Abstract: A medical device for approximating and securing tissue without requiring knots includes a lock-head, a strap section, distal protuberance, and a leader section. The device also includes a transition section between the leader and the strap section and a stiffening section proximal to the protuberance. The leader section is used to draw the strap section into the body through small apertures in tissue and the transition section provides a gradual transition in stiffness and size between the leader and the strap section. Tensioner and cutter and a threading tool configured to be slidably removed from a lumen of the tensioner and cutter is provided. A blade within the lumen of the tensioner and cutter is provided to cut excess leader and/or strap when the procedure is completed.

Abstract: An endotracheal tube is disclosed that allows a patient to speak while intubated. The endotracheal tube includes a balloon for seating against the trachea and a collapsible portion proximal to the balloon that aligns with the vocal cords. The collapsible portion may be held open by an inner tube which translates within the endotracheal tube. Suction and balloon inflation conduits span the collapsible portion so that suction and balloon inflation may be performed while the patient is speaking. A small distal tube that bypasses the balloon provides some airflow while the patient speaks.

Abstract: A venous valve prosthetic implant for treatment of venous disease may include an expandable anchoring frame, a valve seat attached to the anchoring frame, a ball retention member attached to the anchoring frame, and a ball disposed within the lumen of the anchoring frame, between the valve seat and the ball retention member. The anchoring frame may include a first end, a second end, and a middle valve portion, where the middle valve portion expands to a smaller diameter than a diameter of either the first end or the second end. The ball may move back and forth within the middle valve portion, between a fully open position and a fully closed position.

Abstract: An epicardial clip for reshaping the annulus of the mitral valve of a heart includes a curved member having an anterior segment configured to be positioned in the transverse sinus of the heart, a posterior segment configured to be positioned on the posterior side of the heart, such as on or inferior to the atrioventricular groove, and a lateral segment extending between the anterior segment and the posterior segment. The lateral segment includes a curve such that the first end of the member is positioned at or above the plane of the mitral valve and the second end of the member is positioned at or below the plane of the mitral valve.

Abstract: Systems, devices, and methods for endoscopically retracting a target tissue. The device includes a first shaft and a second shaft slidably coupled thereto. An internal member extends in a transverse direction from the first shaft and is configured for advancement through a penetration in the target tissue to atraumatically engage a distal surface of the target tissue after being advanced therethrough. A pair of external members extend from the second shaft generally parallel to the transverse direction. The external members are spaced apart and are configured to atraumatically engage a proximal surface of the target tissue when the internal member is moved longitudinally relative to the external members. The internal member applies traction to the target tissue when retracted past the pair of external members, which apply counter-traction to the target tissue on opposing lateral sides of the internal member, to re-shape the target tissue and enable subsequent suture placement.

Abstract: A medical device for approximating and securing tissue without requiring knots includes a lock-head, a strap section, distal protuberance, and a leader section. The device also includes a transition section between the leader and the strap section and a stiffening section proximal to the protuberance. The leader section is used to draw the strap section into the body through small apertures in tissue and the transition section provides a gradual transition in stiffness and size between the leader and the strap section.

Abstract: Components for an endoscopic vessel harvesting system suitable for harvesting target vessels such as the saphenous vein or radial artery for cardiac artery bypass graft surgery. The main components of such systems include a vessel dissector and a vessel harvester, both of which work in conjunction with a separately provided endoscope. The vessel dissector is an elongated cannula having a blunt tip for separating layers of facial around vessels. The tip may be movable, and is typically transparent to permit viewing forward of the tip using the endoscope. Internal features of the tip may reduce glare back to the endoscope. Several devices improve visibility through the tip by reducing interference from tissue or fluid on the tip. The vessel harvester also has an elongated cannula for receiving the endoscope. Several tools within the harvester permit manipulation, severing, and sealing of vessels forward of the distal end.

Abstract: Systems, devices, and methods for endoscopically retracting a target tissue. The device includes a first shaft and a second shaft slidably coupled thereto. An internal member extends in a transverse direction from the first shaft and is configured for advancement through a penetration in the target tissue to atraumatically engage a distal surface of the target tissue after being advanced therethrough. A pair of external members extend from the second shaft generally parallel to the transverse direction. The external members are spaced apart and are configured to atraumatically engage a proximal surface of the target tissue when the internal member is moved longitudinally relative to the external members. The internal member applies traction to the target tissue when retracted past the pair of external members, which apply counter-traction to the target tissue on opposing lateral sides of the internal member, to re-shape the target tissue and enable subsequent suture placement.

Abstract: A system and method for closing a fascial opening is disclosed. The system may include a strap that may be locked into each of a pair of anchors placed anterior to a muscle and on opposite sides of a fascial opening, one or more delivery tubes for delivering the anchors, and a needle for pulling the strap into each anchor. The method may include the steps of placing a dilating port through a skin incision, inserting an anchor through the dilating port, placing a strap into the body cavity, whereupon the strap may be pulled through the anchor. A second anchor may be placed on the contralateral side of the defect so that the strap may be pulled through the second anchor and cinched tightly closing the defect. The anchors may have a locking aperture that engages with the strap.

Abstract: Systems and methods for closing a tissue defect are disclosed. The systems may include a subcutaneous guide that is placed transcutaneously between two skin access sites and a self-locking strap that may be advanced into the body through a first access site via a first needle and then passed to a second needle. The strap may be withdrawn with the second needle through a second access site to the outside of the body. The strap may be withdrawn from the first needle, leaving the strap placed through both access sites and across the defect. As the subcutaneous guide is withdrawn from the body it pulls the captured strap such that both ends of the strap protrude from the first access site, allowing the strap to be tightened around the defect. Devices for closure of a tissue defect are also disclosed.

Abstract: An epicardial clip for reshaping the annulus of the mitral valve of a heart includes a curved member having an anterior segment configured to be positioned in the transverse sinus of the heart, a posterior segment configured to be positioned on the posterior side of the heart, such as on or inferior to the atrioventricular groove, and a lateral segment extending between the anterior segment and the posterior segment. The lateral segment includes a curve such that the first end of the member is positioned at or above the plane of the mitral valve and the second end of the member is positioned at or below the plane of the mitral valve.

Abstract: Systems, devices and methods for closing a tissue defect comprise a subcutaneous guide that is placed transcutaneously between two skin access sites and a self-locking strap that may be advanced into the body through a first access site via a first needle and then passed to a second needle. The strap may be withdrawn with the second needle through a second access site to the outside of the body. The strap may be withdrawn from the first needle, leaving the strap placed through both access sites and across the defect. As the subcutaneous guide is withdrawn from the body it pulls the captured strap such that both ends of the strap protrude from the first access site, allowing the strap to be tightened around the defect.

Abstract: Systems and methods for closing a tissue defect are disclosed. The systems may include a subcutaneous guide that is placed transcutaneously between two skin access sites and a self-locking strap that may be advanced into the body through a first access site via a first needle and then passed to a second needle. The strap may be withdrawn with the second needle through a second access site to the outside of the body. The strap may be withdrawn from the first needle, leaving the strap placed through both access sites and across the defect. As the subcutaneous guide is withdrawn from the body it pulls the captured strap such that both ends of the strap protrude from the first access site, allowing the strap to be tightened around the defect. Devices for closure of a tissue defect are also disclosed.

Abstract: A cardiac assist system includes a pneumatic effector which is implanted beneath a pericardial sac and over a myocardial surface overlying the patient's left ventricle. A port is implanted and receives a percutaneously introduced cannula. The port is connected to supply a driving gas received from the cannula to the pneumatic effector. An external drive unit includes a pump assembly and control circuitry which operate the pump to actuate the pneumatic effector in response to the patient's sensed heart rhythm. A connecting tube has a pump end connected to the pump and a percutaneous port-connecting end attached to the implantable port.

Abstract: A falloposcope intended for use with a hysteroscope to access, image, and collect samples from a patient's fallopian tube includes a cannula having an angled tip oriented to engage a fallopian tube os when the cannula is transcervically introduced to a patient's uterus through the hysteroscope. The catheter has a distal viewing tip configured to be advanced from a distal end of the cannula into the patient's uterus through a cervical os. A viewing chamber has a wide proximal end attached to the distal viewing tip of the catheter, and the viewing chamber is at least partially transparent and typically tapers in a distal direction to provide a clear viewing zone for the endoscope as well as atraumatic advancement into the fallopian tube.

Abstract: A prosthetic venous valve includes an expanding anchoring frame, a valve seat at the middle portion of the anchoring frame, a ball disposed within the lumen of the anchoring frame and having an outer diameter, and least one ball retention tether coupled with the ball and the anchoring frame. The ball retention tether includes at least one elastic component or material. The anchoring frame has an upstream end, a downstream end, a middle portion and a lumen extending through the anchoring frame from the upstream end to the downstream end. The ball moves between an open position, in which the ball is located apart from the valve seat, and a closed position, in which the ball is located in contact with or near the valve seat to reduce or prevent backflow of blood through the prosthetic venous valve.

Abstract: Systems, devices, and methods for performing catheter-based procedures in the heart. In specific embodiments a procedural catheter is introduced into the mediastinum from a suprasternal access site. The procedural catheter is passed through a wall of the heart, preferably at an extrapericardial location on the atrial dome. The procedural catheter is used to perform a procedure in the heart such as mitral valve repair or replacement, using remote catheter visualization techniques.

Abstract: Forming a proximal anastomosis on an aortic wall includes method and instrumentation and apparatus for forming an aortic puncture and inserting into the vessel through the puncture a fluid-impervious sealing element with a protruding retainer. An anastomosis of a graft vessel over the puncture is partially completed with the retainer of the sealing element protruding through the partial anastomosis. The retainer facilitates removal of the sealing element from the partial anastomosis prior to completion of the procedure.

Abstract: Components for an endoscopic vessel harvesting system suitable for harvesting target vessels such as the saphenous vein or radial artery for cardiac artery bypass graft surgery. The main components of such systems include a vessel dissector and a vessel harvester, both of which work in conjunction with a separately provided endoscope. The vessel dissector is an elongated cannula having a blunt tip for separating layers of facial around vessels. The tip may be movable, and is typically transparent to permit viewing forward of the tip using the endoscope. Internal features of the tip may reduce glare back to the endoscope. Several devices improve visibility through the tip by reducing interference from tissue or fluid on the tip. The vessel harvester also has an elongated cannula for receiving the endoscope. Several tools within the harvester permit manipulation, severing, and sealing of vessels forward of the distal end.