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: 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 The internal member is capable of being withdrawn towards the proximal end of the inflatable element to result in the distal end of the element being withdrawn towards the proximal end internally of the element.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: A dilatation device 10 includes a support 14 and at least one inflatable tube 16. The inflatable tube is wound helically around the support and also defines a series of inflatable zones 26 along its length, with successive inflatable zones spaced by an intermediate zone 28 that is more resistive to radial expansion than the inflatable zones. The inflatable tube further defines a fluid inlet 22, 24 for: introducing fluid to inflate the inflatable zones; and extracting fluid from the inflatable tube to deflate it, with each inflatable zone being in fluid communication with its successive inflatable zones via the intermediate zones. The axial critical buckling load of the inflatable zones is less than the radial critical buckling load of the inflatable zones, to cause the inflatable zones to concertina axially when the inflatable tube is depressurized, thereby causing the intermediate zones to displace towards 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: 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: 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: A dilatation device 10 includes a support 14 and at least one inflatable tube 16. The inflatable tube is wound helically around the support and also defines a series of inflatable zones 26 along its length, with successive inflatable zones spaced by an intermediate zone 28 that is more resistive to radial expansion than the inflatable zones. The inflatable tube further defines a fluid inlet 22, 24 for: introducing fluid to inflate the inflatable zones; and extracting fluid from the inflatable tube to deflate it, with each inflatable zone being in fluid communication with its successive inflatable zones via the intermediate zones. The axial critical buckling load of the inflatable zones is less than the radial critical buckling load of the inflatable zones, to cause the inflatable zones to concertina axially when the inflatable tube is depressurized, thereby causing the intermediate zones to displace towards each other.

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: 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: 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: 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: 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 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: A stent deployment device over which a stent is securable for the purpose of delivery into an operative position in a human body is provided. The device comprises a plurality of elongate wings, each of which has a length consistent with the length of a stent to be deployed using the deployment device, the wings being arranged circumferentially about a central body which extends from, and is operable through, a catheter. The wings are movable between a radially withdrawn delivery position and expanded positions in which they are displaced radially outwards of the body. A flow path is defined internally of the wings in the expanded positions thereof and a temporary valve is provided in such flow path to permit the flow of blood though the flow path predominantly in one direction. An inflatable annular balloon is preferably provided over the wings to cause final expansion of the stent. Locator arms are deployable from the body to assist in locating the body within a natural heart valve.

Abstract: A vascular prosthesis is constructed from a structure having interconnected, helically oriented channel-porosity to allow oriented ingrowth of connective tissue into a wall of the prosthesis. The prosthesis can have a small internal diameter of 6 mm or less. Several different methods can be used to produce the prosthesis, including a fiber winding and extraction technique, a melt extrusion technique, and a particle and fiber extraction technique using either a layered method or a continuous method. Furthermore, mechanical properties of prosthesis are matched with mechanical properties of the host vessel, thereby overcoming problems of compliance mismatch.