Abstract: A catheter delivery system (10) includes: (i) an introducer sheath (12); (ii) a catheter (14) disposed at least partially within the introducer sheath and movable axial along the introducer sheath; (iii) an invaginating tube (16) sealably secured at or near a first axial end (16a) of the invaginating tube to the introducer sheath at or near a first axial end (12 a) of the introducer sheath; (iv) a runner (28) slidably connected to the catheter; (v) the invaginating tube being sealably secured at or near a second axial end (16b) of the invaginating tube to the runner, such that the runner with inavaginating tube secured thereto is sealably connected to the catheter and movable axially along at least a portion of the catheter; and (vi) means for pressurising the annular space defined between the introducer sheath, the catheter and the invaginating tube.

Abstract: An invaginating device includes an inner elongate member and an outer flexible tube with invaginated axial ends. The outer flexible tube is: disposed at a first axial end of the inner elongate member; concentric with the inner elongate member; sized to provide a radial gap there between; sealably connected at the axial ends of the outer flexible tube to the inner elongate member, with the axial spacing between such sealed axial ends being less than the axial length of the outer tube; and extendable to protrude from the first axial end of the inner elongate member and retractable to reduce such protrusion from the first axial end of the inner elongate member. Fluid contained within the radial gap defined between the inner elongate member and the outer flexible tube is either pressurized or a non-compressible fluid.

Abstract: An expandable sleeved stent comprises a stent and a sleeve. The stent comprises a tubular body with: first and second axial ends; a latticed peripheral wall; and at least two arms that, upon radial expansion of the tubular body from a crimped condition to an expanded condition, protrude radially from the latticed peripheral wall, the free end of each arm being radially displaceable relative to the adjacent latticed peripheral wall. The sleeve: (a) extends from the first axial end of the tubular body and circumferentially covers at least a portion of the radial outer surface of the latticed peripheral wall between the free ends of the arms and the first axial end of the tubular body; (b) bridges the spaces between the portions of the latticed peripheral wall adjacent the arms; and the free ends of the arms; and (c) is secured to either: (i) the arms; or (ii) the tubular body in the vicinity between the free ends of the arms and the second axial end of the tubular body.

Abstract: A crimping device includes a housing defining a bore and at least three extendable mechanisms angularly equispaced about the axis of the bore. Each of the extendable mechanisms include: (i) a first elongate arm hingedly connected at or near a first axial end of the first arm to the housing; (ii) a second elongate arm hingedly connected at or near a first axial end of the second arm to the housing, wherein: the first axial ends of the first and second arms are displaceable relative to each other; and the first and second arms are hingedly connected at or near their second axial ends to each other.

Abstract: The invention provides a non-occlusive dilation and deployment catheter device which includes a catheter having a distal end configured for entering a patient and a proximal end for manipulating the device. A distender is provided at or near the distal end which is movable between a collapsed configuration which enables introduction and removal thereof to and from an operative site in a vessel or other hollow organ of a patient, and an expanded configuration in which the distender assumes a radially expanded condition and defines a flow path therethrough. The distender includes a substantially tubular, radially expandable frame having a plurality of spaced apertures and at least one inflatable tube threaded through the apertures and shaped to extend in a spiral when inflated. The distender is movable to the expanded configuration by inflating the tube, and movable to the collapsed configuration from the expanded configuration by deflating the tube.

Abstract: A valve leaflet connecting device includes: a base; and first and second followers extending from the base. A first arm extends from the first follower in a direction away from the second follower and away from the base to define an acute angle between the first follower and first arm for capturing a first leaflet there between.

Abstract: A catheter delivery system (10) includes: (i) an introducer sheath (12); (ii) a catheter (14) disposed at least partially within the introducer sheath and movable axial along the introducer sheath; (iii) an invaginating tube (16) sealably secured at or near a first axial end (16a) of the invaginating tube to the introducer sheath at or near a first axial end (12 a) of the introducer sheath; (iv) a runner (28) slidably connected to the catheter; (v) the invaginating tube being sealably secured at or near a second axial end (16b) of the invaginating tube to the runner, such that the runner with inavaginating tube secured thereto is sealably connected to the catheter and movable axially along at least a portion of the catheter; and (vi) means for pressurising the annular space defined between the introducer sheath, the catheter and the invaginating tube.

Abstract: A valve leaflet connecting device includes: a base; and first and second followers extending from the base. A first arm extends from the first follower in a direction away from the second follower and away from the base to define an acute angle between the first follower and first arm for capturing a first leaflet there between.

Abstract: An expandable stent comprises a cylindrical wall made up of lattice members connected to each other, at least one first arm and at least one second arm. The first arm comprises: a first non-linear member that is connected at each of its axial ends to a lattice member at respective first junctions; a second non-linear member connected at each axial end to a lattice member; and at least one bridge member extending between the first member and the second member. The second arm comprises: a first non-linear member that is connected at each of its axial ends to a lattice member; a second non-linear member connected at each axial end to a lattice member; and at least one bridge member extending between the first member and the second member. The second member of the first arm is generally U-shaped, extending from its axial ends towards: (i) a first axial end of the stent; and (ii) towards the bridge of the first arm.

Abstract: The invention provides a heart valve leaflet capture device (250) comprising a cardiac catheter probe having a proximal end for manipulating the device (250) and a distal end terminating in a transvalve element (256). The transvalve element (256) is configured to pass through a heart valve generally parallel to a longitudinal axis of the catheter and includes two or three leaflet gripping elements (252). The leaflet gripping elements (252) are individually movable by operation of an associated actuating mechanism (260) between a radially retracted position, in which they are withdrawn with respect to the transvalve element (256), and a capture position, in which they diverge outwardly at an acute angle from the transvalve element (256). In the capture position, each leaflet gripping element (252) defines a convergent capture zone that is directed towards the edges of a target valve leaflet and in which the target valve leaflet may be captured.

Abstract: Partially crosslinked polyurethane polymers comprising diisocyanates and aliphatic hydrocarbon soft segments with a short-chain diol chain extender and a multifunctional amine and/or alcohol crosslinker to provide a polyurethane polymer with useful properties for the production of medical implant devices such as heart valves, are described. The polymers have an unexpected linear elastic region in a range from 5-100% and preferably between 10-35%. In some embodiments the polyurethanes are a thermally convertible gel formulation which may be converted to a liquid formulation by extended heating to render the polymer suitable for solvent processing techniques such as casting, spraying, spinning, etc. The invention also provides for living hinge polyurethane polymers which are thermally modifiable from a gel to a liquid and reaction injection moulded (RIM) polyurethanes with an enhanced flex life.

Abstract: An invaginating device includes an inner elongate member and an outer flexible tube with invaginated axial ends. The outer flexible tube is: disposed at a first axial end of the inner elongate member; concentric with the inner elongate member; sized to provide a radial gap there between; sealably connected at the axial ends of the outer flexible tube to the inner elongate member, with the axial spacing between such sealed axial ends being less than the axial length of the outer tube; and extendable to protrude from the first axial end of the inner elongate member and retractable to reduce such protrusion from the first axial end of the inner elongate member. Fluid contained within the radial gap defined between the inner elongate member and the outer flexible tube is either pressurized or a non-compressible fluid.

Abstract: A prosthetic heart valve (10) which includes a stent (14) having three leaflets (12) attached thereto is provided. The stent (14) is compressible so as to be capable of being introduced into a patient's body through a minimally invasive procedure and has a ring-like body (16) defining in its height three arch-shaped elements (18). Each element (18) includes an arc (20) and a pair of haunches (22) extending from opposite sides thereof, with three commissural posts (26) formed by the haunches (22) of adjacent elements (18). The leaflets (12) each have an attachment edge (28) and a free edge (30) with a belly (32) extending therebetween. The leaflets (12) are movable between a coapted condition, in which the free edges (30) abut and prevent fluid flow through the valve (10), and an open condition, in which fluid flow through the valve (10) is permitted. The leaflets (12) are made from a polymeric material and are moulded directly onto the stent (14) so as to provide for continuous attachment thereof.

Abstract: An orientation device (200) for use in mitral valve repair surgery is provided and includes a catheter (202) catheter insertable percutaneously through the mitral valve into a chamber of a heart. At least one pressure sensor (216, 218) and two generally arcuate commissural arms (208, 210) are provided at or near the distal end (204) of the catheter (202). The arms (208, 210) are deployable from a stowed condition, in which the catheter (202) can be introduced percutaneously into the heart, to an operative condition in which they extend outwardly in generally opposite directions. Each arm (208, 210) is shaped to be locatable within a mitral valve commissure and has an indentation (212) shaped to extend, in use, at least partially about a mitral valve commissure to limit movement of the device (200) relative to the mitral valve in the axial direction of the catheter (202).

Abstract: A crimping device includes a housing defining a bore and at least three extendable mechanisms angularly equispaced about the axis of the bore. Each of the extendable mechanisms include: (i) a first elongate arm hingedly connected at or near a first axial end of the first arm to the housing; (ii) a second elongate arm hingedly connected at or near a first axial end of the second arm to the housing, wherein: the first axial ends of the first and second arms are displaceable relative to each other; and the first and second arms are hingedly connected at or near their second axial ends to each other.

Abstract: An expandable stent comprises a cylindrical wall made up of lattice members connected to each other, at least one first arm and at least one second arm. The first arm comprises: a first non-linear member that is connected at each of its axial ends to a lattice member at respective first junctions; a second non-linear member connected at each axial end to a lattice member; and at least one bridge member extending between the first member and the second member. The second arm comprises: a first non-linear member that is connected at each of its axial ends to a lattice member; a second non-linear member connected at each axial end to a lattice member; and at least one bridge member extending between the first member and the second member. The second member of the first arm is generally U-shaped, extending from its axial ends towards: (i) a first axial end of the stent; and (ii) towards the bridge of the first arm.

Abstract: The invention provides an inflatable insertion device capable of being percutaneously introduced into a patient's body. The insertion device comprises an inflatable element having a distal end and a proximal end and which is operable between a collapsed condition and an inflated condition by introducing an inflating fluid therein. An elongate member extends internally of the inflatable element from its distal end. The internal member is capable of being withdrawn towards the proximal end of the inflatable element to result in the distal end of the element being withdrawn towards the proximal end internally of the element. The invention further provides a locating device comprising a catheter having a catheter tube fitted with one or more inflatable insertion devices at a distal end thereof.

Abstract: An orientation device (200) for use in mitral valve repair surgery is provided and includes a catheter (202) catheter insertable percutaneously through the mitral valve into a chamber of a heart. At least one pressure sensor (216, 218) and two generally arcuate commissural arms (208, 210) are provided at or near the distal end (204) of the catheter (202). The arms (208, 210) are deployable from a stowed condition, in which the catheter (202) can be introduced percutaneously into the heart, to an operative condition in which they extend outwardly in generally opposite directions. Each arm (208, 210) is shaped to be locatable within a mitral valve commissure and has an indentation (212) shaped to extend, in use, at least partially about a mitral valve commissure to limit movement of the device (200) relative to the mitral valve in the axial direction of the catheter (202).