535 results about "Neoaortic valve" patented technology

A delivery system and method for delivering a prosthetic heart valve to the aortic valve annulus. The system includes a balloon catheter having a steering mechanism thereon for delivering a balloon-expandable prosthetic heart valve through an introducer in an antegrade fashion to the aortic annulus. The balloon catheter passes through an introducer that accesses the left ventricle through its apex and a small incision in the chest wall. The balloon catheter includes a deflecting segment just proximal to the distal balloon to facilitate positioning of the prosthetic heart valve in the proper orientation within the aortic annulus. A slider in a deflection handle may be coupled to a deflection wire that actuates the deflecting segment. The method includes using two concentric rings of purse-string sutures around the puncture in the left ventricular apex to maintain a good seal around instruments passed therethrough. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.

A percutaneously inserted bistable heart valve prosthesis is folded inside a catheter for transseptal delivery to the patient's heart for implantation. The heart valve has an annular ring, a body member having a plurality of legs, each leg connecting at one end to the annular ring, claws that are adjustable from a first position to a second position by application of external force so as to allow ingress of surrounding heart tissue into the claws in the second position, and leaflet membranes connected to the annular ring, the body member and / or the legs, the leaflet membranes having a first position for blocking blood flow therethrough and a second position for allowing blood flow therethrough. The heart valve is designed such that upon removal of the external force the claws elastically revert to the first position so as to grip the heart tissue positioned within the claws, thereby holding the heart valve in place. The body member and claws may be integrated into a one-piece design. The heart valve may be used as a prosthesis for the mitral valve, aortic valve, pulmonary valve, or tricuspid valve by adapting the annular ring to fit in a respective mitral, aortic, pulmonary, or tricuspid valve opening of the heart.

The percutaneously delivered temporary valve assembly of the present invention, and method of using the same, provides an elongate element and a temporary valve disposed on the elongate element. The temporary valve can comprise struts and a membrane attached to the struts. The elongate element can include at least one lumen. The percutaneously delivered temporary valve assembly can be used to replace an aortic valve by locating a temporary valve in a patient's ascending aorta; deploying the temporary valve; removing the native aortic valve past the temporary valve; implanting the prosthetic aortic valve past the temporary valve; collapsing the temporary valve; and removing the temporary valve from the patient. The temporary valve can be sized to the patient and can be left in place while the prosthetic aortic valve heals in.

A prosthetic device is provided for treatment of an aortic valve, having a compressed state for transarterial delivery and being expandable to an expanded state for implantation. The device includes an expandable support implantable in the expanded state of the prosthetic device in an aortic annulus, and an inner envelope having an upstream portion that lines the inner surface of the support, and a downstream portion which, when the prosthetic device is in the expanded state, extends into an aorta and defines a diverging conical section having a diameter that gradually increases from an upstream end of the section to a downstream end of the section. The section is configured to produce, during systole, a non-turbulent blood flow into the aorta with pressure recovery at the downstream end of the section. Other embodiments are also described.

A prosthetic implant for treating a diseased aortic valve is described. The prosthetic implant includes a substantially tubular body configured to be positioned in an aorta of a patient, at or near the patient's aortic valve. The body includes a lumen extending through the body from a proximal end to a distal end of the body; and an adjustable frame surrounding the lumen. The prosthetic implant further includes at least one adjustable element located in or on the body and extending at least partially around a circumference of the lumen. The at least one adjustable element includes a shape memory material and is transformable, in response to application of an activation energy, from a first configuration to a second configuration, wherein the first configuration and second configuration differ in a size of at least one dimension of the at least one adjustable element. The at least one adjustable element may engage at least one of a root of the aorta, an annulus of the aortic valve, and the patient's left ventricle, when the at least one adjustable element is in the second configuration.

Prosthetic devices as described for use in the treatment of aortic stenosis in the aortic valve of a patient's heart, the prosthetic device having a compressed state for transarterial delivery and being expandable to an expanded state for implantation. The prosthetic device includes an expandable metal base (10) constructed so as to be implantable in the expanded state of the prosthetic device in the aortic annulus of the aortic valve; and an inner envelope lining (11) tune inner surface of the metal base (10). The inner envelope, in the expanded state of the prosthetic device, extends into the aorta and is of a diverging conical configuration, in which its diameter gradually increases from its proximal end within the aortic annulus to its distal end extending into the aorta, such as to produce, during systole, a non-turbulent blood flow into the aorta with pressure recovery at the distal end of the inner envelope. Preferably, the distal end includes a prosthetic valve which is also concurrently implanted, but such a prosthetic valve may be implanted separately in the aorta Also described are preferred methods of implanting such prosthetic devices.

A prosthetic heart valve (10) (e.g., a prosthetic aortic valve) is designed to be somewhat circumferentially collapsible and then re-expandable. The collapsed condition may be used for less invasive delivery of the valve into a patient. When the valve reaches the implant site in the patient, it re-expands to normal operating size, and also to engage surrounding tissue of the patient. The valve includes a stent portion (200) and a ring portion (100) that is substantially concentric with the stent portion but downstream from the stent portion in the direction of blood flow through the implanted valve. When the valve is implanted, the stent portion engages the patient's tissue at or near the native valve annulus, while the ring portion engages tissue downstream from the native valve site (e.g., the aorta).

The present invention relates to an apparatus for replacing a native aortic valve, the apparatus includes an expandable anchor adapted to be endovascularly delivered and secured at a site within the native aortic valve. The expandable anchor has a delivery length in a delivery configuration substantially greater than a deployed length in a deployed configuration. The apparatus may also include and a replacement valve configured to be secured within the anchor.

A prosthetic heart valve having an internal support frame with a continuous, undulating leaflet frame defined therein. The leaflet frame has three cusp regions positioned at an inflow end intermediate three commissure regions positioned at an outflow end thereof. The leaflet frame may be cloth covered and flexible leaflets attached thereto form occluding surfaces of the valve. The support frame further includes three cusp positioners rigidly fixed with respect to the leaflet frame and located at the outflow end of the support frame intermediate each pair of adjacent commissure regions. The valve is desirably compressible so as to be delivered in a minimally invasive manner through a catheter to the site of implantation. Upon expulsion from catheter, the valve expands into contact with the surrounding native valve annulus and is anchored in place without the use of sutures. In the aortic valve position, the cusp positioners angle outward into contact with the sinus cavities, and compress the native leaflets if they are not excised, or the aortic wall if they are. The support frame may be formed from a flat sheet of Nitinol that is bent into a three-dimensional configuration and heat set. A holder having spring-like arms connected to inflow projections of the valve may be used to deliver, reposition and re-collapse the valve, if necessary.

A device for the transvascular implantation and fixation of prosthetic heart valves having a self-expanding heart valve stent (10) with a prosthetic heart valve (11) at its proximal end is introducible into a patient's main artery. With the objective of optimizing such a device to the extent that the prosthetic heart valve (11) can be implanted into a patient in a minimally-invasive procedure, to ensure optimal positioning accuracy of the prosthesis (11) in the patient's ventricle, the device includes a self-expanding positioning stent (20) introducible into an aortic valve positioned within a patient. The positioning stent is configured separately from the heart valve stent (10) so that the two stents respectively interact in their expanded states such that the heart valve stent (10) is held by the positioning stent (20) in a position in the patient's aorta relative the heart valve predefinable by the positioning stent (20).

A prosthetic heart valve having an internal support frame with a continuous, undulating leaflet frame defined therein. The leaflet frame has three cusp regions positioned at an inflow end intermediate three commissure regions positioned at an outflow end thereof. The leaflet frame may be cloth covered and flexible leaflets attached thereto form occluding surfaces of the valve. The support frame further includes three cusp positioners rigidly fixed with respect to the leaflet frame and located at the outflow end of the support frame intermediate each pair of adjacent commissure regions. The valve is desirably compressible so as to be delivered in a minimally invasive manner through a catheter to the site of implantation. Upon expulsion from catheter, the valve expands into contact with the surrounding native valve annulus and is anchored in place without the use of sutures. In the aortic valve position, the cusp positioners angle outward into contact with the sinus cavities, and compress the native leaflets if they are not excised, or the aortic wall if they are. The support frame may be formed from a flat sheet of Nitinol that is bent into a three-dimensional configuration and heat set. A holder having spring-like arms connected to inflow projections of the valve may be used to deliver, reposition and re-collapse the valve, if necessary.

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. The heart muscle or myocardium is paralyzed by the retrograde delivery of a cardioplegic fluid to the myocardium through patient's coronary sinus and coronary veins, or by antegrade delivery of cardioplegic fluid through a lumen in the endovascular aortic partitioning device to infuse cardioplegic fluid into the coronary arteries. The pulmonary trunk may be vented by withdrawing liquid from the trunk through an inner lumen of an elongated catheter. The cardiac accessing system is particularly suitable for removing the aortic valve and replacing the removed valve with a prosthetic valve.

The present invention provides devices and methods for decalcifying an aortic valve. The methods and devices of the present invention break up or obliterate calcific deposits in and around the aortic valve through application or removal of heat energy from the calcific deposits.

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. The shaft of the catheter may have a coaxial or multilumen construction. The catheter may further include piezoelectric pressure transducers at the distal tip of the catheter and within the occlusion balloon. Means to facilitate nonfluoroscopic placement of the catheter include fiberoptic transillumination of the aorta and a secondary balloon at the distal tip of the catheter for atraumatically contacting the aortic valve. The system further includes a dual purpose arterial bypass cannula and introducer sheath for introducing the catheter into a peripheral artery of the patient.

The present invention comprises a method for deploying an aortic valve prosthesis. This valve prosthesis may include any of the known aortic valves including, but not limited to, stented and unstented bioprosthetic valves, stented mechanical valves, and expandable or self-expanding valves, whether biological or artificial. The method involves the steps of: making a first opening leading to the left atrium; passing a valve prosthesis through the opening and into a cardiac chamber of the left side of the heart using a first manipulation instrument; making a second opening in the arterial system and advancing one end of a second manipulation instrument through the arterial opening and into the aforementioned cardiac chamber; securing the second manipulation instrument to the valve prosthesis; and using the second manipulation instrument to retract at least some portion of the valve prosthesis out of the aforementioned cardiac chamber.

Improvements to prosthetic heart valves and grafts for human implantation, particularly to methods and apparatus for coupling a prosthetic heart valve with an artificial graft during a surgical procedure to replace a defective heart valve and blood vessel section, e.g., the aortic valve and a section of the ascending aorta, are disclosed. An annular exterior surface of the prosthetic heart valve is fitted within a vascular graft lumen to dispose the vascular graft proximal end overlying the annular exterior surface, and the proximal end of an elongated vascular graft is compressed against the valve annular exterior surface in a manner that inhibits blood leakage between the vascular graft and the prosthetic heart valve.

Apparatus and methods are disclosed for performing beating heart surgery. Apparatus is disclosed comprising a cannula having a proximal end and a distal end; an aortic filter in connection with the cannula, the aortic filter having a proximal side and a distal side; a check valve in connection with the cannula, the check valve disposed on the distal side of the aortic filter; and a coronary artery filter in connection with the cannula, the coronary artery filter having a proximal end and a distal end, and the distal end of the coronary artery filter extending distally away from the distal end of the cannula. A method is disclosed comprising providing apparatus for performing beating heart surgery; deploying the apparatus in an aorta; performing a procedure on the aortic valve; and removing the apparatus from the aorta.

A prosthetic heart valve is provided with a cuff (85, 285, 400) having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion (90) adapted to bear native aortic valve. The valve may include elements (210, 211, 230, 252, 253) for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness (280) distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part (402) of the cuff may be movable relative to the stent during implantation.

Apparatus for resecting a diseased heart valve, the apparatus comprising: a body portion; a first handle and a second handle; a cutting blade; a set of retaining arms; a pass-off tool having a first attachment device configured to selectively engage the first handle attached to the body portion so as to allow placement of the second handle of the body portion adjacent to the diseased heart valve, and a controller tool having a second attachment device at the distal end thereof, the second attachment device configured to selectively engage the second handle attached to the body portion so as to allow positioning of the body portion adjacent to the diseased heart valve, a cutting blade actuator configured to cause the cutting blade to selectively rotate, and a retaining arm actuator configured to selectively position the set of retaining arms from the contracted state to the expanded state.

A perfusion catheter includes at least one perfusion channel and at least two dilation units disposed at a distance from each other at the distal catheter region in the longitudinal extension of the catheter. Both of the at least two dilation units are projected through by the perfusion catheter and form, in an inflated state, an at least practically fluid-tight occlusion with the aortic wall. At least the dilation unit disposed on the proximal side has at least one passage through which an auxiliary catheter can be introduced in a fluid-tight manner. The perfusion catheter may have a working channel with an outlet opening in the region between the two dilation units and through which at least one auxiliary catheter can be introduced for aortic valve ablation.

The present invention relates to a minimally invasive method of performing annuloplasty. According to one aspect of the present invention, a method for performing a procedure on a mitral valve of a heart includes inserting an implant into a left ventricle and orienting the implant in the left ventricle substantially below the mitral valve. The implant and tissue around the mitral valve are connected and tension is provided to the implant, in one embodiment, in order to substantially reduce an arc length associated with the mitral valve. In another embodiment, the implant is inserted into the left ventricle through the aorta and the aortic valve.

Apparatus for resecting a diseased heart valve, the apparatus comprising: a body portion; a first handle and a second handle; a cutting blade; a set of retaining arms; a pass-off tool having a first attachment device configured to selectively engage the first handle attached to the body portion so as to allow placement of the second handle of the body portion adjacent to the diseased heart valve; and a controller tool having a second attachment device at the distal end thereof, the second attachment device configured to selectively engage the second handle attached to the body portion so as to allow positioning of the body portion adjacent to the diseased heart valve, a cutting blade actuator configured to cause the cutting blade to selectively rotate, and a retaining arm actuator configured to selectively position the set of retaining arms from a contracted state to an expanded state.

A prosthetic valve including a body, a first leaflet, and a second leaflet. The first leaflet extends across and is coupled to the body. The first leaflet is cut from a first porcine aortic valve and defines a first inner surface. The second leaflet extends across and is coupled to the body opposite the first leaflet. The second leaflet is cut from a second porcine aortic valve and defines a second inner surface.