Extravascular implant tools that utilize a bore-in mechanism to safely access extravascular locations and implant techniques utilizing these tools are described. The bore-in mechanism may include a handle and a helix extending from the handle. The bore-in mechanism is used, for example, in conjunction with a tunneling tool to traverse the diaphragmatic attachments to access a substernal location. The tunneling tool may be an open channel tunneling tool or a conventional tunneling tool (e.g., metal rod).

A delivery device for installing a medical device in a patient comprising a body portion having a proximal end and a distal end, the distal end having a chisel shaped tip, a receptacle disposed in the distal end of the body portion for receiving a medical device for implanting in the patient, a handle disposed at the proximal end of the body portion for facilitating advancement of the proximal end of the body portion into the patient.

The present disclosure is a device and method associated with the delivery of medical devices in the pericardial space using a minimally invasive approach with direct visualization. More specifically, the device can be used to deliver permanent pacing, defibrillation and cardiac resynchronization leads, as well as leadless pacemakers for cardiac rhythm management to the epicardial surface of the heart. A subxiphoid procedure is proposed as a minimally invasive alternative to thoracotomy, while the delivery tool incorporates a camera for direct visualization of the procedure. The tool also incorporates a steerable catheter to provide selective control of the placement and orientation of the medical device in the pericardial space.

A method and system for employing a medical device is disclosed. The medical device includes a housing, a processor disposed within the housing, a connector module, and a medical electrical epicardial lead connected to the processor through the connector module. The epicardial lead is used to sense a cardiac signal from tissue of a patient. The lead comprises an insulative lead body that includes a proximal end and a distal end, at least one conductor disposed in the lead body, and a side helical fixation member, disposed a distance from the distal end, the side helical fixation member. The side helical fixation member comprises a set of windings configured to wrap around the lead body circumference. The side helical fixation member includes a distal tip comprising a sharpened elongated flat free end that is perpendicular to the lead body and angled toward an inside of the set of windings.

Methods for implanting leads in the internal thoracic vein (ITV) of a patient may include first screening the patient to determine if various screening criteria are met. The screening criteria may include rib spacing, ITV location, and ITV diameter. When a predetermined parameter of at least one of the screening criteria is met, the implantation of one or more leads extending into the ITV and to a pulse generator are completed.

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.

A lead delivery system having a base for securing a lead delivery device to one or more anatomical structures of a patient and a lead advancer configured to incrementally advance a lead into a patient by a predefined amount.

Devices, systems and methods are provided for enhancing mechanical strength of tissue, allowing direct and secure access to cardiac and vascular structures, either through tiny incisions or percutaneously. The method for accessing a cardiac chamber or a vascular conduit may include providing an access channel into tissue of the chamber or the conduit. The method may also include providing an energy-transducing element configured to provide heat within the access channel. The method may further include applying energy to the tissue or a tissue-stabilizing composition injected into, around, or adjacent to the tissue to mechanically enhance the access channel.

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 curate 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.

A medical access tool includes a needle member extending along a longitudinal axis, and a coiled wire extending around the axis. An inner surface of the coiled wire, along a proximal segment thereof, is spaced radially apart from an outer surface of the needle member, and a distal segment of the coiled wire extends distally to a tissue-engaging tip of the coiled wire, a piercing distal tip of the needle member being recessed proximally from the tissue-engaging tip at a fixed distance. An operator may rotate the coiled wire to engage tissue, for example, that of a pericardial sac or a diaphragmatic attachment, which then travels proximally along the coiled wire and into contact with the needle member's distal tip, to be pierced through thereby. At least one lumen of the needle member provides a passageway through which the operator may advance a guide wire and/or inject a fluid.