Abstract: A valve prosthesis (9) for implantation in the body by use of catheter (11) comprises a stent made from an expandable cylinder-shaped thread structure (2,3) comprising several spaced apices (4). The elastically collapsible valve (6) is mounted on the stent as the commissural points (5) of the valve (6) is secured to the projecting apices (4). The valve prosthesis (9) can be compressed around the balloon means (13) of the balloon catheter (11) and be inserted in a channel, for instance in the aorta (10). When the valve prosthesis is placed correctly the balloon means (13) is inflated thereby expanding the stent and wedging it against the wall of the aorta. The balloon means is provided with beads (14) to ensure a steady fastening of the valve prosthesis on the balloon means during insertion and expansion. The valve prosthesis (9) and the balloon catheter (11) make it possible to insert a cardiac valve prosthesis without a surgical operation comprising opening the thoracic cavity.

Abstract: A method for delivering a therapeutic agent directly to the heart employing minimally invasive techniques and concepts. In particular, the delivery of vascular endothelial growth factors (VEGF) is performed endovascularly or endoscopically to a region of a patient's heart treated with transmyocardial revascularization (TMR). A system is provided for inducing cardioplegic arrest. An aortic occlusion device has an inflatable balloon which occludes the ascending aorta when inflated. Cardioplegic fluid may be infused through a lumen of the aortic occlusion device to stop the heart while the patient's circulatory system is supported on cardiopulmonary bypass. A side-firing fiberoptic laser is introduced through the aortic occlusion device in the endovascular technique to perform TMR. Subsequently, a therapeutic agent delivery catheter is directed into one of the coronary arteries to deliver and dissipate the VEGF into the surrounding vascular plexus to promote angiogenesis stimulation.

Abstract: The invention provides a system and method for performing less-invasive surgical procedures within a body cavity. In a preferred embodiment, the invention provides a system and method for isolating a surgical site such as an anastomosis between an internal mammary artery and a coronary artery in a thoracoscopic coronary artery bypass grafting procedure. The system comprises a foot (11) pivotally coupled to the distal end of a shaft (3) by a linkage (13). The foot has first and second engaging portions (15, 17) with contact surfaces for engaging a tissue surface. The engaging portions are movable between an open position, where the contact surfaces are separated by a gap, and a collapsed position, where the foot is configured for delivery through the percutaneous penetration.

Abstract: A valve prosthesis (9) for implantation in the body by use of catheter (11) comprises a stent made from an expandable cylinder-shaped thread structure (2,3) comprising several spaced apices (4). The elastically collapsible valve (4) is mounted on the stent as the commissural points (5) of the valve (6) are secured to the projecting apices (4).The valve prosthesis (9) can be compressed around the balloon means (13) of the balloon catheter (11) and be inserted in a channel, for instance in the aorta (10). When the valve prosthesis is placed correctly the balloon means (13) is inflated thereby expanding the stent and wedging it against the wall of aorta. The balloon means is provided with beads (14) to ensure a steady fastening of the valve prosthesis on the balloon means during insertion and expansion.The valve prosthesis (9) and the balloon catheter (11) make it possible to insert a cardiac valve prosthesis without a surgical operation comprising opening the thoracic cavity.

Abstract: A thoracic trocar having a deflectable member. The deflectable member has a frustoconical outer surface and is movable between first and second positions. The outer surface is angled toward the distal end in the first position and angled toward the proximal end in the second position. The first and second positions are both stable, unbiased positions and the deflectable member is movable from the first position to the second position upon application of the necessary force.

Abstract: The invention provides devices and method for performing extremely small-scale, minimally-invasive microsurgery such as thoracoscopic coronary artery bypass grafting. The instruments of the invention utilize a symmetrical, forcep-like actuator which provides extremely precise actuation and control of the instrument and which mimics the feel of instruments used in conventional open surgical procedures. The instruments generally include a pair of coaxially arranged shafts, an end-effect at the distal ends of the shafts, and an actuator at the proximal ends of the shafts. The actuator includes a pair of arms pivotally coupled to one of either the outer or inner shaft, and a pair of links pivotally coupled at one end to the arms, and at a second end to the other of the shafts. The links are coupled to a proximal portion of the arms to maximize mechanical advantage and reduce interference.

Abstract: The present invention provides a retractor for providing surgical access through a passage in tissue, together with methods for its use and deployment. The retractor comprises an anchoring frame having an upper surface, a lower surface, and an opening therethrough which defines an axial axis. A flexible tensioning member is attached to the frame, and is extendable from the frame out of the body through the passage when the frame is positioned through the passage and into a body cavity. This tensioning member is selectively tensionable to spread the tissue radially outwardly from the axial axis. Hence, it is the tension imposed on the flexible liner which effects retraction of the tissue, rather than relying on the structural integrity of an artificial lumen.

Abstract: The invention provides a system and method for performing less-invasive surgical procedures within a body cavity. In a preferred embodiment, the invention provides a system and method for isolating a surgical site such as an anastomosis between an internal mammary artery and a coronary artery in a thoracoscopic coronary artery bypass grafting procedure. The system comprises a foot (11) pivotally coupled to the distal end of a shaft (3) by a linkage (13). The foot has first and second engaging portions (15, 17) with contact surfaces for engaging a tissue surface. The engaging portions are movable between an open position, where the contact surfaces are separated by a gap, and a collapsed position, where the foot is configured for delivery through the percutaneous penetration.

Abstract: A catheter system and method for achieving total cardiopulmonary bypass during heart surgery. A venous perfusion catheter is inserted peripherally into a preselected vein where it is advanced and positioned at the atrio-caval junction. The venous perfusion catheter has first and second balloons which when inflated respectively occlude the inferior and superior vena cava thereby precluding blood flow into the right atrium. An arterial perfusion catheter is inserted peripherally into a preselected arterial vessel and advanced within the vessel and positioned in the ascending aorta cephalid of the junction of the coronary arteries with the aortic root. A second flexible arterial cannula is mounted in sliding. relationship with the first flexible cannula and carries an inflatable balloon adjacent its distal end to provide for occlusion of the ascending aorta.

Abstract: Surgical methods and instruments are disclosed for performing port-access or closed-chest coronary artery bypass (CABG) surgery in multivessel coronary artery disease. In contrast to standard open-chest CABG surgery, which requires a median sternotomy or other gross thoracotomy to expose the patient's heart, port-access CABG surgery is performed through small incisions or access ports made through the intercostal spaces between the patient's ribs, resulting in greatly reduced pain and morbidity to the patient. In situ arterial bypass grafts, such as the internal mammary arteries and/or the right gastroepiploic artery, are prepared for grafting by thoracoscopic or laparoscopic takedown techniques. Free grafts, such as a saphenous vein graft or a free arterial graft, can be used to augment the in situ arterial grafts. The graft vessels are anastomosed to the coronary arteries under direct visualization through a cardioscopic microscope inserted through an intercostal access port.

Abstract: A coronary shunt for occluding both sides of an anastomosis site and providing a blood flow path across the anastomosis site. The shunt includes two occluding members sized and configured to occlude the coronary artery. A tether is attached to the coronary shunt and is used to remove the coronary shunt from the coronary artery before completing the anastomosis.

Abstract: Pressure is measured on both sides of an occluding member for determining when pressure forces on the occluding member may cause migration of the occluding member. An alarm indicates when the pressure force on the balloon exceed a predetermined threshold. In another aspect of the invention, a pressure monitor determines when a rate of pressure increase with respect to the fluid volume in the balloon reaches a predetermined threshold when inflating the occluding member. A predetermined amount of fluid is then added to the balloon so that the balloon is not under inflated or over inflated.

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 fist 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: 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: A surgical knot pusher device is described which has a knot pushing head mounted on the distal end of an elongated rod. The head of the device has a smoothly radiused knot pushing surface on the leading edge with two symmetrical suture paths which curve smoothly away from the knot pushing surface. The suture rests in a shallow groove which has a wall on either side to keep the suture in the groove. Near the leading edge of the pushing head the walls of the groove are lower so that the knot can be pushed directly against the tissue being sutured. On one side of the knot pushing head, there is a single eyelet in the path of one of the suture ends. The eyelet is made so that the suture can be easily threaded through the eyelet with the curved needle which is on the end of the suture without any need to remove the needle. Preferably, at least the head of the device is made from polysulfone or another suitable plastic material.

Abstract: An extracorporeal support system including an extracorporeal support apparatus and an arterial circulation support catheter. The arterial circulation support catheter includes a blood lumen with a proximal end coupled to extracorporeal support apparatus and a distal end inserted into the blood circulation. A vent lumen has a distal end that crosses the aortic valve into the left ventricle and provides direct venting of the left ventricle through the vent lumen. An arterial circulation support catheter occluding member is positioned either in an interior or at an exterior of the arterial circulation support catheter. A venous circulation support catheter is provided and includes a blood lumen with a proximal end coupled to the extracorporeal support apparatus and a distal end inserted into the blood circulation. A venous circulation support catheter occluding member is included and positioned in an interior or at an exterior of the venous circulation support catheter.

Abstract: Devices and methods are provided for temporarily inducing cardioplegic arrest in the heart of a patient and for establishing cardiopulmonary bypass in order to facilitate surgical procedures on the heart and its related blood vessels. Specifically, a catheter based system is provided for isolating the heart and coronary blood vessels of a patient from the remainder of the arterial system and for infusing a cardioplegic agent into the patient's coronary arteries to induce cardioplegic arrest in the heart. The system includes an endoaortic partitioning catheter having an expandable balloon at its distal end which is expanded within the ascending aorta to occlude the aortic lumen between the coronary ostia and the brachiocephalic artery. Means for centering the catheter tip within the ascending aorta include specially curved shaft configurations, eccentric or shaped occlusion balloons and a steerable catheter tip, which may be used separately or in combination.

Abstract: A process for inducing cardioplegic arrest 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 process for inducing cardioplegic arrest 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: An aortic occlusion catheter has a blood return lumen for returning oxygenated blood to a patient and an occluding member for occluding the patient's ascending aorta. The blood return lumen has openings on both sides of the occluding member for infusing oxygenated blood on both sides of the occluding member.