Prosthetic heart valve packaging

Abstract

Packaging assemblies for storing bioprosthetic heart valves are disclosed. The packaging assemblies can include a subassembly including a valve holder configured to hold a bioprosthetic heart valve and a clamp configured to receive a shaft of the valve holder. The clamp can include a body having an outer perimeter and opposing inner edges. The opposing inner edges can define a slot in the body for receiving the shaft of the valve holder. The slot can be open at a first end of the body and extend from the first end along a longitudinal axis of the body to a docking hole. The clamp can further include a compliant component in an interference fit region of the slot adjacent to the docking hole. The compliant component can include a cutout adjacent to each of the opposing inner edges such that each of the opposing inner edges defines a beam within the interference fit region.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 882,415, filed August 2, 2019, which is hereby incorporated by reference in its entirety. TECHNICAL FIELD

[0003] The present invention relates generally to packaging for prosthetic heart valves, and more particularly to a packaging subassembly including a clamp having a compliant component. BACKGROUND

[0004] Heart valve disease remains a significant cause of morbidity and mortality. Currently, the primary treatment for heart valve disease is heart valve replacement. Prosthetic heart valves can be sensitive to the environment and must be packaged to protect the valve from impact and contamination during shipping. It is therefore important for the packaging to provide a structure that both protects the heart valve and allows the valve to be easily removed without damage or contamination.

[0005] Manufacturers have suspended bioprosthetic heart valves in packaging containers for shipping and storage prior to use in the operating room. Valves have been stabilized with various structures including, for example, valve holders and retainer clips having radial slots for receiving shafts of valve holders (e.g., shown in U.S. Patent No. 9,539,080), and packaging sleeves that fit tightly in jars and have clip structures for securing valve holders (e.g., shown in U.S. Patent Nos. 8,839,957; 9,918,836; and 9,295,539).

[0006] Interference fits between retainer clips and valve holders have been mixed in their success. For example, during shipping simulations, some valves have been removed from retainer clips while others have been stuck or difficult to remove from the retainer clips. Adjusting the interference fit is challenging because small changes in the interference component can significantly affect the force required to release the valve holder from the retainer clip.

[0007] It will be appreciated that there is a need for improved heart valve packaging systems configured to securely hold a bioprosthetic heart valve within the packaging system while allowing the heart valve to be easily removed from the packaging system without damage or contamination. The present invention satisfies this need and provides further related advantages. SUMMARY

[0008] The present invention is embodied in a packaging assembly for storing a bioprosthetic heart valve. In one embodiment, the packaging assembly includes a subassembly including a valve holder configured to hold the bioprosthetic heart valve and a clip configured to receive a shaft of the valve holder. The shaft has a shaft width, and the clip includes a main body having an outer perimeter and opposing inner edges. The opposing inner edges define a slot in the main body for receiving the shaft of the valve holder. The slot is open at a first end of the main body and extends from the first end to a docking aperture along a longitudinal axis of the main body. The clip further includes a compliant component in an interference fit region of the slot adjacent the docking aperture. In one embodiment, a slot width between the opposing inner edges of the main body in the interference fit region is less than the shaft width. In another embodiment, the compliant component includes a cutout adjacent each of the opposing inner edges such that each of the opposing inner edges defines a beam within the interference fit region.

[0009] In one embodiment, the main body can be substantially planar. In another embodiment, the cutout adjacent each of the opposing inner edges can be oblong. In a further embodiment, the slot width can decrease from the first end of the main body toward the interference fit region. In an additional embodiment, the clip can include a molded polymer. In yet another embodiment, the clip can include high-density polyethylene or acetal resin or polyoxymethylene, such as ( manufactured by Dupont).

[0010] In one embodiment, the beam defined by each of the opposing inner edges can be a fixed beam, a cantilever beam, or a simply supported beam. In an additional embodiment, the beam defined by each of the opposing inner edges can have an average beam width of about 0.5 mm to about 2 mm.

[0011] In one embodiment, the shaft of the valve holder can have a substantially circular cross-section. In another embodiment, the valve holder can further include a cap coupled to a first end of the shaft and an engagement structure coupled to a second end of the shaft, wherein the engagement structure is configured to removably couple to the bioprosthetic heart valve. In a further embodiment, the shaft can separate the cap and the engagement structure. In an additional embodiment, the engagement structure can include a plurality of legs. In yet another embodiment, the plurality of legs can be angled outwardly and downwardly.

[0012] In one embodiment, the packaging assembly can further include a storage tray having a stepped flange around the cavity. In another embodiment, the body of the clamp can be shaped to nest in the stepped flange of the storage tray such that the engagement structure of the valve holder is suspended within the cavity of the storage tray when the valve holder is docked within the docking hole of the clamp. In a further embodiment, the packaging assembly can further include a vented lid coupled to the upper surface of the storage tray.

[0013] The present disclosure is also embodied in a holding assembly including a valve holder configured to hold a bioprosthetic heart valve and a clamp configured to receive a shaft of the valve holder. The shaft has a shaft width, and the clamp includes a body having an outer periphery and opposing inner edges. The opposing inner edges define a slot in the body for receiving the shaft of the valve holder. The slot is open at a first end of the body and extends from the first end along a longitudinal axis of the body to a docking hole. The clamp further includes a compliant component in an interference fit region of the slot adjacent the docking hole. In one embodiment, a slot width between the opposing inner edges of the body in the interference fit region is less than the shaft width. In another embodiment, the compliant component includes a first cutout adjacent one of the opposing inner edges such that the one of the opposing inner edges defines a beam in the interference fit region.

[0014] In one embodiment, the body can be substantially planar. In another embodiment, the beam defined by one of the opposing inner edges can be a fixed beam, a cantilevered beam, or a simply supported beam. In a further embodiment, the compliant component can further include a second cutout adjacent the other of the opposing inner edges such that each of the opposing inner edges defines a beam within the interference fit region.

[0015] In another separate embodiment, a packaging assembly for storing a bioprosthetic heart valve is provided. The packaging assembly can include a valve holder and a clamp. The valve holder can be configured to hold a bioprosthetic heart valve. The valve holder can include a shaft having a shaft width. The clamp can be configured to receive the shaft of the valve holder. The clamp can include a body having a first end and a second end and a peripheral edge extending between the first end and the second end. The clamp can further include a channel in the body for receiving the shaft of the valve holder. The channel can include an opening at the first end of the body, a terminal docking end within the body, and opposing inner edges defining a first slot between the opening and the terminal docking end. The first slot can have a width W2. The clamp can further include a release mechanism. The release mechanism can include holds disposed on the peripheral edge of the body and a second set of one or more slots disposed between the holds. The second set of one or more slots can each have a width W3, an opening at the second end of the body, and a slot end within the body. The holds can be configured to be compressible toward one another to decrease the width W3 of each of the second set of one or more slots. Decreasing the width W3 of each of the second set of one or more slots can increase the width W2 of the first slot to allow insertion of the valve holder into the slot end and removal of the valve holder from the slot end.

[0016] In one embodiment, the clamp can be made of an elastic material. The elastic material can be a molded polymer. The molded polymer can be high-density polyethylene or acetal resin or polyoxymethylene, such as (DuPont manufactured).

[0017] In one embodiment, the holds can have concave surfaces.

[0018] In one embodiment, the release mechanism can include two slots. In one embodiment, the distance dl between the openings of the release mechanism slots can be greater than the distance d2 between the release mechanism slot ends.

[0019] In one embodiment, the clamp can further include a compliant component in the interference fit region of the slot adjacent to the terminal docking end. The width of the slot in the interference fit region can be less than the shaft width. In one embodiment, the compliant component can include a cutout adjacent to each of the opposing inner edges of the interference fit region such that each of the opposing inner edges defines a beam. In one embodiment, the beam defined by each of the opposing inner edges can be a fixed beam, a cantilever beam, or a simply supported beam.

[0020] In one embodiment, the packaging assembly can further include a storage tray having a stepped flange around the cavity. The body of the clamp can be shaped to rest on the stepped flange of the storage tray such that the engagement structure of the valve holder can hang within the cavity of the storage tray when the valve holder is docked within the docking hole of the clamp. The storage tray can include a vented lid coupled to an upper surface of the storage tray.

[0021] In yet a further embodiment, a packaging assembly for storing a bioprosthetic heart valve is provided. The packaging assembly for storing a bioprosthetic heart valve can include a valve holder and a clamp. The valve holder can be configured to hold the bioprosthetic heart valve and can include a shaft and a shaft width. The clamp can be configured to receive the shaft of the valve holder. The clamp can include a body having a first end and a second end and a peripheral edge extending between the first end and the second end. The clamp can further include a channel in the body for receiving the shaft of the valve holder, wherein the channel can include an opening at the first end of the body, opposing inner edges defining a slot, and a terminal docking end within the body. The clamp can further include a flap hingedly coupled to the body and configured to actuate between an open position and a closed position. In the open position, the flap can be hingedly positioned away from the slot to allow the shaft of the valve holder to freely slide within the channel between the opening and the terminal docking end. In the closed position, the flap covers at least a portion of the slot to secure the valve holder in place when positioned in the terminal docking end.

[0022] In one embodiment, one or both of the clamp and the flap can be made of an elastic material. The elastic material can be a molded polymer. The molded polymer can be high-density polyethylene or acetal resin or polyoxymethylene, such as ( manufactured by Dupont).

[0023] In one embodiment, the flap can be sized and shaped to cover or obstruct a portion of the slot to secure the shaft of the valve holder at the terminal docking end and prevent the shaft from sliding out of the opening when the flap is in the closed position. In one embodiment, the flap does not cover the terminal docking end. In one embodiment, the flap can further include a protrusion to allow grasping to open and close the flap. In one embodiment, the channel width can be no less than the shaft width.

[0024] In one embodiment, the clamp can further include a stepped flange disposed within one or both of the slot and the terminal docking end. The flap can rest on the stepped flange in the closed position.

[0025] In one embodiment, the shaft of the valve holder can be held within the terminal docking end without requiring an interference fit within the channel.

[0026] In one embodiment, the packaging assembly can further include a storage tray having a stepped flange surrounding the cavity. The body of the clamp can be shaped to be stored on the stepped flange of the storage tray so that when the valve retainer is docked in the docking hole of the clamp, the engagement structure of the valve retainer is suspended in the cavity of the storage tray. The storage tray can further include a breathable cover coupled to the upper surface of the storage tray.

[0027] Each feature or concept outlined above is independent and can be combined with the other features or possibilities outlined above or with any other features or concepts disclosed in this application. Other features and advantages of the present invention should become apparent from the following description of the preferred embodiments in conjunction with the accompanying drawings (which illustrate the principles of the present invention by way of example). BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 is an exploded perspective view of a packaging assembly for storing a bioprosthetic heart valve, according to one embodiment.

[0029] Figure 2 is a perspective view of a valve holder according to one embodiment.

[0030] Figure 3A is a top orthogonal view of a clamp according to one embodiment.

[0031] Figure 3B yes Figure 3A Bottom orthogonal view of the fixture.

[0032] Figure 3C yes Figure 3A A three-dimensional diagram of the fixture.

[0033] Figure 3D Example of an image that is enlarged for magnification purposes Figure 3A Parts of the fixture.

[0034] Figure 3E Example of an image that is enlarged for magnification purposes Figure 3D and depicting a detailed view of a simply supported beam defined by one of the opposing inner edges of the clamp.

[0035] Figure 3F Example of an image that is enlarged for magnification purposes Figure 3D An alternative embodiment of a portion of a view of the drawings and depicting a detailed view of a cantilever beam defined by one of the opposing inner edges of the clamp.

[0036] Figure 4 A bioprosthetic heart valve and a valve retainer moving along a slot in a body of a clip are illustrated according to one embodiment.

[0037] Figure 5 is a graph illustrating the relationship between the interference force and the interference width in a clamp without a compliant component, and in another clamp with a compliant component, according to one embodiment.

[0038] Figure 6 is an assembled heart valve holder and clamp subassembly inserted into a storage tray, according to one embodiment.

[0039] Figure 7 is an assembled heart valve holder and clamp subassembly placed within a cavity of a storage tray, according to one embodiment, and a vented lid for sealing over the upper surface of the tray.

[0040] Figure 8 is a perspective view of another embodiment of a clamp and valve holder that can be used in conjunction with a storage tray.

[0041] Figure 9 is Figure 8 is a top orthographic view of the clamp depicted in

[0042] Figure 10 is Figure 8 is a top orthographic view of the clamp depicted in

[0043] Figure 11A and 11B is a perspective view of two sides of a further embodiment of a clamp and valve holder that can be used in a storage tray.

[0044] Figure 11C is Figure 11A and 11B is an alternative embodiment of a clamp and valve holder depicted in

[0045] Figure 12 is Figure 11A and 11B is a perspective view of a clamp depicted in

[0046] Figure 13 is Figure 11A and 11B is a perspective view of a clamp depicted in

[0047] Figure 14is a perspective view of a further embodiment of a clip and valve holder that can be used in conjunction with a storage tray.

[0048] Figure 15 is Figure 15 is a top orthogonal view of the clip depicted in DETAILED DESCRIPTION

[0049] Referring now to the exemplary drawings Figure 1 , a packaging assembly 1000 for storing a bioprosthetic heart valve 10 is shown. The packaging assembly 1000 can include a subassembly 100 that includes a valve holder 110 configured to hold the bioprosthetic heart valve 10 and a clip 130 configured to receive a shaft 112 of the valve holder 110. As will be discussed in greater detail below, the subassembly 100 holding the bioprosthetic heart valve 10 can be placed in a container, such as a bottle (not shown), a storage tray 200, and further processed for storage and shipping.

[0050] Referring to Figure 2 , the valve holder 110 can include a cap 118 coupled to a first end 114 of the shaft 112 and an engagement structure 120 coupled to a second end of the shaft 112. In one embodiment, the cap 118 can include a bore having internal threads 124, the shaft 112 can have a shaft width Wl and a substantially circular cross-section, and the engagement structure 120 can be configured to removably couple to the bioprosthetic heart valve 10. For example, Figure 2 The engagement structure 120 illustrated in includes a plurality of legs 122 that are angled outwardly and downwardly. As is known in the art, the legs 122 can be arranged to contact and engage a cusp region of the heart valve 10. Although not shown, one configuration for connecting the legs 122 to the heart valve 10 includes an attachment suture that is looped through a suture- penetrable material of the heart valve 10 and knotted on the valve holder 110. During implantation, a surgeon can manipulate a handle (not shown) that is threaded into the bore 124 and advance the heart valve 10 to an implantation site. Once in place, the surgeon can cut the attachment suture that couples the valve holder 110 to the heart valve 10 and remove the valve holder 110 and the handle.

[0051] According to one exemplary embodiment, a clip is provided that provides an interference fit with a valve holder. Referring now to Figure 3A- 3F, the clamp 130 can include a substantially planar body 132 having an outer perimeter 134 and opposing inner edges 136A, 136B. The opposing inner edges 136A, 136B can define a slot 138 in the body 132 for receiving the shaft 112 of the valve holder 110. The slot 138 can be open at a first end 140 of the body 132 and can extend from the first end 140 along a longitudinal axis I of the body 132 to a docking hole 142.

[0052] In one embodiment, the slot 138 can include an interference fit region 150 adjacent the docking hole 142. The slot width W2 between the opposing inner edges 136A, 136B of the body 132 can decrease from the first end 140 of the body 132 to the interference fit region 150. In one embodiment, the slot width W2 in the interference fit region 150 can be less than the shaft width Wl of the valve holder 110. In this way, when the shaft 112 of the valve holder 110 is pushed inwardly along the slot 138 (as exemplified in FIG. 3F), the shaft 112 will be urged against the opposing inner edges 136A, 136B in the interference fit region 150 before snapping into (or out of) the docking hole 142. Figure 4

[0053] The interference fit region 150 is provided to retain the valve holder 110 within the docking hole 142 during handling, storage, and shipping - until the physician intentionally moves the valve holder 110 out. The interference fit region 150 should retain the valve holder 110 in the docking hole 142 during shipping, and also allow the valve holder 110 to be easily moved out in the operating room. Thus, the force required to move the valve holder 110 through the interference fit region 150 should be about 3 N to about 13 N. This interference force is set by the interference width, which is the difference between the shaft width Wl and the slot width W2 in the interference fit region 150. The interference width can have a tolerance range of about ± 125 pm, for example. However, adjusting the interference width has been challenging because only a 25 pm to 50 pm variation can significantly affect the force required to release the valve holder 110 from the clamp 130. As a result, the use of interference fit between the clamp 130 and the valve holder 110 has been a mixed bag. For example, some valve holders 110 have moved away from the clamp 130 during shipping simulations, while other valve holders 110 have been stuck by or difficult to move out of the clamp 130.

[0054] ​In one embodiment, the interference width can be in a range of about 5 pm or more, about 10 pm or more, about 15 pm or more, about 20 pm or more, about 25 pm or more, about 30 pm or more, about 35 pm or more, about 40 pm or more, about 45 pm or more, about 50 pm or more, about 55 pm or more, about 60 pm or more, about 65 pm or more, about 70 pm or more, about 75 pm or more, about 80 pm or more, about 85 pm or more, about 90 pm or more, about 95 pm or more, about 100 pm or more, about 105 pm or more, about 110 pm or more, about 115 pm or more, about 120 pm or more, and about 125 pm or more. The interference width can also be in a range between any two of the foregoing values and including any two of the foregoing values.

[0055] With continued reference to Figure 3A -3F, the present invention overcomes the challenges associated with the valve holder 110 getting stuck in the clamp 130 or being difficult to remove from the clamp 130 due to interference fit by incorporating a compliant member 152 into the interference fit region 150. With particular reference to Figure 3D , the compliant member 152 can include a cutout 154A, 154B adjacent to at least one of the opposing inner edges 136A, 136B such that at least one of the opposing inner edges 136A, 136B defines a beam 156A, 156B within the interference fit region 150. In the illustrated example, the compliant member 152 includes a cutout 154A, 154B adjacent to each of the opposing inner edges 136A, 136B such that each of the opposing inner edges 136A, 136B defines a beam 156A, 156B within the interference fit region 150. The compliant member 152 allows the beams 156A, 156B to deform (as exemplified by the dashed lines in Figure 3E and 3F , which reduces the force required to push the shaft 112 of the valve holder 110 through the interference fit region 150 and increases the tolerance range of the interference width for a given range of interference forces.

[0056] The shape of the cutouts 154A, 154B and beams 156A, 156B and the average beam width W3 will depend on the application and the range of acceptable interference forces, as well as the materials used to form the clamp 130 and the valve holder 110. In one embodiment, the clamp 130 can include a molded polymer, such as high-density polyethylene or acetal resin or polyoxymethylene, such as DELRIN® (manufactured by Dupont).

[0057] ​In some embodiments, the cutouts 154A, 154B can be elongated and can be symmetric or asymmetric. For example, the cutouts 154A, 154B can have an elliptical, rectangular, rounded rectangular, or stadium shape. The beams 156A, 156B defined by each of the opposing inner edges 136A, 136B can be fixed beams, simply supported beams, or cantilevered beams. Figure 3E An example is shown of a cutout 154A adjacent to the inner edge 136A having a rounded rectangular shape such that the inner edge 136A defines a simply supported beam 156A. Figure 3F An example is shown of an optional embodiment in which the cutout 154A further includes a portion that extends through the inner edge 136A to the slot 138 such that the inner edge 136A defines a cantilevered beam. In one embodiment, the beam 156A can have an average beam width W3 of about 0.5 mm to about 2 mm.

[0058] Figure 5 The graph in FIG. 1 illustrates the effect that the compliant member 152 can have on the relationship between the interference force and the interference width. As shown, the slope of the fixture without the compliant member is steep; the minimum interference width I 最小1 is small between the maximum interference width I 最大1 to produce the desired acceptable force range between F 低 and F 高 On the other hand, the compliant member 152 reduces the slope and increases the range Δ2 between the minimum interference width I 最小2 and the maximum interference width I 最大2 to produce the same desired acceptable force range between F 低 and F 高

[0059] Although Figure 5 the two example curves in FIG. 1 are shown as lines, the relationship between the interference force and the interference width is not necessarily linear. However, a line can be generated for a non-linear relationship that best fits the data, and adding the compliant member 152 to the fixture 110 will reduce the slope of this line and relax the tolerance on the interference width required to produce the interference force within the desired range.

[0060] ​With the bioprosthetic heart valve 10 secured to the valve holder 110 and with the valve holder 110 secured to the clip 130, the subassembly 100 can be placed within a container for further handling, storage, and transport. In some embodiments (not shown), the subassembly 100 can be used with a bioprosthetic heart valve 10 stored in a preservative solution, such as glutaraldehyde. For these cases, the subassembly 100 can be configured to fit tightly within a fluid-tight transport bottle filled with the preservative solution and sealed with a suitable cap, for example, as described in U.S. Patent No. 9,295,539. In other embodiments, the subassembly 100 can be used with a dehydrated or dry bioprosthetic heart valve 10 stored in a dry package, for example, as described in U.S. Patent No. 9,539,080.

[0061] For example, referring now to Figure 6 and 7 , the engagement structure 120 of the bioprosthetic heart valve 10 and the valve holder 110 can be lowered into the cavity 220 of the storage tray 200, and the clip 130 can be stored on the stepped flange 210 of the storage tray 200 such that the clip 130 caps the cavity 220 of the storage tray 200. In one embodiment, the clip 130 can engage the storage tray 200 in a non-rotational manner, allowing the valve holder 110 to remain stationary in the storage tray 200 as a user couples the threaded handle to the threaded aperture 124 of the valve holder 110. The clip 130 is preferably formed to have a shape that corresponds to the shape of the storage tray 200 (or other container). Thus, although the clip 130 is depicted as an irregular hexagon, it should be understood that the clip 130 can be molded or otherwise formed to have a circular, square, rectangular, or any shape that is suitable for the desired container. With the subassembly 10 in place in the storage tray 200, a gas permeable cap 300 of an outer bag (not shown) with adhesive can be sealed over the upper surface 230 of the storage tray 200.

[0062] Referring now to Figures 8-10 , another embodiment of a clip 330 is provided that can be used with the valve holder 110 and the storage tray 200 in a similar manner as the clips depicted and described with respect to Figure 1 , 4 , 6, and 7. Similar to Figure 1 , 4, 6 and 7, the clamp 330 can hold the shaft 112 of the valve holder 110 by means of an interference fit. The clamp 330 may include a body 332 having an outer periphery 334 and opposing inner edges 336A, 336B. The body 332 may be substantially planar, and the opposing inner edges 336A, 336B may define a channel 338 in the body 332 for receiving the shaft 112 of the valve holder 110. The channel 338 may open at a first end 340 of the body 332 and extend from the first end 340 to a terminal stop end 342 along the longitudinal axis l of the body 332. One or both of the terminal stop end 342 and the channel 338 may also include a stepped flange 339, and the first end 114 of the shaft 112 may rest on the stepped flange 339. As Figure 2 As depicted, a portion of the first end 114 of the shaft 112 protrudes radially outward from the shaft 112 so that it can rest on top of the stepped flange 339 .

[0063] In one embodiment, the channel 338 may include an interference fit region 350 adjacent to the terminal stop end 342. The interference fit region 350 may be adjacent to the terminal stop end 342. Figure 1 , 3, 4, 6 and 7 are the same or similar, or may be just a narrow area. For example, the channel width W2 between the opposing inner edges 336A, 336B of the body 332 can decrease from the first end 340 of the body 332 to the interference fit region 350. In one embodiment, the channel width W2 of the interference fit region 350 can be narrower than the shaft width W1 of the valve holder 110. Thus, when the shaft 112 of the valve holder 110 is pushed inward along the channel 338 (e.g., Figure 9 As shown in the example, the shaft 112 will be pushed against the opposing inner edges 336A, 336B in the interference fit area 350 before snapping into (or out of) the terminal rest end 342. In one embodiment, the interference width, which is the difference between the shaft width W1 and the channel width W2 of the interference fit area 350, can be in the range of about 5 μm or greater, about 10 μm or greater, about 15 μm or greater, about 20 μm or greater, about 25 μm or greater, about 30 μm or greater, about 35 μm or greater, about 40 μm or greater, about 45 μm or greater, about 50 μm or greater, about 55 μm or greater, about 60 μm or greater, about 65 μm or greater, about 70 μm or greater, about 75 μm or greater, about 80 μm or greater, about 85 μm or greater, about 90 μm or greater, about 95 μm or greater, about 100 μm or greater, about 105 μm or greater, about 110 μm or greater, about 115 μm or greater, about 120 μm or greater, or about 125 μm or greater. The interference width may also include any two of the above values ​​and be within a range including any two of the above values.

[0064] The clamp 330 may include a release mechanism that can increase the distance between the opposing inner edges 336A, 336B or reduce the channel width W2 of the interference fit region 350 to allow easy insertion and removal of the valve holder 110 into and out of the terminal rest end 342. Figure 9 and 10 As depicted in FIG, the release mechanism may be implemented by a pinch-to-release mechanism. The pinch-to-release mechanism may include one or more slots 380 having an open end disposed from the second end 341 of the body 332 and extending substantially toward the terminal rest end 342. Figures 8-10 In the depicted embodiment, the first end 340 and the second end 341 are opposite edges of the body 332 of the clamp 330. The two slots 380 can extend at an angle from the open end 381 and toward the terminal rest end 342. Figures 8-10 As depicted in , where two slots are provided, the distance d1 between the open ends 381 of the slots 380 may be greater than the distance d2 between the slot ends 382 .

[0065] One or more slots 380 may have the same width or varying widths. Figures 8-10 The embodiment in FIG. 3 depicts a pair of grooves as having substantially the same width W3, but it should be understood that embodiments may also include a single groove or two or more grooves having the same width or varying widths. One or more grooves 380 may be disposed between a pair of clamping handles 390 disposed at a peripheral edge 343 of the body 332. The peripheral edge 343 may extend along a straight line between the first end 340 and the second end 341 of the body 332, or as Figures 8-10 The depicted shape is curved or contoured. The clamping handles 390 can be clamped together to reduce the width W3 of one or more slots 390 (see Figure 9 ), which in turn can increase the channel width W2 to facilitate easy insertion and removal of the valve holder shaft 112 into and out of the terminal rest end 342 with less force. When the clamp handles 390 are compressed together, the width W3 of the one or more slots 380 can be reduced more at the open end 380 than at the area near the slot ends 382. After the clamp handles 390 are clamped together, the force required to slidingly move the valve holder 110 from the terminal rest end 342 and through the channel 338 to remove the valve holder 110 from the clamp 330 is less than 10N, less than 9N, less than 8N, less than 7N, less than 6N, less than 5N, less than 4N, less than 3N, less than 2N, or less than 1N. The one or more slots 380 can provide a more secure fixation of the valve holder 110 and a greater dimensional tolerance.

[0066] Again, an interference fit region 350 is provided to hold the valve holder 110 within the terminal docking end 342 during handling, storage, and transport - until the physician intentionally removes the valve holder 110. The interference fit region 350 should hold the valve holder 110 in the terminal docking end 342 during transport, and also allow easy removal of the valve holder 110 in the operating room. The interference fit region can be provided in the manner described and depicted with reference to Figures 1-7

[0067] Referring now to Figures 14-15 , yet further embodiments of a clip 530 are provided that can be used with the valve holder 110 and storage tray 200 in a similar manner to the clips described and depicted with reference to Figure 1 , 6 , 7, and 8-10. Similar to the embodiments of the clip 330 described and depicted with reference to Figures 8-10 , the clip 530 can hold the shaft 112 of the valve holder 110 by way of an interference fit. The clip 530 can include a body 532 having an outer perimeter 534 and opposing inner edges 536A, 536B. The body 532 can be substantially planar, and the opposing inner edges 536A, 536B can define a channel 538 in the body 532 for receiving the shaft 112 of the valve holder 110. The channel 538 can open at a first end 540 of the body 532, and extend from the first end 540 along a longitudinal axis I of the body 532 to a terminal docking end 542. One or both of the terminal docking end 542 and the channel 538 can also include a stepped flange 539 upon which the first end 114 of the shaft 112 can rest. As described and depicted with reference to Figure 2 , a portion of the first end 114 of the shaft 112 projects radially outward from the shaft 112 so that it can rest on top of the stepped flange 539.

[0068] In one embodiment, the channel 538 can include an interference fit region 550 adjacent the terminal docking end 542. The interference fit region 550 can be the same as or similar to the interference fit regions described and depicted with reference to Figure 1 , 3, 4, 6, 7, and 8-10, or can simply be a narrow region. For example, the channel width W2 between the opposing inner edges 536A, 536B of the body 532 can decrease from the first end 540 of the body 532 to the interference fit region 550. In one embodiment, the channel width W2 in the interference fit region 550 can be narrower than the shaft width Wl of the valve holder 110. In this way, when the shaft 112 of the valve holder 110 is pushed inward along the channel 538 (as described and depicted with reference to Figure 9 ​As shown in the example of FIG. 5A, before the card-in (or card-out) terminal docking end 542, the shaft 112 will be pushed against the opposing inner edges 536A, 536B in the interference fit region 550. In one embodiment, the interference width, which is the difference between the shaft width W1 and the passage width W2 of the interference fit region 550, can be in a range of about 5 pm or more, about 10 pm or more, about 15 pm or more, about 20 pm or more, about 25 pm or more, about 30 pm or more, about 35 pm or more, about 40 pm or more, about 45 pm or more, about 50 pm or more, about 55 pm or more, about 60 pm or more, about 65 pm or more, about 70 pm or more, about 75 pm or more, about 80 pm or more, about 85 pm or more, about 90 pm or more, about 95 pm or more, about 100 pm or more, about 105 pm or more, about 110 pm or more, about 115 pm or more, about 120 pm or more, or about 125 pm or more. The interference width can also include any two of the above values or be in a range of any two of the above values.

[0069] The clip 530 can include a release mechanism that can increase the distance between the opposing inner edges 536A, 536B to allow easy insertion of the valve holder 110 into the terminal docking end 542 and removal of the valve holder 110 from the terminal docking end 542. The release mechanism can be implemented by a clamping release mechanism similar to that depicted in Figure 9 and 10 The release mechanism can be implemented by a clamping release mechanism similar to that depicted in Figure 9 and 10 The clamping release mechanism can include one or more slots 580 having an open end disposed from the second end 541 of the body 532 and extending substantially toward the terminal docking end 542. Further, similar to the embodiment depicted in Figures 8-10 The first end 540 and the second end 541 are opposing edges of the body 532 of the clip 530. The two slots 580 can extend from the open ends 581 and at an angle toward the terminal docking end 542. Thus, similar to the embodiment depicted in Figures 8-10 The distance dl between the open ends 581 of the slots 580 can be greater than the distance d2 between the slot ends 582 in the case where two slots are provided.

[0070] The one or more slots 580 can have the same width or varying widths. Although Figures 14-15The embodiment in FIG. 5 depicts a pair of slots as having substantially the same width W3, but it should be understood that embodiments may also include a single slot or two or more slots having the same or varying widths. The one or more slots 580 may be disposed between a pair of grips 590 disposed on the body 532. The grips 590 may be protrusions from the body 532 that allow fingers to grip to compress the grips 590 together to reduce the width W3 of the one or more slots 590 and increase the channel width W2, which facilitates the use of the same width as the one or more slots 590. Figure 9 542 . The valve holder shaft 112 is easily inserted into and removed from the terminal rest end 542 in a manner similar to the embodiment depicted in FIG. 540 , with less force. Alternatively, the clamp handle 590 may be simply a peripheral edge 543 extending between the first end 540 and the second end 541 . After the clamp handles 590 are clamped together, the force required to slide the valve holder 110 from the terminal rest end 541 and through the channel 538 to remove the valve holder 110 from the clamp 530 is less than 10 N, less than 9 N, less than 8 N, less than 7 N, less than 6 N, less than 5 N, less than 4 N, less than 3 N, less than 2 N, or less than 1 N. The one or more grooves 580 may provide a more secure fixation of the valve holder 110 and greater dimensional tolerances.

[0071] and Figure 1 , 3, 4, 6 and 7, the clamp 530 can further include a plurality of openings 560 disposed within the body 532 to further reduce the force required to slide the valve retainer 110 from the terminal docking end 542 and through the channel 538 to remove the valve retainer 110 from the clamp 530. The plurality of openings 560 can be formed in any number of shapes (e.g., circular, elliptical, ovaline, linear) and can be arranged in a variety of ways. Figure 1 , 3, 4, 6, 7, 14 and 15, the plurality of openings are arranged around the terminal stop end 542. In alternative embodiments, the plurality of openings 560 can be arranged on one or both sides of the terminal stop end 542.

[0072] Again, an interference fit region 550 is provided to hold the valve holder 110 in the terminal rest end 542 during handling, storage, and transport—until the physician intentionally removes the valve holder 110. The interference fit region 550 should hold the valve holder 110 in the terminal rest end 542 during transport and also allow for easy removal of the valve holder 110 in the operating room. Figures 1-7 The interference fit area is provided in the manner depicted and described in and 8-10.

[0073] According to another exemplary embodiment, a clamp is provided that can hold or secure a valve holder without the need for interference fit assembly. Referring now to FIGS. 11-13, a clamp 430 can include a body 432 having an outer perimeter 434 and opposing inner edges 436A, 436B. The body 432 can be substantially planar, and the opposing inner edges 436A, 436B can define a channel 438 in the body 432 for receiving a shaft 112 of a valve holder 110. The channel 438 can be open at a first end 440 of the body 432, and can extend from the first end 440 to a terminal docking end 442 along a longitudinal axis I of the body 432. As depicted in Figure 11C , the terminal docking end 442 and one or both of the channel 438 can optionally further include a stepped flange 439 upon which a first end 114 of the shaft 112 can rest. As depicted in Figure 2 , a portion of the first end 114 of the shaft 112 projects radially outward from the shaft 112.

[0074] The clamp 430 can further include a flap 450 coupled to the body 432. The flap 450 can be actuated between an open position (FIGS. Figure 11A , 11B , 11C and 12) and a closed position (FIGS. Figure 13 ) via a hinge 452. In the open position depicted in Figure 11A , 11B , 11C and 12, the shaft 112 of the valve holder 110 can be freely slidable in the channel 438, and positioned within the terminal docking end 442 of the body 432. As depicted in Figure 13 , upon positioning at the terminal docking end 442, the flap 450 can be actuated in the closed position to secure the valve holder within the clamp 430.

[0075] The flap 450 can be sized and shaped to cover or obstruct at least a portion of the channel 438 to secure the shaft 112 of the valve holder 110 at the terminal docking end 442 and prevent the shaft 112 from sliding out of the terminal docking end 442. According to one aspect of the embodiment, the flap 450 can be sized to rest against the stepped flange 439 of the terminal docking end 442. According to another aspect of the embodiment, the flap 450 can be sized to rest against the first end 114 of the shaft 112. According to yet another aspect of the embodiment, the flap 450 can be sized to rest against both the stepped flange 439 of the terminal docking end 442 and the first end 114 of the shaft 112. Figure 11C11-13 , the flap 450 can be shaped to include a stepped-in portion 460 that covers a portion of the channel 438 and a stepped-out portion 462 that conforms to at least a portion of the outer perimeter 434. Although the hinge depicted in FIG11-13 is a living hinge 452, it should be understood that the flap 450 can be coupled to the body 432 in any other manner that allows the flap 450 to be in the open position ( Figure 11A 、 11B and 12) with closed position ( Figure 13 ) between the flap 450 and the wing 450. The flap 450 may further include a protrusion 454 to allow grasping to open and close the flap 450.

[0076] According to one aspect of this embodiment, the shaft 112 of the valve holder 110 can be retained within the terminal rest end without the need for an interference fit. In other words, the width of one or both of the terminal rest end 442 and the channel 438 does not have to be less than the axial width W1 of the valve holder 100. In one embodiment, the width of one or both of the channel 438 or the terminal rest end 442 is approximately equal to or slightly greater than the width of the shaft 112 of the valve holder 110. In this way, minimal or no force will be required to move the valve holder 110 through the channel 438 and into or out of the terminal rest end 442. The force required to move the valve holder 110 through the channel 438 and into the terminal rest end 442 can be 5N or less, 4N or less, 3N or less, 2N or less, or 1N or less.

[0077] As will be appreciated from the foregoing description, the present invention provides an improved packaging assembly that provides a desired range of interference forces over a larger range of interference widths, thereby securely retaining a bioprosthetic heart valve within the packaging system while also allowing the heart valve to be easily removed from the packaging system without damage or contamination.

[0078] Specific methods, devices, and materials are described, although any methods and materials similar or equivalent to those described can be used in the practice or testing of the present embodiments. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present embodiments belong.

[0079] The terms “a,” “an,” and “at least one” encompass one or more of the specified element. That is, if there are two of the specified element then “a” or “at least one” of the elements is also present, and thus the phrase “a,” “an,” or “at least one” covers the embodiment where one or more of the elements are present. The terms “a plurality of” and “plural” mean two or more of the specified element. The use of the term “or” between the last two items in a list of items means that any of the items can be present or none of the items are present. For example, the phrase “A, B, or C” means “A, B, and / or C,” which covers A, B, C, A and B, A and C, B and C, or A, B, and C. The term “coupled” generally means physically coupled or linked and does not exclude the presence of intermediate elements between the coupled items in the absence of specific contrary language.

[0080] Without further elaboration, it is believed that one skilled in the art can, using the description herein, utilize the present application to its fullest extent. The following detailed description is provided to aid those skilled in the art in applying the principles of the present application. Various modifications can be made by those skilled in the art without departing from the scope of the application. Therefore, the present application should not be limited to the illustrative embodiments set forth herein.

Claims

1. A packaging assembly for storing a bioprosthetic heart valve, the packaging assembly comprising: a valve retainer configured to retain the bioprosthetic heart valve, the valve retainer comprising a shaft having a shaft width, a cap coupled to a first end of the shaft, and an engagement structure coupled to a second end of the shaft; and a clamp configured to receive the shaft of the valve holder, the clamp comprising: a body having a first end and a second end and a peripheral edge extending between the first end and the second end; a channel in the body for receiving the shaft of the valve retainer, wherein the channel includes an opening at a first end of the body, a terminal rest end within the body, and opposing inner edges defining a first slot between the opening and the terminal rest end, the first slot having a width W2; and a release mechanism comprising clamping handles disposed on the peripheral edge of the body and a second set of one or more slots disposed between the clamping handles, the second set of one or more slots each having a width W3, an opening at the second end of the body, and a slot terminus within the body; wherein the clamping handles are configured to be compressible toward each other to reduce the width W3 of each of the second set of one or more slots; and Wherein reducing the width W3 of each of the second set of one or more slots increases the width W2 of the first slot to allow the valve holder to be inserted into and removed from the slot end.

2. The packaging assembly of claim 1, wherein the clamp is made of an elastic material.

3. The packaging assembly of claim 2, wherein the elastic material is a molded polymer.

4. The packaging assembly of claim 3, wherein the molded polymer is high density polyethylene or acetal resin.

5. The packaging assembly of any one of claims 1-4, wherein the clamp handle has a concave surface.

6. The packaging assembly of any one of claims 1-4, wherein the release mechanism comprises two slots.

7. The packaging assembly of claim 6, wherein a distance d1 between the openings of the slots is greater than a distance d2 between the ends of the slots.

8. The packaging assembly of any one of claims 1-4, wherein the clamp further comprises a compliant feature in an interference fit area of ​​the slot adjacent the terminal rest end.

9. The packaging assembly of claim 8, wherein a width of the groove in the interference fit area is less than a width of the shaft.

10. The packaging assembly of claim 9, wherein the compliant feature includes a cutout adjacent each of the opposing inner edges in the interference fit area such that each of the opposing inner edges defines a beam.

11. The packaging assembly of claim 10, wherein the beam defined by each of the opposing inner edges is a fixed beam, a cantilever beam, or a simply supported beam.

12. The packaging assembly of any one of claims 1-4, further comprising a storage tray having a stepped flange surrounding the cavity.

13. The packaging assembly of claim 12, wherein the body of the clamp is shaped to rest against the stepped flange of the storage tray so that when the valve retainer is docked in the docking hole of the clamp, the engaging structure of the valve retainer is suspended in the cavity of the storage tray.

14. The packaging assembly of claim 12, further comprising a breathable cover coupled to an upper surface of the storage tray.

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