Abstract: Devices and methods are provided for less-invasive surgical treatment of cardiac valves whereby the need for a gross thoracotomy or median sternotomy is eliminated. In one aspect of the invention, a delivery system for a cardiac valve prosthesis such as an annuloplasty ring or prosthetic valve includes an elongated handle configured to extend into the heart through an intercostal space from outside of the chest cavity, and a prosthesis holder attached to the handle for releasably holding a prosthesis. The prosthesis holder is attached to the handle in such a way that the holder, prosthesis and handle have a profile with a height smaller than the width of an intercostal space when the adjacent ribs are unretracted, preferably less than about 30 mm.

Abstract: A process for inducing cardioplegicarrest of a heart in situ in a patient's body, comprising maintaining the patient's systemic circulation by peripheral cardiopulmonary by-pass, occluding the ascending aorta through a percutaneously placed arterial balloon catheter, venting the left side of the heart, and introducing a cardioplegic agent into the coronary circulation. This procedure readies the heart for a variety of surgical procedures that can be performed percutaneously through lumina in the catheter. An aortic catheter for use in the process is also described.

Abstract: A trocar which is particularly suited for use as a thoracic trocar. The trocar includes a number of arms at the distal end which are movable from a closed position, which is used for inserting the trocar into the patient, to a second position, which is used for locking the trocar to the patient. The arms may be naturally biased to the open position or may be moved by mechanical actuation.

Abstract: A method for closed-chest cardiac surgical intervention relies on viewing the cardiac region through a thoracoscope or other viewing scope and endovascularly partitioning the patient's arterial system at a location within the ascending aorta. The cardiopulmonary bypass and cardioplegia can be induced, and a variety of surgical procedures performed on the stopped heart using percutaneously introduced tools. The method of the present invention will be particularly suitable for forming coronary artery bypass grafts, where an arterial blood source is created using least invasive surgical techniques, and the arterial source is connected to a target location within a coronary artery while the patient is under cardiopulmonary bypass and cardioplegia.

Abstract: The invention provides a percutaneous visualization system for direct, stereoscopic visualization of a body cavity during minimally-invasive surgical procedures. The visualization system includes a cannula having a distal end, a proximal end, and a passage extending therebetween. The passage is configured to allow stereoscopic vision therethrough, and is preferably tapered from the proximal end to the distal end. A sleeve is positionable in the passage of the cannula, the sleeve having an optical passage also configured to allow stereoscopic vision, preferably by tapering. A lens may be disposed in the optical passage of the sleeve for wide-angle viewing. Magnification means may be positioned in optical alignment with the optical passage to provide a magnified image of a surgical site.

Abstract: An endovascular system for arresting a patient's heart and maintaining the patient on cardiopulmonary bypass. A venous cannula, venting catheter and an aortic occlusion device are all coupled together so that the blood drawn into each of these catheters may be fed to a pump. A manifold has valves which control flows through the venous cannula, venting catheter and aortic occlusion device. A blood storage element is also provided so that the amount of blood in the perfusion circuit may be varied if necessary. The blood storage element is preferably positioned in parallel with the pump so that the pump may be used to add and remove blood to and from the blood storage element.

Abstract: A surgical instrument comprises a shaft, a clamp support at a distal end of the shaft, and a clamp comprising a pair of pivotally mounted jaws within the clamp support. A handle at a proximal end of the shaft comprises an actuator for both opening and closing the jaws of the clamp and for rotating the jaws of the clamp about a deflected axis defined by the clamp support. The actuator includes a lever and a rotatable wheel which are coupled to the clamp via a flexible drive cable extending through the shaft and clamp support. The device is particularly useful for manipulating and driving curved surgical needles in thoracoscopic, laparoscopic, and other endoscopic suturing procedures.

Abstract: A stapler for stapling a tubular structure to another structure. The stapler has an anvil which is expandable from a collapsed position to an expanded position. The stapler has a recess which receives at least a portion of the tubular structure and a shoulder which receives an everted end of the tubular structure. A first actuator moves the anvil relative to the shoulder for compressing the structures which are to be stapled together. A second actuator is used for driving the staples through the structures to be stapled together.

Abstract: Devices, systems, and methods are provided for accessing the interior of the heart and performing procedures therein while the heart is beating. In one embodiment, a tubular access device having an inner lumen is provided for positioning through a penetration in a muscular wall of the heart, the access device having a means for sealing within the penetration to inhibit leakage of blood through the penetration. The sealing means may comprise a balloon or flange on the access device, or a suture placed in the heart wall to gather the heart tissue against the access device. An obturator is removably positionable in the inner lumen of the access device, the obturator having a cutting means at its distal end for penetrating the muscular wall of the heart. The access device is preferably positioned through an intercostal space and through the muscular wall of the heart.

Abstract: A venting catheter, system and method are provided for withdrawing blood and other fluids from a patient's heart to facilitate decompressing the heart during cardioplegic arrest and cardiopulmonary bypass, without the need for a thoracotomy and without puncturing the aorta, pulmonary artery, or heart itself. The venting catheter is configured to be introduced into a peripheral vein and intralumninally advanced through the right side of the heart and into the pulmonary artery. The venting catheter includes a lumen configured to withdraw blood at a rate of at least about 50 ml/min at a pressure of no less than about -350 mmHg. A flow-directing means is provided to facilitate guiding the catheter into the pulmonary artery by being carried by blood flow through the heart. The cardiac venting system may include, in addition to the cardiac venting catheter, a cardiopulmonary bypass system to maintain circulation of oxygenated blood, and means for arresting the patient's heart.

Abstract: retrograde delivery catheter includes at its distal end a balloon configured to occlude the coronary sinus of a patient's heart, and has a length and flexibility which allow the distal end to be positioned in the coronary sinus with the proximal end extending transluminally to a peripheral vein such as an internal jugular vein and out of the body through a puncture therein. The delivery catheter has a delivery lumen extending between its proximal and distal ends which is configured to allow a cardioplegic fluid to be delivered at a flow rate of at least 200 ml/min with a pump pressure less than 300 mm Hg, thereby allowing cardioplegic arrest to be maintained using a blood cardioplegic fluid without causing excessive hemolysis.

Abstract: A method and device for introduction of a catheter and/or delivering a fluid, such as oxygenated blood, to a patient's vascular system includes a cannula having an expandable portion. The expandable portion is movable from a collapsed position to an expanded position. The expandable portion is inserted into the patient in the collapsed position which facilitates introduction and advancement of the cannula through the patient's blood vessel. After introduction into the patient, the expandable portion is moved to the expanded position. The expandable portion protects the blood vessel against fluid forces when flowing a fluid through the cannula and protects the vessel from contact with the catheter advanced through the cannula.

Abstract: A system for performing an end-to-side vascular anastomosis, including an anastomosis device, an application instrument and methods for performing a vascular anastomosis. The system is applicable for performing an anastomosis between a vascular graft and the ascending aorta in coronary artery bypass surgery, particularly in port-access CABG surgery. A first aspect of the invention includes a vascular anastomosis staple. A first configuration has two parts: an anchor member, forming the attachment with the target vessel wall and a coupling member, forming the attachment with the bypass graft vessel. The anastomosis is completed by inserting the coupling member, with the graft vessel attached, into the anchor member. A second configuration combines the functions of the anchor member and the coupling member into a one-piece anastomosis staple.

Abstract: Methods and apparatus for thoracoscopic defibrillation of a patient's heart. The technique involves introducing a first electrode (10) through a percutaneous intercostal penetration, positioning the first electrode against the heart surface (H) and positioning a second electrode (10') against the patient's body. A voltage is then applied through the percutaneous intercostal penetration to the first electrode and to a second electrode to deliver electrical energy to the first electrode, through at least a portion of the patient's heart, and to the second electrode. The electrical energy applies an electric charge to the patient's heart to defibrillate the heart muscle or restart the heart during, for example, cardiac procedures that involve arresting the heart.

Abstract: A valve sizer having a movable element mounted to the distal end of a shaft. A valve sizing portion includes the movable element so that the valve sizing portion may be adjusted to correspond to a number of different available replacement valve sizes. An indicator mounted to the proximal end of the shaft indicates the valve size corresponding to the outer dimension of the valve sizing portion.

Abstract: A system for accessing a patient's cardiac anatomy which includes an endovascular aortic partitioning device that separates the coronary arteries and the heart from the rest of the patient's arterial system. The endovascular device for partitioning a patient's ascending aorta comprises a flexible shaft having a distal end, a proximal end, and a first inner lumen therebetween with an opening at the distal end. The shaft may have a preshaped distal portion with a curvature generally corresponding to the curvature of the patient's aortic arch. An expandable means, e.g. a balloon, is disposed near the distal end of the shaft proximal to the opening in the first inner lumen for occluding the ascending aorta so as to block substantially all blood flow therethrough for a plurality of cardiac cycles, while the patient is supported by cardiopulmonary bypass. The endovascular aortic partitioning device may be coupled to an arterial bypass cannula for delivering oxygenated blood to the patient's arterial system.

Abstract: The present invention provides a method and end-to-side surgical anastomosis apparatus for stapling an end of a tubular tissue structure to a side of a luminal structure including an elongated housing defining a central bore extending longitudinally therethrough. The elongated housing further includes an eversion support surface extending circumferentially about the bore opening adjacent the distal end which is configured to retain and support an everted end of the received tissue structure thereon to face an intimal surface of the tissue structure in an outward direction. The anastomosis apparatus further includes an anvil having a fastener engaging surface, and a compression device having a shoulder portion formed for selectively compressing the everted end of the tissue structure and a surface of the luminal structure together against the fastener engaging surface.

Abstract: A process for forming a multi-lumen catheter which includes the steps of providing a multi-lumen first tube, winding a flexible filament onto the first multi-lumen tube, and positioning a second tube over the wound filament layer of the first tube is disclosed for manufacturing the multi-lumen catheter. The second tube is melted and bonded to the first tube and an occluding member is mounted onto the second tube to occlude a patient's ascending aorta when the occluding member is expanded.

Abstract: A system for accessing a patient's cardiac anatomy which includes an endovascular aortic partitioning device that separates the coronary arteries and the heart from the rest of the patient's arterial system. The endovascular device for partitioning a patient's ascending aorta comprises a flexible shaft having a distal end, a proximal end, and a first inner lumen therebetween with an opening at the distal end. The shaft may have a preshaped distal portion with a curvature generally corresponding to the curvature of the patient's aortic arch. An expandable means, e.g., a balloon, is disposed near the distal end of the shaft proximal to the opening in the first inner lumen for occluding the ascending aorta so as to block substantially all blood flow therethrough for a plurality of cardiac cycles, while the patient is supported by cardiopulmonary bypass. The endovascular aortic partitioning device may be coupled to an arterial bypass cannula for delivering oxygenated blood to the patient's arterial system.

Abstract: An elongate member is coated with a coating, preferably by coextrusion, and the coated elongate member is wound in a helical manner around a mandrel. The coated elongate member preferably has a square cross-sectional shape so that adjacent portions of the coated elongate member engage one another when the coated elongate member is wound around the mandrel. The coated elongate member is then heated so that the coating on adjacent portions of the coated elongate member fuse together to form an integral strcucture. Another layer of material may be provided on the radially inner or outer wall of the coated elongate member.