The present invention provides a novel design for sheaths intended for medical procedures. The sheath includes structures that anchor the sheath in a cavity or space when deployed but are at the same time retractable such that the sheath can be removed without tearing the tissue defining the space.

A trans-atrial septal catheter system for delivery of a steerable sheath into the left atrium contains three components. The first component is a three-segmented needle-guide wire composed of a distal needle designed to flex sharply in relation to the conjoined looped guide wire segment after fossa ovalis puncture and needle advancement. The distal guide wire loops are advanced into the left atrium maintaining the angled needle in a central location relevant to the loops for preserving an atraumatic position while stabilizing the loops in the left atrium. The elongated proximal extra stiff guide wire segment is conjoined to the looped segment which crosses the fossa ovalis and extends proximally to become externalized to the femoral vein. This segment is extra stiff and significantly elongated to permit catheter and device exchanges. The guide wire serves as a support rail over which the dilator and sheath can be advanced into the left atrium. This transseptal system is uniquely forward looking and permits cautious and iterative delivery of the dilator into the fossa ovalis for “tenting” by way of a proximal sheath activator that interacts with the dilator. The proximal externalized GW is then advanced to permit puncture of the fossa ovalis. After puncturing a precise location of the fossa ovalis, the needle and coiled guide wire loops are further advanced into the left atrium. With the proximal activator, the dilator is advanced across the fossa ovalis into the left atrium using single-handed maneuvering for separate dilator advancement and steering of the sheath by way of turning or actuating the sheath handle.

A safe, reliable, reproducible system and method for entry into the pericardial sac. The method and system described generally includes penetration of the subcutaneous tissue with a guide sheath or a relatively blunt stylet contained within a sheath. The stylet is removed from the sheath and a vacuum mechanism is installed. Once in contact with the pericardium, the sheath is engaged with the pericardial tissue, allowing the vacuum mechanism to draw the pericardium away from the heart to create a greater space between the heart and pericardium allowing needle insertion onto the pericardial cavity in a much safer and controlled manner.

Steering engagement catheter devices, systems, and methods of using the same for accessing a tissue, including internal and external tissues of a heart, are disclosed. In at least one embodiment, a steering engagement catheter is provided, comprising an elongated tube having a proximal end, a distal end, and a first wall positioned circumferentially along a length of the elongated tube, the elongated tube configured such that a delivery catheter is capable of at least partial insertion into the elongated tube, at least one steering wire having a proximal end and a distal end, the distal end of the at least one steering wire coupled to the first wall of the elongated tube at or near the distal end of the elongated tube, and a controller operably coupled to the at least one steering wire at or near the proximal end of the at least one steering wire.

The present invention relates to a system comprising a flexible bag (8) for storing the drained secretion with an anti-collapse device (9), being connected on one side to a “T” valve (10) which is provided with protective lid (21) and, on the other side, to the flow control backflow preventer valve (1) consisting of a one-piece circular core (2) of elastomeric material which is secured to the housing (3), said core (2) containing a central plug (4) connected by radial rods (5) to the borderline (6) of the circular body thereof, so that said core (2) is used in two-way housings, an inlet (7) and an outlet (7′), said valve (1) composed of a one-way valve. Said system further comprising within the housing (3) a clot fractioning device (25) at the inlet and an anti-clogging device (26) from the maximum opening point of the core (2).

Devices and methods for assisting cardiac function. In an exemplary embodiment of a device for assisting heart function of the present disclosure, the device includes a first plate and an opposing second plate, each plate having an inner surface, a cardiac processor coupled to at least one of the first plate and the second plate, a bladder having an inner chamber and disposed between the inner surfaces, and a first catheter having a proximal end in communication with the inner chamber of the bladder and a distal end having a first pericardial balloon coupled thereto, wherein a gas and/or a liquid within the inner chamber of the bladder can be injected into the first pericardial balloon upon compression of the first plate relative to the second plate, and wherein the gas and/or the liquid can be removed from the first pericardial balloon upon retraction of the first plate relative to the second plate.

Medical devices and instruments, particularly pericardial access systems and devices and related methods are disclosed. Some example pericardial access devices may include a distally located, expandable skirt configured to engage the pericardium. When extended, the skirt may be wider than the tubular body of the device. Some example pericardial access devices may include an at least partially transparent, repositionable tip.

A medical device that has high pushing performance is capable of forming a hole in a biological tissue in a living body, is capable of being arbitrarily shaped, and is capable of suppressing a kink. The medical device may be used to form a hole in an oval fossa in a living body. The medical device includes: a hollow dilator made of resin; a core made of metal that is disposed in a part in a circumferential direction of the dilator and extends in a long axis direction of the dilator; and an output unit that is disposed in a distal portion of the dilator and outputs energy to form the hole in the oval fossa, in which the core is embedded in between an inner peripheral surface and an outer peripheral surface of the dilator, and the core has conductivity and is electrically connected to the output unit.

A device for the administration of substances onto the epicardial surface of the heart includes a frame structure for at least partially encircling a circumference of the heart which is able to assume shaping, positioning, guiding and stabilizing functions. The frame structure may be coupled to a heart-shaped sleeve. A substance carrier for accommodating the substance to be administered may be coupled to the device.

Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include an access sheath including an elongate body with an internal lumen to facilitate delivery of a device to a target location within a patient. The elongate body may include a distal portion having a distal opening and a plurality of curved segments configured to orient the distal opening relative to the target location.