In one embodiment, a method for operating a system for management of implantable medical devices (IMDs), comprises: conducting communications sessions with a plurality of clinician programmer devices, wherein some of the communication sessions occur while the plurality of clinician programmer devices are engaged in respective programming sessions with IMDs; conducting communications sessions with a plurality of patient controller devices, wherein the communication sessions with the patient controller devices include communication of data pertaining to offline programming of IMDs; reconciling programming session data received from the plurality of clinician programmer devices with programming session data received from patient controller devices to identify instances of unauthorized IMD programming; and distributing revocation data to patient controller devices to be downloaded to corresponding IMDs, wherein the revocation data identifies cryptographic keys that are no longer trusted.
Systems and methods which provide a slip ring anchor configuration in which an anchor body includes inelastic members and a fluted elastomeric casing operable in cooperation to impart a radial compressive force to a corresponding lead body are described. A slip ring anchor body may comprise a plurality of inelastic members alternately disposed in flutes of a fluted elastomeric casing portion of the anchor body. The fluted elastomeric casing may form an anchor lumen through which a lead body may be inserted. Once a slip ring anchor is disposed at a desired position axially along the lead body, manipulation of one or more slip rings may be used to cause a radial compressive force to be imparted upon the lead body. A slip ring actuator tool may be used to manipulate a slip ring between unlocked and locked positions.
The present disclosure provides systems and methods for providing neurostimulation therapy according to patient features. The patient features may be analyzed to develop a patient model between physiological and/or patient reported features and optimal settings for a neurostimulation therapy using machine learning operations. The model is used to control ongoing neurostimulation therapy for the patient.
A61N 1/36 - Applying electric currents by contact electrodes alternating or intermittent currents for stimulation, e.g. heart pace-makers
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/11 - Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
4.
SYSTEM AND METHODS FOR DETECTING LEAKAGE CURRENTS IN HIGH-FREQUENCY ABLATION SYSTEMS
The present disclosure provides systems and methods for detecting leakage currents in radio-frequency (RF) ablation systems. An RF generator may be configured to disable an electrical return path from a patient to a ground terminal. The RF generator may also be configured to apply an electrical signal to an electrode that is positioned to be in proximity to target tissue of the patient. The RF generator may be further configured to measure a leakage impedance while the electrical return path is disabled and the electrical signal is applied to the electrode. The RF generator may also be configured to control RF ablation therapy based, at least in part, on the measured leakage impedance. Other features are also claimed and described.
A61B 18/16 - Indifferent or passive electrodes for grounding
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A61B 18/12 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
5.
SYSTEMS AND METHODS FOR MONITORING ELECTRODE TISSUE ENGAGEMENT DURING ABLATION
An ablation system and method are provided. The ablation system includes an ablation power generator configured to generate ablation energy. An active electrode is coupled to the ablation power generator and is configured to deliver the ablation energy to ablation tissue of interest during an ablation procedure. A return electrode arrangement (REA) is coupled to the ablation power generator and is configured to engage remote tissue, at a remote location from the ablation tissue of interest, to provide a return path during the ablation procedure. The REA transitions between an engaged and disengaged state with the remote tissue. An electrode-tissue engagement (ETE) circuit includes a resonant circuit coupled to the REA. The ETE circuit is configured to detect when the REA is in the engaged state or disengaged state.
A61B 18/12 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A system and method for facilitating remote care management involving a patient having an implantable medical device (IMD). Upon establishing a remote care session between a patient controller device and a clinician programmer, wherein the clinician and the patient are remotely located with respect to each other, input from the patient or the clinician may be received via a user interface control associated with a particular functionality or aspect of the remote care session, including audiovisual (AV) communications, remote therapy programming, and related context. Responsive to the user input, a dialog interface is effectuated at one of the patient controller device and/or the clinician programmer. A user characterization label is received via the dialog interface from the user, wherein the user characterization label is indicative of a subjective assessment of the particular functionality of the remote care session, which may be used in generating user-labeled data pertaining thereto.
G16H 80/00 - ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61N 1/372 - Arrangements in connection with the implantation of stimulators
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G16H 20/30 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
H04L 43/04 - Processing captured monitoring data, e.g. for logfile generation
H04L 65/1069 - Session establishment or de-establishment
This application is generally related to identifying or otherwise programming one or more cycling parameters for operation of an implantable pulse generator to provide a neurostimulation therapy to a patient using a non-paresthesia stimulation pattern. In some embodiments, the cycling parameter is selected by measuring physiological signals during trial stimulation. In other embodiments, multiple cycling parameters are identified for use by the patient using a patient controller device.
A system and method for measuring, monitoring and mitigating EMI interference in an implanted stimulation lead system associated with an IPG. A Kelvin connection scheme operative with a diagnostic circuit is provided for sensing an interference voltage induced at a Kelvin connect electrode of the lead system, wherein the diagnostic circuit is configured to generate one or more control signals for adjusting in substantially real time a common-mode voltage reference provided to supply a biasing voltage to the IPG circuitry.
H02M 3/07 - Conversion of DC power input into DC power output without intermediate conversion into AC by static converters using resistors or capacitors, e.g. potential divider using capacitors charged and discharged alternately by semiconductor devices with control electrode
H03K 5/1252 - Suppression or limitation of noise or interference
H03K 5/24 - Circuits having more than one input and one output for comparing pulses or pulse trains with each other according to input signal characteristics, e.g. slope, integral the characteristic being amplitude
9.
SYSTEM AND METHOD FOR CONTROLLING NEUROSTIMULATION ACCORDING TO USER ACTIVITY DETECTED THROUGH PATIENT USE OF ICON DRIVEN USER INTERFACE
This application is generally related to systems and methods for providing a medical therapy to a patient by tracking patient activity and adjusting medical therapy based on occurrence of different types of activities performed by the patient including user indicated activities inputted from an icon driven user interface of an external patient controller device.
Implementations described and claimed herein provide paddle leads for dorsal root ganglia (DRG) stimulation and methods of implanting the same. In one implementation, the paddle lead has a small profile facilitating deployment into a target space in the neuroforamen dorsal to the DRG and below the vertebral lamina. A paddle body of the paddle lead may include a living hinge and/or a contoured profile to further facilitate implantation in the target space. For suture assisted deployment as well as to resist migration of the paddle lead once deployed, the paddle lead may include a suture loop configuration. The paddle lead further includes an electrode array having electrode contacts arranged in a two dimensional configuration pattern to create an electrical field optimized for stimulation of the DRG.
The present disclosure provides a sheath for use in delivering a lead to a dorsal root ganglion. The sheath includes an inner liner, an outer jacket, a reinforcement braid positioned between the inner liner and the outer jacket, and a marker band extending over a portion of the reinforcement braid, the marker band positioned between the reinforcement braid and the outer jacket, wherein the sheath has an outer diameter less than 0.067 inches
The disclosed principles provide a vein graft preparation pump, and related methods of use and manufacturing thereof, providing a constant and uniform pressure of fluid flowed through a vein graft being prepared for use in a bypass procedure. An exemplary pump includes a syringe holder having an opening for holding a syringe body, and a slot formed within the opening for receiving a flange of the syringe body. The syringe holder also includes left and right side rails, and a spring housing coupled to rear ends of the side rails to secure the rear end of a spring therein. A plunger depressor includes a back in contact with the front end of the spring, and a front having a plunger base for engaging a syringe plunger. Decompression of the spring moves the plunger depressor along the syringe holder during use of the pump thereby providing constant and uniform pressure depressing said syringe plunger.
The disclosed principles provide regulated pressurization and continuity/uniformity in the pressure applied through harvested veins using a unique vein graft preparation pump. Generally speaking, the apparatus incorporates one or more elastic members, each with a predetermined elastic constant or modulus of elasticity, or alternatively a collective predetermined elastic constant or collective modulus of elasticity, that is sufficient to deliver fluids from a syringe through a vessel cannula inserted into the vein section selected for a grafting procedure. Additionally, the disclosed apparatus provides only a limited amount of pressure such that no injury is caused to the vein. Pressure and flow are limited and maintained constant via use of the one or more elastic members, i.e., no pressure changes/spikes, which provides uniform pressurization at a predetermined amount safe for the harvested vein section, thereby eliminating the human error present with manual pressurization during distension of grafted veins.
An elastomeric vein graft preparation pump. The elastomeric vein graft preparation pump can include an elastomeric compliant body configured to contain a fluid, a fluid conduit coupled to the elastomeric compliant body, and a control valve disposed through the fluid conduit. The control valve is configured to regulate a flow of the fluid through the fluid conduit. The elastomeric compliant body provides an elastic recoil pressure based on a volume of the fluid contained in the elastomeric compliant body, and the fluid flows through the fluid conduit at a pressure based on the elastic recoil pressure.
A61M 60/148 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
A61M 60/268 - Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
15.
PRESSURE REGULATED VEIN GRAFT PREPARATION PUMP SYSTEM AND METHOD OF USE
A pressure-regulated vein graft preparation pump for preparing a vein graft. The pressure-regulated vein graft preparation pump includes: a source of pressurized fluid which is configured to supply the pressurized fluid through a flow path extending through a fluid conduit, a cannula configured to be coupled to an end of the fluid conduit, and a pressure control device coupled to the cannula. The pressure control device is located downstream from the source of the pressurized fluid and configured to limit a pressure exerted on the fluid conduit by the pressurized fluid.
The disclosed principles prevent over pressurization of harvested veins by controlling the amount and consistency of pressure applied through the veins from a continuous flow of fluid. This combination of regulated pressurization and continuity/uniformity in the pressure applied through veins is provided using a preparation pump constructed in accordance with the disclosed principles. In some embodiments the pump incorporates a spiral spring to deliver fluids from a bladder within the pump and through a vessel cannula inserted into the grafted vein, and in other embodiments the pump incorporates magnets to compress the bladder. The disclosed apparatus provides only a limited amount of pressure such that no injury is caused to the vein. Pressure and flow are limited and maintained constant, i.e., no pressure changes/spikes, providing uniform pressurization at a predetermined amount safe for the harvested vein, thereby eliminating the human error present with manual pressurization during distension of grafted veins.
A61M 60/135 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
A61M 60/855 - Constructional details other than related to driving of implantable pumps or pumping devices
17.
SHEATH FOR DELIVERING A STIMULATION LEAD TO A DORSAL ROOT GANGLION
The present disclosure provides a sheath (1500) for use in delivering a lead to a dorsal root ganglion. The sheath (1500) includes an inner liner (1602), an outer jacket (1606), a reinforcement braid (1604) positioned between the inner liner and the outer jacket, and a marker band (1508) extending over a portion of the reinforcement braid, the marker band positioned between the reinforcement braid and the outer jacket, wherein the sheath (1500) has an outer diameter less than 0.067 inches.
Embodiments provide methods of conducting operations with an implantable medical device (IMD) and an external controller device for performing authentication operations. In some embodiments, the method comprises: generating or storing an authentication data structure in the external controller device for over-the-air communication between the external device and the IMD, wherein the authentication data structure is generated by: (1) removing attribute fields from a first digital certificate and adding a public key of the external controller device to form an intermediate data structure; (2) creating a digital signature of the first intermediate data structure using a second digital certificate of an issuing certificate authority (CA); and (3) forming the authentication data structure by combining the intermediate data structure, the created digital signature, a public key of the issuing CA, and a digital signature of the public key of the issuing CA created using a third digital certificate of a root CA.
H04L 9/32 - Arrangements for secret or secure communicationsNetwork security protocols including means for verifying the identity or authority of a user of the system
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
19.
SYSTEMS AND METHODS FOR GENERATING PULSED WAVEFORMS THAT APPROXIMATE COLORED NOISE
The present disclosure provides systems and methods for generating pulsed waveforms that approximate colored noise for use in a neurostimulation system. An implantable neurostimulation system includes an implantable stimulation lead including a plurality of contacts, and an implantable pulse generator communicatively coupled to the stimulation lead. The pulse generator is configured to generate a pulsed waveform that approximates colored noise using at least one of a thresholding method and an optimization method, and cause stimulation to be delivered by the stimulation lead based on the pulsed waveform.
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
G16H 20/30 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
An embodiment includes a custom-forming peripheral intravenous (PIV) catheter stabilization system that surrounds and conforms to the PIV catheter hub and/or a luer fitting and/or a needleless connector (NC) administration set connection. The embodiment provides a uniquely stable, energy absorbing primary intravenous (IV) stabilization system.
The present disclosure provides systems and methods for generating burst waveforms. An implantable neurostimulation system includes an implantable stimulation lead including a plurality of contacts, and an implantable pulse generator communicatively coupled to the stimulation lead. The pulse generator is configured to generate a waveform including a burst that includes a leading anodic pulse followed by alternating cathodic pulses and anodic pulses, each cathodic pulse in the burst having a greater amplitude than the previous cathodic pulse.
The present disclosure is directed to providing digital health services. In some embodiments, systems and methods for conducting virtual or remote sessions between patients and clinicians are disclosed. During the sessions, media content (e.g., images, video content, audio content, etc.) may be captured as the patient performs one or more tasks. The media content may be presented to the clinician and used to evaluate a condition of the patient or a state of the condition, adjust treatment parameters, provide therapy, or other operations to treat the patient. The analysis of the media content may be aided by one or more machine learning/artificial intelligence models that analyze various aspects of the media content, augment the media content, or other functionality to aid in the treatment of the patient.
G06T 19/00 - Manipulating 3D models or images for computer graphics
G06V 10/82 - Arrangements for image or video recognition or understanding using pattern recognition or machine learning using neural networks
G06V 40/20 - Movements or behaviour, e.g. gesture recognition
G16H 20/30 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
G16H 80/00 - ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
H04N 5/272 - Means for inserting a foreground image in a background image, i.e. inlay, outlay
A method for fabricating a neurostimulation stimulation lead includes providing a plurality of ring components and hypotubes. An insulative coating is disposed on at least one of (i) inner surfaces of the ring components or (ii) the hypotubes. The method includes welding the hypotubes to the inner surfaces of the ring components, and molding an insulative material to fill interstitial spaces between the ring components and the hypotubes that are welded to form a stimulation tip component of the stimulation lead. The method includes forming segmented electrodes from the ring components after performing the molding.
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
B29C 45/00 - Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mouldApparatus therefor
B29C 45/14 - Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mouldApparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
B29K 75/00 - Use of polyureas or polyurethanes as moulding material
The present application generally relates to neurostimulation systems with stimulation leads and/or stylets with improved malleability and/or flexibility. Stimulation system generates electrical pulses tor application to tissue of a patient to treat one or more disorders of the patient.
SYSTEMS AND METHODS FOR AUTOMATICALLY MODIFYING ONE OR MORE GRAPHICAL USER INTERFACE (GUI) COMPONENTS OF AN IMPLANTABLE MEDICAL DEVICE (IMD)-RELATED APPLICATION BY MONITORING AND ANALYZING PATIENT INTERACTION
The present application is generally related to automatic modification of one or more graphical user interface (GUI) components of an implantable medical device (IMD)-related application by monitoring and analyzing patient interaction with the IMD-related application.
A61N 1/36 - Applying electric currents by contact electrodes alternating or intermittent currents for stimulation, e.g. heart pace-makers
G06F 3/04845 - Interaction techniques based on graphical user interfaces [GUI] for the control of specific functions or operations, e.g. selecting or manipulating an object, an image or a displayed text element, setting a parameter value or selecting a range for image manipulation, e.g. dragging, rotation, expansion or change of colour
G06F 3/0488 - Interaction techniques based on graphical user interfaces [GUI] using specific features provided by the input device, e.g. functions controlled by the rotation of a mouse with dual sensing arrangements, or of the nature of the input device, e.g. tap gestures based on pressure sensed by a digitiser using a touch-screen or digitiser, e.g. input of commands through traced gestures
26.
NEUROSTIMULATION SYSTEMS WITH STIMULATION LEADS AND/OR STYLETS WITH IMPROVED MALLEABILITY AND/OR FLEXIBILITY
The present application generally relates to neurostimulation systems with stimulation leads and/or stylets with improved malleability and/or flexibility.
This application is generally related to systems and methods for providing a medical therapy to a patient by tracking patient activity and adjusting medical therapy based on occurrence of different types of activities performed by the patient while automatically balancing stimulation program duration.
The present disclosure provides systems and methods for wirelessly charging an implantable medical device. An external charging device includes a coil, signal generating circuitry to drive current through the coil at a charging frequency to induce current in a second coil in the implantable medical device, monitoring circuitry to generate an output signal to monitor charging operations, and a comb filter. The comb filter is configured to apply filtering to the output signal to remove noise from the output signal, wherein the filtering is applied based on the charging frequency. The external charging device is configured to process the filtered output signal to detect a circuit state of charging circuitry of the implantable medical device during charging operations, and the external charging device is configured to vary the charging frequency based, in part, on detection of the circuit state of the charging circuitry of the implantable medical device.
A system and method for facilitating device and application authentication between an external device and an implanted medical device (IMD), wherein a therapy application executing on the external device is operative to communicate with the IMD via wireless telemetry communications. A device authentication parameter may be decomposed into two key components, wherein one component may be stored in a cloud key vault and the other component may be distributed to the external device as an obfuscated portion embedded in the therapy application. Upon receiving the therapy application, the external device is operative to separately retrieve both key components and reconstitute the original authentication parameter therefrom, which may be presented to the IMD for authentication.
H04L 9/32 - Arrangements for secret or secure communicationsNetwork security protocols including means for verifying the identity or authority of a user of the system
30.
NEUROSTIMULATOR OUTPUT SWITCHING CIRCUITRY WITH SELF-TEST MODE
An implantable medical device (IMO) includes one or more stimulation engines (SEs) and selectively connectable output switching circuitry for driving a plurality of output nodes associated with a respective plurality of electrodes of the IMO's lead system when implanted in a patient. The output switching circuitry may be configured to facilitate self-test mode (STM) functionality in the IMO (e.g., when it is in a hermetically sealed package) by using a dual mode switch in series with a stimulation engine selection switch with respect to each output node in the output switching circuitry under mode selection control.
A system and method of quantifying, maintaining and managing the functional status and/or therapy settings of an IMD based on code path metrics is disclosed. The codebase of device firmware modules may be instrumented to obtain tracing data and timing metrics data corresponding to different code paths that may be taken when a device subsystem or associated functionality is accessed or activated. Code path metrics of actual code paths may be analyzed to detect a deviation from baseline code path metrics and generate a corresponding graduated response.
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
A61N 1/08 - Arrangements or circuits for monitoring, protecting, controlling or indicating
A61N 1/372 - Arrangements in connection with the implantation of stimulators
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
32.
IMPLANTABLE MEDICAL DEVICE (IMD) WITH CODE PATH METRICS
A system and method of quantifying, maintaining and managing the functional status and/or therapy settings of an IMD based on code path metrics is disclosed. The codebase of device firmware modules may be instrumented to obtain tracing data and timing metrics data corresponding to different code paths that may be taken when a device subsystem or associated functionality is accessed or activated. Code path metrics of actual code paths may be analyzed to detect a deviation from baseline code path metrics and generate a corresponding graduated response.
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
33.
IMPLANTABLE MEDICAL DEVICE (IMD) WITH CODE PATH METRICS
A system and method of quantifying, maintaining and managing the functional status and/or therapy settings of an IMD based on code path metrics is disclosed. The codebase of device firmware modules may be instrumented to obtain tracing data and timing metrics data corresponding to different code paths that may be taken when a device subsystem or associated functionality is accessed or activated. Code path metrics of actual code paths may be analyzed to detect a deviation from baseline code path metrics and generate a corresponding graduated response.
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
34.
IMPLANTABLE MEDICAL DEVICE (IMD) WITH CODE PATH METRICS
A system and method of quantifying, maintaining and managing the functional status and/or therapy settings of an IMD based on code path metrics is disclosed. The codebase of device firmware modules may be instrumented to obtain tracing data and timing metrics data corresponding to different code paths that may be taken when a device subsystem or associated functionality is accessed or activated. Code path metrics of actual code paths may be analyzed to detect a deviation from baseline code path metrics and generate a corresponding graduated response.
G06F 11/34 - Recording or statistical evaluation of computer activity, e.g. of down time, of input/output operation
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
35.
SYSTEM AND METHOD FOR PROVIDING TRANSCUTANEOUS OR SUBCUTANEOUS TEMPORAL INTERFERENCE SPINAL CORD STIMULATION
A noninvasive/minimally invasive neuromodulation system and method for providing therapy to a target neural tissue of a patient. In one arrangement, an example method comprises applying at least two input waveforms to respective pairs of electrodes affixed on the patient's skin or subcutaneously disposed relative to the target neural tissue, wherein the frequencies of the input waveforms are configured such that they combine, when simultaneously applied, to generate a beat waveform having a beat frequency due to interference. The beat waveform is causative of a transcutaneous/subcutaneous temporal interference (T/STI) electric field generated in the patient body, the T/STI electric field including an interference region at least partially overlapping the target neural tissue of the patient, wherein the beat frequency is of a value operative to impart a therapeutic effect to the target neural tissue.
An implantable medical device (IMD) includes multiple stimulation engines for independently stimulating respective electrode sets of a lead system while avoiding collisions and/or channel contention during stimulation delivery. A first voltage multiplier is configured to generate an adjustable target voltage having sufficient headroom at an output node that is commonly coupled to anodic nodes of respective stimulation engines. Each stimulation engine includes a secondary voltage multiplier to drive the respective anode and a current regulator powered by a floating voltage supply, wherein the current regulator is coupled to a cathodic node and configured to control how much stimulation current is pulled from the patient tissue.
The disclosed principles provide for single use caps that may be applied to any of a number of receptacles, containers, vessels, needless connectors, or other device. A single use cap as disclosed herein includes a component that, when the cap is threaded onto a receptacle or device, is moved from an “unused” to a “used” position by the twisting force applied to the cap when secured onto the receptacle or device. Specifically, once the threads of the receptacle or device are received into the cap and a twisting or tightening force is continued to be applied to the cap, the continued twisting force causes this component to rotate laterally so that once the cap is removed from the receptacle or device, the threads of the cap are no longer reachable by the threads on the receptacle or device.
B65D 55/08 - Annular elements encircling container necks
B65D 39/10 - Threaded or like closure members secured by rotationBushes therefor with bayonet cams
B65D 41/06 - Threaded or like caps or cap-like covers secured by rotation with bayonet cams
B65D 45/32 - Clamping or other pressure-applying devices for securing or retaining closure members for applying radial pressure, e.g. contractible bands encircling closure member
38.
IMPLANTABLE MEDICAL DEVICE (IMD) WITH CODE PATH METRICS
A system and method of quantifying, maintaining and managing the functional status and/or therapy settings of an IMD based on code path metrics is disclosed. The codebase of device firmware modules may be instrumented to obtain tracing data and timing metrics data corresponding to different code paths that may be taken when a device subsystem or associated functionality is accessed or activated. Code path metrics of actual code paths may be analyzed to detect a deviation from baseline code path metrics and generate a corresponding graduated response.
A61N 1/36 - Applying electric currents by contact electrodes alternating or intermittent currents for stimulation, e.g. heart pace-makers
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
39.
IMPLANTABLE MEDICAL DEVICE (IMD) WITH CODE PATH METRICS
A system and method of quantifying, maintaining and managing the functional status and/or therapy settings of an IMD based on code path metrics is disclosed. The codebase of device firmware modules may be instrumented to obtain tracing data and timing metrics data corresponding to different code paths that may be taken when a device subsystem or associated functionality is accessed or activated. Code path metrics of actual code paths may be analyzed to detect a deviation from baseline code path metrics and generate a corresponding graduated response.
A61N 1/36 - Applying electric currents by contact electrodes alternating or intermittent currents for stimulation, e.g. heart pace-makers
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
40.
IMPLANTABLE MEDICAL DEVICE (IMD) WITH CODE PATH METRICS
A system and method of quantifying, maintaining and managing the functional status and/or therapy settings of an IMD based on code path metrics is disclosed. The codebase of device firmware modules may be instrumented to obtain tracing data and timing metrics data corresponding to different code paths that may be taken when a device subsystem or associated functionality is accessed or activated. Code path metrics of actual code paths may be analyzed to detect a deviation from baseline code path metrics and generate a corresponding graduated response.
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
41.
IMPLANTABLE MEDICAL DEVICE (IMD) WITH CODE PATH METRICS
A system and method of quantifying, maintaining and managing the functional status and/or therapy settings of an IMD based on code path metrics is disclosed. The codebase of device firmware modules may be instrumented to obtain tracing data and timing metrics data corresponding to different code paths that may be taken when a device subsystem or associated functionality is accessed or activated. Code path metrics of actual code paths may be analyzed to detect a deviation from baseline code path metrics and generate a corresponding graduated response.
G06F 11/07 - Responding to the occurrence of a fault, e.g. fault tolerance
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
G16H 50/70 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
42.
Split key architecture for facilitating authentication between an implanted medical device and an external device
A system and method for facilitating device and application authentication between an external device and an implanted medical device (IMD), wherein a therapy application executing on the external device is operative to communicate with the IMD via wireless telemetry communications. A device authentication parameter may be decomposed into two key components, wherein one component may be stored in a cloud key vault and the other component may be distributed to the external device as an obfuscated portion embedded in the therapy application. Upon receiving the therapy application, the external device is operative to separately retrieve both key components and reconstitute the original authentication parameter therefrom, which may be presented to the IMD for authentication.
H04L 9/32 - Arrangements for secret or secure communicationsNetwork security protocols including means for verifying the identity or authority of a user of the system
43.
IMPLANTABLE MEDICAL DEVICE (IMD) INCLUDING SENSING AMPLIFIER CIRCUITRY
An implantable medical device (IMD) configured to sense biosignals of a patient. The IMD comprises one or more power components for powering the IPG and sensing circuitry for sensing one or more biosignals of the patient, wherein the sensing circuitry comprises a hybrid circuit having a BJT portion and a CMOS FET portion, the BJT portion configured to amplify low voltage signals with low equivalent noise and the CMOS FET portion forming a power-optimized output stage.
A method of forming a stimulation lead includes forming an implantable lead body, including helically winding at least one cable about a mandrel to form a coiled cable assembly in a first, restrained state. Helically winding the at least one cable includes applying a tensile force to the at least one cable as the at least one cable is wound about the mandrel. Forming the lead body also includes releasing the tensile force from the at least one cable to allow the coiled cable assembly to release stored mechanical energy and transition from the restrained state to a second, relaxed state in which the coiled cable assembly is substantially free of stored mechanical energy. The method further includes subjecting the lead body to a reflow process by applying heat to the lead body, where the tensile force is released prior to the lead body being subjected to the reflow process.
An implantable medical device (IMD) configured to sense biosignals of a patient. The IMD comprises one or more power components for powering the IPG and sensing circuitry for sensing one or more biosignals of the patient, wherein the sensing circuitry comprises a hybrid circuit having a BJT portion and a CMOS FET portion, the BJT portion configured to amplify low voltage signals with low equivalent noise and the CMOS FET portion forming a power-optimized output stage.
A system and method for facilitating bi-directional authentication between an external device and an implanted medical device (IMD), wherein a therapy application executing on the external device is operative to communicate with the IMD via wireless telemetry communications. Certified security credentials for respective devices may be provisioned with respect to the therapy application. Upon initiating wireless telemetry communications, respective certified security credentials are mutually verified by the external device and the IMD. Responsive to successful verification, a mutual authentication process may be executed between the external device and the IMD using a respective challenge-response sequence.
H04L 9/32 - Arrangements for secret or secure communicationsNetwork security protocols including means for verifying the identity or authority of a user of the system
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
G16H 20/40 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
The present application relates to a new stimulation design which can be utilized to treat neurological conditions. The stimulation system produces a burst mode stimulation which alters the neuronal activity of the predetermined site, thereby treating the neurological condition or disorder. The burst stimulus comprises a plurality of groups of spike pulses having a maximum inter-spike interval of 100 milliseconds. The burst stimulus is separated by a substantially quiescent period of time between the plurality of groups of spike pulses. This inter-group interval may comprise a minimum of 5 seconds.
In one embodiment, a method for operating a system for management of implantable medical devices (IMDs), comprises: conducting communications sessions with a plurality of clinician programmer devices, wherein some of the communication sessions occur while the plurality of clinician programmer devices are engaged in respective programming sessions with IMDs; conducting communications sessions with a plurality of patient controller devices, wherein the communication sessions with the patient controller devices include communication of data pertaining to offline programming of IMDs; reconciling programming session data received from the plurality of clinician programmer devices with programming session data received from patient controller devices to identify instances of unauthorized IMD programming; and distributing revocation data to patient controller devices to be downloaded to corresponding IMDs, wherein the revocation data identifies cryptographic keys that are no longer trusted.
Stimulation lead includes an elongated lead body having distal and proximal ends and wire conductors extending therebetween. The stimulation lead also includes a lead paddle having a multi-dimensional array of electrodes positioned along a contact side of the lead paddle. The electrodes are electrically coupled to the wire conductors. The lead paddle includes a paddle body and a conductor organizer disposed within the paddle body. The conductor organizer has multiple channels extending along the lead paddle. The channels receive the wire conductors and retain the wire conductors in a designated arrangement with respect to the lead paddle. The conductor organizer has openings to the channels. The wire conductors extend through the openings and are terminated to the respective electrodes.
A noninvasive/minimally invasive neuromodulation system and method for providing therapy to a target neural tissue of a patient. In one arrangement, an example method comprises applying at least two input waveforms to respective pairs of electrodes affixed on the patient's skin or subcutaneously disposed relative to the target neural tissue, wherein the frequencies of the input waveforms are configured such that they combine, when simultaneously applied, to generate a beat waveform having a beat frequency due to interference. The beat waveform is causative of a transcutaneous/subcutaneous temporal interference (T/STI) electric field generated in the patient body, the T/STI electric field including an interference region at least partially overlapping the target neural tissue of the patient, wherein the beat frequency is of a value operative to impart a therapeutic effect to the target neural tissue.
A neurostimulation (NS) system and method are provided. The NS system includes an array of electrodes positioned within a patient. The array of electrodes includes an active electrode. The active electrode is configured to be a cathode electrode located proximate to neural tissue of interest that is associated with a target region. The NS system includes an anode electrode and an electromagnetic interference (EMI) antenna. A control circuit is configured to control delivery of a NS therapy during a therapy delivery interval. The NS therapy is to be delivered between the anode electrode and the active electrode. The NS system develops a residual voltage between the anode electrode and the active electrode over the therapy delivery interval. A current regulator (CR) circuit is connected to the cathode electrode. The CR circuit is configured to control current flow through the cathode electrodes. During a discharge operation, the control circuit is configured to manage the CR circuit to control a discharge current flow over the discharge operation to discharge the residual voltage after therapy delivery in a manner that follows an actively emulated passive discharge (AEPD) profile. During the discharge operation, the CR circuit is connected to the inactive electrode. The CR circuit receives, as a first input, an EMI feedback signal from the EMI antenna. The CR circuit is configured to regulate the discharge current flow through the active electrode based on the EMI feedback signal, to maintain the AEPD profile over the discharge operation while in a presence of an EMI event.
A system and method are provided that include a power supply having positive and negative terminals. The negative terminal defines a reference ground. First and second electrodes are positioned within a patient and configured to be located proximate to tissue of interest that is associated with a target region. A control circuit is configured to control delivery of current for a therapy between the first and second electrodes. A current regulator (CR) circuit is connected to, and configured to control current flow through, at least the first electrode during delivery of the therapy under direction of the control circuit. A floating power supply is connected across power supply terminals of the CR circuit. The CR circuit and floating power supply are coupled to a floating ground node that is electrically separate from the reference ground.
A61N 1/08 - Arrangements or circuits for monitoring, protecting, controlling or indicating
A61N 1/36 - Applying electric currents by contact electrodes alternating or intermittent currents for stimulation, e.g. heart pace-makers
H02M 1/44 - Circuits or arrangements for compensating for electromagnetic interference in converters or inverters
H02M 3/07 - Conversion of DC power input into DC power output without intermediate conversion into AC by static converters using resistors or capacitors, e.g. potential divider using capacitors charged and discharged alternately by semiconductor devices with control electrode
Systems and methods which provide a bulkhead anchor configuration in which an anchor body includes flexure finger members and a radial bulkhead operable in cooperation to impart a radial compressive force to a corresponding lead body are described. A first portion of a bulkhead anchor body may comprise a plurality of flexure finger members disposed in a corolla configuration forming an anchor lumen through which a lead body may be inserted. A second portion of the bulkhead anchor body may comprise a radial bulkhead having a flexure profile configured to operatively engage the flexure finger members. A locking mechanism may be used to retain the first and second portions of the bulkhead anchor in their relative positions such that the radial compressive force is maintained upon the lead body indefinitely.
System and methods for providing a pulsed therapy comprises an implantable pulse generator (IPG) having circuitry configured to control generation and delivery of electrical pulses using at least one electrode of a stimulation lead. The IPG further comprises memory configured to store program instructions and one or more processors configured to execute the program instructions. The one or more processors are configured to deliver the pulses, having a corresponding pulse duration and an amplitude, to the at least one electrode. The amplitude can vary over the pulse duration of at least one of the pulses. The processor(s), monitor a signal indicative of a present level of the amplitude of the at least one pulse, and based on the signal, declare a pulse valid based on the present level satisfying an initial criteria for at a sub-duration of the pulse duration that is less than an entire pulse duration.
Provided is an implantable pulse generator (IPG) for providing electrical pulses to a patient during neurostimulation therapy. The IPG includes a controller for controlling operations of the IPG, a battery for powering the IPG, a therapeutic stimulation circuitry for generating electrical pulses to stimulate neural tissue of the patient, and internal diagnostic circuitry for digitizing device signals to control operations of the IPG. The internal diagnostic circuitry includes a multi-stage comparator including a pre-amplifier configured to receive an analog input signal and convert the analog input signal into a first analog output signal and second analog output signal. The multi-stage comparator also including a first latch circuit with a first receiving device that receives the first analog output signal, a second receiving device that receives the second analog output signal, and configured to convert the first analog output signal and second analog output signal into a digital output signal.
Provided is an implantable pulse generator (IPG) that includes a controller, and stimulation circuitry for generating electrical pulses to stimulate neural tissue of the patient. The IPG also includes a static random-access memory (SRAM) component for storing data to control the generating of the electrical pulses, wherein the SRAM component is connected to at least the controller through a first interface bus at a first word width and is connected to at least the stimulation circuitry through a second interface bus at a second word width. The SRAM component comprises column select logic that decodes read or write (R/W) access from the controller and provides for selective connection of each column of the SRAM component to the first interface bus during the R/W access, or to the second interface bus during stimulation operations to provide stimulation control data to components of the stimulation circuitry.
The present disclosure provides systems and methods for mitigating stimulation pulse glitches when a voltage multiplier is stepped during delivery of stimulation current to a patient. An implantable pulse generator (IPG) includes pulse generating circuitry configured to generate stimulation pulses to be applied to a patient at an output of the IPG, voltage multiplier circuitry configured to step an output voltage to an anode of the pulse generating circuitry, and glitch mitigating circuitry configured to mitigate current glitches generated when the output voltage is stepped during generation of a stimulation pulse.
Devices and methods to effectuate waveform distortion adjusted stimulation therapy of tissue, based on an inverse model of the tissue, are disclosed. In some aspects a linear model of an electrode used to delivery therapy and of the tissue is determined. Parameter values of the linear model may be determined based on measuring voltage feedback during application of stimulation and/or measurement waveforms. The parameter values of the linear model of the electrode and tissue may be used to determine a forward model of the electrical response of the tissue. From the forward model, an inverse model of the tissue may be determined and the inverse model can be used to modify or filter a stimulation waveform to reduce waveform distortion caused by tissue, such as tissue primitive and/or tissue capacitance. Accordingly, providing therapy with the filtered waveform may have increased efficacy by accounting for and adjusting for waveform distortion.
Systems and methods are disclosed for conducting spinal cord stimulation or other neurostimulation and sensing evoked compound action potential (ECAP) signals. The sensed signals may be processed to isolate ECAP features from noise and/or interfering signals. The isolated ECAP features may be used to control neurostimulation therapy for the patient, such as to quantify or measure lead migration and adjust a neurostimulation therapy for the patient to account for an impact of any detected lead migration, or other purposes (e.g., to guide an implant procedure).
Systems and methods are disclosed for conducting spinal cord stimulation or other neurostimulation and sensing evoked compound action potential (ECAP) signals. The sensed signals may be processed to isolate ECAP features from noise and/or interfering signals. The isolated ECAP features may be used to control neurostimulation therapy for the patient, such as to quantify or measure lead migration and adjust a neurostimulation therapy for the patient to account for an impact of any detected lead migration, or other purposes (e.g., to guide an implant procedure).
The present application relates to a new stimulation design which can be utilized to treat neurological conditions. The stimulation system produces a combination of burst and tonic stimulation which alters the neuronal activity of the predetermined site, thereby treating the neurological condition or disorder.
A61N 1/36 - Applying electric currents by contact electrodes alternating or intermittent currents for stimulation, e.g. heart pace-makers
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
A61N 1/372 - Arrangements in connection with the implantation of stimulators
G16H 20/30 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
A system and method for facilitating DBS electrode trajectory planning using a machine learning (ML)-based feature identification scheme configured to identify and distinguish between various regions of interest (ROIs) and regions of avoidance (ROAs) in a patient's brain scan image. In one arrangement, standard orientation image slices as well as re-sliced images in non-standard orientations are provided in a labeled input dataset for training a CNN/ANN for distinguishing between ROIs and ROAs. Upon identification of the ROIs and ROAs in the patient's brain scan image, an optimal trajectory for implanting a DBS lead may be determined relative to a particular ROI while avoiding any ROAs.
A61B 34/10 - Computer-aided planning, simulation or modelling of surgical operations
G06T 7/70 - Determining position or orientation of objects or cameras
G16H 30/40 - ICT specially adapted for the handling or processing of medical images for processing medical images, e.g. editing
G06V 10/25 - Determination of region of interest [ROI] or a volume of interest [VOI]
A61B 5/055 - Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fieldsMeasuring using microwaves or radio waves involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
A sealing device for sealing an opening of an apparatus. The sealing device has a head that defines a cavity and a neck that defines a passage disposed between the cavity at a first end of the neck and an aperture at a second end of the neck. The aperture is configured to collapse and expand, having a first diameter in a collapsed configuration and a second diameter in an expanded configuration. The interior surface of the neck includes an engagement interface that is configured to releasably engage with a spacer. When the engagement interface is engaged with the spacer, the neck is in the expanded configuration.
A system and method for measuring and monitoring charge states of one or more electrodes of an implanted stimulation lead system associated with an IPG. A Kelvin connection scheme operative with a switching circuit is provided for coupling select electrode terminals disposed in a Kelvin connection measurement loop in a switchable manner to sense and reference inputs of an analog-to-digital converter (ADC) configured as at least part of diagnostic circuitry for the IPG.
The systems and methods described herein generally relate to adjusting a neurostimulation (NS) therapy based on drug pharmacokinetics of a patient. The systems and methods deliver an NS therapy to a portion of electrodes of a lead positioned proximate to neural tissue of interest, which is associated with a target region. The NS therapy is defined by stimulation parameters. The systems and methods determine a trigger event indicative of a drug being administered to a patient. The drug is configured to affect at least one of the neural tissue of interest or the target region. The systems and methods adjust one or more of the stimulation parameters based on the PS profile.
A system and method for facilitating remote care management involving a patient having an implantable medical device (IMD). Upon establishing a remote care session between a patient controller device and a clinician programmer, wherein the clinician and the patient are remotely located with respect to each other, input from the patient or the clinician may be received via a user interface control associated with a particular functionality or aspect of the remote care session, including audiovisual (AV) communications, remote therapy programming, and related context. Responsive to the user input, a dialog interface is effectuated at one of the patient controller device and/or the clinician programmer. A user characterization label is received via the dialog interface from the user, wherein the user characterization label is indicative of a subjective assessment of the particular functionality of the remote care session, which may be used in generating user-labeled data pertaining thereto.
G16H 80/00 - ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61N 1/372 - Arrangements in connection with the implantation of stimulators
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G16H 20/30 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
H04L 43/04 - Processing captured monitoring data, e.g. for logfile generation
H04L 65/1069 - Session establishment or de-establishment
A digital healthcare architecture involving a cloud-based virtual clinic platform operative to facilitate remote therapy programming for one or more patients. Upon establishing a remote programming session involving a patient and a clinician, one or more functionalities including A/V session redirection, enablement of third-party participation, remote assistance, and privacy policy control may be effectuated depending on the user input.
A61N 1/372 - Arrangements in connection with the implantation of stimulators
A61B 5/1171 - Identification of persons based on the shapes or appearances of their bodies or parts thereof
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
68.
Systems and methods for burst waveforms with anodic-leading pulses
The present disclosure provides systems and methods for generating burst waveforms. An implantable neurostimulation system includes an implantable stimulation lead including a plurality of contacts, and an implantable pulse generator communicatively coupled to the stimulation lead. The pulse generator is configured to generate a waveform including a burst that includes a leading anodic pulse followed by alternating cathodic pulses and anodic pulses, each cathodic pulse in the burst having a greater amplitude than the previous cathodic pulse.
A digital healthcare architecture involving a cloud-based virtual clinic platform operative to facilitate remote therapy programming for one or more patients. Upon establishing a remote programming session involving a patient and a clinician, one or more functionalities including A/V session redirection, enablement of third-party participation, remote assistance, and privacy policy control may be effectuated depending on the user input.
G16H 80/00 - ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
A61N 1/372 - Arrangements in connection with the implantation of stimulators
G16H 20/30 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
H04L 65/1069 - Session establishment or de-establishment
Pulse pattern detecting circuitry for use with a fractional voltage multiplier of a neurostimulation system is provided. The pulse pattern detecting circuitry is configured to detect an initial overlap of a repeating pulse pattern, wherein the repeating pulse pattern is generated by a plurality of pulse engines that generate pulses at different frequencies, the initial overlap occurring when pulses generated by each of the plurality of pulse engines occur simultaneously, detect a subsequent overlap of the repeating pulse pattern, the subsequent overlap of the pulse pattern occurring when pulses generated by each of the plurality of pulse engines again occur simultaneously, detect a plurality of events between the initial overlap and the subsequent overlap, each event corresponding to at least one of the plurality of pulse engines generating a pulse, and record a voltage multiplier setting for each of the plurality of detected events.
A method for fabricating a segmented electrode is provided. The method includes performing a series of progressive die stamping operations on a foil sheet of material to form an initial electrode, and removing portions of the initial electrode using a centerless grinding process to form a segmented electrode including a plurality of circumferentially spaced contacts.
B23P 13/00 - Making metal objects by operations essentially involving machining but not covered by a single other subclass
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
B21D 22/02 - Stamping using rigid devices or tools
B21D 35/00 - Combined processes according to methods covered by groups
B23P 11/00 - Connecting or disconnecting metal parts or objects by metal-working techniques, not otherwise provided for
H01R 43/16 - Apparatus or processes specially adapted for manufacturing, assembling, maintaining, or repairing of line connectors or current collectors or for joining electric conductors for manufacturing contact members, e.g. by punching and by bending
A61N 1/36 - Applying electric currents by contact electrodes alternating or intermittent currents for stimulation, e.g. heart pace-makers
72.
SYSTEMS AND METHODS FOR ELECTRODE ORIENTATION DETERMINATION IN DEEP BRAIN STIMULATION (DBS)
The present disclosure provides systems and methods for estimating an orientation of an implanted deep brain stimulation (DBS) lead. Such methods include generating an initial image dataset, down-sampling a respective image or adding noise to images of the subset of the initial image dataset, and re-slicing at least a subset of the modified image dataset along an alternative primary imaging axis, to generate an integrated image dataset. The method also include partitioning the integrated image dataset into a preliminary training image dataset and a testing image dataset, and re-sizing at least a subset of the preliminary training image dataset with a localized field of view around a depicted DBS lead, to generate a training image dataset. The method further includes training a machine-learning model using the training image dataset, and executing the trained machine-learning model to estimate, during a DBS implantation procedure, an orientation of a subject implanted DBS lead.
A61B 34/20 - Surgical navigation systemsDevices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
G06T 7/73 - Determining position or orientation of objects or cameras using feature-based methods
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
G16H 30/40 - ICT specially adapted for the handling or processing of medical images for processing medical images, e.g. editing
G16H 20/40 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
G06V 10/40 - Extraction of image or video features
G06F 18/214 - Generating training patternsBootstrap methods, e.g. bagging or boosting
73.
SYSTEM AND METHOD FOR CONTROLLING NEUROSTIMULATION ACCORDING TO USER ACTIVITY AND AUTOMATED RESCHEDULING OF STIMULATION PROGRAMS
This application is generally related to systems and methods for providing a medical therapy to a patient by tracking patient activity and adjusting medical therapy based on occurrence of different types of activities performed by the patient while automatically rescheduling stimulation programs based on detected patient activity.
In some embodiments, a clinician programmer device for controlling a deep brain stimulation (DBS) system is adapted to assist a clinician to conduct an electrode screening review for the DBS system including screening of segmented electrodes. The clinician programmer stores software code for conducting a screening review in memory. The software code may comprise: code for providing one or more interface screens for guiding the user of the device through testing of electrode configurations of the implantable stimulation lead, wherein the code for providing applies at least one testing progression for guiding the user of the device through a defined testing order.
G06F 3/0482 - Interaction with lists of selectable items, e.g. menus
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
75.
METHODS OF IMPLANTING A STIMULATION LEAD FOR STIMULATION OF A DORSAL ROOT
In one embodiment, a method of implanting a stimulation lead to stimulate a dorsal root ganglion (DRG) of a patient, comprises: placing a distal portion of the stimulation lead within an implant tool; accessing the epidural space of the patient with the distal end of the implant tool; contacting a surface of a pedicle of the patient with a distal tip of the implant tool above a foramen leading to a target DRG; after contacting the surface of the pedicle with the distal tip, advancing the stimulation lead from a side port of the implant tool, wherein the side port is located proximal to the distal tip of the implant tool; advancing the stimulation lead through the foramen to position one or more electrodes of the stimulation lead adjacent to the target DRG; and providing electrical stimulation to the target DRG to stimulate the target DRG using one or more electrodes of the stimulation lead.
A61N 1/36 - Applying electric currents by contact electrodes alternating or intermittent currents for stimulation, e.g. heart pace-makers
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
A61N 1/372 - Arrangements in connection with the implantation of stimulators
A61B 6/00 - Apparatus or devices for radiation diagnosisApparatus or devices for radiation diagnosis combined with radiation therapy equipment
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
A61B 6/12 - Arrangements for detecting or locating foreign bodies
A safety cap for use with a needleless connector. The safety cap includes a body configured to at least partially enclose a head of the needleless connector (NC). The body is configured to achieve a first configuration that can be securely sealed to the NC and a second configuration that cannot be securely sealed to the NC. The second configuration is different from the first configuration. The safety cap also includes a detent in communication with the body which is configured to prevent the body from transitioning from the second configuration back to the first configuration.
Devices and methods to effectuate closed loop electrical stimulation of nerve tissue, based on feedback data, to mitigate pain of a patient are disclosed. Feedback data corresponding to bioelectric signals of neurons stimulated by stimulation pulses may be received and analyzed. Based on receipt of the feedback data, it may be determined to modify one or more stimulation parameters, corresponding to the stimulation pulses, to enhance an efficacy of the stimulation pulses at blocking generation and/or propagation of one or more pain signals through a neuroanatomy of the patient. Subsequent and additional stimulation pulses may be provided based on a modified set of stimulation parameters and configured to enhance attenuation of generation and/or transmission of pain signals through the neuroanatomy of the patient to ultimately reduce a level of pain experienced by the patient.
Devices and methods to effectuate closed loop electrical stimulation of nerve tissue, based on feedback data, to mitigate pain of a patient are disclosed. Feedback data corresponding to bioelectric signals of neurons stimulated by stimulation pulses may be received and analyzed. Based on receipt of the feedback data, it may be determined to modify one or more stimulation parameters, corresponding to the stimulation pulses, to enhance an efficacy of the stimulation pulses at blocking generation and/or propagation of one or more pain signals through a neuroanatomy of the patient. Subsequent and additional stimulation pulses may be provided based on a modified set of stimulation parameters and configured to enhance attenuation of generation and/or transmission of pain signals through the neuroanatomy of the patient to ultimately reduce a level of pain experienced by the patient.
Paddle lead including a lead body having a distal end, a proximal end, and a central axis extending therebetween. The lead body includes opposite first and second sides that extend between the distal and proximal ends. The paddle lead also includes electrodes disposed along the first side of the lead body that are configured to apply neurostimulation therapy within an epidural space of a patient. The electrodes are electrically coupled to conductive pathways that extend through the proximal end of the lead body. The lead body includes a flexible material a flexible material that is configured to flex when a fluid pressure is imposed on the lead body in the epidural space. The lead body is configured to have a non-planar contour that folds or curves about the central axis when experiencing the fluid pressure.
This application is generally related to systems and methods for providing a medical therapy to a patient by tracking patient activity and adjusting medical therapy based on occurrence of different types of activities performed by the patient including user indicated activities inputted from an icon driven user interface of an external patient controller device.
Systems and methods are disclosed for conducting spinal cord stimulation or other neurostimulation and sensing evoked compound action potential (ECAP) signals. The sensed signals may be processed to isolate ECAP features from noise and/or interfering signals. The isolated ECAP features may be used to control neurostimulation therapy for the patient and/or guide an implant procedure..
Systems and methods are disclosed for conducting spinal cord stimulation or other neurostimulation and sensing evoked compound action potential (ECAP) signals. The sensed signals may be processed to isolate ECAP features from noise and/or interfering signals. The isolated ECAP features may be used to control neurostimulation therapy for the patient and/or guide an implant procedure.
Systems and methods are disclosed for conducting spinal cord stimulation or other neurostimulation and sensing evoked compound action potential (ECAP) signals. The sensed signals may be processed to isolate ECAP features from noise and/or interfering signals. The isolated ECAP features may be used to control neurostimulation therapy for the patient and/or guide an implant procedure.
Systems and methods are disclosed for conducting spinal cord stimulation or other neurostimulation and sensing evoked compound action potential (ECAP) signals. The sensed signals may be processed to isolate ECAP features from noise and/or interfering signals. The isolated ECAP features may be used to control neurostimulation therapy for the patient and/or guide an implant procedure.
Systems and methods are disclosed for conducting spinal cord stimulation or other neurostimulation and sensing evoked compound action potential (ECAP) signals. The sensed signals may be processed to isolate ECAP features from noise and/or interfering signals. The isolated ECAP features may be used to control neurostimulation therapy for the patient and/or guide an implant procedure.
A single use cap for connectors and corresponding method of use. The single use cap has a carrier with a body including a base that defines an opening separated from an end wall by a side wall. The opening leads into a cavity sized to receive a connector head. The single use cap also has an elastomeric sleeve releasably coupled to the carrier to span the opening. The elastomeric sleeve is configured to be transferred to the connector upon insertion of the head through the opening and at least partially into the cavity.
Systems and methods are disclosed for conducting spinal cord stimulation or other neurostimulation and sensing evoked compound action potential (ECAP) signals. The sensed signals may be processed to isolate ECAP features from noise and/or interfering signals. The isolated ECAP features may be used to control neurostimulation therapy for the patient and/or guide an implant procedure.
A single use cap for connectors and corresponding method of use. The single use cap has a carrier with a body including a base that defines an opening separated from an end wall by a side wall. The opening leads into a cavity sized to receive a connector head. The single use cap also has an elastomeric sleeve releasably coupled to the carrier to span the opening. The elastomeric sleeve is configured to be transferred to the connector upon insertion of the head through the opening and at least partially into the cavity.
An embodiment provides an adjustable intravenous (IV) securement band with non-occlusive retention in case of excessive force (i.e., automatically loosens) and traction for securing an IV to a patient’s arm. Embodiments may further include features such as guides and or channels on the band to hold tubing. Embodiments may be secured to patients to be used as a non-adhesive securement aid for tubing/catheter (e.g., IV’s, enteral tubes, Foley catheters, endotracheal tubes, nasogastric (NG) tubes, chest tubes, and the like) retention on patients. An embodiment includes a series of separable flaps, any of which may be separated from the band to adjust the length of the band
The present disclosure is directed to providing digital health services. In some embodiments, systems and methods for conducting virtual or remote sessions between patients and clinicians are disclosed. During the sessions, media content (e.g., images, video content, audio content, etc.) may be captured as the patient performs one or more tasks. The media content may be presented to the clinician and used to evaluate a condition of the patient or a state of the condition, adjust treatment parameters, provide therapy, or other operations to treat the patient. The analysis of the media content may be aided by one or more machine learning/artificial intelligence models that analyze various aspects of the media content, augment the media content, or other functionality to aid in the treatment of the patient.
A61N 1/372 - Arrangements in connection with the implantation of stimulators
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
93.
SYSTEM AND METHODS TO DELIVER NOISE STIMULATION WAVEFORM
In some embodiments, a method of providing a neurostimulation therapy to a patient, comprises: generating a noise pulse pattern defining a pulse train of pulses to be generated according to a noise profile in an external device; communicated the generated noise pulse pattern to an implantable pulse generator (IPG) of a patient; generating, by the IPG, a series of pulses in sequence for noise stimulation of the patient using the noise pulse pattern from the external device, wherein the IPG applies one or more randomization operations to the pulse pattern from the external device without expanding memory storage for the pulse pattern while maintaining the noise profile of the pulse pattern from the external device; and applying the series of pulses in sequence to neural tissue of the patient using one or more electrodes of one or more stimulation leads.
In some embodiments, a method of providing a neurostimulation therapy to a patient, comprises: generating electrical pulses, by an implantable pulse generator (IPG), comprising respective bursts of a plurality of anodic pulses with each anodic pulse being separated by a time gap, wherein (1) the plurality of anodic pulses comprise successively increasing charge; (2) the plurality of anodic pulses are charge limited to be sub-threshold; (3) each burst of anodic pulses is followed by a discharge phase of intermittent time periods to discharge charge build up from the anodic pulses; and (4) each successive intermittent time period increases in time through the discharge phase to avoid action potential (AP) generation; and applying the generated electrical pulses to neural tissue of the patient to inhibit neural activity of the patient.
In some embodiments, a method of providing a neurostimulation therapy to a patient, comprises: generating a noise pulse pattern defining a pulse train of pulses to be generated according to a noise profile in an external device; communicated the generated noise pulse pattern to an implantable pulse generator (IPG) of a patient; generating, by the IPG, a series of pulses in sequence for noise stimulation of the patient using the noise pulse pattern from the external device, wherein the IPG applies one or more randomization operations to the pulse pattern from the external device without expanding memory storage for the pulse pattern while maintaining the noise profile of the pulse pattern from the external device; and applying the series of pulses in sequence to neural tissue of the patient using one or more electrodes of one or more stimulation leads.
In some embodiments, a method of providing a neurostimulation therapy to a patient, comprises: generating electrical pulses, by an implantable pulse generator (IPG), comprising respective bursts of a plurality of anodic pulses with each anodic pulse being separated by a time gap, wherein (1) the plurality of anodic pulses comprise successively increasing charge; (2) the plurality of anodic pulses are charge limited to be sub-threshold; (3) each burst of anodic pulses is followed by a discharge phase of intermittent time periods to discharge charge build up from the anodic pulses; and (4) each successive intermittent time period increases in time through the discharge phase to avoid action potential (AP) generation; and applying the generated electrical pulses to neural tissue of the patient to inhibit neural activity of the patient.
An apparatus, system, and method for controlling tracheostomy weaning. The apparatus includes a lumen defining a flow path for air. The flow path is configured to communicate fluidically with an airway of a patient. A control valve coupled to the lumen is configured to automatically and selectively occlude the lumen to control a flowrate of the air passing through the lumen in real time based on respiratory data obtained from the patient.
The present disclosure provides systems and methods for providing neurostimulation therapy using multi-dimensional patient features. The multi-dimensional patient features may include features in respective frequency bands for selected cortical sites from EEG localization data. Additionally or alternatively, the multi-dimensional patient features may include features from patient physiological data or other patient activity data. The multi-dimensional feature data may be compared against AI/ML models of patient and/or healthy population members. Closed-loop therapy adjustments may be applied to a respective patient's neurostimulation therapy using the multi-dimensional patient feature analysis.
The present disclosure provides systems and methods for providing neurostimulation therapy using multi-dimensional patient features. The multi-dimensional patient features may include features in respective frequency bands for selected cortical sites from EEG localization data. Additionally or alternatively, the multi-dimensional patient features may include features from patient physiological data or other patient activity data. The multi-dimensional feature data may be compared against AI/ML models of patient and/or healthy population members. Closed-loop therapy adjustments may be applied to a respective patient’s neurostimulation therapy using the multi-dimensional patient feature analysis.
A61N 1/36 - Applying electric currents by contact electrodes alternating or intermittent currents for stimulation, e.g. heart pace-makers
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
G16H 80/00 - ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
100.
SYSTEMS AND METHODS FOR PROVIDING NEUROSTIMULATION THERAPY USING MULTI-DIMENSIONAL PATIENT FEATURES
The present disclosure provides systems and methods for providing neurostimulation therapy using multi-dimensional patient features. The multi-dimensional patient features may include features in respective frequency bands for selected cortical sites from EEG localization data. Additionally or alternatively, the multi-dimensional patient features may include features from patient physiological data or other patient activity data. The multi-dimensional feature data may be compared against AI/ML models of patient and/or healthy population members. Closed-loop therapy adjustments may be applied to a respective patient's neurostimulation therapy using the multi-dimensional patient feature analysis.
A61N 1/36 - Applying electric currents by contact electrodes alternating or intermittent currents for stimulation, e.g. heart pace-makers
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
G16H 80/00 - ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
