Compliant surgical heart valve sewing ring

Abstract

A contoured or compliant suture ring is used for surgical prosthetic heart valves suitable for implantation at the natural tricuspid annulus. The suture ring can be substantially D-shaped, with a flat side defined by a corner. The suture ring may have an elastic inner core surrounded by a biocompatible fabric. The inner core can be molded with an inner wall that divides the volume of the inner core into units open to both its inflow and outflow surfaces. The biocompatible fabric surrounding most of the periphery of the inner core can be substantially incompressible, except on the flat side, which is a highly compressible fabric, thus eliminating the need for attachment members in this area. By aligning the flat side with the highly compressible fabric with the spacer face of the tricuspid annulus, the absence of attachment members such as sutures helps prevent damage to the heart's conduction system. Another suture ring may have an axial bulge projecting in the outflow direction and adapted to accommodate irregular tricuspid annulus shapes. Yet another shape may be generally oval, with two elongated lips extending outward from the circular inner wall along the long axis of the suture ring.

Description

[0001] Related applications

[0002] This application claims the benefit of U.S. Patent Application No. 63 / 626,637, filed January 30, 2024, the entire contents of which are incorporated herein by reference for all purposes. Technical Field

[0003] This application relates generally to implantable prosthetic heart valves, and more specifically to contoured or compliant suture rings for specific placement. Background Technology

[0004] In vertebrates, the heart is a hollow muscular organ with four pumping chambers: the left and right atria and the left and right ventricles, each with its own one-way valve. Natural heart valves are identified as the aortic valve, mitral valve (or bicuspid valve), tricuspid valve, and pulmonary valve, and each valve has flexible leaflets that interlock to prevent backflow. Heart valve disease remains a significant cause of morbidity and mortality, resulting from numerous conditions including rheumatic fever and birth defects. Recent statistics show that valvular heart disease causes nearly 20,000 deaths annually in the United States and is a contributing factor to approximately 42,000 deaths. Currently, the primary treatment for aortic valve disease is valve replacement surgery. Approximately 300,000 heart valve replacement surgeries are performed worldwide each year.

[0005] The most common type of surgical prosthetic heart valve is the tissue-type or “bioprosthetic” valve, which has flexible leaflets supported by a basal structure and protruding into the flow. Its function is very similar to that of natural human heart valves, mimicking their natural bending action to merge with each other to ensure unidirectional blood flow. In tissue-type valves, the fluid occlusion surface can be provided by a complete xenograft valve (e.g., a porcine valve), a composite porcine valve (where the non-coronary tips of three different porcine valves are sutured together to avoid anatomical variations in different parts of a complete valve), or multiple xenograft leaflets (e.g., bovine or porcine pericardium). Synthetic leaflets have been proposed, therefore the term “flexible leaflet valve” refers to both natural “tissue-type” and artificial “tissue-type” valves. The valve components are typically assembled with one or more biocompatible fabrics (e.g., Dacron® polyester) coverings, and fabric-covered suture loops are positioned at the inflow end of the peripheral support structure. An example of a flexible leaflet valve is disclosed in U.S. Patent No. 6,585,766 to Huynh et al., the disclosure of which is hereby expressly incorporated herein by reference.

[0006] In most prosthetic valves, an annular metallic or polymeric structure supports flexible leaflets extending from it. Two or more flexible leaflets are mounted within a peripheral support structure, which typically includes columns or commissures extending in the outflow direction to mimic the natural fibrous commissures in a natural valve annulus. One such support is an elastic “support frame,” sometimes called a “wireframe” or “scaffold,” having multiple (typically three) large-radius apexes that support the apical regions of the flexible leaflets (e.g., in a whole xenograft valve or three individual leaflets). Other “support frame” constructions present a sheet-like, tubular shape but still define commissures and apexes at their outflow ends, such as those shown in U.S. Patent No. 5,984,973 to Gerard et al., the disclosure of which is hereby expressly incorporated herein by reference.

[0007] Surgical prosthetic heart valves contrast with transcatheter valves in that they are non-collapseable and must be implanted using conventional open-heart techniques while the heart is stopped and the patient is on cardiopulmonary bypass. Transcatheter valves collapse and are delivered via catheter or sheath as the heart beats. With or without leaflets, a surgical prosthetic heart valve is attached to the patient's fibrous annulus fibrosus.

[0008] Replacement surgical heart valves, whether mechanical or bioprosthetic, are typically attached to the valve annulus using a suture ring or cuff. The suture ring is usually constructed from silicone, expanded PTFE, woven polyester fabric (e.g., polyethylene terephthalate or polyester), silk, polypropylene, and other fibrous or woven materials, or combinations thereof. The most common implantation sites for prosthetic heart valves are the aortic and mitral valves, which are associated with the left ventricle and generate higher pressures in both ventricles. However, tricuspid and pulmonary valve replacements are increasingly being investigated as alternatives to simple repairs, such as annulus annuloplasty rings. Johnson's U.S. Patent No. 7,776,084 discloses a prosthetic mitral heart valve with a suture ring that better matches the mitral annulus by having two ascending portions formed within a fabric-covered waffle-shaped silicone structure.

[0009] Generally speaking, suture rings used for surgical heart valves perform well, at least relative to other complications associated with prosthetic valve implantation. However, there is still a need for improved suture rings that better conform to specific valve annulus features. Summary of the Invention

[0010] This document discloses contoured or compliant suture rings suitable for implantation in surgical prosthetic heart valves at natural tricuspid annulments. The suture ring may be substantially D-shaped, having a flat side defined by a corner. The suture ring may have an elastic inner core surrounded by a biocompatible fabric. The inner core may be molded with an inner wall that divides the volume of the inner core into units open to both its inflow and outflow surfaces. The biocompatible fabric surrounding most of the periphery of the inner core may be substantially incompressible, except on the flat side, which is a highly compressible fabric, thus eliminating the need for attachment members in this area. By aligning the flat side with the highly compressible fabric with the spacer face of the tricuspid annulment, the absence of attachment members such as sutures helps prevent damage to the heart's conduction system. Another suture ring may be generally oval, having two elongated lips extending outward from the circular inner wall along the long axis of the suture ring. Yet another shape may have an axial bulge projecting in the outflow direction and adapted to accommodate irregular tricuspid annulments.

[0011] The various prosthetic heart valves with compliant suture rings disclosed herein are suitable for implantation at the natural tricuspid annulus. As seen when viewed from the inflow side of the tricuspid valve, the tricuspid annulus defines an asymmetrical oval shape surrounding the following anatomical landmarks of the natural tricuspid valve, as seen in a clockwise direction in sequence: the anterior septal commissure, the anterior leaflet on the anterior side, the anterior-posterior commissure, the posterior leaflet on the posterior side, the posterior septal commissure, and the septal leaflet on the septal side. The natural tricuspid valve also has a length generally extending from the anterior septal commissure to the posterior septal commissure, with the septal leaflet extending between the anterior and posterior septal commissures. The septal leaflet is located medial to the cardiac electrical structures including the atrioventricular node (AV node) and the His bundle extending clockwise from the AV node, which is then located clockwise near the apex of the Koch triangle, formed by the septal side, the coronary sinus ostium, and the Todaro tendon.

[0012] Each prosthetic heart valve is covered with a fabric-covered valve stent that defines an orifice around a central axis. The stent has an inflow end and an outflow commissure extending away from the inflow end in the outflow direction, wherein inflow is downward and outflow is upward. Multiple flexible leaflets are attached to the valve stent and extend within the valve stent orifice to regulate unidirectional blood flow through the orifice.

[0013] A first exemplary prosthetic heart valve has a suture ring permeable to sutures, which is attached around the inflow end of a valve stent. The suture ring defines a circular inner wall and a substantially D-shaped outer periphery, one of which is flatter than the remaining convex periphery. The suture ring may be formed from a fabric-covered elastomeric core, and the core may be molded to have walls that divide the volume of the core into units open at least toward the outflow side of the core. The core walls may form units open toward both the inflow and outflow sides of the core. The fabric covering the core may be mostly a smooth and relatively incompressible biocompatible fabric, except on the flat side, where a highly compressible plush fabric is disposed. The plush fabric may be disposed only on the outer periphery of the suture ring and not extend radially inward into the valve stent. The plush fabric may be disposed only in the middle portion of the flat side, wherein the outer corners of the flat side have a smooth and relatively incompressible biocompatible fabric. The suture loop may be formed from rolled or folded fabric or felt that is smooth and relatively incompressible, except on a flat side which is a highly compressible plush fabric. The plush fabric may be disposed only on the outer periphery of the suture loop, without extending radially inward to the valve stent. The plush fabric may be disposed only within the middle portion of the flat side, wherein the outer corners of the flat side have rolled or folded fabric or felt. The suture loop may define a flat annular shape without an upward or downward portion.

[0014] A second exemplary prosthetic heart valve has a suture-permeable ring attached around the inflow end of a valve stent. The ring defines a circular inner wall and a generally oval outer periphery having a long axis and a short axis. The generally oval outer periphery forms an elongated lip projecting outward from the inner wall along the long axis, longer than the portion extending outward from the inner wall along the short axis. The suture ring may be formed from a fabric-covered elastomeric core, molded to have walls that divide the core's volume into units open towards both the inflow and outflow sides. The core may have a frustoconical outer profile with a generally axially oriented inner wall that defines a circle to receive the fabric-covered valve stent. An outer edge may form the outermost extent of the core, wherein the inner wall is interrupted by three arched flanges whose size and shape are configured to receive the inflow tip of the fabric-covered valve stent. The inner core may have an angled web that separates the units formed between the radial ribs that open towards the outflow surface from the units formed between the radial ribs that open towards the inflow surface. The elongated lip may include a larger lip with a radial width W and a smaller lip with a smaller width w, the smaller width being between approximately 50% and 75% of the width W. The outer periphery may be convex, except along a flat side intersecting the minor axis.

[0015] A third exemplary prosthetic heart valve has a suture-permeable ring attached around the inflow end of a valve stent. The ring defines a flat annular shape around most of its periphery and has an axial bulge extending in the outflow direction on one side. The inner core is molded with walls that divide its volume into units open towards both the inflow and outflow sides of the core. The angle of the axial bulge can range from 80° to 100°. The axial bulge can gradually rise from the originally flat outflow side. The axial bulge can have both a solid outer wall and a solid inner wall. The inner core can have an angled web that separates the units formed between the radial ribs that open towards the outflow side from the units formed between the radial ribs that open towards the inflow side.

[0016] The fourth exemplary prosthetic heart valve has a suture ring that is permeable to sutures and is attached around the inflow end of a valve stent. The suture ring is formed from an elastic inner core covered with fabric and the inner core is molded to have walls that divide the volume of the inner core into units that are open toward both the inflow and outflow sides of the inner core.

[0017] A method for implanting a prosthetic heart valve with a compliant suture ring at the natural tricuspid annulus, the method comprising:

[0018] Prosthetic heart valves are provided, which have:

[0019] A fabric-covered valve stent that defines an orifice around a central axis, the stent having an inflow end and an outflow connecting post extending away from the inflow end in the outflow direction, wherein the inflow is downward and the outflow is upward;

[0020] Multiple flexible leaflets are attached to the valve stent and extend within the stent orifices to regulate unidirectional blood flow through the orifices; and

[0021] A suture-permeable suture ring is attached around the inflow end of a valve stent. The suture ring has a substantially D-shaped periphery, one of which is flatter than the remaining convex periphery, and wherein the outer side of the suture ring is a smooth and relatively incompressible biocompatible fabric, except for the flat side, which is a highly compressible fabric.

[0022] It stops the patient's heart and provides access to the tricuspid valve annulus on the atrial side;

[0023] Advance the heart valve until it contacts the tricuspid annulus; and

[0024] The suture ring is secured to the valve annulus using attachment members around the periphery of the D-shape, except for the middle portion on the flat side, where there are no attachment members or clamping force to hold the suture ring to the valve annulus.

[0025] In this method, the suture loop can be formed from an elastic inner core covered with fabric, and the inner core is molded to have walls that divide the volume of the inner core into units open towards both the inflow and outflow surfaces of the inner core. The suture loop can be formed from rolled or folded fabric. No sutures or attachment devices may be placed within 2 mm of the His bundle or AV knot.

[0026] A further understanding of the nature and advantages of the invention will become apparent from the remainder of the specification and the accompanying drawings. Attached Figure Description

[0027] The features and advantages of the invention will become clearer with reference to the specification, claims, and drawings, in which:

[0028] Figure 1 This is a perspective view of a prosthetic heart valve having a compliant suture ring covered by the first exemplary fabric of this application;

[0029] Figure 2 yes Figure 1 The exploded diagram illustrates the sub-assemblies of three flexible leaflets supported by a peripheral support structure and a compliant suture ring.

[0030] Figure 3A It is the first peripheral bracket or wireframe. Figure 3B It is a second peripheral support made of polymer material, and Figure 3C It is a third peripheral support made of metal;

[0031] Figure 4 The image shows three flexible leaflets in their relatively closed or occlusal positions within a prosthetic heart valve;

[0032] Figure 5 yes Figure 1 A perspective view of the inner core of an exemplary compliant suture ring, the inner core having a slightly D-shaped shape with a flat side;

[0033] Figures 6A to 6D yes Figure 5 Perspective and orthographic views of the D-shaped inner core of the suture ring;

[0034] Figure 7 This is the outflow plan view of the D-shaped inner core;

[0035] Figure 8A It is along Figure 7 A radial sectional view across the D-shaped inner core, taken along diagonal 8A-8A, and Figure 8B and Figure 8C This is an enlarged view of the relative sidewalls;

[0036] Figure 9A and Figure 9BThese are outflow and inflow perspective views of an alternative inner core for the compliant suture ring used in this application, the inner core having waffle-shaped units on both its upper and lower surfaces. Figure 9C yes Figure 9A A partial cross-sectional view, and Figure 9D and Figure 9E It is an enlarged view of the cross-section through its opposite sidewalls;

[0037] Figure 10A and Figure 10B These are outflow and inflow perspective views of the inner core of another type of compliant suture ring, which has a slightly D-shaped form with a flat side and waffle-shaped units on both the upper and lower surfaces. Figure 10C This is a flow plan view of the inner core of the compliant suture ring. Figure 10D It is another outflow perspective view. Figure 10E yes Figure 10A A partial cross-sectional view, and Figure 10F and Figure 10G It is an enlarged view of the cross-section through its opposite sidewalls;

[0038] Figure 11A and Figure 11B This is an outflow perspective view of another inner core for a compliant suture ring, which has opposing outward lips on opposing longitudinal sides and waffle-shaped units on both the upper and lower surfaces. Figure 11C and Figure 11D It is a flow-in and flow-out plan view of another inner core used for compliant suture rings;

[0039] Figure 12A This is an outflow perspective view of an alternative inner core for a compliant suture ring, which has a rising portion on one side and waffle-shaped units on both the upper and lower surfaces. Figure 12B This is a side front view illustrating the extent of the rising section;

[0040] Figure 13 It is a schematic plan view of the tricuspid valve annulus, showing the typical orientation as seen from the inflow side, and indicating the position of the aortic valve within the heart;

[0041] Figure 14 This is a plan view of the natural tricuspid valve and surrounding anatomical structures from the inflow side;

[0042] Figure 15 This is a plan view of the natural tricuspid valve and surrounding anatomical structures from the inflow side, showing only... Figure 1 The suture ring of the valve is sutured to the natural tricuspid valve and surrounding anatomical structures at the implantation site;

[0043] Figure 16This is another planar view of the natural tricuspid valve and annulus, where the heart valve has been sutured to the natural tricuspid valve and annulus at the implantation site. Figures 11A to 11D The suture ring;

[0044] Figure 17A It is a schematic cross-sectional view of the heart, showing the atrioventricular valves between the atria and ventricles, and Figure 17B The steps for advancing a surgical prosthetic heart valve into the tricuspid annulus during its implantation are shown.

[0045] Figure 17C A surgically implanted prosthetic heart valve at the tricuspid annulus is shown, and Figure 17D It is along Figure 17C A view of the outflow end of a heart valve as seen from the right ventricle, with line 17D-17D in the middle.

[0046] Figure 18 This is an outflow plan view of the surgical prosthetic heart valve with compliant suture ring of this application;

[0047] Figure 19 It is observed from the ventricular side. Figure 18 The outline of the heart valves superimposed on the tricuspid valve;

[0048] Figure 20A This is a perspective view of another surgical prosthetic heart valve with a compliant suture ring without fabric covering, and Figure 20B This is a separate perspective view of the inner core of the suture ring;

[0049] Figure 21 It is observed from the ventricular side. Figure 20A The outline of the heart valves superimposed on the tricuspid valve;

[0050] Figure 22A is a schematic cross-sectional view of the right side of the heart, showing a common shape of the tricuspid valve annulus, and Figure 22B The surgical implantation at the tricuspid valve annulus is shown. Figure 20A Prosthetic heart valves;

[0051] Figure 23A This is a perspective view of the inner core of another compliant suture ring, a portion of which has been removed, and Figure 23B This is a side view of the inner core;

[0052] Figure 24 It is observed from the ventricular side. Figure 23A The outline of the heart valve, with its suture rings superimposed on the tricuspid valve;

[0053] Figure 25A and Figure 25B This is a perspective view and inflow plan of another type of surgical prosthetic heart valve, showing a compliant suture ring with a plush fabric portion thereon; and

[0054] Figures 26A to 26C Examples are given. Figure 25A The sequence of heart valve delivery to the tricuspid annulus, and Figure 26D A heart valve implanted from the ventricular side is shown. Detailed Implementation

[0055] The right ventricle and left ventricle are separated from the right atrium and left atrium by the tricuspid and mitral valves (e.g., atrioventricular valves), respectively. A septal wall extends between the right and left atria and between the right and left ventricles. This specification and figures provide aspects and features of this disclosure in the context of several embodiments of replacement heart valves, delivery systems, and methods configured for use in a patient's vascular system, such as for replacement of a patient's natural heart valves. Surgical valve replacement in the mitral or tricuspid annulus is the primary focus of this application; however, certain features of the delivery systems described herein can also be used for other valve implantation sites, and therefore, unless explicitly limited, the claims should not be limited to mitral or tricuspid valve replacement.

[0056] The anatomy of each of the different valvular annulus rings is completely different from each other. The aortic annulus defines an undulating fibrous structure around a generally circular ring to support the upper and lower shapes of the tips and commissures of the three roughly similar natural leaflets. The three leaflets attach along these anatomical landmarks, and prosthetic surgical heart valves typically attempt to mimic the shape of the leaflets. Because the annulus has such a pronounced undulating shape, prosthetic aortic heart valves usually have sutures that undulate to at least partially conform to the annulus. On the other hand, the mitral annulus has a slightly fibrous linear anterior face across the septum from the aortic valve, but the posterior face defining most of the annulus is relatively less fibrous and relatively more muscular. Furthermore, the posterior face is roughly oval, causing the mitral annulus to present an aberrant "D" shape during systolic ejection, when the mitral valve closes, the anterior side of the annulus moves out of the left ventricular outflow tract to avoid obstructing the flow of blood out of the left ventricle through the aortic valve, while the posterior side of the annulus retains its oval shape. On the other hand, the tricuspid valve is an asymmetric tricuspid valve, which does not have a plane of symmetry passing through an oval or roughly egg-shaped ring with a long axis and a short axis, and one long end is wider than the other.

[0057] Atrioventricular valves (e.g., mitral and tricuspid valves) have contoured or three-dimensional annulus structures, although they are slightly less defined in their superior-inferior axial or flow direction, as are aortic valve annulus structures. Therefore, prosthetic heart valves used in atrioventricular implants are typically characterized by relatively flat suture rings. U.S. Patent No. 7,776,084 discloses a prosthetic surgical mitral heart valve that includes two axially raised or ascending portions on the outflow side, which enhance the contact between the suture ring and the surrounding mitral annulus. These two raised portions also elevate the anterior side upwards, thereby tilting the entire valve away from the left ventricular wall to reduce the risk of the posterior column of the valve contacting the endocardial surface of the left ventricle. Features of the '084 patent are incorporated into the MITRIS® mitral heart valve, available from Edwards Lifesciences, Irvine, CA. The MITRIS valve is described as having a saddle-shaped suture ring that mimics the natural mitral valve annulus. On the other hand, annuloplasty rings used to repair atrioventricular valves typically have a three-dimensional profile that attempts to match the anatomical valve annulus (see, for example, U.S. Patent No. 7,367,991). Although such a three-dimensional structure exists in mitral and atrioventricular annuloplasty rings, a valve for tricuspid valve replacement has not yet been developed in this regard.

[0058] Therefore, this application discloses contoured suture rings that are specifically designed to minimize contact between the tricuspid valve struts and the endocardium of the right ventricle while allowing natural movement of the right ventricular chambers. The design of the suture ring in the tricuspid valve is complicated by the highly dynamic nature of the valve annulus. In other words, the annulus changes shape between the peak systolic and diastolic ejection phases of the cardiac cycle. Furthermore, the aorta, which extends upwards from the adjacent aortic valve, invades the tricuspid valve, primarily below the anterior septal commissure along the septal wall. Additionally, certain anatomical features, particularly the septal wall and funnel-shaped folds, are at risk of contact and abrasion due to the protrusion of the outflow struts or commissural columns of the tricuspid valve into the right ventricle. Finally, as stated above, the electrical system of the atrioventricular node is adjacent to the tricuspid valve annulus. In short, anticipating all these potential dangers is challenging when designing suture rings for the tricuspid valve.

[0059] Figure 1 This is a perspective view of a prosthetic surgical heart valve 20 having the first exemplary compliant suture ring of this application. Figure 2 yes Figure 1An exploded view shows the leaflet assembly 22 and the compliant suture ring 24. The subassembly 22 includes a peripheral support frame having three upright syndesmatures 26 alternating with three arcuate valve tips 28. The peripheral support frame is fabric-covered and supports three flexible leaflets 30, which are typically sutured to the peripheral support frame along the valve tips 28. Each of the flexible leaflets 30 has a free edge 32 extending to the middle of the heart valve 20 to provide an occlusal surface. More specifically, the leaflets are shown in a closed or opposed position, where the free edge 32 clasps in the flow orifice to prevent backflow. Periodic heart rhythms generate downstream flow to open the leaflets 30, thus causing the syndesmatures 26 to project in the downstream or outflow direction. Consequently, the leaflets adjacent to the valve tips 28 bend in the upstream or inflow direction.

[0060] like Figure 2 As seen, the conforming suture ring 24 has a circular or annular profile 34 surrounding most of its periphery, except for a relatively straightened or flat side 36 on one side. Thus, the suture ring 24 forms a slightly D-shaped form. The radial dimension of the suture ring 24 increases at the corner 38 of the flat side 36. More details regarding the profile of the suture ring will be provided below, and it will be understood that the external fabric covering generally conforms to these profiles. The fabric covering provides strength when the heart valve 20 is implanted using anchoring sutures.

[0061] Figure 3 to Figure 4 The internal components of an exemplary heart valve 20 are shown in the figure. Figures 3A to 3C Three alternative possibilities for the peripheral stents used to support the flexible leaflet 30 are shown. Each of these peripheral stents has an arcuate apex region, and the apex edge 40 of the leaflet 30 ( Figure 4 It can be attached to the tip region of the arcuate valve.

[0062] Figure 3A This is a first peripheral support bracket or wire frame 42, which has upright connecting posts 44 pointing downstream at the outlet end of the bracket, these upright connecting posts alternating with arched petal tips 46 curved upstream at the inlet end. The wire frame 42 is typically made of a metal alloy or a superelastic metal (such as nitinol) and can be formed as a single continuous piece or from wire bent and connected by a crimping member (not shown). Injection-molded polymer parts that mimic the function of the wire frame have also been employed.

[0063] Figure 3B The second peripheral support scaffold 50 is made of polymer material. The scaffold 50 includes an annular base ring 52 located at the inflow end and an upright connecting post 54. The base ring 52 has an upper edge defining the arcuate leaflet tips, to which the leaflet tip edges 40 can be attached.

[0064] Figure 3CA third peripheral support bracket 60 is made of a metal (such as an alloy, nitinol, or titanium). The bracket 60 has an annular base ring 62 at the inflow end, which engages with an undulating upper ring defining an arcuate tip 64 alternating with an upright connecting post 66. Multiple axial struts 68 connect the base ring 62 to the tip 64.

[0065] Figure 4 The relative positions of the three flexible leaflets 30 within the prosthetic heart valve 20 are shown. As stated, the trilobed arrangement of the leaflets 30 can be secured to fabric covering any of the three support structures 42, 50, or 60. A typical surgical heart valve has three individual flexible leaflets 30, which are then coupled to the surrounding support structure, as shown, or the three flexible leaflets may be provided from a complete xenograft heart valve (such as a heart valve from a pig). The individual leaflets 30 have been made from a variety of xenograft materials, but bovine pericardial tissue is the most common. In some existing surgical valves, the three individual leaflets 30 are first trimmed to a certain size and joined together before being coupled to the rest of the valve structure.

[0066] Figure 2 A leaflet assembly 22 of a fabric-covered peripheral stent is shown, having syndesmoid posts 26 and leaflet tips 28 connected to three leaflets 30. Again, this could be, for example, a single leaflet 30 or an entire xenograft porcine valve. The fabric covering the stent is used to anchor the edges of the leaflets using stitching or a similar method. In many valves, the peripheral stent has an undulating shape at its inflow end, where the arched leaflet tips 28 are separated by short gaps raised by the syndesmoid posts 26.

[0067] Figure 5 yes Figure 1 A perspective view of the inner core 70 of an exemplary compliant stitched loop shows a slightly D-shaped form with a largely circular portion 34 and a flat side 36 defined on both sides by corner portions 38. The inner core 70 is shown in more detail in Figures 6 through 8 and has an inner wall 72 with a generally axial orientation and a tapered outer wall 74. The tapered wall 74 is angled outwards in the downstream or outflow direction. As can be seen, the inner core 70 is ideally molded to have walls that divide the volume of the inner core into units to obtain greater compressibility. However, it should be noted that certain aspects of the stitched loop described herein can be obtained without an inner core by using only rolled or folded fabric or felt. In this context, fabric refers to a broad category of woven fabrics made of various fibers, while felt is a nonwoven fabric formed by tangling and pressing fibers together, resulting in a denser, more fuzzy texture. The fabric or felt of the implant is usually made of synthetic fibers such as PET (polyethylene terephthalate) or Teflon (polytetrafluoroethylene or PTFE).

[0068] Figures 6A to 6D An example is shown of the peripheral edge 76 of the inner core 70 at the outermost extent of the conical outer wall 74. The core 70 has a waffle-shaped structure extending from the outer wall 74 to the intermediate wall 78. The waffle structure is formed by a plurality of generally radially oriented planar walls 80, which are circumferentially spaced in the space between the outer wall 74 and the intermediate wall 78 to form open units 82. The units 82 are open in the outflow direction of the core 70, but closed at the inflow end.

[0069] Return to reference Figure 5 Multiple concave flanges 84 can be seen connecting the inner wall 72 to the intermediate wall 78. The flanges 84 are generally radially oriented and extend between circumferentially spaced bosses 86. The flanges 84 bend downwards in the inflow direction from each boss 86 and then upwards to the next boss. The concave flanges 84 are shaped to receive each arcuate tip 28 of the leaflet assembly 22, as... Figure 2 As seen in the figure. In fact, although the inner core 70 is also covered with fabric, the fabric conforms to the flange 84, as shown. Therefore, the leaflet assembly 22 is positioned such that the leaflet tip 28 is located on the flange 84 and is attached to the seam loop 24 using, for example, braided thread (not shown).

[0070] Returning to the overall shape of the suture ring 24, Figure 6D The inner core 70 is shown to be substantially flat, having the indicated height h. (As shown) Figure 6C As seen in the figure, the inner wall 72 is circular and mirrored by a circular periphery 34 surrounding most of the core, except for the relatively flat side 36. The term "relatively flat" regarding side 36 means that its shape is relatively flatter than the rest of the circular periphery 34. However, it is apparent that the flat side 36 has a slight concavity and is therefore not perfectly flat. For example, most of the circular periphery 34 may have a radius R1 centered on the center of the core 70, which is smaller than the radius R2 of the flat side 36. In one exemplary embodiment, the radius R1 is between approximately 30% and 50% of the radius R2. Figure 6C It also indicates a reference axis A extending through the relatively flat side 36. Axis A is imaginary, although it can be indicated by marking lines, etc., and is used by the surgeon to orient the suture ring during implantation at the tricuspid valve annulus, as shown below.

[0071] Figure 9A and Figure 9BThese are outflow and inflow perspective views of the annular inner core 90 of the alternative compliant suture ring of this application, which has waffle-shaped units on both sides. As in the previous embodiments, the inner core 90 is formed of a compressible, suture-permeable material (preferably silicone rubber) and then covered with a biocompatible fabric (not shown). The inner core 90 has a truncated conical outer profile, which begins at its widest point on the outflow surface at the circular outer edge 92 surrounding the circular radial inner wall 94. Also as in the previously described embodiments, the core 90 defines an intermediate wall segment 96 above each of a plurality of radially oriented flanges 98. The inner wall 94 and the intermediate wall segment 96 are generally axially oriented and circularly depicted to receive the leaflet assembly. The flanges 98 are sized and positioned to receive the arcuate inflow tip of the leaflet assembly, generally as described above. The outflow surface of the core 90 is defined between the outer edge 92 and the inner edge 100, as... Figure 9A As seen in the text.

[0072] Figure 9C yes Figure 9A A partial cross-sectional view, and Figure 9D and Figure 9E This is an enlarged cross-sectional view of its opposite sidewalls. The waffle-shaped unit includes those units open to the outflow surface and those units located on the angled surfaces of the truncated conical outer contour. That is, a plurality of radially oriented ribs 102, circumferentially distributed around the core 90, extend between the outer edge 92 and the inner edge 100 to define a plurality of units 104 open to the outflow surface. An angled web 105 extends outward from the inner wall 94 or intermediate wall 96 to the outer edge 92 and surrounds the core 90 to provide a base plate for the open units 104. Similarly, a plurality of radially oriented ribs 106, distributed around the truncated conical outer contour of the core 90, extend between the outer edge 92 and the inflow corner 99 to define a plurality of units 108 open to the inflow surface. The angled web 105 provides a separator for the two open units 104, 108. Figure 9D and Figure 9E The cross-section best shows the various wall shapes of the defining units 104 and 108. Chamfers 109 are provided at both the inflow and outflow surfaces, which helps to improve the assembly of the suture ring and leaflet assembly, as well as reduce the volume of the core 90 and improve compressibility.

[0073] The inner core 90 is entirely circular or annular, without the relatively straight segments as in the embodiments described above. Although the circular suture ring does not fit perfectly within a regular natural valve annulus, opening units 102, 108 are provided on both the inflow and outflow surfaces of the core 90, which increases compressibility and thus improves compliance with irregular valve annulus. The suture ring with the inner core 90 can then be stretched and compressed more effectively around its periphery as needed to achieve a tighter seal with the valve annulus, resulting in less blood leakage around the valve.

[0074] Figure 10A and Figure 10B These are outflow and inflow perspective views of an annular inner core 110 of another type of compliant suture ring, which is a combination of cores 70 and 90 described above. That is, the overall peripheral shape of core 110 is similar to that of core 70 because it has a slightly D-shaped form, in which most of the circular portion 112 is interrupted by a generally flat side 114 between the corners 115. Additionally, core 110 has waffle-shaped units on both faces, like core 90. Figure 10C It is an outflow plan. Figure 10D It is another outflow perspective view. Figure 10E yes Figure 10A A partial cross-sectional view, and Figure 10F and Figure 10G It is an enlarged view of the cross-section through its opposite sidewalls.

[0075] Similar to the circular core 90, the D-shaped core 110 has a truncated conical outer profile with generally axially oriented inner walls that define a circle to receive the leaflet assembly. An outer edge 116 forms the outermost extent of the core 110, and the inner walls are interrupted by three arched flanges 118 whose size and shape are configured to receive the inflow tip of the leaflet assembly, such as... Figure 2 As shown.

[0076] The core 110 has waffle-shaped units on both sides. Specifically, units 120 formed between the radial ribs open to the outflow side, and units 122 formed between the radial ribs open to the inflow side within a truncated conical outer profile. An angled web 124 terminating at the outer edge 116 provides a separator between the two units 120, 122. Due to the open units on both sides and the generally flat side 114, the core 110 conforms better to the non-uniform and asymmetrical tricuspid annulus than existing suture rings when covered with fabric and assembled into the heart valve.

[0077] Figure 11A and Figure 11B This is an outflow perspective view of a slightly oval core 130 for a compliant suture ring, the core having opposing outward lips on opposing longitudinal sides and waffle-shaped units on both sides. Figure 11C and Figure 11D These are the inflow and outflow plans of the core. Similar to the circular cores 90 and 110, the oval core 110 has a truncated conical outer profile with generally axially oriented inner walls 131 that define a circle to receive the leaflet assembly. The outer edge 132 forms the outermost extent of the core 130, and the inner walls are interrupted by three arched flanges 134 whose size and shape are configured to receive the inflow tips of the leaflet assembly, such as... Figure 2 As shown. The core 130 has waffle-shaped units on both sides. Angled web 136 separates the units 138 formed between radial ribs open to the outflow side from the units 138 formed between radial ribs open to the inflow side in the truncated conical outer profile.

[0078] As mentioned, the inner core 130 has a generally circular central opening defined by the inner wall 131, but has a generally oval outer periphery. Figure 11C This is a view of the outflow surface, indicating four main regions surrounding the outer perimeter. The perimeter is convex except along the generally flat side 144. Outwardly extending lips 145, 146 define the longitudinal axis X of the core 130, while the short convex side 147 and the relatively flat side 144 define the transverse axis Y. Because the inner wall is circular, the wider lips 145, 146 mean that the ribs and units 138, 140 on both faces are larger around these regions. That is, the distance between the outer edge 132 and the inner wall 131 is greater in the lips 145, 146.

[0079] observe Figure 11D The inflow view indicates the relative widths of the lips 145, 46. The larger lip 145 has a width W, while the smaller lip 146 has a smaller width w. The width between the inner wall 131 and the outer edge 132 gradually decreases between the two lips 145, 146, reaching a minimum at the flat side 144 and the short convex side 147. In a preferred embodiment, the width w of the smaller lip 146 is about 50% to 75% of the width W of the larger lip 145, while the width around the flat side 144 and the short convex side 147 is about 25% to 40% of the width W of the larger lip 145.

[0080] The outer oval shape of the suture ring with inner core 130 is shaped to closely conform to the contour of the tricuspid valve annulus. Furthermore, open units 138, 140 on both sides of core 130 provide high compliance to the suture ring. Finally, a flat side 144 is provided to help avoid placing the anchoring suture as a component of the heart's electrical system surrounding the tricuspid valve annulus, as seen below. During assembly, the orifice for flow through the valve body is slightly biased towards the anterior septal commissure.

[0081] Figure 12A This is an outflow perspective view of the inner core 160 for another alternative compliant suture ring, which has a rising portion on one side and waffle-shaped units on both sides. Figure 12B This is a side front view illustrating the extent of the ascending portion. As before, the suture ring has an outermost edge 162 and an inner wall 164, both of which are substantially circular in the plan view. Three arcuate flanges 166 interrupt the inner wall 164 to receive the tips of the leaflet assemblies, such as... Figure 2 As shown.

[0082] The core 160 rises on one side at an axial ridge 168. The ridge 168 can be at any angle from 80° to 100°, and it gradually rises from the originally flat outflow side. As shown, the ridge has a solid outer wall 170 and a solid inner wall 172. A series of intercostal units 174 open to the outflow side, while a series of intercostal units 178 open to the inflow side on the outer truncated conical profile of the core 160. An angled septum 178 extending between the outer edge 162 and the inner wall 164 separates units 174, 176. The ridge 168, extending from the originally flat suture ring, is designed to fit into an anatomical depression located near the anterior septal commissure for better conformation to the tricuspid valve annulus.

[0083] Figure 13 This is a schematic diagram of the tricuspid valve orifice as seen from its inflow side (from the right atrium), with peripheral landmarks marked as: anterior septal commissure, anterior leaflet, anterior and posterior commissure, posterior leaflet, posterior septal commissure, and septal leaflet. Contrary to the traditional orientation nomenclature, the tricuspid valve is almost vertical, as reflected in these sector markings.

[0084] From the same perspective, the tricuspid valve 220 is... Figure 14 The mitral valve is shown in surgical exposure, with the valve annulus 222 and three leaflets 224a, 224b, 224c extending medially into the flow orifice. A chordae tendineae 226 connects the leaflets to papillary muscles located in the right ventricle to control leaflet movement. The tricuspid annulus 222 is an oval fibrous ring at the base of the leaflets, less prominent than the mitral annulus, but with a larger circumference. The annulus 222 is generally planar, but slopes downward toward the ventricle in a depression near the anterior septal commissure, which generally continues along the septal leaflet 224a.

[0085] Reflecting their true anatomical location, Figure 14 The three leaflets are designated as spacer 224a, anterior leaflet 224b, and posterior leaflet (or “wall leaflet”) 224c. The leaflets join together on three prominent, juxtaposed regions, and the peripheral junctions of these regions are typically described as commissure 228 (in...). Figure 13 (Anatomy reference markings are shown in the middle). Leaflet 224 is tethered to commissure 228 by fan-shaped chordae tendineae 226 originating from the papillary muscles of the right ventricle. Septal leaflet 224a is attached to the fibrous trigone, a fibrous "skeleton" structure within the heart through which the heart's electrical system passes. Anterior leaflet 224b (the largest of the three leaflets) typically has a notch or cleft. Posterior leaflet 224c (the smallest of the three leaflets) is typically scalloped.

[0086] The ostium 230 of the right coronary sinus opens into the right atrium, and the Todaro tendon 232 extends adjacent to this ostium. The conduction system formed by the initial portions of the AV node 234 and the His bundle 236 is located in the superior septal region of the tricuspid valve circumference. The AV node 234 is located directly on the right atrial side of the central fibrous body in the muscular portion of the AV septum, just above and anterior to the ostium 230 of the coronary sinus 230. Measuring approximately 1.0 mm x 3.0 mm x 6.0 mm, the node 234 is flat and generally oval. The AV node 234 is located at the apex of the Koch triangle 238, which is formed by the tricuspid annulus 222, the coronary ostium 230, and the Todaro tendon 232. The AV knot 234 typically continues to the His bundle 236 via a route below the anterior septal commissure 228 between the septal leaflet 224a and the anterior leaflet 224b of the tricuspid valve; however, the precise route of the His bundle 236 near the tricuspid valve may vary. Furthermore, the location of the His bundle 236 may be difficult to discern in a resected view of the right atrium because it lies beneath the valve annulus tissue.

[0087] Koch's triangle 238 and Todaro tendon 232 provide anatomical landmarks for locating the conduction system during tricuspid valve repair and replacement procedures. A key factor to consider during surgery is the proximity of the conduction system (AV knot 234 and His bundle 236) to the septal leaflet 224a. Naturally, the surgeon must avoid placing sutures too close to or within the AV knot 234. C-rings are a good choice for tricuspid valve repair because they allow the surgeon to locate the rupture site within the ring near the AV knot 234, thus eliminating the need for sutures at that location. However, valves used in valve replacement do not have such rupture sites, therefore this application attempts to accommodate these sensitive conduction structures to avoid damage to them.

[0088] Figure 15 This is a plan view of the natural tricuspid valve and surrounding anatomical structures from the inflow side, showing only... Figure 1 The suture ring 24 of the valve is sutured to the natural tricuspid valve and surrounding anatomy at the implantation site using braided suture 250. Only the suture ring 24 is shown to visualize more of the anatomy within the tricuspid valve annulus. It should be noted that the inner core 70 of the suture ring 24 has the same shape as the inner core 110, therefore the suture ring 24 may also have a double-sided opening.

[0089] The valve with the suture ring 24 is oriented such that the relatively straight or flat side 36 of the D-shaped suture ring is positioned along the tricuspid annulus at the septal leaflet, precisely within the heart's major electrical components surrounding the tricuspid annulus. That is, the reference axis A of the flat side 36 is approximately parallel to the AV node 234, the His bundle 236, and the Koch triangle 238. In this way, by reducing the amount of the suture ring extending into the heart's electrical system, the likelihood of unwanted stress in the heart's electrical system is reduced.

[0090] Furthermore, the corner portions 38 located on both sides of the flat side 36 provide additional space within the open unit of the waffle core of the suture ring to facilitate the placement or wiring of pacing leads below or through the suture ring. Typically, such pacing leads are placed near the posterior septal commissure, which is adjacent to one of the corner portions 38 located on both sides of the flat side 36.

[0091] Figure 16 This is another planar view of the natural tricuspid valve and annulus, where the heart valve has been sutured to the natural tricuspid valve and annulus at the implantation site. Figures 11A to 11D The suture ring core 130 is oriented such that the elongated axis X of the suture ring core 130 is aligned with the elongated axis of the tricuspid annulus. Furthermore, the flat side 144 is generally parallel to the electrical system surrounding the tricuspid annulus, causing the suture ring to retract radially inward in this region and reducing the likelihood of damage to the anchoring sutures. The larger lip 145 extends outward in the region of the anterior septal commissure, while the shorter lip 146 extends outward in the region of the posterior septal commissure. Similarly, these enlarged structures help the suture ring conform to the irregular tricuspid annulus while also providing additional space for the passage or cabling of pacing leads.

[0092] Figure 17A This is a schematic cross-sectional view of the heart, showing the atrioventricular valves between the atria and ventricles. In general, the mitral valve (MV) controls flow between the left atrium (LA) and left ventricle (LV), while the tricuspid valve (TV) performs the same function between the right atrium (RA) and right ventricle (RV). The leaflets in both valves are shown open, allowing blood to flow down from each atrium to the corresponding ventricle. The reference plane R across the tricuspid valve TV is roughly perpendicular to the direction of blood flow. The opening of the mitral valve (MV) and tricuspid valve (TV) occurs simultaneously during diastole, the cardiac cycle phase in which the myocardium relaxes to expand the ventricles, allowing blood to flow into them. Systole involves the opposite, where the myocardium contracts to force blood out of the ventricles through the aortic and pulmonary valves (not shown).

[0093] Figure 17BThe procedure for advancing a surgical prosthetic heart valve 20 into the tricuspid annulus during its implantation is illustrated. The surgical prosthetic heart valve is delivered while the heart is stopped, and blood is pumped through the patient's circulatory system using an external cardiopulmonary bypass machine. Various access routes to the heart are known, including complete or partial sternotomy, which provides access to the upper or superior portion of the heart. An incision in the wall of the right atrium RA is shown, which is widened and stabilized using a retractor 260. The replacement surgical valve can be implanted onto the natural leaflet, or, as shown, the leaflet can be removed, leaving a small medial portion of the tricuspid annulus TA, forming various step-like structures. Anchoring or implantation sutures 262 are then passed downward through the tricuspid annulus TA and then back upward, with the free ends of these sutures passed through the suture ring 24 externally using a suture needle. A generally circular array of the circular sutures 262 is threaded at appropriate locations around the suture ring 24, allowing the heart valve 20 to descend or parachute along the suture array onto the tricuspid annulus TA. The typical number is 12 to 24 sutures.

[0094] Figure 17C A prosthetic heart valve 20 surgically implanted at the tricuspid annulus TA is shown. A suture ring 24 rests on the atrial side of the tricuspid annulus TA and is secured to this atrial side by knots 264 formed by tying each of the aforementioned suture rings. Clips or other knotless fasteners may sometimes be used alternatively. The tricuspid annulus TA is a relatively tough fibrous ring, and a variable number of sutures 262 (e.g., 12 to 24) are sufficient to hold the heart valve 20 in place against the pressure generated by the ventricles, which causes the leaflets 30 to close. It should be noted that the heart valve 20 is oriented such that the central line C / L passing through it is substantially aligned with the direction of blood flow from the right atrium RA to the right ventricle RV. Therefore, the central line C / L is perpendicular to the reference plane R.

[0095] Figure 17D This is a view of the outflow end of heart valve 20 as seen from the right ventricle. Therefore, the outline of the tricuspid annulus is... Figure 13 A mirror image of the outline shown. As mentioned above, the heart's electrical system extends primarily through the septal wall between the right and left ventricles, and other locations. Therefore, the suture rings described herein are ideally shaped to minimize damage or puncture to the septal wall or at least the corresponding valve annulus adjacent to the septal wall. Similarly, such as Figure 17C and Figure 17D The septal wall SW, as seen in the figure, is spaced slightly closer to the outflow portion of the heart valve 20 extending into the right ventricle RV. Therefore, the prosthetic heart valve 20 is intended to be rotated so that the syndesm 26 are not positioned close to the septal wall SW; for example, no syndesm is directly adjacent to the septal wall SW.

[0096] Figure 17DA preferred orientation of a heart valve 20 having three suture posts 26 is illustrated. That is, none of the three suture posts 26, which are rotated 120° apart from each other, is directly adjacent to the septal wall SW. To ensure this orientation, the heart valve 20 preferably has at least two external markings 266 on the suture ring 24, each external marking aligned with one of the suture posts 26. The markings 266 allow the surgeon to rotate the heart valve 20 so that no suture post 26 is in a problematic position; that is, no suture post is directly adjacent to the septal wall SW. For example, the surgeon can align two markings 266 with the anterior septal suture and the anterior and posterior sutures, as described below. The markings 266 can be colored sutures sewn into the fabric of the suture ring 24, or printed or laser-applied markings. Preferably, the markings 26 are simply axially oriented lines that cross the suture ring 24 and are centered on the position of the suture post 26.

[0097] Figure 18 It is an outflow plan view of a surgical prosthetic heart valve 20 with a compliant suture ring 24 having a flat side 36, and Figure 19 This is the outline of the heart valve superimposed on the tricuspid valve, viewed from the ventricular side. Clearly, the approximate annular outline 34 of the suture ring 24 does not perfectly match the asymmetrical oval outline of the tricuspid valve periphery, and it should be understood that the suture ring 24 and / or the valve annulus naturally deform to some extent when the surgical heart valve is lowered into place; this is natural and adapted by the relatively flexible nature of both. The compliant suture ring 24 may form a fabric-covered core (such as those shown above at cores 70 and 110), where molded walls divide the volume of the core into units. Alternatively, the suture ring 24 may be rolled or folded fabric without a core.

[0098] Figure 18 and Figure 19 All commissural posts 26 are oriented in generally preferred positions such that no commissural post is directly adjacent to the septal wall SW from which the septal leaflet extends. Instead, one commissural post 26a is located approximately at the anterior septal commissure, another commissural post 26b is approximately coincident with the anterior and posterior commissures, and a third commissural post 26c is located at the posterior end of the septal leaflet. Furthermore, no commissural post 26 is directly adjacent to the most sensitive parts of the conduction system—the His bundle 236 and the AV node 234. The commissural post 26 is the highest point of the valve extending into the ventricle, and it is undesirable to risk impacting the His bundle by placing the post directly near it. Similarly, this orientation avoids positioning post 26 near the AV node 234 (see [link to relevant documentation]). Figure 14 ).

[0099] Orienting the suture ring 24 in this manner places the flat side 36 substantially along the septal leaflet, which is slightly flatter than the remaining oval tricuspid annulus. As will be seen below, fewer anchoring sutures or no anchoring sutures may be used in this area to further avoid potential damage to the conduction system in the septal wall SW.

[0100] Figure 20A This is a perspective view of another surgical prosthetic heart valve 280 with compliant suture rings, showing... Figure 12A The inner core 160 is without fabric covering. Typically, there is fabric covering around the inner core 160, but this is omitted for clarity. The heart valve 280 is shown having the aforementioned leaflet assembly 22 housed within the suture ring 160. To reiterate, the sub-assembly 22 includes a peripheral support having three upright syndesmature posts 26 alternating with three arcuate valve tips 28, which support three flexible leaflets 30 with mate free edges 32. Figure 20B This is a separate perspective view of the inner core 160, where several features are identified by numbers. As before, the inner core 160 has open cells on two faces.

[0101] Based on anatomical considerations, the axial bulge 168 on one side of the inner core 160 may be located at several positions around the valve 280. For example, Figure 21 It is observed from the ventricular side. Figure 20A The outline of the heart valve superimposed on the tricuspid valve. Parentheses 282 indicate a potential arrangement of the axial bulge 168. In this location, the axial bulge 168 begins from the first syndesm 26a and extends to the second syndesm 26c, traversing the apical region of the heart valve. Although Figure 21 The perspective is from the ventricular side, but the axial bulge 168 begins precisely anterior to the anterior septal commissure and extends through approximately half of the septal leaflet. Studies have shown that many patients have an anatomical recess facing the ventricular side near the anterior septal commissure, and the axial bulge 168 is designed to conform to this recess. Of course, the exact contour of the tricuspid annulus varies among patients, but it can be assumed that the recess is located at the stent 282 to capture the anatomy of most patients. In this regard, a second axial bulge or recess may be included as needed to conform to other anatomical features, and this application envisions more than one of each type of bulge or recess.

[0102] Figure 22A is a schematic cross-sectional view of the right side of the heart, showing a common shape of the tricuspid valve annulus. The previously described reference plane R remains in the same position, illustrating how the septal plane SA of the tricuspid valve annulus typically slopes downward toward the right ventricle RV. Figure 22B The surgical implantation was shown. Figure 20AThe prosthetic heart valve 280 has an axially raised portion 168 shown conforming to the recessed septal surface SA. Therefore, the compliant suture ring 160 keeps the centerline C / L of the heart valve 280 perpendicular to the original reference plane R, thus aligning the blood flow through the valve with the natural blood flow.

[0103] When determining the specific shape of the compliant suture ring, the dynamic profile of the tricuspid annulus is an important factor to consider, particularly its position relative to adjacent valves. For example, the anterior side of the aortic annulus exhibits an upward movement away from the aorta during systolic ejection, forming a saddle shape. This upward movement carries the mitral annulus out of the LVOT during systolic ejection. During diastole, the aortic annulus flattens and becomes more rounded to maximize the flow area as blood flows from the atria to the ventricles. The tricuspid annulus exhibits a similar dynamic movement, although it folds downward away from the aorta in the anterior septal commissure region during systolic ejection to avoid compressing the aorta and restricting flow. Based on observation and modeling, this is why the anterior septal commissure region descends during valve closure but rises during diastole as the valve opens. Placing a large suture ring around a prosthetic tricuspid valve in the anterior septal region may impede this movement of the aorta. (See the location of the aorta for more details.) Figure 13 )

[0104] Figure 23A This is a perspective view of the inner core 290 of another compliant suture ring, a portion of which has been removed. Figure 23B This is a side view of the inner core. The inner core 290 shown is... Figure 12A The inner core 160 is almost identical, but has a cut 292 on one side that opens toward the outflow edge of the core. The cut 292 extends partially into the axial ridge 168 and continues across the commissural region into the adjacent apex region.

[0105] Figure 24 This is the outline of the heart valve 294 with suture rings, viewed from the ventricular side. Figure 23A The inner core 290 is superimposed on the tricuspid valve. The bracketed area 296 indicates where the incision 292 will be located. That is, the incision 292 in the suture ring is intended to be located in the anterior septal commissure region to reduce pressure on the aorta from the tricuspid valve suture ring. See again. Figure 13 This allows us to understand the approximate location of the aorta when viewed from the atrial side of the tricuspid valve. By reducing the amount of material in the inner core 290 located in the anterior septal commissure region, we minimize any influence of the suture ring and any attached sutures on aortic motion.

[0106] Tricuspid valve with discontinuous anchor

[0107] Figure 25A and Figure 25BThis is a perspective view and inflow plan view of another type of surgical prosthetic heart valve 300, showing a compliant suture ring 302 with a plush fabric portion 304 thereon. The heart valve 300 is in most respects similar to... Figure 1 The heart valve 20 seen in the figure is similar, therefore the same elements will be given the same reference numerals. The difference lies in the plush fabric portion 304. As before, the suture loop 302 has a substantially annular periphery, with the flat side 36 located between the two corners 38. The plush fabric 304 is disposed between the two corners 38 in the flat side 34. Figure 25B This refers to reference axis A, which extends through the relatively flat side 36, and is mentioned above regarding... Figure 6C The axis A is described. It can be indicated by a marking line or similar on the inflow side of the suture ring 302 and can be used by the surgeon to orient the suture ring during implantation at the tricuspid valve annulus.

[0108] Highly textured fabrics elicit a more intense fibrous tissue response, therefore it is advantageous to provide plush fabric 304 only in the septal region. This fabric should also be highly compressible, so that the seams placed at both ends of the septal region, entering the annulus, allow the fabric to contact the valve annulus across the entire width of the septum. Therefore, this application envisions the plush fabric 304 surrounding the entire heart valve 300, or only in the flat side 36 region (e.g., Figure 25A and Figure 25B (As seen in the text). To reiterate, the stitching loop 302 may form an inner core covered with fabric (such as those shown above at core 70 and core 110), wherein the molded walls divide the volume of the inner core into units, or the stitching loop 302 may be rolled or folded fabric without an inner core.

[0109] The plush fabric 304 differs from the other smooth and relatively incompressible biocompatible fabrics on the rest of the suture ring 302. The plush fabric 304 is designed to promote a degree of inward tissue growth and fill any gaps along the septal portion of the valve annulus to prevent leakage around the valve, as an alternative to using attachment sutures or the like across the entire septal portion of the valve annulus where key conduction system features are located. It is well known that surgical prosthetic heart valves can be attached to the target valve annulus using sutures, clips, staples, or similar means, and the term "one or more attachment members" will be used to refer to any of these means. The plush fabric 304 is provided to eliminate the need for placing sutures or other attachment members along the entire length of the cardiac septal region, thereby limiting the use of sutures to the fibrous portions of the valve annulus adjacent to the septal / anterior commissure and septal / posterior commissure.

[0110] The pressure gradient across the closed tricuspid valve is much lower than that across the aortic or mitral valve, as the RV pressure ranges from 20 to 30 mmHg, while the left ventricular pressure ranges from approximately 90 to 140 mmHg and can exceed approximately 200 mmHg. Therefore, the pressure driving perivalvular blood leakage between the suture ring and the natural valve annulus is relatively small. Consequently, this application envisions surgical placement of the tricuspid valve using sutures or other attachments without placing any sutures or attachments near the AV knot or His bundle (e.g., in the region between the anterior and posterior septal commissures) to avoid the risk of damaging the conduction system. One possible technique is to avoid placing sutures or attachments within 2 mm of the His bundle or AV knot.

[0111] Improvements to this implantation procedure involve the use of a highly textured, compressible, plush fabric 304, such as double-layered fleece, in the septal region. Fabric configurations for sealing other heart valves, such as transcatheter heart valves without sutures securing the valve to the annulus, are disclosed in WO 2018 / 222799, US 11,389,310, US 2008 / 039521, US 2024 / 0081988, US 2024 / 0008978, and US 12,064,348, all of which are explicitly incorporated herein by reference. However, transcatheter heart valves include an expandable frame that provides outward pressure on the annulus. Surgical valves, on the other hand, are static in shape (e.g., incompressible and non-expandable) and require some form of attachment structure. Therefore, the area where the plush fabric 304 is disposed has attachment members only at the ends of the plush fabric to ensure that the valve is attached to the fibrous structure of the valve annulus, but there are no clamping structures (such as expandable supports or clamping mechanisms) near the conduction system, as in some prior art stitchless anchoring solutions. The plush fabric 304 only contacts the valve annulus, and nothing else holds it in place.

[0112] This method does not involve using sutures, hooks, or clamping structures to press the spacer portion of the suture ring against the valve annulus. The width of the plush fabric 304 should be limited to the area along the spacer side of the valve annulus, without any pressing structure within a distance of at least 6 mm. Of course, the width of the plush fabric 304 can extend across the entire distance of the flat side 36, which is approximately the distance between the corners 38 or the distance between the two joining portions 26 of the valve 300. The plush fabric 304 can extend above the inflow surface of the suture ring for ease of manufacture, although it typically only functions on the outflow surface of the suture ring extending to the periphery of the suture ring. That is, Figure 25A and Figure 25BA plush fabric 304 is shown located only on the outer periphery of the suture ring 302, without extending radially inward. In a preferred embodiment, the plush fabric 304 is disposed only in the contact area between the valve ring and the suture ring.

[0113] Figures 26A to 26C Examples are given. Figure 25A The sequence of heart valve delivery to the tricuspid annulus, and Figure 26D This shows a heart valve implanted from the ventricular side. The tricuspid valve 220 is shown. Figure 14 The diagram shows a valve ring 222 and three leaflets extending inward into the flow orifice. The components of the conduction system adjacent to the spacer leaflets are shown again to indicate the sensitive area.

[0114] In standard implantation procedures, an array of sutures 310 is pre-installed around the valve annulus 222. Two terminal sutures 312 are placed at the very end of the fibrous septum, passing through the natural commissure on both sides of the septal leaflet, but still outside the conduction system area. Figure 26B The image shows the heart valve 300 after it has been parachuted down along the array of sutures 310, 311 (only a subset is shown for clarity) until the suture ring 302 contacts the tricuspid annulus 222. Subsequently, Figure 26C Knots 314 and 316, already tied between each free end of the suture loop 310, are shown to secure the suture loop 302 to the valve annulus. Two knots 316 are located at the corners of the flat side 36 corresponding to the terminal sutures 312. It should be noted that there are no knots 314 in the middle of the flat side 36 of the suture loop 302, adjacent to the conduction system and the spacer leaflet of the tricuspid valve annulus. The sutures are placed at either end of the flat portion of the suture loop to ensure the valve is connected through the fibrous region of the loop and to press the plush fabric against the spacer ring.

[0115] exist Figure 26D In the image, the outflow side of the prosthetic heart valve 300 can be seen extending downwards into the ventricle. The portion of the suture ring 310 passing through the tricuspid annulus is also visible. Region 314 indicates a sensitive area adjacent to the conduction system where no attachment suture is installed. Instead, a plush fabric 304 on the outer edge of the suture ring 302 provides an initial and long-term perivalvular seal around the suture ring 302. It is believed that eliminating attachment members and any clamping structures along the septal leaflets in this manner significantly reduces the chance of injury to the cardiac conduction system.

[0116] While the foregoing provides a complete description of preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Furthermore, it will be apparent that certain other modifications may be practiced within the scope of the appended claims.

Claims

1. A prosthetic heart valve with a compliant suture ring suitable for implantation at a natural tricuspid annulus, as seen when viewed from the inflow side of the tricuspid valve, the tricuspid annulus defining an asymmetric oval shape surrounding the following anatomical landmarks of the natural tricuspid valve, as seen in a clockwise direction in sequence: anterior septal commissure, anterior leaflet on the anterior side, anterior and posterior commissure, posterior leaflet on the posterior side, posterior septal commissure, and septal leaflet on the septal side, the natural tricuspid valve further having a length generally extending from the anterior septal commissure to the posterior septal commissure, wherein the septal leaflet extends between the anterior and posterior septal commissures, and wherein the septal leaflet is located medial to a cardiac electrical structure including the atrioventricular node (AV node) and a His bundle extending clockwise from the AV node, the AV node being subsequently located clockwise near the apex of the Koch triangle, the Koch triangle being formed by the septal side, the coronary sinus ostium, and the Todaro tendon, the heart valve comprising: A fabric-covered valve stent, the valve stent defining an orifice around a central axis, the valve stent having an inflow end and an outflow connecting post extending away from the inflow end in an outflow direction, wherein the inflow is downward and the outflow is upward; Multiple flexible leaflets are attached to the valve stent and extend within the valve stent orifice to achieve unidirectional flow regulation of blood through the orifice; as well as A suture-permeable suture ring is attached around the inflow end of the valve stent, the suture ring defining a circular inner wall and a substantially D-shaped outer periphery, one of which is flatter than the remaining convex periphery.

2. The heart valve of claim 1, wherein the suture ring is formed of an elastic inner core covered with fabric, and the inner core is molded to have a wall that divides the volume of the inner core into units that are open at least toward the outflow surface of the inner core.

3. The heart valve of claim 2, wherein the inner core wall forms a unit that is open to both the inflow surface and the outflow surface of the inner core.

4. The heart valve of claim 2, wherein the fabric covering the inner core is mostly a smooth and relatively incompressible biocompatible fabric, except for the flat side, on which a highly compressible plush fabric is disposed.

5. The heart valve of claim 4, wherein the plush fabric is disposed only on the outer periphery of the suture ring and does not extend radially inward to the valve stent.

6. The heart valve of claim 4, wherein the plush fabric is disposed only in the middle portion of the flat side, wherein the outer corner of the flat side has the smooth and relatively incompressible biocompatible fabric.

7. The heart valve of claim 1, wherein the suture ring is formed of rolled or folded fabric or felt that is smooth and relatively incompressible, except on the flat side, which is a highly compressible plush fabric.

8. The heart valve of claim 7, wherein the plush fabric is disposed only on the outer periphery of the suture ring and does not extend radially inward to the valve stent.

9. The heart valve of claim 7, wherein the plush fabric is disposed only in the middle portion of the flat side, wherein the outer corner of the flat side has the rolled-up or folded fabric or felt.

10. The heart valve of claim 1, wherein the suture ring defines a flat annular shape without an upward or downward portion.

11. A prosthetic heart valve with a compliant suture ring suitable for implantation at a natural tricuspid annulus, as seen when viewed from the inflow side of the tricuspid valve, the tricuspid annulus defining an asymmetric oval shape surrounding the following anatomical landmarks of the natural tricuspid valve, as seen in a clockwise direction in sequence: anterior septal commissure, anterior leaflet on the anterior side, anterior and posterior commissure, posterior leaflet on the posterior side, posterior septal commissure, and septal leaflet on the septal side, the natural tricuspid valve further having a length generally extending from the anterior septal commissure to the posterior septal commissure, wherein the septal leaflet extends between the anterior and posterior septal commissures, and wherein the septal leaflet is located medial to a cardiac electrical structure including the atrioventricular node (AV node) and a His bundle extending clockwise from the AV node, the AV node being located clockwise near the apex of the Koch triangle, the Koch triangle being formed by the septal side, the coronary sinus ostium, and the Todaro tendon, the heart valve comprising: A fabric-covered valve stent, the valve stent defining an orifice around a central axis, the valve stent having an inflow end and an outflow connecting post extending away from the inflow end in an outflow direction, wherein the inflow is downward and the outflow is upward; Multiple flexible leaflets are attached to the valve stent and extend within the valve stent orifice to achieve unidirectional flow regulation of blood through the orifice; as well as A suture-permeable suture ring is attached around the inflow end of the valve stent. The suture ring defines a circular inner wall and a generally oval outer periphery having a long axis and a short axis. The generally oval outer periphery forms an elongated lip that projects outward from the inner wall along the long axis, and the elongated lip is longer than the portion extending outward from the inner wall along the short axis.

12. The heart valve of claim 11, wherein the suture ring is formed of an elastic inner core covered with fabric, and the inner core is molded to have a wall that divides the volume of the inner core into units open toward both an inflow side and an outflow side of the inner core.

13. The heart valve of claim 12, wherein the inner core has a truncated conical outer profile, the truncated conical outer profile having a generally axially oriented inner wall that defines a circle to receive the fabric-covered valve stent.

14. The heart valve of claim 13, wherein the outer edge forms the outermost extent of the inner core, and the inner wall is interrupted by three arcuate flanges, the size and shape of which are configured to receive the inflow tip of the fabric-covered valve stent.

15. The heart valve of claim 12, wherein the inner core has an angled web separating units formed between the radial ribs that open toward the outflow surface from units formed between the radial ribs that open toward the inflow surface.

16. The heart valve of claim 11, wherein the elongated lip comprises a larger lip having a radial width W and a smaller lip having a smaller width w, the smaller width being between about 50% and 75% of the width W.

17. The heart valve of claim 11, wherein the outer periphery is convex except along a flat side intersecting the short axis.

18. A prosthetic heart valve with a compliant suture ring suitable for implantation at a natural tricuspid annulus, as seen when viewed from the inflow side of the tricuspid valve, wherein the tricuspid annulus defines an asymmetric oval shape surrounding the following anatomical landmarks of the natural tricuspid valve, as seen in a clockwise direction in sequence: anterior septal commissure, anterior leaflet on the anterior side, anterior and posterior commissure, posterior leaflet on the posterior side, posterior septal commissure, and septal leaflet on the septal side, the natural tricuspid valve further having a length generally extending from the anterior septal commissure to the posterior septal commissure, wherein the septal leaflet extends between the anterior and posterior septal commissures, and wherein the septal leaflet is located medial to a cardiac electrical structure including the atrioventricular node (AV node) and a His bundle extending clockwise from the AV node, the AV node being subsequently located clockwise near the apex of the Koch triangle, the Koch triangle being formed by the septal side, the coronary sinus ostium, and the Todaro tendon, the heart valve comprising: A fabric-covered valve stent, the valve stent defining an orifice around a central axis, the valve stent having an inflow end and an outflow connecting post extending away from the inflow end in an outflow direction, wherein the inflow is downward and the outflow is upward; Multiple flexible leaflets are attached to the valve stent and extend within the valve stent orifice to achieve unidirectional flow regulation of blood through the orifice; as well as A suture-permeable suture ring is attached around the inflow end of the valve stent, the suture ring defining a flat annular shape around most of its periphery, having an axial bulge on one side of the suture ring extending in the outflow direction, and the inner core is molded to have a wall that divides the volume of the inner core into units open toward both the inflow and outflow surfaces of the inner core.

19. The heart valve of claim 18, wherein the angle of the axial bulge is between 80° and 100°.

20. The heart valve of claim 18, wherein the axial bulge gradually rises from the originally flat outflow surface.

21. The heart valve of claim 18, wherein the axial bulge has both a solid outer wall and a solid inner wall.

22. The heart valve of claim 18, wherein the inner core has an angled web separating units formed between the radial ribs that open toward the outflow surface from units formed between the radial ribs that open toward the inflow surface.

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