293 results about "Valve prosthesis" patented technology

A valve prosthesis device is disclosed suitable for implantation in body ducts. The device comprises support stent, comprised of a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location, the support stent provided with a plurality of longitudinally rigid support beams of fixed length; valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet. When flow is allowed to pass through the valve prosthesis device from the inlet to the outlet the valve assembly is kept in an open position, whereas a reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly providing blockage to the reverse flow.

A valve prosthesis which is especially useful in the case of aortic stenosis and capable of resisting the powerful recoil force and to stand the forceful balloon inflation performed to deploy the valve and to embed it in the aortic annulus, comprises a collapsible valvular structure and an expandable frame on which said valvular structure is mounted. The valvular structure is composed of physiologically compatible valvular tissue that is sufficiently supple and resistant to allow the valvular structure to be deformed from a closed state to an opened state. The valvular tissue forms a continuous surface and is provided with strut members that create stiffened zones which induce the valvular structure to follow a patterned movement in its expansion to its opened state and in its turning back to its closed state.

A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

The invention concerns an assembly comprising a valve prosthesis to be implanted and a support receiving said valve. The support comprises: at least a tubular portion made of a pliable material slightly stretchable in the circumferential direction; means for fixing said tubular portion to the wall of the corporeal duct; and a plurality of elongated reinforcing elements, arranged on the circumference of said tubular portion and linked to said tubular portion independently of one another; the valve is linked at least partly to said elongated reinforcing elements, in particular at the commissures of its leaflets, and said elongated reinforcing elements jointly form, in extended position, a structure having a predetermined diameter that ensures sufficient extension of said valve.

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.

Methods and apparatus are provided for valve repair or replacement. In one embodiment, the method comprises providing an apparatus having a valve prosthesis, a valve leaflet support and a valve excisor, the apparatus having a first configuration and a second configuration; accessing the aortic root without placing the patient on a heart-lung machine; advancing the apparatus in the first configuration where the valve leaflet support is advanced through a valve, wherein the support is positioned below a valve annulus; expanding the apparatus into a second configuration so that the support will engage the valve; and moving the valve leaflet support and valve excisor together to remove leaflets of the valve. Penetrating members may be advanced into the tissue wherein the penetrating members may act as fasteners to hold the prosthesis in place.

A valve prosthesis for implantation in the body by use of a catheter includes a stent made from an expandable cylinder-shaped thread structure including several spaced apices. The elastically collapsible valve is mounted on the stent as the commissural points of the valve are secured to the projecting apices. The valve prosthesis can be compressed around balloons of the balloon catheter and inserted in a channel, for instance, in the aorta. When the valve prosthesis is placed correctly, the balloons are inflated to expand the stent and wedge it against the wall of the aorta. The balloons are provided with beads to ensure a steady fastening of the valve prosthesis on the balloons during insertion and expansion. The valve prosthesis and the balloon catheter make it possible to insert a cardiac valve prosthesis without a surgical operation involving opening the thoracic cavity.

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 is sized and configured to rest within a blood path subject to antegrade and retrograde blood flow. A trestle element on the prosthesis extends across the blood path. A leaflet assembly is suspended from the trestle element and extends into the blood path in alignment with blood flow. At least one mobile leaflet member on the leaflet assembly is sized and configured to assume orientations that change according to blood flow direction. The mobile leaflet member has a first orientation that permits antegrade blood flow and a second orientation that resists retrograde blood flow. The valve prosthesis, when implanted in a heart chamber or great vessel, serves to supplement and / or repair and / or replace native one-way heart valve function.

Valve prostheses are disclosed that are adapted for secure and aligned placement relative to a heart annulus. The valve prostheses may be placed in a non-invasive manner, e.g., via trans-catheter techniques, and may be positioned / repositioned until proper alignment and positioning is achieved. The valve prosthesis may include a resilient ring, a plurality of leaflet membranes mounted with respect to the resilient ring, and a plurality of positioning elements movably mounted with respect to the flexible ring, each of the positioning elements defining a first tissue engaging region and a second tissue engaging region spaced from the first tissue engaging region. The positioning elements are adapted to substantially completely invert by rotating relative to the resilient ring between a first position in which each of the first and second tissue engaging regions is inwardly directed for facilitating positioning of the valve prosthesis within a delivery catheter, and a second position in which each of the first and second tissue engaging regions is outwardly directed for engaging tissue. The valve prosthesis may also include a valve skirt mounted with respect to the resilient ring.

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.

The invention concerns an assembly comprising a valve prosthesis to be implanted and a support receiving said valve. The support comprises: at least a tubular portion made of a pliable material slightly stretchable in the circumferential direction; means for fixing said tubular portion to the wall of the corporeal duct; and a plurality of elongated reinforcing elements, arranged on the circumference of said tubular portion and linked to said tubular portion independently of one another; the valve is linked at least partly to said elongated reinforcing elements, in particular at the commissures of its leaflets, and said elongated reinforcing elements jointly form, in extended position, a structure having a predetermined diameter that ensures sufficient extension of said valve.

A valve delivery device and method of use is provided. In one embodiment, a method for attaching a valve prosthesis to a target tissue includes providing a ring having a portion defining a groove and a plurality of fasteners coupled to the ring. A portion of the valve prosthesis is placed in the groove on the ring. The valve prosthesis portion in the groove is then secured to the ring. The ring is mounted on a delivery device and the delivery device is positioned so that the fasteners will engage the target tissue when the fasteners are deployed. A shaped plunger member may then deployed through an interior of the ring to swing said fasteners from a first position to a second tissue engagement position.

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.

Valve prosthesis systems and methods / systems for placement of such valve prostheses are provided that facilitate efficient, reliable and minimally invasive delivery modalities. The placement systems and methods permit remote manipulation and positioning of the valve prosthesis such that desirable placement relative to anatomical structures, e.g., the heart annulus, may be achieved. The valve prosthesis includes a resilient ring, a plurality of leaflet membranes mounted with respect to the resilient ring, and a plurality of positioning elements movably mounted with respect to the flexible ring. The delivery system includes a first elongate element that terminates at the valve prosthesis and is manipulable by an operator to remotely rotate the positioning elements relative to the flexible ring. A second elongate element terminates at the valve prosthesis and is manipulable by an operator to remotely advance the valve prosthesis downward into an anatomical annulus. The second elongate element may be manipulated to remotely advance the valve prosthesis into the anatomical annulus to assume a position for supporting post-implantation function of the valve prosthesis in situ. The first elongate element may be further manipulated to remotely rotate the positioning element relative to the flexible ring to cause the positioning element to engage tissue associated with the anatomical annulus and to thereby maintain the post-implantation position of the valve prosthesis in situ. Methods for valve prosthesis deployment are also provided.

A valve prosthesis which is especially useful in the case of aortic stenosis and capable of resisting the powerful recoil force and to stand the forceful balloon inflation performed to deploy the valve and to embed it in the aortic annulus, comprises a collapsible valvular structure and an expandable frame on which said valvular structure is mounted. The valvular structure is composed of physiologically compatible valvular tissue that is sufficiently supple and resistant to allow the valvular structure to be deformed from a closed state to an opened state. The valvular tissue forms a continuous surface and is provided with strut members that create stiffened zones which induce the valvular structure to follow a patterned movement in its expansion to its opened state and in its turning back to its closed state.

A valve prosthesis includes one or more anti-paravalvular leakage components coupled to a stent. The anti-paravalvular leakage component may encircle the stent and include a radially expandable control ring coupled to an unattached edge of a flexible skirt which extends the unattached skirt edge outwardly away from the stent and against the native heart valve to form an open-ended annular pocket around the stent. The anti-paravalvular leakage component may encircle the perimeter of the stent and include a flexible skirt having opposing edges coupled to the stent to form one or more enclosed compartments around the stent. Each compartment includes a one-way valve which allows for blood flow into the compartment but prevents blood flow out of the compartment. The anti-paravalvular leakage component may be at least one flap that is coupled to an inner surface of the stent and formed of a flexible material moveable by blood flow.

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.

A heart valve assembly includes an annular prosthesis and a valve prosthesis. The annular prosthesis includes an annular ring for dilating tissue within a biological annulus and a conformable sewing cuff extending radially from the annular member. The valve prosthesis includes a frame and a valve component. The annular ring is introduced into the biological annulus to dilate tissue surrounding the biological annulus and the sewing cuff conforms to tissue above the biological annulus. Fasteners are directed through the sewing cuff to secure the annular prosthesis to the biological annulus. The annular prosthesis may include a baleen element for biasing fabric on the annular ring outwardly to enhance sealing against the biological annulus. A valve prosthesis is then advanced into the sinus cavity, and secured relative to the annular prosthesis. The sewing cuff may enhance a seal between the valve prosthesis and annular prosthesis.

This invention relates to the design and function of a device which allows for retrieval of a previously implanted valve prosthesis from a beating heart without extracorporeal circulation using a transcatheter retrieval system, including a guide component to facilitate the compression of the valve and retraction into a retrieval catheter, as well as an improved prosthetic transcatheter heart valve having one or more of: a series of radially extending tines having a loop terminus to improve sealing a deployed prosthetic mitral valve against hemodynamic leaking, a pre-compressible stent-in-stent design, or an articulating cuff attached to a covered stent-valve and a commissural sealing skirt structure attached to the underside of the articulating cuff.

A valve prosthesis device is disclosed suitable for implantation in body ducts. The device comprises a support stent, comprised of a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location, and a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet. The support stent is provided with a plurality of longitudinally rigid support beams of fixed length. When flow is allowed to pass through the valve prosthesis device from the inlet to the outlet, the valve assembly is kept in an open position, whereas a reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly providing blockage to the reverse flow. The device is configured so that retrograde flow will be altered from laminar flow and directed towards the leaflets to effect closing.

A method for making a bioprosthetic heart valve includes providing a non-contact cutting apparatus and a layer of tissue. The non-contact cutting apparatus may include a laser cutting system or high pressure water jet system. A leaflet is cut from the layer of tissue using a predefined template, and a plurality of alignment holes in the leaflet are created in the leaflet, e.g., along a peripheral edge. A support structure is provided having a plurality of alignment holes corresponding to alignment holes in the leaflet. The leaflet is secured to the support structure by securing one or more sutures through corresponding alignment holes in the leaflet and the support structure to provide a leaflet subassembly. A bioprosthetic heart valve is made by securing a set of leaflet subassemblies to a frame.

A valve prosthesis, implantation device, and methods for use are provided. The implantation device utilizes movable claspers for both positioning and anchoring the valve prosthesis. Alternative designs of the devices allow different methods for minimally invasive implantation of a sutureless valve prosthesis, including transapical and transcatheter approaches. Also provided is a delivery device for delivery of a medical prosthesis though minimally invasive means.

Multiple component heart valves and apparatus and methods for implanting them are provided. The heart valve generally includes a first annular prosthesis and a second valve prosthesis. The first prosthesis includes an annular member compressible from a relaxed condition to a contracted condition to facilitate delivery into a biological annulus, the annular member being resiliently expandable towards the relaxed condition. The first prosthesis also includes guide rails extending therefrom. The second prosthesis includes an annular frame, valve elements, and receptacles for receiving respective guide rails therethrough when the second prosthesis is directed towards the first prosthesis. In addition, a valve holder may releasably carry the valve prosthesis that includes channels for receiving respective guide rails therethrough when the guide rails are received through the valve prosthesis. A delivery tool is also provided that includes an actuator for selectively compressing the annular member into the contracted condition.

A valve delivery device is provided. The device comprises a heart valve prosthesis support having a proximal portion and a distal portion; a plurality of fasteners ejectably mounted on the support; a heart valve prosthesis being releasably coupled to said distal portion of said heart valve prosthesis support; and where the heart valve prosthesis and support are configured for delivery to the heart through an aortotomy formed in the patient's aorta. The device may include an anvil movable along a longitudinal axis of the device to engage tissue disposed between the anvil and the valve prosthesis.

A heart valve assembly includes a first annular prosthesis for implantation within a tissue annulus, a second valve prosthesis, and a plurality of magnets on the first and second prostheses to secure the second prosthesis to the first prosthesis. In one embodiment, the magnets are arranged to allow the second prosthesis to be secured to the first prosthesis in a predetermined angular orientation. During use, the first annular prosthesis is implanted into the annulus, and the second valve prosthesis is inserted into the annulus. The magnets orient the second prosthesis relative to the first prosthesis to align the second prosthesis with the first prosthesis in a predetermined angular orientation; and secure the second prosthesis to the first prosthesis in the predetermined angular orientation.

Valve prostheses are disclosed that are adapted for secure and aligned placement relative to a heart annulus. The valve prostheses may be placed in a non-invasive manner, e.g., via transcatheter techniques. The valve prosthesis may include a resilient ring, a plurality of leaflet membranes mounted with respect to the resilient ring, and a plurality of positioning elements movably mounted with respect to the flexible ring. Each of the positioning elements defines respective proximal, intermediate, and distal tissue engaging regions cooperatively configured and dimensioned to simultaneously engage separate corresponding areas of the tissue of an anatomical structure, including respective first, second, and third elongate tissue-piercing elements. The proximal, distal, and intermediate tissue-engaging regions are cooperatively configured and dimensioned to simultaneously engage separate corresponding areas of the tissue of an anatomical structure so as to stabilize a position of the valve prosthesis with respect to the anatomical structure, including wherein for purposes of so simultaneously engaging the separate corresponding areas of tissue, at least one of the first, second, and third elongate tissue-piercing elements is pointed at least partially opposite the direction of blood flow, and at least another thereof is pointed at least partially along the direction of blood flow. The valve prosthesis may also include a skirt mounted with respect to the resilient ring for sealing a periphery of the valve prosthesis against a reverse flow of blood around the valve prosthesis.