Abstract: This document discusses, among other things, systems and methods for managing pain of a subject. A system may include a motion sensor configured to sense at least one functional signal indicative a physical state of the subject. The at least one functional signal may include at least one motor activity signal or at least one sleep state signal. A pain analyzer circuit may extract, from the functional signal, signal metrics indicative of subject motor control or kinetics, and generate a pain score using the signal metrics. The pain score may be output to a user or a process. The system may additionally include an electrostimulator to generate and deliver a closed-loop pain therapy according to the pain score.

Abstract: Systems and techniques are disclosed to adjust programming of an implantable electrical neurostimulation device for treating chronic pain of a human subject, through the use of a dynamic model adapted to identify pain treatment parameters for a human patient and determine a best device operational program to implement the pain treatment parameters to address the chronic pain condition. In an example, the system to adjust programming of the neurostimulation device performs operations that: obtain data related to a state of pain of the human subject; identify pain treatment parameters using a dynamic model adapted to evaluate the pain treatment parameters in the human subject over a time period, based on the data related to the state of pain; and select a neurostimulation program for the neurostimulation device, corresponding to at least a portion of the identified pain treatment parameters.

Abstract: A method, programmer for a neurostimulator, and neurostimulation kit are provided. The kit comprises a neurostimulator, and a plurality of elongated lead bodies configured for being coupled to the neurostimulator, each having a plurality of proximal contacts and a plurality of distal electrodes respectively electrically coupled to the proximal contacts, wherein an in-line connectivity between the electrodes and proximal contacts carried by the different lead bodies differs from each other. Electrical energy is conveyed between the electrodes of the selected lead body and the tissue, an electrical fingerprint is measured at the proximal contacts of the selected lead body in response to the conveyed electrical energy, and the selected lead body is identified based on the measured electrical fingerprint. These steps can be performed by the programmer.

Abstract: An example of a system for delivering neurostimulation energy may include a stimulation control circuit to control the delivery of the neurostimulation energy according to each of stimulation test patterns. The stimulation control circuit may include a sensing input configured to receive an electrospinogram (ESG) signal recording electrical activity from the spinal cord, a measurement circuit configured to determine one or more response parameters for each test pattern using the received ESG signal, and a selection circuit configured to select a neurostimulation therapy pattern from the stimulation test patterns based on the response parameter(s) and one or more selection criteria. The electrical activity includes responses to the delivered neurostimulation energy, and the response parameter(s) are each indicative of one or more characteristics of the responses. The selection may include selecting a type of stimulation waveform from multiple types of stimulation waveform in the stimulation test patterns.

Abstract: A method of treating an ailment suffered by a patient using one or more electrodes adjacent spinal column tissue of the patient, comprises delivering electrical modulation energy from the one or more electrodes to the spinal column tissue in accordance with a continuous bi-phasic waveform having a positive phase and a negative phase, thereby modulating the spinal column tissue to treat the ailment. An implantable electrical modulation system, comprises one or more electrical terminals configured for being coupled to one or more modulation leads, output modulation circuitry capable of outputting electrical modulation energy to the electrical terminal(s) in accordance with a continuous bi-phasic waveform, and control circuitry configured for modifying a shape of the continuous bi-phasic waveform, thereby changing the characteristics of the electrical modulation energy outputted to the electrode(s).

Abstract: A system may include electrodes on at least one lead configured to be operationally positioned for use in modulating a volume of neural tissue, a neural modulation generator configured to deliver energy using at least some electrodes to modulate the volume of neural tissue, a programming system configured to program the programmed modulation parameter set, including determine electrode fractionalizations for the electrodes based on a target multipole. The programmed parameter set may include the determined electrode fractionalizations. The target multipole may be used to determine electrode fractionalizations having at least three target poles that directionally and progressively stack fractionalizations of target poles to provide a linear electric field over the volume of tissue. The neural modulation generator may be configured to use the programmed modulation parameter set to provide the linear electric field over the volume of tissue.

Abstract: Recovery circuitry for passively recovering charge from capacitances at electrodes in an Implantable Pulse Generator (IPG) is disclosed. The passive recovery circuitry includes passive recovery switches intervening between each electrode node and a common reference voltage, and each switch is in series with a variable resistance that may be selected based on differing use models of the IPG. The passive recovery switches may also be controlled in different modes. For example, in a first mode, the only recovery switches closed after a stimulation pulse are those associated with electrodes used to provide stimulation. In a second mode, all recovery switches are closed after a stimulation pulse, regardless of the electrodes used to provide stimulation. In a third mode, all recovery switches are closed continuously, which can provide protection when the IPG is in certain environments (e.g., MRI), and which can also be used during stimulation therapy itself.

Abstract: Disclosed herein are circuits and methods for a multi-electrode implantable stimulator device incorporating one decoupling capacitor in the current path established via at least one cathode electrode and at least one anode electrode. In one embodiment, the decoupling capacitor may be hard-wired to a dedicated anode on the device. The cathodes are selectively activatable via stimulation switches. In another embodiment, any of the electrodes on the devices can be selectively activatable as an anode or cathode. In this embodiment, the decoupling capacitor is placed into the current path via selectable anode and cathode stimulation switches. Regardless of the implementation, the techniques allow for the benefits of capacitive decoupling without the need to associate decoupling capacitors with every electrode on the multi-electrode device, which saves space in the body of the device.

Abstract: A connector and lead (or other elongated body) can produce a tactile sensation that indicates alignment between connector contacts of the connector and the terminals on the lead (or other elongated body). For example, a terminal or retention sleeve of the lead (or other elongated body) may include an indented circumferential groove that interacts with a connector contact or retention contact of the connector to produce the tactile sensation. As another example, one or more terminals or spacers may have a larger diameter than adjacent spacers or terminals to interact with a connector contact to produce the tactile sensation.

Abstract: A system for estimating a volume of activation around an implanted electrical stimulation lead for a set of stimulation parameters includes a display; and a processor coupled to the display and configured to: receive a set of stimulation parameters including a stimulation amplitude and a selection of one of more electrodes of the implanted electrical stimulation lead for delivery of the stimulation amplitude; determine an estimate of the volume of activation based on the set of stimulation parameters using the stimulation amplitude and a database including a plurality of planar distributions of stimulation threshold values and a map relating the planar distributions to spatial locations based on the one or more electrodes of the implanted electrical stimulation lead selected for delivery of the stimulation amplitude; and output on the display a graphical representation of the estimate of the volume of activation.

Abstract: A lead-implantation tool for implanting a lead into a patient includes an elongated body having a distal portion with a tip configured to separate patient tissue to form, or extend through, a tunnel in the tissue when the body is advanced along the tissue. A lead-retention element is formed along the distal portion of the body and includes a cutout defined along the body with a cutout surface wall inset from the body's outer surface. A protrusion extends outwardly from the cutout surface wall with at least a portion of the protrusion extending towards the tip. The protrusion is entirely inset from, or flush with, the body's outer surface. The protrusion is configured to removably receive and retain a portion of the lead while the distal portion of the body is advanced along the tissue and to separate from the lead as the body is withdrawn from the tissue.

Abstract: A system for use with a neurostimulator coupled to one or more electrodes implanted adjacent neural tissue of a patient. The system comprises a user input device configured for allowing a user to select different nerve fiber diameters and to select a set of stimulation parameters. The system further comprises processing circuitry configured estimating regions of activation within the neural tissue of the patient based on the selected nerve fiber diameters and the selected stimulation parameter set. The system further comprises a display device configured for displaying the estimated regions of tissue activation. The user input device may further be configured for allowing the user to select different tissue regions of therapy, in which case, the display device may display the different tissue region on a human body map, and different indicia associating the displayed tissue regions for therapy to displayed estimated regions of tissue activation.

Abstract: A system may comprise a controller configured to implement an algorithm on a received input to produce an output, and a system input operably connected to the controller and configured for use to enter at least one input into the algorithm. The at least one input may include: one or more sensor inputs or one or more inputs from smart appliances or one or more user inputs regarding at least one of time of day or mental or physical state; or at least one of a user-inputted disease, a user-inputted disease state, or a user-inputted symptom-related information into the algorithm. The controller may be configured to provide instructions through the system output to implement a system action. The algorithm implemented by the controller may be configured to identify one, or a combination of more than one, of the neuromodulation modes as a candidate neuromodulation mode based on the input(s).

Abstract: An example of a system for providing a patient with pain management includes a pain monitoring circuit. The pain monitoring circuit may include parameter analyzer circuitry and pain score generator circuitry. The parameter analyzer circuitry may be configured to receive and analyze one or more timing parameters and one or more baroreflex parameters allowing for determination of baroreflex sensitivity (BRS) of the patient. The one or more timing parameters are indicative of time intervals during which values of the one or more baroreflex parameters are used to determine the BRS. The pain score generator circuitry may be configured to compute a pain score using an outcome of the analysis. The pain score is a function of the BRS during the time intervals and indicative of a degree of pain of the patient.

Abstract: Methods and systems for testing and treating spinal cord stimulation (SCS) patients are disclosed. Patients are eventually treated with sub-perception (paresthesia free) therapy. However, supra-perception stimulation is used during “sweet spot searching” during which active electrodes are selected for the patient. This allows sweet spot searching to occur much more quickly and without the need to wash in the various electrode combinations that are tried. After selecting electrodes using supra-perception therapy, therapy is titrated to sub-perception levels using the selected electrodes. Such sub-perception therapy has been investigated using pulses at or below 10 kHz, and it has been determined that a statistically significant correlation exists between pulse width (PW) and frequency (F) in this frequency range at which SCS patients experience significant reduction in symptoms such as back pain.

Abstract: Methods of providing electrical neural modulation to a patient's brain are disclosed herein. The methods involve differentially modulating two or more target regions of the brain. For example, a first target region may be provided with an electrical neural modulation signal that activates that target region while a second target region is provided with an electrical neural modulation signal that suppresses or deactivates that target region. As the implantable pulse generators (IPGs) described herein include independent current sources, such differential modulation can be provided with a single IPG.

Abstract: A method is disclosed for programming a patient's stimulator device using an external device. The method provides a Graphical User Interface (GUI) on the external device that allows the patient to select from a plurality of displayed stimulation modes to program stimulation provided by one or more electrodes of the stimulator device. The external device stores a model derived for the patient, which model comprises information indicative of a plurality of frequency/pulse width/amplitude coordinates predicted to provide optimal stimulation for the patient. Each stimulation mode corresponds with a subset of coordinates defined in accordance with the plurality of coordinates in the model. Selection of one of the stimulation modes limits programming the stimulator device with coordinates that are within the corresponding subset of coordinates.

Abstract: An example of a system for programming a neurostimulator may include a storage device and a user interface. The storage device may be configured to store waveform building blocks. The user interface may include a display screen, a user input device, and an interface control circuit. The interface control circuit may include a waveform composer configured to allow for composition of one of more building blocks and composition of a pattern of neurostimulation pulses using selected one or more waveform building blocks. The waveform composer may include a library controller and waveform building block editors. The library controller may be configured to display a library management area on the screen. The displayed library management area allows a user to manage the stored waveform building blocks. The waveform building block editors may each be configured to allow the user to compose a type of the waveform building blocks.

Abstract: Systems and methods for optimizing neuromodulation field design for pain therapy are discussed. An exemplary neuromodulation system includes an electrostimulator to stimulate target tissue to induce paresthesia, a data receiver to receive pain data including pain sites experiencing pain, and to receive patient feedback on the induced paresthesia including paresthesia sites experiencing paresthesia. The neuromodulation system includes a processor circuit configured to generate a spatial correspondence indication between the pain sites and the paresthesia sites over one or more dermatomes, determine an anodic weight and a cathodic weight for each of multiple electrode locations using the spatial correspondence indication, and generate a stimulation field definition for neuromodulation pain therapy.

Abstract: A field measurement algorithm and measuring circuitry in an implantable stimulator, and an field modelling algorithm operable in an external device, are used to determine an electric field in a patient's tissue. The field measuring algorithm provides at least one test current between two electrodes, and a plurality of voltage differentials are measured at different combinations of the electrodes. The voltage differential data is telemetered to the field modelling algorithm which determines directional resistance at different locations in the patient's tissue. The field modelling algorithm can then use a stimulation program selected for the patient and the determined directional resistances to determine voltages in the patient's tissue at various locations, which in turn can be used to model a more-accurate electric field in the tissue, and preferably to render an electric field image for display in a graphical user interface of the external device.