Abstract: Techniques for remotely titrating a therapy delivered using an implantable medical device system are disclosed. An implantable medical device delivers therapy according to a first program. The system collects patient data relating to at least one of an efficacy of, or side effects resulting from, the delivered therapy, and transmits the patient data to a remote network device. A clinician may then analyze the patient data and determine if changes to the therapy are warranted. The clinician may then transmit a programming change, e.g., a modification to the first program or a new, second program, to the implantable medical device system, and the implantable medical device may deliver therapy according to the changed programming. The process of receiving patient data and modifying the therapy programming may be repeated multiple times until the therapy is adequately titrated, e.g., until the patient data indicates adequate efficacy and/or acceptable side effects.

Abstract: Systems, apparatus, methods and computer-readable storage media facilitating trusted pairing between an implantable medical device (IMD) and an external device are provided. In one embodiment, an IMD includes a housing configured to be implanted within a patient, a memory and circuitry within the housing and a processor that executes executable components stored in the memory.

Abstract: Systems and methods may monitor electrical activity of a patient's heart using electrodes during delivery of cardiac conduction system pacing therapy, generate electrical heterogeneity information (EHI) based on the monitored electrical activity during delivery of cardiac conduction system pacing therapy, and determine whether the cardiac conduction system pacing therapy would benefit from supplemental cardiac pacing therapy based on the generated EHI.

Abstract: Novel tools and techniques are provided for implementing an imaging discovery utility for augmenting clinical image management. In some embodiments, in response to receiving a request for a first medical image file(s) from a requesting device, a non-relational (“NoSQL”) data management system (“DMS”) may access a NoSQL database containing, inter alia, a plurality of medical image files that are mirrored copies of a plurality of medical image files stored in a relational (“SQL”) database, the medical image files each being organized in an image-centric hierarchy with image data being at a top level and patient information associated with the image data being at a lower level. Based on a successful search of the NoSQL database based on search terms in the request, the NoSQL DMS may identify a corresponding second medical image(s) in the SQL database, and may retrieve and send (to the requesting device) the identified second medical image(s).

Abstract: Connector enclosure assemblies for medical devices provide an angled lead passageway. The lead passageway which is defined by electrical connectors and intervening seals within the connector enclosure assembly establishes the angle relative to a base plane of the connector enclosure assembly. Various other aspects may be included in conjunction with the angled lead passageway, including an angled housing of the connector enclosure assembly, feedthrough pins that extend to the electrical connectors where the feedthrough pins may include angled sections, and a set screw passageway set at an angle relative to the lead passageway to provide fixation of a lead within the lead passageway.

Abstract: A transseptal system includes a needle, a guidewire, a handle, and a dilator. The handle defines a needle passage to slidably receive the needle, and a guidewire passage to slidably receive the guidewire. The dilator defines a lumen having a distal region and a proximal region. The dilator is coupled to the handle such that the lumen is open to the needle passage and the guidewire passage. The proximal region of the lumen is sized to simultaneously receive the needle body and the guidewire. The distal region is sized to slidably receive one of the needle and the guidewire on an individual basis. A transseptal puncture and access procedure can be performed, including puncturing tissue with the needle followed by immediate advancement of the guidewire into the accessed area, eliminating the need for multiple instrument exchanges during the procedure.

Abstract: A trial stimulation system includes a trial electrical stimulator. Additionally, systems for securing a disposable trial stimulator to the body of a patient are described, which may function to improve the durability of the system during the trial period and reduce the risk of damage or malfunction to the system due to lead/electrode dislocation and/or off-label uses like showering or bathing with the trial stimulator still secured to the body.

Abstract: A system and method for detecting and verifying bradycardia/asystole episodes includes sensing an electrogram (EGM) signal. The EGM signal is compared to a primary threshold to sense events in the EGM signal, and at least one of a bradycardia or an asystole is detected based on the comparison. In response to detecting at least one of a bradycardia or an asystole, the EGM signal is compared to a secondary threshold to sense events under-sensed by the primary threshold. The validity of the bradycardia or the asystole is determined based on the detected under-sensed events.

Abstract: An implantable medical device system and method for delivering cardiac resynchronization therapy (CRT) pacing that includes determining capture associated with the delivered CRT pacing is ineffective in response to the delivered CRT pacing. A reason for capture being ineffective is determined and a safety margin is adjusted if the determined reason for capture being ineffective is loss of capture and a left ventricle (LV) pre-excitation is adjusted if the determined reason for capture being ineffective is delayed LV depolarization. Monitoring for a change in effective cardiac resynchronization therapy is used to confirm that the adjustment of the CRT pacing was effective in resolving the ineffective capture.

Abstract: A medical device processor is configured to receive a first cardiac electrical signal sensed from a first sensing electrode vector, receive a second cardiac electrical signal sensed from a second sensing electrode vector different than the first sensing electrode vector, and construct a third cardiac electrical signal from the first cardiac electrical signal and the second cardiac electrical signal. In some examples, the system determines sensed cardiac events according to at least one setting of a cardiac event sensing threshold control parameter from at least the third cardiac electrical signal and may determine at least one acceptable setting of a sensing control parameter based on the determined sensed cardiac events. The processor may generate an output representative of the determined sensed cardiac events.

Abstract: Valve delivery catheter assemblies including components that limit trauma to the expanded prosthetic valve and body channels as the distal tip of the catheter is withdrawn through the expanded valve and thereafter from the body. Catheter assemblies according to the present invention can include a handle assembly, an introducer sheath, and a distal tip assembly. The handle assembly can include a fixed main handle and two or more rotating handles that allow a user to control the distal tip assembly of the catheter. A safety button can be included on the handle assembly to allow for precise and consistent positioning of the prosthetic valve in the body. A valve retaining mechanism can be included to assist in retaining the prosthetic valve prior to deployment.

Abstract: Systems and methods that automatically adjust, or adapt, stimulation waveforms delivered to brain structures. Closed loop system embodiments can automatically be reconfigured into a more suitable closed loop control system in response to measures of control system performance. Measures can be internal performance characteristics of the adaptive control system or external inputs provided by another subsystem. As these measures change in time, the robust adaptive system changes in response.

Abstract: A medical device is configured to determine time intervals between consecutive cardiac events sensed from a cardiac electrical signal, increase a value of a tachyarrhythmia interval count in response to each of the determine time intervals detected as a tachyarrhythmia interval. The device is further configured to detect normal sinus rhythm events and the decrease the value of the tachyarrhythmia interval count in response to a threshold number of detected normal sinus rhythm events.

Abstract: This disclosure is directed to techniques for recording and recognizing physiological parameter patterns associated with symptoms. A medical device system includes a medical device including an accelerometer configured to collect an accelerometer signal that indicates one or more patient movements that occur during a cough. Additionally, the medical device system includes processing circuitry configured to: determine whether the accelerometer signal satisfies a set of criteria corresponding to a cough pattern comprising a smooth increase from a baseline, then a sharp decrease, a peak within the sharp decrease, then a gradual return to the baseline; and identify a cough based on the determination that the accelerometer signal satisfies the set of criteria.

Abstract: In some examples, determining a heart failure status using a medical device comprising one or more sensors includes determining a first value of a heart beat variability metric of a patient while an activity state of a patient satisfies an inactivity criterion based on a signal received from the one or more sensors, and determining, within a predetermined period of time after further determining that the activity state of the patient no longer satisfies the inactivity criterion, a second value of the heart beat variability metric while the activity state of the patient no longer satisfies the inactivity criterion based on the signal. A difference between the first value of the heart beat variability metric and the second value of the heart beat variability metric may be determined and the heart failure status of the patient may be determined based on the difference.

Abstract: Techniques are disclosed for treating arrhythmias using an implantable medical device. An implantable medical device that is adapted for implantation wholly within a heart chamber of the heart of a patient may include a reservoir containing one or more therapeutically useful doses of a drug for treating an arrhythmia. The implantable medical device may include processing circuitry configured to detect an occurrence of the arrhythmia in the heart of the patient. The implantable medical device may include a valve operable to be opened in response to detecting the occurrence of the arrhythmia in the heart of the patient to release a therapeutically useful dose of the drug into the heart of the patient to treat arrhythmia of the heart.

Abstract: An intrathecal drug delivery system configured to improve dispersion of medicament with cerebral spinal fluid in a subarachnoid space of a patient. The intrathecal drug delivery system including an implantable medical pump and a catheter having a wall defining a lumen extending between a proximal end in fluid communication with the implantable pump and structure defining a medicament exit positionable within the subarachnoid space of the patient, the wall further defining at least one feature configured to generate vortices within the cerebrospinal fluid for the purpose of improving intrathecal drug dispersion.

Abstract: A system includes a medical device for implanting in a valve of a subject, the implantable medical device having a self-expanding frame; and a holder configured to retain the frame of the implantable medical device in a constricted configuration and to control expansion of the frame. The holder has a controllably constrictable and expandable loop, wherein the loop is disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.

Abstract: A recapturable external LAA exclusion clip system includes a clip comprising first and second clip struts, at least one of the struts having a connector interface comprising a first portion of a lock, and a delivery device comprising a handle and an end effector. The handle comprises jaw and lock controls. The end effector is connected to the handle and comprises a clevis and first and second jaws. The jaws are connected to the clevis and operatively connected to the jaw control to actively articulate at least one of the jaws with respect to the other. At least one of the jaws has a connector comprising a second portion of the lock operatively connected to the lock control to removably lock with the first portion of the lock. The first and second portions of the lock have a locked state and are configured to unlock the locked state upon actuation of the lock control.

Abstract: A neuromodulation therapy is delivered via at least one electrode implanted subcutaneously and superficially to a fascia layer superficial to a nerve of a patient. In one example, an implantable medical device is deployed along a superficial surface of a deep fascia tissue layer superficial to a nerve of a patient. Electrical stimulation energy is delivered to the nerve through the deep fascia tissue layer via implantable medical device electrodes.