PACESETTER, INC.

An implantable medical device is disclosed herein and can be in the form of an implantable medical lead or a leadless pulse generator. The implantable medical device includes a body, at least one electrode and a tube-cut helical fixation anchor. The body includes a distal end and a proximal end opposite the distal end. The at least one electrode is supported on the body. The tube-cut helical fixation anchor distally extends from the distal end. The tube-cut helical fixation anchor may be fixed or extendable/retractable relative to the distal end. The tube-cut helical fixation anchor may be a result of a manufacturing process comprising cutting the tube-cut helical fixation anchor from a thin-walled tubular body.

An implantable medical device includes a body and a coating. The body has a metal surface. The coating is deposited on the metal surface of the body. The coating includes a bonding layer and a polymer layer. The bonding layer includes a first layer comprising a first silane coupling agent and a second layer comprising a second silane coupling agent. The first layer is deposited on the metal surface, and the second layer is deposited on the first layer. The polymer layer is deposited on the second layer. The first silane coupling agent is capable of forming a stronger bond with the metal surface of the body than with the polymer layer. The second silane coupling agent is capable of forming a stronger bond with the polymer layer than the metal surface.

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.

An implantable medical device (IMD) is provided that can include electronic circuitry, a first sensor configured to detect a magnetic field in an environment of the IMD, and a second sensor configured to obtain environmental data. The IMD can also includes one or more processors, and a memory coupled to the one or more processors. The memory stores program instructions, wherein the program instructions are executable by the one or more processors to discriminate between a first magnet mode and a second magnet mode based on the environmental data and switch the mode of operation with the electronic circuitry based on discriminating between the first magnet mode and the second magnet mode.

A method and system for managing delivery of a respiration gated defibrillation shock from a subcutaneous implantable medical device (S-IMD) having one or more extra vascular electrodes. The method and system sense cardiac events of a heart. Additionally, the method and system utilize one or more processors to declare a shockable arrhythmia based on the cardiac events, obtain a respiration proxy signal indicative of respiration, track a respiration state related (RSR) characteristic from the respiration proxy signal, gate delivery of a high voltage (HV) shock based on occurrence of a respiration-gated (RG) trigger in connection with the RSR characteristic, and deliver the HV shock along a shocking vector between extra vascular electrodes based on the RG trigger to time delivering of the HV shock to occur during the select state within the respiration cycle.

A method and device for dynamic device based AV delay adjustment are provided. The method provides electrodes that are configured to be located proximate to an atrial (A) site and a right ventricular (RV) site. The method utilizes one or more processors, in an implantable medical device (IMD), for detecting an atrial paced (Ap) event or atrial sensed (As) event. The method determines a measured AV interval corresponding to an interval between the Ap event or the As event and a ventricular sensed event and calculates a percentage-based (PB) offset based on the measured AV interval. The method automatically dynamically adjusting an AV delay, utilized by the IMD, based on the measured AV interval and the PB offset and manages a pacing therapy, utilized by the IMD, based on the AV delay after the adjusting operation.

Described herein are methods, devices, and systems that use electrogram (EGM) or electrocardiogram (ECG) data for sleep apnea detection. An apparatus and method detect potential apnea events (an apnea or hypopnea event) using a signal indicative of cardiac electrical activity of a patient's heart, such as an EGM or ECG. Described herein are also methods, devices, and systems for classifying a patient as being asleep or awake, which can be used to selectively enable and disable sleep apnea detection monitoring, as well as in other manners.

Systems and methods described herein improve visibility of P-waves of an EGM or ECG signal segment to be displayed on a display screen. There is a determination of whether relatively small features, including the P-waves, of the ECG or EGM signal segment would be difficult to visualize if an original signal segment range of the ECG or EGM signal segment were caused to be displayed on the display screen. In response to determining that the relatively small features of the ECG or EGM signal segment would be difficult to visualize, a portion of the EGM or ECG signal segment is displayed on the display screen in a manner that magnifies the P-waves of the EGM or ECG signal segment compared to if an entirety of the EGM or ECG signal segment within the original signal segment range were instead caused to be displayed on the display screen.

Methods and devices herein are provided for managing atrial (A) pacing in connection with premature atrial contracts (PAC). The methods and devices obtain an atrial pace-on-PAC (APAC) interval and cardiac activity (CA) signals. The methods and devices are configured to: i) during a first cardiac beat; following a ventricular paced (VP) or ventricular sensed (VS) event, activate a timer for a post ventricular-atrial refractory period (PVARP) interval; and determine whether a first atrial refractory (AR) event occurs during the PVARP interval; ii) during a second cardiac beat; in response to the detecting that the first AR event occurred, initiate an APAC interval; during the APAC interval for the second cardiac beat, determine whether a second AR event occurs; and update a count of APAC events when the second AR event occurs; and iii) repeat i) and ii) for multiple cardiac beats, to track the count of APAC events.

An implantable lead is described that includes a header coupling, a helix shaft, and a fixation helix. The header coupling extends from a proximal end to a distal end thereof, and defines a central lumen from the proximal end to the distal end. The header coupling includes a base section and a distal tube section extending from the base section to the distal end. The helix shaft includes a proximal shank that extends into the central lumen of the header coupling through a distal opening of the distal tube section. The fixation helix is mounted to a distal segment of the helix shaft and is configured to penetrate tissue of a patient. A surface of the header coupling directly engages and is fixedly secured to a surface of the helix shaft, forming a sealed joint that seals the central lumen of the header coupling and prevents fluid from migrating into the central lumen of the lead.