Mitral valve holder and retainer assembly

Abstract

A heart valve holder and retainer assembly for a heart valve having an inflow sewing ring, a support structure that defines flexible outflow commissure posts terminating in tips, and flexible leaflets supported by the support structure. The valve holder having a holder body abutting the heart valve and a plurality of constriction sutures routed to a tensioning mechanism for flexing the commissure posts inward. A packaging clip defines a cavity opening to one side to receive and hold the holder body. Spring retention clasps having thumb levers are connected to teeth that engage cutouts in the holder body. The spring retention clasps have a relaxed configuration where the teeth positively retain the holder body within the cavity and a flexed configuration where the teeth are moved to permit the valve holder to be slid out of the cavity.

Description

PCT / US26 / 11048 13 January 2026 (13.01.2026)SSHIN-24O81WOO1 5,O4O,865_IMITRAL VALVE HOLDER AND RETAINER ASSEMBLY CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Application No. 63 / 745,660, filed January 15, 2025, the entire disclosure which is incorporated by reference for all purposes.TECHNICAL FIELD

[0002] The present disclosure relates generally to prosthetic heart valves, and to holders and related packaging to facilitate the implantation of the prosthetic heart valves at native heart valves sites, for example, for a mitral valve replacement procedure.BACKGROUND

[0003] When a valve becomes diseased or damaged, the efficiency and / or general functionality of the heart may be compromised. Diseased heart valves may be categorized as either stenotic, wherein the valve does not open sufficiently to allow adequate forward flow of blood through the valve, and / or incompetent, wherein the valve does not close completely, causing excessive backward flow of blood through the valve when the valve is closed. Valve disease can be severely debilitating and even fatal if left untreated. Currently, the primary treatment of severe valve disease is valve replacement. Many patients received bioprosthetic heart valves, which utilize biologically derived tissues for flexible fluid occluding leaflets.

[0004] Bioprosthetic heart valves are conventionally packaged in jars left dry or filled with preserving solution for shipping and storage prior to use in the operating theater. To minimize the possibility of damage to the relatively delicate bioprosthetic heart valves, they are stabilized with bracketing structure to prevent them from striking the inside of the jar. Prior to implantation in a patient, the valve is removed from the jar and then rinsed in a shower or immersing and agitated it in a bath. Prosthetic valves typically have a valve holder centrally located and sutured thereto, and the holders used for both are attached to the proximal end - to the inflow sewing ring for mitral valves and to the outflow commissure tips for aortic valves - so that an attached surgical delivery handle extends proximally out of the implant site.

[0005] Despite these and other techniques for storing and deploying heart valves at the time of surgery, more reliable systems are needed.SUMMARY

[0006] The present application discloses a heart valve holder and retainer assembly, the heart valve having an inflow sewing ring, a support structure that defines flexible outflow commissure posts terminating in tips, and flexible leaflets supported by the support structure and having free edges extending between the commissure posts. The assemblyPCT / US26 / 11048 13 January 2026 (13.01.2026)SSHIN-24O81WOO1 5,O4O,865_Icomprises a valve holder having a holder body shaped to abut the sewing ring of the heart valve and a packaging clip. The packaging clip has a generally planar configuration with a cavity opening to one lateral side thereof, the cavity sized and configured to receive the holder body which may be held by the cavity at a closed end thereof. The packaging clip further includes a pair of spring retention clasps at the closed end that terminate in teeth. The spring retention clasps both have a relaxed configuration where the teeth are positioned to positively retain the holder body and valve holder within the cavity and a flexed configuration where the teeth are moved to permit the valve holder to be removed from the cavity.

[0007] The holder body may have a pair of upstanding ears that each define outwardly-opening rails, and the cavity having parallel side edges facing one another spaced apart as wide as the rails defined by the holder body so that the holder body may be slid laterally into the cavity with the rails receiving the side edges to be held within the cavity. The rails may have a cutout therein that the teeth of the spring retention clasps engage.

[0008] The packaging clip further may include a pair of thumb levers connected to the spring retention clasps, wherein squeezing the thumb levers toward each other moves the spring retention clasps from their relaxed configurations to their flexed configurations. The thumb levers may project upward out of a plane defined by the generally planar packaging clip.

[0009] The spring retention clasps are desirably molded in one homogeneous part integrated with the packaging clip. The spring retention clasps may be primarily positioned within a plane defined by the generally planar packaging clip. The thumb levers may be the only part of the spring retention clasps that project upward out of the plane of the packaging clip.

[0010] The closed end of the cavity may define a centered projection flanked by spaces, and the spring retention clasps are positioned within the spaces. The spring retention clasps may have an elongated linear form parallel to the cavity and be connected to the side edges via angled living hinges, and the spring retention clasps terminate at an end facing toward the open end of the cavity in the teeth which are inwardly-directed. The projection may define a pair of fulcrum corners at an end facing toward the open end of the cavity, and in moving from the relaxed configuration to the flexed configuration the spring retention clasps contact the fulcrum corners which displaces the teeth outward. The holder body may have a pair of upstanding ears that each define outwardly-opening rails, and the cavity has parallel side edges facing one another spaced apart as wide as the rails defined by the holder body so that the holder body may be slid laterally into the cavity with the rails receiving the sidePCT / US26 / 11048 13 January 2026 (13.01.2026)SSHIN-24O81WOO1 5,O4O,865_Iedges to be held within the cavity. Each of the rails may have a cutout therein that the teeth of the spring retention clasps engage.

[0011] The holder body preferably has internal channels, the valve holder also having a plurality of constriction sutures threaded through the internal channels and through the heart valve to cross over between commissure post tips, each constriction suture being routed to a tensioning mechanism within the valve holder for creating tension and flexing the commissure posts inward.

[0012] The present application also discloses a heart valve holder and retainer assembly where the valve body has a pair of upstanding ears that a pair of outwardly-opening rails each having a cutout therein. The packaging clip has a generally planar configuration with a cavity opening to one lateral side thereof, the cavity having parallel side edges facing one another spaced apart as wide as the rails defined by the holder body so that the holder body may be slid into the cavity with the rails receiving the side edges. The packaging clip further includes a pair of thumb levers connected to teeth that engage cutouts in the holder body, the thumb levers being connected to move the teeth from a position positively retaining the holder body and valve holder within the cavity to a position permitting the valve holder to be slid out of the cavity.

[0013] The present application also discloses heart valve holder and retainer assembly for a heart valve having an inflow sewing ring, a support structure that defines flexible outflow commissure posts terminating in tips, and flexible leaflets supported by the support structure. The valve holder having a holder body abutting the heart valve and a plurality of constriction sutures routed to a tensioning mechanism for flexing the commissure posts inward. A packaging clip defines a cavity opening to one lateral side to receive and hold the holder body. Spring retention clasps having thumb levers are connected to teeth that engage cutouts in the holder body. The spring retention clasps have a relaxed configuration where the teeth positively retain the holder body within the cavity and a flexed configuration where the teeth are moved to permit the valve holder to be slid out of the cavity.

[0014] A further understanding of the nature and advantages of the present invention are set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] To further clarify various aspects of embodiments of the present disclosure, a more particular description of the certain embodiments will be made by reference to various aspects of the appended drawings. It is appreciated that these drawings depict only typicalPCT / US26 / 11048 13 January 2026 (13.01.2026)SSHIN-24O81WOO1 5,O4O,865_Iembodiments of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, while the figures may be drawn to scale for some embodiments, the figures are not necessarily drawn to scale for all embodiments.Embodiments of the present disclosure will be described and explained with additional specificity and detail using the accompanying drawings.

[0016] Figure 1 is a sectional view of the heart illustrating the internal chambers and valves therebetween;

[0017] Figure 2 is a perspective view of an assembled flexible leaflet prosthetic mitral heart valve of the prior art having a contoured sewing ring;

[0018] Figure 3 is a partial vertical section illustrating the conventional placement of the heart valve of Figure 2 in a mitral annulus;

[0019] Figure 4 an atrial view of the prosthetic valve fully implanted at a mitral annulus, and Figure 4A is a detail of one type of knotless fastener used to secure the valve;

[0020] Figure 5 is an elevational view of the heart valve of Figure 2 mounted on a prior art valve holder which constricts the valve commissure posts;

[0021] Figures 6A-6C illustrate a sequence of removing a prosthetic heart valve assembled with the valve holder from a packaging container and preparing the valve prior to implantation in a patient;

[0022] Figure 7 is a packaging clip of the prior art used to stabilize a prosthetic heart valve within a packaging container;

[0023] Figure 8 is an enlarged perspective view of a portion of a valve holder held within the packaging clip of Figure 7;

[0024] Figures 9A and 9B show the prior art valve holder attached to a prosthetic heart valve illustrating constriction of the valve commissure posts;

[0025] Figure 10 is an exploded perspective view of the components of the prior art valve holder from Figure 5;

[0026] Figure 11 is an exploded perspective view of components of a valve holder of the present application;

[0027] Figures 12A and 12B are perspective views of one component, a holder body, of the valve holder of Figure 11;

[0028] Figures 13A-13C are perspective views of an assembly of a portion of the valve holder of the holder body of the valve holder of Figure 11 coupled to a packaging clip of the present application illustrating several steps in decoupling the two components;PCT / US26 / 11048 13 January 2026 (13.01.2026)SSHIN-24O81WOO1 5,O4O,865_I

[0029] Figures 14A-14B are top plan views of Figures 13A-13B; and

[0030] Figures 15A-15B are top partial plan views of the packaging clip as in Figures 14A-14B.DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] The following description refers to the accompanying drawings, which illustrate specific embodiments. Other embodiments having different structures and operation do not depart from the scope of the present disclosure. The present application discloses systems and methods for preventing suture looping during surgical mitral valve replacement.

[0032] Figure 1 is a cutaway view of the human heart in its systolic phase. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and mitral valve MV; e.g., the atrioventricular valves. Additionally, the aortic valve AV separates the left ventricle LV from the ascending aorta (not identified) and the pulmonary valve PV separates the right ventricle from the pulmonary artery (also not identified). Each of these valves has flexible tissue leaflets extending inward across the respective orifices that come together or “coapt” in the flowstream to form the one-way fluid occluding surfaces. The regurgitation reduction devices of the present application are primarily intended for use to treat the mitral valve MV.

[0033] In terms of blood circulation through the heart, the right atrium RA receives deoxygenated blood from the venous system through the superior vena cava SVC and the inferior vena cava IVC, the former entering the right atrium above, and the latter from below. The coronary sinus CS is a collection of veins joined together to form a large vessel that collects deoxygenated blood from the heart muscle (myocardium), and delivers it to the right atrium RA. During the diastolic phase, or diastole, the venous blood that collects in the right atrium RA is pulled through the tricuspid valve TV by expansion of the right ventricle RV, and oxygenated blood is pulled from the left atrium LA through the mitral valve MV by expansion of the left ventricle LV. In the systolic phase, or systole, seen in Figure 1, the right ventricle RV collapses to force the venous blood through the pulmonary valve PV and pulmonary artery into the lungs, while the left ventricle LV collapses to force the oxygenated blood through the aortic valve AV to the vasculature. During systole, the leaflets of the tricuspid valve TV and mitral valve MV close to prevent the pressurized blood on both sides from regurgitating back into the respective atrium.

[0034] Figure 2 is a perspective view of an assembled flexible leaflet heart valve 20 of the prior art having a contoured sewing ring 22, and Figure 3 is a partial vertical section illustrating the conventional placement of the heart valve 20 in a mitral annulus MA. The prosthetic heart valve 20 is designed for implantation at a mitral annulus because of thePCT / US26 / 11048 13 January 2026 (13.01.2026)SSHIN-24O81WOO1 5,O4O,865_Icontoured sorting 22. More particularly, the sewing ring 22 has a generally planar distal or downstream face 24 interrupted by two rises or bumps 26a, 26b. The heart valve 20 includes three commissure posts 28a, 28b, 28c projecting generally axially in the downstream direction. The commissure posts 28 are formed by an internal support structure that is typically covered by a biocompatible fabric and supports flexible leaflets 30 across a flow orifice. The internal support structure may include a wireform, a metallic or polymer stent, or both. The internal support structure is not particularly critical to the functioning of the valve holder described herein, though the commissure posts 28 are formed of material which flexes so that they may be constricted inward toward each other for delivery of the heart valves as will be explained.[OO35] Figure 3 shows the heart valve 20 after implantation at the mitral annulus MA. The contoured sewing ring 22 surrounds an inflow end of the valve and is attached using anchoring sutures 34 or the like above the mitral annulus MA - e.g., in a supra-annular implant position. The valve leaflets 30 are shown open permitting blood flow BF from the left atrium to the left ventricle. This is the diastolic phase, or diastole, when the left ventricle fills up with blood prior to exposing the blood through the vascular system. Figure 2 illustrates two radially-oriented commissure markers 32 which are used as visual guides by the surgeon when rotationally orienting the valve 20 at the mitral annulus MA. The commissure markers 32 coincide with the two axial bumps 26a, 26b which, when positioned correctly, help angle the heart valve 20 in a manner which reduces the possibility of abrasive contact between the commissure posts 28 and the surrounding subvalvular structures. It should be noted that the commissure posts 28 in Figure 3 are shown in a relaxed, generally axially-projecting orientation, which facilitates valve functioning. However, because the commissure posts 28 form the leading end of the heart valve 20 during delivery, they are constricted radially inward toward each other during delivery to reduce the possibility of looping the anchoring sutures 34 around any of the posts.

[0036] Figure 4 is an atrial view of the prosthetic valve 20 fully implanted at the annulus after having been parachuted down the array of anchoring sutures 34. The pairs of looped sutures 34 may be tied off in knots 42 on the upper or accessible side of the sewing ring 22, or fasteners 44 may be deployed to avoid the knot tying. The fastener 44 shown in detail in Figure 5E is a COR-KNOT device also from LSI Solutions which is dropped down on a pair of looped sutures 34 and crimped or crushed. The sutures 34 are trimmed whether using knots 42 or fasteners 44.

[0037] Figure 5 is an elevational view of the heart valve 20 of Figure 2 mounted on a prior art valve holder 50 which constricts the valve commissure posts 28, and with the anchoring sutures 34 threaded through the sewing ring 22. The valve holder 50 includes aPCT / US26 / 11048 13 January 2026 (13.01.2026)SSHIN-24O81WOO1 5,O4O,865_Iholder body 52 that abuts on the inflow side of the sewing ring 22. A handle having an elongated shaft 54 and distal coupler 56 connects to the holder 50 for delivery of the valve 20 to the annulus. By virtue of moving shafts, pull wires or the like within the handle, the holder 50 is actuated to tension a plurality of filaments or sutures 58 that extend down through the valve 20 and span the flow orifice between the tips of the commissure posts 28. When tensioned, the constriction sutures 58 pull the commissure posts 28 inward toward each other as shown. This generally conical configuration in conjunction with the sutures 58 spanning the tips of the commissure posts 28 greatly reduces the possibility of looping an anchoring suture 34 around any of the commissure posts tips, which can cause delays and even damage to the heart valve.

[0038] Figures 6A-6C illustrate a sequence of removing a prosthetic heart valve 20 assembled with a prior art valve holder 50 from a packaging container and preparing the valve prior to implantation in a patient. The heart valve 20 is typically stabilized within the packaging container 64 by a packaging clip 62 coupled to the valve holder 50. The packaging container 64 is shown as a molded shell having a cavity for receiving the heart valve, and although not shown, typically has an upper sheet-like cover which may be peeled off.However, other packaging containers such as jars and the like can be used, and the term packaging container should not be considered limited to the illustrated embodiment. In a preferred embodiment, the heart valve 20 is stored in a dry condition within the packaging container without any preservative liquid, though some valves are stored that way in jars.

[0039] Figure 6B shows a technician holding the packaging clip 62 with one hand while rotating an activator dial 94 with another hand. As will be shown below, the activator dial 94 forms a part of the valve holder 50 and rotation thereof serves to tension a number of constriction sutures to pull flexible commissure tips of the valve inward in preparation for advancement into the body to the target annulus. Embossed or printed rotation arrows 65 may be provided on the activator dial 94 with a larger rotation arrow 66 visible on an upper surface of the packaging clip 62. The former are used to indicate which direction to rotate the activator dial 94 relative to the packaging clip 62, while the latter tells the user which direction to rotate a delivery handle 54 to couple it to the valve holder 50. Section of the commissure posts 28 by rotation of the activator dial 94 is illustrated in Figures 9A and 9B, described below. Once the commissure tips of the valve 20 have been constricted inward, the activator dial 94 can be removed.

[0040] Figure 6C shows the delivery handle 54 attached to the valve holder 50 via the distal coupler 56, and a user separating the heart valve from the packaging clip 62. The conventional structure requires simply pulling the assembly of the valve 20 and holder 50 from within an elongated cavity 68 of the packaging clip 62 using the delivery handle 54, asPCT / US26 / 11048 13 January 2026 (13.01.2026)SSHIN-24O81WOO1 5,O4O,865_Iindicated. As will be explained below, the packaging clip 62 is provided with structure for nominally retaining the valve / holder assembly.

[0041] Figure 7 is a top plan view of the packaging clip 62, while Figure 8 is an enlarged perspective view of just the holder body 52 of the valve holder 50 held within the cavity 68, with the delivery handle 54 and remaining parts of the valve holder removed for clarity. The holder body 52 has a pair of outwardly bent ears 70 projecting from an upper surface which engage inner edges 71 of the cavity 68 of the packaging clip 62. That is, the inner edges 71 fit closely into slots or rails formed between a horizontal portion of the ears 70 and the platelike upper surface of the holder body 52. The holder body 52 may thus be slid laterally into the cavity 68 with the rails receiving the inner edges 71, and likewise maybe slid laterally out of the cavity.

[0042] In a midsection of both inner edges 71, a small inward bump or detent 72 is provided. Outer faces of the vertical portions of the ears 70 are spaced apart approximately the same distance as the inner edges 71, while the detents 72 project inward from the edges and create an interference fit with the ears. The detents 72 thus hold the holder body 52, and thus the valve holder 50 and valve 20, at the inner end of the cavity 68. Removing the assembly of the valve 20 and valve holder 50 from the cavity 68 requires simply pulling the assembly laterally out of the cavity 68 so that the ears 70 can pass the detents 72. The detents 72 are rounded and the cantilevered sides of the packaging clip 62 somewhat flexible to spread apart so that the valve holder is easily removed. However, these detents 72 are sensitive to shipping conditions and valve removal issues, and the necessary removal force is often exceeded causing issues during valve preparation just prior to the operation. In addition, a relatively low retention force provided by the detent 72 can mean the valve 20 moves around during shipping.

[0043] Figures 9A and 9B show the prior art valve holder 50 attached to the prosthetic heart valve 20 to illustrate constriction of the valve commissure posts 28 from rotation of the activator dial 94. Although the path is not entirely shown, the constriction sutures 58 pass from the valve holder 50 downward through the sewing ring 22 and along the commissure posts 28, crossing between the commissure posts, as seen in Figure 9A. Figure 9B shows the constriction sutures 58 having been placed in tension to flex the commissure posts 28 inward. As is described in detail in U.S. Patent Application Publication No. 2022 / 0313429 to Chang, expressly incorporated herein, the constriction sutures 58 may be crossed over and between the tips of the commissure posts 28 in various ways to facilitate this constriction.

[0044] Figure 10 is an exploded perspective view of the components of the prior art valve holder 50 from Figure 5 for comparison with the components of the valve holder 150 of thePCT / US26 / 11048 13 January 2026 (13.01.2026)SSHIN-24O81WOO1 5,O4O,865_Ipresent application in Figure 11. A fuller explanation of the prior art valve holder 50 is seen in U.S. Patent Application Publication No. 2022 / 0313429 to Chang.

[0045] The prior valve holder 50 has the aforementioned wide disk-shaped holder body 52 having a planar upper surface 53. The holder body 52 abuts the heart valve and has internal channels through which the constriction sutures pass. A rotor 84 that tensions the constriction sutures sits within a central cavity of the holder body 52 and a guide body 86 extends downward over the rotor. A handle adapter 88 then engages and is connected to the guide body 86. The handle adapter 88 incorporates a guard 90 that covers a cutting guide 92 on the guide body 86 to prevent premature severing of the constriction sutures. Finally, the activator dial 94 having a lower shaft 96 is used to turn the rotor 84 and constrict the commissure posts, as mentioned. However, the activator dial 94 is not used during valve delivery, and must be removed and replaced with the elongated handle or shaft 54 (Figure 5). It should be noted that the upstanding ears 70 are each formed by a solid or uninterrupted tang or flange that extends upward from the planar upper surface 53 of the holder body 52 and bends outward.

[0046] Figure 11 is an exploded perspective view of components of a valve holder 150 of the present application. The components of the holder 150 are much the same as the prior art holder 50 of Figure 10, with the exception of a modified disk-shaped holder body 152 that abuts the heart valve. As before, a rotor 154 sits within a central cavity of the holder body 152 and a guide body 156 extends downward to cover the rotor. A handle adapter 158 then engages and is connected to the guide body 156. Finally, an activator dial 160 is used to constrict the commissure posts, as mentioned.

[0047] Two upstanding ears 162 are each formed by a tang or flange that extends upward from the planar upper surface 163 of the holder body 152 and bends outward. The upstanding ears 162 are shaped similarly to the ears 70 described above in the context of the prior art holder, and are also used to secure the holder body 152 to a packaging clip, as will be explained.

[0048] Figures 12A and 12B are perspective views of the holder body 152 of the valve holder 150, illustrating the modified bent ears 162. As mentioned, the ears 162 extend vertically upward from the upper surface 163 of the holder body 152 and bend outward. This bent shape again provides outwardly-opening slots or rails of sort that can be used to slide the holder body 152, and thus the valve holder 150, onto a packaging clip. However, rather than a solid or uninterrupted element, each of the bent ears 162 has a cutout 164 therein. Each of the cutouts 164 opens to both sides of the respective ear 162, extending upward from the planar surface 163 to approximately the bend in the ear. As will be seen, the cutouts 164 provide openings for a locking tooth on the modified packaging clip to secure the valvePCT / US26 / 11048 13 January 2026 (13.01.2026)SSHIN-24O81WOO1 5,O4O,865_Iholder 150 to the clip more securely and thus stabilize the valve within a packaging container.

[0049] Figures 13A-13C are perspective views of an assembly of the holder body 152 of the valve holder 150 coupled to a packaging clip 170 of the present application illustrating several steps in decoupling the two components. As before, the remaining components of the valve holder 150 as well as a delivery handle 54 are not shown for clarity in Figures 13A and 13B. The packaging clip 170 again has a generally planar configuration with a cavity 171 opening to one lateral side thereof. The cavity 171 is defined by generally parallel side edges 172 that are received by the outwardly-opening slots or rails formed by the bent ears 162. The holder body 152 may thus be slid laterally into the cavity 171 with the rails receiving the side edges 172, and likewise may be slid laterally out of the cavity. The cavity 171 is a dead end with the side edges 172 leading from an open end to a closed end. The process of decoupling the valve holder 150 from the packaging clip 170 involves simply squeezing a pair of thumb levers 174 inward as seen in Figure 13B, and then pulling the valve holder 150 and valve 20 laterally out of the open end of the cavity 171, as seen in Figure 13C. It should be understood that though the valve holder 150 slides laterally into and out of the cavity 171 of the packaging clip 170, other arrangements wherein the holder couples to the valve holder in different orientations are contemplated.

[0050] To better explain the mechanism for coupling the valve holder 150 to the packaging clip 170, Figures 14A-14B are top plan views of Figures 13A-13B, and Figures 15A-15B are top partial plan views of just the packaging clip 170 during the same steps. In these views, the cavity 171 opens downward and has vertical side edges 172. The thumb levers 174 are a feature of a pair of spring retention clasps 176 and are the only part of the spring retention clasps that project upward from the planar main portion of the packaging clip 170. It should be noted that the thumb levers 174 could also be oriented within the plane of the packaging clip 170 and projected to the rear thereof, or otherwise angled out of the plane. The spring retention clasps 176 are preferably molded as a homogeneous or integrated part of the packaging clip 170, and reside within narrow spaces 178 (Figure 15A) at a closed end of the cavity 171 defined by and generally within the plane of the packaging clip. The spaces 178 flank a projection 180 centered at the closed end of the cavity 171 defining a pair of fulcrum corners 182. The spaces 178 commence at a point where the side edges 172 of the cavity 171 widen, as best seen in Figure 15A. The spring retention clasps 176 have an elongated linear form parallel to the cavity 171 and are connected to the side edges 172 via angled living hinges 184. Each spring retention clasp 176 terminates in an inwardly-directed tooth 186 at an end facing toward the open end of the cavity 171.PCT / US26 / 11048 13 January 2026 (13.01.2026)SSHIN-24O81WOO1 5,O4O,865_I

[0051] As seen in Figure 15B, squeezing the thumb levers 174 causes each of the spring retention clasps 176 to contact the fulcrum corner 182 which displaces the teeth 186 outward. As will be explained, this movement releases the valve holder 150 from the packaging clip 170.

[0052] Figures 14A and 15A show the arrangement when the spring retention clasps 176 are in a relaxed configuration, generally parallel to the side edges 172 of the cavity 171. The two inwardly-directed teeth 186 are seen visible from above through the cutouts 164 in each of the ears 162 of the holder body 152. In this configuration, the teeth 186 positively hold the holder body 152, and thus the holder 150 and valve 20 within the cavity 171 defined by the packaging clip 170. This positive retention structure eliminates any possibility that the assembly of the valve 20 and holder 150 can come loose and slide around within the packaging container.

[0053] Figure 14B shows the position of the inwardly-directed teeth 186 after squeezing the thumb levers 174 together to place the spring retention clasps 176 in a flexed configuration. As mentioned, this causes the spring retention clasps 176 to pivot about the fulcrum corners 182 while flexing the living hinges 184, thus moving the teeth 186 outward from within the cutouts 164 in the ears 162. There is then nothing preventing separation of the holder body 152 and holder 150 from the packaging clip 170. There are no longer any small inward bumps on the side edges 172 of the cavity 171, so that the user can simply slide the assembly of the prosthetic heart valve 20 and valve holder 150 out of the cavity 171. This makes the packaging assembly much more secure, and simplifies and makes more dependable and safe the process of decoupling the heart valve 20 from the packaging clip 170.

[0054] While the foregoing is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Moreover, it will be obvious that certain other modifications maybe practiced within the scope of the appended claims.

Claims

SSHIN-24081W001 5,O4O,865_IWHAT IS CLAIMED IS:

1. A heart valve holder and retainer assembly, the heart valve having an inflow sewing ring, a support structure that defines flexible outflow commissure posts terminating in tips, and flexible leaflets supported by the support structure and having free edges extending between the commissure posts, the assembly comprising:a valve holder having a holder body shaped to abut the sewing ring of the heart valve;anda packaging clip having a generally planar configuration with a cavity opening to one lateral side thereof, the cavity being sized and configured to receive the holder body which may be held by the cavity at a closed end thereof, the packaging clip further including a pair of spring retention clasps at the closed end that terminate in teeth, the spring retention clasps both having a relaxed configuration where the teeth are positioned to positively retain the holder body and valve holder within the cavity and a flexed configuration where the teeth are moved to permit the valve holder to be removed from the cavity.

2. The assembly of claim i, wherein the holder body has a pair of upstanding ears that each define outwardly-opening rails, and the cavity having parallel side edges facing one another spaced apart as wide as the rails defined by the holder body so that the holder body may be slid laterally into the cavity with the rails receiving the side edges to be held within the cavity.

3. The assembly of claim 2, wherein each of the rails has a cutout therein that the teeth of the spring retention clasps engage.

4. The assembly of claim 1, wherein the packaging clip further including a pair of thumb levers connected to the spring retention clasps, wherein squeezing the thumb levers toward each other moves the spring retention clasps from their relaxed configurations to their flexed configurations.

5. The assembly of claim 4, wherein the thumb levers project upward out of a plane defined by the generally planar packaging clip.

6. The assembly of any previous claim, wherein the spring retention clasps are molded in one homogeneous part integrated with the packaging clip.

7. The assembly of claim 6, wherein the spring retention clasps are primarily positioned within a plane defined by the generally planar packaging clip.

8. The assembly of claim 7, wherein the thumb levers are the only part of the spring retention clasps that project upward out of the plane of the packaging clip.SSHIN-24081W001 5,O4O,865_I9. The assembly of any previous claim, wherein the closed end of the cavity defines a centered projection flanked by spaces, and the spring retention clasps are positioned within the spaces.

10. The assembly of claim 9, wherein the spring retention clasps have an elongated linear form parallel to the cavity and are connected to the side edges via angled living hinges, and the spring retention clasps terminate at an end facing toward the open end of the cavity in the teeth which are inwardly-directed.

11. The assembly of claim 10, wherein the projection defines a pair of fulcrum corners at an end facing toward the open end of the cavity, and in moving from the relaxed configuration to the flexed configuration the spring retention clasps contact the fulcrum corners which displaces the teeth outward.

12. The assembly of claim 11, wherein the holder body has a pair of upstanding ears that each define outwardly-opening rails, and the cavity having parallel side edges facing one another spaced apart as wide as the rails defined by the holder body so that the holder body may be slid laterally into the cavity with the rails receiving the side edges to be held within the cavity.

13. The assembly of claim 12, wherein each of the rails has a cutout therein that the teeth of the spring retention clasps engage.

14. The assembly of any previous claim, wherein the holder body has internal channels, the valve holder also having a plurality of constriction sutures threaded through the internal channels and through the heart valve to cross over between commissure post tips, each constriction suture being routed to a tensioning mechanism within the valve holder for creating tension and flexing the commissure posts inward.

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