Patent Grant
8821569
The present invention relates generally to heart valves that may be implanted within a patient, and, more particularly, to multiple component heart valve assemblies that may be assembled together, and to apparatus and methods for using them.
Prosthetic heart valves can replace defective human valves in patients. For example, one piece valves have been suggested that include sewing rings or suture cuffs that are attached to and extend around the outer circumference of a prosthetic valve. In addition, multiple component valves have also been suggested that include a sewing ring that is separate from a valve component. The sewing rings of either type of prosthetic valve can be tedious and time consuming to secure within a target site, i.e., within an annulus of a heart where a natural heart valve has been removed.
For example, to implant a sewing ring within an annulus of a heart, between twelve and twenty sutures may be secured initially to tissue surrounding the annulus. The sewing ring and/or the entire prosthetic valve may then be advanced or “parachuted” down the sutures into the annulus. Knots may then be tied with the sutures to secure the sewing ring within the annulus, whereupon the sutures may be cut. Consequently, this procedure can be very complicated, requiring management and manipulation of many sutures. The complexity of the procedure also provides a greater opportunity for mistakes and requires a patient to be on cardiopulmonary bypass for a lengthy period of time.
Because the annulus of the heart may not match the circular cross-section of the sewing ring and/or prosthetic valve, the prosthetic valve may not fit optimally within the annulus. As a result, natural blood hemodynamics through and around the valve may be impaired, resulting in clotting, possible emboli production, and eventual calcification of the valve structure.
To address this concern, flexible sewing rings have been suggested for use with multiple component valves. The sewing ring may be implanted within the annulus, e.g., using the procedure described above, i.e., parachuted down an arrangement of sutures. The sewing ring may conform at least partially to the anatomy of the annulus. Alternatively, instead of using sutures, it has also been suggested to drive staples through the sewing ring into the surrounding tissue to secure the sewing ring.
When a mechanical or prosthetic valve is then attached to the sewing ring, however, the valve and sewing ring may not mate together effectively, e.g., if the shape of the sewing ring has been distorted to conform to the annulus, which may also impair natural blood hemodynamics, create leaks, and/or otherwise impair performance of the prosthetic valve.
In addition, less invasive or minimally invasive procedures are often desirable, because they may reduce stress on the patient's body and/or accelerate recovery after a procedure. Such procedures may involve creating smaller access sites and/or even using ports to access a procedure site. During valve replacement, in order to introduce a prosthetic heart valve and/or sewing ring into a patient's heart, the heart must be accessed, e.g., by sternotomy or thoracotomy. The resulting opening must be sufficiently large to permit passage of the prosthetic heart valve and still allow the physician to access and/or observe the site of implantation. Thus, conventional procedures for implanting prosthetic heart valves may not be compatible with less invasive or minimally invasive procedures.
The present invention is directed to prosthetic heart valves that may be implanted within a patient, and, more particularly, to multiple component heart valve assemblies that may be assembled together, and to tools, apparatus, systems, and methods for making and implanting them.
In accordance with one embodiment, a prosthesis is provided for receiving a valve prosthesis to replace a natural or prosthetic heart valve within a biological annulus. The prosthesis may include an annular member implantable within the biological annulus for contacting tissue surrounding the biological annulus, a sewing cuff extending from the annular member, and a plurality of elongate guide rails or other leaders extending from one of the annular member and the sewing cuff for guiding a valve prosthesis towards the prosthesis. Optionally, the annular member may be resiliently compressible, expandable, and/or otherwise biased, and/or may include a collar extending upwardly therefrom, a skirt, one or more guide shields, and/or other components.
In accordance with another embodiment, a prosthesis is provided for receiving a valve prosthesis to replace a natural or prosthetic heart valve within a biological annulus. The prosthesis may include an annular member that is compressible radially inwardly from a relaxed or expanded condition to a contracted condition to facilitate delivery into a biological annulus. When the annular member is released from the contracted condition, the annular member may resiliently expand towards the expanded condition, e.g., to dilate tissue surrounding the biological annulus. Optionally, the prosthesis may include a sewing cuff extending from the annular member, a collar extending upwardly therefrom, a skirt, a plurality of elongate guide rails or other leaders extending from the prosthesis for guiding a valve prosthesis member towards the prosthesis, and/or other components.
In accordance with yet another embodiment, a prosthesis is provided for receiving a valve prosthesis to replace a natural or prosthetic heart valve within a biological annulus. The prosthesis may include an annular member, and a plurality of guide rails or other leaders extending from the annular member. Each of the leaders may include a proximal end, a distal end secured to the annular member, and one or more ratchets, clasps, locking tabs, or other retention elements or connectors, e.g., configured to allow a valve member to be directed distally but not proximally over the connectors. In an exemplary embodiment, each of the connectors may include a tapered proximal surface and a blunt distal surface. The connectors may be spaced a predetermined distance from the annular member to secure the valve member against or immediately adjacent the annular member. Optionally, the annular member may be compressible radially inwardly from a relaxed or expanded condition to a contracted condition to facilitate delivery into a biological annulus, resiliently expandable towards the expanded condition, and/or otherwise biased.
In accordance with still another embodiment, a heart valve assembly is provided that includes a first annular prosthesis implantable within a biological annulus, a second valve prosthesis, and a plurality of elongate guide rails or other leaders extending from the first prosthesis for guiding the second prosthesis into engagement with the first prosthesis. In exemplary embodiments, the second prosthesis may be a mechanical valve or a bioprosthetic valve, e.g., including multiple tissue leaflets carried by a frame.
Optionally, the second prosthesis may include a plurality of receptacles or other features for receiving respective leaders. For example, the features may be ports or other receivers fixed to a frame or wall of the second prosthesis, a plurality of tubular members that may be removable from a frame, fabric covering, or other portion of the second prosthesis, and the like.
In one embodiment, one or more connectors may be provided on at least one of the first and second prostheses for securing the second prosthesis to the first prosthesis. For example, the one or more connectors may include one or more cooperating clips, detents, and the like that self-engage one another when the second prosthesis is directed towards the first prosthesis. In addition, or alternatively, the leaders may include one or more ratchets, clasps, locking tabs, or other retention elements or connectors for securing the second prosthesis against or immediately adjacent the first prosthesis.
In addition or alternatively, the first prosthesis may include an annular member, a sewing cuff extending radially from the annular member, and/or a skirt to enhance sealing between the first prosthesis and surrounding tissue. In one embodiment, the first prosthesis may also include a collar extending upwardly from the annular member for receiving the valve member. The sewing cuff and/or collar may be formed from resiliently flexible material, e.g., silicone or polyester film, covered with a fabric covering.
In accordance with yet another embodiment, a prosthetic heart valve system is provided that includes a first annular prosthesis, a second valve prosthesis, and one or more delivery tools for introducing the first and/or second prostheses. The first prosthesis may include an annular member implantable within a biological annulus for contacting tissue surrounding the biological annulus, a sewing cuff extending radially outwardly from the annular member, and a plurality of elongate guide rails or other leaders extending from one of the annular member and the sewing cuff for guiding the valve prosthesis towards the sewing cuff.
The one or more delivery tools may include an elongate member including a proximal end, a distal end sized for introduction into a biological annulus, and an actuator for directing the first prosthesis between an expanded or relaxed condition and a contracted condition that facilitates introduction into a biological annulus. In one embodiment, the tool may include a groove or lumen extending between the proximal and distal ends thereof for receiving portions of the leaders therethrough. The actuator may include a handle at the proximal end and one or more mechanisms for locking, tightening, and/or releasing the leaders received in the groove or lumen, e.g., to facilitate tightening and/or loosening the leaders. Thus, the first prosthesis may be releasably engaged with the distal end of the delivery tool when the leaders are secured to the delivery tool. For example, the first prosthesis may be compressible from an expanded or relaxed condition to a contracted condition when the leaders are tensioned, thereby drawing portions of the first prosthesis inwardly towards the distal end of the delivery tool.
In another embodiment, the tool may include a central hub or support and a plurality of movable arms for capturing the first prosthesis between the support and arms. The actuator may direct the arms inwardly and outwardly for directing the first prosthesis to the contracted condition and releasing the first prosthesis from the tool. In an exemplary embodiment, in the contracted condition, the first prosthesis may assume a clover or other multiple lobular shape, while, in the expanded condition, the first prosthesis may have a substantially circular shape. The first prosthesis may be resiliently compressible such that, when the first prosthesis is released, the first prosthesis may resiliently expand towards the expanded condition.
In accordance with still another embodiment, a prosthetic heart valve system is provided that includes a first annular prosthesis and a delivery tool. The first prosthesis may be resiliently compressible from a relaxed or expanded condition to a contracted condition. The delivery tool may include one or more constraints for maintaining the first prosthesis in the contracted condition. For example, the delivery tool may include a plurality of movable arms surrounding a central hub or set of supports, the arms being movable towards and away from the hub for capturing and/or compressing the first prosthesis between the arms and the hub. The first prosthesis may be resiliently compressible such that, when released from the one or more constraints, the first prosthesis may resiliently expand towards the expanded condition.
In accordance with yet another embodiment, a method is provided for implanting a prosthetic heart valve assembly to replace a natural or prosthetic heart valve within a biological annulus below a sinus cavity. A first annular prosthesis may be inserted into the biological annulus while in a contracted condition. In one embodiment, the first prosthesis may include a plurality of guide rails or other leaders extending from the prosthesis. At least a first portion of the first prosthesis may be deployed in the annulus so that the first prosthesis expands to an enlarged state therein, e.g., to at least partially dilate tissue surrounding the biological annulus. In addition or alternatively, the first prosthesis may include a flexible sewing cuff and/or skirt extending around the first prosthesis, which may be disposed supra-annularly and/or sub-annularly when the first portion is deployed in the biological annulus. One or more connectors, e.g., sutures, clips, and the like, may be directed through the first prosthesis, e.g., through the sewing cuff, and adjacent tissue, to secure the first prosthesis relative to the annulus.
A second valve prosthesis, e.g., a mechanical or bioprosthetic valve, may be directed into the annulus adjacent the first prosthesis. For example, the valve prosthesis may be advanced along guide rails or other leaders extending from the first prosthesis until the second prosthesis engages or otherwise contacts the implanted first prosthesis. In one embodiment, the valve prosthesis may be secured to the first prosthesis using one or more connectors, e.g., one or more sutures, clips detents, and/or other cooperating connectors, e.g., on the first prosthesis and a frame of the valve prosthesis. In addition or alternatively, the second prosthesis may be secured to the first prosthesis by ratcheting, locking, or other retention elements or connectors on the leaders.
In accordance with yet another embodiment, a method is provided for implanting a prosthetic heart valve assembly to replace a natural or prosthetic heart valve within a biological annulus below a sinus cavity. A gasket member and delivery tool may be provided with a plurality of elongate guide rails or other leaders extending from the gasket member into a distal end of the delivery tool. The leaders may be secured relative to the delivery tool, e.g., by a locking mechanism. A tightening mechanism on the delivery tool may be actuated to tension the leaders to compress the gasket member to a contracted condition. Alternatively, the delivery tool and gasket member may be initially provided with the leaders already tensioned.
The distal end of the delivery tool may be introduced into the sinus cavity, thereby carrying the gasket member in the contracted state at least partially into the biological annulus. The gasket member may be at least partially released from the delivery tool, e.g., to at least partially dilate tissue surrounding the biological annulus. For example, the locking mechanism on the delivery tool may be released, unlocked, or otherwise actuated to release the gasket member, allowing the gasket member to expand resiliently towards an enlarged condition. The gasket member may be attached to the biological annulus, e.g., using one or more fasteners, such as sutures, clips, and the like.
A valve member may then be introduced into the sinus cavity and secured to the first prosthesis. Optionally, the valve member may be carried by the same delivery tool used to introduce the gasket member or by a separate tool. The valve member may be secured to the gasket member by one or more connectors, e.g., sutures, clips, detents, ratcheting or other retention elements, and the like. In one embodiment, the valve member may be introduced into the sinus cavity along the leaders and/or may be secured to the gasket member by one or more connectors on the leaders.
In accordance with still another embodiment, a valve holder device may be provided for delivering a valve prosthesis into a biological annulus for connection to an annular prosthesis previously introduced into the biological annulus and including one or more guide rails or other leaders extending therefrom. For example, the valve holder device may include one or more elements, e.g., a head, for releasably carrying the valve prosthesis on a distal end of the valve holder device. In addition, the valve holder device may include one or more channels or other receivers for receiving respective leaders, the receivers slidably receiving the leaders while the valve holder device and valve prosthesis are directed towards the annular prosthesis. Optionally, the valve holder device may include one or actuators that may be manipulated to sever the leaders after the valve prosthesis is secured relative to the annular prosthesis.
Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.
The drawings illustrate exemplary embodiments of the invention, in which:
Turning to the drawings,
In one embodiment, the annular ring 18 may have a generally circular shape. Alternatively, the annular ring 18 may have a multi-lobular shape about the circumference, e.g., including three lobes separated by scallops or cusps (not shown) depending upon the anatomy within which the annular ring 18 is to be introduced. The annular ring 18 may be formed from an elastic or superelastic material, for example, metal, such as Nitinol, stainless steel, and the like, a polymer, or a composite material. Such material may facilitate compression and/or expansion of the annular ring 18, as described further below.
In an exemplary embodiment, the annular ring 18 may be cut from a flat sheet of base material having a desired thickness for the annular ring 18, for example, by laser cutting, mechanical cutting, and the like. Thus, the annular ring 18 may be initially formed as a long band of material, having a width corresponding to the desired width of the annular ring 18 and a length corresponding to the desired circumference of the annular ring 18. The band may be wrapped around a mandrel or otherwise restrained in a generally cylindrical shape with the ends adjacent to one another, and the band may be heat treated or otherwise processed to program the generally cylindrical shape into the material to create the annular ring 18. The generally cylindrical shape may include the ends overlapping one another, spaced apart from one another to provide an open “C” shape, or attached to one another. In another exemplary embodiment, the annular ring 18 may be manufactured from a solid rod of material, e.g. Nitinol, stainless steel, a polymer, or composite material, e.g., by machining, electrical discharge machining (“EDM”), laser cutting, or other processes.
Optionally, the annular ring 18 may be heat treated to program a shape memory into the band material, e.g., when the material is in an austentic state. For example, the programmed shape may be an enlarged or relaxed condition, e.g., having a substantially circular shape. The composition of the material may be such that the annular ring 18 transforms to a substantially martensitic state substantially below body temperature, e.g., at or below ambient temperatures (e.g., 20° C. or less). Thus, in the martensitic state (before delivery), the annular ring 18 may be relatively soft such that the annular ring 18 may be plastically compressed or otherwise deformed, e.g., into a contracted condition to facilitate delivery, as described below. A transition temperature of the material may be set such that the annular ring 18 transforms substantially back to an austenitic state close to or at about body temperature (e.g., at 37° C. or more). Thus, once the annular ring 18 is exposed within a patient's body, the annular ring 18 may automatically become biased towards the enlarged condition due the shape memory of the austenitic state.
Alternatively, the material may be programmed to assume an austenitic state at both ambient and body temperatures, but within the elastic or superelastic range of the material. Thus, the annular ring 18 may be elastically compressed into the contracted condition, but may resiliently expand towards the enlarged condition when released from any constraints maintaining the annular ring 18 in the contracted condition.
The annular ring 18 may be at least partially covered with fabric, e.g., for tissue ingrowth, by wrapping fabric around the annular ring 18, while accommodating expansion and contraction of the annular ring 18. For example, at least near the ends of the band forming the annular ring 18, the fabric may not be secured to the annular ring 18, allowing the ends to slide circumferentially relative to the fabric. Optionally, sutures and the like (not shown) may be used to secure the fabric to the annular ring 18 at locations removed from the ends, e.g., at an intermediate location about the circumference of the annular ring 18. Alternatively, the entire annular ring 18 may be free to slide within the fabric wrapped around the annular ring 18.
With continued reference to
Optionally, the sewing cuff 20 may include flexible core material (not shown) that may be attached to or otherwise extend around the annular ring 18. For example, the core may be secured around the annular ring 18 by an interference fit, bonding, fusing a portion of the core to the annular ring 18, e.g., along an upper edge thereof, and the like. The core may be substantially covered with fabric, similar to the annular ring 18.
In an exemplary embodiment, the core may include a lattice (not shown) extending around a circumference of the core, e.g., including at least two spaced apart circumferential elements and a plurality of ribs or transverse elements extending between the circumferential elements, thereby defining openings through the lattice. The openings may be completely open, i.e., free from any material. Alternatively, the openings may be recesses including a relatively thin wall of core material, i.e., that is substantially thinner than the circumferential elements and/or ribs. In other embodiments, the core may include a base or web and a plurality of fins or ribs extending from the web to provide a flexible structure, e.g., which may facilitate sealing between the sewing cuff 20 and valve member 14.
Exemplary materials for the core include silicone or other elastomeric materials, foam, fabric, felt, polymers, and the like. In addition or alternatively, the core may include swellable material, e.g., foam or sponge materials that may expand when exposed to fluid, such as blood. The materials may be molded or otherwise formed into the core, e.g., using known molding, extrusion, cutting, or other manufacturing procedures. For example, the core may be injection molded or otherwise formed in its annular shape.
Alternatively, the core may be molded or otherwise formed as a flat sheet, and rolled into the annular shape. In this alternative, the ends of the sheet may be attached to one another, e.g., using sutures, adhesives, ultrasonic welding, and the like. Optionally, to provide a tapered shape, one or more wedges (not shown) may be cut out of the band to provide a desired tapered but annular shape. In another option, portions of the core may be disconnected from other portions, e.g., to prevent puckering. For example, if the core is formed from a rolled sheet (not shown), ends of the sheet (also not shown) may remain loose to allow the ends to move relative to one another.
In a relaxed state (free from external forces), the sewing cuff 20 may adopt an undulating annular shape or a generally planar annular shape. The sewing cuff 20 may also be tapered, as shown in
The material of the core may be substantially flexible, e.g., manufactured in a desired annular shape, yet easily deformed, e.g., deflected, stretched, and/or compressed. The core may be sufficiently flexible to be “floppy,” i.e., such that the core conforms easily to the particular anatomy and/or implantation arrangements encountered during implantation. Thus, when the sewing cuff 20 is placed above or within a biological annulus within a patient's heart, the core may conform to the surrounding anatomy and/or may deform when the valve member 14 is secured to the gasket member 12, e.g. to enhance sealing between the valve member 14 and the gasket member 12, as described further below. Additional information on flexible cores or other constructions of the sewing cuff 20 may be found in U.S. Publication No. US 2006/0195184, filed as Ser. No. 11/069,081, the entire disclosure of which is expressly incorporate by reference herein.
With continued reference to
The leaders 50 may be threads, filaments, wires, rails, or other tethers that extend from the gasket member 12. For example, the leaders 50 may be monofilaments or multifilament structures, e.g., braided, spun, or otherwise formed into a unitary member. The leaders 50 may be formed from wire or suture materials, e.g., plastic, such as polyethylene, metal, such as stainless steel, cat gut, or composite materials, using known methods. The leaders 50 may be stiff or flexible, and/or may be resiliently bendable or plastically pliable. The retention elements 54 may be integrally formed on the leaders 50, e.g., at the time the leaders 50 are formed, or may be separate elements (made from the same or different materials than the leaders 50) that are bonded, fused, or otherwise attached to the leaders 50 at predetermined locations. Alternatively, the leaders 50 may be flat bands, e.g., formed from plastic or other material, and may have the retention elements 54 formed therein or attached thereto, as described elsewhere herein.
With continued reference to
Each leader 50 may be attached to, pre-threaded through, or otherwise placed on the gasket member 12, e.g., at spaced apart intervals from one another. For example, leaders 50 may be provided on the gasket member 12 that are aligned with the commissures (not shown) on the valve member 14 and/or a biological annulus into which the gasket member 12 is to be implanted. Thus, for example, for a prosthesis for an aortic valve having three commissures, three leaders 50 may be provided, as shown.
Each leader 50 may be attached to the gasket member 12 by directing the first end 51 through a predetermined location in the gasket member 12 and melting or otherwise expanding the first end 51 (e.g., similar to a rivet or nail head) to prevent subsequent removal. Alternatively, the first end 51 may be looped back around the leader 50 and bonded, fused, tied, or otherwise secured to the leader 50. In another alternative, the first end 51 may be pulled and secured or disposed adjacent the second end 52 (not shown), e.g., similar to a double-arm suture. The leaders 50 may be attached to the fabric of the sewing cuff 20 immediately adjacent the annular ring 18, or to other portions of the gasket member 12, e.g., to the annular ring 18, the core of the sewing cuff (not shown), or other portions of the fabric covering of gasket member 12.
Optionally, the gasket member 12 may include one or more additional components. For example, the gasket member 12 may include a collar or stand-off 58 that extends upwardly from the sewing cuff 20 for receiving the valve member 14, such as that shown in
Turning to
To contract the gasket member 12, tension may be applied to the leaders 50 (e.g., using delivery tool 60, described further below), e.g., to draw one or more portions of the gasket member 12 inwardly towards the central axis 17. For example, inward and/or proximal tension may be applied to the leaders 50, e.g., by pulling the leaders 50 at least partially into the delivery tool 60, as described further below, which may pull the ends of the leaders 50 inwardly towards the central axis 17. As the leaders 50 are tensioned, the annular ring 18 may contract inwardly to assume a multiple lobular shape, e.g., as shown in
The annular ring 18 may deform elastically towards the contracted condition. Alternatively, as described elsewhere herein, the annular ring 18 may be cooled to a martensitic state, e.g., by immersing the gasket member 12 in ice, ice water, or other fluid maintained at a temperature below the final martensitic temperature of the annular ring 18. In this alternative, the annular ring 18 may be plastically deformed while the annular ring 18 is in the relatively soft, martensitic state.
When tension of the leaders 50 is released, e.g. by releasing the leaders 50 at least partially from the delivery tool 60, the annular ring 18 may resiliently expand outwardly, e.g., to a shape having a generally circular cross-section, thereby returning the gasket member 12 towards the expanded condition, e.g., as shown in
Turning to
The handle 65 may also include one or more actuators 66, 68, e.g., one or more locking, tightening, and/or loosing mechanisms for manipulating the leaders 50. For example, the delivery tool 60 may include a locking mechanism 64 for releasably securing the second ends of the leaders 50, e.g., one or more clamping structures, detents, and the like. In addition or alternatively, the actuators 66, 68 may allow the second ends of the leaders 50 to be directed proximally or distally, e.g., to apply or release tension, as described further below. As shown, the locking mechanism 64 includes a lever 66 that may be actuated to release the second ends of the leaders 50, and a latch 68 that may be actuated to increase and/or decrease tension applied to the leaders 50.
For example, the leaders 50 may be loaded into the distal end 63 of the delivery tool 60 and through the lumen 67 until the second ends are engaged or otherwise received by the locking mechanism 64. Optionally, the leaders 50 may be loaded by a user shortly before a procedure, e.g., allowing a gasket member 12 of a desired size “D1” to be selected and loaded onto the delivery tool 60. Alternatively, the leaders 50 may be preloaded into a delivery tool 60 during manufacturing, although this may require providing multiple delivery tools 60 before a procedure, each carrying a different size gasket member 12.
When it is desired to compress the gasket member 12, the latch 68 may be actuated to pull the leaders 50 proximally a predetermined distance within the delivery tool 60. This action may pull the gasket member 12 proximally against the distal end 63 of the delivery tool 60 and/or radially inwardly, as shown in
When it is desired to deploy the gasket member 12, the lever 66 may be actuated, thereby releasing the leaders 50 from the delivery tool 60. Alternatively, the tension on the leaders 50 may be released by actuating the latch 68, e.g., in the opposite direction, from that used to apply the tension, without releasing the leaders 50 entirely from the delivery tool 60. In a further alternative, the lever 66 and latch 68 may be combined into a single actuator having multiple settings or positions, depending upon the action desired (e.g., tension, tension release, fully release).
It will be appreciated that other constraints and/or delivery tools may be provided to compress and/or maintain the gasket member 12 in a contracted condition. For example, a delivery tool (not shown) may be provided that includes a tubular body or other structure into which the entire gasket member 12 may be loaded, e.g., after compressing the gasket member 12 to the contracted condition. The delivery tool may include a plunger or other device (not shown) within the tubular body that may be used to deploy the gasket member 12 from the tubular body. In an exemplary embodiment, the gasket member 12 may be compressed by flattening the annular ring 18 along the plane 16 and then folding or rolling the resulting flattened annular ring 18. For example, after flattening the annular ring 18, the annular ring 18 may be rolled into a spiral, folded in half, e.g., into a “C” shape, such as that shown in
Returning to
Alternatively, the valve member 14 may be a connecting device to which a valve (not shown) may be connected or that may otherwise receive a valve component, such as the connection adapter elements shown in U.S. Publication No. US as 2005/0043760, filed as Ser. No. 10/646,639, the entire disclosure of which is expressly incorporated by reference herein. In another alternative, the valve 14 may include a mechanical valve or other valve (not shown), such as those disclosed in US 2005/0165479 and US 2007/0016285725, incorporated by reference above.
Turning to
The tubular members 76 may be formed from a variety of materials, e.g., a section of hypotube, made from metal, such as stainless steel, plastic, or composite materials. The tubular members 76 may be preloaded onto the frame 32, e.g., during manufacturing, or loaded onto the frame 32 shortly before a procedure. As described further below, the tubular members 76 may be removed from the frame 32 at any time, e.g., immediately before or after securing the valve member 14 to the gasket member 12.
Turning to
Before implanting the heart valve assembly 10, the patient may be prepared for the procedure using known methods. For example, the patient may be placed on cardiopulmonary bypass (CPB), and the patient's heart may be exposed, e.g., by sternotomy, thoracotomy, or other open or minimally invasive procedure. An incision may be created in the blood vessel above the valve being replaced (not shown), e.g., the aorta for an aortic valve replacement, in order to access the annulus 90. The existing natural or prosthetic heart valve and/or leaflets (also not shown) may be removed from the annulus 90 using known methods.
A heart valve assembly 10, e.g., including a gasket member 12 and a valve member 14, may be selected based upon the anatomy encountered, e.g., having a plurality of lobes, matching the lobes of the biological annulus 90 and/or having a cross-sectional dimension corresponding to the interior cross-section of the biological annulus 90. Optionally, a gasket member 12 and/or valve member 14 may be selected having a size that is larger than the biological annulus 90. For example, the gasket member 12 may have a diameter in its relaxed condition that is slightly larger than the biological annulus 90, e.g., such that the gasket member 12 may at least partially dilate the biological annulus 90 upon implantation. In addition or alternatively, the valve member 14 may have a diameter or other cross-section that is substantially larger than the biological annulus 90, e.g., for supra-annular or intra-sinus implantation, which may accommodate the larger size.
With reference to
In an alternative embodiment, the user may load the leaders 50 into the deliver tool 60 immediately before the procedure, and then apply the desired tension to compress and/or stabilize the gasket member 14. This alternative may be particularly desirable when a single delivery tool 60 is used to deliver one of various sized gasket members available to the user. Thus, once the implantation site is exposed, the physician may measure the size of the biological annulus 90 and select an appropriate gasket member 12 (and/or valve member 14) based upon the specific anatomy encountered.
Once constrained in the contracted condition, the gasket member 12 may be introduced into the patient's body and advanced into the biological annulus 90, e.g., by directing the distal end 63 of the delivery tool 60 into the patient's body. The gasket member 12 may be advanced until the annular ring 18 extends at least partially into the biological annulus 90. In one embodiment, the annular ring 18 may extend through the biological annulus 90, i.e., with a lower edge of the annular ring 18 disposed within the sub-annular space below the biological annulus 90. Optionally, the gasket member 12 may include a flexible skirt (not shown) that may surround and/or extend from the annular ring 18 through the biological annulus 90. The skirt may be biased to extend outwardly to provide a smooth transition and/or enhance a seal between the gasket member 12 and the biological annulus 90.
Turning to
With the annular ring 18 deployed within the biological annulus 90, the sewing cuff 20 may contact the tissue surrounding the supra-annular space above the biological annulus 90, as shown in
Turning to
In the exemplary embodiment shown in
Alternatively, as shown in
With the leaders 50 received through the valve member 14, the valve member 14 may be advanced distally over the leaders 50 towards the gasket member 12, i.e., in the direction of arrow 94, until the valve member 14 engages or otherwise contacts the gasket member 12. As shown in
In an exemplary embodiment, the retention elements 54 may be disposed a predetermined distance from the first ends 51 of the leaders 50, thereby securing the valve member 14 against or immediately adjacent the gasket member 12. The predetermined distance may be set such that the frame 32 of the valve member 14 substantially contacts the sewing cuff 20, e.g., to at least partially compress the core, which may enhance sealing between the valve member 14 and the gasket member 14.
In addition or alternatively, one or more knots may be directed down the leaders 50 after the valve member 14 engages or contacts the gasket member 12. In another alternative, if the gasket member 12 includes a collar (not shown, see, e.g.,
Turning to
With additional reference to
Turning to
In addition, the gasket member 112 includes a plurality of guide shields 156 removably attached to the gasket member 112, e.g., by one or more sutures to the sewing cuff 120. The guide shields 156 may extend upwardly and/or outwardly from the sewing cuff 120, e.g., to at least partially define a passage 124 for guiding a valve prosthesis (not shown) downwardly towards the gasket member 112, as described further below. In a relaxed condition, the guide shields 156 may extend diagonally outwardly from the gasket member 112, but may be deflectable radially inwardly towards a central axis 117 of the gasket member 112, e.g., during delivery.
The guide shields 156 may be formed from a relatively thin and/or transparent sheet, e.g., a plastic such as polyester or Mylar or any other polymeric film or material, such as high-density or low-density polyethylene, polystyrene, and the like. The sheet may be cut or otherwise formed to include one or more bands, e.g., defining a relatively wide base that may be attached to the gasket member 112 and a relatively narrow loose upper end. For example, as shown in
Optionally, the upper ends 156b may include one or more features that partially restrain the guide rails 150 away from the passage 124 or otherwise out of the operator's field of view during a procedure. For example, as shown in
The guide shields 156 may be attached to the sewing cuff 120, e.g., by one or more sutures (not shown) sewn through fabric of the sewing cuff 120 (and/or other portion of the gasket member 12) and holes (also not shown) in the base 156a. Optionally, a chain stitch or other stitch may be used, e.g., that may unravel upon being cut at a single location, which may facilitate removing the sutures and, consequently, the guide shields 156 after implantation. Additional information on methods for removably attaching the guide shields 156 to the gasket member and/or methods for using the guide shields 156 may be found in co-pending application Ser. No. 60/914,742, incorporated by reference herein.
Turning to
In addition, the tool 160 includes a plurality of arms 168 movably mounted to the distal end 163. For example, one end 168a of the arms 168 may be attached to the distal end 163 of the tool 160, e.g., proximal to the supports 166, and the other free end may include tips 168b disposed adjacent the supports 166. As shown, the arms 168 may be offset radially relative to the supports 166 such that each arm 168 is disposed between adjacent supports 166. The arms 168 may be movable from an outer position, e.g., as shown in
The actuator 165 may include a lever or other mechanism that may selectively move the tips 168b of the arms 168 between the outer and inner positions. For example, as shown in
For example, the arms 168 may be deflectable radially inwardly by an inward force applied to the arms 168 as the sleeve 165b passes over the first ends 168a. The arms 168 may be sufficiently resilient to return outwardly when the sleeve 165b is retracted from over the first ends 168a. Alternatively, the arms 168 may include hinges or other components coupled to the sleeve 165b and/or linkage 165c such that the arms 168 are movable inwardly and outwardly.
The handle 165a may be temporarily locked against the shaft 162 with the arms 168 in the inner position, e.g., by a lock or other interlocking features (not shown) on the handle 165a, linkage 165c, and/or shaft 162. For example, the linkage 165c may include a slot 165f and the handle 165a may include a sliding button, switch or other control 165g that includes a cross pin 165h that may be received in the slot 165f when the handle 165a is directed against the shaft 162. The control 165g may be manually moved to engage and/or disengage the cross pin 165h and the slot 165f Optionally, the control 165g may be biased, e.g., towards or away from the end of the handle 165a, for example by a spring (not shown), such that when the handle 165a is directed against the shaft 162, the cross pin 165h slides into the slot 165f, preventing subsequent movement of the handle 165a. The control 165g may be directed against the bias of the spring, e.g., distally or proximally, to release the cross pin 165h from the slot 165f, whereupon the spring 165d may then bias the handle 165a outwardly. Thus, the slot 165f may be oriented to engage with the cross pin 165h as the control 165g is translated along the handle 165a in a distal or proximal direction, and to release the cross pin 165h as the control 165g is translated in an opposite proximal or distal direction. When it is desired to release the handle 165a and arms 168 back to the outer position, the control 165g may be released, whereupon the spring 165d may then bias the handle 165a outwardly, thereby automatically opening the arms 168 towards the outer position. Alternatively, the levers involved may be designed such that the bias of the spring 165d is removed when the handle 165a is directed against the shaft 162, thereby maintaining the arms 168 in the inner position. In this alternative, the handle 165a may simply be pulled away from the shaft 162 such that the spring 165d again biases the handle 165a to move outwardly, directing the arms 168 to the outer position.
During use, with the arms 168 in the outer position, a gasket member 112 may be placed between the supports 166 and the arms 168, e.g., with the nadir regions of the sewing cuff 120 aligned radially with the arms 168 and the commissure regions of the sewing cuff 120 aligned radially with the supports 166. The arms 168 may then be directed to the inner position, thereby securing the gasket member 112 between the supports 166 and the arms 168. As shown in
Turning to
As shown in
Turning to
Turning to
Turning to
Returning to
In addition, the valve holder 210 may include one or more actuators for causing separation of at least a portion of the guide rails 150 from the gasket member 112, as described further below. For example, in one embodiment, each of the tubular members 230 may be rotatable about an individual central axis 231, as shown in
Alternatively, the entire hub 234 may be rotatable around the shaft 210, which may cause all of the guide rails 150 to separate substantially simultaneously at the weakened regions or other locations adjacent the distal ends 263. In a further alternative, shown in
For example, as best seen in
With the outer housing 252 open relative to the inner member, ends of the guide rails 150 may be received within the recess 253a, e.g., when the guide rails 150 are loaded through the tubular members 230. The outer housing 252 may then be rotated to engage the ends of the guide rails 150, e.g., with the catch(es) 253b and/or by at least partially closing the recess 253a to clamp the ends of the guide rails 150, thereby preventing the guide rails 150 from being separated from the actuator 250. Optionally, similar to the embodiment shown in
During use, a portion of the guide rails 150 may be received in or otherwise engaged with the actuator 250, e.g., when the guide rails 150 are loaded through the tubular members 230. When the actuator 250 is moved from the distal position, shown in
This configuration of the valve holder tool 210 may allow the actuator 250 to be located at a distance proximally from the head 220. For example, this may facilitate actuation, allowing the user to actuate the valve holder 210 without having to reach into the biological annulus. In addition, this configuration of the valve holder tool 210 may also allow the actuator 250 to be moved a substantial distance away from the head 220 and the implantation site. For example, if the shaft 212 were replaced with a flexible catheter, and the guide rails 150 were sufficiently long and/or flexible, the valve holder 210 may be used in a percutaneous implantation or other procedure wherein the actuator is located outside the patient's body, while the head 220 (and valve 14 thereon) are located within the body at the implantation site, e.g., as disclosed in US 2007/0016288, incorporated by reference herein.
In another alternative, shown in
Each cam-lock 258′ includes a cap 258a′ pivotally mounted to the actuator 250′ by a hinge or element, such that the cap 258a′ may be moved between an open position, e.g., extending away from the inner member 256′ as shown, and a closed position covering a respective track 257b′ and/or opening 257c′. In addition, each cam-lock 258′ includes a tab 258b′ or other feature that is received in the track 257b′ when the cap 258a′ is moved to the closed position. Thus, a guide rail 150 may be directed from a tubular member 230′ along the guide channel 257a′ into the track 257b,′ e.g., until the catch 257c′ is received in the hole 153, as shown in
Turning to
Before introducing the head 220 and valve 14 into the biological annulus, a gasket member (not shown) may be delivered and/or secured within the biological annulus, e.g., as described above. As can be seen in
Turning to
For example, as shown in
Returning to
Turning to
As shown in
For example, turning to
Turning to
With additional reference to
Optionally, the valve holder tool may include one or more safety features that prevent final engagement of the valve 14 with the gasket member until the user makes an affirmative decision to complete this step. For example, as shown in
After securing the valve 14 to the gasket member, the guide rails 150 may then be severed or otherwise separated from the gasket member, e.g., above the retention elements 154, as shown in
Turning to
Turning to
Turning to
As shown in
Turning to
The receptacle 380 includes a channel 386 along a back surface of the main body 382 and a pair of locking tabs 388 within the channel 386, as shown in
The receptacle 380 may include one or more additional features formed therein, e.g., holes 383 for receiving sutures 390 or other fasteners therethrough.
Turning to
The frame 332 may then be covered with fabric, e.g., over the receptacles 380, using similar procedures for assembling valves described elsewhere herein and in the references incorporated by reference herein. Slits or other openings (not shown) may be formed in the fabric covering above and below the receptacles 380, e.g., to provide access to the receptacles 380 during use.
With the receptacles 380 attached to the frame 332, the channel 386 may be spaced apart from the frame 332, thereby defining a vertical passage between the receptacles 380 and the frame 332, similar to other embodiments described herein.
Turning to
It will be appreciated that elements or components shown with any embodiment herein are exemplary for the specific embodiment and may be used on or in combination with other embodiments disclosed herein.
While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.
This application claims benefit of co-pending provisional application Ser. No. 60/746,038, filed Apr. 29, 2006, and 60/914,742, filed Apr. 29, 2007, the entire disclosures of which are expressly incorporated by reference herein.
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