Abstract: An embodiment of the present invention includes a tray and a method for loading a medical device on a catheter assembly. The tray can include a tray body defining a first receptacle for seating the handle assembly of the catheter assembly, an elongate receptacle for seating a delivery shaft of the catheter assembly, and a reservoir for holding a fluid. A portion of the elongate receptacle slopes downward towards the reservoir. The reservoir has a bottom surface that is below a portion of the elongate receptacle that is contiguous with the reservoir. Accordingly, when the reservoir is filled with a fluid and the catheter assembly is seated in the first receptacle and the elongate receptacle, the distal tip of the catheter assembly is submerged in the fluid in the reservoir. The tray body is also configured to prevent movement of a catheter assembly seated therein.

Abstract: In an embodiment, a device for loading a prosthesis onto a delivery system comprises a cap and a reducing member. The cap has a piston member that seats a prosthesis. The piston member has at least one side wall configured to contact a portion of the side of the prosthesis seated therein. The reducing member has a conical wall, a first open end, and a second open end. The first open end is configured to receive the piston member. The reducing member reduces an external dimension of at least a portion of the prosthesis seated in the piston member as the prosthesis is moved along an inner surface of the conical wall.

Abstract: Apparatus and methods are provided, including a plurality of anchoring elements, each of the anchoring elements being an elongate element that is curved to define an opening. A housing holds each of the anchoring elements. A mandrel is reversibly disposable through the openings defined by the anchoring elements. The anchoring elements are configured such that, in response to removal of the mandrel from the openings, ends of the anchoring elements automatically move outwardly, and diameters of the openings decrease, due to elastic loading of the anchoring elements. Other embodiments are also described.

Abstract: A prosthesis is provided for implantation at a native semilunar valve of a native valve complex, the native valve complex having three semilunar sinuses and three native commissures. The prosthesis includes a valve prosthesis support, which comprises a support structure comprising exactly three engagement arms that meet one another at three respective junctures. The engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses, such that each of the peak complexes is disposed distal to and in rotational alignment with a respective one of the native commissures, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses.

Abstract: A prosthesis for implantation at a native semilunar valve includes a prosthetic distal valve, which includes a pliant material configured to collapse inwardly towards a longitudinal axis of the prosthesis during diastole, and to open outwardly during systole, and a distal fixation member configured to be positioned in a downstream artery of the subject. The apparatus also includes a proximal fixation member coupled to the distal fixation member, and configured to be positioned at least partially on a ventricular side of the native semilunar valve. The proximal fixation member is shaped so as to define a lattice that is shaped so as to define an intermediary portion that is coupled to the pliant material of the valve and diverges outwardly from the longitudinal axis, and a distal portion that is distal to the intermediary portion and diverges outwardly from the intermediary portion of the lattice. Other embodiments are also described.

Abstract: A method is provided, including providing a semilunar valve prosthesis, and implanting the prosthesis without using any imaging techniques. Another method is provided, including providing a semilunar valve prosthesis, placing the prosthesis in a body of a subject, and determining a correct rotational disposition of the prosthesis with respect to a semilunar valve site based on tactile feedback. Other embodiments are also described.

Abstract: A prosthesis is provided for implantation at a native semilunar valve of a native valve complex. The prosthesis includes a distal fixation member, configured to be positioned in a downstream artery, and to apply a first axial force directed toward a ventricle. The prosthesis further includes a proximal fixation member coupled to the distal fixation member, the proximal fixation member configured to be positioned at least partially on a ventricular side of the native valve complex, and to apply a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex by axially sandwiching the native valve complex from a downstream side and the ventricular side. A ratio of the first axial force to a radial force applied outwardly by the prosthesis against the native semilunar valve is greater than 1.5:1. Other embodiments are also described.

Abstract: A prosthesis for implantation at a native semilunar valve includes a prosthetic distal valve, which includes a pliant material configured to collapse inwardly towards a longitudinal axis of the prosthesis during diastole, and to open outwardly during systole, and a distal fixation member configured to be positioned in a downstream artery of the subject. The apparatus also includes a proximal fixation member coupled to the distal fixation member, and configured to be positioned at least partially on a ventricular side of the native semilunar valve. The proximal fixation member is shaped so as to define a lattice that is shaped so as to define an intermediary portion that is coupled to the pliant material of the valve and diverges outwardly from the longitudinal axis, and a distal portion that is distal to the intermediary portion and diverges outwardly from the intermediary portion of the lattice. Other embodiments are also described.

Abstract: Apparatus and methods are provided, including a plurality of anchoring elements, each of the anchoring elements being an elongate element that is curved to define an opening. A housing holds each of the anchoring elements. A mandrel is reversibly disposable through the openings defined by the anchoring elements. The anchoring elements are configured such that, in response to removal of the mandrel from the openings, ends of the anchoring elements automatically move outwardly, and diameters of the openings decrease, due to elastic loading of the anchoring elements. Other embodiments are also described.

Abstract: Apparatus and methods are provided for use with a mitral valve of a heart of a subject. The apparatus includes a P1-anchor, a P2-anchor, and a P3-anchor, that are anchored to tissue in a vicinity of, respectively, P1, P2 and P3 segments of a posterior leaflet of the mitral valve, a tether being fixedly coupled to the P2-anchor, and slidably coupled to the P1 and P3 anchors. A cardiac-site anchor anchors the tether to an anchoring location that is at a cardiac site that is anterior and inferior to the posterior leaflet. Other embodiments are also described.

Abstract: A method of treating a native aortic valve insufficiency includes positioning the closed ends of a stent's three first arches within respective native valve pockets such that the closed ends engage the respective native valve pockets. The method further includes clamping three native valve leaflets between the three first arches and the three second arches such that the three native valve leaflets are disposed radially inward of the three first arches and radially outward of the three second arches.

Abstract: An embodiment of the present invention includes a tray and a method for loading a medical device on a catheter assembly. The tray can include a tray body defining a first receptacle for seating the handle assembly of the catheter assembly, an elongate receptacle for seating a delivery shaft of the catheter assembly, and a reservoir for holding a fluid. A portion of the elongate receptacle slopes downward towards the reservoir. The reservoir has a bottom surface that is below a portion of the elongate receptacle that is contiguous with the reservoir. Accordingly, when the reservoir is filled with a fluid and the catheter assembly is seated in the first receptacle and the elongate receptacle, the distal tip of the catheter assembly is submerged in the fluid in the reservoir. The tray body is also configured to prevent movement of a catheter assembly seated therein.

Abstract: A method for implanting a valve prosthesis at a native cardiac valve complex of a subject comprises implanting a distal fixation member of the valve prosthesis downstream of a native valve of the native valve complex such that two or more engagement arms of the distal fixation member apply, to a downstream side of the native valve, a first axial force directed upstream. The method also comprises implanting a proximal fixation member of the valve prosthesis at least partially upstream of the native valve, such that the proximal fixation member applies, to an upstream side of the native valve, a second axial force directed downstream, such that application of the first and second forces couples the valve prosthesis to the native valve complex. The engagement arms and the proximal fixation member capture leaflets of the native valve therebetween without folding over leaflets of the native valve.

Abstract: Apparatus is provided that includes a valve prosthesis for attachment to a native valve complex of a subject. The prosthesis is configured to assume a compressed delivery state and an uncompressed implantation state. The prosthesis includes a support frame, which is shaped so as to define an upstream inlet having upstream-most portions that are tapered in an upstream direction toward a central longitudinal axis of the prosthesis when the prosthesis assumes the compressed delivery state. The prosthesis further includes a flexible prosthetic heart valve component, coupled to the support frame. Other embodiments are also described.

Abstract: A prosthesis including a distal fixation member that defines two or more engagement arms that are configured to apply a first axial force to tissue of the subject on a downstream side of the native valve complex. The prosthesis also includes a proximal fixation member configured to apply a second axial force to tissue of the subject on an upstream side of the native valve complex such that application of the first and second axial forces couples the prosthesis to the native valve complex. The proximal fixation member and the distal fixation member are fabricated as one integrated structure. The engagement arms and the proximal fixation member are configured to capture leaflets of the native valve complex therebetween without folding over of leaflets of the native valve complex, upon implantation of the prosthesis.

Abstract: A prosthetic apparatus includes a main body having a lumen and configured for placement within a native annulus of a native valve complex. The main body is radially compressible to a radially compressed state for delivery into the heart and self-expandable from the compressed state to a radially expanded state. The apparatus also includes at least one arm coupled to and disposed outside of the main body. The arm being coupled to the main body such that when the main body is compressed to the compressed state, a leaflet-receiving space between the arm and an outer surface of the main body increases to receive a native valve leaflet therebetween, and when the main body expands to the expanded state in the absence of any radial inward forces on the main body or the arm, the space decreases to capture the leaflet between the outer surface of the main body and the arm.

Abstract: A mitral valve prosthesis and methods for implanting the prosthesis transapically (i.e., through the apex of the heart), transatrially (i.e., through the left atrium of the heart), and transseptally (i.e., through the septum of the heart). The prosthesis generally includes a self-expanding frame and two or more support arms. A valve prosthesis is sutured to the self-expanding frame. Each support arm corresponds to a native mitral valve leaflet. At least one support arm immobilizes the native leaflets, and holds the native leaflets close to the main frame.

Abstract: A prosthesis is provided for implantation at a native semilunar valve of a native valve complex. The prosthesis includes a distal fixation member, configured to be positioned in a downstream artery, and shaped so as to define exactly three proximal engagement arms that are configured to be positioned at least partially within respective ones of semilunar sinuses, and, in combination, to apply, to tissue that defines the semilunar sinuses, a first axial force directed toward a ventricle. The prosthesis further includes a proximal fixation member coupled to the distal fixation member, the proximal fixation member configured to be positioned at least partially on a ventricular side of the native semilunar valve, and to apply, to the ventricular side of the native valve complex, a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex.

Abstract: Apparatus and methods are provided including a mitral valve prosthesis. The prosthesis includes an inner support structure having downstream and upstream sections, the upstream section having a cross-sectional area greater than the downstream section. The inner support structure is configured to be positioned on an atrial side of the native valve complex, and to prevent the prosthesis from being dislodged into the left ventricle. A prosthetic valve having prosthetic valve leaflets is coupled to the inner support structure. An outer support structure has engagement arms, downstream ends of the engagement arms being coupled to the inner support structure. The prosthesis is configured such that, upon implantation thereof: downstream ends of the native valve leaflets, downstream ends of the engagement arms, and downstream ends of the prosthetic leaflets, are disposed at a longitudinal distance from one another of less than 3 mm. Other embodiments are also described.

Abstract: Catheter assemblies including a handle assembly located on the proximal end of the catheter assembly and a distal tip assembly located on the distal end of the catheter assembly. A crimping funnel is slidably positioned along the catheter. The crimping funnel includes a distal end having a first diameter and a proximal end having a second diameter smaller than the first diameter. An axial split is formed in the proximal end. A first collar is provided encompassing a portion of the proximal end. The first collar is configured to hold the axial split in the proximal end together when the first collar is at a first axial location along the proximal end, and to allow the axial split in the proximal end to open when the first collar is at a second axial location along the proximal end, such that the crimping funnel can be removed from the catheter assembly. Various methods of retaining a prosthetic valve on the catheter assembly during the crimping process are described.