programming device includes the programming control circuit.
In Example 4, the subject matter of Example 3 may optionally be configured such that the external programming device is configured to import one or more of one or more waveform building blocks of the waveform building blocks or the pattern of the neurostimulation pulses from the remote device. The external programming device includes a second user interface including a second display screen, a second user input device, and a second interface control circuit coupled to the second display screen and the second user input device. The second interface control circuit includes a stimulation adjuster configured to allow for adjustment of the imported one or more of the one or more waveform building blocks of the waveform building blocks or the pattern of the neurostimulation pulses.
In Example 5, the subject matter of any one or any combination of Examples 1 to 4 may optionally be configured such that the waveform composer is configured to allow the delivery of the neurostimulation pulses to be turned on and off by the user during the composition of the one or more building blocks of the waveform building blocks and during the composition of the pattern of the neurostimulation pulses.
In Example 6, the subject matter of any one or any combination of Examples 1 to 5 may optionally be configured such that the waveform composer is configured to allow one of the library controller and editors of the plurality of waveform building block editors to be selected by the user for access one at a time.
In Example 7, the subject matter of Example 6 may optionally be configured such that the library controller is configured to display the library management area on the screen in response to a user selection for access to the library controller, and the library management area displays the waveform building blocks each selectable for editing by a corresponding editor of the plurality of waveform building block editors.
In Example 8, the subject matter of Example 7 may optionally be configured such that the library controller is further configured to allow for importation of a new waveform building block to be added to the waveform building blocks in the first storage device.
In Example 9, the subject matter of Example 8 may optionally be configured such that the library controller is further configured to allow for exportation of a waveform building block selected from the waveform building blocks in the first storage device.
In Example 10, the subject matter of any one or any combination of Examples 6 to 9 may optionally be configured such that each editor of the plurality of waveform building block editors is configured to display a library area on the first screen in response to a user request for access to that editor. The library area lists available waveform building blocks of a type of the waveform building blocks of the plurality of types of the waveform building blocks.
In Example 11, the subject matter of Example 10 may optionally be configured such that each editor is configured to display a composition area for the type of the waveform building blocks on the first screen in response to a waveform building block being selected from the listed waveform building blocks. The composition area allows the user to edit the selected waveform building block or to create a new building block to be added to the waveform building blocks stored in the first storage device.
In Example 12, the subject matter of any one or any combination of Examples 6 to 11 may optionally be configured such that the plurality of waveform building block editors includes a pulse editor configured to display a pulse composition area on the first screen in response to a user selection for access to the pulse editor. The pulse composition area allows the user to compose a pulse of the waveform building blocks.
In Example 13, the subject matter of Example 12 may optionally be configured such that the plurality of waveform building block editors includes a burst editor configured to display a burst composition area on the first screen in response to a user selection for access to the burst editor. The burst composition area allows the user to compose a burst of the waveform building blocks, the burst including a group of the pulses.
In Example 14, the subject matter of Example 13 may optionally be configured such that the plurality of waveform building block editors includes a train editor configured to display a train composition area on the first screen in response to a user selection for access to the train editor. The train composition area allows the user to compose a train of the waveform building blocks, the train including a group of the bursts.
In Example 15, the subject matter of Example 14 may optionally be configured such that the plurality of waveform building block editors includes a sequence editor configured to display a sequence composition area on the first screen in response to a user selection for access to the sequence editor. The sequence composition area allows the user to compose a sequence of the waveform building blocks, the sequence including a group of the pulses, bursts, and trains.
An example (e.g., “Example 16”) of a method for operating an external system for programming an implantable neurostimulation device is also provided. The method may include storing waveform building blocks in a storage device of the external system and allowing a user to perform waveform composition using a user interface of the external system. The waveform composition may include composition of one of more building blocks of the waveform building blocks and composition of a pattern of the neurostimulation pulses using one of more building blocks selected from the waveform building blocks. Allowing the user to perform the waveform composition may include displaying a library management area on a screen of the user interface and allowing the user to select a waveform building block from the stored waveform building blocks and edit the selected waveform building block using the user input device. The displayed library management area may allow the user to manage the stored waveform building blocks using a user input device of the user interface.
In Example 17, the subject matter of Example 16 may optionally include allowing the user to perform the waveform composition using a remote device of the external system, and further include allowing another user to adjust the composed one of more building blocks of the waveform building blocks and the composed pattern of the neurostimulation pulses using an external programming device of the external system, the external programming device communicatively coupled to the remote device.
In Example 18, the subject matter of Example 17 may optionally further include generating a plurality of stimulation parameters controlling delivery of neurostimulation pulses from the neurostimulator according to the pattern of the neurostimulation pulses using the external programming device.
In Example 19, the subject matter of allowing the user to select the waveform building block from the stored waveform building blocks and edit the selected waveform building block as found in Example 16 may optionally include displaying a library area for a type of the waveform building blocks of a plurality of types of the waveform building blocks on the screen and displaying a composition area for the type of the waveform building blocks on the screen in response to the selection of the building block of the type of the waveform building blocks. The displayed library area allows the user to select a building block of the type of the waveform building blocks using the user input device. The displayed composition area allows the user to edit the selected building block of the type of the waveform building blocks using the user input device.
In Example 20, the subject matter of displaying the composition area as found in Example 19 may optionally further include displaying the composition area to allow the user to create a new building block to be added to the stored waveform building blocks.
In Example 21, the subject matter of Example 20 may optionally further include allowing the user to create a new building block to be added to the stored waveform building blocks, to import a building block to be added to the stored waveform building blocks, and to export a building block selected from the stored waveform building blocks.
In Example 22, the plurality of types of the waveform building blocks as found in Example 19 may optionally include pulses, bursts each including a group of the pulses, trains each including a group of the bursts, and sequences each including a group of the pulses, the bursts, and the trains.
This Summary is an overview of some of the teachings of the present application and not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details about the present subject matter are found in the detailed description and appended claims. Other aspects of the disclosure will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which are not to be taken in a limiting sense. The scope of the present disclosure is defined by the appended claims and their legal equivalents.
The drawings illustrate generally, by way of example, various embodiments discussed in the present document. The drawings are for illustrative purposes only and may not be to scale.
In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural, logical and electrical changes may be made without departing from the spirit and scope of the present invention. References to “an”, “one”, or “various” embodiments in this disclosure are not necessarily to the same embodiment, and such references contemplate more than one embodiment. The following detailed description provides examples, and the scope of the present invention is defined by the appended claims and their legal equivalents.
This document discusses a method and system for programming neurostimulation pulse patterns using a user interface, such as a graphical user interface (GUI). Advancements in neuroscience and neurostimulation research have led to a demand for using complex and/or individually optimized patterns of neurostimulation pulses for various types of therapies. The capability of a neurostimulation system in treating various types of disorders will be limited by the programmability of such patterns of neurostimulation pulses. In various embodiments, the present system allows for custom definition of a pattern of neurostimulation pulses, which includes custom definition of waveforms being the building blocks of the pattern. Such custom definition is achieved by using a user interface that makes it possible for the user to perform the custom definition of potentially very complex patterns of neurostimulation pulses by creating and editing graphical representations of relatively simple individual building blocks for each of the patterns. In various embodiments, the individually definable waveforms may include pulses, bursts of pulses, trains of bursts, and sequences of pulses, bursts, and trains. In various embodiments, the present system provides for patterns of neurostimulation pulses not limited to waveforms predefined at the time of manufacturing, thereby accommodating need for customization of neurostimulation pulse patterns as well as need for new types of neurostimulation pulse patterns that may, for example, result from future research in neurostimulation. This may also facilitate design of a general-purpose neurostimulation device that can be configured by a user for delivering specific types of neurostimulation therapies by programming the device using the user interface.
In various embodiments, the present system includes a neurostimulator programming device with a user interface that enables users to understand, manage, and program stimulation and create patterns of stimuli. Users of the programming device can have different levels of knowledge and expertise with respect to different aspects of programming a neurostimulator, as well as different needs and constraints. Examples include: a physician in an operation room may have very limited time for programming a neurostimulator for a patient under surgery; an academic researcher may have limited understanding of electrical engineering aspects of the stimulation; some users want to know what the stimuli look like; and some users may have limited understanding of anatomy, neuromodulation, and how electrical stimulation actually works. Therefore, the user interface provides access to different levels of access to various aspects of neurostimulation programming to reduce distraction, ensure accuracy and patient safety, and increase efficiency during programming of a neurostimulator.
In various embodiments, the user interface allows for neurostimulation programming starting with templates/presets to enable valuable time savings in defining stimulation waveforms. In various embodiments, the user interface provides for complete editorial control as well as simplified, guided, and template-based editorial options. In various embodiments, the user interface provides the user with interpretation of editorial features and guide rails.
In various embodiments, the present system may be implemented using is a combination of hardware and software designed to provide users such as researchers, physicians or other caregivers, or neurostimulation device makers with ability to create custom waveforms and patterns in an effort to increase therapeutic efficacy and/or patient satisfaction for neurostimulation therapies, including but not being limited to deep brain stimulation (DBS), spinal cord stimulation (SCS), peripheral nerve stimulation (PNS), and vagus nerve stimulation (VNS). While neurostimulation is specifically discussed as an example, the present subject matter may apply to any therapy that employs stimulation pulses of electrical or other form of energy.
In various embodiments, programming device 102 includes a user interface that allows the user to set and/or adjust values of the user-programmable parameters by creating and/or editing graphical representations of various waveforms. Such waveforms may include, for example, the waveform of a pattern of neurostimulation pulses to be delivered to the patient as well as waveform building blocks that can be used in the pattern of neurostimulation pulses. Examples of such waveform building blocks include pulses, bursts each including a group of the pulses, trains each including a group of the bursts, and sequences each including a group of the pulses, bursts, and trains, as further discussed below. In various embodiments, programming device 102 allows the user to edit existing waveform building blocks, create new waveform building blocks, import waveform building blocks created by other users, and/or export waveform building blocks to be used by other users. The user may also be allowed to define an electrode selection specific to each waveform building block. In the illustrated embodiment, the user interface includes a user interface 110. In various embodiments, user interface 110 may include a GUI or any other type of user interface accommodating various functions including waveform composition as discussed in this document.
In various embodiments, the number of leads and the number of electrodes on each lead depend on, for example, the distribution of target(s) of the neurostimulation and the need for controlling the distribution of electric field at each target. In one embodiment, lead system 208 includes 2 leads each having 8 electrodes.
In various embodiments, user interface 310 includes a waveform composer 320 that allows the user to manage the waveform building blocks, including creating and importing waveform building blocks to be added to the waveform building blocks stored in storage device 318, exporting waveform building blocks selected from the waveform building blocks stored in storage device 318, and editing each of the waveform building blocks. In various embodiments, user interface 310 includes a GUI that allows for graphical editing of each of the waveform building blocks. In various embodiments, waveform composer 320 allows the user to compose the pattern of neurostimulation pulses to be delivering to the patent using stimulation device 104 using waveform building blocks such as pulses, bursts each including a group of the pulses, trains each including a group of the bursts, and/or sequences each including a group of the pulses, bursts, and trains. In various embodiments, waveform composer 320 allows the user to create each waveform building block using one or more waveform building blocks stored in storage device 318 as templates. In various embodiments, waveform composer 320 allows each newly created waveform building block to be saved as additional waveform building block stored in storage device 318.
In one embodiment, user interface 310 includes a touchscreen. In various embodiments, user interface 310 includes any type of presentation device, such as interactive or non-interactive screens, and any type of user input devices that allow the user to edit the waveforms or building blocks and schedule the programs, such as touchscreen, keyboard, keypad, touchpad, trackball, joystick, and mouse. In various embodiments, circuits of neurostimulation 100, including its various embodiments discussed in this document, may be implemented using a combination of hardware and software. For example, the circuit of user interface 100, stimulation control circuit 214, and programming control circuit 316, including their various embodiments discussed in this document, may be implemented using an application-specific circuit constructed to perform one or more particular functions or a general-purpose circuit programmed to perform such function(s). Such a general-purpose circuit includes, but is not limited to, a microprocessor or a portion thereof, a microcontroller or portions thereof, and a programmable logic circuit or a portion thereof.
Implantable system 422 includes an implantable stimulator (also referred to as an implantable pulse generator, or IPG) 404, a lead system 424, and electrodes 406, which represent an embodiment of stimulation device 204, lead system 208, and electrodes 206, respectively. External system 402 represents an embodiment of programming device 302. In various embodiments, external system 402 includes one or more external (non-implantable) devices each allowing the user and/or the patient to communicate with implantable system 422. In some embodiments, external 402 includes a programming device intended for the user to initialize and adjust settings for implantable stimulator 404 and a remote control device intended for use by the patient. For example, the remote control device may allow the patient to turn implantable stimulator 404 on and off and/or adjust certain patient-programmable parameters of the plurality of stimulation parameters.
The sizes and sharps of the elements of implantable system 422 and their location in body 499 are illustrated by way of example and not by way of restriction. An implantable system is discussed as a specific application of the programming according to various embodiments of the present subject matter. In various embodiments, the present subject matter may be applied in programming any type of stimulation device that uses electrical pulses as stimuli, regarding less of stimulation targets in the patient's body and whether the stimulation device is implantable.
In various embodiments, sensing circuit 530 (if included), stimulation output circuit 212, stimulation control circuit 514, implant telemetry circuit 534, implant storage device 532, and power source 536 are encapsulated in a hermetically sealed implantable housing. In various embodiments, lead(s) 424 are implanted such that electrodes 406 are places on and/or around one or more targets to which the neurostimulation pulses are to be delivered, while implantable stimulator 404 is subcutaneously implanted and connected to lead(s) 424 at the time of implantation.
External telemetry circuit 646 provides external programming device 602 with wireless communication with another device such as implantable stimulator 404 via telemetry link 426, including transmitting the plurality of stimulation parameters to implantable stimulator 404. In one embodiment, external telemetry circuit 646 also transmits power to implantable stimulator 404 through the inductive couple.
External storage device 618 stores a plurality of waveform building blocks each selectable for use as a portion of the pattern of the neurostimulation pulses. In various embodiments, each waveform building block of the plurality of waveform building blocks includes one or more pulses of the neurostimulation pulses, and may include one or more other waveform building blocks of the plurality of waveform building blocks. Examples of such waveforms include pulses, bursts each including a group of the pulses, trains each including a group of the bursts, and sequences each including a group of the pulses, bursts, and trains. External storage device 618 also stores a plurality of stimulation fields. Each waveform building block of the plurality of waveform building blocks is associated with one or more fields of the plurality of stimulation fields. Each field of the plurality of stimulation fields is defined by one or more electrodes of the plurality of electrodes through which a pulse of the neurostimulation pulses is delivered and a current distribution of the pulse over the one or more electrodes.
Programming control circuit 616 represents an embodiment of programming control circuit 316 and generates the plurality of stimulation parameters, which is to be transmitted to implantable stimulator 404, according to the pattern of the neurostimulation pulses. The pattern is defined using one or more waveform building blocks selected from the plurality of waveform building blocks stored in external storage device 618. In various embodiment, programming control circuit 616 checks values of the plurality of stimulation parameters against safety rules to limit these values within constraints of the safety rules. In one embodiment, the safety rules are heuristic rules.
User interface 610 represents an embodiment of user interface 310 and allows the user to define the pattern of neurostimulation pulses and perform various other monitoring and programming tasks. In one embodiment, user interface 610 includes a GUI. User interface 610 includes a display screen 642, a user input device 644, and an interface control circuit 640. Display screen 642 may include any type of interactive or non-interactive screens, and user input device 644 may include any type of user input devices that supports the various functions discussed in this document, such as touchscreen, keyboard, keypad, touchpad, trackball, joystick, and mouse. In one embodiment, user interface 610 includes a GUI that has an interactive screen for displaying a graphical representation of a waveform building block and allows the user to adjust the waveform building block by graphically editing the waveform building block. User interface 610 may also allow the user to perform any other functions discussed in this document where graphical editing is suitable as may be appreciated by those skilled in the art.
Interface control circuit 640 controls the operation of user interface 610 including responding to various inputs received by user input device 644 and defining the one or more stimulation waveforms. Interface control circuit 640 includes waveform composer 320.
In various embodiments, external programming device 602 has operation modes including a composition mode and a real-time programming mode. Under the composition mode (also known as the pulse pattern composition mode), User interface 610 is activated, while programming control circuit 616 is inactivated. Programming control circuit 616 does not dynamically updates values of the plurality of stimulation parameters in response to any change in the one or more stimulation waveforms. Under the real-time programming mode, both user interface 610 and programming control circuit 616 are activated. Programming control circuit 616 dynamically updates values of the plurality of stimulation parameters in response to changes in the set of one or more stimulation waveforms, and transmits the plurality of stimulation parameters with the updated values to implantable stimulator 404.
In various embodiments, waveform building block editors 750 each display a composition area for a type of the waveform building blocks of the plurality of types of the waveform building blocks on display screen 642 in response to a user selection of the type of the waveform building blocks. The displayed composition area allows the user to compose a waveform building block of the type of the waveform building blocks. The composition of the waveform building block includes editing a waveform building block selected from the waveform building blocks stored in external storage device 618 or creating a new waveform building block to be added to the waveform building blocks stored in external storage device 618.
In various embodiments, each type of the plurality of types of the waveform building blocks represents a level of a plurality of levels of the waveform building blocks. A waveform building block of each level may include one or more waveform building blocks of one or more lower levels. In various embodiments, the plurality of types of the waveform building blocks may include, but is not limited to, pulses (e.g., each having a time scale of milliseconds), bursts (e.g., each having a time scale of milliseconds to seconds) each including a group of the pulses, trains (e.g., each having a time scale of milliseconds to minutes) each including a group of the bursts, and sequences (e.g., each having a time scale of minutes to weeks) each including a group of the pulses, bursts, and trains. Pauses (each being a time interval during which no pulse is to be delivered) may each be placed between two of the waveform building blocks. The sequences may each be composed for a specific therapy. The levels in the order from the lowest to the highest: pulse, burst, train, and sequence;
In various embodiments, waveform composer 720 allows each of library controller 748 and editors of the plurality of waveform building block editors 750 to be selected by the user for access. In one embodiment, waveform composer 720 displays on display screen 642 tags each associated with one of the library controller and the editors of the plurality of waveform building block editors, and allows the user to select a tag from the displayed tags. In various embodiments, waveform composer 720 allows the delivery of the neurostimulation pulses to be turned on and off, such that the user can decide whether to suspend the delivery of the neurostimulation pulses during the composition of waveform building blocks and/or composition of the pattern of the neurostimulation pulses.
Library controller 848 represents an embodiment of library controller 748 and displays a library management area on display screen 642 in response to a user selection for access to the library controller.
Waveform building block editors 850 represents an embodiment of waveform building block editors 750, and includes an editor for each type of the plurality of types of waveform building blocks. In the illustrated embodiment, waveform building block editors 850 include a pulse editor 852, a burst editor 854, a train editor 856, and a sequence editor 858.
Pulse editor 852 displays a pulse composition area on display screen 642 in response to a user selection for access to the pulse editor. The pulse composition area allows the user to compose a pulse of the waveform building blocks.
Burst editor 854 displays a burst composition area on display screen 642 in response to a user selection for access to the burst editor. The burst composition area allows the user to compose a burst of the waveform building blocks.
Train editor 846 displays a train composition area on display screen 642 in response to a user selection for access to the train editor. The train composition area allows the user to compose a train of the waveform building blocks.
Sequence editor 848 displays a sequence composition area on display screen 642 in response to a user selection for access to the sequence editor. The sequence composition area allows the user to compose a sequence of the waveform building blocks.
Controls editor 860 displays a controls area on display screen 642 in response to a user command. The controls area allows the user to edit pulse parameters used for a waveform building block.
In various embodiments, waveform composer 820 displays the library management area, the pulse composition area, the burst composition area, the train composition area, the sequence composition area, and the controls area on display screen 642 one at a time according to a selection made by the user. This allows the user to focus on one task (area) at a time without distraction, while being able to switch to another area directly from the displayed area.
At 1710, waveform building blocks are stored in a storage device of the programming device. Examples of the waveform building blocks include, but are not limited to, the pulses, bursts, trains, and sequences as discussed above in this document.
At 1720, a user is allowed to perform waveform composition using a user interface of the programming device. The waveform composition includes composition of one of more waveform building blocks and composition of a pattern of the neurostimulation pulses using one of more waveform building blocks selected from the waveform building blocks stored in the storage device. At 1722, a library management area is displayed on a screen of the user interface. The displayed library management area allows the user to manage the stored waveform building blocks using a user input device of the user interface. In one embodiment, the waveform building blocks displayed in the library management area are each selectable for editing. At 1724, a composition area for a type of the waveform building blocks of a plurality of types of the waveform building blocks is displayed on the screen. The displayed composition area allows the user to compose a building block of the type of the waveform building blocks using the user input device. In one embodiment, a controls area is displayed on the screen in response to a user command. The controls area allows the user to edit pulse parameters for a waveform building block selected from the waveform building blocks. In various embodiments, the composition area is displayed to allow the user to edit a waveform building block selected from the stored waveform building blocks and to allow the user to create a new building block to be added to the stored waveform building blocks. In various embodiments, performing a waveform composition includes receiving a user selection and displaying the library management area or the composition area, one at a time, according to the user selection. The composition area corresponds to the type of the waveform building blocks selected from the plurality of types of the waveform building blocks according to the user selection. In various embodiments, the user is allowed to import a waveform building block to be added to the stored waveform building blocks and to export a waveform building block selected from the stored waveform building blocks.
At 1730, a plurality of stimulation parameters controlling delivery of neurostimulation pulses from the neurostimulator is generated according to a pattern of the neurostimulation pulses. At 1740, the plurality of stimulation parameters is transmitted to a neurostimulator to control delivery of neurostimulation pulses according to the pattern of the neurostimulation pulses.
In various embodiments, external system 402 may include one or more devices.
In one embodiment, external programming device 1870 may be configured for use by users such as clinicians and/or medical technicians who program stimulation devices for patients, while remote device may be configured for use by researchers and/or clinicians who composes the stimulation waveforms. In other words, remote device 1872 may be used to develop neurostimulation patterns, and external programming device 1870 may be used to apply the neurostmulation patterns to patients, with limited adjustment or customization for each patient. This allows users with different levels of expertise and/or tasks to focus on their tasks without being distracted or overwhelmed by the amount of programmable variables that can be controlled by external system 1802. In various embodiments, remote device 1872 may be a computer programmed to allow for development of the neurostimulation patterns. While remote device 1872 is shown in
External telemetry circuit 646 provides external programming device 1970 with wireless communication with another device such as implantable stimulator 404 via telemetry link 426, including transmitting the plurality of stimulation parameters to implantable stimulator 404. In one embodiment, external telemetry circuit 646 also transmits power to implantable stimulator 404 through the inductive couple.
External storage device 618 stores a plurality of waveform building blocks each selectable for use as a portion of the pattern of the neurostimulation pulses. In various embodiments, the plurality of waveform building blocks include waveform building blocks imported from remote device 1972 and/or any other source where waveform building blocks may be composed. In various embodiments, the plurality of waveform building blocks may also include waveform building blocks created and/or edited by the user using external programming device 1970. In various embodiments, each waveform building block of the plurality of waveform building blocks includes one or more pulses of the neurostimulation pulses, and may include one or more other waveform building blocks of the plurality of waveform building blocks. Examples of such waveforms include pulses, bursts each including a group of the pulses, trains each including a group of the bursts, and sequences each including a group of the pulses, bursts, and trains. External storage device 618 also stores a plurality of stimulation fields. Each waveform building block of the plurality of waveform building blocks is associated with one or more fields of the plurality of stimulation fields. Each field of the plurality of stimulation fields is defined by one or more electrodes of the plurality of electrodes through which a pulse of the neurostimulation pulses is delivered and a current distribution of the pulse over the one or more electrodes.
Programming control circuit 616 represents an embodiment of programming control circuit 316 and generates the plurality of stimulation parameters, which is to be transmitted to implantable stimulator 404, according to the pattern of the neurostimulation pulses. The pattern is defined using one or more waveform building blocks selected from the plurality of waveform building blocks stored in external storage device 618. In various embodiment, programming control circuit 616 checks values of the plurality of stimulation parameters against safety rules to limit these values within constraints of the safety rules. In one embodiment, the safety rules are heuristic rules.
User interface 1910 represents an embodiment of user interface 310 and allows the user to define and/or adjust the pattern of neurostimulation pulses and perform various other monitoring and programming tasks. In one embodiment, user interface 1910 includes a GUI. User interface 1910 includes display screen 642, user input device 644, and an interface control circuit 1940. Display screen 642 may include any type of interactive or non-interactive screens, and user input device 644 may include any type of user input devices that supports the various functions discussed in this document, such as touchscreen, keyboard, keypad, touchpad, trackball, joystick, and mouse. In one embodiment, user interface 1910 includes a GUI that has an interactive screen for displaying a graphical representation of a waveform building block and allows the user to adjust the waveform building block by graphically editing the waveform building block. User interface 1910 may also allow the user to perform any other functions discussed in this document where graphical editing is suitable as may be appreciated by those skilled in the art.
Interface control circuit 1940 controls the operation of user interface 1910 including responding to various inputs received by user input device 644 and defining the one or more stimulation waveforms. Interface control circuit 640 includes a stimulation adjustor 1982. Stimulation adjustor 1982 allows the user to adjust the pattern of neurostimulation pulses before programming a stimulation device such as stimulation device 104 or implantable stimulator 404 for delivery to the patent, as further discussed below with reference to
Remote storage device 1981 of remote device 1972 stores a plurality of waveform building blocks each selectable for use as a portion of the pattern of the neurostimulation pulses. In various embodiments, each waveform building block of the plurality of waveform building blocks includes one or more pulses of the neurostimulation pulses, and may include one or more other waveform building blocks of the plurality of waveform building blocks. Examples of such waveforms include pulses, bursts each including a group of the pulses, trains each including a group of the bursts, and sequences each including a group of the pulses, bursts, and trains. Remote storage device 1981 also stores a plurality of stimulation fields. Each waveform building block of the plurality of waveform building blocks is associated with one or more fields of the plurality of stimulation fields. Each field of the plurality of stimulation fields is defined by one or more electrodes of the plurality of electrodes through which a pulse of the neurostimulation pulses is delivered and a current distribution of the pulse over the one or more electrodes. In various embodiments, external storage device 618 and remote storage device 1981 may store similar and/or identical types of information associated with waveform building blocks when, for example, remote device 1972 is used to compose waveform building blocks, and external programming device 1970 is used to imported the composed waveform building blocks from remote device 1972, adjust them when necessary, and apply them in programming the stimulation device such as implantable stimulator 404.
User interface 1974 of remote device 1972 allows the user to modify the waveform building blocks in remote storage device 1981 and create new waveform building blocks to store in remote storage device 1981. In one embodiment, user interface 1974 includes a GUI. User interface 1974 includes a display screen 1976, a user input device 1978, and an interface control circuit 1980. Display screen 1976 may include any type of interactive or non-interactive screens, and user input device 1978 may include any type of user input devices that supports the various functions discussed in this document, such as touchscreen, keyboard, keypad, touchpad, trackball, joystick, and mouse. In one embodiment, user interface 1974 includes a GUI that has an interactive screen for displaying a graphical representation of a waveform building block and allows the user to adjust the waveform building block by graphically editing the waveform building block. User interface 1974 may also allow the user to perform any other functions discussed in this document where graphical editing is suitable as may be appreciated by those skilled in the art.
Interface control circuit 1980 controls the operation of user interface 1974 including responding to various inputs received by user input device 1978 and defining the one or more stimulation waveforms. Interface control circuit 1920 includes a waveform composer 1920. Waveform composer 1920 represents an embodiment of waveform composer 720 and allows for composition of waveform building blocks and composition of the pattern of the neurostimulation pulses using one of more waveform building blocks, as further discussed below with reference to
Library controller 2048 represents an embodiment of library controller 848 and displays a library management area on display screen 1976 in response to a user selection for access to the library controller. In various embodiments, library controller 2048 can be configured to perform the functions of library controller 848 and/or the functions discussed below with reference to
Waveform building block editors 2050 represents an embodiment of waveform building block editors 850, and includes an editor for each type of the plurality of types of waveform building blocks. In the illustrated embodiment, waveform building block editors 2050 include a pulse editor 2052, a burst editor 2054, a train editor 2056, and a sequence editor 2058. In various embodiments, waveform building block editors 2050 can be configured to perform the functions of waveform building block editors 850 as discussed above and/or the functions discussed below with reference to
Pulse editor 2052 represents an embodiment of pulse editor 852 and displays a pulse library area on display screen 1976 in response to a user selection for access to the pulse editor.
In response to a pulse being selected, pulse editor 2052 displays a pulse composition area on display screen 1976. The pulse composition area allows the user to compose a pulse of the waveform building blocks.
Burst editor 2054 represents an embodiment of pulse editor 854 and displays a burst library area on display screen 1976 in response to a user selection for access to burst editor 2054.
In response to a burst being selected, burst editor 2054 displays a burst composition area on display screen 1976. The burst composition area allows the user to compose a burst of the waveform building blocks.
In one embodiment, which may be referred to as pulse amplitude modulation, burst editor 2054 allows the amplitude of the pulses to be edited by selecting points along the burst duration by hand and determining their percentage amplitude. In one embodiment, which may be referred to as Keyframe editing, burst editor 2054 allows the pulse width of the pulses to be edited by selecting points along the burst duration and determining their size along key points. In one embodiment, which may be referred to as score editing, burst editor 2054 allows the selection of the pulses to be edited by choosing from a set of pulses and placing them along a timeline. In one embodiment, which may be referred to as code editing, burst editor 2054 allows the selection of the pulses to be edited by writing code in a development window. The values are expressed graphically to the right of the code. In one embodiment, which may be referred to as stimulation quality nuance editing, burst editor 2054 allows additional nuanced variables can be added and edited, to add different qualities to the stimulation.
Train editor 2056 represents an embodiment of train editor 856 displays a train library area on display screen 1976 in response to a user selection for access to the train editor.
In response to a train being selected, train editor 2056 displays a train composition area on display screen 1976. The train composition area allows the user to compose a train of the waveform building blocks.
Sequence editor 2048 displays a sequence library area on display screen 1976 in response to a user selection for access to the sequence editor.
In response to a sequence being selected, sequence editor 2058 displays a sequence composition area on display screen 1976. The sequence composition area allows the user to compose a sequence of the waveform building blocks.
Basic adjustment module 3184 displays a basic adjustment area on display screen 642 in response to a user selection for performing basic programming.
In various embodiments, stimulation adjuster 3182 can be configured for specific therapy applications, with the basic adjustment module 3184 displaying a unique basic adjustment area that is suitable for each specific therapy application. Examples of such specific therapy applications include SCS, DBS, PNS, and VNS therapies.
Advanced adjustment module 3186 displays an advanced adjustment area on display screen 642 in response to a user selection for performing advanced programming.
In various embodiments, system 100 may include any one or any combination of the physical and functional structures discussed above and/or one or more other physical and functional structures configured to be used in programming a stimulation device for neurostimulation. In addition to the Examples 1-22 discussed in the Summary Section above, some other non-limiting examples are provided as follows.
An example (e.g., “Example 23”) of a system for a user to program a neurostimulator configured to deliver neurostimulation to a patient may include a storage device, a programming control circuit, and a user interface. The storage device may be configured to store waveform building blocks. The programming control circuit may be configured to generate a plurality of stimulation parameters controlling delivery of neurostimulation pulses from the neurostimulator according to a pattern of the neurostimulation pulses. The user interface may include a display screen, a user input device, and an interface control circuit coupled to the display screen and the user input device. The interface control circuit may include a waveform composer that may be configured to allow for composition of one of more building blocks of the waveform building blocks and composition of the pattern of the neurostimulation pulses using one of more building blocks selected from the waveform building blocks. The waveform composer may include a library controller and a plurality of waveform building block editors. The library controller may be configured to display a library management area on the screen. The displayed library management area allows the user to manage the waveform building blocks stored in the storage device. The plurality of waveform building block editors may each be configured to display a composition area for a type of the waveform building blocks of a plurality of types of the waveform building blocks on the screen. The displayed composition area allows the user to compose a building block of the type of the waveform building blocks.
In Example 24, the subject matter of Example 23 may optionally be configured such that the user interface includes a graphical user interface (GUI).
In Example 25, the subject matter of any one or any combination of Examples 23 and 24 may optionally be configured such that each editor of the plurality of waveform building block editors is configured to display the composition area to allow the user to edit a building block selected from the waveform building blocks stored in the storage device.
In Example 26, the subject matter of Example 25 may optionally be configured such that each editor of the plurality of waveform building block editors is further configured to display the composition area to allow the user to create a new building block to be added to the waveform building blocks stored in the storage device.
In Example 27, the subject matter of any one or any combination of Examples 23 to 26 may optionally be configured such that the waveform composer is configured to allow the delivery of the neurostimulation pulses to be turned on and off by the user during the composition of waveform building blocks and composition of the pattern of the neurostimulation pulses.
In Example 28, the subject matter of any one or any combination of Examples 23 to 27 may optionally be configured such that the waveform composer is configured to allow one of the library controller and editors of the plurality of waveform building block editors to be selected by the user for access one at a time.
In Example 29, the subject matter of Example 28 may optionally be configured such that the library controller is configured to display the library management area on the screen in response to a user selection for access to the library controller, and the library management area displays the waveform building blocks each selectable for editing by a corresponding editor of the plurality of waveform building block editors.
In Example 30, the subject matter of Example 29 may optionally be configured such that the library controller is further configured to allow for importation of a new waveform building block to be added to the waveform building blocks in the storage device.
In Example 31, the subject matter of Example 30 may optionally be configured such that the library controller is further configured to allow for exportation of a waveform building block selected from the waveform building blocks in the storage device.
In Example 32, the subject matter of any one or any combination of Examples 28 to 31 may optionally be configured such that the plurality of waveform building block editors comprises a pulse editor configured to display a pulse composition area on the screen in response to a user selection for access to the pulse editor. The pulse composition area allows the user to compose a pulse of the waveform building blocks.
In Example 33, the subject matter of Example 32 may optionally be configured such that the plurality of waveform building block editors comprises a burst editor configured to display a burst composition area on the screen in response to a user selection for access to the burst editor. The burst composition area allows the user to compose a burst of the waveform building blocks, the burst including a group of the pulses.
In Example 34, the subject matter of Example 33 may optionally be configured such that the plurality of waveform building block editors comprises a train editor configured to display a train composition area on the screen in response to a user selection for access to the train editor. The train composition area allows the user to compose a train of the waveform building blocks, the train including a group of the bursts.
In Example 35, the subject matter of Example 34 may optionally be configured such that the plurality of waveform building block editors comprises a sequence editor configured to display a sequence composition area on the screen in response to a user selection for access to the sequence editor. The sequence composition area allows the user to compose a sequence of the waveform building blocks, the sequence including a group of the pulses, bursts, and trains.
In Example 36, the subject matter of any one or any combination of Examples 23 to 35 may optionally be configured such that the waveform composer further comprises a controls editor configured to display a controls area on the screen in response to a user command. The controls area allows the user to edit pulse parameters for a waveform building block selected from the waveform building blocks.
In Example 37, the subject matter of any one or any combination of Examples 23 to 36 may optionally be configured such that the pulse parameters for the selected waveform building block comprise at least a pulse amplitude and a pulse type for each pulse in the selected waveform building block.
An example (e.g., “Example 38”) of a method for operating a programming device for neurostimulation is also provided. The method may include storing waveform building blocks in a storage device of the programming device, allowing a user to perform waveform composition using a user interface of the programming device, and generating a plurality of stimulation parameters controlling delivery of neurostimulation pulses from the neurostimulator according to a pattern of the neurostimulation pulses. The waveform composition may include composition of one of more building blocks of the waveform building blocks and composition of a pattern of the neurostimulation pulses using one of more building blocks selected from the waveform building blocks. To allow the user to perform the waveform composition, a library management area may be displayed on a screen of the user interface, and a composition area for a type of the waveform building blocks of a plurality of types of the waveform building blocks may be displayed on the screen. The displayed library management area allows the user to manage the stored waveform building blocks using a user input device of the user interface. The displayed composition area allows the user to compose a building block of the type of the waveform building blocks using the user input device.
In Example 39, the subject matter of displaying the composition area as found in Example 38 may optionally include displaying the composition area to allow the user to edit a building block selected from the stored waveform building blocks and to allow the user to create a new building block to be added to the stored waveform building blocks.
In Example 40, the subject matter of Example 39 may optionally further include allowing the user to import a building block to be added to the stored waveform building blocks and to export a building block selected from the stored waveform building blocks.
In Example 41, the subject matter of allowing the user to perform waveform composition as found in claim 40 may optionally include receiving a user selection and displaying the library management area or the composition area, one at a time, according to the user selection, and the composition area corresponds to the type of the waveform building blocks selected from the plurality of types of the waveform building blocks according to the user selection.
In Example 42, the subject matter of displaying the library management area as found in Example 41 may optionally include displaying the waveform building blocks each selectable for editing.
In Example 43, the subject matter of the plurality of types of the waveform building blocks as found in Example 41 may optionally include pulses, bursts each including a group of the pulses, trains each including a group of the bursts, and sequences each including a group of the pulses, the bursts, and the trains.
In Example 44, the subject matter of allowing the user to perform waveform composition as found in Example 41 may optionally further include displaying a controls area on the screen in response to a user command The controls area allows the user to edit pulse parameters for a waveform building block selected from the waveform building blocks.
It is to be understood that the above detailed description is intended to be illustrative, and not restrictive. Other embodiments will be apparent to those of skill in the art upon reading and understanding the above description. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
This application is a continuation of U.S. application Ser. No. 16/552,926, filed Aug. 27, 2019, which is a continuation of U.S. application Ser. No. 15/290,776, filed Oct. 11, 2016, which claims the benefit of priority under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Ser. No. 62/241,965, filed on Oct. 15, 2015, and U.S. Provisional Patent Application Ser. No. 62/333,551, filed on May 9, 2016, which are herein incorporated by reference in their entireties.
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Number | Date | Country | |
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20220249839 A1 | Aug 2022 | US |
Number | Date | Country | |
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62333551 | May 2016 | US | |
62241965 | Oct 2015 | US |
Number | Date | Country | |
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Parent | 16552926 | Aug 2019 | US |
Child | 17732351 | US | |
Parent | 15290776 | Oct 2016 | US |
Child | 16552926 | US |