A method can include engaging the pericardium of a patient at two engagement positions of the pericardium. The method can further include moving the two engagement positions of the pericardium away from each other to tension a portion of the pericardium. The method can further include advancing an access device through the tensioned portion of the pericardium to introduce the access device into the pericardial space of the patient. Other and further methods are also disclosed.

A pair of cooperating catheters are used together to provide rapid access to the Left heart for diagnostic or therapeutic interventions. The initial entry point for the catheter pair is the groin. The pair of catheters can be used to carry out an electrographic determination of the location of the Fossa Ovalis on the septum. Features on the Catheter system permit quick and reliable confirmation of the catheter location via echo or x-rays. Once across the septum the inner catheter is removed from the outer catheter and a standard intervention may be carried out through the lumen of the outer catheter.

A transseptal insertion device is provided including device housing, a pusher slidably disposed in the device housing and a guide element extending from the pusher. The device housing is configured to be inserted into the right atrium of a patient's heart and the guide element can then be advanced from the device housing and against the cardiac septum to facilitate stable puncturing of the cardiac septum by a needle carried by a catheter inserted through the device housing, to provide access to the left atrium. The guide element can be formed as a webbing or ring. The pusher and/or guide element can optionally be inflatable.

A system and method of accessing a heart of a patient is provided. A cardiac access channel is established through an apical wall of the heart to provide direct access through the apical wall to the left ventricle. A vascular access channel is established through the skin to a peripheral blood vessel. A first end of an elongate member is advanced from the outside of the apical wall through the cardiac access channel and into the left ventricle. A second end disposed opposite the first end remains outside the patient. The elongate member is drawn into and through the vascular access channel to externalize the first end of the elongate member while leaving the second end outside the apical wall of the heart.

Devices and methods are described for accessing the mediastinum without an intercostal incision and without deflating the lungs. In some embodiments, the devices and methods facilitate mediastinal access via a single percutaneous needle puncture. In some embodiments, a first puncture below the ribs or sternum, and a second puncture that is intercostal are used. Devices and methods to facilitate concurrent access to the pericardial and mediastinal spaces are also described. Multiple minimally invasive procedures are described that advantageously utilize the pericardial and mediastinal space access procedures.

An endoluminal traversing system and tissue crossing system are described wherein the access systems are controlled by actuators that allow for robotic control of system functions. The robotic system can be configured for full manual control over the actuators, full computerized control, or a combination of human and computer (AI, neural net, rule set) guidance.

An apparatus for forming a passageway through tissue includes a dilator mounted to a shaft, wherein the dilator includes a first portion, which has an increasing taper from a first outer diameter to a larger second outer diameter, and a second portion, which has a decreasing taper from the first portion to a distal end of the dilator, and which includes an external non-cutting thread formed along the decreasing taper. Lumens of the dilator and shaft provide a conduit for means to pierce through the tissue, for example, an elongate wire that includes a piercing tip. In some cases, the dilator first portion is expandable to, and contractible from, the larger second outer diameter, wherein the apparatus may include a spreading member configured to slide between the shaft and the first portion. The apparatus may be included in a system with an introducer sheath.

A method for pericardial puncture includes contacting a pericardium of a heart of a patient with an electrode of a medical device, and while the heart is in a contracted state, delivering radiofrequency energy from the electrode to puncture the pericardium. A stimulus signal can be delivered to the heart to force contraction and transient standstill of the heart in the contracted state. Electrocardiography monitoring and/or medical imaging can be used to determine when the heart is in the contracted state.

A system of medical devices includes an introducer, a puncture device, and an indicator system. The introducer has a lumen extending therethrough from a proximal end thereof a distal end thereof, and includes a first indicator electrode that faces radially inwardly toward the lumen. The puncture device has a radiofrequency puncture electrode at a distal end thereof, and a second indicator electrode that is positioned proximal of the radiofrequency puncture electrode and that faces radially outwardly.

An endoluminal punch and introducer sheath are described wherein the endoluminal punch comprises a guidewire lumen through which a user is capable of placing a guidewire. The endoluminal punch system further comprises a mechanism affixed to the hub which is capable of controlling the axial positioning of the guidewire relative to the endoluminal punch distal end. The control mechanism can be released so that the endoluminal punch can be removed from a patient while retaining the guidewire in place within the patient. The endoluminal punch introducer, including a sheath and dilator, can comprise energy emitting electrodes or transducers for cutting larger size holes in stubborn (friable, scarred, or fibrotic) tissue. In other embodiments, the endoluminal punch can comprise a guidewire or stylet, wherein the guidewire or stylet is capable of emitting energy to cut through tissue.