Patent Description:
This invention relates generally to packaging for prosthetic heart valves and, more particularly, to a packaging sub-assembly comprising a clip having a compliance feature.

Heart valve disease continues to be a significant cause of morbidity and mortality. Currently, the primary treatment of heart valve disease is heart valve replacement. A prosthetic heart valve can be environmentally sensitive and must be packaged to protect the valve from impacts and contamination during transportation. It is important, therefore, for packaging to provide a structure that can protect the heart valve, but also allow the valve to be easily removed without damage or contamination.

Manufacturers have suspended bioprosthetic heart valves within packaging containers for shipping and storage prior to use in the operating room. The valves have been stabilized with various structures, including, for example, a valve holder and a retainer clip having a radial slot for receiving a shaft of the valve holder (as shown, for example, in <CIT>), and a packaging sleeve that fits closely within a jar and has a clip structure for securing a valve holder (as shown, for example, in <CIT>; <CIT>; and <CIT>).

Current use of an interference fit between the retainer clip and the valve holder has had mixed success. For example, some valves have become dislodged from the retainer clip during shipping simulation, while other valves have become stuck or difficult to remove from the retainer clip. Adjusting the interference fit is a challenge, as a minuscule change in the interference feature can significantly affect the force required to release the valve holder from the retainer clip.

It should be appreciated that there is a need for an improved heart-valve packaging system that is configured to securely maintain a bioprosthetic heart valve within the packaging system, while allowing for easy removal of the heart valve from the packaging system without damage or contamination. The present invention fulfills this need and provides further related advantages. <CIT>discloses a holder for heart valve prostheses. Embodiments of the holder include a hub portion having a longitudinal axis, an engagement portion coupled to the hub portion and including plural finger members variably positionable relative to the hub portion between a collapsed condition wherein the finger members are closed onto the hub portion and an expanded condition wherein the finger members radially protrude with respect to the hub portion to engage a heart valve prosthesis. The finger members are L-shaped. Also disclosed is a storage arrangement. The storage arrangement is similar as the packaging assembly of claim <NUM>, but does at least not include a compliance feature that allows a beam to deform so that the force needed to push a shaft of a valve holder past an interference-fit area is reduced.

The present invention relates to a packaging assembly for storing a bioprosthetic heart valve as defined in claim <NUM>. Embodiments of the invention are recited in the dependent claims. The present invention is embodied in a packaging assembly for storing a bioprosthetic heart valve. In one embodiment, the packaging assembly includes a sub-assembly comprising 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 comprises 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, along a longitudinal axis of the body, from the first end to a docking aperture. The clip further comprises a compliance feature in an interference-fit area of the slot adjacent to the docking aperture. In one embodiment, a slot width between the opposing inner edges of the body in the interference-fit area is less than the shaft width. In another embodiment, the compliance feature comprises 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 area.

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

In one embodiment, the beam defined by each of the opposing inner edges can be a fixed beam, a cantilevered 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 from about <NUM> to about <NUM>.

In one embodiment, the shaft of the valve holder can have a substantially circular cross-section. In another embodiment, the valve holder can further comprise 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 comprise a plurality of legs. In yet another embodiment, the plurality of legs can be outwardly and downwardly angled.

In one embodiment, the packaging assembly can further comprise a storage tray having a stepped ledge surrounding a cavity. In another embodiment, the clip's body can be shaped to rest on the stepped ledge of the storage tray such that the valve holder's engagement structure is suspended within the cavity of the storage tray when the valve holder is docked within the clip's docking aperture. In a further embodiment, the packaging assembly can further comprise a gas-permeable lid coupled to an upper surface of the storage tray.

The clip can further comprise a release mechanism. The release mechanism can comprise holds provided on peripheral edges extending between the first end of the body and a second end of the body and a second set of one or more slots provided between the holds. The second set of one or more slots can each have a width W<NUM>, an opening at the second end of the body and a slot end within the body. The holds can be configured to be compressible towards one another to decrease the width W<NUM> of each one of the second set of one or more slots. Decreasing the width W<NUM> of each one of the second set of the one or more slots can increase the width W<NUM> of the slot between the opposing inner edges, i.e. the first slot, to permit insertion and removal of the valve holder to and from the slot end.

In one embodiment, the clip can be made of a resilient material.

In one embodiment, the holds can have a concave surface.

In one embodiment, the release mechanism can comprise two slots. In one embodiment, a distance d<NUM> between the openings of the release mechanism slots can be greater than a distance d<NUM> between the release mechanism slot ends.

The clip can further include a flap hingedly coupled to the body and configured to be actuated between an open position and a closed position.

In one embodiment, one or both of the clip and the flap can be made of a resilient material. The resilient material can be a molded polymer. The molded polymer can be a high-density polyethylene or an acetal resin or a polyoxymethylene, such as DELRIN® (manufactured by Dupont).

In one embodiment, the flap can further comprise a protrusion to allow grasping to open and close the flap.

Each feature or concept outlined above is independent, and can be combined with the other features or concepts outlined above or with any other feature or concept disclosed in this application. Other features and advantages of the invention should become apparent from the following description of the preferred embodiments, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention.

With reference now to <FIG> of the illustrative drawings, there is shown a packaging assembly <NUM> for storing a bioprosthetic heart valve <NUM>. The packaging assembly <NUM> can include a sub-assembly <NUM> comprising a valve holder <NUM> configured to hold the bioprosthetic heart valve <NUM>, and a clip <NUM> configured to receive a shaft <NUM> of the valve holder <NUM>. As will be discussed in more detail below, the sub-assembly <NUM> holding the bioprosthetic heart valve <NUM> can be placed into a container such as a jar (not shown) or a storage tray <NUM>, and further processed for storage and shipment.

With reference to <FIG>, the valve holder <NUM> can comprise a cap <NUM> coupled to a first end <NUM> of the shaft <NUM> and an engagement structure <NUM> coupled to a second end of the shaft <NUM>. In one embodiment, the cap <NUM> can comprise a bore with internal threads <NUM>, the shaft <NUM> can have a shaft width W<NUM> and a substantially circular-cross-section, and the engagement structure <NUM> can be configured to removably couple to the bioprosthetic heart valve <NUM>. For example, the engagement structure <NUM> illustrated in <FIG> comprises a plurality of legs <NUM> that are outwardly and downwardly angled. The legs <NUM> can be arranged to contact and engage cusp regions of the heart valve <NUM>, as is known in the art. Although not shown, one configuration for connecting the legs <NUM> to the heart valve <NUM> includes attachment sutures that loop through suture-permeable material in the heart valve <NUM> and tie off on the valve holder <NUM>. During implant, a surgeon can manipulate a handle (not shown) screwed into the threaded bore <NUM> and advance the heart valve <NUM> into implant position. Once in position, the surgeon can sever the attachment sutures coupling the valve holder <NUM> to the heart valve <NUM>, and remove the valve holder <NUM> and the handle.

In accordance with one exemplary embodiment, a clip that provides an interference-fit with a valve holder is provided. With reference now to <FIG>, the clip <NUM> can comprise a substantially planar body <NUM> having an outer periphery <NUM> and opposing inner edges 136A, 136B. The opposing inner edges 136A, 136B can define a slot <NUM> in the body <NUM> for receiving the shaft <NUM> of the valve holder <NUM>. The slot <NUM> can be open at a first end <NUM> of the body <NUM> and can extend, along a longitudinal axis l of the body <NUM>, from the first end <NUM> to a docking aperture <NUM>.

In one embodiment, the slot <NUM> can include an interference-fit area <NUM> adjacent to the docking aperture <NUM>. A slot width W<NUM> between the opposing inner edges 136A, 136B of the body <NUM> can decrease from the first end <NUM> of the body <NUM> to the interference-fit area <NUM>. In one embodiment, the slot width W<NUM> in the interference-fit area <NUM> can be less than the valve holder's <NUM> shaft width W<NUM>. As such, when the shaft <NUM> of the valve holder <NUM> is pushed inward along the slot <NUM> (as illustrated in <FIG>), the shaft <NUM> will push against the opposing inner edges 136A, 136B in the interference-fit area <NUM> before snapping into (or out of) the docking aperture <NUM>.

The interference-fit area <NUM> is provided to maintain the valve holder <NUM> within the docking aperture <NUM>, during processing, storage, and shipment-until the valve holder <NUM> is deliberately removed by the physician. The interference-fit area <NUM> should maintain the valve holder <NUM> in the docking aperture <NUM> during transportation, and also allow for the easy removal of the valve holder <NUM> in the operating room. Accordingly, the force required to move the valve holder <NUM> past the interference-fit area <NUM> should be from about <NUM> N to about <NUM> N. This interference force is set by the interference width, which is the difference between the shaft width W<NUM> and the slot width W<NUM> in the interference-fit area <NUM>. The interference width might, for example, have a tolerance range of about ±<NUM>. However, adjusting the interference width has been a challenge as a mere <NUM> to <NUM> change can significantly affect the force required to release the valve holder <NUM> from the clip <NUM>. As a result, current use of an interference fit between the clip <NUM> and the valve holder <NUM> has had mixed success. For example, some valve holders <NUM> have become dislodged from the clip <NUM> during shipping simulation, while other valve holders <NUM> have become stuck or difficult to remove from the clip <NUM>.

In one embodiment, the interference width can be in the range of about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, and about <NUM> or more. The interference width can also be in a range between and including any two of the foregoing values.

With continued reference to <FIG>, the present invention overcomes the challenges associated with the valve holder <NUM> becoming stuck or difficult to remove from the clip <NUM> as a result of the interference fit by incorporating a compliance feature <NUM> in the interreference-fit area <NUM>. With particular reference to <FIG>, the compliance feature <NUM> can comprise a cutout 154A, 154B adjacent to at least one of the opposing inner edges 136A, 136B such that the at least one of the opposing inner edges 136A, 136B defines a beam 156A, 156B within the interference-fit area <NUM>. In the example shown, the compliance feature <NUM> includes a cutout 154A, 154B adjacent 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 area <NUM>. The compliance feature <NUM> allows the beams 156A, 156B to deform (as illustrated by the phantom beam in <FIG>), which reduces the force needed to push the shaft <NUM> of the valve holder <NUM> past the interference-fit area <NUM>, and increases the tolerance range of the interference width for a given range of interference forces.

The shape of the cutout 154A, 154B and the beam 156A, 156B, as well as the average beam width W<NUM>, will depend on the application and the range of acceptable interference forces, as well as on the materials used to form the clip <NUM> and the valve holder <NUM>. In one embodiment, the clip <NUM> can comprise a molded polymer, such as a high-density polyethylene or an acetal resin or a polyoxymethylene, such as DELRIN® (manufactured by Dupont).

In some embodiments, the cutout 154A, 154B can be oblong, and can be symmetrical or asymmetrical. For example, the cutout 154A, 154B can have an elliptical, rectangular, rounded rectangular, or stadium shape. The beam 156A, 156B defined by each of the opposing inner edges 136A, 136B can be a fixed beam, a simply-supported beam, or a cantilevered beam. <FIG> illustrates a cutout 154A having a rounded rectangular-shape, adjacent to the inner edge 136A, such that the inner edge 136A defines a simply-supported beam 156A. <FIG> illustrates an alternative embodiment in which the cutout 154A further includes a portion that extends through the inner edge 136A to the slot <NUM> such that the inner edge 136A defines a cantilevered beam. In one embodiment, the beam 156A can have an average beam width W<NUM> from about <NUM> to about <NUM>.

The graph in <FIG> illustrates the impact that a compliance feature <NUM> can have on the relationship between the interference force and the interference width. As is shown, the slope for a clip having no compliance feature is steep; and the range Δ<NUM> between a minimum interference width Imin1 and a maximum interference width Imax1-to produce a desired range of acceptable forces between FLow and FHigh-is small. On the other hand, the compliance feature <NUM> reduces the slope and increases the range Δ<NUM> between the minimum interference width Imin2 and the maximum interference width Imax2-to produce the same desired range of acceptable forces between FLow and FHigh.

While the two exemplary curves in <FIG> are shown as lines, the relationship between the interference force and the interference width is not necessarily linear. Nevertheless, a line of best fit can be produced for a non-linear relationship, and the addition of a compliance feature <NUM> to the clip <NUM> will reduce the slope of this line and broaden the tolerance of the interference width needed to produce interference forces within a desired range.

With the bioprosthetic heart valve <NUM> secured to the valve holder <NUM> and with the valve holder <NUM> secured to the clip <NUM>, the sub-assembly <NUM> can be placed into a container for further processing, storage, and transportation. In some embodiments (not shown), the sub-assembly <NUM> can be used with a bioprosthetic heart valve <NUM> that is stored in a preservative solution, such as glutaraldehyde. For these cases, the sub-assembly <NUM> can be configured to fit closely within a fluid-tight shipping jar, which is filled with preserving solution and sealed with a suitable lid, as described, for example, by <CIT>. In other embodiments, the sub-assembly <NUM> can be used with a dehydrated or dry bioprosthetic heart valve <NUM> that is stored in dry packaging, as described, for example, by <CIT>.

For instance, with reference now to <FIG> and <FIG>, the bioprosthetic heart valve <NUM> and the engagement structure <NUM> of the valve holder <NUM> can be lowered into a cavity <NUM> of a storage tray <NUM>, and the clip <NUM> can sit on a stepped ledge <NUM> of the storage tray <NUM> such that the clip <NUM> caps the cavity <NUM> of the storage tray <NUM>. In one embodiment, the clip <NUM> can engage the storage tray <NUM> in a non-rotating matter, allowing the valve holder <NUM> to be held stationary in the storage tray <NUM> while a user couples a threaded handle to the threaded bore <NUM> of the valve holder <NUM>. The clip <NUM> is preferably formed to have a shape that corresponds with the shape of the storage tray <NUM> (or other container). Thus, while the clip <NUM> is depicted as an irregular hexagon, it should be understood that the clip <NUM> can be molded or otherwise formed to have a periphery that is round, square, rectangular, or any shape that is appropriate for a desired container. With the sub-assembly <NUM> in place within the storage tray <NUM>, a gas-permeable lid <NUM> having an outer band of adhesive (not shown) can be sealed over the upper surface <NUM> of the storage tray <NUM>.

With reference now to <FIG>, another embodiment of a clip <NUM> is provided that can be used with the valve holder <NUM> and storage tray <NUM> in a manner similar to the one depicted and described in relation to <FIG>, <FIG>, <FIG> and <FIG>. Similar to the embodiment of the clip <NUM> depicted in <FIG>, <FIG>, <FIG>, and <FIG>, the clip <NUM> can retain the shaft <NUM> of the valve holder <NUM> by way of an interference fit. The clip <NUM> can comprise a body <NUM> having an outer periphery <NUM> and opposing inner edges 336A, 336B. The body <NUM> can be substantially planar and the opposing inner edges 336A, 336B can define a passageway <NUM> in the body <NUM> for receiving the shaft <NUM> of the valve holder <NUM>. The passageway <NUM> can be open at a first end <NUM> of the body <NUM> and can extend along a longitudinal axis l of the body <NUM> from the first end <NUM> to a terminal docking end <NUM>. One or both of the terminal docking end <NUM> and the passageway <NUM> can also comprise a stepped ledge <NUM> onto which a first end <NUM> of the shaft <NUM> can rest. As depicted in <FIG>, a portion of the first end <NUM> of the shaft <NUM> protrudes radially outwardly of the shaft <NUM> such that it can rest on top of the stepped ledge <NUM>.

In one embodiment, the passageway <NUM> can include an interference-fit area <NUM> adjacent to the terminal docking end <NUM>. The interference-fit area <NUM> can be the same or similar to the one described in relation to <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> or can simply be a narrowed area. For example, a passageway width W<NUM> between the opposing inner edges 336A, 336B of the body <NUM> can decrease from the first end <NUM> of the body <NUM> to the interference-fit area <NUM>. In one embodiment, the passageway width W<NUM> of the interference-fit area <NUM> can be narrower than the valve holder's <NUM> shaft width W<NUM>. As such, when the shaft <NUM> of the valve holder <NUM> is pushed inward along the passageway <NUM> (as illustrated in <FIG>), the shaft <NUM> will push against the opposing inner edges 336A, 336B in the interference-fit area <NUM> before snapping into (or out of) the terminal docking end <NUM>. In one embodiment, the interference width, which is the difference between the shaft width W<NUM> and the passageway width W<NUM> of the interference-fit area <NUM> can be in the range of about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, or about <NUM> or more. The interference width can also be in a range including and within any two of the foregoing values.

The clip <NUM> can include a release mechanism which can increase the distance between the opposing inner edges 336A, 336B or increase the passageway width W<NUM> of the interference-fit area <NUM> to allow easy insertion and removal of the valve holder <NUM> into and from the terminal docking end <NUM>. The release mechanism can be effectuated by a pinch-to-release mechanism as depicted in <FIG>. The pinch-to-release mechanism can comprise one or more slots <NUM> having open ends disposed from a second end <NUM> of the body <NUM> and extending substantially towards the terminal docking end <NUM>. In the embodiment depicted in <FIG>, the first <NUM> and second <NUM> ends are opposing edges of the body <NUM> of the clip <NUM>. The two slots <NUM> can extend at an angle from the open ends <NUM> and towards the terminal docking end <NUM>. Thus, as depicted in <FIG>, where two slots are provided, the distance d<NUM> between open ends <NUM> of the slots <NUM> can be greater than the distance d<NUM> between the slot ends <NUM>.

The one or more slots <NUM> can have the same width or varying widths. While the embodiment in <FIG> depicts a pair of slots as having substantially the same width W<NUM>, it is understood that an embodiment can also comprise a single slot or two or more slots having the same or varying widths. The one or more slots <NUM> can be provided between a pair of holds <NUM> provided at the peripheral edges <NUM> of the body <NUM>. The peripheral edge <NUM> can extend between the first <NUM> and second <NUM> ends of the body <NUM> in a straight line or in a curved and contoured shape as depicted in <FIG>. The holds <NUM> can be pinched together to decrease the widths W<NUM> of the one or more slots <NUM> (see <FIG>) which, in turn, can increase the passageway width W<NUM> to facilitate easy insertion and removal of the valve holder's shaft <NUM> into and out of the terminal docking end <NUM> with less force. The widths W<NUM> of the one or more slots <NUM> may be decreased more substantially at the open ends <NUM> than at the area near the slot ends <NUM> when the holds <NUM> are compressed together. Once the holds <NUM> are pinched together, the force required to slidably move the valve holder <NUM> from the terminal docking end <NUM> and through passageway <NUM> to remove it from the clip <NUM> 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 <NUM> can provide for a more secure fixation of the valve holder <NUM> and a larger dimensional tolerance.

Again, the interference-fit area <NUM> is provided to maintain the valve holder <NUM> within the terminal docking end <NUM> during processing, storage, and shipment-until the valve holder <NUM> is deliberately removed by the physician. The interference-fit area <NUM> should maintain the valve holder <NUM> in the terminal docking end <NUM> during transportation, and also allow for the easy removal of the valve holder <NUM> in the operating theater. The interference-fit area may be provided in a manner depicted and described with reference to <FIG>.

With reference now to <FIG>, yet a further embodiment of a clip <NUM> is provided that can be used with the valve holder <NUM> and storage tray <NUM> in a manner similar to the ones depicted and described in relation to <FIG>, <FIG>, <FIG>, and <FIG>. Similar to the embodiment of the clip <NUM> depicted in <FIG>, the clip <NUM> can retain the shaft <NUM> of the valve holder <NUM> by way of an interference fit. The clip <NUM> can comprise a body <NUM> having an outer periphery <NUM> and opposing inner edges 536A, 536B. The body <NUM> can be substantially planar and the opposing inner edges 536A, 536B can define a passageway <NUM> in the body <NUM> for receiving the shaft <NUM> of the valve holder <NUM>. The passageway <NUM> can be open at a first end <NUM> of the body <NUM> and can extend along a longitudinal axis l of the body <NUM> from the first end <NUM> to a terminal docking end <NUM>. One or both of the terminal docking end <NUM> and the passageway <NUM> can also comprise a stepped ledge <NUM> onto which a first end <NUM> of the shaft <NUM> can rest. As depicted in <FIG>, a portion of the first end <NUM> of the shaft <NUM> protrudes radially outwardly of the shaft <NUM> such that it can rest on top of the stepped ledge <NUM>.

In one embodiment, the passageway <NUM> can include an interference-fit area <NUM> adjacent to the terminal docking end <NUM>. The interference-fit area <NUM> can be the same or similar to the one described in relation to <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> or can simply be a narrowed area. For example, a passageway width W<NUM> between the opposing inner edges 536A, 536B of the body <NUM> can decrease from the first end <NUM> of the body <NUM> to the interference-fit area <NUM>. In one embodiment, the passageway width W<NUM> in the interference-fit area <NUM> can be narrower than the valve holder's <NUM> shaft width W<NUM>. As such, when the shaft <NUM> of the valve holder <NUM> is pushed inwardly along the passageway <NUM> (as illustrated in <FIG>), the shaft <NUM> will push against the opposing inner edges 536A, 536B in the interference-fit area <NUM> before snapping into (or out of) the terminal docking end <NUM>. In one embodiment, the interference width, which is the difference between the shaft width W<NUM> and the passageway width W<NUM> of the interference-fit area <NUM> can be in the range of about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, about <NUM> or more, or about <NUM> or more. The interference width can also be in a range including and within any two of the foregoing values.

The clip <NUM> can include a release mechanism which can increase the distance between opposing inner edges 536A, 536B to allow easy insertion and removal of the valve holder <NUM> into and from the terminal docking end <NUM>. The release mechanism can be effectuated by a pinch-to-release mechanism similar to the one depicted in <FIG>. Similar to the embodiment depicted in <FIG>, the pinch-to-release mechanism can comprise one or more slots <NUM> having open ends disposed from a second end <NUM> of the body <NUM> and extending substantially towards the terminal docking end <NUM>. Furthermore, similar to the embodiment depicted in <FIG>, the first <NUM> and second <NUM> ends are opposing edges of the body <NUM> of the clip <NUM>. The two slots <NUM> can extend at an angle from the open ends <NUM> and towards the terminal docking end <NUM>. Thus, similar to the embodiment depicted in <FIG>, where two slots are provided, the distance d<NUM> between open ends <NUM> of the slots <NUM> can be greater than the distance d<NUM> between the slot ends <NUM>.

The one or more slots <NUM> can have the same width or varying widths. While the embodiment in <FIG> depicts a pair of slots as having substantially the same width W<NUM>, it is understood that an embodiment can also comprise a single slot or two or more slots having the same or varying widths. The one or more slots <NUM> can be provided between a pair of holds <NUM> provided on the body <NUM>. The holds <NUM> can be a protrusion from the body <NUM> that allows a finger grip to compress the holds <NUM> together to decrease the widths W<NUM> of the one or more slots <NUM> and increase the passageway width W<NUM>,which facilitates easy insertion and removal of the valve holder's shaft <NUM> into and out of the terminal docking end <NUM> with less force in a manner similar to the embodiment depicted in <FIG>. Alternatively, the holds <NUM> can also simply be the peripheral edge <NUM> that extends between the first <NUM> and second <NUM> ends. Once the holds <NUM> are pinched together, the force required to slidably move the valve holder <NUM> from the terminal docking end <NUM> and through passageway <NUM> to remove it from the clip <NUM> 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 <NUM> can provide for a more secure fixation of the valve holder <NUM> and a larger dimensional tolerance.

As with the embodiment of the clip depicted in <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>, the clip <NUM> can further include a plurality of openings <NUM> disposed within the body <NUM> to further decrease the force required to slidably move the valve holder <NUM> from the terminal docking end <NUM> and through passageway <NUM> to remove it from the clip <NUM>. The plurality of openings <NUM> can be formed in any number of shapes (e.g. circular, oval, ovaline, rectilinear) and can be arranged in a variety of ways. In the embodiment depicted in <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG> and <FIG>, the plurality of openings is arranged around the terminal docking end <NUM>. In alternative embodiments, the plurality of openings <NUM> can be arranged on one or both sides of the terminal docking end <NUM>.

Again, the interference-fit area <NUM> is provided to maintain the valve holder <NUM> within the terminal docking end <NUM> during processing, storage, and shipment-until the valve holder <NUM> is deliberately removed by the physician. The interference-fit area <NUM> should maintain the valve holder <NUM> in the terminal docking end <NUM> during transportation, and also allow for the easy removal of the valve holder <NUM> in the operating theater. The interference-fit area may be provided in a manner depicted and described with reference to <FIG> and <FIG>.

In accordance with another exemplary embodiment, a clip that can retain or secure a valve holder without requiring an interference fit is provided. With reference now to <FIG>, the clip <NUM> can comprise a body <NUM> having an outer periphery <NUM> and opposing inner edges 436A, 436B. The body <NUM> can be substantially planar and the opposing inner edges 436A, 436B can define a passageway <NUM> in the body <NUM> for receiving the shaft <NUM> of the valve holder <NUM>. The passageway <NUM> can be open at a first end <NUM> of the body <NUM> and can extend along a longitudinal axis l of the body <NUM> from the first end <NUM> to a terminal docking end <NUM>. One or both of the terminal docking end <NUM> and the passageway <NUM> can optionally also comprise a stepped ledge <NUM>, as depicted in <FIG>, onto which a first end <NUM> of the shaft <NUM> can rest. As depicted in <FIG>, a portion of the first end <NUM> of the shaft <NUM> protrudes radially outwardly of the shaft <NUM>.

The clip <NUM> can further comprise a flap <NUM> that is coupled to the body <NUM>. The flap <NUM> can be actuated between an open position (<FIG>, <FIG>, <FIG> and <FIG>) and a closed position (<FIG>) via a hinge <NUM>. In the open position depicted in <FIG>, <FIG>, <FIG> and <FIG>, the shaft <NUM> of the valve holder <NUM> can freely slide in the passageway <NUM> and be positioned in the terminal docking end <NUM> of the body <NUM>. Once positioned at the terminal docking end <NUM>, the flap <NUM> can be actuated in the closed position, as depicted in <FIG> to secure the valve holder within the clip <NUM>.

The flap <NUM> can be sized and shaped to cover or block at least a portion of the passageway <NUM> so as to secure the shaft <NUM> of the valve holder <NUM> at the terminal docking end <NUM> and prevent the shaft <NUM> from sliding out of the terminal docking end <NUM>. In accordance with one aspect of the embodiment, the flap <NUM> can be sized to rest on top of the stepped ledge <NUM> shown in <FIG> to prevent it ffrom over rotating or falling below the body <NUM>. As depicted in the exemplary embodiment in <FIG>, the flap <NUM> can be shaped to include a stepped-in portion <NUM> covering a portion of the passageway <NUM> and a stepped-out portion <NUM> that conforms to at least a portion of the outer periphery <NUM>. While the hinge depicted in <FIG> is a living hinge <NUM>, it is understood that the flap <NUM> can be coupled to the body <NUM> in any other way that permits the flap <NUM> to actuate between the open (<FIG>, <FIG> and <FIG>) and closed (<FIG>) positions. The flap <NUM> can further comprise a protrusion <NUM> to allow grasping to open and close the flap <NUM>.

In accordance with one aspect of this embodiment, the shaft <NUM> of the valve holder <NUM> can be retained within the terminal docking end without requiring an interference fit. In other words, the widths of either or both of the terminal docking end <NUM> and the passageway <NUM> need not be less than the valve holder's <NUM> shaft width W<NUM>. In one embodiment, the widths of one or both of the passageway <NUM> or terminal docking end <NUM> is roughly equal to or slightly greater than the width of the shaft <NUM> of the valve holder <NUM>. As such, minimal to no force would be required move the valve holder <NUM> through the passageway <NUM> and into or out of the terminal docking end <NUM>. The force required to move the valve holder <NUM> through the passageway <NUM> and into the terminal docking end <NUM> can be 5N or less, 4N or less, 3N or less, 2N or less, or 1N or less.

It should be appreciated from the foregoing description that the present invention provides an improved packaging assembly that provides an interference force within a desired range over a larger range of interference widths, thereby securely maintaining a bioprosthetic heart valve within the packaging system, while also allowing easy removal of the heart valve from the packaging system without damage or contamination.

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 embodiment. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art to which this embodiment belongs.

The terms "a," "an," and "at least one" encompass one or more of the specified element. That is, if two of a particular element are present, one of these elements is also present and thus "an" element is present. The terms "a plurality of" and "plural" mean two or more of the specified element. The term "or" used between the last two of a list of elements means any one or more of the listed elements. For example, the phrase "A, B, or C" means "A, B, and/or C," which means "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 absent specific contrary language.

Claim 1:
A packaging assembly (<NUM>) for storing a bioprosthetic heart valve (<NUM>), the packaging assembly (<NUM>) comprising:
a sub-assembly (<NUM>) comprising a valve holder (<NUM>) configured to hold the bioprosthetic heart valve (<NUM>), and a clip (<NUM>) configured to receive a shaft (<NUM>) of the valve holder (<NUM>), the shaft (<NUM>) having a shaft width, wherein the clip (<NUM>) comprises:
a body (<NUM>) having an outer periphery (<NUM>) and opposing inner edges (136A, 136B), the opposing inner edges (136A, 136B) defining a slot (<NUM>) in the body (<NUM>) for receiving the shaft (<NUM>) of the valve holder (<NUM>), wherein the slot (<NUM>) is open at a first end (<NUM>) of the body (<NUM>) and extends, along a longitudinal axis (I) of the body (<NUM>), from the first end (<NUM>) to a docking aperture (<NUM>); and
a compliance feature (<NUM>) in an interference-fit area (<NUM>) of the slot (<NUM>) adjacent to the docking aperture (<NUM>);
wherein a slot width (W<NUM>) between the opposing inner edges (136A, 136B) of the body in the interference-fit area (<NUM>) is less than the shaft width, and
wherein the compliance feature (<NUM>) comprises 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 area (<NUM>), characterized in that the compliance feature (<NUM>) allows the beam to deform so that the force needed to push the shaft (<NUM>) of the valve holder (<NUM>) past the interference-fit area (<NUM>) is reduced.