Methods and devices herein are provided for managing atrial (A) pacing in connection with premature atrial contracts (PAC). The methods and devices obtain an atrial pace-on-PAC (APAC) interval and cardiac activity (CA) signals. The methods and devices are configured to: i) during a first cardiac beat; following a ventricular paced (VP) or ventricular sensed (VS) event, activate a timer for a post ventricular-atrial refractory period (PVARP) interval; and determine whether a first atrial refractory (AR) event occurs during the PVARP interval; ii) during a second cardiac beat; in response to the detecting that the first AR event occurred, initiate an APAC interval; during the APAC interval for the second cardiac beat, determine whether a second AR event occurs; and update a count of APAC events when the second AR event occurs; and iii) repeat i) and ii) for multiple cardiac beats, to track the count of APAC events.
A61N 1/368 - Heart stimulators controlled by a physiological parameter, e.g. by heart potential comprising more than one electrode co-operating with different heart regions
Method and system for monitoring atrioventricular (AV) conduction and controlling pacing therapy includes determining atrial events for a series of heartbeats over a detection period using a leadless implantable medical device (LIMD) implanted in or on an atrial chamber of a heart. Surrogate AV intervals are determined for at least a portion of the atrial events over the detection period based on a signal indicative of ventricular activity. The surrogate AV intervals are trended over time to generate diagnostic data. The diagnostic data is evaluated against one or more criteria stored in at least one of the LIMD or an external device, and in response to the evaluation satisfying the one or more criteria, an action is initiated to modify an operational mode of at least one LIMD or to generate an alert. The action includes changing the operational mode of at least one LIMD or transmitting the alert to the external device.
A61N 1/368 - Heart stimulators controlled by a physiological parameter, e.g. by heart potential comprising more than one electrode co-operating with different heart regions
An implantable lead is described that includes a header coupling, a helix shaft, and a fixation helix. The header coupling extends from a proximal end to a distal end thereof, and defines a central lumen from the proximal end to the distal end. The header coupling includes a base section and a distal tube section extending from the base section to the distal end. The helix shaft includes a proximal shank that extends into the central lumen of the header coupling through a distal opening of the distal tube section. The fixation helix is mounted to a distal segment of the helix shaft and is configured to penetrate tissue of a patient. A surface of the header coupling directly engages and is fixedly secured to a surface of the helix shaft, forming a sealed joint that seals the central lumen of the header coupling and prevents fluid from migrating into the central lumen of the lead.
An implantable medical device includes a header configured to be mounted to an end of a device housing that contains an electronics module therein. The header includes an antenna, a sensing electrode, and a header body that at least partially surrounds the antenna and the sensing electrode. The sensing electrode includes a first body portion, a second body portion, and a bridge portion that mechanically and electrically connects the first and second body portions. The first body portion is at least partially exposed to an external environment along a first side of the header, and the second body portion is at least partially exposed to the external environment along a second side of the header that is different from the first side.
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
A leadless biostimulator, such as a leadless cardiac pacemaker, having a header assembly is described. The header assembly includes a helix mount mounted on a flange. An inner surface of the helix mount conforms to an outer surface of the flange, and the outer surface has a non-circular profile such that the conforming surfaces interfere with rotation of the helix mount relative to the flange. The non-circular profile includes a linear segment, such as a radial segment, that resists rotational movement of the helix mount. The helix mount has a protrusion that extends into a recess of the flange to interfere with longitudinal movement between the helix mount and the flange. The protrusion is formed before or after mounting the helix mount on the flange. The interfering surfaces threadlessly interconnect the header assembly components. Other embodiments are also described and claimed.
Implantable medical devices and methods that utilize a sensing circuit to sense cardiac activity (CA) signals and an accelerometer to obtain accelerometer data. Memory stores program instructions and device parameters associated with a collection of ventricular arrhythmia (VA) therapies. A processor analyzes the CA signals over one or more cardiac beats, determines a VA episode based on the analysis of the CA signals, determines the VA episode to be hemodynamically stable or unstable based on at least one of the accelerometer data or the CA signals, selects a first VA therapy from the collection of VA therapies based on whether the VA episode is hemodynamically stable or unstable, and apply the first VA therapy using at least one of the at least two coils.
Described herein are methods, devices, and systems that enable a remote non-implantable device (RNID) to send commands to a leadless pacemaker (LP) implanted within a patient. The RNID provide commands to a local non-implantable device (LNID) over one or more communication networks, and the LNID sends the commands to a second implantable device (SID) by transmitting radio frequency (RF) communication signals, which include the commands, using an antenna of the LNID. After receiving the commands from the LNID, by receiving RF communication signals that include the commands using an antenna of the SID, the SID transmits conductive communication signals, which include the commands, using electrodes of the SID. The LP receives the commands from the SID by receiving the conductive communication signals, which include the commands, using electrodes of the LP, and the LP performs command responses based on the commands that originated from the RNID.
An attachment device for coupling a biostimulator to a delivery system includes a case, a tether dock, and a filament. The case has a wall, a first end, and a second end opposite the first end. The wall defines a passage and a slot. The passage extends between the first end and the second end. The slot extends through the wall such that the passage is accessible through the slot. The tether dock extends from second end of the case. The tether dock defines a groove extending therethrough. The filament has a fixed end and free end. The fixed end is attached to the first end of the case. The free end includes a bulb that is selectively receivable in the passage of the case through the slot.
A system and method for use during an implant procedure during which a delivery system is being used to implant a leadless pacemaker (LP) within a patient may, while the delivery system is being used to position the LP at a potential implant site within the patient: receive, from the LP, data comprising one or more pacing impedance measurements and at least one measurement obtained by the LP other than pacing impedance; provide the data to a model that is produced prior to the implant procedure based on data collected from other patients; and use the model to output an indication of whether the LP should be chronically implanted at the potential implant site.
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
10.
METHOD AND SYSTEM FOR DETERMINING HEALTH RISK BASED ON RESPIRATION AND SECONDARY DATA
A healthcare system and method are provided that comprise first and second medical devices (MD). The first MD has sensing circuitry to obtain IEGM and/or ECG signals for a patient that include a cardiac activity (CA) component and an electrical respiratory component. A filter receives the IEGM and/or ECG signals, block the cardiac activity component and pass the electrical respiratory component. A second medical device collects and outputs second MD data that includes body generated analyte (BGA), second IEGM and/or second ECG data associated with the patient. One or more processors receive respiration data and the second MD data and analyze the respiration data and the second MD data utilizing an application specific model (ASM) to calculate a health risk index associated with the patient.
An implantable pulse generator and a method of manufacturing the implantable pulse generator are described. The implantable pulse generator includes a battery, a header, one or more connector receptacles, and an electronics module. The battery includes a battery housing, battery cell(s) within the battery housing, and power conductors provided on a first side of the battery housing. The header is mounted to the first side of the battery housing and includes a header body. The connector receptacle(s) are located within the header body and configured to electrically connect to one or more electrodes. The electronics module is located within the header body and is electrically connected to the connector receptacle(s) and to the battery via the power conductors. The electronics module includes circuitry for generating electrical stimulation that is conveyed via the connector receptacle(s) and the electrode(s) to patient tissue.
Fabricating a capacitor includes using a first etching solution to etch a first sheet of material so as to generate a spent etchant. At least one chemical component is recovered from the spent etchant. A second etching solution is used to etch a second sheet of material. The second etchant includes at least one of the chemical components that was recovered from the spent etchant.
A method of producing a capacitor electrode includes forming an oxide layer on a foil. The method also includes heating the foil to a target temperature so as to induce defects in the oxide layer. The target temperature is about 350° C. to 560° C. and the duration of heating the foil to the target temperature is less than 6 minutes. The oxide layer is reformed so as to generate a reformed oxide layer that is an aluminum oxide with a boehmite phase and a pseudo-boehmite phase.
A biostimulator includes a housing having a longitudinal axis and containing an electronics compartment. A pacing element is coupled to the housing. The pacing element includes a flexible conductor extending along the longitudinal axis. A fixation element mount is mounted on the housing. The fixation element mount includes a distal mount end. A fixation element is mounted on the fixation element mount. The fixation element extends about the longitudinal axis. A radiopaque marker has a distal marker end longitudinally aligned with the distal mount end of the fixation element mount. Other embodiments are also described and claimed.
Systems and methods for delivering and retrieving a leadless pacemaker are described. A leadless pacemaker retrieval system includes a catheter system having a snare assembly to capture the leadless pacemaker. The catheter system includes sheaths extending distally from a shaft, and the snare assembly includes several snare legs, such as segments of snare loops, that extend from one sheath to connect to another sheath. The snare loops can have bights that connect to opposing sheaths to form a docking space between the legs of the snare loops and radially between the sheaths. The snare assembly is movable between an engaged position and a disengaged position by translating the snare legs within lumens of the corresponding sheaths. In the engaged position, the snare assembly tightens around the leadless pacemaker to allow the leadless pacemaker to be retrieved. Other embodiments are also described and claimed.
A61B 17/00 - Surgical instruments, devices or methods
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61B 17/221 - Calculus gripping devices in the form of loops or baskets
Described herein is an ED configured to wirelessly communicate with an IMD, a method for use by the ED, a system including the ED and the IMD, and a method for use by such a system. While a wireless connection is being established between the ED and the IMD, the ED receive an IMD anchor point transmitted by the IMD, and the ED stores the IMD anchor point and an ED anchor point. Thereafter, time stamps of signal data and the stored anchor points are used to synchronize the display of different physiologic signals, at least one of which is displayed based on signal data obtained from the IMD via the wireless connection, and another of which is obtained by the ED not using the wireless connection. Such embodiments enable the synchronized co-display of such physiologic signals even in noisy environments where the wireless connection is relatively poor.
A61N 1/372 - Arrangements in connection with the implantation of stimulators
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/28 - Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
H04W 4/80 - Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
A biostimulator includes a housing having a longitudinal axis and containing an electronics compartment. The biostimulator includes a fixation element coupled to the housing. The fixation element extends about the longitudinal axis. The biostimulator includes a pacing element coupled to the housing. The pacing element includes a flexible conductor extending along the longitudinal axis and a stiffening strand extending beside the flexible conductor. A bending stiffness of the stiffening strand is greater than a bending stiffness of the flexible conductor. Other embodiments are also described and claimed.
Systems and methods for pacing and classifying response to pacing impulses include applying, using a pulse generator, an impulse through a stimulating electrode to induce a response from a patient heart. A response to the impulse is measured using at least one sensing electrode and characteristics of the response are analyzed to determine whether capture has occurred and, if so, what type of capture has occurred. To facilitate analysis, the response measured from the patient heart may also be filtered to pass or stop frequencies indicative of certain capture types.
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
A61N 1/368 - Heart stimulators controlled by a physiological parameter, e.g. by heart potential comprising more than one electrode co-operating with different heart regions
A delivery system and method are described that include a catheter (102) and a stylet (200). The catheter (102) defines a delivery lumen (146) therethrough. The stylet (200) extends through the delivery lumen (146) of the catheter (102) and is movable relative to the catheter (102). The stylet (200) includes a tip section (220) at a distal end (212) of the stylet (200). The tip section (220) selectively transitions between a narrow state and a flared state. The tip section (220) in the flared state has a greater lateral extension than the tip section (220) in the narrow state. The tip section (220) in the narrow state is configured to project beyond a distal end (116) of the catheter (102) to pierce cardiac tissue. The tip section (220) is configured to transition from the narrow state to the flared state to anchor the stylet (200) to the cardiac tissue.
Dual chamber leadless pacemaker systems comprising an aLP and a vLP, and methods for use therewith, are disclosed. Such systems and methods can detect and terminate pacemaker mediated tachycardia (PMT) even when the implant-to-implant (i2i) communication from the vLP to aLP (V2A) is compromised. The vLP monitors for PMT in response to reception of an i2i communication from the aLP indicating compromised V2A i2i communication and initiates, following detection of a PMT, initiate a PMT PV interval in response to reception of an i2i communication from the aLP indicating an atrial sensed event. The PMT PV interval is shorter than a PV interval that the vLP would otherwise use for ventricular pacing if PMT was not detected. The vLP also delivers a ventricular pacing pulse to the ventricular cardiac chamber in response to the PMT PV interval expiring without an intrinsic ventricular event being detected during the PMT PV interval.
A61N 1/368 - Heart stimulators controlled by a physiological parameter, e.g. by heart potential comprising more than one electrode co-operating with different heart regions
A61N 1/372 - Arrangements in connection with the implantation of stimulators
A61N 1/375 - Constructional arrangements, e.g. casings
21.
METHODS AND DEVICES FOR IMPROVED EVOKED RESPONSE DETECTION AND PACEMAKER CAPTURE MANAGEMENT
Described herein are leadless pacemakers (LPs) and methods for use therewith. In certain embodiments an LP stores a polarization artifacts template or a capture plus polarization artifacts template in memory of the LP. The LP uses the stored template when performing autocapture and/or other types of capture detection to mitigate adverse effects of electrode polarization. Such embodiments are especially useful where the LP is an atrial LP, but can also be used to other types of LPs, such as a ventricular LP.
Embodiments are disclosed of a pacing lead tool. The pacing lead tool has a tool body with a proximal body end, a distal body end, and a lumen extending from the proximal body end to the distal body end. The lumen is adapted to receive a proximal lead end of a pacing lead, and is also adapted to receive a stylet therein. A retainer is coupled to, or formed in, the tool body and adapted to engage the stylet when the stylet is inserted in the lumen. The retainer substantially prevents proximal movement of the stylet until a proximal force applied to the stylet exceeds a threshold force.
A bearing assembly adapted to be coupled to a distal end of a catheter comprises a housing attached to the distal end of the catheter, the housing including a central opening and an outer bearing race formed in the housing around the central opening. A docking cap stem is positioned in the central opening and rotatable relative to the housing, the docking cap stem being adapted to be coupled to a torque shaft of the catheter, wherein the docking cap stem forms an inner bearing race and wherein the outer bearing race and the inner bearing race together form a bearing race. Several ball bearings is positioned in, and contained by, the bearing race, and a docking cap is coupled to the docking cap stem.
F16C 19/06 - Bearings with rolling contact, for exclusively rotary movement with bearing balls essentially of the same size in one or more circular rows for radial load mainly with a single row of balls
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
A61N 1/375 - Constructional arrangements, e.g. casings
Systems and methods for slitting a delivery device are described. A slitter assembly for slitting the delivery device in accordance with the present disclosure includes a housing, a lock mechanism coupled to the housing, and a clamshell mechanism coupled to the lock mechanism. The clamshell mechanism defines a channel having an adjustable diameter and sized to receive a device. The slitter assembly also includes a blade configured to slit a tubular shaft of the delivery device.
Disclosed herein is a screw-in lead implantable in the pericardium of a patient heart and a system for delivering such leads to an implantation location. The leads include a helical tip electrode and a curvate body including a defibrillator coil with improved contact between the defibrillator coil and the patient heart. The delivery system includes a delivery catheter and lead receiving sheath disposed within the catheter. A fixation tine is disposed on one of the delivery catheter and the lead receiving sheath such that the delivery system may be anchored into the pericardium during fixation of the screw-in lead. In certain implementations, an implantable sleeve receives the leads to bias the defibrillator coil against the patient heart.
Methods and systems for monitoring heart valve operation using signals detected by a heart sound sensor includes memory to store program instructions and one or more processors that, when executing the program instructions receive seismocardiography (SCG) signals detected by a heart sound sensor along an axis. The SCG signals include heart sound signals for a series of heartbeats over a first time period. The SCG signals are segmented into SCG segments for corresponding heartbeats within the series of heartbeats over the first time period. A template is calculated based on a first subset of the SCG segments. At least a portion of a second subset of the SCG segments are compared to the template to determine matching scores, and an alert is generated in response to a select number of the second subset of SCG segments having the matching scores that satisfy a matching threshold.
An implantable medical device (IMD) is provided and includes sensing circuitry coupled to electrodes. The sensing circuitry is configured to sense electrical biological signals indicative of a non-physiologic condition of interest experienced by a patient during a magnetic resonance imaging (MRI) procedure, and in the presence of an MRI scanning sequence, the MRI scanning sequence includes at least one of radio frequency (RF) or gradient fields that are in an active state for active field intervals. The device includes memory to store the biological signals and to store program instructions and includes a processor that, when executing the program instructions, is configured to: determine start times for the active field intervals when the at least one of RF or gradient fields switch to the active state and manage generation of MRI-induced-noise corrected (MRI-INC) biological signals, based on the start times for the active field intervals, by at least one of: 1) applying a blanking interval to the sensing circuitry to blank a sensing operation during at least portions of the active field interval or 2) modifying segments of the biological signal sensed during at least the portions of the active field interval, and 3) comparing biologic signal sensed during at least the portions of the active field interval to a template. The device analyzes the biological signals for an indication that the patient is experiencing the non-physiologic condition.
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 method for temperature-based diagnosis and treatment using an implantable medical device (IMD) is provided. The method includes collecting treatment temperature data from a temperature sensor of the implantable medical device (IMD) at a first rate in a first mode and collecting diagnostic temperature data from the temperature sensor in a second mode at a second rate that is less than the first rate. The method also includes utilizing one or more processors to perform: in the first mode analyzing the treatment temperature data and delivering a treatment of the IMD based on the treatment temperature data. The method also includes utilizing the one or more processors in the second mode to analyze the diagnostic temperature data and communicate an alert based on the diagnostic temperature data.
Catheter-based delivery systems for delivery and retrieval of a leadless pacemaker include features to facilitate improved manipulation of the catheter and improved capture and docking functionality of leadless pacemakers. Such functionality includes mechanisms directed to deflecting and locking a deflectable catheter, maintaining tension on a retrieval feature, protection from anti-rotation, and improved docking cap and drive gear assemblies.
A medical data and diagnostics management system for processing classified EGM datasets includes a server system that receives transmissions of classified EGM datasets, each corresponding to an arrhythmic episode detected by an IMD, and applies a machine-learning model to each classified EGM dataset stored in a database, thereby determining for each of the classified EGM datasets to which the model is applied a respective indicator of whether the IMD classification is a false positive or a true positive. The system is further configured to remove from the database one or more of the classified EGM data sets for which the respective IMD classification is identified using the machine-learning model as being a false positive, thereby creating a plurality of machine-adjudicated patient database records stored in the database. The system may also provide for display a selected one of the machine-adjudicated EGM datasets and/or facilitate reprograming the IMD.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
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
31.
IMPROVED CONDUCTIVE IMPLANT TO IMPLANT COMMUNICATION FOR USE WITH IMPLANTABLE MEDICAL DEVICES
While in a first conductive i2i communication mode, during a cardiac cycle, an IMD transmits an outgoing conductive i2i communication message to another IMD, and attempts to receive a valid incoming conductive i2i communication message from the other IMD. In response to the IMD detecting that a quantity of invalid messages received during a cardiac cycle reaches an invalid message count threshold, which is indicative of noise adversely affecting the conductive i2i communication, the IMD switches from the first conductive i2i communication mode to a second conductive i2i communication mode that consumes on average less power per cardiac cycle. The IMD remains in the second conductive i2i communication mode for up to M cardiac cycles before switching back to the first mode, or switches back earlier if the IMD determines using one or more conductive i2i beacon messages that noise that caused the initial switch is likely no longer present.
A61N 1/372 - Arrangements in connection with the implantation of stimulators
A61N 1/365 - Heart stimulators controlled by a physiological parameter, e.g. by heart potential
A61N 1/375 - Constructional arrangements, e.g. casings
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
H04B 13/00 - Transmission systems characterised by the medium used for transmission, not provided for in groups
32.
BIOSTIMULATOR TRANSPORT SYSTEM HAVING PROTECTIVE SLEEVE
A biostimulator transport system includes a catheter shaft extending to a distal shaft end. The biostimulator transport system includes a biostimulator coupling mounted on the distal shaft end to receive a biostimulator having a fixation element. The biostimulator transport system includes a protective sleeve movable relative to the biostimulator coupling between a protective state and an unprotective state. The protective sleeve covers the fixation element in the protective state. The protective sleeve does not cover the fixation element in the unprotective state. The protective sleeve has a distal section including one or more folds that open when the protective sleeve moves from the protective state to the unprotective state.
A biostimulator, such as a leadless cardiac pacemaker, including a fixation element to engage tissue and one or more backstop elements to resist back-out from the tissue, is described. The fixation element can be mounted on a housing of the biostimulator such that a helix of the fixation element extends distally to a leading point. The leading point can be located on a distal face of the helix at a position that is proximal from a center of the distal face. The backstop elements can include non-metallic filaments, such as sutures, or can include a pinch point of the biostimulator. The backstop features can grip the tissue to prevent unscrewing of the fixation element. Other embodiments are also described and claimed.
A retrieval system for a biostimulator, such as a leadless cardiac pacemaker, is described. The biostimulator retrieval system includes a docking cap rotatably coupled to an outer catheter by a bearing. A torque shaft extends through the outer catheter and attaches to the docking cap to transmit torque to the docking cap to cause rotation of the docking cap relative to the outer catheter. The rotating docking cap can transmit torque to an attachment feature of a biostimulator received within the docking cap. The attachment feature can be captured by a snare that extends through the torque shaft. A cincher tube extends through the torque shaft around the snare, and advances over the snare independently from the torque shaft that is attached to the docking cap, to cinch the snare onto the attachment feature. Other embodiments are also described and claimed.
A pacemaker device including a pacemaker portion and an integrated connector. The pacemaker device includes a housing assembly defining a plurality of housing cavities for containing pacing electronics, battery material and an IS-1 connector. The connector is enclosed within the housing and is configured to receive a lead which is electrically connectable with the pacing electronics. The pacemaker device may include a leadless pacemaker portion inserted in the housing assembly configured to convert the leadless pacemaker into a leaded configuration. The leadless pacemaker may be removably attached from the pacemaker device and replaced with another leadless pacemaker.
Embodiments described herein relate to an implantable device that include an inductor coil, a storage capacitor, active circuitry, and a sensor, but doesn't include an electrochemical cell, and methods for use therewith. During first periods of time, the storage capacitor accumulates and stores energy received via the inductor coil from a non-implanted device. During second periods of time, interleaved with the first periods of time, and during which energy is not received from the non-implanted device, the active circuitry of the implantable device is powered by the energy stored on the storage capacitor and is used to perform at least one of a plurality of predetermined operations of the implantable device, including, e.g., obtaining a sensor measurement from the sensor of the implantable device, transmitting a communication signal including a sensor measurement to the non-implanted device, and/or receiving a communication signal from the non-implanted device.
Described herein are external devices, and methods for use therewith, that are configured to communicate with one or more implantable medical devices (IMDs) implanted within a patient using conductive communication, wherein the external device includes or is communicatively coupled to at least three external electrodes that are in contact with the patient. Certain such methods involve the external device identifying, for each IMD, of the plurality of IMDs, which one of the plurality of communication vectors is a preferred communication vector for communicating with the IMD, based on respective indicators of conductive communication quality that are determined for the plurality of communication vectors. Certain embodiments involve determining when there should be a reassessment of which one of the plurality of communication vectors is the preferred communication vector for communicating with an IMD, and in response thereto, identifying an updated preferred communication vector for communicating with the IMD.
A delivery system for an intracorporeal device includes a sheath defining one or more lumens shaped to receive a delivery catheter or shaft and a guidewire. The system may include a delivery shaft having a distal coupling feature adapted to releasably couple with a proximal coupling feature of the intracorporeal device. The delivery system may further include a hub through which the delivery shaft and guidewire are passed. The delivery shaft may be coupled to a feature, such as a knob, that enables manipulation of the delivery shaft to decouple the distal fixation feature from the proximal fixation feature of the intracorporeal device in order to deploy the intracorporeal device within a patient.
A method for controlling an implantable medical device (IMD) is provided. The method can include obtaining, with a monitoring device, cardiac activity signals, and obtaining, with an accelerometer, candidate heart sound (HS) signals. The method can also include analyzing the cardiac activity signals based on an initial criteria and eliminating candidate HS signals based on the analyzing to provide remainder candidate HS signals. The method also can include analyzing the remainder candidate HS signals based on HS quality criteria related to the remainder candidate HS signals, eliminating additional candidate HS signals from the remainder candidate HS signals based on analyzing the remainder candidate HS signals to provide a HS ensemble, and controlling the IMD based on the HS ensemble. An IMD is also provided.
An implantable medical device and method are described that include a housing, a right ventricle (RV) near field (NF) electrode, a far field (FF) electrode, and sensing circuitry. The housing contains one or more processors. The RV NF electrode is electrically connected to the one or more processors and configured to be located within the RV of a heart of a patient and either in contact with ventricular myocardial tissue of the heart or within a threshold proximity of the ventricular myocardial tissue. The FF electrode is configured to be positioned beyond the threshold proximity of the ventricular myocardial tissue. The sensing circuitry is coupled to the RV NF electrode and the FF electrode and configured to define an atrial sensing vector to collect atrial sensing data associated with atrial cardiac activity. The one or more processors are configured to receive the atrial sensing data.
A system and method are provided for communication between first and second devices utilizing a predetermined protocol. The system and method utilize at least one of communication circuitry or a processor, within one of the first and second devices, for, receiving a data packet; determining whether the data packet exhibits an error; when the data packet exhibits the error, incorporating the data packet into a candidate packet register (CPR) within the one of the first medical device and the second device; analyzing a content the CPR for errors; and based on the analyzing, designating the content of the CPR to be a resultant packet and output the resultant packet as a corrected version of the data packet.
H04L 1/00 - Arrangements for detecting or preventing errors in the information received
H04W 4/80 - Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
A system for monitoring a physiologic condition of a patient includes an implantable medical device (IMD) comprising: an accelerometer configured to output an accelerometer signal; sensing circuitry configured to sense a cardiac activity (CA) signal; and a memory configured to store program instructions. One or more processors that, when executing the program instructions, are configured to: determine a heart rate (HR) at a point in time based on the CA signal; determine an activity level (AL) at the point in time based on accelerometer data that is based on the accelerometer signal, the HR and AL forming an HR-AL event; compare the HR-AL event to a heart condition (HC) metric that defines combinations of HRs and ALs representing a physiologically normal heart condition and a physiologically abnormal heart condition; and transmit the HR-AL event or a result of the comparison to a second device for use in diagnosing and/or treating a heart condition.
A61B 5/11 - Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
G16H 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indicesICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
43.
DELIVERY SYSTEM AND METHOD FOR PERCUTANEOUS INTRAVASCULAR PROCEDURES
A delivery system and method are described that include an access introducer sheath and a delivery catheter. The access introducer sheath defines a channel through a body thereof from a proximal end to a distal end. The delivery catheter is disposed within the channel of the access introducer sheath, and defines a lumen that extends along a central axis of the delivery catheter. A distal end segment of the delivery catheter projects beyond the distal end of the access introducer sheath. The lumen is configured to receive a dilator therein that projects beyond the distal end of the delivery catheter so that the distal end segment of the delivery catheter is disposed between a tip segment of the dilator and the distal end of the access introducer sheath along the central axis.
Embodiments described herein relate to an IMD operating in a backup mode in a manner that mitigates against adverse effects of a memory failure. The IMD includes a NVM that stores backup mode firmware, a RAM that includes multiple separate RAM blocks, a processor, and a counter. The processor executes the backup mode firmware to operate the IMD in accordance with a backup mode in response to detection of a malfunction that when detected should cause the IMD to operate in accordance with the backup mode. While the processor operates the IMD in accordance with the backup mode the processor stores and accesses variables in one of the RAM blocks. The counter is selectively incremented and used to select which one of the RAM blocks the variables are stored within while the processor executes the backup mode firmware to operate the IMD in accordance with the backup mode.
A biostimulator transport system includes a biostimulator coupling along a central axis, and one or more location guides. The location guides are deployable radially outward from the central axis. When deployed, the location guides engage anatomical landmarks. Other embodiments are also described and claimed.
A system and method for modeling patient-specific spinal cord stimulation (SCS) is disclosed. The system and method acquire impedance and evoked compound action potential (ECAP) signals from a lead positioned proximate to a spinal cord (SC). The lead includes at least one electrode. The system and method determine a patient-specific anatomical model based on the impedance and ECAP signals, and transform a dorsal column (DC) map template based on a DC boundary of the patient-specific anatomical model. Further, the system and method map the transformed DC map template to the patient-specific anatomical model. The system and method may also include the algorithms to solve extracellular and intracellular domain electrical fields and propagation along neurons. The system and method may also include the user interfaces to collect patient responses and compare with the patient-specific anatomical model as well as using the patient-specific anatomical model for guiding SCS programming.
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 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 30/40 - ICT specially adapted for the handling or processing of medical images for processing medical images, e.g. editing
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
47.
IMPLANTABLE MEDICAL SYSTEMS AND METHODS USED TO DETECT, CHARACTERIZE OR AVOID ATRIAL OVERSENSING WITHIN AN IEGM
Certain embodiments of the present technology described herein relate to detecting atrial oversensing, characterizing atrial oversensing, determining when atrial oversensing is likely to occur, and or reducing the chance of atrial oversensing occurring. Some such embodiments relate to specifying an atrial oversensing avoidance (AOA) period corresponding to when atrial oversensing may occur following one or more paced or sensed atrial events, and after specifying the AOA period selectively using an atrial oversensing avoidance technique during one or more instances of the AOA period that follow paced or sensed atrial events to thereby reduce a likelihood of atrial oversensing during the one or more instances of the AOA period.
A61B 5/33 - Heart-related electrical modalities, e.g. electrocardiography [ECG] specially adapted for cooperation with other devices
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
A61N 1/368 - Heart stimulators controlled by a physiological parameter, e.g. by heart potential comprising more than one electrode co-operating with different heart regions
48.
METHOD AND SYSTEM FOR CALIBRATING SENSING CIRCUITRY OF AN IMPLANTED MEDICAL DEVICE
A system is provided that includes electrodes configured to be implanted in a body, and a pulse generator (PG) circuitry to deliver a stimulus to one or more of the electrodes. The system also includes sensing circuitry configured to define a sensing channel between one or more of the electrodes to sense signals indicative of a physiologic activity of interest, and the sensing circuitry further configured to collect a calibration signal over the sensing channel. The sensing circuitry and PG circuitry are housed within an implantable medical device (IMD). The system also includes one or more processors configured to determine a signal characteristic of interest (COI) of the calibration signal. The one or more processors are also configured to compare a signal COI of the stimulus to the signal COI of the calibration signal, and adjust a parameter of the sensing circuitry or PG circuitry based on the comparison.
In at least one embodiment, a system and method for implanting an implantable medical device (IMD) within a patient may include an IMD including a housing and an attachment member, and a delivery catheter including a tethering snare that is configured to be selectively extended out of the delivery catheter and retracted into the delivery catheter. In at least one embodiment, a system and method for implanting an implantable medical device (IMD) within a patient may include an IMD including a housing and an attachment member, wherein the attachment member includes a central passage connected to a connection chamber, and a delivery catheter including first and second tethers that may be moved outwardly from and retracted into the delivery catheter.
A dual chamber leadless pacemaker (LP) system includes a first leadless pacemaker (LP1) and a second leadless pacemaker (LP2), wherein the LP1 is configured to be implanted in or on a first cardiac chamber and to deliver pacing pulses to the first cardiac chamber, and the LP2 is configured to be implanted in or on a second cardiac chamber and to deliver pacing pulses to the second cardiac chamber. Information is obtained about a magnitude of the pacing pulses that the LP2 is configured to deliver to the second cardiac chamber and/or a sensitivity of a sense circuit of the LP1 that is configured to be used by the LP1 to detect intrinsic depolarizations of the first cardiac chamber. A crosstalk protection duration is determined based on at least some of the information so that when crosstalk protection is perform, it is performed for an appropriate duration.
A61N 1/375 - Constructional arrangements, e.g. casings
A61N 1/368 - Heart stimulators controlled by a physiological parameter, e.g. by heart potential comprising more than one electrode co-operating with different heart regions
51.
IMPLANTABLE MEDICAL DEVICES, SYSTEMS AND METHODS FOR REDUCING T-WAVE OVERSENSING AND ARRHYTHMIA UNDERSENSING
Described herein are implantable medical devices and systems, and methods for use therewith, for reducing T-wave oversensing and arrythmia undersensing that occur due to inappropriate filtering of a signal indicative of cardiac electrical activity. A method includes obtaining a signal indicative of cardiac electrical activity, and using a first bandpass filter to produce a first filtered version thereof, using a second bandpass filter to produce a second filtered version thereof, wherein the first bandpass filter passes frequencies within a first frequency range, and the second bandpass filter passes frequencies within a second frequency range that is wider than the first frequency range. The method also includes selectively changing from using the first filtered version of the signal to monitor for a VS event, to using the second filtered version of the signal to monitor for a VS event, based on first criteria, and vice versa, based on second criteria.
An extraction tool includes a handle and a tray that extends from the handle. The tray is configured to be advanced into a subcutaneous region of a patient. The tray includes a platform and a raised rim that projects above a top surface of the platform. The top surface of the platform and the raised rim define a cavity configured to receive and contain a subcutaneous implantable medical device (S-IMD) therein. The handle is configured to be manipulated by an operator to withdraw the extraction tool from the patient with the S-IMD on the tray.
A61B 1/06 - Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopesIlluminating arrangements therefor with illuminating arrangements
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
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
A biostimulator and a biostimulator system for septal pacing, is described. The biostimulator includes a burrowing nose to allow the biostimulator to embed within a target tissue. The embedded biostimulator has a reduced exposed length within a heart chamber, and is less likely to interfere with adjacent heart structures. Embodiments include burrowing ridges on a nose or a housing of the biostimulator to affix the embedded biostimulator to the target tissue. Other embodiments are also described and claimed.
Implantable leadless biostimulators and related methods are described. The implantable leadless biostimulator comprises first, second and third electrodes, and also includes circuitry configured to cause a first set of the electrodes, which includes the first electrode and the third electrode, but does not include the second electrode, to be used during first periods of time to deliver stimulation pulses to the patient tissue. The circuitry is also configured to cause a second set of the electrodes, which includes the second electrode and the third electrode, to be used during second periods of time to at least one of transmit conductive communication pulses to, or receive conductive communication pulses from, one or more other devices. The second set of electrodes optionally includes the first electrode electrically connected to the second electrode.
A61N 1/368 - Heart stimulators controlled by a physiological parameter, e.g. by heart potential comprising more than one electrode co-operating with different heart regions
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
A61N 1/36 - Applying electric currents by contact electrodes alternating or intermittent currents for stimulation, e.g. heart pace-makers
A61N 1/375 - Constructional arrangements, e.g. casings
A biostimulator system includes a biostimulator coupled to a biostimulator transport system. The biostimulator includes a header assembly. The header assembly includes a flange having a central axis. A fixation element mount is mounted on the flange. The fixation element mount includes a mounting ring on an insulator base. The mounting ring extends around the central axis within a groove of the insulator base. A fixation element is coupled to the mounting ring. Other embodiments are also described and claimed.
A capacitor is provided that includes a capacitor stack including an anode layer, cathode layer, and electrolytic layer electrically coupled together, the capacitor stack including a capacitor stack periphery. The capacitor also includes a first cover portion having a first cover portion periphery that aligns with the capacitor stack periphery, and a second cover portion having a second cover portion periphery that aligns with the capacitor stack periphery and received the first cover portion periphery to form a shell body for encasing the capacitor stack therein. The capacitor stack is isolated from the second cover portion to provide a neutrally charged second cover portion that is electrically coupled within an implanted medical device.
An implantable lead includes a lead body extending along a central axis from a proximal lead portion to a distal lead portion. The lead body includes a central lumen in the distal lead portion. The implantable lead includes a drive coupling rotatably mounted in the central lumen. The drive coupling includes a screw drive. The implantable lead includes a helical fixation element mounted on the drive coupling. Other embodiments are also described and claimed.
A biostimulator transport system includes a locking tube having a central lumen. The biostimulator transport system includes a tether extending through the central lumen. The tether includes a locking end coupled to a tether body. The locking end is wider than the tether body. Other embodiments are also described and claimed.
A biostimulator, such as a leadless cardiac pacemaker, having a header assembly that includes an antenna, is described. The antenna can be integrated into an insulator that separates an electrode of the header assembly from a flange of the header assembly. The antenna includes an antenna loop embedded in a ceramic material of the insulator. The antenna loop is located distal to the flange to reduce the likelihood of signal interference and increase communication range of the antenna. The header assembly is mounted on a housing have an electronics compartment, and an antenna lead extends from the antenna loop to electronic circuitry contained within the electronics compartment. Other embodiments are also described and claimed.
A61N 1/372 - Arrangements in connection with the implantation of stimulators
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
A61N 1/375 - Constructional arrangements, e.g. casings
H01Q 1/40 - Radiating elements coated with, or embedded in, protective material
H01Q 7/00 - Loop antennas with a substantially uniform current distribution around the loop and having a directional radiation pattern in a plane perpendicular to the plane of the loop
A biostimulator and a biostimulator system for septal pacing, is described. The biostimulator includes an articulation to allow an electrode axis of a pacing electrode to be directed differently than a housing axis of a housing. The housing contains electrical circuitry that is electrically connected to the pacing electrode. The differently directed axes allow the pacing electrode to affix to target tissue of an interventricular septal wall of a heart when the housing of the biostimulator is located near an apex of the heart. The articulation can include a flexible portion of an extension, a hinge, or a tether. Other embodiments are also described and claimed.
Embodiments are disclosed of a loading tool for a biostimulator transport system. The loading tool includes a plunger having a free end and a tether end. A tether is coupled to the tether end of the plunger and coupled to a biostimulator. The plunger is stored in a storage container and can exit the storage container through an outlet.
A method of manufacturing an electrolytic capacitor includes impregnating an electrolytic capacitor with a first electrolyte to form a first impregnated capacitor, aging the first impregnated capacitor using a first aging process to form a first aged capacitor, impregnating the first aged capacitor with a second electrolyte to form a second impregnated capacitor, and aging the second impregnated capacitor using a final aging process to form a final aged capacitor.
A method for manufacturing an electrolytic capacitor for an implantable medical device is provided. The method can include placing a metal foil within an etch solution and etching tunnels in the metal foil during an electrochemical reaction. In addition, the method may include vibrating the metal foil while the metal foil is within the etch solution.
An introducer sheath for implanting a subcutaneous lead into a patient includes a gripping element and a tubular body. The gripping element is configured to be held by an operator. The tubular body extends a length from the gripping element to a distal end of the introducer sheath. The tubular body defines an internal cavity that extends the length of the tubular body. The internal cavity is sized and shaped to accommodate a rod of a tunneling tool therethrough. The tubular body defines an array of flushing holes at different locations along the length of the tubular body and at different radial locations along a perimeter of the tubular body.
A tethering apparatus is described. The tethering apparatus includes a support wire and a distal anchor coupled to the support wire. The distal anchor includes a tether attachment adapted to secure a first end of a tether. A proximal anchor is coupled to the support wire proximal to the distal anchor. A tethering mechanism is coupled to the proximal anchor and adapted to receive a second end of a tether. The tethering mechanism is movable between a closed position that retains the second end of the tether and an open position that releases the second end of the tether.
A delivery system and method are described that include a catheter and an active wire. The catheter has a catheter body that defines a primary lumen and a secondary lumen therethrough, which are spaced apart from each other. A distal end of the catheter body is configured to be located within a chamber of a heart proximate to myocardial tissue at a site of interest (SOI). The primary lumen has a greater cross-sectional size than the secondary lumen. The primary lumen is configured to receive at least a portion of an IMD therein and to permit the portion of the IMD to move relative to the catheter. The active wire is configured to extend through the secondary lumen so that a distal end of the active wire projects beyond the distal end of the catheter body to pierce the myocardial tissue at the SOI.
An implantable medical device (IMD), and methods for use therewith, are described herein. The IMD includes sense circuitry configured to produce a differential signal (e.g., an ECG or EGM signal) indicative of a voltage potential difference between first and the second electrodes. The IMD additionally includes disturbance detection circuitry configured to detect a non-biological disturbance based at least in part on a slew rate of the differential signal exceeding a slew rate threshold. The non-biological disturbance can be, e.g., at least one of the first or the second electrodes losing contact with the tissue of the patient within which the IMD is implanted, exposure of the IMD to EMI, or exposure of the IMD to a time-varying gradient magnetic field from an MRI system.
Methods, systems, and devices that detect an arrhythmic and/or perform arrhythmia discrimination are described. Such a system includes an LP that senses a NF-EGM, and a NV-ICD that senses a FF-EGM. The LP determines cardiac activity information based on at least the NF-EGM. The NV-ICD normally monitors for an arrhythmia and/or performs arrhythmia discrimination based on cardiac activity detected by the NV-ICD itself from the FF-EGM, without using cardiac activity information obtained from the LP. When the NV-ICD determines that an extracardiac signal is likely preventing the NV-ICD from accurately detecting cardiac activity based on the FF-EGM sensed by the NV-ICD, the NV-ICD sends i2i message(s) to the LP requesting that the LP provide cardiac activity information to the NV-ICD, based upon which the NV-ICD monitors for an arrhythmia and/or performs arrhythmia discrimination. The LP normally does not send i2i messages including the cardiac activity information to the NV-ICD.
A61N 1/375 - Constructional arrangements, e.g. casings
A61N 1/372 - Arrangements in connection with the implantation of stimulators
69.
METHODS AND SYSTEMS FOR DETERMINING WHETHER R-WAVE DETECTIONS SHOULD BE CLASSIFIED AS FALSE DUE TO T-WAVE OVERSENSING (TWO) OR P-WAVE OVERSENSING (PWO)
Described herein are methods, devices and systems for classifying an R-wave detection as a false R-wave detection due to T-wave oversensing (TWO) or P-wave oversensing (PWO), by determining whether at least one of first TWO or PWO temporal criteria or second TWO or PWO temporal criteria are met for R-wave detections in a window leading up to an arrhythmic episode detection, and based on an extent of the R-wave detections classified as being false R-wave detections due to TWO or PWO selectively preventing or aborting delivery of therapy intended to treat the arrhythmic episode, selectively preventing transmission by the IMD to an external device of data corresponding to the arrhythmic episode that can be used for diagnostic purposes, or selectively adjusting at least one parameter of the R-wave detection threshold that can be used by the IMD for detecting further R-waves and thereby detecting a further arrhythmic episode.
While an external device is not in an active conductive communication session with one or more IMD(s), a test vector is selected and used to search for advertisement sequence(s) transmitted by the IMD(s) during an OOS search window. If the advertisement sequence(s) is/are not detected using the test vector during the OOS search window, another electrode combination is selected and used as the test vector. In response the advertisement sequence(s) being detected, an active conductive communication session is established with the IMD(s) and a respective score is determined. Then different combinations of other ones of the external electrodes are used as the test vector during an accelerated search window having a duration shorter than the OOS search window, and a respective score is determined for each of the other test vectors. Based on the scores, a preferred vector is selected and used to perform further conductive communication with the IMD(s).
A system is provided that includes one or more processors, and a memory coupled to the one or more processors. The memory stores program instructions, and the program instructions are executable by the one or more processors. When executed, the one or more processors obtain cardiac activity (CA) signals for a series of beats, and identify whether a characteristic of interest (COI) from a first segment of the CA signals exceeds a COI limit. The one or more processors also analyze morphology of the CA signals for the series of beats responsive to the first segment of the CA signals exceeding the COI limit, and based on the analyze operation, identify a premature ventricular contraction (PVC) within the series of beats.
A communication system is provided that includes a remote electronic device configured to communicate with a medical device of a patient via a local programming electronic device. The remote electronic device can include one or more processors configured to control operations of the local programming electronic device to program the medical device during a dynamic session. The one or more processors can also be configured to terminate the dynamic session in response to 1) a persistent action of a user of the remote electronic device exceeding a static persistent state threshold and 2) a monitored event exceeding a dynamic threshold.
A leadless implantable medical device (IMD) and method of using same are provided. The IMD comprises: a housing, a fixation element, electrodes configured to sense electrical cardiac activity (CA) signals over a period of time, an HS sensor configured to sense HS signals over the period of time, memory to store specific executable instructions, and one or more processors. The one or more processors and method: identify a characteristic of interest (COI) of a heartbeat from the CA signals, calculate a center of mass (COM) for at least one HS based on the HS signals to obtain a corresponding at least one HS COM, and calculate at least one of a therapy-related (TR) delay or a sensing-related (SR) blanking interval (BI) based on the at least one HS COM.
A biostimulator includes a housing, a fixation element, and a probe. The housing includes an electronics compartment containing circuitry. The fixation element is coupled to the housing. The probe is coupled to the housing and electrically connected to the circuitry. The probe includes a flexible body extending to a tip. The flexible body includes a conductive layer laminated on a substrate layer. Other embodiments are also described and claimed.
An implantable system includes an implantable medical device (IMD) and a non-transvenous lead that is configured to be implanted outside of a heart. The IMD includes an output configured to be connected at least to the lead, a current generator (CG) circuit configured to generate pacing pulses, a switching circuit coupled between the CG circuit and the output, one or more capacitors coupled in parallel with the CG circuit and the switching circuit, and a control circuit coupled to the CG circuit. The control circuit is configured to manage the CG circuit to generate the pacing pulses with a constant current at the output.
A capacitor and methods of processing an anode metal foil are presented. The capacitor includes a housing, one or more anodes disposed within the housing, one or more cathodes disposed within the housing, one or more separators disposed between an adjacent anode and cathode, and an electrolyte disposed around the one or more anodes, one or more cathodes, and one or more separators within the housing. The one or more anodes each include a metal foil that includes a first plurality of tunnels through a thickness of the metal foil in a first ordered arrangement having a first diameter, and a second plurality of tunnels through the thickness of the metal foil having a second ordered arrangement and a second diameter greater than the first diameter.
Methods and systems for dynamically modifying pacing timing and backup pacing delivery in cardiac stimulation devices include applying pacing impulses, measuring corresponding responses, and, based on such responses, automatically modifying timing or operational settings of the stimulation device to improve pacing functionality. Among other things, the approaches described herein reduce unnecessary backup pacing impulses in HIS bundle pacing applications, facilitate fusion in bundle branch block applications, and automatically enable or disable backup pacing in response to achieving QRS complex correction.
The invention relates to leadless cardiac pacemakers (LBS), and elements and methods by which they affix to the heart. The invention relates particularly to a secondary fixation of leadless pacemakers which also include a primary fixation. Secondary fixation elements for LBS's may passively engage structures within the heart. Some passive secondary fixation elements entangle or engage within intraventricular structure such as trabeculae carneae. Other passive secondary fixation elements may engage or snag heart structures at sites upstream from the chamber where the LBS is primarily affixed. Still other embodiments of passive secondary fixation elements may include expandable structures.
Devices, systems and methods for improving conductive communication between medical devices, such as leadless cardiac pacers (LCPs) and non-vascular implantable cardioverter defibrillators (NV-ICDs), are described herein. To provide enhanced channel noise resistance, implant-to-implant (i2i) communications can encode bit values as orthogonal pseudo noise pulse waveforms. When a first implantable device is communicating with multiple devices, the multiple data streams for the devices can be encoded as composite bits, with each composite bit including a bit for each of the multiple intended receiving devices, with at least one of each of the data streams encoded as the orthogonal pseudo noise pulse waveforms.
A biostimulator transport system, such as a biostimulator delivery system, having a swaged torque shaft, is described. The torque shaft includes an outer cable coaxially arranged with an inner coil. The inner coil has a single wire coil extending around a central axis in a first helical direction, and the outer cable has several outer strands that extend around the central axis in a second helical direction that is different than the first helical direction. The outer cable can be swaged to form a close fit to the inner coil. The close fit of the swaged coaxial torque shaft structure can track to a target site through tortuous vessels and efficiently transfer torque from a handle to a docking cap of the biostimulator transport system to drive a biostimulator into the target site. Other embodiments are also described and claimed.
An introducer hub assembly, such as an introducer hub assembly of a leadless cardiac pacemaker, including a hemostatic seal having a cross-slit configuration, is described. The hemostatic seal can be retained between a hub cap and an introducer hub. The hemostatic seal includes a first section having first slits intersecting along a longitudinal axis of the introducer hub, and a second section having second slits intersecting along the longitudinal axis. The first slits are angularly offset relative to the second slits to reduce a likelihood that fluid will leak directly through the seal. Other embodiments are also described and claimed.
Disclosed herein is a delivery catheter for implanting a leadless biostimulator. The delivery catheter includes a shaft and a tubular body having a lumen and an atraumatic end. The atraumatic end includes at least one of a braided, woven or mesh construction configured to facilitate the atraumatic end changing diameter. When a distal portion of the shaft is coupled to a proximal region of the leadless biostimulator, at least one of distally displacing the tubular body relative to the shaft or proximally displacing the shaft relative to the tubular body causes the leadless biostimulator to be received in the volume of the atraumatic end and the atraumatic end to encompass the leadless biostimulator. Conversely, at least one of proximally displacing the tubular body relative to the shaft or distally displacing the shaft relative to the tubular body causes the leadless biostimulator to exit the volume of the atraumatic end.
Embodiments disclosed herein can be used to enable and/or improve conductive communication between an external device and one or more implantable medical devices (IMDs) in time, cost and/or energy efficient manners. Certain embodiments relate to specifying an appropriate edge detection threshold for use when performing conductive communication. Certain embodiments relate to use of the edge detection threshold to produce edge detections and decode a received conductive communication signal. Other embodiments relate to an external device's tiered search for an advertisement sequence transmitted by an IMD to enable the external device to detect the presence of the IMD and establish an active conductive telemetry session with the IMD. Still other embodiments relate to first, second, and third segments of a frame include respective first, second, and third CRC codes. Addition embodiments of the present technology are also disclosed herein.
System and method for declaring arrhythmias in cardiac activity are provided. The system includes memory to store specific executable instructions and a machine learning (ML) model. One or more processors are configured to execute the instructions to obtain device classified arrhythmia (DCA) data sets generated by an implantable medical device (IMD) for corresponding candidate arrhythmias episodes declared by the IMD. The DCA data sets include cardiac activity (CA) signals for one or more beats sensed by the IMD and one or more device documented (DD) markers generated by the IMD. The system applies the ML model to the DCA data sets to identify a valid sub-set of DCA data sets that correctly characterize the corresponding CA signals and an invalid sub-set of the DCA data sets that incorrectly characterize the corresponding CA signals. A display is configured to present information concerning at least one of the valid sub-set or invalid sub-set.
A biostimulator, such as a leadless cardiac pacemaker, having a patch antenna integrated into a housing, is described. The housing includes an annular wall that contains electronic circuitry of the biostimulator and provides a ground plane of the antenna. The patch antenna includes a meandering trace embedded in a curved dielectric layer that is mounted on the annular wall. The trace provides a conductor of the antenna and the dielectric layer provides a dielectric substrate of the antenna between the conductor and the ground plane. The electronic circuitry contained within the annular wall is electrically connected to the trace via an electrical feedthrough that passes through the annular wall and the dielectric layer. The electrical feedthrough places the electronic circuitry in communication with the antenna to transmit or receive wireless communication signals from an external device. Other embodiments are also described and claimed.
A system is provided that includes one or more electrodes configured to be implanted proximate to a sensing site, and a memory configured to store first and second sets of filter parameters that define first and second noise stop bands. The system also includes an implantable medical device (IMD) that has inputs configured to receive sensed signals, the sensed signals include frequency components associated with physiology activity and frequency components associated with noise. The IMD also includes a band-stop filter communicating with the sensing channel inputs. When executing program instructions, a processor switches the band-stop filter from the first set of filter parameters to the second set of filter parameters to shift from the first noise stop band to the second noise stop band based on the noise in the environment of the patient.
A computer implemented method and system for monitoring types of capture within a distributed implantable system having a leadless implantable medical device (LIMD) to be implanted entirely within a local chamber of the heart and having a subcutaneous implantable medical device (SIMD) to be located proximate the heart are provided. The method is under control of one or more processors of the SIMD configured with program instructions. The method collects far field (FF) evoked cardiac signals following the pacing pulses delivered by the LIMD for an event and analyzes the FF evoked cardiac signals to identify a type of HIS capture as loss of capture (LOC), selective capture, myocardial tissue-only (MT-only) capture, or a non-selective (NS) capture and records a label for the event based on the type of HIS capture identified.
Described herein are methods for use with an implantable system including at least an atrial leadless pacemaker (aLP). Also described herein are specific implementations of an aLP, as well as implantable systems including an aLP. In certain embodiments, the aLP senses a signal from which cardiac activity associated with a ventricular chamber can be detected by the aLP itself based on feature(s) of the sensed signal. The aLP monitors the sensed signal for an intrinsic or paced ventricular activation within a ventricular event monitor window. In response to the aLP detecting an intrinsic or paced ventricular activation itself from the sensed signal within the ventricular event monitor window, the aLP resets an atrial escape interval timer that is used by the aLP to time delivery of an atrial pacing pulse if an intrinsic atrial activation is not detected within an atrial escape interval.
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
A61N 1/365 - Heart stimulators controlled by a physiological parameter, e.g. by heart potential
A61N 1/368 - Heart stimulators controlled by a physiological parameter, e.g. by heart potential comprising more than one electrode co-operating with different heart regions
Disclosed herein are methods for use with an IMD configured to deliver pacing pulses to cardiac tissue, and related systems for use with and/or including an IMD. A method includes determining a pacing impedance of the cardiac tissue, a first capture threshold of the cardiac tissue, and an estimate of a maximum membrane response for the cardiac tissue. Additionally, the method includes using the maximum membrane response to determine an iso-safety factor strength duration curve. The method also includes determining a current or charge drain curve, and determining, based on the iso-safety factor strength duration curve and the current or charge drain curve, a preferred pacing parameter set that includes a preferred pulse width and a preferred pacing amplitude, which provides a specified safety margin.
A61N 1/372 - Arrangements in connection with the implantation of stimulators
A61N 1/375 - Constructional arrangements, e.g. casings
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
90.
SYSTEMS AND METHODS FOR MANAGING ATRIAL-VENTRICULAR DELAY ADJUSTMENTS
A system and method are provided for managing atrial-ventricular (AV) delay adjustments. An AV interval is measured that corresponds to an interval between an atrial paced (Ap) event or an atrial sensed (As) event and a sensed ventricular (Vs) event. A candidate AV delay is set based on the AV interval and a bundle branch adjustment (BBA) value. A QRS characteristic of interest (COI) is measured while utilizing the candidate AV delay in connection with delivering a pacing therapy. The BBA value is adjusted and the candidate AV delay is reset based on the BBA value as adjusted. A collection of QRS COIs and corresponding candidate AV delays are obtained and one of the candidate AV delays is selected as a BBA AV delay. The pacing therapy is managed, based on the BBA AV delay.
A61N 1/368 - Heart stimulators controlled by a physiological parameter, e.g. by heart potential comprising more than one electrode co-operating with different heart regions
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
An implantable biostimulator has fixation tines. A housing of the biostimulator has a longitudinal guide. A frame of the biostimulator movably engages the longitudinal guide. Fixation tines are at a distal end of the frame. Other embodiments are also described and claimed.
An implantable medical device (IMD) for managing therapy is provided that can include a lead with an electrode, a memory configured to store program instructions and one or more processors. The one or more processors can be configured to execute the program instructions to determine a sensed right atrium (RAs) event or a paced right atrial (RAp) event (RAs,p event), determine a sensed right ventricle (RVs) event by detecting a cardiac activity (CA) signal reaches a threshold amplitude and determining a maximum amplitude in a determined period of time after the CA signal reaches the threshold amplitude, and determine an RAs,p-RVs interval between the RAs,p event and RVs event. The one or more processors can also be configured to calculate an atrioventricular delay (AV) delay based on the RAs,p-RVs interval, and manage therapy, provided by the IMD, based on the AV delay that is calculated.
A61N 1/368 - Heart stimulators controlled by a physiological parameter, e.g. by heart potential comprising more than one electrode co-operating with different heart regions
93.
MEDICAL TOOL EMPLOYING A WARNING MECHANISM NOTIFYING THAT A ROTATIONAL LIMIT HAS BEEN REACHED
A medical tool includes a rotation mechanism that further includes a warning feature. The warning feature provides an indication when the rotation mechanism has achieved a number of rotations.
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
A biostimulator transport system includes an input shaft and an output shaft. The input shaft extends distally to an input gear. The output shaft extends proximally from an output gear to a biostimulator coupling. The output gear is rotationally coupled to the input gear such that rotation of the input shaft drives rotation of the biostimulator coupling. Other embodiments are also described and claimed.
Computer implemented methods and systems for detecting noise in cardiac activity are provided. The method and system obtain a far field cardiac activity (CA) data set that includes far field CA signals for a series of beats, overlay a segment of the CA signals with a noise search window, and identify turns in the segment of the CA signals. The method and system determine whether the turns exhibit a turn characteristic that exceed a turn characteristic threshold, declare the segment of the CA signals as a noise segment based on the determining operation, shift the noise search window to a next segment of the CA signal and repeat the identifying, determining and declaring operations; and modify the CA signals based on the declaring the noise segments.
A valve bypass tool, and a biostimulator transport system having such a valve bypass tool, is described. The valve bypass tool includes an annular seal to seal against a protective sheath of the biostimulator transport system. The valve bypass tool is slidably mounted on the protective sheath and includes a bypass sheath to insert into an access introducer. The valve bypass tool can lock onto the access introducer by mating a locking tab of the valve bypass tool with a locking groove of the access introducer. The locking tab can have a detent that securely fastens the components to resist decoupling when the biostimulator transport system is advanced through the access introducer into a patient anatomy. Other embodiments are also described and claimed.
A biostimulator includes a housing, an electrode extension, and an expandable frame. The housing has a longitudinal axis and an electronics compartment containing pacing circuitry. The electrode extension extends distally between the housing and an electrode. The biostimulator includes an expandable frame including several struts disposed about the longitudinal axis. Other embodiments are also described and claimed.
A biostimulator, such as a leadless cardiac pacemaker, including coaxial fixation elements to engage or electrically stimulate tissue, is described. The coaxial fixation elements include an outer fixation element extending along a longitudinal axis and an inner fixation element radially inward from the outer fixation element. One or more of the fixation elements are helical fixation elements that can be screwed into tissue. The outer fixation element has a distal tip that is distal to a distal tip of the inner fixation element, and an axial stiffness of the outer fixation element is lower than an axial stiffness of the inner fixation element. The relative stiffnesses are based on one or more of material or geometric characteristics of the respective fixation elements. Other embodiments are also described and claimed.
A catheter system for retrieving a leadless cardiac pacemaker from a patient is provided. The cardiac pacemaker can include a docking or retrieval feature configured to be grasped by the catheter system. In some embodiments, the retrieval catheter can include a snare configured to engage the retrieval feature of the pacemaker. The retrieval catheter can include a torque shaft selectively connectable to a docking cap and be configured to apply rotational torque to a pacemaker to be retrieved. Methods of delivering the leadless cardiac pacemaker with the delivery system are also provided.
A61B 17/00 - Surgical instruments, devices or methods
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
A biostimulator, such as a leadless cardiac pacemaker, including a fixation element that can be locked to a helix mount, is described. The fixation element includes a fastener that engages a keeper of the helix mount. When engaged with the keeper, the fastener locks the fixation element to the helix mount. Accordingly, the fixation element does not move relative to the helix mount when the biostimulator is delivered into a target tissue. Other embodiments are also described and claimed.
