US20100161046A1 - Holder for flexible heart valve - Google Patents

Abstract

A holder for a highly flexible tissue-type heart valve is disclosed that maintains an implant shape to the valve. The holder may have cusp and commissure contacting supports, and may be attached at all six such supports, or only three. The holder may be flexible to permit inward flexing of the heart valve during implant for greater visibility when implanting using a running suture method. The holder may be formed of flexible wires such as Nitinol, and shaped to resist excessive axial and torsional deformation of the valve. A short handle connector suitable for manual grasping may be attached and stored with the valve, with the handle connector having a coupling for receiving a longer delivery handle. A two stage holder may be utilized to accommodate different implant methods.

Description

RELATED APPLICATIONS
• The present application is a continuation of pending U.S. application Ser. No. 12/557,404 filed Sep. 10, 2009, entitled “FLEXIBLE HEART VALVE AND ASSOCIATED CONNECTING BAND;” which is a continuation of U.S. application Ser. No. 12/391,212 filed Feb. 23, 2009, entitled “FLEXIBLE HEART VALVE AND ASSOCIATED CONNECTING BAND”; which is a continuation U.S. application Ser. No. 12/188,826 filed Aug. 8, 2008, entitled “FLEXIBLE HEART VALVE AND ASSOCIATED CONNECTING BAND”; which is a continuation of U.S. application Ser. No. 10/729,035, filed Dec. 5, 2003, entitled FLEXIBLE HEART VALVE AND ASSOCIATED CONNECTING BAND, which is a continuation of U.S. application Ser. No. 09/847,930, filed May 3, 2001, entitled HOLDER FOR FLEXIBLE HEART VALVE, which is a continuation-in-part of U.S. application Ser. No. 09/332,759, filed Jun. 14, 1999, entitled FLEXIBLE HEART VALVE, now U.S. Pat. No. 6,558,418, which claims priority under 35 U.S.C §119(e) to provisional application No. 60/117,445, filed on Jan. 26, 1999, the disclosures of which are expressly incorporated herein by reference.
FIELD OF THE INVENTION
• The present invention relates to prosthetic heart valves, and, more particularly, to a flexible prosthetic heart valves and associated holders.
BACKGROUND OF THE INVENTION
• Prosthetic heart valves are used to replace damaged or diseased heart valves. In vertebrate animals, the heart is a hollow muscular organ having four pumping chambers: the left and right atria and the left and right ventricles, each provided with its own one-way outflow valve. The natural heart valves are identified as the aortic, mitral (or bicuspid), tricuspid and pulmonary valves. The valves of the heart separate chambers therein, and are each mounted in an annulus therebetween. The annuluses comprise dense fibrous rings attached either directly or indirectly to the atrial and ventricular muscle fibers. Prosthetic heart valves can be used to replace any of these naturally occurring valves, although repair or replacement of the aortic or mitral valves are most common because they reside in the left side of the heart where pressures are the greatest. In a valve replacement operation, the damaged leaflets are excised and the annulus sculpted to receive a replacement valve.
• The four valves separate each ventricle from its associated atrium, or from the ascending aorta (left ventricle) or pulmonary artery (right ventricle). After the valve excision, the annulus generally comprises a ledge extending into and defining the orifice between the respective chambers. Prosthetic valves may attach on the upstream or downstream sides of the annulus ledge, but outside of the ventricles to avoid interfering with the large contractions therein. Thus, for example, in the left ventricle a prosthetic valve is positioned on the inflow side of the mitral valve annulus (in the left atrium), or on the outflow side of the aortic valve annulus (in the ascending aorta).
• Two primary types of heart valve replacements or prostheses are known. One is a mechanical-type heart valve that uses a ball and cage arrangement or a pivoting mechanical closure to provide unidirectional blood flow. The other is a tissue-type or “bioprosthetic” valve which is constructed with natural-tissue valve leaflets which function much like a natural human heart valve, imitating the natural action of the flexible heart valve leaflets which seal against each other to ensure the one-way blood flow.
• Prosthetic tissue valves comprise a stent having a rigid, annular ring portion and a plurality of upstanding commissures to which an intact xenograft valve or separate leaflets of, for example, bovine pericardium are attached. The entire stent structure is typically cloth-covered and a sewing ring is provided around the periphery for attaching to the natural annulus. Because of the rigidity of the material used in the stent and/or wireform, conventional valves have a diameter that is minimally affected by the natural motion of the heart orifice. In the aortic position, the commissures extend in the downstream direction a spaced distance from the walls of the downstream aortic wall. Movement of the aortic wall or sinuses does not directly affect movement of the cantilevered commissures, though fluid flow and pressures generated by movement of the walls ultimately does cause the commissures to dynamically flex to some extent (i.e., they are cantilevered downstream in the aorta). Because of the inherent rigidity in conventional heart valves, the natural dilatation of the annulus is restricted, imposing an artificial narrowing of the orifice, and increasing the pressure drop therethrough.
• Accordingly, there is a need for a more flexible heart valve that responds to the natural motions of the annulus and downstream vessel walls.
SUMMARY OF THE INVENTION
• The present invention allows the prosthesis to follow the aortic wall motion as well as that of the annulus during systole and diastole phases, thus reducing the loss in pressure caused by restriction of such motions. The solution is a heart valve having a plurality of leaflets, preferably three, directly sutured to the aortic wall, replacing the native valve.
• The present invention provides a heart valve including a flexible wireform or stent that allows relative cusp movement or pivoting. The continuous maintenance of leaflet orientation at the commissures provides durability and predictability. Though the leaflets are not wholly independent, they are allowed to move in regions of greatest anatomical motion.
• The present invention differs in another respect from bioprosthetic tissue valves of the prior art because it does not include a conventional sewing ring with attendant rigid stent. Alternating peripheral cusps and commissures of the prosthetic valve are attached to the annulus region and the sinus region of the ascending aorta of the host (in the aortic valve version), downstream from the location of the natural leaflets (typically excised).
• In accordance with one aspect of the present invention, a prosthetic heart valve is provided including a flexible, generally cylindrical stent having alternating cusps and commissures. A plurality of flexible leaflets is attached to the stent so as to form a one-way valve within the cylinder. A flexible band is attached along the stent and has a free edge extending away from the stent along the alternating cusps and commissures for connecting the heart valve to an anatomical orifice.
• Another aspect of the present invention is a highly flexible heart valve including a stent/leaflet subassembly having a peripheral stent and a plurality of leaflets disposed therewithin. The stent/leaflet subassembly defines alternating cusps and the commissures. A connecting band is attached to the stent/leaflet subassembly and follows the alternating cusps and commissures. The band includes a free edge extending from the stent for connecting the heart valve to an anatomical orifice.
• In a still further aspect of present invention, a prosthetic heart valve comprises a plurality of flexible leaflets, each having an arcuate cusp edge and a coapting edge. The heart valve includes a stent with a plurality of cusps connected to each other at upstanding commissures to generally define a substantially cylindrical volume therebetween. The leaflets are attached to the stent within the cylindrical volume and the cusps are free to move with respect to one another about the commissures.
• In another embodiment, the present invention provides a prosthetic heart valve comprising a stent having a plurality of stent members adjacently disposed generally around a circle to define a substantially cylindrical volume therebetween. The stent includes a plurality of alternating cusps and commissures. Preferably, the stent members each have a cusp and two commissure regions, with adjacent commissure regions of the stent members together defining each of the commissures of the stent. The stent members may be coupled together to pivot or flexibly move with respect to one another. The coupling may be permanent, or may comprise a bio-resorbable structure that permits the stent members and associated leaflets to move independently from one another.
• Desirably, the stent of the prosthetic heart valve of the present invention is configured to permit the cusps and commissures to move radially in and out. In one embodiment, the stent comprises a cloth covered rod-like structure. The cloth covering closely surrounds the stent and includes a flap projecting therefrom substantially the entire length of the cusps and commissures for connecting the stent to both the flexible band and the leaflets. The band preferably comprises a suture-permeable inner member, such as silicone, covered by cloth. The cusps of the stent may be pivotally or flexibly coupled to each other at the commissures. Preferably, the stent comprises separate cloth-covered stent members that each define a cusp region and two commissure regions, adjacent commissure regions of the stent members together defining each of the commissures of the stent. The commissure regions of the separate stent members desirably remain spaced apart, with the leaflets extending therethrough to be attached between the cloth covering and the outer connecting band. In this manner, the leaflets are connected to separate stent members, and not to each other to facilitate flexing of the valve.
• In another aspect of the present invention, a holder is provided for mounting the flexible heart valve. The holder includes a central hub with a plurality of radially outward upper legs, and a plurality of lower legs angled downward and outward. The upper and lower legs are adapted to connect to the alternating cusps and commissures of a flexible valve so as to maintain the position of the valve during implantation.
• The present invention further provides a combination of a flexible prosthetic heart valve and a rigid holder. The flexible heart valve includes alternating cusps and commissures in a generally cylindrical configuration adapted to move radially in and out with respect to one another. The holder includes structure for maintaining a fixed shape of the flexible prosthetic heart valve during implantation.
• In a still further aspect of the present invention, a heart valve leaflet is provided comprising a flexible, planar body having an arcuate cusp edge terminating at outer tips. The planar body includes a coapting edge that is defined by two relatively angled lines joined at an apex directed away from the cusp edge midway between the two tips. Desirably, the leaflet is made of pericardial tissue.
• The present invention further provides a method of implantation of a heart valve, including the steps of: providing a flexible heart valve having alternating cusps and commissures in a generally cylindrical configuration and adapted to move radially in out with respect to one another; attaching a holder to the valve that restricts relative movement of the cusps and commissures; positioning the heart valve in proximity to an anatomical orifice; implanting the heart valve; and, disconnecting the holder from heart valve.
• The present invention provides a holder for a heart valve including a flexible stent that allows relative cusp movement or pivoting. The continuous maintenance of leaflet orientation at the commissures provides durability and predictability. Though the leaflets are not wholly independent, they are allowed to move in regions of greatest anatomical motion. The heart valve may be highly flexible and include a stent/leaflet subassembly having a peripheral stent and a plurality of leaflets disposed therewithin. The stent/leaflet subassembly defines alternating cusps and the commissures. A connecting band may be attached to the stent/leaflet subassembly and follows the alternating cusps and commissures. The band may include a free edge extending from the stent for connecting the heart valve to an anatomical orifice.
• In one aspect of the invention, a holder for attaching to and holding a flexible heart valve is provided. The heart valve is of the type that has multiple leaflets joined together at a periphery of the valve at valve commissures that are generally axially aligned and evenly disposed about a valve axis, the valve commissures are located between adjacent curvilinear valve cusps along the periphery of the valve. The holder comprises a plurality of cusp supports arranged around an axis to contact the heart valve generally along the valve cusps, and a plurality of commissure supports connected to and intermediate each two cusp supports and arranged to abut the valve commissures. The commissure supports are desirably radially flexible enabling the valve commissures to be flexed inward while in contact with the holder commissure supports. For example, the commissure supports may be made of Nitinol. Preferably, at least one leg extends radially inward from a cusp support to a location surrounded by the plurality of cusp supports, and more preferably multiple legs extend radially inward from each cusp support and attach together at a common location. The common location may be on the axis of the holder that coincides with the valve axis when the holder and valve are attached.
• A connector may be provided extending along the holder axis to which the legs join. The connector has a coupling for receiving a handle for the holder and a length suitable for manually grasping. In one embodiment, the connector is formed separately from the legs and joined thereto. In addition, the legs may be formed separately from the cusp supports and joined thereto.
• In an exemplary form, the cusp supports are multiple pieces joined together, wherein each piece may include two halves of adjacent cusp supports and a commissure support. In the multiple piece embodiment, multiple legs may extend radially inward from each cusp support and attach together at a common location, wherein each piece has two leg halves extending radially inward from each of its cusp support halves, and wherein each pair of adjacent leg halves makes up one of the holder legs.
• The holder may further include a central hub with a plurality of radially outward upper legs connected to the commissure supports, and a plurality of lower legs angled downward and outward connected to the cusp supports. Each lower leg preferably has a width from the hub to a terminal end that is greatest at the terminal end to provide more surface area to contact the corresponding valve cusp.
• Another aspect of the invention is a combined flexible heart valve and holder. The combination includes a prosthetic flexible heart valve having multiple leaflets joined together at a periphery of the valve at valve commissures that are generally axially aligned and evenly disposed about a valve axis. The valve commissures are configured for radial movement with respect to the valve axis and are each disposed between adjacent curvilinear valve cusps along the periphery of the valve. The valve leaflets coapt along the valve axis and curve in a direction to form an inflow side and an outflow side of the valve. The combination includes a holder attached to the outflow side of the valve having cusp supports that contact and axially support the valve cusps. The holder also has commissure supports between each two of the cusp supports that axially support the valve commissures yet permit radial their radial movement with respect to the valve axis.
• The holder preferably includes structure for substantially preventing torsional deformation of the flexible heart valve during implantation. The holder further may include a valve contacting portion having a generally continuous curvilinear structure conforming to the periphery of the valve and defining the alternating cusp and commissure supports. A central hub with a plurality of legs angled downward and outward may be connected to the cusp supports. In one version, the valve contacting portion is integrally formed separate from the legs, while in another the valve contacting portion is formed of a plurality of separate pieces, each piece defining at least a part of one of the legs. Each separate piece may define a half of two adjacent cusp supports, and may be formed of a wire.
• The combination further may include commissure attachment sutures connecting the commissure supports to the valve commissures. The flexible heart valve may include a sewing band that generally conforms to the valve cusps and commissures, wherein the commissure attachment sutures connect the commissure supports to the sewing band at the valve commissures. The holder further may include a valve contacting portion having a generally continuous curvilinear structure conforming to the periphery of the valve and defining the alternating cusp and commissure supports, wherein the commissure attachment sutures are severable at the commissure supports and wherein the commissure supports include leaflet guard sections that structurally protect the valve leaflets from being cut by a blade in severing the commissure attachment sutures.
• The combination further may include cusp attachment sutures connecting the cusp supports to the valve cusps. The flexible heart valve may include a sewing band that generally conforms to the valve cusps and commissures, wherein the cusp attachment sutures connect the cusp supports to the sewing band at the valve cusps. Desirably the cusp attachment sutures are routed so as to cross a common cut point on the holder such that the plurality of attachments between the cusp supports and valve cusps can be severed with one cut. The holder may further include a central hub with a plurality of legs angled downward and outward connected to the cusp supports, wherein the cusp attachment sutures each loop through the valve at the valve cusps with one segment being tied to the cusp support and a second segment extending up the corresponding leg to the hub, across the common cut point. A sleeve may surround each leg within which the second segment is contained.
• The holder may include two stages, a first stage having the cusp supports and a second stage having the commissure supports, the two stages being formed so as to be separable. The first stage may include a central hub and a plurality of legs angling outward and downward to form the cusp supports at their terminal ends. The second stage may include a flexible band around which the commissure supports are spaced, the band permitting the commissure supports to flex radially with respect to one another.
• In another aspect of the present invention, a holder is provided for mounting the flexible heart valve. The holder includes a central hub with a plurality of radially outward upper legs, and a plurality of lower legs angled downward and outward. The upper and lower legs are adapted to connect to the alternating cusps and commissures of a flexible valve so as to maintain the position of the valve during implantation.
• The present invention further provides a combination of a flexible prosthetic heart valve and a rigid holder. The flexible heart valve includes alternating cusps and commissures in a generally cylindrical configuration adapted to move radially in and out with respect to one another. The holder includes structure for maintaining a relatively fixed shape of the flexible prosthetic heart valve during implantation.
• The present invention further provides a method of implantation of a heart valve, including the steps of: providing a flexible heart valve having alternating cusps and commissures in a generally cylindrical configuration and adapted to move radially in out with respect to one another; attaching a holder to the valve that restricts relative axial and torsional movement of the cusps and commissures; positioning the heart valve in proximity to an anatomical orifice; implanting the heart valve; and, disconnecting the holder from heart valve. The holder may include cusp supports that contact and axially support the valve cusps and commissure supports between each two of the cusp supports that axially support the valve commissures yet permit radial their radial movement with respect to the valve axis. In the latter case, the method may include visualizing the site of valve implantation by flexing one of the valve commissures radially inward while being supported by the corresponding commissure support of the holder.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a sectional view through the left half of a human heart showing a systolic phase of left ventricular contraction;
• FIG. 2 is a sectional view through the left half of a human heart showing a diastolic phase of left ventricular expansion;
• FIG. 3 is an exploded perspective view illustrating sub-assemblies of a prosthetic heart valve of the present invention;
• FIG. 4A is a top plan view of an internal stent of the prosthetic heart valve of the present invention;
• FIG. 4B is an elevational view of the internal stent ofFIG. 4A;
• FIG. 5 is an elevational view of a stent assembly of the prosthetic heart valve;
• FIGS. 6A and 6B are sectional views through two locations of the stent assembly, taken alonglines6A-6A and6B-6B ofFIG. 5;
• FIGS. 7A,7B, and7C are plan views of leaflets suitable for use in the prosthetic heart valve of the present invention;
• FIG. 8 is an exploded perspective view of a stent/leaflet sub-assembly and a connecting band of the prosthetic heart valve of the present invention;
• FIG. 9 is an elevational view of an inner member of the connecting band;
• FIG. 10 is a cross-sectional view through a cusp of the connecting band shown inFIG. 8;
• FIG. 11 is a perspective view of an assembled prosthetic heart valve of the present invention;
• FIG. 12A is a cross-sectional view through a cusp region of the prosthetic heart valve of the present invention, taken along line12A-12A ofFIG. 11, and showing a portion of the host annulus in phantom;
• FIG. 12B is a cross-sectional view through a commissure region of the prosthetic heart valve of the present invention, taken alongline12B-12B ofFIG. 11, and showing a portion of the host aortic wall in phantom;
• FIG. 13 is a schematic view showing relative movement of the aortic and annulus walls during systolic flow;
• FIG. 14A is a plan view of only the stent members of the prosthetic valve flexed in accordance with the anatomical motions during systole shown inFIG. 13;
• FIG. 14B is an elevational view of the stent members flexed in accordance with the anatomical motions during systole shown inFIG. 13;
• FIG. 15 is a schematic view showing relative movement of the aortic and annulus walls during diastolic flow;
• FIG. 16A is a plan view of only the stent members of the prosthetic valve flexed in accordance with the anatomical motions during diastole shown inFIG. 15;
• FIG. 16B is an elevational view of the stent members flexed in accordance with the anatomical motions during diastole shown inFIG. 15;
• FIG. 17 is a perspective view of an alternative stent assembly for use in a prosthetic heart valve in accordance with the present invention;
• FIG. 18 is a perspective view of an internal stent of the stent assembly ofFIG. 17;
• FIG. 19 is an exploded view of a commissure tip region of the stent assembly ofFIG. 17;
• FIGS. 20A-20E are elevational views of alternative stents for use in a prosthetic heart valve in accordance with the present invention;
• FIG. 21 is a detailed view of a commissure region of the alternative stent ofFIG. 20E;
• FIG. 22 is a detailed view of a commissure region of a still further alternative stent accordance with the present invention;
• FIG. 23 is an exploded perspective view of the prosthetic heart valve of the present invention and a holder used during implantation of the valve;
• FIG. 24 is a perspective view of the holder coupled to the valve;
• FIG. 25 is a top plan view of the holder coupled to the valve;
• FIG. 26 is a cross-sectional view through the holder and valve, taken along line26-26 ofFIG. 25;
• FIGS. 27A ad27B are perspective views of an alternative holder for the prosthetic heart valve of the present invention used during implantation of the valve;
• FIG. 28 is a perspective view of an exemplary holder attached to a flexible heart valve of the present invention having cusp and commissure supporting sections;
• FIGS. 29A-29D are detail views of portions of the combined holder and heart valve ofFIG. 28;
• FIG. 30 is an assembled perspective view of the valve holder ofFIG. 28;
• FIG. 31 is an exploded perspective view of the valve holder ofFIG. 28;
• FIG. 32 is a perspective view of one piece of a valve contacting portion of the valve holder ofFIG. 28;
• FIG. 33 is a top plan view of a portion of the valve holder ofFIG. 28 attached to a flexible heart valve;
• FIG. 34 is a perspective view of an alternative heart valve holder of the present invention having cusp and commissure supporting sections;
• FIG. 35 is a perspective view of a still further alternative heart valve holder of the present invention having cusp and commissure supporting sections, and attachment points only at the valve commissures;
• FIG. 36 is a detail view of a removable attachment of the holder ofFIG. 35 to a valve commissure;
• FIG. 37 is a perspective view of a one-piece heart valve holder of the present invention having cusp and commissure supporting sections;
• FIG. 38 is a perspective view of a two-piece heart valve holder of the present invention having cusp and commissure supporting sections;
• FIG. 39 is a perspective view of an alternative one-piece heart valve holder of the present invention having cusp and commissure supporting sections and a series of suture attachment apertures;
• FIG. 40 is a perspective view of an alternative one-piece heart valve holder of the present invention having cusp and commissure supporting sections and a handle connection joined to a single cusp supporting section;
• FIG. 41 is a perspective view of a two-stage heart valve holder of the present invention attached to a flexible heart valve;
• FIG. 42 is an exploded perspective view of the two-stage heart valve holder ofFIG. 41;
• FIG. 43 is a perspective view showing the two-stage heart valve holder ofFIG. 41 exploded from the flexible heart valve; and
• FIG. 44 is a perspective view showing the two-stage heart valve holder ofFIG. 41 exploded into its two parts with a flexible stage remaining attached to the flexible heart valve.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
• The present invention provides a highly flexible aortic heart valve that is attached generally along a scalloped or undulating perimeter downstream from where the natural leaflets were originally attached. The natural leaflets include arcuate cusp portions separated by common commissure portions. If the natural valve has three leaflets, and has a vertically oriented flow axis, the leaflets are evenly distributed circumferentially 120° apart with lower cusp portions and upstanding commissure portions. The commissure portions are connected between the cusp portions and are generally axially aligned along the aortic wall. The annular root of an aortic valve is composed of fibrous tissue and generally conforms to the undulating perimeter of the valve to support the leaflets. In this respect, implanting the aortic heart valve of the present invention involves excising the natural leaflets and attaching the prosthetic heart valve proximate the fibrous annulus, but also in part up the aortic wall. Because of the particular construction of the present heart valve, as will be described below, the attachment means, be it sutures, staples, adhesives, or otherwise, may be anchored into the aortic wall itself, adjacent to the fibrous annulus.
• To better illustrate the advantages of the flexible heart valve of the present invention, an understanding of the movement of the annulus and aorta is helpful. In this regard,FIGS. 1 and 2 illustrate the two phases of left ventricular function; systole and diastole. Systole refers to the pumping phase of the left ventricle, while diastole refers to the resting or filling phase.FIGS. 1 and 2 illustrate in cross section the left chamber of the heart with theleft ventricle20 at the bottom, and the ascendingaorta22 and leftatrium24 diverging upward from the ventricle to the left and right, respectively.
• FIG. 1 illustrates systole with theleft ventricle20 contracting, whileFIG. 2 illustrates diastole with the left ventricle dilating. Theaortic valve28 is schematically illustrated here as havingleaflets30. Contraction of theventricle20 causes themitral valve26 to close and theaortic valve28 to open, and ejects blood through the ascendingaorta22 to the body's circulatory system, as indicated inFIG. 1 by thearrows32. Dilation of theventricle20 causes theaortic valves28 to close andmitral valve26 to open, and draws blood into the ventricle from theleft atrium24, as indicated inFIG. 2 by thearrows33.
• The walls of the left chamber of the heart around the aortic valve can be generally termed theannulus region34 and thesinus region36. Theannulus region34 generally defines an orifice that is the narrowest portion between theventricle20 and ascendingaorta22, which as noted above is composed of generally fibrous tissue. Thesinus region36 is that area just downstream from theannulus region34 and includes somewhat elastic, less fibrous tissue. Specifically, thesinus region36 typically includes three identifiable, generally concave sinuses (formally known as Sinuses of Valsalva) in the aortic wall intermediate the upstanding commissures of thevalve28. The sinuses are relatively elastic and are constrained by the intermediate, more fibrous commissures of the aortic annulus. Those of skill in the art will understand that theannulus region34 andsinus region36 are not discretely separated into either fibrous or elastic tissue, as the fibrous commissures of the annulus extend into thesinus region36.
• The sinuses tend to move in and out to facilitate fluid dynamics of the blood in conjunction with systole and diastole. During systole, as seen inFIG. 1, thesinus region36 expands somewhat to a diameter A. This facilitates blood flow through the ascendingaorta22 to the rest of the body. In contrast, during the diastolic phase as seen inFIG. 2, thesinus region36 contracts somewhat to a smaller diameter B. The diameters A and B are intended to be a measurement of the radial movement of the commissure regions of thevalve28. In this regard it will be understood that the cross-sections shown are not taken in a single plane, but instead are taken along two planes angled apart 120° with respect one another and meeting at the midpoint of theaorta22. Thesinus region36 has a neutral, or relaxed diameter (not shown) somewhere in between diameters A and B.
• Theannular region34 also moves in and out during the systolic and diastolic phases. As seen inFIG. 1, theannular region34 contracts somewhat to a diameter C during systole. In contrast, during the diastolic phase as seen inFIG. 2, theannular region34 expands somewhat to a larger diameter D. Much like thesinus region36, theannular region34 has a neutral, or relaxed diameter (not shown) somewhere in between diameters C and D.
• As will be explained more fully below, the prosthetic valve of the present invention accommodates the in and out movements of both theannular region34 and thesinus region36. That is, alternating peripheral portions of the prosthetic valve are attached to theannular region34 and thesinus region36 and move accordingly. It is important to point out that the preceding discussion of dynamic movement of the annulus and sinus regions is based on preliminary understanding of such movement. That is, direct measurements of these movements are problematic, and thus certain assumptions and predictions must be made. The actual dynamic movement in any particular human heart may be different, but the principles of the present invention would still apply. That is, relative movement in the annulus and sinus regions during systole and diastole does exist, and the flexible prosthetic heart valve of the present invention can accommodate any such movement.
• Valve Subassemblies
• With reference now toFIG. 3, the primary sub-assemblies of a preferred embodiment of theprosthetic heart valve40 of the present invention are shown in exploded view. For purposes of discussion, the directions up and down, upper and lower, or top and bottom, are used with reference toFIG. 3, but of course the valve can be oriented in any direction both prior to and after implantation. From top to bottom, theheart valve40 comprises agroup41 of threeleaflets42, threeangled alignment brackets44, astent assembly46, and a connectingband48. Each of the sub-assemblies seen inFIG. 3 is procured and assembled separately (except for the group of leaflets, as will be explained), and then joined with the other sub-assemblies to form the fully assembledvalve40 as seen inFIG. 11.
• Theprosthetic valve40 is a trifoliate valve with threeleaflets42. Although three leaflets are preferred, and mimic the natural aortic valve, the principles of the present invention can be applied to the construction of a prosthetic valve with two or more leaflets, depending on the need.
• Each of the sub-assemblies seen inFIG. 3 include three cusps separated by three commissures. Theleaflets42 each include an arcuatelower cusp edge50 terminating inupstanding commissure regions52. Eachleaflet42 includes a coapting orfree edge54 opposite thecusp edge50. In the assembledvalve40, the cusp edges50 andcommissure regions52 are secured around the periphery of the valve, with thefree edges54 permitted to meet or “coapt” in the middle. Thestent assembly46 also includes threecusps60 separated by threeupstanding commissures62. In like manner, the connectingband48 includes threecusp portions64 separated by threeupstanding commissure portions66. Each of the sub-assemblies will now be described in detail.
• Stent Assembly
• Various components of apreferred stent assembly46 are seen inFIGS. 4-6. Thestent assembly46 comprises aninner stent70 and anouter cloth cover72. More specifically, theinner stent70 desirably includes three identical andseparate stent members74, each of which has a separate cloth covering. As seen best inFIG. 4B, eachstent member74 comprises an arcuatelower cusp region76 andupstanding commissure regions78 each terminating at atip80. Thestent members74 comprise elongate rods or wires, preferably made out of an elastic biocompatible metal and/or plastic alloy, such as Elgiloy®, Nitinol, polypropylene, etc.. The material selected forstent members74 should be elastic to permit flexing along their lengths, but should possess a relatively high modulus of elasticity to avoid asymmetric deformation of the constructedvalve40. Thestent70 supplies an inner frame for thevalve40 that is relatively more rigid than the other components. Therefore, thestent70 acts to limit total flexibility of thevalve40.
• Alternatively, the material for thestent70 may be highly flexible so as to add relatively little reinforcement to thevalve40. For example, thestent members74 may be formed of a length of medical grade silicone that provides some physical structure around the valve that helps in stitching fabric around the valve, and also helps provide some bulk for grasping and sewing the valve in place, but otherwise does not reduce the flexibility of the other components. In this case, thestent70 is desirably formed of a single piece (such as seen inFIG. 20D) and the commissures are inherently flexible, enabling thecusp regions76 to flex or pivot with respect to one another. This very high flexibility of thevalve40 minimizes any unwanted impediment to the natural annulus and aortic wall movement, and desirably maximizes the flow orifice formed though the valve, thus reducing any pressure loss therethrough. The highly flexible stent material may be provided in one or multiple filaments, with or without a surrounding enclosing sleeve, and may be silicone as mentioned, polypropylene, Delrin, polyurethane, polytetrafluoroethylene (PTFE), or the like. An exemplary thickness of the highly flexible stent material is about 0.011-0.013 inches for a monofilament version, or up to 0.025 inches with multiple filaments.
• Thestent members74 are desirably bent into the illustrated shape, using conventional wire-forming techniques. Each of thestent members74 is identical, and terminates in thetips80 which are bent inward with respect to thearcuate cusp regions76 to nearly form closed circles. As is seen inFIG. 4B, a gradual radially outward bend82 (with respect to the cylindrical stent70) is provided in thestent members74 at a transition between each of thecommissure regions78 and theintermediate cusp region76. Thisbend82 permits each of thestent members74 to remain in a circular configuration, as seen from above inFIG. 4A. That is, if thecusp regions76 extended in a plane between each of thecommissure regions78, the plan view would be somewhat triangular. Instead, each of thecusp regions76 includes alower apex84, and the apices of all of the cusps define a circle concentric with and having the same diameter as a circle defined by all of thetips80. Thestent70 thus defines a substantially cylindrical volume therewithin. Of course, other volumes may be defined by thestent70 wherein thetips80 define a circle that is smaller or larger than a circle defined by theapices84. For example, theapices84 may be provided outward from thetips80 so thestent70 defines a frusto-conical volume therewithin.
• As seen inFIG. 5, each of thestent members74 is preferably covered with a generallytubular cloth72 from tip totip80. Thecloth cover72 is a biocompatible fabric, such as polyterephthalate, and has a varying cross sectional shape, as indicated inFIGS. 6A and 6B. More specifically, thecloth cover72 includes a tubular portion closely conforming around each of thestent members74 and aflap86 extending radially outward from the stent member (with respect to the curvature of the cusp regions76). Thecloth cover72 is formed by wrapping an elongated sheet of fabric around each of thestent members74 and joining the free edges withsutures88 to form theflaps86. As seen inFIG. 5, theflap86 extends from eachstent member74 in a direction that is generally outward with respect to thecusp region76, and continues in the same general orientation up thecommissure regions78 to thetips80. Theflap86 has a dimension that is longest at the apex84 of eachcusp region76 and shortest at thetips80. Indeed, theflap86 is preferably nonexistent at thetips80, and gradually increases in size from thetip80 to the apex84. Therefore, the cross-section ofFIG. 6A taken through thecommissure region78 shows theflap86 having a small dimension d1, and the cross-section ofFIG. 6B taken through the apex84 shows theflap86 having a longer dimension d2.
• The final component of thestent assembly46 is an attachment means90 for joining each of a cloth-coveredstent members74. Preferably, the attachment means90 comprises threads or sutures sewn through the central holes in each of thecircular tips80, as shown inFIG. 5, although other suitable attachment means could be used, such as rings, cinches, or the like. The attachment means90 may be wrapped around or sewn through thecloth cover72. In joining thetips80, the attachment means90 are desirably not wrapped extremely tightly, but are instead provided with some slack to permit relative movement of the tips, as will be described below. When thestent members74 are attached, as seen inFIG. 5, thestent70 exhibits three cusps corresponding to thecusp region76 of each member, and three upstanding commissures defined by the juxtaposition of adjacent pairs ofcommissure regions78.
• In a preferred embodiment of the present invention the attachment means90 comprises a non-bioresorbable material to ensure that theindividual stent members74 are maintained in the shape of thestent70. In an alternative configuration, however, the attachment means90 comprises a bioresorbable material that dissolves over a period of time after implantation. In such an embodiment, the natural host tissues may have grown in and around the porous portions of thevalve40 to help retain the original shape of thestent70. In some instance, however, very little tissue overgrowth may have occurred prior to the attachment means90 dissolving, and theindividual stent members74 are permitted to move radially a great deal with respect to one another. In the latter embodiment, wherein thestent members74 are permitted to spread apart, the connectingband48 may be re-configured to be non-continuous at the commissure portions66 (seeFIG. 3). As a consequence, eachindividual stent member74 and associatedleaflet72 moves entirely independently of the others, albeit all oscillating with the natural contractions and expansions of the surrounding aortic wall. Such independent leaflet movement may greatly reduce any potential pressure drop across the valve. Although one embodiment is to provide a bioresorbable attachment means90 such as the sutures shown in the embodiment ofFIG. 5, those of skill in the art will understand that any of the coupling means connecting theindividual stent members74 disclosed in the present application could be modified to resorb over time.
• Thestent assembly46 provides an inner support frame that is generally rigid along any one ofstent members74, but which permits the stent members to move with respect to one another. In this context, “generally rigid” refers to the structural strength of thestent members74 that is sufficient to maintain the general shape of thestent70, but that permits some flexing along the length of the stent members. Though thestent members74 are generally rigid, they are able to move with respect to one another. More particularly, joining thestent members74 with the attachment means90 creates nodes or pivot points of thevalve40 at thecommissures62 of thestent assembly46. As will be more fully explained below with reference toFIGS. 13-16, thestent members74 are permitted to pivot with respect to one another as they move radially inward and outward. Inward pivoting is permitted byspaces94, seen inFIG. 5, defined between adjacent cloth-coveredcommissure regions78 of eachstent member74. Theseregions94 are generally triangular and gradually increase in size from the attached commissure tips to the diverging cusps.
• Leaflet Configurations
• FIGS. 7A,7B, and7C are plan views of various configurations ofleaflets42 suitable for use in theprosthetic heart valve40.FIG. 7A shows aleaflet42 having theaforementioned cusp50,commissure regions52, andfree edge54. It will be noted that thecoapting edge54 comprises two linear portions extending from an apex100 toouter tips102. The two portions of thefree edge54 are angled with respect to one another and define sides of atriangular region104 having as its hypotenuse animaginary line106 extending between theopposed tips102. Thetriangular region104 of eachleaflet42 is under less tension during dynamic motion of thevalve40, and helps ensure coaptation of the leaflets. That is, theleaflets42 are generally secured along thecusp50 andcommissure regions52, and thus the majority of eachleaflet42 is placed in stress except in the region aboveimaginary line106. In this regard, an imaginary (dashed)fold line108 defines anouter margin110 of theleaflet42 that is used to secure the leaflets into thevalve40. As will be clear from the discussion below, themargins110 are sutured between thestent assembly46 and connecting band48 (FIG. 3), and thefree edge54 of the leaflet extends across the cylindrical region defined within thevalve40, and is generally free to move in that region. Because thetriangular leaflet region104 is relatively stress-free, it tends to roll over under the influence of fluid dynamic forces, thus helping the three leaflets to coapt and prevent valve insufficiency.
• FIG. 7B shows aleaflet112 that is substantially the same as theleaflet42 ofFIG. 7A, and thus like elements will be given the same numbers. Theleaflet112 includes a pair of generally triangular shapedcommissure tabs114 in thecommissure regions52. Thetips102 are thus spaced farther apart than in the version shown inFIG. 7A. Thecommissure tabs114 are used to more securely fasten each of the leaflets to thecommissures62 of the stent assembly46 (FIG. 3). Thecloth cover72 of thestent assembly46 includes a flap86 (FIG. 5) which diminishes in size in the commissure regions. Thetabs114 are thus wrapped farther around the cloth-coveredstent assembly46 in the commissure regions and sutured thereto, thus facilitating a more durable connection.
• FIG. 7C is a further variation of aleaflet116 which is, again, the same in all respects to the leaflets described above, except for somewhat trapezoidal-shapedcommissure tabs118. Again, thecommissure tabs118 help to secure theleaflets116 in theprosthetic valve40.
• Stent/Leaflet Sub-Assembly
• FIG. 8 illustrates a stent/leaflet sub-assembly120 in which theleaflets42 are secured to thestent assembly46. Preferably,leaflets42 are pre-attached to align the free edges54. In this manner, thefree edges54 of each twoadjacent leaflets42 extend outward in juxtaposition and are received within thetriangular space94 defined between thecommissure regions78 of the stent assembly46 (FIG. 5). The group ofleaflets41 is thus “inserted” underneath thestent assembly46 until the juxtaposedfree edges54 of theleaflets42 are in close proximity below the attachment means90. Theouter margin110 of eachleaflet42 is folded underneath the correspondingcusp60 of thestent assembly46. At this point, sutures or other such means attach themargins110 to theflap86 of thestent assembly46. Theleaflets42 can remain attached to one another at their adjacent tips102 (or along thefree edges54 near the tips), or can be separated for maximum valve flexibility or when the stent is designed to separate into individual stent members by bio-resorption of a commissure couple.
• If either theleaflet112 orleaflet116 ofFIG. 7B or7C are used, therespective commissure tabs114 or118 are wrapped around the adjacent part of thestent assembly46 and secured thereto. In a preferred assembly method, theleaflets42 are simply retained in position with respect to thestent assembly46 with temporary sutures or other such means, to permit the stent/leaflet subassembly120 to be finally joined together with the connectingband48 ofFIG. 8.
• FIG. 8 also illustrates the threealignment brackets44 and that each has a generally L-shaped cross-section and comprises a cloth-covered inner member (not separately numbered). The inner member preferably has minimum elasticity, but is relatively thin and lightweight. One preferred material for the inner member is a polyester film such as Mylar®. Thebrackets44 are preferably joined to thevalve40 at the time the stent/leaflet sub-assembly120 and connectingband48 are joined, and thus will be described more fully below with respect toFIG. 11.
• Connecting Band
• FIGS. 9 and 10 illustrate the connectingband48 in more detail, comprising aninner member130 surrounded by acloth cover132. As mentioned previously with respect toFIG. 3, the connectingband48 includes threecusp portions64 alternating withcommissure portions66, all generally formed in a tubular configuration. This shape is provided by theinner member130, with thecloth cover132 simply draped and sewn thereover. In a preferred embodiment, theinner member130 is molded of silicone rubber, and thecloth cover132 is polyterephthalate.
• Theinner member130 has a varying cross sectional shape along the cusps and commissures.FIG. 10 is cross-section through one of thecusp portions64 of the connectingband48, and shows a region of theinner member130 having aninner ledge134 and upwardly angled outerfree margin136. The cloth-coveredledges134 extend generally radially and define threestent support regions138 of the connectingband48, as seen inFIG. 8. Theledge134 has its greatest radial dimension at the midpoint of each of thecusp portions64 and gradually tapers down in size toward thecommissure portions66 Likewise, thefree margins136 form their greatest outward angle with respect to a central axis of the connectingband48 at eachcusp portion64, and gradually re-align to be parallel to the central axis in thecommissure portions66. The cross-section of theinner member130 at thecommissure portions66 is seen inFIG. 12B. A series of triangular shapedribs140 projects outward from theinner member130. Theribs140 are formed around the entireinner member130, along both the cusp and commissure regions. As seen inFIG. 8, thecommissure portions66 of the connectingband48 define generallyaxial gaps142 that help permit flexing of thevalve40. It should be noted that the connectingband48 may be discontinuous at thecommissure portions66 if the valve has bioresorbable commissures and is designed to separate into individual “leaflets.”
• Assembled Valve
• FIG. 11 illustrates the assembledvalve40 in perspective, whileFIGS. 12A and 12B show cross-sections through avalve cusp150 andvalve commissure152, respectively. The connectingband48 is sewn or otherwise attached to the exterior of the stent/leaflet subassembly120. Actually, as seen inFIG. 12A, the connectingband48 is attached underneath the stent/leaflet subassembly120 in thecusp150, but thefree margins136 of the connecting band are positioned to the outside of the subassembly. In addition, thealignment brackets44 are installed with avertical leg156 interposed between thecommissures62 of thestent assembly46 and the commissure portions66 (FIG. 3) of the connectingband48. Ahorizontal leg154 of each of thealignment brackets44 projects radially inward to cover thetips80 of thestent assembly46. Thealignment brackets44 help hold each twoadjacent tips80 of the three-piece stent70 together, especially helping to prevent radial mis-alignment. The brackets also provide flat surfaces which a holder can contact, as seen best inFIG. 26.
• With reference to the cross-section ofFIG. 12A, the sandwiched configuration of thestent assembly46,leaflet42, and connectingband48 can be seen. More specifically, thecloth flap86 of thestent assembly46 aligns with theleaflet margins110, which in turn rest on the stent supports138. A series of suture stitches158 are used to secure these elements together. Preferably, theflap86 terminates at the same location as themargin110 of eachleaflet42, and at the corner defined in the connectingband48 between eachledge134 andfree margin136. The radially innermost wall of theledge134 is preferably inward from thestent member74. This construction helps prevent thestent70 from migrating downward with respect to the connectingband48.
• Thehost annulus162 is seen in phantom with theaortic wall164 continuing upward therefrom. It can be readily seen that the angled shape of thecusp portions64 of the connectingband48 conform nicely to the host annulus region. Thetriangular ribs140 provide volume at thefree margins136 of the connectingband48 to facilitate connection to the natural tissue; in other words, more volume provides more of a “bite” for the surgeon to secure theband48 with a suture needle. Although the conventional means for attaching thevalve40 to the host tissue is with sutures, which are not shown, the present invention should not be construed as limited to being implanted with sutures and other means such as staples, adhesives, and the like could be used.
• Now with reference toFIG. 12B, the assembly of the valve components in the commissure region is seen. The commissure edges52 of each of theleaflets42 are sandwiched in between thestent assembly46 and connectingband48. More particularly, the commissure edges52 are sandwiched between theflaps86 and the generallyplanar commissure portions66 of the connecting band48 (FIG. 8).Sutures170 are provided to join these elements together. Again, the commissure edges52 preferably terminate at the same location as theflaps86.FIG. 12B also illustrates thegap142 provided in the commissure regions of the connectingband48, and the lack of structural connection between the two sides of eachvalve commissure152.
• FIG. 12B shows in phantom a portion of theaortic wall172 to which thecommissures152 of thevalve40 are attached. Again, the particular attachment means is not shown, but the connectingband48 is traditionally sutured to thewall172.
• Dynamic Motion of the Prosthetic Heart Valve
• FIGS. 13 and 15 illustrate a conduit portion of a heart in the region of the aortic valve and relative motions of the conduit walls during systole and diastole, respectively. In particular,FIG. 13 shows anopen valve200 andsystolic blood flow202, whileFIG. 15 shows aclosed valve204 and diastolic back flow ofblood206. As described with respect toFIGS. 1 and 2, the regions around the aortic valve can be generally separated into anannulus region208 and asinus region210.
• As mentioned previously, theannulus region208 is expected to contract during the systolic phase, as indicated by thearrows212 inFIG. 13, and expand during the diastolic phase, as indicated by thearrows214 inFIG. 15. Conversely, thesinus region210 is expected to expand during the systolic phase, as indicated by thearrows216 inFIG. 13, and is expected to contract during the diastolic phase, as indicated by thearrows218 inFIG. 15. The movements of the conduit walls are shown with respect to a neutral orrelaxed position220, and may be exaggerated from the true movements. Also, as mentioned above, these movements are educated guesses and may be different for some, if not most patients. However, the flexible heart valve of the present invention accommodates all variations of such movements.
• FIGS. 14 and 16 schematically illustrate the synchronous movement of theprosthetic valve40 of the present invention with respect to the movements of the host tissue in systolic and diastolic phases as seen inFIGS. 13 and 15. To simplify this explanation,FIGS. 14 and 16 only illustrate thestent70 of the present invention, which as previously described acts as a limitation to movement of theentire valve40 and fairly represents movement of the entire valve.
• With reference toFIGS. 14A and 14B, during systole the valve experiences outward commissure movement, as indicated by thearrows230. At the same time, the valve experiences inward movement at the cusps, as indicated by thearrows232. During diastole, in contrast, and as seen inFIGS. 16A and 16B, the valve experiences inward commissure movement, as indicated by thearrows234. At the same time, the valve experiences outward movement at the cusps, as indicated by thearrows236.
• Alternative Stents
• FIGS. 17-19 illustrate analternative stent assembly250 comprising aninner stent252 and anouter cloth cover254. As with theearlier stent assembly46, thestent assembly250 includes alternatingcusps256 andcommissures258. As best seen inFIG. 18, thestent252 includes threeseparate stent members260 havingarcuate commissure tips262 that are curved toward one another. A generally disk-shapedcommissure housing264 encompasses theadjacent commissure tips262, retaining thestent members260 together while permitting relative pivoting.
• FIG. 19 illustrates twoadjacent commissure tips262 and thecommissure housing264 exploded into amale housing portion266 and afemale housing portion268. The housing portions are so named because they are joined together through interference between abutton270 of themale housing portion266 and anaperture272 on thefemale housing portion268. Each portion of thecommissure housing264 includes acircular groove274 for receiving thearcuate tips262. Thegrooves274 combined to form a circular channel having anaxis276 within which thearcuate tips262 are received and can slide. When assembled together, thecommissure housings264 thus provide nodes of rotation for each of thestent members260.
• FIG. 20A illustrates analternative stent280 suitable for use in a heart valve of the present invention. Thestent280 includes threestent members282, each having commissures with aflex region284 andtips286. Thetips286 ofadjacent stent members282 are secured together by sutures or other suitable means (not shown). Theflex regions284 comprise sections of eachstent member282 which are bent away from each other. Thestent members282 can thus pivot with respect to one another about theconnected tips286. Upon inward movement of thestent members282, afulcrum288 is created by interaction between the stent members at the lower end of theflex region284. The relative flexibility in inward or outward movement of thestent members282 can be modified by selection of the cross sectional size and shape of the stent members, and overall configuration of theflex region284.
• FIG. 20B illustrates a secondalternative stent290 suitable for use in a heart valve of the present invention. Thestent290 includes threewires292 and hascommissure regions294 formed by bent ends of the wires and ajunction member296. In this embodiment, thejunction member296 either rigidly holds the terminal ends of each of thewires292, or permits the wires to slide or otherwise flex with respect to one another. If the wires are rigidly attached to thejunction member296 the shape of the wires in thecommissure region294 reduces stress risers in bending.
• FIG. 20C illustrates a thirdalternative stent300 suitable for use in a heart valve of the present invention. Thestent300 comprising threeseparate wires302 terminating atcircular commissure tips304. Each of thecommissure tips304 is rotatably fastened around apin306 provided on ajunction plate308 common toadjacent wires302. In this manner, thetips304 remained located close to one another, while the cusps of thewires302 can pivot in and out.
• FIG. 20D illustrates a fourthalternative stent310 suitable for use in a heart valve of the present invention. Thestent310 is made in one piece with a series of alternatingcusps312 andcommissures314. Thecommissures314 comprising a nearly360° bend in thestent310 which permits eachcusp312 to easily flex with respect to the other cusps.
• FIG. 20E illustrates a fifthalternative stent320 suitable for use in a heart valve of the present invention. Thestent320 comprises three wire-like stent members322, adjacent ones of which are joined together atcommissure regions324 by aU-shaped coupling326 and a pairflexible sleeves328.FIG. 21 is a detail of one of thecommissure regions324 showing in hidden lines the adjacent ends of thecoupling326 andstent members322. Thecouplings326 are preferably sized with the same diameter as thestent members322, and thesleeves328 are tubular with a constant diameter lumen. Thesleeves328 may be made of silicone, or a flexible polymer such as polyurethane or the like. Other flexible interfaces such assleeves328 are contemplated, such as, for example, a single block of silicone into which thecommissure regions324 of thestent members322 are molded.
• FIG. 22 is a detailed view of acommissure region330 of a still further alternative stent suitable for use in a heart valve of the present invention. The stent is made in one piece withadjacent cusps332 being joined by acoil spring tip334. Again, great flexibility is provided by thecoil spring tips334 to enable relative motion of thecusps332. The amount of flexibility is selected as in any spring by varying the material, cross-sectional size and shape, and number of turns of the spring.
• Valve Holder
• FIGS. 23-26 illustrate apreferred holder350 useful for implanting theflexible heart valve40 of the present invention. As theheart valve40 is relatively flexible, theholder350 must provide adequate support to insure a stable platform for the surgeon to position the valve for attachment to the natural tissue. In other words, because the flexibleprosthetic heart valve40 of the present invention exhibits alternating cusps and commissures in a generally cylindrical configuration that are adapted to move radially in and out with respect to one another, theholder350 desirably provides rigid structure for maintaining a fixed shape of the valve during implantation. In addition, theholder350 must include structure to allow quick release from thevalve48 after the valve is implanted.
• As seen inFIG. 23, theholder350 comprises aproximal handle socket352 having aninner bore354 for receiving the distal end of a handle (not shown). Thesocket352 may be provided with internal threads, or other such quick-release coupling structure to facilitate handle connection and disconnection. Theholder350 has three radially outwardly-directedcommissure legs356, and three outwardly and downwardly angledcusp legs358. Consistent with the distribution of thecusps150 andcommissures152 of thevalve40, thecommissure legs356 are oriented 120° apart, and thecusp legs358 are oriented 120° apart, with the three commissure legs being offset with respect to the three cusp legs by 60°.
• As seen inFIG. 24, each of thecommissure legs356 extends outward from thehandle socket352 into proximity with one of the valve commissures152 and is secured thereto with anupper suture360 Likewise, each of thecusp legs358 extends outward and downward from thehandle socket352 into proximity with a midpoint of one of thevalve cusps150, and is secured thereto with alower suture362. The lower end of eachcusp leg358 includes a concavity for mating with the corresponding rod-like stent member74, as seen inFIG. 26. In this manner, each of thecusps150 andcommissures152 of thevalve40 is securely held in relation to the others, thus facilitating implantation by the surgeon.
• Details of thecommissure legs356 will now being described with reference toFIGS. 23 and 26. Eachcommissure leg356 extends outward from thehandle socket352 in a generally rectangular cross-section interrupted by an upwardly-facinginner notch370 oriented cross-wise to the leg. And upwardly-facingradial channel372 having a depth of approximately half of eachcommissure leg356 extends from about theinner notch370 to the outermost end of the leg. Theinner notch370 is not quite as deep as thechannel372, as seen inFIG. 26. Theradial channel372 divides the upper portion of eachcommissure leg356 into twowalls374a,374b.Aneyehole376 is formed in one of thewalls374a,and a correspondingouter notch378 is formed in the other wall374baligned with the eyehole. Theouter notch378 is also not quite as deep as thechannel372.
• With reference toFIGS. 24 and 26, theupper suture360 is preferably tied to theeyehole376 in thefirst wall374a.Thesuture360 then passes across thechannel372, through theouter notch378, and is passed along theinner notch370, again traversing thechannel372. The suture368 is then passed through a suture-permeable portion of thevalve commissure152, such as through the connectingband48. After passing through thecommissure152, thesuture360 is again looped through one or both of thenotches370,378 and re-tied to theeyehole376. By proper threading of theupper suture360, eachcommissure152 can be secured to thecommissure leg356 and easily released by inserting a scalpel blade into theradial channel372 to sever the portions of the suture therein.
• Details of eachcusp leg358 can be seen inFIGS. 23 and 26. A pair oflongitudinal rails380a,380bare provided on the outer side of eachcusp leg358. Toward the lower end of therails380a,b,a pair of alignedeyeholes382 provide anchoring locations for thelower suture362. A scalpel guide orrelief384 is formed in one of the rails380b.As seen inFIG. 24, thelower suture362 extends downward from theeyeholes382, passes through a suture-permeable portion of thecusp150, and is then returned and secured to theeyeholes382. Therelief384 exposes a portion of thelower suture362 for severing by the surgeon using a scalpel blade. It will thus be understood that theholder350 can be quickly released from thevalve40 by a series of six scalpel strokes, with each of thesutures360,362 remaining attached to theholder350 and being withdrawn from thevalve40 as the holder is withdrawn.
• FIGS. 27A and 27B illustrate analternative holder390 useful for implanting theflexible heart valve40 of the present invention. Theholder390 is substantially similar to theholder350 described above, but the ends of each of a plurality of rigid legs for attaching to the valve cusps are flared, or, more precisely, each lower leg has a width from a hub to a terminal end that is greatest at the terminal end to provide more surface area to contact the corresponding valve cusp. That is, theholder390 includes a plurality ofupper legs392 having a generally constant width, and a plurality oflower legs394 having flared ends396, the legs extending from acentral hub398. Again, theupper legs392 extend radially outward to connect to thevalve commissures152, and thelower legs394 angle radially outward and downward to connect to thevalve cusps150. The flared ends396 impart greater stability to theflexible valve40 during implantation, especially helping to prevent movement of thecusps150. In addition, the legs194 remain fairly narrow until the flared ends396 to maintain good visibility through the spaces between the plurality of legs. That is, for example, the surgeon can continue to view thevalve leaflets42 between the legs as a check on valve orientation.
• FIG. 28 illustrates afurther holder420 of the present invention attached to aflexible heart valve422. (It should be noted that inFIGS. 28-33, thevalve422 is only schematically shown so as to better illustrate theholder420 structure.) As before, thevalve422 includesmultiple leaflets424 joined together at adjacent juxtaposedvalve commissures426 that are generally axially aligned and commonly disposed about a valve axis (not illustrated) and are each disposed between adjacentcurvilinear valve cusps428. Theholder420 is shown without thevalve422, assembled inFIG. 30 and exploded inFIG. 31.
• As described and shown above in previous embodiments, theholder420 attaches to and securely maintains each of thecusps428 andcommissures426 of theflexible valve422 in relation to the others, thus facilitating implantation by the surgeon. In this regard, theholder420 may be relatively rigid to support and define the valve shape against inadvertent external forces during the implant process. Optionally, theholder420 may be somewhat flexible and resilient so to enable deliberate manipulation by the surgeon desiring to view a portion of the heart anatomy occluded by thevalve422. For example, one of thecommissures426 orcusps428 may be radially bent inward along with the adjacent portion of theholder420 so as to view the underlying annulus. Various flexible constructs of theholder420 are contemplated, which will be further described below.
• For orientation purpose, the coordinate axes of theholder420 and attachedvalve422 are: the axial direction or axis generally along the flow path through the valve and coincident with a central handle for the holder; the radial direction with respect to the axis; and the circumferential or tangential direction also with respect to the axis. Most tissue heart valves include threecommissures426 and threecusps428 that mimic the natural valve peripheral shape. The threecommissures426 are generally evenly circumferentially disposed about the flow axis (i.e., 120° apart), with the threecusps428 being circumferentially disposed midway between each two commissure. Theholder420 of the present invention desirably maintains the axial and circumferential orientation of the valve, while permitting some radial flexure. The need for such flexure depends on the implantation technique used, and will be described below.
• With reference toFIGS. 28-31, and in particularFIG. 30, anexemplary holder420 includes avalve contacting portion430 and ahandle connector432. Thevalve contacting portion430 includes a plurality of cusp supports434 arranged to contact theheart valve422 generally along thevalve cusps428, and a plurality of commissure supports436 connected to the cusp supports and arranged to abut thevalve commissures426. In a preferred embodiment, the commissure supports436 are radially flexible enabling thevalve commissures426 to be flexed inward while in contact therewith; for example, the commissure supports436 may be made of a resilient, biocompatible material such as Nitinol.
• The cusp supports434 are formed in the same curve and dimensions as the associatedflexible heart valve420, as seen inFIG. 28. Thevalve420 shown includes anouter sewing band440 and the cusp supports434 are shaped to abut and contact, or at least closely conform to, the inner surface of this band when the holder is positioned on the outflow side of theleaflets424. Through attachment structure to be described below, the cusp supports434 andouter sewing band440 at thevalve cusps428 are coupled so as to reinforce theflexible valve422 at those locations. It should be understood that other flexible heart valves than the version illustrated may be delivered using theexemplary holder420, or other holders illustrated herein, and that the cusp supports434 may attach to structure other than thesewing band440, such as to a cloth-covered frame or stent structure.
• As illustrated best inFIGS. 30 and 31, a plurality of wire-like elements define thevalve contacting portion430 of theexemplary holder420, desirably forming a plurality (preferably three) of alternating and contiguous curvilinear cusp supports434 and commissure supports436. There is no discrete transition between the alternatingsupports434,436, the curvilinear cusp supports eventually straightening and becoming oriented generally axially atintermediate sections442 prior to the commissure supports.
• The contiguous cusp supports434 and commissure supports436 join to thehandle connector432 via a plurality oflegs444. Thelegs444 emanate radially outward from the centrally located distal end of thehandle connector432 to several locations on thevalve contacting portion430. For example, as shown inFIG. 30, threelegs444 may extend between thehandle connector432 and a mid-point of eachcusp support434, although the legs may also extend to the commissure supports436 or both. The common connection of the threelegs444 at the distal end of thehandle connector432 enables positioning of the holder420 (and attached valve422) to be controlled by manipulation of the handle connector.
• FIGS. 31 and 32 best illustrate the exemplary wire-likevalve contacting portion430 and associatedlegs444 formed in threepieces450a,450b,450c.With specific reference toFIG. 32, each one of the three pieces450 comprises twohalves452a,452bof adjacent cusp supports434 and acommissure support436. Each of the three pieces450 also has twoleg halves454a,454bextending radially inward from a respectivecusp support half452aor452b.When the threepieces450a,450b,450care positioned evenly about an axis, each pair of adjacent leg halves454 makes up one of theholder legs444 and two adjacent cusp support halves452a,452bin different holder pieces define awhole cusp support434. Each leg half454 terminates at afree end456 that extends generally axially and can be easily joined along with the other similarly aligned free ends to thehandle connector432. Preferably, each of the three pieces450 is identical and the free ends456 coincide generally along a central axis, so that thehandle connector432 lies along the central axis as well. Eachcommissure support436 includes aleaflet guard section460 that is bent radially inward from the adjacentintermediate sections442. The function of theleaflet guard sections460 will be described below with respect to the structure used to attach theholder420 to thevalve422.
• FIG. 31 illustrates thehandle connector432 having aproximal stem470 and handlecoupling472 exploded from adistal hub member473. Alternatively, of course, theentire handle connector432 may be one piece, and formed by molding, for example. Thecoupling472 includes structure such as an internally threaded socket for receiving a valve delivery handle (not shown). Thestem470 has a length suitable to enable a surgeon to manually grasp it and manipulate theholder420 and attachedvalve422. Desirably, the length of thehandle connector432 is at least one inch, and preferably between one and four inches. Thehandle connector432 is made of a material that is capable of being stored in a solution in which thevalve422 is stored between manufacture and usage. For example, typical bioprosthetic valves may be stored for periods of years in glutaraldehyde, and thehandle connector432 may be made of a polymer that can withstand such storage conditions, such as Delrin. Thedistal hub member473 may be internally threaded for mating with external threads on thestem470, wherein mutual cooperation of the two elements may serve to clamp the free ends456 of the holder pieces together, such as having a bifurcateddistal end474 of the stem that constricts upon mating with the hub member. Of course, numerous other ways to secure the free ends456 to thehandle connector432 are possible, including molding as a homogeneous structure.
• FIGS.28 and29A-29D illustrate an exemplary system for removably securing theholder420 to thevalve422 using sutures. In one embodiment, at least the commissure supports436 are secured to thevalve commissures426 in a manner that permits easy release, but preferably both the commissure supports and cusp supports434 are so connected. Sutures are preferred as the means for attaching various points on theholder420 with coincidental points on thevalve422 because of their flexibility, strength and severability. Of course, other means of attachment are contemplated, such as hooks, spring clamps, and the like. Theholder420 andvalve422 may be attached at relatively separated discrete points, as shown, or may be attached at multiple points along their mating surfaces to result in a more continuous coupling.
• With reference toFIGS. 28,29A,29B and33, an exemplary arrangement for joining each of the cusp supports434 to thevalve422 with sutures is shown. Eachcusp support434 joins to thevalve422 with two lengths ofsuture material480a,480bthat are secured to thehandle connector432 and extend in parallel segments down each of thelegs444. The lengths ofsuture material480a,480bcouple to thehandle connector432 in a visible or otherwise accessible manner to enable severing by a knife blade. More specifically, and as seen inFIGS. 28 and 29A, the lengths ofsuture material480a,480bextending along eachleg444 are gathered at the lower end of thehandle connector432 and passed through aneye hole475 provided in aflange476 projecting outward from thedistal hub member473. The six strands of sutures then tie to a throughhole477 or other such feature in theproximal stem470. In this manner,common segments478 of all sixsutures480 are exposed on the exterior of thehandle connector432 to facilitate severing, or in other words thesutures480 are routed so as to cross a common cut point on theholder420.
• As seen inFIG. 29B, each length ofsuture material480a,480btravels down therespective leg444 and passes through a portion of thesewing band440 at aloop481. From theloops481, each length ofsuture material480a,480bturns radially inward and fastens by tying atknots482, for example, to one of thepieces450a,450bof thevalve contacting portion430. Anti-migration sleeves483 (such as shrink-fit sleeves) prevent theknots482 from sliding along thepieces450a,450b.As mentioned above, the suture may also be secured to a different part of thevalve422 than thesewing band440, as long as it may easily be removed by pulling on its loose ends. Theloop481 is so formed and thesewing band440 is constructed to permit the suture to slide from within the band by pulling one loose end.
• FIG. 29D shows the cross-section through one of theexemplary holder legs444, and in particular the two lengths ofsuture material480a,480bwithin a shapedsleeve484 that conforms around the two juxtaposed leg halves454a,454b.Thesleeve484 may be formed of a polymer tube that is shrink fit around the twoleg halves454a,454b.A cylindrical forming mandrel (not shown) is desirably placed in a triangular array along with the juxtaposed leg halves454a,454b,with thesleeve484 circumscribing all three rods. After shrinking, thesleeve484 conforms closely around the three rods and the mandrel is then removed, leaving the hollow space as shown for easy assembly and sliding passage of the two lengths ofsuture material480a,480b.
• Now with reference toFIGS. 28,29C and33, two lengths ofsuture material490a,490beach extends from a first anchor orknot491 secured to a midpoint of theleaflet guard section460, via aloop492 that passes through thesewing band440, to a second anchor orknot493 also on the leaflet guard section. In the embodiment shown, wherein theleaflet guard section460 is part of a wire-like member, smallanti-migration sleeves494,495 may be provided to prevent eachknot491,493 from sliding along the wire. The segment of thesutures490a,490bthat extend between thefirst knots491 to theloop492 are accessible for severing with a blade. The distance between theleaflet guard section460 andsewing band440 is exaggerated in the drawing, and the guard section will be desirably be configured to prevent the possibility of nicking the valve or leaflets with the blade.
• In use, theholder420 andvalve422 are removed from their sterile packaging in the operating room, and the valve washed or otherwise prepared for implant. The surgeon may wish to connect a longer handle to the holder using thehandle coupling472 of theconnector432. A typical handle length is between about 6-10 inches. After opening an access passage to the aortic valve implant site, thevalve422 is delivered using theholder420 and attached handle.
• There are two generally accepted methods for implanting a heart valve. In the first, called the interrupted or parachute suture method, a number of separate lengths of suture material are pre-anchored in the appropriate places in the native annulus and surrounding tissue. Each length loops through the tissue, and thus two free ends extend out of the implant site. The two free ends are then threaded through corresponding points on thesewing band440. After all such sutures are pre-threaded through the native tissue andsewing band440, thevalve422 is lowered along the array of sutures into position in the annulus. Each pair of free ends of the sutures is tied off to secure the valve in place with a plurality of separate one loop suture segments. The second method, called the running suture method, employs one or more sutures that extend in a series of loops through the native tissue andsewing band440 for a more continuous structure. The surgeon threads the continuous suture through the annulus and valve after delivering the valve. In this method, visibility of the annulus and surrounding tissue may be occluded by the valve or holder, and so some manipulation of the valve and holder structure may be necessary.
• Specifically, in the running suture method, the surgeon may manipulate thevalve commissures426 by flexing them inward along with the holder commissure supports436 so as to visualize the implant site under the valve. Also, the longer handle may be removed from theconnector432 for greater visibility. As mentioned above, thepreferred holder420 is radially flexible to permit inward flexure and visualization of the implant site, but desirably resists deformation in either the axial or circumferential directions. Stiffness in the axial direction helps prevent excess compression of thevalve422 against the annulus caused by inadvertent excess axial force imparted by the surgeon. Resistance to torsional forces helps maintain the 120° orientation of thecommissures426. An added benefit of the radial flexibility of theholder420 is its ability to be radially compressed to pass through delivery tubes smaller than the relaxed size of the holder/valve combination.
• After attaching the valve to the annulus and ascending aorta using an interrupted pattern, or one or more continuous stitches, or other such means, theholder420 is removed. To remove theholder420, each suture at the commissures and cusps is severed. For the cusps, thecommon segments478 of the lengths of suture material480 (FIG. 29A) extending along eachleg444 are severed with one cut. At the commissures, the segments of suture that extend between theknots491 and theloop492 are severed, two at a time per commissure for a total of three cuts. The inwardly bentleaflet guard section460 prevents the knife blade from contacting the leaflets during this operation. Therefore, there are a total of four cuts to release the valve from the holder. Each length of suture remains attached to the holder, and only free or loose segments pass through the valve. After severing all sutures, the holder may be removed from the now implantedvalve422, with the loose segments of sutures easily pulling free from thevalve sewing band440.
• FIG. 34 illustrates a portion of analternative valve holder500 of the present invention similar to theholder420 described above, and desirably comprising three sire-like pieces. Only avalve contacting portion502 is shown, along with a plurality oflegs504 extending between cusp supports and a central location, defined by acircle506 drawn in dashed line. Because of this modified arrangement, the inner ends508 of the legs may be secured to the outside of a connecting member rather than the inside. Also, rather than anti-migration sleeves at the commissures, eachleaflet guard section510 includes asmall anchor point512, such as a section that is bent in a U-shape.
• FIGS. 35 and 36 illustrate a stillfurther holder520 of the present invention having a single wire-like piece that conforms around the cusps and commissures of the valve522. Theholder520 includes cusp and commissure supports but only attaches to the valve522 at the three commissures, as indicated in the detail ofFIG. 36. Specifically, one or more lengths of suture may be tied to bent portions of the commissure supports of the holder, with two shown having relatively moreaccessible severing segments524 extending between the holder and valve. A separate handle or connecting member (not shown) may be used, or the holder may be removed using forceps.
• FIGS. 37 and 38 illustrate a one-piece holder540 and a two-piece holder550, respectively. Theholders540,550 may be molded pieces of Delrin or other suitable polymer. As before, bothholders540,550 include cusp and commissure supports, and attach to a heart valve at three or six locations. The material is such that inward flexing of the cusp regions is permitted during the implant operation. In the twopiece holder550, ahandle portion552 along withradial legs554 may be removed from avalve contacting portion556 during implant for greater visibility of the implant area.
• FIG. 39 illustrates a one-piece holder560 that is similar to the one-piece holder540 ofFIG. 37 but includes a continuous series ofsuture apertures562 along both the cusp supports564 and commissure supports566. Thus, theholder560 may be relatively continuously coupled to a flexible heart valve to provide more uniform support thereto. It should also be noted that eachleg568 is molded so as to be relatively circumferentially wider close to therespective cusp support564 than near the handle, and axially thicker near the handle than near thecusp support564. This illustrates the potential for customizing the shape of the holders of the present invention (i.e., by molding) to provide either flexibility or rigidity in the appropriate places.
• FIG. 40 shows a one-piece moldedholder570 that has a handle572 that joins to asingle cusp support574. This arrangement minimizes structure within the periphery of theholder570 and thus maximizes visibility of the valve attached thereto. Also, the three cusp supports574 and three commissure supports576 are decoupled and thus have greater flexibility in the radial direction than earlier embodiments where multiple legs from the holder periphery joined at a common point along the central axis.
• FIGS. 41 and 42 are assembled and exploded views, respectively, of a two-stage holder600 of the present invention, along with aflexible heart valve602 such as described above. Theholder600 includes a relativelyrigid stage604 coupled to a relativelyflexible stage606 with one ormore sutures608. Therigid stage604 forms a proximal part of the holder and includes asocket610 for receiving a delivery handle (not shown). Three cusp supports612 extend at an angle outward and distally from a base614 on which thesocket610 resides. One or more cutting guides616 may be provided on the base614 over which thesutures608 are threaded for easy release of theflexible stage606 from therigid stage604. In the illustrated embodiment, asingle suture608 andsingle cutting guide616 are used.
• Theflexible stage606 includes three commissure supports620 that include anchor holes or other such structure to which sutures622 attach the supports to the commissures of thevalve602. The commissure supports620 are coupled together with three relativelythin band segments624 that permit relative radial flexing of the supports. Of course, other arrangements in which the commissure supports620 are coupled together yet remain radially flexible with respect to one another are contemplated.
• FIGS. 43 and 44 illustrate two modes of use of theholder600 depending on the implant method. In the interrupted or parachute method, the relativelyrigid stage604 remains coupled to the relativelyflexible stage606 during delivery and anchoring of thevalve602. After implant, thesutures622 holding the commissure supports620 to the valve commissures are severed and theholder600 pulled free. When the running suture method is used, thesuture608 is severed at the cuttingguide616 thus permitting the relativelyrigid stage604 to be removed, as seen inFIG. 44. The relativelyflexible stage606 remains attached to thevalve602 with thesutures622. Thearrows626 illustrate the radial flexibility of the valve commissures as coupled to the relativelyflexible stage606, which flexibility is permitted by the three relativelythin band segments624. Such flexibility helps the surgeon manipulate the holder/valve combination for greater visibility of the progress of the running sutures. At the same time, the circumferential orientation of the three valve commissures (and cusps) is maintained by the continued attachment of theflexible stage606. After implant, theflexible stage606 is removed by severing thesutures622.
• A holder for a highly flexible tissue-type heart valve is disclosed that maintains an implant shape to the valve. The holder may have cusp and commissure contacting supports, and may be attached at all six such supports, or only three. The holder may be flexible to permit inward flexing of the heart valve during implant for greater visibility when implanting using a running suture method. The holder may be formed of flexible wires such as Nitinol, and shaped to resist excessive axial and torsional deformation of the valve. A short handle connector suitable for manual grasping may be attached and stored with the valve, with the handle connector having a coupling for receiving a longer delivery handle. A two stage holder may be utilized to accommodate different implant methods.
• The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. In particular, though the flexible nature of the present heart valve has been described as being particularly suitable for use in the aortic position, the advantage of flexibility could equally apply to a valve implanted in other positions, such as the mitral position. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims (13)

1. A holder for a heart valve, the heart valve having multiple leaflets joined together at a periphery of the valve at valve commissures that are generally axially aligned and evenly disposed about a valve axis, the valve commissures each being disposed between adjacent curvilinear valve cusps along the periphery of the valve, the holder comprising:

a plurality of cusp supports connected to the heart valve generally along the valve cusps, wherein the heart valve is a flexible heart valve.

2. The holder ofclaim 1, wherein the commissures are radially flexible enabling the valve commissures to be flexed inward while the holder is attached to the heart valve.

3. The holder ofclaim 2, wherein the commissure are made of Nitinol.

4. The holder ofclaim 1, wherein sutures connect the holder to the commissures.

5. The holder ofclaim 4, wherein the cusp supports are connected to the heart valve with sutures.

6. The holder ofclaim 5, wherein the sutures connecting the cusp supports to the heart valve are cut to release the holder from the heart valve.

7. The holder ofclaim 6, wherein the sutures connecting the commissures to the holder are cut to release the holder from the heart valve.

8. A holder for attaching to and holding a heart valve, the heart valve having multiple leaflets joined together at a periphery of the valve at valve commissures, the valve commissures each being disposed between adjacent curvilinear valve cusps about the periphery of the valve generally at an inflow end thereof, the holder comprising: a plurality of cusp supports arranged around a holder axis that coincides with the valve axis when the holder and valve are attached, the cusp supports being adapted to contact and attach to the heart valve along the valve cusps, wherein the valve commissures can be flexed inwards for increased visibility during implantation while the holder is attached to the valve cusps.

9. The holder ofclaim 8, wherein the commissure are made of Nitinol.

10. The holder ofclaim 8, wherein sutures connect the holder to the commissures.

11. The holder ofclaim 10, wherein the cusp supports are connected to the heart valve with sutures.

12. The holder ofclaim 11, wherein the sutures connecting the cusp supports to the heart valve are cut to release the holder from the heart valve.

13. The holder ofclaim 12, wherein the sutures connecting the commissures to the holder are cut to release the holder from the heart valve.

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