In at least one embodiment, a medical device can comprise an elongate outer sheath that extends along a sheath longitudinal axis and defines a central lumen extending therethrough, the elongate outer sheath can comprise a proximal sheath portion and a distal sheath portion. A first guidewire can comprise a first guidewire end and a second guidewire end, the first guidewire can extend from the first and second guidewire ends through the central lumen and can form a distal looped portion. An occlusion device can be disposed at a distal end of an elongate flexible shaft. The elongate flexible shaft can extend from the proximal sheath portion through the central lumen. The occlusion device can include a guide lumen through which the first guide wire passes.

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.

A catheter delivery system is disclosed. The system includes a sheath having a bend disposed proximal to a distal end, a pigtail dilator having a loop portion in the shape of a pigtail disposed proximal to a distal end, and a straight dilator. A diameter of the loop portion is smaller than a diameter of an aortic valve and larger than a cusp of the aortic valve. The sheath and pigtail dilator are percutaneously inserted together into a blood vessel without an exchange procedure and advanced together into the left ventricle of a heart through the aortic valve without an exchange procedure.

Apparatus and methods are described herein for use in the delivery of a prosthetic mitral valve. In some embodiments, an apparatus includes an epicardial pad configured to engage an outside surface of a heart to secure a prosthetic heart valve in position within the heart. The epicardial pad defines a lumen configured to receive therethrough a tether extending from the prosthetic valve. The epicardial pad is movable between a first configuration in which the epicardial pad has a first outer perimeter and is configured to be disposed within a lumen of a delivery sheath and a second configuration in which the epicardial pad has a second outer perimeter greater than the first outer perimeter. The epicardial pad can be disposed against the outside surface of the heart when in the second configuration to secure the prosthetic valve and tether in a desired position within 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.

A surgical access system is disclosed. The surgical access system having a cannula may include a distal tip having one or more longitudinal channels distributed around a circumference of the distal tip, and one or more circumferential channels around the distal tip. The surgical access system also includes an obturator coaxially insertable within the cannula which may include a distal tip and a retractable cutting element having an actuator. The surgical access system also includes an articulation interface. The surgical access system may also include a distal tip of the cannula that may further include one or more bridges distributed circumferentially along the one or more circumferential channels of the distal tip. The obturator further may include an elongated tube and a slidable plunger element configured to control fluid flow inside the elongated tube of the obturator.

Devices, systems and methods for cardiac and vascular access configured to allow for intracardiac access to conduct medical procedures. The devices, systems and methods are particularly useful in trans-cardiac extra-corporeal membrane oxygenation (ECMO) procedures, ventricular assist procedures, cardiopulmonary bypass, or other medical procedures where intracardiac access may be required.

A surgical access assembly includes a housing, a tubular member, and a valve assembly. The tubular member extends from the housing. The valve assembly is positioned in the housing and includes a centering mechanism, a guard assembly disposed on a first side of the centering mechanism, and an instrument seal disposed on a second side of the centering mechanism. The instrument seal including petals that are arrange in an overlapping arrangement.

An access system includes a proximal handle, an overtube coupled to the handle, and an endoscope port extending through handle and overtube sized for receiving an endoscope therethrough. The overtube includes anatomic wall securing system that secures a distal portion of the overtube within a hole in the anatomic wall. The overtube is provided with a shaped distal portion or a controllably shapeable distal portion that aids in directing an endoscope inserted through the port to a particular location within the peritoneal cavity. The access system includes a system for insufflating/deflating the peritoneal space separately from the body cavity accessible via a natural orifice. The access system includes a closure system to cinch closed the hole made in the anatomical wall after the access system has been removed from the hole. Methods are provided for inserting the access system through the anatomical wall to perform intra-abdominal surgery.

Penetrative access devices for assisting users in performing any one or more of various medical procedures that require inserting a needle into a patient, such as for vascular access, pneumothorax decompression, catheterization, abscess draining, etc. In some embodiments, a penetrative access device of this disclosure is a handheld device that is fully self-contained in that it contains all of the hardware and software needed to perform the penetrative access. In some embodiments, a penetrative access device of this disclosure is a handheld device that cooperates, within a penetrative access system, with one or more devices external to the penetrative access device in providing the requisite penetrative access features. Various related methods are also disclosed, including methods of using a penetrative access device/system of the disclosure, methods of performing access operations, and methods of contactlessly calibrating needle-tip location for accurate needle-tip guidance.