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
11.
SYSTEMS AND METHODS FOR MANAGING ATRIAL-VENTRICULAR DELAY
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
12.
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 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.
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 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.
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.
A biostimulator includes a body having a longitudinal axis and an electronics compartment containing pacing circuitry. The biostimulator includes a header assembly mounted on the body along the longitudinal axis. The header assembly includes a header housing having a lateral surface facing laterally outward from the longitudinal axis. The header assembly includes an electrode channel in the lateral surface. A pacing electrode extends through the electrode channel along an electrode axis. The electrode axis is substantially orthogonal to the longitudinal axis. Other embodiments are also described and claimed.
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.
Disclosed herein are implantable medical devices and systems, and methods for used therewith, that selectively perform atrial pacing at an atrial pacing rate that is faster than an intrinsic atrial rate of a patient while the patient is experiencing an atrial tachycardia or atrial fibrillation and the intrinsic atrial rate of the patient is within the specified range, to attempt to convert the arrhythmia to a normal sinus rhythm.
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
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 system for monitoring a physiologic condition of a patient including an accelerometer configured to be implanted in the patient, the accelerometer configured to obtain multi-dimensional (MD) accelerometer data along at least two axes. When executing program instructions, the one or more processors may be configured to initiate a data collection interval in connection with patient activity, obtain the MD accelerometer data during the patient activity for at least one of a select period of time or until receiving a data collection halt instruction, and calculate a travel-related (TR) parameter based on the MD accelerometer data. The one or more processors may also be configured to correlate the TR parameter with physiologic data obtained during the patient activity, and store the TR parameter and physiologic data as indicators of a current physiologic state of the patient.
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
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61B 5/0205 - Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
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
27.
CROSSTALK PROTECTION FOR USE IN MULTI-CHAMBER LEADLESS PACEMAKER SYSTEMS
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.
An implantable medical device (IMD) that includes a transceiver configured to broadcast an advertising data packet that includes a unique identifier, and to receive a scan request data packet from an external device. A memory stores program instructions, and stores an approved device list, and one or more processors are configured to execute the program instructions to identify a device identifier (ID) from the scan request data packet received, apply an advertising filter to determine if the scan request data packet is from an authorized external device based on the device ID and the approved device list, based on the determination by the advertising filter, deny transmission of a scan response data packet from the transceiver when the advertising filter determines that the scan request data packet is from an unauthorized external device, and establish a communication session with an authorized external device independent of the scan request data packet.
Methods and devices for managing establishment of a communications link between an external instrument (EI) and an implantable medical device (IMD) are provided. A method performed by the EI includes scanning one or more channels for an advertisement notice transmitted by the IMD in accordance with a scanning schedule, wherein the scanning schedule defines a temporal pattern of scanning windows that are separated by one or more scanning intervals. The method also includes changing the scanning schedule, in response to a duration of the scanning the one or more channels exceeding a predetermined threshold without a valid advertisement notice being received by the EI from the IMD, and scanning the one or more channels for the advertisement notice in accordance with the scanning schedule as changed, wherein the scanning schedule as changed defines a different temporal pattern of scanning windows that are separated by one or more scanning intervals.
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
A biostimulator includes a body having an electronics compartment containing pacing circuitry. The biostimulator includes an electrode arm pivotably coupled to the body. The electrode arm is pivotable from an undeployed state to a deployed state. A pivot angle between the electrode arm and the body is greater in the deployed state than in the undeployed state. Other embodiments are also described and claimed.
A dual chamber LP system includes an aLP and a vLP that collectively provide AAI+VVI operation, and selectively transition from the AAI+VVI operation to collectively providing coordinated dual chamber operation (e.g., DDD operation, but not limited thereto), and vice versa. While providing the AAI operation, the aLP performs atrial pacing when an intrinsic atrial event is not detected within a specified AA interval, performs atrial sensing, and inhibits the atrial pacing when the intrinsic atrial event is detected within the specified AA interval. While providing the VVI operation, the vLP performs ventricular pacing when an intrinsic ventricular event is not detected within a specified VV interval, performs ventricular sensing, and inhibits the ventricular pacing when the intrinsic ventricular event is detected within the specified VV 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
A system includes, or is for use with, an atrial leadless pacemaker (aLP) and a ventricular leadless pacemaker (vLP) configured to communicate with one another and collectively provide DDD operation when an a2v message transmitted by the aLP is successfully received by the vLP and a v2a message transmitted by the vLP is successfully received by the aLP, during a cardiac cycle. The aLP and the vLP are also configured to collectively provide VDD operation, DDI operation or VDI operation at least some times when an a2v message transmitted by the aLP is not successfully received by the vLP, and/or a v2a message transmitted by the vLP is not successfully received by the aLP. One or more processors of the system is/are configured to determine an AV synchrony metric for the period of time, and provide one or more responses based thereon. Related methods are also described.
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
An implantable medical device includes an electrode and an insulative material secured to the electrode. The electrode includes a metal substrate and a metal coating. The metal coating is disposed on an outer surface of the metal substrate. The insulative material is secured to the electrode via an adhesive that adheres to the metal coating.
A61N 1/375 - Constructional arrangements, e.g. casings
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
H01B 1/02 - Conductors or conductive bodies characterised by the conductive materialsSelection of materials as conductors mainly consisting of metals or alloys
H01B 7/04 - Flexible cables, conductors, or cords, e.g. trailing cables
34.
BIOSTIMULATOR TRANSPORT SYSTEM HAVING WELDLESS BEARING RETAINER
A transport system for delivery or retrieval of a biostimulator, such as a leadless cardiac pacemaker, is described. The biostimulator transport system includes a docking cap supported by a bearing within a bearing housing. The bearing allows relative rotation between a torque shaft connected to the docking cap and an outer catheter connected to the bearing housing. The bearing housing and the docking cap include respective bearing retainers that constrain the bearing within the bearing housing without a weld attachment. The weldless retainers of the biostimulator transport system provide a robust mechanical securement of the bearing that is not vulnerable to corrosion. Other embodiments are also described and claimed.
Embodiments reduce burden associated with analyzing EGM segments obtained from an IMD that monitors for arrhythmic episodes. Respective EGM data and respective classification data is obtained for each arrhythmic episode detected by the IMD during a period of time. A representative R-R interval or HR for each of the arrhythmic episodes is determine by the IMD, wherein a manner for determining the representative R-R interval or HR depends on the type of the arrhythmic episode, such that for at least two different types of arrhythmic episodes the manners differ. An external system(ES) obtains data from the IMD, directly or indirectly, and selects arrhythmic episode(s) for which corresponding EGM segments are to be displayed for each type of arrhythmic episode, wherein the selecting is performed based on the representative R-R intervals or HRs determined by the IMD for the arrhythmic episodes. Additional and alternative embodiments are also described herein.
A biostimulator system includes a biostimulator having a header module and a housing module. The header module includes a fixation element, a pacing electrode, and an electrical pin. The housing module includes pacing circuitry that is electrically connected to a power source, and an electrical socket to receive and electrically connect the electrical pin to the pacing circuitry. The biostimulator system includes a biostimulator transport system to deliver the header module to an interventricular septal wall and to deliver the housing module to a ventricular chamber. The modules are then electrically connected within the ventricular chamber. Other embodiments are also described and claimed.
A biostimulator and a biostimulator system for septal pacing are described. The biostimulator includes a housing having an electronics compartment containing pacing circuitry and an electrical extension having an elongated electrical conductor, wherein the electrical extension extends from a proximal extension end at the housing to a distal extension end. The biostimulator further includes a pacing extension body mounted on the distal extension end of the electrical extension. The pacing extension body includes a pacing electrode electrically coupled to the pacing circuitry through the elongated electrical conductor, a fixation mechanism, and a drive mechanism to transmit torque to the fixation mechanism. Other embodiments are also described and claimed.
Fabricating a capacitor includes forming conduits in a porous layer of material. The porous layer of material has particles that each include a dielectric on a core. The formation of the conduits causes a portion of the dielectric to convert from a first phase to a second phase. The method also includes removing at least a portion of the second phase of the dielectric from the porous layer of material.
Computer-implemented methods and systems are provided that receive, at an implantable medical device (IMD), a programming package comprising a collection of configuration change requests, transaction credentials, and a signature indicative of a source of the programming package. The transaction credentials include a first hash of the collection of configuration change requests. The IMD validates an external device as the source by decrypting the signature using a key that is uniquely associated with the external device. The IMD verifies the transaction credentials and the configuration change requests of the programming package, and generates a second hash of the collection of configuration change requests. Responsive to both (i) the second hash matching the first hash and (ii) the transaction credentials and the configuration change requests being verified, the IMD executes the collection of configuration change requests to update an operating configuration of the IMD.
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 1/372 - Arrangements in connection with the implantation of stimulators
G06F 21/34 - User authentication involving the use of external additional devices, e.g. dongles or smart cards
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 9/06 - Arrangements for secret or secure communicationsNetwork security protocols the encryption apparatus using shift registers or memories for blockwise coding, e.g. D.E.S. systems
H04L 9/30 - Public key, i.e. encryption algorithm being computationally infeasible to invert and users' encryption keys not requiring secrecy
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
40.
BIOSTIMULATOR TRANSPORT SYSTEM HAVING GRIP MECHANISM
A biostimulator transport system includes a gripper pivotably coupled to an elongated catheter body. A wedge or a pin is movable relative to the elongated catheter body. Distal movement of the wedge causes the gripper to pivot outward from a grip state to a release state. Retraction of the pin causes the gripper to pivot outward from the grip state to the release state. A biostimulator transport system includes a capsule mounted on an elongated catheter body. The capsule includes a port extending in a distal direction through a distal capsule face from a cavity to a surrounding environment. A shuttle is slidable within the cavity, and the shuttle includes a pair of prongs longitudinally aligned with the port. Other embodiments are also described and claimed.
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 450 °C to 560 °C and the duration of heating the foil to the target temperature is less than 4 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 device for loading a leadless pacemaker onto a catheter-based delivery system includes a distal portion and a proximal portion. The distal portion includes a retention feature configured to receive the leadless pacemaker. The proximal portion is proximal the distal portion and includes a funneling structure opening toward the retention feature. The distal and proximal portions of the device are configured such that, when a distal end of the catheter-based delivery system is brought towards the proximal portion of the loading device and the leadless pacemaker is retained by the retention feature, the funneling structure guides features of the distal end of the catheter-based delivery system through an opening in an attachment feature located at a proximal end of the leadless pacemaker.
A biostimulator includes a housing having an electronics compartment containing pacing circuitry. A fixation guide is mounted on the housing and includes a guide passage. A fixation element is movable through the guide passage from an undeployed state to a deployed state. In the undeployed state, a fixation tip of the fixation element is within the guide passage. In the deployed state, the fixation tip extends out of the guide passage. A biostimulator system includes the biostimulator mounted on a biostimulator transport system to deliver the biostimulator to, and extend the fixation tip into, a target anatomy. Other embodiments are also described and claimed.
System and method for declaring pause in cardiac activity comprises memory to store specific executable instructions and a convolutional neural network (CNN) model comprising a global average pooling (GAP) layer. One or more processors are configured to execute the specific executable instructions to obtain device classified arrhythmia (DCA) data sets generated by an implantable medical device (IMD) for corresponding candidate pause episodes declared by the IMD. The DCA data sets include cardiac activity (CA) signals for one or more beats sensed by the IMD. The processor(s) apply the CNN model to the DCA data sets to identify a valid subset of the DCA data sets that correctly characterizes the corresponding CA signals. A display is configured to present information concerning the valid subset of the DCA data sets.
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
45.
SYSTEM AND METHOD FOR MANAGING BLUETOOTH ENERGY ADVERTISING
Computer implemented methods and systems are provided that comprise, under control of one or more processors of a medical device, where the one or more processors are configured with specific executable instructions. The methods and systems include sensing circuitry configured to define a sensing channel to collect biological signals, memory configured to store program instructions, a processor configured to implement the program instructions to at least one of analyze the biological signals, manage storage of the biological signals or deliver a therapy, and communication circuitry configured to wirelessly communicate with at least one other implantable or external device, the communication circuitry configured to transition between a sleep state, a partial awake state and a fully awake state. When in the fully awake state, the communication circuitry is configured to execute tasks and actions associated with a communications protocol startup (CPS) instruction set that includes an advertisement scanning related (ASR) instruction subset and a non-ASR instruction subset. When in the partially awake state, the communication circuitry is configured to execute, as the ASR instruction subset, transmit advertising notices over one or more channels according to a wireless communications protocol, scan the one or more channels for a connection request from an external device. When a connection request is not received, return to the sleep state, without performing actions or tasks associated with the non-ASR instruction subset of the CPA instruction set.
H04W 4/80 - Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
H04W 48/16 - DiscoveringProcessing access restriction or access information
Described herein are methods, devices, and systems for identifying false R-R intervals, and false arrhythmia detections, resulting from R-wave undersensing or intermittent AV conduction block. Each of one or more of the R-R intervals is classified as being a false R-R interval in response to a duration the R-R interval being greater than a first specific threshold, and the duration the R-R interval being within a second specified threshold of being an integer multiple of at least X other R-R intervals for which information is obtained, wherein the integer multiple is at least 2, and wherein X is a specified integer that is 1 or greater. When performed for R-R intervals in a window leading up to a detection of a potential arrhythmic episode, results of the classifying can be used to determine whether the potential arrhythmic episode was a false positive detection.
G16H 10/65 - 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 stored on portable record carriers, e.g. on smartcards, RFID tags or CD
G16H 40/20 - 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 or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
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
G16H 70/60 - ICT specially adapted for the handling or processing of medical references relating to pathologies
47.
METHOD AND SYSTEM FOR BIVENTRICULAR OR LEFT VENTRICULAR PACING
A system and method have at least one implantable lead comprising a right ventricular (RV) electrode and one or more left ventricular (LV) electrodes, at least one processor, and a memory coupled to the at least one processor. The memory stores program instructions. The program instructions are executable by the at least one processor to determine a right ventricular to left ventricular (RV-LV) conduction time representative of a conduction time between a right ventricular (RV) paced event and one or more responsive left ventricular (LV) sensed events, determine a left ventricular to right ventricular (LV-RV) conduction time representative of a conduction time between one or more LV paced event and an RV sensed events, calculate a relation between the RV-LV conduction time and the LV-RV conduction time, and set a pacing mode of an implantable medical device to one of i) a biventricular (BiV) pacing mode and ii) an LV only pacing mode based on the relation between the RV-LV conduction time and the LV-RV conduction time.
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
48.
METHODS, SYSTEMS AND DEVICES FOR REDUCING COMMUNICATION BURDEN BETWEEN LEADLESS PACEMAKERS
An atrial leadless pacemaker (aLP), of a dual chamber leadless pacemaker system that also includes a ventricular leadless pacemaker (vLP), senses intrinsic atrial events and for each intrinsic atrial event that is sensed determines a respective atrial-to-atrial interval (AA interval) that corresponds to a duration between the intrinsic atrial event and an immediately preceding intrinsic atrial event. Additionally, the aLP, based on the determined AA intervals, selectively transmits and selectively abstains from transmitting atrial event messages to the vLP. When the aLP abstains from transmitting atrial event messages to the vLP, the aLP conserves power thereby increasing its longevity. The aLP can also be configured to operate in a similar manner for paced atrial events, to further conserve power. The vLP utilizes its VV interval timer to determine when to deliver ventricular stimulation, during those times that the aLP abstains from transmitting atrial event messages to the vLP.
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 medical device (IMD) that can include a HS sensor configured to sense heart sound (HS) signals along an axis over a first period of time and a filtering assembly configured to filter the HS signals utilizing first and second bandwidths to output first and second bandwidth HS components. The IMD can also include one or more processors that can be configured to identify a first characteristic of interest (COI) of a heartbeat from the first bandwidth HS component and identify a second COI of the heartbeat from the second bandwidth HS component. The one or more processors can also be configured to select one of the first and second bandwidths based on a comparison of the first and second COI, obtain additional HS signals during a second period of time and utilize the one of the first and second bandwidths selected to filter the additional HS signals.
A device includes an electrode stack including a plurality of conductive anodes, a plurality of conductive cathodes, a plurality of separators arranged between the conductive anodes and the conductive cathodes, and a dielectric material disposed on a surface of each of the conductive anodes. The stack has a top surface, a bottom surface, and an edge extending between the top surface and the bottom surface. A continuous electrically insulating film overlies the edge, peripheral portions of the top surface and peripheral portions of the bottom surface so that a central portion of the top surface and a central portion of the bottom surface are exposed. An electrolyte is disposed between the conductive anodes and the conductive cathodes.
Disclosed herein is an IMD configured to communicate with another IMD and/or an external device using conducted communication. The fully-differential receiver has a pair of inputs, a pair of outputs, and a plurality of active stages therebetween. The pair of inputs of the fully-differential receiver are coupled to electrodes of the IMD. The fully-differential receiver is configured to operate in first and second modes. When operating in the first mode, the fully-differential receiver draws a first amount of current and is configured to monitor for a wakeup signal within a first frequency range. When operating in the second mode, the fully-differential receiver draws a second amount of current that is higher than the first amount of current, and is configured to receive one or more message content pulses within a second frequency range that is higher than the first frequency range.
A valve bypass tool for an implantable medical device (IMD) delivery system includes a back panel and a tube connected to the back panel and extending from the back panel to a distal end of the tube. The back panel defines an inlet opening. The tube is cylindrical and the distal end of the tube is configured to dilate a seal of an access introducer. The tube defines a channel therethrough that aligns with and is open to the inlet opening in the back panel. The inlet opening and the channel of the tube are sized to receive an IMD therethrough.
Diurnal and nocturnal pacing for an implantable medical device (IMD) that includes a temperature sensor, one or more electrodes, one or more pulse generators and a control circuit is managed. A temperature signal indicative of a core body temperature is sensed at the temperature sensor. The control circuit produces first and second moving composite temperature (MCT) signals based on the temperature signal sensed over first and second periods of time, respectively, wherein the second period of time is longer than the first period of time. A current temperature signal is compared to the first and second MCT signals, and a pacing rate for pacing pulses, generated by the one or more pulse generators and delivered to the one or more electrodes, is controlled based on one or more relations between the current temperature signal, the first MCT signal and the second MCT signal.
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 strain relief surrounding a flexible conductor distal to the fixation element. A stiffness of the strain relief decreases in a distal direction. Other embodiments are also described and claimed.
A leadless biostimulator includes a housing, and distal and proximal electrodes disposed on or integrated into the housing. The distal electrode includes an electrode body and an electrode tip mounted on a distal end of the electrode body, wherein the electrode tip is electrically conductive and configured to be placed in contact with a stimulation site. The electrode tip includes a distal tip end facing a surrounding environment and opposite a proximal tip end. The electrode tip defines a tip hole extending through the electrode tip along a longitudinal axis of the housing from the distal tip end to the proximal tip end. The tip hole comprises a through hole having a first diameter at the distal tip end and a second diameter at the proximal tip end of the tip electrode, wherein the first diameter of the tip hole is less than the second diameter of the tip hole.
Devices and methods for improving conductive communication are described herein. One of the devices involved in the conductive communication can be an external device while the other device is an IMD, or both of the devices can be IMDs. In certain embodiments, a preferred conductive communication vector for use is identified based on obtained information indicative of the at least one of a physical or physiologic state of the patient within which an IMD is implanted.
Devices and methods for improving conductive communication are described herein. One of the devices involved in the conductive communication can be an external device while the other device is an IMD, or both of the devices can be IMDs. In certain embodiments, each of at least three different conductive communication vectors are used to produce a respective bitstream, and a valid bit stream is selected or produced based on the at least three bitstreams. Message data included in and/or decoded from the valid bitstream is then stored and/or used.
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
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.
A leadless biostimulator including an attachment feature to facilitate precise manipulation during delivery or retrieval is described. The attachment feature can be monolithically formed from a rigid material, and includes a base, a button, and a stem interconnecting the base to the button. The stem is a single post having a transverse profile extending around a central axis. The transverse profile can be annular and can surround the central axis. The leadless biostimulator includes a battery assembly having a cell can that includes an end boss. A tether recess in the end boss is axially aligned with a face port in the button to receive tethers of a delivery or retrieval system through an inner lumen of the stem. The attachment feature can be mounted on and welded to the cell can at a thickened transition region around the end boss. Other embodiments are also described and claimed.
A loading tool for loading a biostimulator onto a biostimulator delivery system is described. The loading tool includes a first body portion and a second body portion connected by a hinge. A latch is mounted on the first body portion, and the latch can be locked to fasten the first body portion to the second body portion. A biostimulator can be mounted in the loading tool, and a tether of a biostimulator delivery system can be inserted through a funnel in the loading tool to engage the biostimulator. An operator can use only one hand to unlock the latch, open the loading tool, and remove the loading tool from the biostimulator prior to delivering the biostimulator into a patient. Other embodiments are also described and claimed.
An implantable cardioverter-defibrillator (ICD) includes one or more capacitors, a secondary battery and a primary battery. The implantable cardioverter-defibrillator also includes a capacitor charging circuit. A controller operates the capacitor charging circuit such that the one or more capacitors are charged with electrical energy from the secondary battery or the primary battery. In some instances, the controller selects whether the capacitors are charged with electrical energy from the secondary battery or the primary battery. In some instances, the one or more capacitors are charged with electrical energy from the secondary battery and the ICD includes a charging circuit that the controller operates such that electrical energy from the primary battery recharges the secondary battery.
The battery includes an electrode assembly in an interior of an electrically insulating container. The electrode assembly includes one or more first electrodes alternated with one or more second electrodes. The container is positioned is in an interior of an electrically conducting battery case. The container being is constructed such that the battery case is not in electrical communication with the one or more first electrodes and the one or more second electrodes, and such that an electrolyte positioned in an interior of the container does not contact the battery case.
A healthcare system comprises memory configured to store program instructions, a first device data translator (DDT), a second DDT, and one or more processors. The first DDT is configured to process data from a first type of medical device. The second DDT is configured to process data from a second type of medical device that is different from the first type of medical device. The one or more processors that, when executing the program instructions, are configured to receive patient data, the patient data comprising physiological data and at least one corresponding unique device identifier (ID) associated with a first medical device, wherein the first medical device is configured to acquire the physiological data from a patient, determine whether the unique ID is associated with the first DDT or the second DDT, and route patient data associated with the first medical device to the first DDT or the second DDT that is associated with the unique ID.
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 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
64.
BIOSTIMULATOR HAVING LOW-POLARIZATION ELECTRODE(S)
A biostimulator, such as a leadless pacemaker, having electrode(s) coated with low-polarization coating(s), is described. A low-polarization coating including titanium nitride can be disposed on an anode, and a low-polarization coating including a first layer of titanium nitride and a second layer of platinum black can be disposed on a cathode. The anode can be an attachment feature used to transmit torque to the biostimulator. The cathode can be a fixation element used to affix the biostimulator to a target tissue. The low-polarization coating(s) impart low-polarization to the electrode(s) to enable an atrial evoked response to be detected and used to effect automatic output regulation of the biostimulator. Other embodiments are also described and claimed.
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.
Implementations described and claimed herein provide systems and methods for delivering and retrieving a leadless pacemaker. In one implementation, a leadless pacemaker has a docking end, and the docking end has a docking projection extending from a surface. A docking cap has a body defining a chamber. A retriever has sheaths extending with lumens distally from the chamber. A snare extends between the lumens forming a first snare loop pointing in a first direction and a second snare loop pointing in a second direction with a docking space formed therebetween. The snare is movable between an engaged position and a disengaged position by translating the first snare wire and the second snare wire within the first snare lumen and the second snare lumen. The engaged position includes the first snare wire and the second snare wire tightened around the docking projection within the docking space.
Systems, devices, and methods are disclosed herein, wherein a first implantable medical device (IMD) uses normal conductive communication to transmit message(s) intended for a second IMD, during a first period of time that a first trigger event is not detected. The first IMD, in response to detecting the first trigger event, starts a timer or counter and transitions to using boosted conductive communication to transmit one or more messages intended for the second IMD during a second period of time. In response to the first IMD either detecting a second trigger event, or detecting based on the timer or counter that a specified amount of time or cardiac cycles elapsed since the timer or counter was started, the first IMD transitions back to using normal conductive communication to transmit one or more messages intended for the second IMD during a third period of time. Other embodiments are also disclosed herein.
Systems and methods for improving conducted i2i communication between first and second implantable medical device (IMDs) are described, wherein at least one of the IMDs comprises a leadless pacemaker (LP). Respective information is stored within each of the first and second IMDs that specifies a primary communication window (PCW) for performing the conducted communication with one another when using a primary conducted communication protocol (PCCP), and also specifies an alternate communication window (ACW) for performing the conducted communication with one another when using an alternate conducted communication protocol (ACCP). At least one of the first and second IMDs monitors quality metric of the conducted communication therebetween while the PCCP is being used, and in response to the quality metric falling below a corresponding threshold, the first and second IMDs perform conducted i2i communication with one another in accordance with the ACCP during the ACW of one or more cardiac cycles.
Described herein are methods, devices, and systems that monitor heart rate and/or for arrhythmic episodes based on sensed intervals that can include true R-R intervals as well as over-sensed R-R intervals. True R-R intervals are initially identified from an ordered list of the sensed intervals by comparing individual sensed intervals to a sum of an immediately preceding two intervals, and/or an immediately following two intervals. True R-R intervals are also identified by comparing sensed intervals to a mean or median of durations of sensed intervals already identified as true R-R intervals. Individual intervals in a remaining ordered list of sensed intervals (from which true R-R intervals have been removed) are classified as either a short interval or a long interval, and over-sensed R-R intervals are identified based on the results thereof. Such embodiments can be used, e.g., to reduce the reporting of and/or inappropriate responses to false positive tachycardia detections.
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.
Preparing a battery electrode includes preparing a slurry having a solid content less than 80 wt %. The slurry includes ingredients in one or more solvents. The ingredients are components of an active medium of the battery electrode. The slurry is mixed so as to apply a shear rate higher than 94200/minute to the slurry and form a mixed slurry. The ingredients are separated from the one or more solvents in the mixed slurry. The ingredients are applied to a current collector after the ingredients are separated from the one or more solvents in the mixed slurry.
Shocking electrodes for implantable medical devices may include a coiled conductor that has an oblong cross-sectional shape and is configured to deliver high-voltage shocks for defibrillation therapy. The coiled conductor includes an electrically conductive element that is helically wrapped and defines the oblong cross-sectional shape. The electrically conductive element is one of (i) a multi-filar ribbon wire that includes multiple strands disposed side-by-side along a length of the multi-filar ribbon wire, (ii) a micro-coil that includes a coiled strand, or (iii) a micro-cable that includes multiple interwoven strands along a length of the micro-cable.
Methods, devices and program products are provided for managing a pacing therapy using an implantable medical device (IMD). The methods, devices and program products sense cardiac activity (CA) signals at electrodes located proximate to multiple left ventricular (LV) sites and a right ventricular (RV) site of the heart and utilizing one or more processors to measure activation times between the multiple LV sites and the RV site based on the CA signals. The processors program an order of activation for the multiple LV sites based on the activation times and identify an RV activation time and a septum activation time based on the CA signals. The processors calculate a septum to RV activation time (SRAT) based on the RV and septum activation times and program an AVSRAT delay based on the SRAT.
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 1/375 - Constructional arrangements, e.g. casings
74.
Laser drilling of metal foils for assembly in an electrolytic capacitor
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.
A biostimulator and a biostimulator transport system for deep septal pacing. The biostimulator includes a housing having a longitudinal axis and containing pacing circuitry in an electronics compartment. A fixation element and a pacing element are connected to the housing. The pacing element is longitudinally movable relative to the fixation element. Other embodiments are also described and claimed.
Disclosed herein is a catheter for delivering an implantable medical lead to an implantation site near an ostium leading to a proximal region of a coronary sinus. The catheter includes a distal end, a proximal end opposite the distal end, a tubular body extending between the distal and proximal ends, an atraumatic fixation structure defining a distal termination of the distal end, and a lead receiving lumen. The atraumatic fixation structure is configured to enter the ostium and passively pivotally anchor with the proximal region of the coronary sinus. The lead receiving lumen extends along the tubular body from the proximal end to an opening defined in a side of the tubular body near the distal end and proximal the atraumatic fixation structure.
Implementations described and claimed herein provide systems and methods for delivering and retrieving a leadless pacemaker. In one implementation, a leadless pacemaker has a docking end, and the docking end having a docking projection extending from a surface. A docking cap has a body defining a chamber. The docking cap has a proximal opening into the chamber. The proximal opening is coaxial with a longitudinal axis of a lumen of a catheter. A retriever has a flexible grasper with a first arm disposed opposite a second arm. Each of the first arm and the second arm form a hinge biased radially outwards from the longitudinal axis. The docking cap locks the first arm and the second arm on the docking projection when the body is sheathed over the retriever until the flexible grasper is disposed within the chamber.
A lead of an implantable medical device (IMD) includes a shocking electrode configured to deliver high-voltage shocks for defibrillation therapy. The shocking electrode includes a base structure that has an oblong cross-sectional shape with a first side and a second side that is opposite the first side. The base structure has a set of grooves defined along the first side. The grooves in the set are configured to receive a cable assembly that is placed into the grooves in a side-loading direction.
Methods and systems are provided that comprise: sensing cardiac events of a heart; utilizing one or more processors to perform: declaring a ventricular fibrillation (VF) episode based on the cardiac events charging a single charge storage capacitor; delivering a multi-phase VF therapy that includes phase I and phase II therapies, wherein: a) during the phase I therapy, a combination of two or more medium voltage (MV) shocks are delivered entirely from the single charge storage capacitor; and b) during the phase II therapy, a low voltage pulse train is delivered at least partially from the single charge storage capacitor. Methods and systems are provided that comprise delivering first and second pulses of at least a first biphasic shock, wherein a parallel-series reconfiguration circuit connects and configures the capacitors of the capacitor bank in a parallel configuration to deliver a parallel biphasic shock; connecting the capacitors of the capacitor bank in a series configuration; and delivering first and second pulses of a second biphasic shock while the capacitors are connected in series to deliver a series biphasic shock.
The capacitor has an electrode stack with faces between one or more edges. A bent portion of the one or more edges has a bend in the one or more edges. An adhesive film is positioned on the electrode stack such that an edge region of the adhesive film is over the bent portion of the one or more edges. The adhesive film includes multiple flaps. The multiple flaps include a first flap connected to a first portion of the edge region and a second flap connected to a second portion of the edge region. The first flap and the second flap are positioned over a first one of the faces of the electrode stack. A lateral edge of the first flap intersects a lateral edge of the second flap at a common location.
An implantable medical device (IMD) includes one or more sensing circuits configured to sense one or more physiological characteristics and to generate physiological data indicative of the one or more physiological characteristics. An input is configured to receive a trigger. Responsive to receiving the trigger, a continuous data collection mode (CDCM) comprising a predetermined sampling rate is enabled. Physiological data is continuously generated. The physiological data is continuously stored in a buffer memory at the predetermined sampling rate for a duration of a collection session associated with the CDCM. The amount of data stored in the buffer memory during the collection session, including the physiological data, exceeds a capacity of the buffer memory. Connect and transmit operations are performed at a periodic communication interval during the collection session to connect with the external device and transmit at least a portion of the physiological data stored in the buffer memory.
The present disclosure provides systems and methods for confirming cardiac events based on heart sounds. An implantable medical device includes a sensing component configured to acquire a signal, and a processing component communicatively coupled to the sensing component, the processing component configured to receive the signal from the sensing component, analyze the received signal to detect the presence or absence of at least one heart sound, and confirm whether an initial detection of a cardiac event is accurate based on the detected presence or absence of the at least one heart sound.
An implantable medical device, external device and method for managing a wireless communication are provided. The IMD includes a transceiver configured to communicate wirelessly, with an external device (ED), utilizing a protocol that utilizes multiple physical layers. The transceiver is configured to transmit information indicating that the transceiver is configured with first, second, and third physical layers (PHYs) for wireless communication. The IMD includes memory configured to store program instructions. The IMD includes one or more processors configured to execute instructions to obtain an instruction designating one of the first, second and third PHY to be utilized for at least one of transmission or reception, during a communication session, with the external device and manage the transceiver to utilize, during the communication session, the one of the first, second and third PHY as designated.
A pacing device, such as a pacing lead or a biostimulator, includes a tip electrode electrically connected to an electrical conductor. The electrical conductor conveys pacing impulses from pacing circuitry to the tip electrode. The tip electrode extends along a spiral axis and has a surface that, at a position along the spiral axis, includes an insulative portion and a conductive portion. Other embodiments are also described and claimed.
A biostimulator, such as a leadless cardiac pacemaker, having a flexible circuit assembly, is described. The flexible circuit assembly is contained within an electronics compartment between a battery, a housing, and a header assembly of the biostimulator. The flexible circuit assembly includes a flexible substrate that folds into a stacked configuration in which an electrical connector and an electronic component of the flexible circuit assembly are enfolded by the flexible substrate. An aperture is located in a fold region of the flexible substrate to allow a feedthrough pin of the header assembly to pass through the folded structure into electrical contact with the electrical connector. The electronic component can be a processor to control delivery of a pacing impulse through the feedthrough pin to a pacing tip. Other embodiments are also described and claimed.
System and methods are provided for determining a stimulation threshold for closed loop spinal cord stimulation (SCS). The system and methods provide a lead coupled to an implantable pulse generator (IPG). The system and methods deliver SCS pulses from the IPG to the lead electrodes in accordance with an SCS therapy and determine an evoked compound action potential (ECAP) amplitude based on an ECAP waveform resulting from the SCS therapy. The system and methods increase the SCS therapy by increasing at least one of an amplitude, a duration, and number of the SCS pulses associated with the SCS therapy. The system and methods also include iteratively repeat the delivering, determining and increasing operations until the ECAP amplitude exhibits a downward trend divergence. The system and methods define a stimulation threshold based on the ECAP amplitude at the trend divergence.
An implantable medical device (IMD) is provided that includes one or more processors and a memory coupled to the one or more processors, wherein the memory stores program instructions. The program instructions are executable by the one or more processors to obtain an initial capacitor maintenance time interval for performing maintenance on a capacitor of the IMD, obtain characteristics of interest related to at least one of the capacitor or the patient, and adjust the initial capacitor maintenance time interval to a first adjusted capacitor maintenance time interval based on the characteristics of interest.
An implantable medical device (IMD) and process are provided comprising one or more electrodes configured to be implanted to define a pacing vector through at least a portion of a ventricle. Sensing circuitry is configured to sense intrinsic atrial activity (As) and intrinsic ventricular activity (Vs). A pulse generator (PG) if provided, and memory configured to store program instructions and an atrioventricular delay search parameter (AVDSEARCH). The AVDSEARCH is an interval of time. One or more processors, that when executing the program instructions, is configured to direct the PG to deliver ventricular pacing pulses based on an atrioventricular delay (AVD) and periodically initiate an AVD search operation utilizing the AVDSEARCH. A heart rate is determined and compared to a threshold. Responsive to determining that the heart rate exceeds the threshold, the AVDSEARCH is reduced, and cardiac activity is detected during the AVD search operation utilizing the reduced AVDSEARCH.
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 1/365 - Heart stimulators controlled by a physiological parameter, e.g. by heart potential
A capacitor has an anode with one or more active layers that each includes fused particles positioned on a current collector. The current collector includes tunnels that extend from a first face of the current collector to a second face of the current collector.
A system is provided that includes a lead configured to be located within a septal wall, a monitor configured to obtain cardiac activity signals, and a memory configured to store program instructions. The system also includes one or more processors that, when executing the program instructions, are configured to obtain morphology data related to the cardiac activity signals indicative of the lead located at different depths within the septal wall, the morphology data including a set of data values associated with different depths of the lead within the septal wall, and determine when the lead is located at a target depth within the septal wall based on the morphology data.
A system is provided that includes a lead configured to be located within a septal wall, a monitor configured to obtain cardiac activity signals, and a memory configured to store program instructions. The system also includes one or more processors that, when executing the program instructions, are configured to obtain morphology data related to the cardiac activity signals indicative of the lead located at different depths within the septal wall, the morphology data including a set of data values associated with different depths of the lead within the septal wall, and determine when the lead is located at a target depth within the septal wall based on the morphology data.
The present disclosure provides systems and methods for applying anti-tachycardia pacing (ATP) using subcutaneous implantable cardioverter-defibrillators (SICDs). An SICD implantable in a subject includes a case including a controller, and at least one conductive lead extending from the case. The at least one conductive lead includes a plurality of coil electrodes, wherein the SICD is configured, via the controller, to apply anti-tachycardia pacing (ATP) to the subject using the at least one conductive lead.
A healthcare system comprises an MR platform comprising non-transitory memory storing program instructions and patient specific records that include information associated with an implantable medical device (IMD) and a patient. The MR platform has processors that, when executing the program instructions, are configured to i) receive an MRI exam referral requesting an MRI exam associated with a first patient specific record from within the patient specific records that has a first IMD and a first patient; ii) responsive to the MRI exam referral, automatically transmit an MRI exam request alert; iii) responsive to receiving a response to the MRI exam request alert, provide access to the first patient specific record; iv) receive MRI settings associated with the first patient specific record that are configured to be programmed into the first IMD in advance of the MRI exam; and v) store the MRI settings in the patient specific record.
G16H 10/65 - 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 stored on portable record carriers, e.g. on smartcards, RFID tags or CD
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
94.
IMPLANTABLE LEAD HAVING VARIABLE ELECTRODE SPACING
An implantable lead includes an inner lead subassembly contained within and movable relative to an outer lead subassembly. The inner lead subassembly has a helical electrode to pace a target anatomy. The outer lead subassembly includes a ring electrode to sense or pace the target anatomy. A threaded interface interconnects the inner lead subassembly and the outer lead subassembly such that relative rotation of the lead subassemblies causes relative axial movement between the helical electrode and the ring electrode. Other embodiments are also described and claimed.
A leadless cardiac pacemaker is provided which can include any number of features. In one embodiment, the pacemaker can include a tip electrode, pacing electronics disposed on a p-type substrate in an electronics housing, the pacing electronics being electrically connected to the tip electrode, an energy source disposed in a cell housing, the energy source comprising a negative terminal electrically connected to the cell housing and a positive terminal electrically connected to the pacing electronics, wherein the pacing electronics are configured to drive the tip electrode negative with respect to the cell housing during a stimulation pulse. The pacemaker advantageously allows p-type pacing electronics to drive a tip electrode negative with respect to the can electrode when the can electrode is directly connected to a negative terminal of the cell. Methods of use are also provided.
Methods, devices, and program products are provided under control of one or more processors within an implantable medical device (IMD) that senses far field (FF) signals between a combination of electrodes coupled to the IMD. Correlation scores are determined by comparing the FF signals associated with a number of beats to a template. The correlation scores of the number of beats are compared to a correlation threshold, and correlation variability scores are determined for the number of beats. Shock delivery, by a pulse generator within the IMD, is postponed in response to i) a first number of beats within the number of beats having the correlation scores that are less than the correlation threshold, and ii) a second number of beats within the number of beats having correlation variability scores that are less than a correlation variability threshold.
A system is provided that includes a first electrode configured to be located within a septal wall, and a second electrode configured to be located outside of the septal wall. The system also includes an impedance circuit configured to measure impedance along an impedance monitoring (IM) vector between the first and second electrodes. One or more processors are also provided that are configured to obtain impedance data indicative of an impedance along the IM vector with the first electrode located at different depths within the septal wall, the impedance data including a set of data values associated with different depths of the first electrode within the septal wall. The one or more processors are also configured to determine when the first electrode is located at a target depth within the septal wall based on the impedance data.
A leadless biostimulator, such as a leadless cardiac pacemaker, having a header assembly that includes overmolded components, is described. The header assembly includes a helix mount overmolded on a flange of an electrical feedthrough assembly. A fixation element is mounted on the helix mount. The overmolded helix mount fills a recess in an outer surface of the flange to robustly join the header assembly components. The electrical feedthrough assembly includes an electrode contained within the flange to deliver electrical impulses to a target anatomy, and an insulator that separates the electrode from the flange. The overmolded helix mount can conform or adhere to the outer surfaces of the flange and the insulator to electrically isolate the electrode from the flange. Other embodiments are also described and claimed.
A biostimulator, such as a leadless cardiac pacemaker, including a fixation element and an electrode mounted on a resilient scaffold, is described. The fixation element and the resilient scaffold are coupled to a housing of the biostimulator. The resilient scaffold can support the electrode against a target tissue at a location that is radially offset from a location where the fixation element anchors the housing to the target tissue. A flexibility of the resilient scaffold allows the electrode to conform to a shape and movement of the target tissue when the housing is rigidly fixed to the target tissue by the fixation element. The resiliently supported electrode that is radially offset from the anchor point can reliably pace the target tissue without piercing the target tissue. Other embodiments are also described and claimed.
A subcutaneous implantable medical device and method (SIMD) provided. A pulse generator (PG) is configured to be positioned subcutaneously within a lateral region of a chest of a patient. The PG has a housing that includes a PG electrode. The PG has an electronics module. An elongated lead is electrically coupled to the pulse generator. The elongated lead includes a first electrode that is configured to be positioned along a first parasternal region proximate a sternum of the patient and a second electrode that is configured to be positioned at an anterior region of the patient. The first and second electrodes are coupled to be electrically common with one another. The electronics module is configured to provide electrical shocks for antiarrhythmic therapy along at least one shocking vector between the PG electrode and the first and second electrodes.
