Abstract: Devices and methods for treating mitral regurgitation by reshaping the mitral annulus in a heart. One preferred device for reshaping the mitral annulus is provided as an elongate body having dimensions as to be insertable into a coronary sinus. The elongate body includes a proximal frame having a proximal anchor and a distal frame having a distal anchor. A ratcheting strip is attached to the distal frame and an accepting member is attached to the proximal frame, wherein the accepting member is adapted for engagement with the ratcheting strip. An actuating member is provided for pulling the ratcheting strip relative to the proximal anchor after deployment in the coronary sinus. In one preferred embodiment, the ratcheting strip is pulled through the proximal anchor for pulling the proximal and distal anchors together, thereby reshaping the mitral annulus.

Abstract: Methods of implanting an annuloplasty ring to correct maladies of the mitral annulus that not only reshapes the annulus but also reconfigures the adjacent left ventricular muscle wall. A posterior portion of the ring rises or bows upward from adjacent sides to pull the posterior aspect of the native annulus farther up than its original, healthy shape. In doing so, the ring also pulls the ventricular wall upward which helps mitigate some of the effects of congestive heart failure. Further, one or both of the posterior and anterior portions of the ring may also bow inward. The methods include securing the annuloplasty ring with the anterior portion against the annulus anterior aspect and the posterior portion against the annulus posterior aspect so that the ring posterior portion elevates, and may also pull radially inward, the annulus posterior aspect and corrects the mitral regurgitation.

Abstract: An expandable lumen cannula which includes an elongate tube having a proximal end, a distal end, an intermediate flexible region, and a lumen therebetween. The cannula further includes a balloon occluder mounted on the distal end of the tube. The intermediate flexible region of the tube further includes an elongate generally cylindrical balloon disposed circumferentially about the flexible region which, upon inflation, expands the luminal diameter of the intermediate region. First and second inflation ports are in fluid communication with the balloon occluder and the cylindrical balloon. The cannula may optionally include a cardioplegia port disposed within the distal region of the tube, proximal the balloon occluder and distal the generally cylindrical balloon.

Abstract: An introducer system having an elongate shaft with proximal and distal ends. A flexible sleeve is mounted on the distal end of the shaft and is adapted to circumferentially cover the outer surface of a distal end of a cannula when the shaft is positioned within a lumen of the cannula. The introducer system has dilation capabilities which facilitates insertion of a medical device into a vessel or organ. Methods of using the devices herein are also disclosed.

Abstract: A probe having the ability to deliver cardioplegia solution to the coronary sinus under direct visualization and to provide venous drainage from the right atrium for cardiopulmonary bypass. The probe has an elongate tubular member, including a distal end, a proximal end, and a lumen. A membrane, optionally perforated, mounted within the lumen of the tubular member partitions the lumen and is removable or penetrable by a cardioplegia catheter. The distal end comprises a toroidal balloon or a circumferential recessed vacuum manifold. A vacuum port communicates with the distal end of the tubular member or the vacuum manifold. Methods of using the cardioplegia access view probe for catheterization of the coronary sinus and for venous return as herein described are also disclosed.

Abstract: The invention provides a nested tubing cannula which comprises outer and inner elongate tubular members, each having a proximal end, a distal end, and a lumen therebetween. The inner tubular member is sealed at its distal end and is nested substantially coaxially within the lumen of the outer tubular member, so that the gap between the inner and the outer tubular member defines a second lumen whereas the first lumen is the lumen of the inner tubular member. A tubular sleeve is disposed coaxially between the inner and outer tubular members. A balloon is mounted on a distal region of the outer tubular member and is in communication with the first lumen. The cannula further comprises a port proximal or distal the balloon occluder and is in communication with the second lumen. Methods for making the devices herein are disclosed.

Abstract: A balloon arterial cannula and methods for filtering blood. The devices generally include a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta, a structure adapted to open and close the mesh within the blood vessel, a means to actuate the structure, and a balloon occluder which typically includes a flexible material enclosing a chamber. The methods generally include the steps of introducing a mesh into a blood vessel to capture embolic material, adjusting the mesh, if necessary, during the course of filtration, inflating the balloon occluder to occlude the vessel upstream of the mesh, and thereafter deflating the balloon occluder and removing the mesh and the captured foreign matter from the blood vessel. Additionally, visualization techniques are used to ensure effective filtration.

Abstract: A balloon arterial cannula and methods for filtering blood. The devices generally include a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta, a structure adapted to open and close the mesh within the blood vessel, a means to actuate the structure, and a balloon occluder which typically includes a flexible material enclosing a chamber. The methods generally include the steps of introducing a mesh into a blood vessel to capture embolic material, adjusting the mesh, if necessary, during the course of filtration, inflating the balloon occluder to occlude the vessel upstream of the mesh, and thereafter deflating the balloon occluder and removing the mesh and the captured foreign matter from the blood vessel. Additionally, visualization techniques are used to ensure effective filtration.

Abstract: Methods and apparatus for placing a bifurcated aortic graft, with extensions, into a body lumen. An aortic graft is provided with a unique combination of self-expanding a balloon expandable wires. The aortic graft is bifurcated and includes ipsilateral and contralateral legs. Two extension grafts are provided for frictional engagement with the legs of the aortic graft. For placement of the bifurcated aortic graft with extensions, an introducer assembly including a dilator and a sheath assembly provides access for the introduction of a main catheter and a directional catheter. The main catheter is provided for deployment of the bifurcated aortic graft within the lumen of a vessel. A balloon is provided on the main catheter for expanding the balloon-expandable wires of the aortic graft. The directional catheter, which includes a deflecting spring portion, permits placement of a guidewire through the ipsilateral leg and into the contralateral leg of the aortic graft.

Abstract: A system for delivering and implanting a radially expandable endoluminal prosthesis within a body lumen (e.g., blood vessel). The system comprises a) an introducer/dilator assembly, and b) a delivery catheter/loader assembly. The introducer/dilator assembly comprises an elongate tubular introducer sheath which may be provided with a valving assembly mounted on the proximal end thereof. Such valving assembly may incorporate i) a hemostatic valve, ii) a first sealing valve and iii) a second sealing valve, positioned in series, to prevent leakage of body fluid out of the proximal end of the introducer and to permit two or more elongate members (e.g., catheters, guidewires) having differing outer diameters to be inserted through the introducer without leakage of body fluid therefrom. A dilator, which has regionalized differences in stiffness, is initially deployable within the lumen of the introducer to facilitate advancement of the introducer to its desired location within the body.

Abstract: Methods and apparatus for placing a bifurcated aortic graft, with extensions, into a body lumen. An aortic graft is provided with a unique combination of self-expanding a balloon expandable wires. The aortic graft is bifurcated and includes ipsilateral and contralateral legs. Two extension grafts are provided for frictional engagement with the legs of the aortic graft. For placement of the bifurcated aortic graft with extensions, an introducer assembly including a dilator and a sheath assembly provides access for the introduction of a main catheter and a directional catheter. The main catheter is provided for deployment of the bifurcated aortic graft within the lumen of a vessel. A balloon is provided on the main catheter for expanding the balloon-expandable wires of the aortic graft. The directional catheter, which includes a deflecting spring portion, permits placement of a guidewire through the ipsilateral leg and into the contralateral leg of the aortic graft.

Abstract: A sizer measures a valve annulus to determine a size of an artificial heart valve to be sewn in the valve annulus during heart-valve replacement surgery. The sizer includes a support member and a resilient member. The support member has a size corresponding to the size of one of a plurality of artificial heart valves. The resilient member is disposed about the support member and has a resiliency substantially equal to the resiliency of a sewing ring of the artificial heart valve. Accordingly, when a surgeon inserts the sizer into a valve annulus, the resilient member conforms to the shape of the valve annulus much like the sewing ring will conform when positioned in the annulus and sewn in place. The surgeon is therefore able to determine more accurately the size of the annulus and, thereafter, to select a properly sized artificial valve.

Abstract: An apparatus and method for intraluminal delivery and deployment of an expandable prosthesis at a site within a body canal is provided. The apparatus comprises an elongated sleeve and an outer shaft disposed within the elongated sleeve and movable relative to the sleeve. A securing member is disposed on a distal area of the outer shaft. The expandable prosthesis is housed within a distal area of the elongated sleeve, and a distal area of the prosthesis is secured to the outer shaft by the securing member. The stent is deployed by displacing the sleeve in a proximal direction relative to the outer shaft to expose the stent and by releasing the stent from the securing member. If necessary, the stent can be repositioned prior to releasing the stent from the securing member.

Abstract: A vascular graft for a primary vessel adapted to bridge a side branch. The graft is especially useful for providing a support tube for a primary graft in the primary vessel on one side of the side branch. The graft includes first and second tubular sections separated by a gap. A bridging member connects the first and second tubular sections across the gap and may include a relatively rigid strut to prohibit relative axial movement of the two sections. There may be one, two or more bridging members to define one, two or more apertures through which blood can flow from within the graft through to the vessel side branch. The graft may include a flexible, desirably fabric, body supported by a wireform stent that is either self- or balloon-expandable. The graft may be deployed within the abdominal aorta on both sides of the renal arteries and have two apertures for blood to flow from the aorta to the renals.

Abstract: A stentless aortic bioprosthesis having patent, non-ligated coronary artery segments extending therefrom, and methods for surgical replacement of aortic and/or non-aortic (e.g., pulmonary) heart valves with such stentless aortic bioprosthesis. The presence of the patent, non-ligated coronary segments facilitates end to end anastomosis of the patient's native coronary arteries and/or existing coronary artery bypass grafts to the coronary segments of the bioprosthesis even when such native coronary arteries (or coronary grafts) are too short to reach the wall of the aortic segment of the bioprosthesis. The presence of such patent, non-ligated coronary segments also eliminates the need for removal of a “button” or segment of the native aorta in connection with the native coronary artery segments prior to implantation of the bioprosthesis, and is thus advantageous for patients whose ascending aorta is diseased or otherwise compromised.

Abstract: Biocompatible surfaces on medical devices, particularly those formed of synthetic materials, are produced by providing coating compounds having crosslinked regions capable of entrapping biocompatible molecules on the surfaces of medical devices in order to form a stable base layer. The crosslinked base layer is lubricious and is able to function as an entrapping or coupling site for additional biocompatible agents, which agents may be stably incorporated into its crosslinked lattice. Thus, the coatings of the present invention have enhanced lubricity and may also have antimicrobial, protein-repelling, and/or antithrombotic properties. The present invention thus discloses novel, stable, biocompatible coating compositions, devices coated with the compositions of the present invention, methods of making and applying such compounds, and methods of preparing and using devices and apparatus coated with such compositions.

Abstract: The present invention is directed to a new and useful device and method for stabilizing cardiac tissue at a surgical site during heart surgery, and specifically useful during beating heart surgery. The device includes a foot for contacting a heart tissue and two arms movably connected together for selective movement to vary and adjust the position of the foot on the heart. The foot and the arm assembly are designed to optimize stability of the foot in contact with heart tissue, and therefore, to optimize stability of the heart during surgical procedure. The device is capable of being mounted on a chest spreader. The foot has a bottom surface which is angled for better stabilization and engagement with the heart.

Abstract: A system for sensing a characteristic of fluid flowing to or from the body of a human or animal comprising a conduit having a first end adapted to be outside the body, a second end adapted to be received within the body, and a flow passage through which fluid can flow between the first and second ends and a probe including a sensor for sensing a characteristic of the fluid. The probe is mounted on the conduit with the sensor in the flow passage. The sensor is isolated from the fluid flowing in the flow passage.

Abstract: A vascular access graft that is radially supported and self-sealing upon puncture with, for example, a dialysis needle. The graft has at least one access segment that is formed by an inner layer, an intermediate layer, and outer layer. The intermediate layer has, in longitudinal cross-section, regions of different densities. Radial support members within the intermediate layer prevent collapse of vascular access graft and may be formed of a material that has a lower melting temperature than the other components of the graft. A porous or low-density material is provided between the radial support members to permit blood seepage therein, and the graft is formed by heating to cause the radial support members to melt slightly into the interstitial spaces of the low-density material. The radial support members may be individual turns of a helical coil of FEP, and the low-density material may be compressed PTFE “cotton”. The inner and outer layers may also be formed of PTFE.

Abstract: Universal, biocompatible coating platforms for articles intended to contact physiological fluids or tissues and associated methods of production are disclosed. The coating platforms of the present invention are composed of a polyelectrolyte molecular film containing one or more biologically active compounds. The molecular film is further complexed with the surface of an article by a crosslinked interpenetrating network (IPN) made from at least one multifunctional molecule and at least one crosslinking agent. The IPN may entrap additional biologically active compounds within the coating platform, or additional biologically active compounds may be bound to its outer surface. The coating platform of the present invention is ideally suited for providing medical devices with anti-thrombogenic coatings.