Neuromodulation of autonomic nervous system

Abstract

Systems and methods for controlling autonomic nerve symptoms or side effects via spinal cord stimulation are discussed. An exemplary neuromodulation system includes an electrical stimulator to provide spinal cord stimulation (SCS) to a neural target, a user interface device to receive user input including autonomic nerve symptoms and affected anatomy, and a controller circuit to determine or adjust stimulation parameters based at least on the autonomic nerve symptoms and the affected anatomy. Spinal cord stimulation may be delivered according to the determined or adjusted stimulation parameters to alleviate autonomic symptoms or treat or alleviate autonomic disorders.

Description

[0001] Related Applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 339,768, filed on May 9, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0003] This document relates generally to medical devices, and more particularly to systems, devices, and methods for modulating the autonomic nervous system via spinal cord stimulation. Background Art

[0004] Chronic pain, defined as pain that persists for six months or more most days of the year, is an extremely common affliction that is consistently associated with psychological illness. Chronic pain may result from trauma, injury, or infection, or there may be an ongoing cause of pain. Chronic pain may also occur without any evidence of past injury or physical damage. Common chronic pain conditions may include headaches, back pain, cancer pain, arthritis pain, neuropathic pain (pain caused by damage to the peripheral nerves or central nervous system), or psychogenic pain (pain that is not caused by a past illness or injury or any visible signs of damage within or outside the nervous system).

[0005] Chronic pain can be treated or relieved using medication, acupuncture, surgery, and neuromodulation therapy. Neuromodulation (or "neuro-neuromodulation", also known as "neurostimulation" or "neuroexcitation") has been proposed as a therapy for a variety of conditions. Typically, neuromodulation and neurostimulation are used interchangeably to describe excitatory stimulation that causes action potentials as well as inhibition and other effects. Examples of neuromodulation include spinal cord stimulation (SCS), deep brain stimulation (DBS), peripheral nerve stimulation (PNS), and functional electrical stimulation (FES). As an example but not limited to this, SCS has been used to treat chronic pain syndromes. PES has been used to treat chronic pain syndromes and urinary incontinence, and many other applications are being studied. FES systems have been used to restore some functions of paralyzed limbs in patients with spinal cord injuries. DBS can be used to treat a variety of diseases or conditions.

[0006] Neuromodulation systems have been developed to provide a variety of therapeutic therapies, such as SCS for the management of chronic pain syndromes. An implantable neuromodulation system may include an implantable neurostimulator, also known as an implantable pulse generator (IPG), which can electrically stimulate tissue or nerve centers to treat nerve or muscle conditions. In one example, an IPG can deliver electrical pulses to specific areas in a patient's spinal cord, such as specific spinal nerve roots or nerve bundles, to produce an analgesic effect that masks the sensation of pain. Summary of the invention

[0007] Autonomic symptoms (e.g., pain) may exist due to the disease or as a side effect of neuromodulation therapies (e.g., SCS). For example, patients with diabetes may experience peripheral neuropathy, a type of nerve damage caused by chronic high blood sugar levels that can cause numbness, loss of sensation, and sometimes pain in the patient's feet, legs, or hands. Depending on the nerves affected, some patients may experience nerve damage not only in the limbs, but also in other parts of the body, causing symptoms in the patient's digestive system, urinary tract, blood vessels, and heart. On the other hand, patients who receive neuromodulation therapies (e.g., SCS) to control pain may experience side effects such as physical fatigue, headaches, and other autonomic symptoms. For example, some patients who receive SCS for their lower back pain or leg pain may experience gastrointestinal side effects (e.g., constipation) or urinary side effects (e.g., incontinence). These side effects or autonomic symptoms may be due to the direct effects of SCS on the autonomic nervous system (sympathetic preganglionic neurons) through spinal segmental circuits. SCS-related symptoms can be attributed to overstimulation or inappropriate stimulation settings (e.g., stimulation dose, electrode configuration, stimulation waveform, and other stimulation parameters). Prompt identification of such symptoms or side effects and appropriate adjustment or reconfiguration of the SCS can help avoid or alleviate such symptoms and improve patient outcomes.

[0008] Neuromodulation such as SCS can have therapeutic effects in treating certain conditions or diseases, including, for example, cardiac neuropathy, limb ischemia, impotence, endometriosis, and various conditions, dysfunctions or symptoms associated with the autonomic nervous system (ANS), commonly referred to as autonomic dysregulation. The postganglionic axonal processes of motor neurons in the autonomic ganglia innervate organs and tissues throughout the body (eyes, salivary glands, heart, stomach, bladder, blood vessels, etc.). For example, SCS at the T1-T5 level of the spinal cord or associated spinal nerves can be used to treat cardiac neuropathy due to its therapeutic effects of stabilizing the ANS, reducing pathological sympathetic tone, and preventing cardiac events such as ischemia. Another condition that can be treated or alleviated with SCS is visceral pain, which refers to pain originating from or associated with visceral organs or blood vessels, such as bladder pain, endometriosis, irritable bowel syndrome, and prostate pain. SCS can modulate the ANS through spinal segment circuits (e.g., sympathetic preganglionic neurons) to affect visceral function, thereby relieving visceral pain in certain internal organs.

[0009] The various embodiments discussed herein can provide more efficient and effective personalized management of autonomic symptoms or side effects of neuromodulation therapy for patients receiving SCS for chronic pain, and additionally or alternatively, provide personalized SCS for treating or alleviating conditions or symptoms affecting various internal organs or tissues. A portable user interface device, such as a handheld remote control device or smart phone executing a dedicated software application as described in various examples of the present disclosure, allows a user (e.g., a patient receiving SCS for pain control) to promptly identify autonomic symptoms or side effects caused by or associated with SCS, and conveniently adjust the SCS configuration (automatically or manually) in his or her home without the need for a clinic visit or consultation with a device specialist. According to one aspect of the present disclosure, a neuromodulation system includes an electrical stimulator configured to provide neural stimulation (e.g., SCS) to a patient's neural targets, a user interface device for receiving user input including an identification of an autonomic symptom and an affected anatomical structure (e.g., an affected anatomical system or organ), and a controller circuit communicatively coupled to the user interface device. The controller circuit may determine or adjust stimulation parameters based on user input, and generate control signals to the electrical stimulator to deliver neural stimulation energy according to the determined or adjusted stimulation parameters, thereby relieving autonomic symptoms or treating or alleviating autonomic disorders.

[0010] The following examples illustrate various aspects of the embodiments described herein.

[0011] Example 1 is a system for providing electrical stimulation to a patient, comprising: an electrical stimulator configured to provide neural stimulation to a neural target of the patient via an electrode array; a user interface device configured to receive user input, the user input comprising autonomic symptoms and identification of affected anatomical structures; and a controller circuit communicatively coupled to the user interface device, the controller circuit configured to: determine or adjust stimulation settings based on the user input of the autonomic symptoms and identification of the affected anatomical structures; and generate a control signal to the electrical stimulator to deliver neural stimulation energy according to the determined or adjusted stimulation settings to relieve autonomic symptoms or treat autonomic disorders.

[0012] In Example 2, the subject matter of Example 1 optionally includes neurostimulation, which may include spinal cord stimulation (SCS) of spinal nerve targets to control pain in the patient, and wherein the user input of autonomic symptoms and identification of affected anatomical structures is responsive to the SCS.

[0013] In Example 3, the subject matter of any one or more of Examples 1-2 optionally includes a stimulation setup, which may include one or more stimulation parameters, including: electrode configuration; one or more stimulation pulse parameters, including pulse amplitude, pulse width, or stimulation frequency; stimulation pulse waveform; an on-off cycle scheme comprising an on period for delivering a stimulation pulse and a subsequent off period without stimulation; or charges per second (CPS) or charge per hour (CPH) delivered to a neural target.

[0014] In Example 4, the subject matter of Example 3 optionally includes a stimulation setup that can include: an on-off cycle scheme represented by a ratio of an on period to a subsequent off period in a range of 1:1 to 1:8, wherein each stimulation pulse during the on period has a waveform that includes an active recharge phase.

[0015] In Example 5, the subject matter of any one or more of Examples 1-4 optionally includes a stimulation setting represented by a single composite neural stimulation dose taking values ​​within a particular range of values, the composite neural stimulation dose corresponding to a plurality of stimulation parameters each taking respective values.

[0016] In Example 6, the subject matter of any one or more of Examples 1-5 may optionally include a user interface device that may be configured to display user input of the autonomic symptom and the identification of the affected anatomical structure.

[0017] In Example 7, the subject matter of any one or more of Examples 1-6 may optionally include user input, which may further include a user indication of severity of the autonomic symptom.

[0018] In Example 8, the subject matter of any one or more of Examples 1-7 optionally includes neural stimulation, which may include spinal cord stimulation (SCS) via an electrode array placed on a spinal nerve target, wherein, to determine or adjust stimulation settings, the controller circuit is configured to select one or more active electrodes from the electrode array for delivering SCS based at least on (i) the position of the electrode array relative to the spinal nerve target, and (ii) the anatomical system or organ innervated by the spinal nerve and its spinal origin.

[0019] In Example 9, the subject matter of Example 8 optionally includes a memory circuit configured to store a lookup table representing a correspondence between anatomical systems or organs and spinal origins within the stimulation field created by the electrode array.

[0020] In Example 10, the subject matter of any one or more of Examples 8-9 may optionally include a controller circuit that may be further configured to determine a current or energy subdivision across the selected one or more active electrodes in order to determine or adjust the stimulation settings.

[0021] In Example 11, the subject matter of any one or more of Examples 1-10 optionally includes the user interface device, which can be further configured to: display a treatment recommendation including the determined or adjusted stimulation setting; and receive a user acceptance, rejection, or modification of the stimulation setting determined or adjusted by the controller circuit.

[0022] In Example 12, the subject matter of any one or more of Examples 1-11 optionally includes a user interface device that can be further configured to: prompt a user to provide feedback on the relief of autonomic symptoms or treatment of autonomic disorders by neural stimulation based on the determined or adjusted stimulation settings; and display treatment recommendations including further adjustment of one or more stimulation parameters.

[0023] In Example 13, the subject matter of any one or more of Examples 1-12 optionally includes a user interface device that can be further configured to receive a user selection or adjustment of a single composite neural stimulation dose within a particular value range, the composite neural stimulation dose corresponding to a plurality of stimulation parameters that each take values ​​within their respective value ranges.

[0024] In Example 14, the subject matter of Example 13 optionally includes user selection or adjustment of a single composite neural stimulation dose, which may be provided via a user interface control element comprising a slider along a one-dimensional dose bar.

[0025] In Example 15, the subject matter of any one or more of Examples 1-14 may optionally include a user interface device which may be further configured to receive a user selection from one or more stimulation modes, each stimulation mode being defined by a plurality of stimulation parameters having their respective values ​​or value ranges.

[0026] Example 16 is a method for providing electrical stimulation to a patient, the method comprising: receiving user input including autonomic symptoms and identification of affected anatomical structures via a user interface device; determining or adjusting stimulation settings of an electrical stimulator based on the received identification of the autonomic symptoms and affected anatomical structures; and delivering neural stimulation energy to the patient using the electrical stimulator and an electrode array to relieve autonomic symptoms or treat autonomic disorders based on the determined or adjusted stimulation settings.

[0027] In Example 17, the subject matter of Example 16 optionally includes neurostimulation, which may include spinal cord stimulation (SCS) of spinal nerve targets to control pain in a patient, and receiving user input of autonomic symptoms and identification of affected anatomical structures in response to the SCS.

[0028] In Example 18, the subject matter of any one or more of Examples 16-17 optionally includes a stimulation setting represented by a single composite neural stimulation dose taking values ​​within a particular range of values, the composite neural stimulation dose corresponding to the plurality of stimulation parameters each taking respective values.

[0029] In Example 19, the subject matter of any one or more of Examples 16-18 optionally includes: displaying user input of autonomic symptoms and identification of affected anatomical structures, the severity of the autonomic symptoms, and the determined or adjusted stimulation settings on a display of a user interface device; and receiving user acceptance, rejection, or modification of the determined stimulation settings via the user interface device.

[0030] In Example 20, the subject matter of any one or more of Examples 16-19 optionally includes neural stimulation, which may include spinal cord stimulation (SCS) of a spinal nerve target via an electrode array, wherein determining or adjusting stimulation settings includes: selecting one or more active electrodes from the electrode array for delivering SCS based at least on (i) the position of the electrode array relative to the spinal nerve target, and (ii) the anatomical system or organ innervated by the spinal nerve and its spinal origin.

[0031] In Example 21, the subject matter of any one or more of Examples 16-20 optionally includes receiving, via a user interface device, a user selection or adjustment of a single composite neurostimulation dose within a particular value range, the composite neurostimulation dose corresponding to a plurality of stimulation parameters each taking values ​​within their respective value ranges.

[0032] This disclosure is an overview of some of the teachings of this application and is not intended to be an exclusive or exhaustive treatment of the subject matter. Further details on this subject matter can be found in the detailed description and the appended claims. Other aspects of the disclosure will be apparent to those skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which should not be construed as limiting. The scope of the disclosure is determined by the appended claims and their legal equivalents. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Various embodiments are shown by way of example in the accompanying drawings. These embodiments are illustrative and are not intended to be exhaustive or exclusive embodiments of the subject matter.

[0034] Figure 1A-1B A portion of the spinal cord is shown.

[0035] Figure 2 Embodiments of neural modulation systems are shown by way of example.

[0036] Figure 3 By way of example, it is shown that Figure 2 An embodiment of a modulation device implemented in a neural modulation system.

[0037] Figure 4 By way of example, a programming device such as may be implemented as Figure 2 An embodiment of a programming device in a neural modulation system.

[0038] Figure 5 Portions of an implantable neuromodulation system and an environment in which the system may be used are shown by way of example.

[0039] Figure 6 An embodiment of a spinal cord stimulation (SCS) system is shown by way of example.

[0040] Figure 7 Some features of the neuromodulation leads and waveform generator are shown by way of example.

[0041] Figure 8 Partial views of both the neuroanatomy and bony anatomy of the spine are shown.

[0042] Figures 9A-9C The lateral, coronal, and angled views of the nerve root are shown, respectively.

[0043] Figures 10A-10G Various examples of lead placement on the spinal cord are shown by way of example.

[0044] Fig. 10HA breakdown of the anode current delivered to electrodes on an electrical neuromodulation lead is shown by way of example.

[0045] Fig.11 Parts of the autonomic nervous system are shown, along with the spinal origins of the spinal nerves that supply and innervate various organs and tissues.

[0046] Fig.12 By way of example and not limitation, a block diagram of a neuromodulation system that can provide neural stimulation to a neural target to avoid or alleviate autonomic symptoms and side effects is shown.

[0047] Fig.13 A lookup table showing the correspondence between (i) anatomical systems and organs and (ii) spinal levels (i.e., the spinal origins of nerves innervating the corresponding organs) within the stimulation fields produced by electrodes of existing implantable lead systems is shown.

[0048] Figures 14A-14D An example of a portable device configured to receive user feedback on symptoms and affected anatomy of a neurostimulation therapy such as SCS, as well as user programming or adjustment of stimulation settings is shown.

[0049] Figures 15A-15B An example of a single neural stimulation dose parameter obtained by projecting a multi-dimensional stimulation parameter space onto a one-dimensional dose domain and its corresponding relationship to a plurality of stimulation parameters having respective values ​​in a tabular presentation is shown.

[0050] Fig.16 By way of example and not limitation, a flow chart of a method for programming and providing neural stimulation to neural targets to avoid or alleviate autonomic symptoms and side effects is shown.

[0051] Fig.17 A block diagram of an example machine 1700 is generally shown, upon which any one or more of the techniques (eg, methodologies) discussed herein may be executed. DETAILED DESCRIPTION

[0052] The following detailed description of the present subject matter refers to the accompanying drawings, which illustrate by way of illustration specific aspects and embodiments in which the present subject matter can be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the present subject matter. Other embodiments may be utilized, and structural, logical, and electrical changes may be made without departing from the scope of the present subject matter. References to "one," "single," or "various" embodiments in this disclosure do not necessarily refer to the same embodiment, and such references contemplate more than one embodiment. Therefore, the following detailed description should not be construed as limiting, and the scope is limited only by the appended claims and the full scope of the legal equivalents to which these claims are entitled.

[0053] Various embodiments described herein relate to spinal cord stimulation.A brief description of spinal cord physiology is provided herein to aid the reader. Figure 1A-1B A portion of a spinal cord 100 is illustrated, including white matter 101 and gray matter 102 of the spinal cord. The gray matter 102 includes cell bodies, synapses, dendrites, and axon terminals. Thus, synapses are located in the gray matter. The white matter 101 includes myelinated axons that connect gray matter regions. A typical cross-section of the spinal cord includes a central "butterfly" shaped central region of the gray matter 102, which is substantially surrounded by an elliptical outer region of the white matter 101. The white matter of the dorsal column (DC) 103 primarily includes large myelinated axons that form afferent fibers that extend axially. The dorsal portion of the "butterfly" shaped central region of the gray matter is called the dorsal horn (DH) 104. In contrast to the DC fibers that extend axially, the DH fibers can be oriented in many directions, including perpendicular to the longitudinal axis of the spinal cord. Figure 1A-1B Also shown are spinal nerves, including dorsal roots (DR) 105, dorsal root ganglia 109, dorsal root ganglia (DRG) 106, ventral roots 107, and ventral root ganglia 117. The dorsal roots 105 carry sensory signals into the spinal cord primarily via the dorsal root entry zone (DREZ) 119 of the DH 104, and the ventral roots 107 serve as efferent motor roots that carry motor signals primarily out of the spinal cord. The dorsal and ventral roots connect to form a mixed spinal nerve root 108.

[0054] SCS has been used to relieve pain. Figure 1A-1B As shown, the therapeutic goal of conventional SCS programming has been to maximize stimulation (i.e., recruit) of DC fibers extending along the longitudinal axis of the spinal cord in the white matter, and to minimize stimulation of other fibers extending perpendicular to the longitudinal axis of the spinal cord (dominantly dorsal root fibers). The white matter of DC mainly includes large myelinated axons, forming afferent fibers extending along the axial direction. Although the full mechanism of pain relief is not well understood, it is believed that the perception of pain signals is inhibited by the gating theory of pain, which indicates that the enhanced activity of harmless touch or pressure input via electrical stimulation produces interneuronal activity in the DH of the spinal cord, which releases inhibitory neurotransmitters (gamma-aminobutyric acid (GABA), glycine), which in turn reduces the hypersensitivity of wide dynamic range (WDR) sensory neurons to the harmful afferent input of pain signals propagated from dorsal root (DR) nerve fibers that innervate the patient's pain area, as well as treating general WDR ectopia. Therefore, the large sensory input of DC nerve fibers has been targeted to provide amplitude stimulation for pain relief.

[0055] An implantable neuromodulation system can include electrodes implanted adjacent to, i.e., resting near the dorsal column of the patient's spinal cord or located on the dura mater and along the longitudinal axis of the patient's spinal cord. In some examples, the electrodes can be placed so as to selectively or preferentially stimulate DR tissue rather than other neural tissues, such as but not limited to the dorsal root, dorsal rootlet, DRG, DREZ or Lissauer bundle. One or more leads including a plurality of electrodes can be positioned to place a plurality of electrodes near a target nerve root. For example, the electrode can be placed adjacent to a target nerve root, dorsal rootlet or DREZ. Leads can be placed using surgical approaches (such as lateral antegrade approaches, lateral retrograde approaches, sacral hiatus approaches or trans-gradient approaches). The lateral antegrade approach inserts the lead extradurally below the target point, and then advances the lead in an antegrade direction (towards the head) until the lead is located at the target nerve root. The lateral retrograde approach can be used to allow lead delivery closer to the DRG for selective root stimulation by inserting the lead epidurally above the target site and then advancing the lead retrogradely (away from the head) to the target nerve root. The sacral hiatal approach introduces the guide needle into the epidural space through the sacral hiatus and advances it in an antegrade direction (towards the head) to the target nerve root. Upon reaching the target nerve, the lead can be guided through the foramen to position the extraforaminal, intervertebral, and intraspinal electrodes along the target nerve root. The transverse approach enters the contralateral interlaminar space and guides the electrode out of the contralateral foramen to position the extraforaminal, intervertebral, and intraspinal electrodes along the target nerve root.

[0056] Stimulation of DR tissue can be used to treat focal pain because it can provide the required coverage for pain without the stimulation spillover that can cause undesirable effects in other areas of the body. Stimulation of DR tissue can be used to deliver sub-perceptual therapy, which avoids the paresthesias that accompany conventional SCS therapy when large sensory DC nerve fibers are activated. Patients sometimes report that these sensations are unwanted. Sub-perceptual therapy can effectively treat pain without the patient feeling the delivery of the modulated field (e.g., paresthesias). Selective modulation of DR tissue for sub-perceptual therapy or treatment of focal pain can be delivered at a higher frequency (e.g., more than 1500 Hz, such as a frequency in the range of 2 kHz to 20 kHz), or can be delivered at a lower frequency (e.g., equal to or less than 1500 Hz, such as a frequency equal to or less than 1200 Hz, a frequency equal to or less than 1000 Hz, a frequency equal to or less than 500 Hz, a frequency equal to or less than 350 Hz, or a frequency equal to or less than 130 Hz). Selective modulation can be delivered at a low frequency (e.g., as low as 2 Hz), or can even be delivered without a pulse (e.g., 0 Hz). By way of example and not limitation, the selective modulation may be delivered within a frequency range selected from the following frequency ranges: 2 Hz to 1200 Hz; 2 Hz to 1000 Hz, 2 Hz to 500 Hz; 2 Hz to 350 Hz; or 2 Hz to 130 Hz. Systems may be developed to increase the lower end of any of these ranges from 2 Hz to other frequencies, such as, by way of example and not limitation, 10 Hz, 20 Hz, 50 Hz, or 100 Hz. By way of example and not limitation, it should also be noted that the selective modulation may be delivered with a duty cycle, wherein stimulation (e.g., a burst of pulses) is delivered during the stimulation ON portion of the duty cycle and is not delivered during the stimulation OFF portion of the duty cycle. By way of example and not limitation, the duty cycle may be approximately 10% ± 5%, 20% ± 5%, 30% ± 5%, 40% ± 5%, 50% ± 5%, or 60% ± 5%. For example, a burst of pulses lasting 10 ms during the stimulation ON portion, followed by 15 ms of no pulses, corresponds to a duty cycle of 40%. Some waveforms may combine low frequency pulses and high frequency pulses into more complex waveforms (e.g., bursts of high frequency pulses interleaved between one or more pulses delivered at a lower frequency). A waveform may have a regular pattern of pulses that repeats at regular intervals between pulses or between bursts of pulses. A waveform may have an irregular pulse pattern that includes different intervals between pulses and / or different intervals between bursts of pulses. A waveform may include straight line pulses, or may include other morphological shapes that are non-straight lines.

[0057] Figure 2An embodiment of a neuromodulation system is shown. The system 210 shown includes an electrode 211, a modulation device 212, and a programming device 213. The electrode 211 is configured to be placed on or near one or more neural targets of a patient, such as one or more dorsal nerve roots. The modulation device 212 is configured to be electrically connected to the electrode 211 and deliver neuromodulation energy (such as in the form of electrical pulses or other waveform shapes) to the one or more neural targets through the electrode 211. The modulation device 212 can be an implantable device or an external device with a lead inserted percutaneously to be positioned to stimulate the dorsal root. The delivery of neuromodulation is controlled by using multiple modulation parameters, such as modulation parameters that specify the electrical pulses and the selection of electrodes used as anodes and the selection of electrodes used as cathodes (through which each electrical pulse is delivered). The modulation parameters can also include a subdivided distribution of energy (e.g., current) provided across the anode electrode and the cathode electrode. In various embodiments, at least some of the multiple modulation parameters can be programmed by a user (such as a doctor or other caregiver). The programming device 213 provides access to user-programmable parameters to the user. In various embodiments, programming device 213 is configured to be communicatively coupled to the modulation device via a wired or wireless link. In various embodiments, programming device 213 includes a graphical user interface (GUI) 214 that allows a user to set and / or adjust the value of a user-programmable modulation parameter.

[0058] Figure 3 It shows that Figure 22. Embodiment of a neuromodulation device 312 implemented in a neuromodulation system 210 of the present invention. The illustrated embodiment of the neuromodulation device 312 includes a neuromodulation output circuit 315 and a neuromodulation control circuit 316. It will be understood by those skilled in the art that the neuromodulation device 312 may include additional components, such as sensing circuits, telemetry circuits, and power supplies for feedback control of patient monitoring and / or treatment. The neuromodulation output circuit 315 generates and delivers neuromodulation pulses. The neuromodulation control circuit 316 uses a plurality of neuromodulation parameters to control the delivery of neuromodulation pulses. The combination of the neuromodulation output circuit 315 and the neuromodulation control circuit 316 may be collectively referred to as a pulse generator. The lead system 317 includes one or more leads, each of which is configured to be electrically connected to the neuromodulation device 312 and a plurality of electrodes 311-1 to 311-N (where N≥2), which are distributed in an electrode arrangement using one or more leads. Each lead may have an electrode array consisting of two or more electrodes, which may also be referred to as a contact. Multiple leads may provide multiple electrode arrays to provide an electrode arrangement. Each electrode is a single conductive contact that provides an electrical interface between the neuromodulation output circuit 315 and the patient's tissue. Neuromodulation pulses are each delivered from the neuromodulation output circuit 315 through a set of electrodes selected from electrodes 311-1 to 311-N. The number of leads and the number of electrodes on each lead can depend on, for example, the distribution of targets for neuromodulation and the need to control the electric field distribution at each target. In one embodiment, by way of example and not limitation, the lead system includes two leads, each having eight electrodes. Some embodiments may use a lead system including one or more leads of the same or different types, such as percutaneous leads, linear paddles, multi-column paddles, or directional leads, etc.

[0059] The neuromodulation system can be configured to modulate spinal cord target tissue or other neural tissue. The configuration of electrodes for delivering electrical pulses to target tissues constitutes an electrode configuration, wherein the electrodes can be selectively programmed to act as anodes (positive), cathodes (negative) or off (zero). In other words, the electrode configuration represents a polarity of positive, negative or zero. The electrode configuration can be used to control or change the electrical waveform for delivery. The electrical waveform can be an analog or digital signal. In some embodiments, the electrical waveform includes pulses. The pulses can be delivered in a regular repeating pattern, or can be delivered using a complex pulse pattern that appears irregular. Other parameters that can be controlled or changed include the amplitude, pulse width and rate (or frequency) of the electrical pulses. Each electrode configuration together with the electrical pulse parameters can be referred to as a "neuromodulation parameter set". Each neuromodulation parameter set, including a subdivided current distribution to the electrode (as a cathode current percentage, an anode current percentage or off), can be stored and combined into a neuromodulation program, which can then be used to modulate multiple areas in the patient's body.

[0060] The combination of the number of available electrodes and the ability to generate a variety of complex electrical pulses provides a clinician or patient with a large number of neuromodulation parameter sets to choose from. For example, if the neuromodulation system to be programmed has sixteen electrodes, millions of neuromodulation parameter sets are available for programming into the neuromodulation system. Furthermore, an SCS system, for example, may have thirty-two electrodes (plus additional electrodes for the "can" or housing of the device), which exponentially increases the number of neuromodulation parameter sets available for programming. To facilitate this selection, clinicians typically program the neuromodulation parameter sets through a computerized programming system to allow for the determination of preferred neuromodulation parameters based on patient feedback or other means, and subsequent programming of the desired neuromodulation parameter set.

[0061] The patient's paresthesia perception may be used to program SCS therapy, for example by selecting or determining an appropriate set of neuromodulation parameters. The paresthesia induced by neuromodulation and perceived by the patient may be located at approximately the same location of the patient's body where pain is felt, and thus is a target site for treatment. Conventionally, when leads are implanted in a patient, an operating room (OR) mapping procedure may be performed to apply neuromodulation to test placement of the leads and / or electrodes, thereby ensuring that the leads and / or electrodes are implanted in an effective location in the patient's body.

[0062] Once the lead is correctly positioned, an adaptation process, which may be referred to as a navigation session, may be performed to program the external control device and, if applicable, the neuromodulation device with a set of neuromodulation parameters that best addresses the pain site. Thus, the navigation session may be used to precisely determine the volume of activation (VOA) or area associated with pain. This process may be implemented to target tissue during implantation, or after implantation if the lead gradually or accidentally moves causing the neuromodulation energy to migrate away from the target site. By reprogramming the neuromodulation device (typically by independently varying the neuromodulation energy on the electrodes), the VOA may typically be moved back to the effective pain site without having to re-operate the patient to reset the lead and its electrode array. According to various embodiments discussed herein, in addition to information about the dermatomal coverage, such as the correspondence between the painful body site and the induced paresthesia body site, one or more patient information, such as feedback on the induced paresthesia or the patient's perception threshold, may be used to optimize the target neuromodulation field. This may not only improve the accuracy of neuromodulation and thus improve treatment outcomes, but may also save time for the system operator and ease the burden of programming the neuromodulation system.

[0063] Figure 4 An embodiment of a programming device is shown by way of example, such as may be implemented as Figure 2A programming device in a neural modulation system of a computer program product. The programming device 413 includes a storage device 419, a programming control circuit 420, and a GUI 414. The programming control circuit 420 generates a plurality of modulation parameters that control the delivery of neural modulation pulses according to the pattern of neural modulation pulses. In various embodiments, the GUI 414 includes any type of presentation device, such as an interactive or non-interactive screen, and any type of user input device that allows a user to program the modulation parameters, such as a touch screen, a keyboard, a keypad, a touchpad, a trackball, a joystick, and a mouse. The storage device 419 can store modulation parameters to be programmed into the modulation device, etc. The modulation parameters can be organized into one or more modulation parameter sets. The programming device 413 can send a plurality of modulation parameters to the modulation device. In some embodiments, the programming device 413 can send power to the modulation device. The programming control circuit 420 can generate a plurality of modulation parameters. In various embodiments, the programming control circuit 420 can check the values ​​of the plurality of modulation parameters against the security rules to limit the values ​​within the constraints of the security rules.

[0064] In various embodiments, the neural modulation circuitry, including the various embodiments thereof discussed in this document, can be implemented using a combination of hardware, software, and firmware. For example, the GUI circuitry, the modulation control circuitry, and the programming control circuitry, including the various embodiments thereof discussed in this document, can be implemented using dedicated circuitry constructed to perform one or more specific functions or general purpose circuitry programmed to perform such functions. Such general purpose circuitry includes, but is not limited to, microprocessors or portions thereof, microcontrollers or portions thereof, and programmable logic circuitry or portions thereof.

[0065] Figure 5Portions of an implantable neuromodulation system and an environment in which the system can be used are shown by way of example. The system is shown for implantation near the spinal cord. System 521 includes an implantable system 522, an external system 523, and a telemetry link 524 that provides wireless communication between the implantable system 522 and the external system 523. The implantable system is shown to be implanted in a patient. The implantable system 522 includes an implantable modulation device (also referred to as an implantable pulse generator or IPG) 512, a lead system 518, and electrodes 511. The lead system 518 includes one or more leads, each of which is configured to be electrically connected to the modulation device 512, and a plurality of electrodes 511 distributed in the one or more leads. In various embodiments, the external system 523 includes one or more external (non-implantable) devices, each of which allows a user (e.g., a clinician or other caregiver and / or patient) to communicate with the implantable system 522. In some embodiments, the external system 523 includes a programming device intended for a clinician or other caregiver to initialize and adjust the settings of the implantable system 522 and a remote control device intended for use by the patient. For example, the remote control device may allow the patient to turn therapy on and off and / or adjust specific patient-programmable parameters of a plurality of modulation parameters.External systems 523 may include other local or remote servers or computer systems accessible via various networks.

[0066] The neuromodulation leads of the lead system 518 can be placed near the dorsal root tissue to be stimulated (e.g., such as resting near or on the dura mater, adjacent to the dura mater). Due to the lack of space near the location of the implanted neuromodulation leads, the implantable modulation device 512 can be implanted in a surgically created pocket above the abdomen or buttocks, or can be implanted in other locations of the patient's body. Lead extensions can be used to facilitate implantation of the implantable modulation device 512 away from the exit point of the neuromodulation lead.

[0067] Figure 6An embodiment of an SCS system is shown by way of example, which may also be referred to as a spinal cord modulation system. An SCS system 625 may generally include one or more (shown as two) implantable neuromodulation leads 626, an implantable pulse generator (IPG) 627, an external remote control RC 628, a clinician's programmer (CP) 629, and an external trial modulator (ETM) 630. The IPG 627 may be physically connected to a neuromodulation lead 626 carrying a plurality of electrodes 632 via one or more percutaneous lead extensions 631. When implanted in a patient, the electrodes form an electrode arrangement. As shown, the neuromodulation lead 626 may be a percutaneous lead in which the electrodes are arranged in a straight line along the neuromodulation lead. Any suitable number of neuromodulation leads may be provided, including only one, as long as the number of electrodes is greater than two (including the IPG shell functioning as a shell electrode) to allow lateral steering of the current. Alternatively, a surgical paddle lead may be used instead of one or more percutaneous leads. The IPG 627 includes pulse generation circuitry that delivers electrical modulation energy to the electrodes in the form of a pulsed electrical waveform (ie, a temporal sequence of electrical pulses) according to a set of modulation parameters.

[0068] The ETM 630 may also be physically connected to the neuromodulation lead 626 via a percutaneous lead extension 633 and an external cable 634. The ETM 630 may have a pulse generation circuit similar to the IPG 627 to deliver electrical modulation energy to the electrodes according to a set of modulation parameters. The ETM 630 is a non-implanted device that may be used on a trial basis after the neuromodulation lead 626 has been implanted and prior to implantation of the IPG 627 to test the responsiveness of the modulation to be provided. The functions described herein with respect to the IPG 627 may also be performed with respect to the ETM 630.

[0069] The RC 628 may be used to telemetrically control the ETM 630 via a two-way RF communication link 635. The RC 628 may be used to telemetrically control the IPG 627 via a two-way RF communication link 636. Such control allows the IPG 627 to be turned on or off and programmed with different sets of modulation parameters. The IPG 627 may also be operated to modify the programmed modulation parameters to actively control the characteristics of the electrical modulation energy output by the IPG 627. The clinician may program the modulation parameters into the IPG 627 and the ETM 630 using the CP 629 in the operating room and in subsequent sessions.

[0070] CP 629 can communicate indirectly with IPG 627 or ETM 630 through RC 628 via IR communication link 637 or other links. CP 629 can communicate directly with IPG 627 or ETM 630 via RF communication link or other link (not shown). The clinician's detailed modulation parameters provided by CP 629 can also be used to program RC 628, so that the modulation parameters can be subsequently modified by the operation of RC 628 in stand-alone mode (i.e., without the assistance of CP 629). Various devices can be used as CP 629. Such devices can include portable devices such as laptop personal computers, small computers, personal digital assistants (PDAs), tablet computers, phones, or remote controls (RCs) with extended functions. Therefore, the programming method can be run by executing software instructions contained in CP 629. Alternatively, firmware or hardware can be used to run such a programming method. In any case, the CP 629 can actively control the characteristics of the electrical modulation generated by the IPG 627 to allow the desired parameters to be determined based on patient feedback or other feedback, and for subsequently programming the IPG 627 with the desired modulation parameters. To allow a user to operate these functions, the CP 629 can include a user input device (e.g., a mouse and keyboard) and a programming display screen housed in a housing. In addition to or in lieu of a mouse, other directional programming devices can be used, such as a trackball, touch pad, joystick, touch screen, or directional keys included as part of the keys associated with a keyboard. The external device (e.g., CP) can be programmed to provide a display screen that allows the clinician to select or enter patient profile information (e.g., name, date of birth, patient identification, physician, diagnosis, and address) in both the surgical setting and the clinical setting, enter procedural information (e.g., programming / follow-up, implantation of trial system, implantation of IPG, implantation of IPG and leads, replacement of IPG, replacement or modification of leads, removal, etc.), generate a pain map for the patient, define the configuration and orientation of the leads, initiate and control the electrical modulation energy output by the neuromodulation leads, and select and program the IPG using modulation parameters including electrode selection. The display screen can be used to suggest electrodes for stimulating the target dorsal root. The external device (e.g., CP and / or RC) can be configured to communicate with other devices (including local devices and / or remote devices). For example, wired and / or wireless communications can be used to communicate between or among devices.

[0071] External charger 638 may be a portable device for transcutaneously charging the IPG via a wireless link such as inductive link 636. Once the IPG has been programmed and its power source has been charged or otherwise replenished by the external charger, the IPG may function as programmed in the absence of RC or CP.

[0072] Figure 7 Some features of the neuromodulation lead 726 and the pulse generator 727 are shown by way of example. The pulse generator 727 can be an implantable device (IPG) or can be an external device such as one that can be used to test electrodes during the implantation process. In the example shown, the neuromodulation lead has eight electrodes 732 (labeled E1-E8). The actual number and shape of the leads and electrodes can vary for the intended application. An implantable pulse generator (IPG) can include a housing for housing electronic components and other components. The housing can be made of a conductive biocompatible material (e.g., titanium) that forms an airtight sealed compartment in which the internal electronics are protected from body tissue and fluids. In some cases, the housing can be used as an electrode (e.g., a housing electrode). The IPG may include electronic components such as a controller / processor (e.g., a microcontroller), memory, a battery, a telemetry circuit, a monitoring circuit, a modulation output circuit, and other suitable components known to those skilled in the art. The microcontroller executes a suitable program stored in the memory for directing and controlling the neuromodulation performed by the IPG. Electrical modulation energy is provided to the electrodes according to a set of modulation parameters programmed into the pulse generator. The electrical modulation energy can be in the form of a pulsed electrical waveform. Such modulation parameters can include an electrode combination, in which electrodes activated as anodes (positive), cathodes (negative), and off (zero) are defined, a percentage of modulation energy is allocated to each electrode (subdivided electrode configuration), and electrical pulse parameters, which define pulse amplitude (which can be measured in milliamps or volts, depending on whether the pulse generator supplies a constant current or a constant voltage to the electrode array), pulse width (which can be measured in microseconds), pulse rate (which can be measured in pulses per second), and burst rate (which can be measured as modulation on duration X and modulation off duration Y). Electrodes selected to send or receive electrical energy are referred to herein as "activated", while electrodes not selected to send or receive electrical energy are referred to herein as "inactive".

[0073] Electrical modulation occurs between or among multiple activated electrodes, one of which may be the IPG housing. The system may be capable of transmitting modulated energy to the tissue in a unipolar or multipolar (e.g., bipolar, tripolar, etc.) manner. When a selected lead electrode is activated together with the housing of the IPG, unipolar modulation occurs, so that the modulated energy is transmitted between the selected electrode and the housing. Any of the electrodes E1-E8 and the housing electrodes may be assigned to up to k possible groups or timing "channels". In one embodiment, k may be equal to 4. The timing channel identifies which electrodes are selected to synchronously sink or pull current to generate an electric field in the tissue to be stimulated. The amplitude and polarity of the electrodes on the channel may vary. In particular, the electrodes may be selected to be positive (anode, pull current), negative (cathode, sink current) or closed (no current) polarity in any of the k timing channels. The IPG can be operated in a mode for delivering electrically modulated energy that is therapeutically effective and causes the patient to perceive the energy delivery (e.g., therapeutically effective pain relief with perceived paresthesia), and can be operated in a sub-perceptual mode for delivering electrically modulated energy that is therapeutically effective and does not cause the patient to perceive the energy delivery (e.g., therapeutically effective pain relief without perceived paresthesia).

[0074] The IPG can be configured to individually control the magnitude of the current flowing through each electrode. For example, the current generator can be configured to selectively generate individual current-regulated amplitudes from independent current sources for each electrode. In some embodiments, the pulse generator can have a voltage-regulated output. Although individually programmable electrode amplitudes are required to achieve fine control over the shape and size of the resulting modulation field, a single output source switched across the electrodes can also be used, although with less fine control in programming. Neuromodulators can be designed with hybrid current and voltage modulation devices.

[0075] For the convenience of readers, Figure 8 A partial view of both the neuroanatomy and bony anatomy of the spine is shown. The neuroanatomy includes the spinal cord 100, such as Figure 1A-1B As shown. The neuroanatomy also includes the dorsal horn (DH) 104, dorsal root 105, DRG 106, ventral root 107 and mixed spinal nerve root 108. The bony anatomy refers to the vertebrae including the vertebral body 839 and the bony ring 840 attached to the vertebral body 839. The stacked vertebrae provide a spinal canal that protects the spinal cord 100. The nerve roots branch off from both sides through the gaps ("intervertebral foramina") between the vertebrae and leave the spine. The spinal cord is surrounded by the dura mater 841, which retains the cerebrospinal fluid surrounding the spinal cord 100. The space between the walls of the spinal canal and the dura mater is called the epidural space 842.

[0076] Figures 9A-9CTransverse top view, coronal side view and angled view of the spinal cord 100, dorsal root 105, DRG 106, ventral root 107 and mixed spinal nerve root 108 are shown respectively. Fig. 9A Also shown are bone 943, fat 944, dura mater 945, and cerebrospinal fluid 946.

[0077] Figures 10A-10G Schematic diagram of an embodiment of placing a neuromodulation lead on a patient's spinal cord. Specifically, Fig. 10A is a schematic diagram of a single electrical neuromodulation lead 1039 implanted approximately on the longitudinal midline of the spinal cord 100. It should be understood that additional leads or lead paddles may be used, such as may be used to provide a wider electrode arrangement and / or to provide electrodes closer to dorsal horn elements, and that these electrode arrays may also enable subdivided current flow. Fig. 10B An embodiment of implanting two electrical neuromodulation leads near the spinal cord is shown. The first electrical neuromodulation lead 1041 is implanted more laterally relative to the spinal cord, thereby placing it near the dorsal horn of the spinal cord. The second electrical neuromodulation lead 1042 is implanted more centrally relative to the spinal cord, thereby placing it near the dorsal column of the spinal cord 100.

[0078] For sub-sensory treatment, it may be desirable to place the lead closer to the DH than the DC to preferentially stimulate the DH rather than the DC neural elements. Lead placement may also allow for preferential neuromodulation of the dorsal root over other neural elements. Any other multiple leads or multiple rows of paddle leads may also be used. The longitudinal component of the electric field is directed along the Figures 10A-10B The y-axis depicted in each of the two diagrams is directed, and the transverse component of the electric field is directed along Figures 10A-10B Each of the x-axis depicted in FIG is directed. Some embodiments may include a directional lead having one or more directional electrodes. The directional electrodes may extend less than 360 degrees around the circumference of the lead body. For example, a row of two or more directional electrodes (e.g., "segmented electrodes") may be positioned along the circumference of the lead body. Activating selected electrodes in the segmented electrodes can help extend and shape the field in a preferred direction.

[0079] It should be understood that additional neuromodulation leads or paddles of the same or different types may be used, such as to provide a wider electrode arrangement and / or to provide electrodes closer to dorsal horn elements. In some examples, the neuromodulation lead or paddle may be placed at a more caudal region of the spinal cord distal end, and the electrode array on the neuromodulation lead may also achieve a subdivided current. Figures 10C-10Gis a schematic diagram of an embodiment of a neuromodulation lead placed in the caudal region of the spinal cord, such as at the L3-L5 and S1 levels, where the spinal cord is not actually present, but only the dorsal roots and other neural structures. The neuromodulation lead or paddle can be placed lateral or medially to the spinal cord, and proximal to one or more dorsal roots, and is configured to deliver modulated energy to the dorsal root fibers. Fig. 10C In the present invention, three percutaneous leads 1010 are positioned toward the left side of the spinal canal and in Fig. 10D In , two percutaneous leads 1020 are positioned toward the left side of the spinal canal. Fig. 10E In the embodiment, a single four-row paddle lead 1030 is positioned toward the left side of the spinal canal and in Fig.10F In FIG. 1 , a single two-column paddle lead 1040 is positioned toward the left side of the spinal canal. Figure 10G , a single percutaneous lead 1050 is positioned toward the left side of the spinal canal. In the example shown, the percutaneous lead 1050 includes multiple segmented electrodes that enable lateral control of the stimulation location via a single lead. In addition, because the segmented electrodes are placed in close lateral proximity, they can be used to provide a high degree of lateral stimulation resolution.

[0080] Although Figures 10C-10G The examples shown in show electrode leads placed to the left side of the spinal canal, but these are by way of example and not limitation. Figures 10C-10G In any of the above, lead placement to the right side of the spinal canal can also be utilized. As can be seen from the figure, different types of leads (including types different from those shown) with different numbers of electrodes and different electrode spacings can be used to provide dorsal root stimulation. These exemplary lead placements differ from the lead placements that are closer to the anatomical midline in traditional spinal cord stimulation (SCS) treatments.

[0081] Figures 10C-10G The dorsal root trajectories 1002A and 1002B in FIG. 1 show that the dorsal root fibers have a different trajectory than the dorsal column fibers and that they are not aligned with the anatomical midline. Figures 10C-10G As shown, the relative position (e.g., lead entry angle) between the lead and the neural target (e.g., dorsal column fibers or dorsal root fibers) can vary at different anatomical regions. When neuromodulation specifically targets dorsal root fibers, the location of the dorsal root needs to be known so that stimulation can be customized. Various embodiments are described herein that incorporate anatomical information of the target neural tissue (e.g., dorsal root trajectory) and patient feedback on paresthesias into the stimulation field design process, which can help improve neuromodulation accuracy and thereby improve treatment outcomes, such as pain relief.

[0082] Fig. 10H1043 is a schematic diagram of an electrical neuromodulation lead 1043 showing examples of subdivisions of anode current delivered to electrodes on the electrical neuromodulation lead. These figures illustrate subdivisions using monopolar neuromodulation, where the housing electrode of the IPG is the only cathode and carries 100% of the cathode current. Fig. 10E The subdivision of the anode current shown does not deliver an equal amount of current to each electrode 1044 because this embodiment takes into account electrode / tissue coupling differences, which are differences in how the tissue underlying each electrode responds to electrical neuromodulation. In addition, the ends of portions of the electrical neuromodulation lead include electrodes with lower gradients in the longitudinal direction. The magnitude of the electric field tapers at the ends of the electrical neuromodulation lead. The subdivision of the current can accommodate changes in the tissue underlying those electrodes. The subdivision across the electrical neuromodulation lead can be varied in any manner as long as the sum of the subdivided currents equals 100%.

[0083] Fig.11 1100, which provides spinal nerves to innervate various organs and tissues throughout the body, including, for example, blood vessels, stomach, intestines, liver, kidneys, bladder, genitals, lungs, pupils, heart, sweat glands, salivary glands, and digestive glands. The innervating spinal nerves originate primarily from motor neurons in the autonomic ganglia, which are located on both sides of the spinal cord and in two paravertebral chains parallel to the spinal cord. In patients who receive SCS for pain control via electrodes placed at neural targets at specific spinal levels or spinal nerves (e.g., dorsal roots or dorsal root ganglia), stimulation of such neural targets may produce side effects or symptoms specific to those organs or tissues innervated by the spinal nerves. As shown in FIG. Fig.11 As shown, in a patient implanted with an SCS lead system 1110, stimulation energy (e.g., a pulse train) delivered at selected electrodes, such as electrodes 1112 at spinal levels T9-T10, may cause side effects or symptoms at organs 1120 innervated by autonomic nerves originating from those spinal levels, including the stomach, liver, adrenal glands, and small and large intestines. In each affected organ, the patient may experience gastrointestinal symptoms such as constipation, diarrhea, flatulence, and bloating, among others. This correspondence between anatomical systems, organs, and tissues and spinal levels (i.e., the spinal origins of the nerves innervating the corresponding organs and tissues) may be used to titrate SCS configurations or doses to relieve autonomic symptoms or side effects, or to treat or relieve autonomic disorders, including, for example, visceral pain originating from or associated with internal organs or blood vessels.

[0084] Fig.12A block diagram of a neuromodulation system 1200 is shown by way of example and not limitation, the neuromodulation system being configured to provide or adjust neural stimulation to a neural target to avoid or alleviate autonomic symptoms and side effects. In one example, the system 1200 can provide spinal cord stimulation (SCS) at a spinal nerve target. SCS can be part of a pain management regimen, and the system 1200 can automatically or with user intervention optimize stimulation settings to avoid or alleviate autonomic symptoms or side effects while maintaining or improving pain control for the patient. In some examples, the system 1200 can titrate neural stimulation to treat or alleviate specific autonomic disorders, including, for example, visceral pain originating from or associated with internal organs or blood vessels.

[0085] Neuromodulation system 1200, as an embodiment of neuromodulation system 210, may include one or more of user interface device 1210, controller circuit 1220, database 1230, and electrical stimulator 1240. Portions of neuromodulation system 1200 may be implemented in implantable system 521 or external system 522. In one example, user interface device 1210 and controller circuit 1220 may be included in a programming device, such as programming device 413.

[0086] The user interface device 1210 may be Figure 2 and Figure 4 The example of the programming device 213 or programming device 413 shown in the figure can allow a user (e.g., a patient, a physician managing a patient, or an equipment specialist) to interact with the neuromodulation system 1200 by providing feedback on the SCS and programming or modifying stimulation settings. In one example, the user interface device 1210 can be a portable (e.g., handheld) device that can be operated by the patient at home without the need for additional clinic visits or consultation with an equipment specialist. The portable device can be an RC 628 or a smart phone executing a dedicated software application. The patient can provide feedback on the SCS, including pain relief and autonomic symptoms or side effects caused by or associated with the existing SCS, adjust one or more SCS parameters to avoid or alleviate SCS-related side effects or symptoms, while maintaining or improving pain relief. In another example, the user interface device 1210 can be a programmer device, such as a CP 629, which allows a physician to remotely view stimulation settings and treatment history, consult with a patient to obtain information including pain relief and SCS-related side effects or symptoms, perform remote programming of the electrical stimulator 1240, or provide other treatment options to the patient.

[0087] like Fig.12As shown, the user interface device 1210 may include a user input unit 1211 and an output unit 1212. The user input unit 1211 may include one or more user interface (UI) control elements, which can be operated by a user to provide information including autonomic symptoms 1213 and identification of affected anatomical structures 1214 associated with the autonomic symptoms 1213. The autonomic symptoms 1213 may be related to a disorder, dysfunction or symptom associated with the autonomic nervous system (ANS). An example of such a disorder or symptom is visceral pain, which refers to pain originating from or associated with an internal organ or blood vessel, such as bladder pain, endometriosis, irritable bowel syndrome and prostate pain. In addition or alternatively, the autonomic symptoms 1213 may be caused by or related to a neuromodulation therapy (such as an SCS delivered to a patient according to a specific stimulation setting). In this article, the stimulation setting can be defined by a set of stimulation parameters with corresponding programmable or preset values. Examples of stimulation parameters may include electrode configuration (e.g., stimulation lead and electrode location, selection of active electrodes, designation of anodes and cathodes, and subdivision of stimulation current or energy across electrodes), stimulation dose parameters (e.g., pulse width, frequency, pulse amplitude), stimulation pulse waveform or on-off cycle of stimulation bursts (including a pulse train during an on period followed by a pulse-free period during an off period), etc. Affected anatomical structures 1214 may include certain systems (e.g., body, head, cardiovascular, gastrointestinal, or urinary systems) or organs (e.g., heart, stomach, intestines, bladder, endometrium, skin) where the side effect or symptom occurs or persists. In some examples, the user may additionally provide information about the severity of the autonomic symptom or side effect. The severity may be in the form of a numerical value (e.g., 1 to 5) or a categorical value (e.g., "mild," "moderate," or "severe"). The user may provide the autonomic symptoms 1213 and affected anatomical structures 1214 in different formats (such as text, graphics, or verbal descriptions, etc.).

[0088] In some examples, the user can additionally provide pain data or feedback on pain relief caused by existing SCS therapy via user input unit 1211. Pain data or feedback on pain relief can include identification of pain sites, distribution of pain, pain intensity at various pain sites, or time patterns such as duration of pain at various pain sites, pain mapping with pain markers identifying the location, intensity, pattern of pain, and other information. In some examples, the user can provide information about the patient's health or medical information such as medications, physical activity, changes in medical procedures received, and other information via user input unit 1211. The neuromodulation system 1200 can use such additional information together with autonomic symptoms 1213 and affected anatomical structures 1214 to optimize neurostimulation therapy.

[0089] The output unit 1212 may include a display to present in text or graphical form the identification of autonomic symptoms 1213 and affected anatomical structures 1214, as well as other information provided by the user via the user input unit 1211. In one example, a pre-generated list of symptoms associated with systems, organs, or tissues that may be affected based on lead placement and electrode position may be displayed to the user. The user may select applicable symptoms and / or affected anatomical structures from the list, for example, via a UI control on the user input unit 1211.

[0090] In some examples, the user input unit 1211 may include a tool (e.g., a UI control element) that allows a user (e.g., a patient) to program or modify the stimulation settings of an existing CSC therapy, such as by adjusting the value of one or more stimulation parameters, to improve pain relief and / or avoid or alleviate SCS-related side effects or symptoms. In some examples, the neuromodulation system 1200 may automatically determine a "preferred" or improved stimulation setting, or recommend adjustments to one or more stimulation parameters based on the autonomic symptoms 1213 received from the user and the identified affected anatomical structures 1214. The output unit 1212 may present the "preferred" or improved stimulation setting or the recommended parameter adjustment to the user. The user may accept, reject, or modify the stimulation setting via the user input unit 1211. Refer to the following for details. Figures 14A-14D Examples of user interface devices for receiving user input of autonomic symptoms and affected anatomy, and user programming of stimulation settings or modifications of recommended stimulation settings are discussed.

[0091] Controller circuit 1220, as an example of programmed control circuit 420, can be communicatively coupled to user interface device 1210, such as via a wireless communication link. Controller circuit 1220 can determine a "preferred" or improved stimulation setting (as defined by a set of stimulation parameters with corresponding optimized values). The stimulation setting is "preferred" or improved in the sense that the neural stimulation delivered therein is likely to achieve the desired therapeutic outcome: avoiding or alleviating side effects or symptoms associated with the current stimulation while maintaining or improving the pain relief effect. Controller circuit 1220 may include a circuit group that includes one or more other circuits or sub-circuits, such as a neural target identifier 1221 and a stimulation controller 1222. The circuits or sub-circuits may perform the functions, methods, or techniques described herein, alone or in combination. In one example, the hardware of the circuit group may be immutably designed to perform a specific operation (e.g., hardwired). In one example, the hardware of the circuit group may include a variably connected physical component (e.g., an execution unit, a transistor, a simple circuit, etc.) that includes a computer-readable medium that is physically modified (e.g., magnetically, electrically movable placement of a constant mass particle, etc.) to encode instructions for a specific operation. When the physical components are connected, the basic electrical characteristics of the hardware components change, for example, from an insulator to a conductor, or vice versa. The instructions enable embedded hardware (e.g., an execution unit or a loading mechanism) to create a member of the circuit group in hardware via a variable connection to perform a portion of a specific operation when operating. Therefore, when the device operates, the computer-readable medium is communicatively coupled to other components of the circuit group component. In one example, any physical component can be used in more than one member of more than one circuit group. For example, under operation, an execution unit can be used in a first circuit of a first circuit group at one point in time and reused by a second circuit in the first circuit group or by a third circuit in the second circuit group at a different time.

[0092] In various examples, portions of the functionality of the controller circuit 1220 may be implemented as part of a microprocessor circuit. The microprocessor circuit may be a dedicated processor, such as a digital signal processor, an application specific integrated circuit (ASIC), a microprocessor, or other types of processors for processing information including physical activity information. Alternatively, the microprocessor circuit may be a general purpose processor that may receive and execute a set of instructions for performing the methods or techniques described herein.

[0093] The neural target identifier 1221 can identify one or more neural targets, such as spinal levels or spinal nerves to be modulated by an existing implanted lead system to achieve a desired treatment outcome (e.g., adequate pain relief and avoidance or relief of SCS-related side effects or symptoms). Such identification of neural targets can be based on user input of autonomic symptoms 1213 and affected anatomical structures 1214, optionally with pain data and patient feedback on pain relief. As described above with reference to Fig.11 As described above, implantable lead placement and electrode location relative to neural targets (e.g., spinal levels or spinal nerves) and other factors will determine the anatomical systems or organs that may be affected by stimulation and the extent of symptoms or side effects perceived at those affected organs. Thus, depending on lead placement and electrode location, only certain anatomical systems or organs may be affected by CSC.

[0094] The neural target identifier 1221 can use the information stored in the database 1230 to more accurately identify the spinal cord target to be modulated for pain relief and symptom control. The database 1230 can reside in the memory of an implantable device (e.g., IPG 627), RC 628, CP 629, or a device in the external system 523 (e.g., a patient medical record server). The information retrieved from the database 1230 for identifying the spinal cord target can include the correspondence between the spinal origin (spinal level) and the anatomical system or organ innervated by the spinal nerves, information about the implanted leads (including the lead type (e.g., percutaneous lead, linear paddle, multi-column paddle, or directional lead, etc.) and lead placement and electrode location), patient health status and medical history (e.g., medications, physical activity, changes in medical procedures received), and other information. In one example, the database 1230 can store a lookup table representing the correspondence between a spinal level or lateral spinal cord target and the corresponding anatomical system or organ innervated by the spinal nerves originating from the corresponding spinal level. Reference is made to Fig.13 An example of such a lookup table is discussed.

[0095] A stimulation controller 1222 coupled to the neural target identifier 1221 can generate a "preferred" or recommended stimulation setup for stimulating a spinal nerve target automatically identified by the neural target identifier 1221. The "preferred" or recommended stimulation setup can include an electrode configuration (e.g., monopolar, bipolar, or tripolar stimulation, anode and cathode designation); a location of a stimulation center point representing the focus of the stimulation field; one or more stimulation parameters (e.g., current amplitude or voltage amplitude, pulse width, pulse waveform, pulse rate, duty cycle); a modulation waveform of the amplitude or pulse width or frequency of a continuous modulated pulse train, where the modulation waveform can be a random signal, a sine wave, a triangle wave, an exponential wave, a logarithmic wave, a quadratic wave, or any other modulation function. In one example, the stimulation setup can include an on-off cycle of a stimulation burst, which includes a pulse train in an on period followed by a pulse-free period in an off period.

[0096] In one example, the stimulation setting may include stimulation based on paresthesia, which may cause a sense of paresthesia during stimulation. Examples of stimulation based on paresthesia may include monopolar stimulation mode, bipolar stimulation mode, tripolar stimulation mode, steering mode, sensory mode, and rotation mode. The stimulation may be a cathode or an anode. In one example, monopolar anode stimulation may be applied after searching through different electrode-tissue contacts using multiple independent current control (MICC) to refine the size and shape of the stimulation field and customize treatment for individual patients. In one example, monopolar anode stimulation may be applied with time-variant pulses (TVP), such as defined as a rate, pulse width, or amplitude modulated with a specific function (such as a sine wave function, a random function following a statistical distribution (e.g., Poisson distribution or uniform distribution) or other arbitrary waveform). After searching for a sweet spot using MICC through different contacts, a TVP with monopolar anode stimulation may be applied. The sweet spot is the desired or preferred position of the neuromodulation field. In one example, the test area can be started with a sub-sensory neuromodulation field, and the sweet spot can be identified as a neural tissue that is effective in treatment when targeted with sub-sensory neuromodulation. The sweet spot test can involve a manual process of reprogramming the neuromodulation field parameter set with different values ​​to change the target position of the neuromodulation field. In some embodiments of the test, the target position can be automatically changed (e.g., trolled) by automatically changing the value of the neuromodulation field parameter set. Some embodiments can semi-automatically change the value of the neuromodulation field parameter set to change the target position of the neuromodulation field. In one example, monopolar cathode stimulation can be applied with or without TVP. In another example, bipolar stimulation can be applied with or without TVP. The bipolar configuration includes an anode located at the rootlet and a cathode located in the middle lead. In one example, tripolar stimulation can be applied in the head and tail direction. In some examples, the shunt cathode can be used in a MICC manner to make the anode stimulation more localized (e.g., along the head and tail direction and the middle and side directions). Because the rootlet crosses out at this point, the cathode can be used to shunt the anode current from the rootlet that does not correspond to the rootlet of interest. In one example, a long head-to-tail anode monopole can be used to excite a larger area of ​​the DREZ.

[0097] In one example, stimulation settings can include non-paresthesia stimulation, which does not usually cause paresthesia sensation during stimulation. Non-paresthesia stimulation can include fast-acting sub-perception therapy (Fast-Acting Sub-perception Therapy, FAST) mode, Dorsal Horn Modulation (DHM) mode, burst mode and low-rate active recharge (Low-Rate Active Recharge, LRAR) mode. FAST mode allows the delivery of stimulation pulses to provide deep non-paresthesia pain relief in a short period of time (e.g., a few minutes) by increasing surrounding inhibition. DHM is a stimulation mode that can target inhibitory interneurons on dorsal column fibers. In LRAR mode, sub-perception stimulation pulses are delivered at a frequency lower than the typical DHM frequency.

[0098] In some examples, based on the location of lead placement, the stimulation controller 1222 can generate multiple CPSs. Each CPS represents a focus of a stimulation field established by stimulation energy applied to an electrode on a portion of an epidural lead. The stimulation field corresponding to multiple CPSs can activate corresponding spinal nerve targets at different spinal levels. To generate multiple CPSs, a user can program corresponding multiple electrodes on the lead with corresponding paresthesia-based or non-paresthesia-based stimulation and corresponding stimulation parameters. Commonly assigned U.S. Patent Application No. 17 / 589,738, entitled “SYSTEM AND METHODS FOR SELECTABLE LATERALSPINAL CORD STIMULATION,” by Block et al., describes various examples of programming stimulation on a user interface to treat pain and avoid undesirable effects, the disclosure of which is incorporated herein by reference in its entirety.

[0099] The stimulation controller 1222 can generate control signals for adjusting stimulation settings, such as by tuning one or more stimulation parameters (e.g., pulse width, amplitude, duty cycle (stimulation on / off cycle scheme), stimulation rate, modulation frequency, modulation depth, etc.), and trigger the electrical stimulator 1240 to deliver neuromodulation energy at one or more spinal nerve targets, such as automatically identified by the neural target identifier 1221 or manually selected by the user, according to the recommended stimulation settings provided by the stimulation controller 1222. The electrical stimulator 1240 can be an implantable module, such as incorporated within the implantable system 521. Alternatively, the electrical stimulator 1240 can be an external stimulation device, such as incorporated with the external system 522. In some examples, the user can accept, reject, or modify the recommended stimulation settings via the user input unit 1211, or separately provide stimulation settings different from the recommended stimulation settings, and the control signal can trigger the electrical stimulator 1240 to deliver neuromodulation energy according to the user-modified or separately provided stimulation settings. The identified spinal nerve targets and stimulation settings may be stored in a storage device, such as storage device 419 of programming device 413 .

[0100] In some examples, the user can provide feedback on pain control and / or symptom relief in response to electrical stimulation, such as via user interface device 1210. Based on patient feedback, stimulation controller 1222 can maintain existing stimulation settings if satisfactory pain control and symptom relief have been achieved, or further adjust and optimize stimulation settings if pain control is insufficient or symptoms or side effects are exacerbated.

[0101] Fig.13 By way of example and not limitation, a lookup table 1300 is shown that represents the correspondence between (i) anatomical systems 1310 and one or more organs 1320 in each system and (ii) spinal levels 1330 (i.e., the spinal origins of nerves innervating the corresponding organs) within the stimulation field created by the electrodes of the existing implanted lead system in the patient. The lookup table 1300 may additionally include an identification of the electrodes 1340 on the implanted leads at each spinal level 1330. The lookup table may be used to select electrodes on the implanted lead system for the autonomic symptom and affected organ identified by the user, as described below with reference to Fig. 14C discussed.

[0102] Figures 14A-14D An example of a portable device 1400 is shown that is configured to receive user feedback on symptoms and affected anatomy of a neurostimulation therapy such as SCS and user programming or adjustment of stimulation settings. The portable device 1400, as an example of a user interface device 1210, can be a personal mobile device (e.g., a smartphone) that executes a dedicated software application for CSC-related symptom management. Fig.14AA portion of a user interface on a display of a portable device 1400 is shown showing a main menu including user-selectable submenus or commands (represented by corresponding icons) including a program menu 1412 for programming stimulation settings or selecting from a list of predetermined stimulation programs, a schedule menu 1414 for changing the stimulation schedule, and a symptom menu 1416 for providing user feedback on SCS-related symptoms or side effects. The user may tap the symptom menu 1416 icon (or otherwise click on the symptom menu 143 using a UI control element on the user interface) to enter a screen that allows the user to provide feedback on SCS-related symptoms or side effects.

[0103] Fig. 14B A portion of a user interface is shown that displays a list of anatomical systems or organs supported by a lead system implanted in a patient. Display of the list of anatomical systems or organs may be triggered by a user selecting a symptom menu 143. The "supported" anatomical systems and organs identifiable by the neural target identifier 1221 as described above are anatomical structures innervated by spinal nerves whose spinal origins or spinal nerve targets are located within the stimulation field created by the electrodes of the existing implanted lead system. By way of example and not limitation, anatomical systems may include the body, head, cardiovascular, gastrointestinal, urinary and reproductive systems, among others. Depending on lead placement and electrode location, anatomical organs may include the heart, stomach, intestines, bladder, endometrium, and skin, among others.

[0104] From the list of anatomical systems and organs displayed on the user interface, the patient can select an anatomical system or organ associated with a symptom or side effect caused by or associated with SCS therapy, such as by tapping or clicking a corresponding icon for the system or organ. Fig. 14C shows a portion of a user interface that displays the Fig. 14B 1422. A list of pre-generated symptoms 1424 associated with a particular anatomical system or organ may be determined based on data collected from a patient population (e.g., a patient survey). For example, intestinal symptoms may include constipation, diarrhea, or flatulence and bloating. In another example, symptoms 1424 may include visceral pain in one or more internal organs, such as bladder pain, endometriosis, irritable bowel syndrome, and prostate pain. The patient may select an applicable symptom (e.g., constipation in this example) from the displayed symptoms, such as by tapping or clicking on a corresponding icon for the symptom. The user may provide additional characterization or description of the identified symptom, such as symptom severity 1426. Severity 1426 may have a numerical value (e.g., on a scale of 1 to 5) or a categorical value (e.g., "mild," "moderate," or "severe").

[0105] The controller circuit 1220 of the neuromodulation system 1200 can generate "preferred" or recommended stimulation settings 1430 based on user feedback on symptoms and affected anatomical structures. In some examples, such as the correspondence between spinal levels / spinal nerves and the anatomical systems or organs innervated by the nerves (e.g., Fig.13 The "preferred" or recommended stimulation setting may also be determined based on other information such as the lookup table 1300 in the user interface, the patient's implanted lead placement, or the patient's health status and medical history. For example, the lookup table 1300 may be used to select electrodes on the implanted lead system for autonomic symptoms and affected organs identified by the user. For example, for constipation symptoms in the intestine, electrodes at spinal levels T6-T12 may be selected. The "preferred" or recommended stimulation setting may be determined to be one that has a reduced stimulation dose (e.g., a smaller pulse amplitude, a shorter pulse width, a lower stimulation frequency, or an on-off cycle scheme with a shorter on period) on the selected electrodes at spinal levels T6-T12 to relieve constipation. The "preferred" or recommended stimulation setting 1430 may be displayed in a recommendation panel on the user interface.

[0106] In one example, a stimulation setting may be represented by a single composite neural stimulation dose within a particular range of values ​​(eg, 0-100%), where higher values ​​indicate higher stimulation doses. Fig. 14C A "preferred" or recommended composite neurostimulation dose of 40% as determined by the controller circuit 1220 is shown. A single composite neurostimulation dose can be obtained by projecting a multidimensional parameter space onto a single composite neurostimulation dose dimension. The multidimensional parameter space is spanned by a plurality of stimulation parameters (e.g., amplitude, pulse width, frequency, on and off cycle duration, etc.), each stimulation parameter taking values ​​within its respective value range. The projection of the multidimensional parameter space to a 1-D composite neurostimulation dose can be performed according to a particular projection rule. In one example, the projection rule can be represented by a projection matrix, such that a 1-D composite neurostimulation dose can be calculated as a combination of a plurality of stimulation parameters, followed by a quantization of the combined value int value within a specified range (e.g., 0-100%). The composite neurostimulation dose so calculated corresponds to a plurality of stimulation parameters, each stimulation parameter taking a respective value within its respective value range. In another example, the projection rule is a dimension selection rule, in which case the composite neurostimulation dose represents a particular parameter selected from a plurality of stimulation parameters. Reference is made below to Figures 15A-15B An example of the correspondence between a composite neural stimulation dose and multiple stimulation parameters is discussed.

[0107] exist Fig. 14CIn the example shown, the recommended stimulation setting may be represented by a single composite neurostimulation dose of 40%. The recommended composite neurostimulation dose may be graphically displayed on a modulatable 1-D dose bar 1440 representing a range of values ​​from 0 to 100%. The user may accept or reject the recommended composite neurostimulation dose, or modify the recommended dose, such as by dragging a slider 1442 along the 1-D dose bar 1440 and positioning the slider 1442 at a desired dose value other than the recommended value. Since the composite neurostimulation dose is a projection from multiple stimulation parameters, a user modification of the neurostimulation dose (e.g., via a slider 1442 along the 1-D dose bar 1440) will result in simultaneous titration of multiple stimulation parameters.

[0108] In some examples, portable device 1400 may allow a user to perform device programming by adjusting each of a plurality of stimulation parameters. Fig.14D A portion of a user interface is shown that displays, by way of example and not limitation, a 1-D dose bar 1440 (similar to Fig. 14C), one or more of an optional stimulation waveform menu 1450, a stimulation site selector 1460, and a stimulation mode menu 1470. The optional stimulation waveform menu 1450 allows a user to select a treatment from a set of treatments (e.g., Tx1, Tx2, and Tx3). Each treatment includes one or more treatment parameters, such as a stimulation waveform mode. In one example, a stimulation waveform mode may include a biphasic waveform that includes a first charging phase and a subsequent active recharging (or charge recovery) phase, such as used in a Fast-Acting Sub-Perception Therapy (FAST) stimulation mode. The optional stimulation waveform menu 1450 may also allow a user to select or adjust a duty cycle, which defines the amount of time a stimulation pulse (such as a stimulation pulse with an active recharging waveform) is delivered (on period) or suppressed (off period). The duty cycle can be represented by a ratio of an on period to an off period (e.g., 1:1 for equal on and off periods, and 1:8 for an off period that is eight times the duration of the on period). Alternatively, the duty cycle can be represented by the percentage of time that the stimulation is on (e.g., between 0 and 100%). For example, a duty cycle of 100% corresponds to stimulation pulses that run continuously, 0% corresponds to stimulation that is completely off, and 50% corresponds to stimulation pulses that run for an on period (from seconds to minutes) followed by an off period of equal duration. In an example, the selectable stimulation waveform menu 1450 can include active recharge waveforms with different duty cycles, such as a range from 1:1 to 1:8 (e.g., 1 minute on / 3 minutes off; 30 seconds on / 2 minutes off; 30 seconds on / 4 minutes off), as well as other selectable duty cycles. The stimulation pulses can be fixed pulses or modulated pulses (e.g., via one or more of frequency modulation, pulse width modulation, amplitude modulation) or random pulses.

[0109] The stimulation site selector 1460 allows the user to reassign the stimulation anatomical location and / or electrical configuration. For example, the user may be recommended to use a multiple independent current control (MICC) drag algorithm to redirect stimulation to another location to refine the size and shape of the stimulation field and customize treatment for individual patients, or select a neurostimulation program to stimulate a target location, such as one of the fast-acting sub-sensory therapy (FAST) mode, dorsal horn modulation (DHM) mode, burst mode, or low rate active recharge (LRAR) modes as described above. For example, the user may be recommended to position and configure the electrodes to create a 16 mm DHM electric field at approximately the mid-T9 vertebra.

[0110] The stimulation mode menu 1470 allows the user to select a stimulation mode from a predetermined stimulation mode set including, for example, a comfort mode, an economy mode, an intense mode, or a sensory mode. The comfort mode can be used for normal daily use. The economy mode can provide stimulation parameters with low power consumption. For example, if the patient is experiencing pain and will benefit from a stronger stimulation, the intense mode can be used. The sensory mode allows the patient to feel stimulation (super-perception). The stimulation mode menu 1470 can additionally include a mode optimized for patient activity, such as a sleep mode that optimizes the stimulation parameters for the patient during sleep (e.g., when the patient lies down and does not move significantly), an exercise mode that provides stimulation parameters suitable for when the patient is exercising (e.g., when the patient stands up and moves significantly), or other stimulation modes designed for different patient postures (such as supine, prone, standing, sitting, etc.) or for different conditions (such as cold or bad weather). The patient can select from these stimulation modes, and this selection can program the electrical stimulator to provide a subset of stimulation parameters useful for the mode controlled by the preferred stimulation parameters.

[0111] In a multidimensional parameter space spanned by a plurality of stimulation parameters, each stimulation parameter taking a value within its respective value range, the stimulation modes each represent a corresponding subspace in the multidimensional parameter space. Each subspace is defined by a stimulation parameter taking a value in a respective subset of the value range. For example, the comfort mode, the eco mode, the intense mode, and the sensation mode each represent a corresponding subspace in the parameter space, wherein the eco mode may have a stimulation frequency range of approximately 2-100 Hz and a PW range of approximately 350-400 microseconds (μs); the comfort mode may have a stimulation frequency range of approximately 100-400 Hz and a PW range of approximately 150-250 μs; the intense mode may have a stimulation frequency range of approximately 400-1200 Hz and a PW range of approximately 50-150 μs; the sensation mode may have a stimulation frequency range of approximately 2-100 Hz and a PW range of approximately 250-350 μs. The sensation mode corresponds to super-sensory stimulation, while the comfort mode, the eco mode, and the intense mode all correspond to sub-sensory stimulation.

[0112] like Fig.14DThe user interface shown may additionally receive feedback 1480 on the stimulation settings recommended by the system or provided by the user. Feedback may be provided by the user, including, for example, the user's satisfaction level with pain relief and symptom control as a result of neural stimulation according to the recommended or user-provided stimulation settings. Depending on the user satisfaction level, a confirmation of the user feedback and further recommendations may be generated and presented to the user. For example, if the patient is satisfied with the current settings, the stimulation controller 1222 may maintain the existing stimulation settings, or if the patient is dissatisfied with the current settings, automatically adjust the parameter settings or recommend different parameter settings. Alternatively or in addition, feedback 1480 may be represented by signals collected from a biosensor (e.g., a wearable sensor). For example, a cardiac patch and / or wristwatch may provide cardiovascular metrics (related to heart rate, blood pressure, etc.) using different sensing technologies. These feedback signals may be used to automatically adjust parameter settings or recommend different parameter settings for neural stimulation.

[0113] Figures 15A-15B A table showing the correspondence between a single neural stimulation dose parameter (D) and multiple stimulation parameters {P1, P2, ..., PN} (e.g., Fig.15A Parameter table 1510 and Fig. 15B 1520), each stimulation parameter takes its own value. Figures 14C-14D As discussed, a single neural stimulation dose can be obtained by projecting a multidimensional stimulation parameter space spanned by a plurality of stimulation parameters (e.g., pulse amplitude, pulse width, frequency, duty cycle represented by an on-off cycle scheme including an on period and an off period) onto a one-dimensional dose domain, each stimulation parameter taking values ​​within its respective range of values. A single neural stimulation dose represents a combination of stimulation parameter sets. Each dose value (e.g., Fig. 14C 40% shown) represent unique combinations of parameter sets that take on their respective values.

[0114] Figures 15A-15B The table shown in represents discrete composite neural stimulation dose values ​​(ranging from 0 to 100% in 1% increments) and sets of parameters that take their respective values. For example, in the first row of the table, D1 corresponds to {P1=a1, P2=a2, ..., PN=aN}, for the rows in the table, D2 corresponds to {P1=b1, P2=b2, ..., PN=bN}, etc., where ai's and bi's are parameter values. Fig.15AParameter table 1510 in shows the composite neural stimulation dose values ​​and the corresponding stimulation parameters on period, off period, and charge per hour (CPH, representing the estimated charge in microcoulombs per hour (μC), as consumed by the electrical stimulator). Pulse amplitude (A), pulse width (PW), and frequency (Freq) are set to their corresponding fixed values ​​(A=2.8mA, PW=200 microseconds, Freq=200Hz) and are not included in parameter table 1510. According to parameter table 1510, each composite neural stimulation dose value corresponds to an on period, an off period, and a CPH value. For example, the dose value D=0 corresponds to continuous stimulation (i.e., fully on, no period of time); D=1 corresponds to the minimum period (2 minutes of on period, 30 seconds of off period); D=100 corresponds to the maximum period (30 seconds of on period and 5 minutes of off period). Similarly, Fig. 15B The parameter table 1520 in FIG. 1 shows the composite neural stimulation dose values ​​and the corresponding parameters: pulse width, pulse amplitude, frequency, duty cycle represented by an on-off cycle (including an on period and an off period), on time per hour (seconds / hour), and CPH. According to the parameter table 1520, each composite neural stimulation dose value corresponds to an on period, an off period, and a CPH value. Fig.15A As shown, 40% of the recommended combined neural stimulation dose value corresponds to an on period of 90 seconds, an off period of 30 seconds, and a CPH of 101 μC. By accepting the recommended dose value or by, for example, Fig. 14C The 1-D dose bar 1440 sets the composite neural stimulation dose to different values, and the parameter value on the corresponding row of the table can be automatically selected and programmed to the electrical stimulator 1240 to deliver electrical stimulation accordingly.

[0115] In one example, parameter table 1510 or parameter table 1520 may be sorted with respect to one or more parameters, such as in descending or ascending order of one or more stimulation parameters at corresponding columns on the table. A 1-D dose bar (0-100%) may then be arranged according to the sorted table. For example, in Fig.15A In the example shown, the parameter table 1510 can be sorted in descending order of duty cycle (or ratio of on period to off period) or on period (e.g., from 2 minutes to 30 seconds), and the 1-D dose bars (0-100%) can be arranged according to the descending order of duty cycle or on period. Alternatively, the parameter table 1520 can be sorted with respect to other parameters such as off period, charge per hour (CPH), frequency (e.g., from 1000 Hz down to 50 Hz), pulse width or amplitude, and the 1-D dose bars (0-100%) can be arranged according to the sorted table.

[0116] Fig.16A flow chart of a method 1600 for programming and providing neural stimulation to neural targets to avoid or alleviate autonomic symptoms and side effects is shown by way of example and not limitation. The method 1600 may be performed using a medical system such as one of the neuromodulation systems 210 or 1200. Portions of the method 1600 may be implemented in an external device, such as a device in the external system 522, or one of the programming devices 213 or 413, the CP 629, or the RC 628.

[0117] In one example, method 1600 can be used to program and provide spinal cord stimulation (SCS) at a spinal nerve target. SCS can be part of a pain management regimen. By performing method 1600, a programming device or an external device can program a neuromodulation device (e.g., one of neuromodulation devices 212, 312, or 512, or IPG 627, or electrical stimulator 1240) to deliver stimulation to various spinal nerve targets. Method 1600 can be used to optimize SCS settings to avoid or alleviate autonomic symptoms or side effects caused by SCS while maintaining or improving pain control efficacy. Additionally or alternatively, method 1600 can be used to titrate SCS to treat or alleviate certain autonomic disorders.

[0118] Method 1600 may begin at 1610 to receive information about autonomic symptoms and affected anatomical structures from a user (e.g., a patient or a healthcare provider) via a user interface. Autonomic symptoms may be caused by or associated with an SCS delivered to a patient according to a specific stimulation setting. The stimulation setting may be defined by a set of stimulation parameters with corresponding programmed values. The affected anatomical structures 1214 may include certain systems (e.g., body, head, cardiovascular, gastrointestinal, or urinary systems) or organs (e.g., heart, stomach, intestines, bladder, endometrium, skin) where side effects or symptoms occur or persist. In some examples, the user may additionally provide information about the severity of the autonomic symptoms or side effects. The severity may be in the form of a numerical value (e.g., 1 to 5) or a categorical value (e.g., "mild," "moderate," or "severe"). The autonomic symptoms, the affected anatomical structures, the severity of the symptoms, and the patient's response to electrical stimulation (feedback provided by the patient or a signal sensed by a biosensor) may be provided in different formats, such as text, graphics, or verbal descriptions.

[0119] In some examples, pain data, patient feedback on pain relief caused by existing SCS therapies, and / or patient health or medical information may also be received at 1610. Such information along with autonomic symptoms and affected anatomy may be used to optimize SCS therapy.

[0120] The user input of the autonomic symptom and the identified affected anatomical structure may be presented on a display of the user interface along with other information received at step 1610. In one example, a pre-generated list of symptoms and anatomical systems or organs that may be affected by SCS may be displayed on the user interface. The user may use one or more UI control elements to select the applicable symptom, the affected system or organ, and optionally the severity of the symptom, such as Figures 14A-14D shown.

[0121] At 1620, stimulation settings for the electrical stimulator may be determined or adjusted based on the autonomic symptoms and affected anatomical structures received from 1610. The stimulation settings may be defined by a set of stimulation parameters having individually "optimized" or recommended values ​​that, when used for neurostimulation therapies such as SCS for pain control, may help avoid or alleviate SCS-related side effects or symptoms while maintaining or improving pain relief. In order to determine "preferred" or recommended stimulation settings, one or more neural targets may be identified as those within the stimulation field created by the electrodes of an existing implanted lead system in the patient. Such identification of neural targets may be based on autonomic symptoms and affected anatomical structures, optionally together with pain data and patient feedback on pain relief. In one example, the correspondence between the spinal origin (spinal level) and the anatomical systems or organs innervated by the spinal nerves, information about existing leads implanted in the patient (including lead type, lead placement, and electrode location) may also be used to facilitate identification of spinal cord targets covered by the implanted lead system. In one example, Fig.13 The lookup table 1300 in can be used to select electrodes on the implanted lead system for user-identified autonomic symptoms and affected organs. A "preferred" or recommended stimulation setting can be determined as one having a reduced stimulation dose (e.g., a smaller pulse amplitude, a shorter pulse width, a lower stimulation frequency, or an on-off cycle scheme with a shorter on period) on selected electrodes at spinal levels T6-T12 to relieve constipation. In one example, a "preferred" or recommended stimulation setting can be represented by a single composite neural stimulation dose obtained by projecting a multidimensional parameter space onto a single composite neural stimulation dose dimension. The recommended stimulation setting can be graphically represented on a 1-D dose bar, such as Fig. 14C shown.

[0122] At 1630, a user's acceptance, rejection, or modification of the recommended stimulation settings may be received from the user interface. Alternatively, the user may separately provide stimulation settings that differ from the recommended stimulation settings. For example, in an example where the recommended stimulation settings are represented by a single composite neural stimulation dose (e.g., 40%) on a 1-D dose bar (e.g., Fig. 14CThe user can accept or reject the recommended dose, or modify the recommended dose to a different dose value. By adjusting the composite neural stimulation dose value, multiple stimulation parameters can be adjusted simultaneously according to the projection rules as described above. In various examples, the user can accept, reject or modify one or more stimulation parameters, such as the stimulation waveform, stimulation site or stimulation mode, as described above with reference to Fig.14D In some examples, one or more biosensors (e.g., wearable sensors) can sense corresponding signals in response to stimulation delivered according to recommended stimulation settings. Sensor signals indicative of the patient's response to the stimulation can be used to automatically adjust the recommended stimulation settings, or alternatively presented to a user to help optimize the stimulation settings.

[0123] At 1640, neurostimulation energy may be delivered to the patient via the electrical stimulator according to stimulation settings that are automatically generated and recommended to the user, or stimulation settings that are otherwise modified or manually provided by the user. In some examples, the user interface may prompt the user to provide feedback on the current stimulation settings, such as an indication of the level of satisfaction with pain relief and symptom control. Depending on the user satisfaction level, a confirmation of the user feedback and further recommendations may be generated and displayed to the user. If the patient is satisfied with the treatment and symptom relief, the existing stimulation settings may remain unchanged for future use, and if the patient is not satisfied with the current settings, different settings may be generated and recommended to the user.

[0124] Fig.17 Generally, a block diagram of an example machine 1700 is shown on which any one or more of the techniques (eg, methods) discussed herein may be executed. Portions of the present description may be applied to a computing framework of various portions of a neuromodulation device or an external programming device.

[0125] In alternative embodiments, the machine 1700 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, the machine 1700 may operate as a server machine, a client machine, or both in a server-client network environment. In one example, the machine 1700 may act as a peer machine in a peer-to-peer (P2P) (or other distributed) network environment. The machine 1700 may be a personal computer (PC), a tablet computer, a set-top box (STB), a personal digital assistant (PDA), a mobile phone, a network device, a network router, a switch or a bridge, or any machine capable of executing instructions (sequentially or otherwise) specifying actions to be taken by the machine. In addition, although only a single machine is shown, the term "machine" should also be deemed to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methods discussed herein, such as cloud computing, software as a service (SaaS), and other computer cluster configurations.

[0126] As described herein, examples may include logic or multiple components or mechanisms, or may be operated by logic or multiple components or mechanisms. A circuit group is a collection of circuits implemented in a tangible entity, including hardware (e.g., simple circuits, gates, logic, etc.). Circuit group members may be flexible over time and underlying hardware variability. A circuit group includes components that can perform specified operations individually or in combination when operating. In one example, the hardware of a circuit group may be immutably designed to perform a specific operation (e.g., hardwired). In one example, the hardware of a circuit group may include a variably connected physical component (e.g., an execution unit, a transistor, a simple circuit, etc.), which includes a computer-readable medium that is physically modified (e.g., magnetically, electrically, a movable placement of a constant mass particle, etc.) to encode instructions for a specific operation. When the physical components are connected, the basic electrical properties of the hardware components change, for example, from an insulator to a conductor, and vice versa. Instructions enable embedded hardware (e.g., an execution unit or a loading mechanism) to create members of a circuit group in hardware via a variable connection to perform parts of a specific operation when operating. Thus, when the device is operating, the computer-readable medium is communicatively coupled to other components of the circuit group member. In one example, any physical component can be used in more than one member of more than one circuit group. For example, in an operational situation, an execution unit can be used in a first circuit of a first circuit group at one point in time and reused by a second circuit in the first circuit group or by a third circuit in the second circuit group at a different time.

[0127] The machine (e.g., computer system) 1700 may include a hardware processor 1702 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 1704, and a static memory 1706, some or all of which may communicate with each other via an interconnect (e.g., a bus) 1708. The machine 1700 may also include a display unit 1710 (e.g., a raster display, a vector display, a holographic display, etc.), an alphanumeric input device 1712 (e.g., a keyboard), and a user interface (UI) navigation device 1714 (e.g., a mouse). In one example, the display unit 1710, the input device 1712, and the UI navigation device 1714 may be a touch screen display. The machine 1700 may additionally include a storage device (e.g., a drive unit) 1716, a signal generating device 1718 (e.g., a speaker), a network interface device 1720, and one or more sensors 1721, such as a global positioning system (GPS) sensor, a compass, an accelerometer, or other sensors. The machine 1700 may include an output controller 1728, such as a serial (e.g., universal serial bus (USB), parallel or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate with or control one or more peripheral devices (e.g., a printer, a card reader, etc.).

[0128] The storage device 1716 may include a machine-readable medium 1722 having stored thereon one or more sets of data structures or instructions 1724 (e.g., software) that embody or are utilized by any one or more of the techniques or functionality described herein. The instructions 1724 may also reside, completely or at least partially, within the main memory 1704, within the static memory 1706, or within the hardware processor 1702 during execution by the machine 1700. In one example, one or any combination of the hardware processor 1702, the main memory 1704, the static memory 1706, or the storage device 1716 may constitute a machine-readable medium.

[0129] Although the machine-readable medium 1722 is illustrated as a single medium, the term “machine-readable medium” may include a single medium or multiple media (eg, a centralized or distributed database, and / or associated caches and servers) configured to store one or more instructions 1724 .

[0130] The term "machine-readable medium" may include any medium capable of storing, encoding or carrying instructions for execution by the machine 1700 and causing the machine 1700 to perform any one or more of the techniques of the present disclosure, or any medium capable of storing, encoding or carrying data structures used by such instructions or associated with such instructions. Non-limiting machine-readable medium examples may include solid-state memory and optical and magnetic media. In one example, the aggregated machine-readable medium includes a machine-readable medium of multiple particles with constant (e.g., stationary) mass. Therefore, the massive machine-readable medium is not an instantaneous propagation signal. Specific examples of large-capacity machine-readable media may include: non-volatile memory, such as semiconductor memory devices (e.g., electrically programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EPSOM)) and flash memory devices; disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.

[0131] The instructions 1724 may also be sent or received over a communication network 1726 via the network interface device 1720 using a transmission medium that utilizes any of a number of transmission protocols (e.g., frame relay, Internet Protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP), etc.). Example communication networks may include a local area network (LAN), a wide area network (WAN), a packet data network (e.g., the Internet), a mobile telephone network (e.g., a cellular network), a plain old telephone (POTS) network, and a wireless data network (e.g., a wireless network known as a wireless network). The Institute of Electrical and Electronics Engineers (IEEE) 802.11 family of standards, known as 16 family of standards), IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, etc. In one example, the network interface device 1720 may include one or more physical jacks (e.g., Ethernet, coaxial, or telephone jacks) or one or more antennas to connect to the communication network 1726. In one example, the network interface device 1720 may include multiple antennas to wirelessly communicate using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) technology. The term "transmission medium" shall be deemed to include any intangible medium that is capable of storing, encoding, or carrying instructions for execution by the machine 1700, and includes digital or analog communication signals or other intangible media to facilitate the communication of such software.

[0132] Various embodiments are shown in the above figures. One or more features from one or more of these embodiments may be combined to form other embodiments.

[0133] The method examples described herein may be at least partially machine or computer implemented. Some examples may include a computer readable medium or machine readable medium encoded with instructions, which are operable to configure an electronic device or system to perform the method described in the above example. The implementation of such a method may include code, such as microcode, assembly language code, high-level language code, etc. Such code may include computer readable instructions for performing various methods. The code may form part of a computer program product. In addition, the code may be tangibly stored on one or more volatile or non-volatile computer readable media during execution or at other times.

[0134] The foregoing detailed description is intended to be illustrative rather than limiting. The scope of the disclosure should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

1. A system for providing electrical stimulation to a patient, comprising: an electrical stimulator configured to provide neural stimulation to a neural target of the patient via the electrode array; a user interface device configured to receive user input including an autonomic symptom and an identification of an affected anatomical structure; and a controller circuit communicatively coupled to the user interface device, the controller circuit being configured to: determining or adjusting stimulation settings based on the user input of the autonomic symptoms and the identification of the affected anatomical structure; and A control signal is generated to the electrical stimulator to deliver neural stimulation energy according to the determined or adjusted stimulation settings to relieve the autonomic symptoms or treat the autonomic disorder.

2. The system according to claim 1, wherein: The neural stimulation includes spinal cord stimulation (SCS) of spinal nerve targets to control pain in the patient, and wherein the user input of the autonomic symptoms and the identification of the affected anatomical structure is responsive to SCS.

3. The system according to any one of claims 1 to 2, wherein: The stimulation settings include one or more stimulation parameters, the one or more stimulation parameters including: Electrode configuration; one or more stimulation pulse parameters, including pulse amplitude, pulse width, or stimulation frequency; Stimulation pulse waveform; an on-off cycle regimen comprising an on period for delivering stimulation pulses followed by an off period without stimulation; or Charges per second (CPS) or charges per hour (CPH) delivered to a neural target.

4. The system according to claim 3, wherein: The stimulation setup includes an on-off cycle scheme represented by a ratio of an on period to a subsequent off period in the range of 1:1 to 1:8, wherein each stimulation pulse during the on period has a waveform including an active recharge phase.

5. The system according to any one of claims 1 to 4, wherein: The stimulation setup is represented by a single composite neural stimulation dose taking values ​​within a particular range of values, the composite neural stimulation dose corresponding to a plurality of stimulation parameters each taking respective values.

6. The system according to any one of claims 1 to 5, wherein: The user interface device is configured to display the user input of the autonomic symptom and the identification of the affected anatomical structure.

7. The system according to any one of claims 1 to 6, wherein: The user input also includes: a user indication of the severity of the autonomic symptom.

8. The system according to any one of claims 1 to 7, wherein: The neural stimulation includes spinal cord stimulation (SCS) via an electrode array placed on a spinal nerve target, Wherein, in order to determine or adjust the stimulation settings, the controller circuit is configured to select one or more active electrodes from the electrode array for delivering the SCS based at least on (i) the position of the electrode array relative to the spinal nerve target, and (ii) the anatomical system or organ innervated by the spinal nerve and its spinal origin.

9. The system of claim 8, comprising a memory circuit configured to store a lookup table representing a correspondence between the anatomical system or organ and the origin of the spinal column within the stimulation field created by the electrode array.

10. The system according to any one of claims 8-9, wherein: To determine or adjust stimulation settings, the controller circuit is further configured to determine a current or energy breakdown across the selected one or more active electrodes.

11. The system according to any one of claims 1 to 10, wherein: The user interface device is further configured to: displaying a treatment recommendation including the determined or adjusted stimulation settings; and A user acceptance, rejection, or modification of the stimulation settings determined or adjusted by the controller circuit is received.

12. The system according to any one of claims 1 to 11, wherein: The user interface device is further configured to: prompting a user to provide feedback on alleviating the autonomic symptom or treating the autonomic disorder through the neural stimulation according to the determined or adjusted stimulation settings; and A treatment recommendation including further adjustment of one or more stimulation parameters is displayed.

13. The system according to any one of claims 1 to 12, wherein: The user interface device is further configured to receive a user selection or adjustment of a single composite neural stimulation dose within a particular range of values, the composite neural stimulation dose corresponding to a plurality of stimulation parameters each taking values ​​within their respective ranges of values.

14. The system according to claim 13, wherein: The user selection or adjustment of a single composite neural stimulation dose is provided via a user interface control element comprising a slider along a one-dimensional dose bar.

15. The system according to any one of claims 1 to 14, wherein: The user interface device is further configured to receive a user selection from one or more stimulation modes, each stimulation mode being defined by a plurality of stimulation parameters having their respective values ​​or value ranges.

Images