856 results about "Prosthetic heart" 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 delivery system for delivering a prosthetic heart valve to a native valve site within the human vasculature. The prosthetic valve is disposed on a balloon at the end of a balloon catheter. The balloon catheter passes through a delivery sleeve assembly and handle. A pull wire travels from the handle to a distal end of the delivery sleeve assembly. Actuation of the handle pulls on the pull wire, which causes openings in a slotted tube of the delivery sleeve assembly to close, thus causing the delivery sleeve assembly to bend. A stretchable cover is placed over the slotted tube for biasing the steerable catheter toward a straight position. Once advanced to the native valve site, the prosthetic valve is deployed by inflating the balloon.

Prosthetic valves and their component parts are described, as are prosthetic valve delivery devices and methods for their use. The prosthetic valves are particularly adapted for use in percutaneous aortic valve replacement procedures. The delivery devices are particularly adapted for use in minimally invasive surgical procedures.

Expandable heart valves for minimally invasive valve replacement surgeries are disclosed. In a first embodiment, an expandable pre-assembled heart valve includes a plastically-expandable annular base having plurality of upstanding commissure posts. A tubular flexible member including a prosthetic section and a fabric section is provided, with the prosthetic section being connected to the commissure posts and defining leaflets therebetween, and the fabric section being attached to the annular base. In a second embodiment, an expandable heart valve includes an annular tissue-engaging base and a subassembly having an elastic wireform and a plurality of leaflets connected thereto. The annular base and subassembly are separately stored and connected just prior to delivery to the host annulus. Preferably, the leaflet subassembly is stored in its relaxed configuration to avoid deformation of the leaflets. The expandable heart valves maybe implanted using a balloon catheter. Preferably, the leaflets of the heart valves are secured to the commissure regions of the expandable stents using a clamping arrangement to reduce stress.

A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment.

Apparatus for delivering a prosthetic heart valve into a patient by means that are less invasive than conventional open-chest, open-heart surgery. The prosthetic valve may be collapsed while in a delivery device. When the valve reaches the desired implant site in the patient, the valve can be released from the delivery device, which allows the valve to re-expand to the configuration in which it can function as a heart valve. For example, the delivery device may be constructed to facilitate delivery of the prosthetic valve into the patient via the apex of the patient's heart.

A percutaneous heart valve assembly includes a gasket member or other first prosthesis and a valve member or other second prosthesis. The first and second prostheses are contractible from an enlarged or relaxed condition into a contracted or delivery condition. The prostheses may be loaded into the same or separate catheters or other delivery devices for delivery through a patient's vasculature to an implantation site, e.g., a biological annulus within a heart. The first prosthesis may be deployed adjacent or within the biological annulus and secured at least partially into the biological annulus. The second prosthesis may then be deployed adjacent the biological annulus, expanded, and docked to the first prosthesis. In one embodiment, the first and / or second prostheses may be advanced over one or more sutures or other filaments secured to tissue surrounding or adjacent the biological annulus.

A heart valve prosthesis (100) comprises a housing component (110) and a valve component (130). The housing component (110) comprises a housing body (111) having a housing passage (112) extending therethrough. The housing body (111) is configured to be located in, or adjacent to and communicating with, a native valve orifice (16) of a heart (10) and to engage structure of the heart (10) to fix the housing body (111) in relation to the valve orifice (161). The housing component (111) is collapsible for delivery via catheter (2). The valve component (130) comprises a valve body (131) having a valve passage (132) extending therethrough. The valve body (131) is configured to be fixed within the housing passage (112) with the valve passage (132) extending along the housing passage (112). One or more flexible valve elements (131) is / are secured to the valve body and extend across the valve passage (132) for blocking blood flow in a first direction through the valve passage (132) whilst allowing blood flow in the opposing direction. The valve component (130) is collapsible for delivery via catheter (2) separate to the housing component (110). An associated method of replacing a failed or failing heart valve utilising the heart valve prosthesis (100) is also disclosed.

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).

A surgical stapler for securing a prosthetic heart valve within a patient generally includes a first cylindrical portion for carrying at least one staple assembly on a distal end thereof; a second cylindrical portion positioned concentrically about the first cylindrical portion and having a camming arm on a distal end thereof, the camming arm configured to cam the at least one staple assembly radially outward and drive the at least one staple assembly distally such that a first leg of the at least one staple assembly penetrates a cuff of the prosthetic heart valve and a second leg of the at least one staple assembly pierces a portion of heart tissue surrounding the prosthetic heart valve, as the second cylindrical portion is moved distally relative to the first cylindrical portion; and a third cylindrical portion positioned concentrically about the second cylindrical portion and having an anvil flange on a distal end thereof, the anvil flange configured to crimp the second leg of the at least one staple assembly toward the first leg of the at least one staple assembly to secure the prosthetic heart valve to the surrounding heart tissue as the third cylindrical portion is moved relative to the second cylindrical portion. A method of installing a heart valve within a patient which includes the steps of accessing a site within a heart from which a natural heart valve has been removed; lowering a prosthetic heart valve into position within the site in the heart; positioning a surgical stapler having at least one staple assembly removably held on a distal end thereof adjacent the prosthetic heart valve within the site in the heart; driving a first leg of the at least one staple assembly through a peripheral cuff of the prosthetic heart valve; and crimping a second leg of the at least one staple assembly in a direction toward the first leg such that the second leg pierces a portion of heart tissue surrounding the prosthetic heart valve, thereby securing the prosthetic heart valve to the surrounding heart tissue.

A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment.

A valve prosthesis includes a plurality of flexible leaflets and a stent having a central lumen. A slit in the stent extends from the central lumen to an outer surface. An occluding portion of the flexible leaflets extends across the central lumen and an attachment portion extends from the central lumen through the slit and forms a sewing cuff for attachment to a patient's tissue. The attachment portion forms a sewing cuff for attachment to native heart tissue.

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 delivery system and method for delivering a prosthetic heart valve to the aortic valve annulus. The system includes a delivery catheter having a steering mechanism thereon for delivering a balloon-expandable prosthetic heart valve to the aortic annulus in an antegrade fashion through an introducer passing into the left ventricle through its apex. The introducer may have a more floppy distal section than a proximal section to reduce trauma to the heart wall while preserving good operating field stability. The delivery catheter includes a deflecting segment just proximal to a distal balloon to facilitate positioning of the prosthetic heart valve in the proper orientation within the aortic annulus. A trigger in a catheter handle may be coupled to a deflection wire that actuates the deflecting segment, while a slider in the handle controls retraction of a valve pusher. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.

A tubular prosthetic semilunar or atrioventricular heart valve is formed by cutting flat, flexible leaflets according to a pattern. The valve is constructed by aligning the side edges of adjacent leaflets so that the leaflet inner faces engage each other, and then suturing the leaflets together with successive stitches along a fold line adjacent the side edges. The stitches are placed successively from a proximal in-flow end of each leaflet toward a distal out-flow end. During operation, when the leaflets open and close, the leaflets fold along the fold line. Distal tabs extend beyond the distal end of each leaflet. The successive stitches terminate proximal of the distal tab portion so that no locked stitches are placed along the distal portion of the fold line. The tab portions of adjacent leaflets are folded over each other and sewn together to form commissural attachment tabs. The commissural tabs provide commissural attachment points to accommodate sutures and the like in order to secure the tab to a vessel wall, if a semilunar valve, and papillary muscles and / or chordae tendineae if an atrioventricular valve.

A prosthetic heart value assembly comprising a prosthetic heart valve and a fixation band. The fixation band comprises a tubular frame and a tube. The tubular frame comprises longitudinally-extending members having hooks on their distal ends and fixation means on proximal ends, and a stabilizing laterally-extending member. The tube is positioned inside the longitudinally-extending members, a distal end of the tube being everted over the hooks. A sewing cuff is formed in the tube. The prosthetic valve is secured to the fixation band by suturing a prosthetic valve sewing cuff to a fixation band sewing cuff. The prosthetic valve and fixation band are advanced to the valve's seat. The fixation band's hooks are passed through the wall of the everted tube and into surrounding tissue and the fixation band's fixation means are deployed.

Prosthetic valves and their component parts are described, as are prosthetic valve delivery devices and methods for their use. The prosthetic valves are particularly adapted for use in percutaneous aortic valve replacement procedures. The delivery devices are particularly adapted for use in minimally invasive surgical procedures.

A tubular prosthetic semilunar or atrioventricular heart valve is formed by cutting flat, flexible leaflets according to a pattern. The valve is constructed by aligning the side edges of adjacent leaflets so that the leaflet inner faces engage each other, and then suturing the leaflets together with successive stitches along a fold line adjacent the side edges. The stitches are placed successively from a proximal in-flow end of each leaflet toward a distal out-flow end. During operation, when the leaflets open and close, the leaflets fold along the fold line. Distal tabs extend beyond the distal end of each leaflet. The successive stitches terminate proximal of the distal tab portion so that no locked stitches are placed along the distal portion of the fold line. The tab portions of adjacent leaflets are folded over each other and sewn together to form commissural attachment tabs. The commissural tabs provide commissural attachment points to accommodate sutures and the like in order to secure the tab to a vessel wall, if a semilunar valve, and papillary muscles and / or chordae tendineae if an atrioventricular valve.

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.