阅读说明：本技术 用于包装和制备假体心脏瓣膜和相关联的递送系统的方法和系统 (Methods and systems for packaging and making prosthetic heart valves and associated delivery systems ) 是由 V·P·罗杰帕罗 D·S·帕特尔 M·R·比亚拉斯 B·R·劳里 R·亨顿 A·T·畅 于 2016-08-31 设计创作，主要内容包括：本发明名称为用于包装和制备假体心脏瓣膜和相关联的递送系统的方法和系统。用于在非流体环境中存储假体瓣膜和细长的递送系统的包装系统。包装系统包含用于固定假体瓣膜和细长的递送系统两者的托盘。托盘包括空腔,所述空腔的大小和形状设成以容纳含有假体瓣膜的瓣膜罩和细长的递送系统的远侧部的至少部分。安装表面将瓣膜罩可拆卸地偶接到空腔底板并防止瓣膜罩移动。接合表面安置在空腔的周边并升高到空腔底板上方。斜坡从接合表面向下延伸并通过限定在周边侧壁中和邻近空腔的底板的开口进入空腔。接合表面和斜坡配置成将细长的递送系统的至少部分固定在空腔的外部。(The invention provides methods and systems for packaging and making prosthetic heart valves and associated delivery systems. A packaging system for storing a prosthetic valve and an elongate delivery system in a non-fluid environment. The packaging system includes a tray for securing both the prosthetic valve and the elongate delivery system. The tray includes a cavity sized and shaped to receive a valve cover containing the prosthetic valve and at least a portion of the distal portion of the elongate delivery system. The mounting surface removably couples the valve cover to the cavity floor and prevents the valve cover from moving. The engagement surface is disposed at the periphery of the cavity and is elevated above the cavity floor. The ramp extends downwardly from the engagement surface and into the cavity through an opening defined in the peripheral sidewall and adjacent the floor of the cavity. The engagement surface and the ramp are configured to secure at least a portion of the elongate delivery system outside of the cavity.)

1. A packaging system for storing a prosthetic valve and an elongate delivery system in a non-fluid environment, the packaging system comprising:

a tray for securing both a prosthetic valve and an elongate delivery system, the prosthetic valve being maintained in a compressed state about a distal portion of the elongate delivery system by a valve cover coupled to the prosthetic valve, the tray comprising:

a cavity comprising an open end, a floor, and a peripheral sidewall defining a depth of the cavity, the cavity being sized and shaped to receive the valve cover and the prosthetic valve;

a mounting surface removably coupling the valve cover to the cavity floor;

an engagement surface at the periphery of the cavity and elevated above the cavity floor; and

a ramp extending downwardly from the engagement surface and into the cavity through an opening defined in the peripheral sidewall and the floor adjacent the cavity;

wherein the engagement surface and the ramp are configured to secure at least a portion of the elongate delivery system outside of the cavity.

2. The packaging system of claim 1, wherein the prosthetic valve comprises a stent and a plurality of leaflets coupled to the stent, the plurality of leaflets comprising biological tissue.

3. The packaging system of any one of the preceding claims, wherein the engagement surface comprises a channel formed in the tray and shaped to receive the elongate delivery system, and wherein the channel comprises a protrusion to resiliently engage the elongate delivery system within the channel.

4. The packaging system of any one of the preceding claims, wherein the ramp slopes downwardly from the engagement surface to the floor of the cavity.

5. The packaging system of claim 4, wherein the ramp is provided at an angle of about 4 degrees to about 10 degrees relative to a horizontal plane bisecting the tray.

6. The packaging system of any one of the preceding claims, further comprising a lock configured to be removably coupled to one or both of the valve cover and the distal portion of the elongate delivery system.

7. The packaging system of claim 6, further comprising:

a cover removably coupled to the tray and partially closing the open end of the cavity, the cover defining an opening to the cavity.

8. The packaging system of claim 7, wherein the lock comprises a first end and a second end, wherein the first end is removably coupled to one or both of the valve cover and the distal portion of the elongate delivery system.

9. The packaging system of claim 8, wherein the second end is configured to protrude outside of the cavity through an aperture disposed on the lid, the second end being sized and shaped to prevent passage through the aperture.

10. The packaging system of claim 8, wherein the second end is secured to or integrated with the lid.

Technical Field

The present invention relates to packaging for medical devices and, more particularly, to methods and systems for packaging and making prosthetic valves and their associated delivery systems.

Background

There are at least two options for replacing a diseased heart valve: surgical valve replacement, including open heart surgery and minimally invasive valve surgery, and transcatheter heart valve replacement. For some high risk patients, surgical valve replacement may not be appropriate due to its invasive nature, and transcatheter heart valve replacement may be a viable alternative for these patients. Transcatheter heart valve replacement is less invasive and allows the replacement heart valve to be delivered through the patient's vasculature, typically through the femoral artery.

There is a strong incentive for efficiency in the operating room as reducing the operating room time reduces the amount of time the patient is under anesthesia and the overall cost to the doctor or hospital. However, preparing replacement heart valves and their associated delivery systems can be complex and time consuming. The steps of deploying a heart valve on its delivery system for implantation must be performed accurately and in a specific sequence. Any deviation from the prescribed procedure may damage the replacement heart valve or impair the inherent function of its associated delivery device. Furthermore, because the procedure typically requires the involvement of multiple operating room caregivers and physicians in non-sterile and sterile fields, there is always the possibility of human error or error.

Disclosure of Invention

The packaging systems disclosed herein provide a platform for compact storage and transport of replacement heart valves and their associated delivery systems. The packaging system also provides for the handling, preparation, and assembly of replacement heart valves and their associated delivery systems in an operating room. The packaging system described herein provides a combination of features that facilitate this process in an efficient manner by reducing the number of operating room personnel and steps required to prepare and assemble a replacement heart valve onto its delivery system, and also by ensuring that the steps are performed in the required order. The features of the packaging system also advantageously allow the prosthetic valve and associated delivery system to be secured in a compact configuration, allowing the overall size (dimensions) of the packaging system to be reduced.

It should be understood that the packaging systems disclosed herein are applicable not only to the prosthetic valves and delivery systems specifically disclosed herein, but also to other prosthetic valves and delivery systems, such as those disclosed in U.S. publication No. 2010/0049313, published on 25/2 2010, U.S. publication No. 2012/0239142, published on 20/9/2012, and U.S. publication No. 2014/0343670, published on 20/11/2014; the entire contents of each of the above-mentioned patents are incorporated herein by reference.

A packaging system for storing a prosthetic valve and an elongate delivery system in a non-fluid environment is provided. The packaging system can include a tray that can secure both the prosthetic valve and the elongate delivery system. The prosthetic valve may be maintained in a compressed state around the distal portion of the elongate delivery system by a valve cover (valve cover) coupled to the prosthetic valve.

The tray may include a cavity having an open end, a floor, and a peripheral sidewall defining a depth of the cavity. The cavity may be sized and shaped to receive a valve cover and a prosthetic valve. The tray may also include an engagement surface peripheral to the cavity and elevated above the cavity floor.

A mounting surface may be provided that removably couples the valve cover to the cavity floor.

The tray may include a ramp extending downwardly from the engagement surface and into the cavity through an opening defined in the peripheral sidewall and adjacent the floor of the cavity.

The engagement surface and the ramp may be configured to secure at least a portion of the elongate delivery system outside of the cavity.

In an alternative embodiment, a prosthetic valve can comprise a stent and a plurality of leaflets coupled to the stent, the plurality of leaflets comprising biological tissue.

In another alternative embodiment, the engagement surface may comprise a channel formed in the tray and shaped to receive the elongated delivery system. The channel may contain a tab to resiliently engage the elongate delivery system within the channel.

In a further alternative embodiment, the ramp may slope downwardly from the engagement surface to the floor of the cavity. The ramp may be provided at an angle of about 4 degrees to about 10 degrees relative to the horizontal plane of the bisecting (bisecting) tray.

In yet another alternative embodiment, the packaging system can include a lock configured to be removably coupled to one or both of the valve cover and the distal portion of the elongate delivery system. The packaging system can further comprise a lid removably coupled to the tray and partially closing the open end of the cavity. The cap may further define an opening to the cavity through which fluid may be injected into the cavity. The locking member may include a first end and a second end. The first end of the lock can be removably coupled to one or both of the valve cover and the distal portion of the elongate delivery system. The second end may be configured to protrude outside the cavity through an aperture disposed on the cover. The second end may be sized and shaped to prevent passage through the aperture. Alternatively, the second end may be fixed to or integral with the cover. In any of the foregoing embodiments, removing the cap can also remove the first end of the locking element from one or both of the valve cover and the elongate delivery system.

In yet a further alternative embodiment, the valve cover may comprise an inner cavity. The internal cavity can be sized and dimensioned to receive the nose piece, the prosthetic valve, and a portion of the distal portion of the elongate delivery system. A lock can be provided that is removably coupled to both the valve cover and the distal portion of the elongate delivery system. The first end of the lock may be positioned to maintain separation between the nose piece and the prosthetic valve.

In another alternative embodiment, the valve cover may include wings extending laterally from opposite sides of the valve cover. The wing portion may be configured to couple to a mounting surface disposed from the cavity floor. The mounting surface may be one of a pair of protrusions or a pair of recesses configured to mate with corresponding features of the wing. The corresponding part of the wing may be the other of the pair of projections or the pair of recesses. The wings and mounting surface may engage in a resilient snap-fit (snap-fit).

In a further alternative embodiment, the cavity may further comprise a fill line disposed from a peripheral sidewall of the cavity between the floor and the open end.

In yet another alternative embodiment, the free section of the elongated delivery system may be provided outside of the cavity and not in direct physical contact with the tray. Space may be provided around the free section to allow a user's hand to grasp the free section and lift at least a portion of the elongated delivery system on both sides of the free section out of engagement with the tray.

In yet a further alternative embodiment, the proximal end of the elongated delivery device may be engaged within the perimeter of the tray. The tray can include a support surface for maintaining the proximal end of the elongate delivery system in a position coupling the proximal end to the handle when the proximal end is disengaged from and extends outwardly from the perimeter of the tray.

In yet a further alternative embodiment, the mounting surface may resiliently engage at least a portion of the valve cover. The valve cover may include a flared open end, an opposite fixed end, and a locking ring slidably mounted around the fixed end between a locked position and an unlocked position. In the locked position, the locking ring may apply a radially inward force around the secured end of the valve cover to secure the valve cover to the delivery system. In the unlocked position, the radially inward force applied by the locking ring may be released to allow removal of the delivery device from the valve cover. The locking ring may be received within a spaced area of the mounting surface to allow the locking ring to slide between a locked position and an unlocked position.

In yet a further alternative embodiment, the lid may completely enclose the upper surface of the tray.

In yet further alternative embodiments, the packaging system may further comprise a handle attached to the delivery system and packaged within the tray.

Methods for preparing a prosthetic valve and its associated delivery system for implanting the prosthetic valve in a patient are also provided. The method may comprise any one or a combination of steps (a) to (e) as described below.

Step (a) can include obtaining a tray containing a prosthetic valve in a first compressed state and coupled to an elongate delivery system.

In an alternative embodiment, the tray may include a cavity comprising an open end, a floor, and a peripheral sidewall defining a depth of the cavity. The cavity can be sized and shaped to receive the prosthetic valve and at least a portion of the distal portion of the elongate delivery system. A mounting surface can be provided to substantially secure and maintain the prosthetic valve within the cavity. The tray may further comprise an engagement surface at the periphery of the cavity that secures at least a portion of the elongated delivery system outside of the cavity. According to one aspect of this embodiment, the cavity does not contain a liquid or preservative solution.

Step (b) may include at least partially filling the cavity with a first moisturizing fluid to completely submerge the prosthetic valve.

Step (c) may include soaking the prosthetic valve in a first moisturizing fluid for a period of time. In one embodiment, the period of time may be at least 5 minutes, at least 10 minutes, at least 15 minutes, at least 20 minutes, at least 25 minutes, or at least 30 minutes.

Step (d) can include flushing the elongate delivery system by delivering the second moisturizing fluid into the proximal end of the elongate delivery system and passing the second moisturizing fluid through a lumen extending through the elongate delivery system and out of the distal portion of the elongate delivery system.

Step (e) can include loading the prosthetic valve into a lumen of a delivery sheath associated with the elongate delivery system while the prosthetic valve is coupled to the cavity floor via the mounting surface. The loading may be performed by axially moving the delivery sheath over the prosthetic valve. The delivery sheath can compress and contain the prosthetic valve in the second compressed state within a lumen of the delivery sheath. The diameter of the prosthetic valve in the first compressed state can be greater than the diameter of the prosthetic valve in the second compressed state.

Step (f) can include removing the elongate delivery device from the tray, wherein the prosthetic valve is loaded into the lumen of the delivery sheath, including disengaging the prosthetic valve from the mounting surface.

In an alternative embodiment, steps (a) through (e) can be performed while the prosthetic valve is substantially fixed and maintained within the cavity.

The method may further comprise after (a) and before (d) coupling a handle to a proximal end of the elongate delivery system.

Methods for preparing a prosthetic valve and its associated delivery system for implanting the prosthetic valve in a patient are also provided. The method may comprise any one or a combination of steps (a) to (e) as described below.

Step (a) can comprise obtaining a tray comprising a prosthetic valve in a first compressed state and coupled to an elongate delivery system.

In an alternative embodiment, the tray may include a cavity comprising an open end, a floor, and a peripheral sidewall defining a depth of the cavity. The cavity can be sized and shaped to receive a valve cover containing a prosthetic valve and at least a portion of a distal portion of an elongate delivery system. A mounting surface can be provided to substantially secure and maintain a valve cover coupled to a distal end of the elongate delivery system and the prosthetic valve within the cavity. An adjacent container may be provided in fluid communication with the cavity. According to one aspect of this embodiment, the cavity does not contain a liquid or preservative solution.

Step (b) can comprise at least partially filling the cavity with the first moisturizing fluid until the first moisturizing fluid overflows into an adjacent container.

Step (c) may comprise flushing the elongate delivery system by delivering the second hydrating fluid through the first lumen extending through the elongate delivery system lumen.

Step (d) can include loading the prosthetic valve into a lumen of a delivery sheath associated with the elongate delivery system while the valve cover is coupled to the mounting surface. During loading, the delivery sheath can compress and contain the prosthetic valve in the second compressed state within a lumen of the delivery sheath. The diameter of the prosthetic valve in the first compressed state can be greater than the diameter of the prosthetic valve in the second compressed state.

Step (e) may comprise flushing the elongate delivery system by delivering a third hydrating fluid through a second lumen extending through the elongate delivery system.

Step (f) may comprise removing the elongate delivery device from the valve cover and the tray, wherein the prosthetic valve is loaded into the lumen of the delivery sheath.

Steps (a) through (e) may be performed while the valve cover is substantially fixed and maintained within the cavity.

Other objects, features and advantages of the preferred embodiments will become apparent to those skilled in the art from the following detailed description. It should be understood, however, that the detailed description and the specific examples, while indicating preferred embodiments of the present invention, are given by way of illustration and not limitation. Many changes and modifications may be made within the scope of the present invention without departing from the spirit thereof, and the invention includes all such modifications.

Drawings

Preferred and non-limiting embodiments of the present invention may be more readily understood by reference to the accompanying drawings, in which:

FIG. 1 is an exploded perspective view of an embodiment of a packaging system for storage and transport that includes a prosthetic valve and its associated delivery system;

FIG. 2 is a perspective view of the assembled packaging system, prosthetic valve, and associated delivery system of FIG. 1;

FIG. 3 is a top view of the packaging system, prosthetic valve, and associated delivery system of FIG. 1;

FIG. 4 is a front view of side 4-4 of the packaging system, prosthetic valve, and associated delivery system of FIG. 3;

FIG. 5 is a front view of side 5-5 of the packaging system, prosthetic valve, and associated delivery system of FIG. 3;

FIG. 6 is a cross-sectional view of the packaging system, prosthetic valve, and associated delivery system of FIG. 3 taken along 6-6;

FIG. 7 is a perspective view of a prosthetic valve that may be used to replace a native aortic valve of the heart;

fig. 8A and 8B depict actuation of the delivery sheath from an unloaded configuration to a loaded configuration, respectively. In the loaded configuration, the heart valve is contained within the delivery sheath;

fig. 9 depicts a distal portion of a delivery system including a heart valve, a valve cover, and a lock in an assembled configuration;

FIG. 10 is an exploded perspective view of the valve cover and valve lock;

11A-11I depict a sequence of steps performed in preparing a heart valve for implantation and its associated delivery device using an exemplary embodiment of the packaging system;

FIG. 12 is an exploded perspective view of another embodiment of a packaging system comprising, from bottom to top, a tray, a prosthetic valve delivery system, and a cover;

FIG. 13 is a perspective view of the packaging system with the tray, prosthetic valve delivery system, and cover of FIG. 12 assembled together for storage and transport;

FIG. 14A is a top view of the assembled packaging system of FIG. 13;

FIG. 14B is a top view of the packaging system of the assembled packaging system of FIG. 13 without the lid;

FIG. 15 is an elevation view of side 15-15 of the assembled packaging system of FIG. 14A;

FIG. 16 is an elevation view of side 16-16 of the assembled packaging system of FIG. 14A;

FIG. 17 is an elevation view of side 17-17 of the assembled packaging system of FIG. 14A;

FIG. 18 is an elevation view of side 18-18 of the assembled packaging system of FIG. 14A;

FIG. 19 is an elevation view of side 19-19 of the assembled packaging system of FIG. 14B.

Like reference numerals refer to like parts throughout the several views of the drawings.

Detailed Description

Specific, non-limiting embodiments of the present invention will now be described with reference to the accompanying drawings. It should be understood that such embodiments are by way of example only and are merely illustrative of but a few of the embodiments within the scope of the present invention. Various changes and modifications apparent to those skilled in the art to which the invention pertains are deemed to be within the spirit, scope and contemplation of the invention as further defined in the appended claims.

Fig. 1-6 illustrate an embodiment of a packaging system 1 containing a prosthetic valve 10 and its associated delivery system 400 (both packaged within a tray 100). Specific details of exemplary delivery systems that may be used in conjunction with the packaging system 1 disclosed herein may include, for example, U.S. publication No. 2010/0049313 filed on 23/4/2009; U.S. publication No. 2012/0239142 filed on 24/2/2012; and those described in U.S. publication No. 2014/0343670 filed 5/20/2014. Each of these references is incorporated herein in its entirety as if fully set forth herein. Of course, it should be understood that other heart valves and delivery systems may be used with the packaging systems described herein.

Fig. 7 depicts an exemplary prosthetic valve 10 having an inflow end 16 and an outflow end 18. The prosthetic valve 10 can include an expandable frame member or stent 12 that supports flexible leaflet portions 14. The flexible leaflet portion 14 may contain biological tissue such as pericardium, epidermis, blood vessels, skin, dura, small intestinal mucosa, tissue heart valves, ligaments, and tendons. In one embodiment, the aforementioned biological tissue may be derived from animal sources, such as from bovine, equine, porcine, and kangaroo species. In another embodiment, the aforementioned biological tissue may be derived from autologous or allogeneic human sources. Biological tissue may be chemically or mechanically treated so that it does not need to be submerged in a liquid preservative solution for storage and transport. Exemplary methods for treating biological tissue are described in U.S. patent No. 7,972,376 and U.S. patent No. 8,007,992, which are incorporated by reference herein in their entirety. As noted above, it should be understood that other heart valves and delivery systems may be used with the packaging systems described herein.

In one embodiment, the prosthetic valve 10 used in conjunction with the various embodiments of the packaging systems described herein comprises leaflets 14, the leaflets 14 comprising biological tissue and having been at least partially dried or dehydrated to allow storage of the prosthetic valve 10 without immersion in a liquid or preservative solution. According to one aspect of this embodiment, the biological tissue leaflet 14 can be chemically or mechanically treated so as to reduce the water content of about 50 wt.% or less, 25 wt.% or less, 10 wt.% or less, 5 wt.% or less, 2 wt.% or less, 1 wt.% or less, 0.5 wt.% or less, 0.25 wt.% or less, or 0.10 wt.% or less of the total weight of the biological tissue leaflet 14. Additionally, the moisture content of the biological tissue leaflet 14 can be between and including any two of the foregoing values. The biological tissue leaflets 14 can comprise interstices within the tissue structure in which at least a portion of the water has been replaced with a different substance, such as a polyol, or more specifically, ethanol or glycerol. According to another aspect of this embodiment, the biological tissue leaflets 14 can be completely dried or dehydrated, wherein the moisture content present in the tissue does not exceed an amount due to the humidity of the surrounding environment.

The prosthetic valve 10 may be deployed in the native aortic annulus, although it may also be used to replace the heart or other native valves in the body, such as venous valves. Thus, it should be understood that the prosthetic valve 10 may be a prosthetic heart valve, a prosthetic venous valve, or other valve that may be implanted within a body lumen. The prosthetic valve 10 is radially compressible to a compressed state of smaller diameter for delivery through the body's vasculature and to a deployment site. As shown in fig. 7, once the prosthetic valve 10 reaches its deployment site, it can expand to its functional size.

In certain embodiments, the prosthetic valve 10 can be self-expanding; that is, the prosthetic valve 10 can radially expand to its functional size when advanced from the distal portion 410 of the delivery system 400. In other embodiments, the prosthetic valve 10 can be balloon expandable and can be adapted to be mounted in a compressed state on a balloon of the elongate delivery system 400. The prosthetic valve 10 can be expanded to its functional size at the deployment site by inflating a balloon (which in turn expands the prosthetic valve 10 as is known in the art). In still other embodiments, the prosthetic valve 10 can be mechanically expandable, relying neither on self-expansion nor on a balloon to expand the valve to its functional size.

An exemplary delivery system 400 that can be stored in the tray 100 with the prosthetic valve 10 is depicted in fig. 8A and 8B. The delivery system 400 can include a distal portion 410 on which the prosthetic valve 10 is mounted and a proximal portion 420 to which the handle 80 is attached.

The distal portion 410 of the delivery system 400 may include a nose piece 412 secured to the distal portion 410 of the shaft. The nose piece 412 may be shaped as a cone with a tapered outer surface for atraumatic tracking through the patient's vasculature. The shaft extends from the nose piece 412 through the prosthetic valve 10 and coaxially through the main catheter 418. The main catheter 418 has a distal end coupled to the delivery sheath 416, and the delivery sheath 416 is axially movable in either of a distal direction and a proximal direction. It should be understood that the distal direction corresponds to a direction toward the nose piece 412 or away from the proximal portion 420 of the delivery catheter, and the proximal direction corresponds to a direction away from the nose piece 412 or toward the proximal portion 420 of the delivery system 400. The shaft may optionally contain a guidewire (not shown) so that the delivery system 400 can be advanced over the guidewire inside the vasculature of a patient.

The proximal portion 420 of the delivery system 400 may be attached to the handle 80. As shown in fig. 8B, the handle 80 may have a motor for operating the delivery device by depressing a button and for driving the delivery sheath 416 to move axially in the distal and proximal directions. As shown in fig. 8B, when the delivery sheath 416 is actuated to move in the distal direction, it compresses and contains the prosthetic valve 10 within the delivery sheath 416. As shown in fig. 8A, when the delivery sheath 416 is actuated to move in a proximal direction, it will expose the prosthetic valve 10 from the delivery sheath 416 and allow it to assume an expanded configuration for implantation. The handle 80 may be provided separately from the packaging system 1.

Returning now to fig. 1-6, the tray 100 can store and transport the prosthetic valve 10 coupled to the delivery system 400. In one embodiment, the prosthetic valve 10 can be mounted around a portion of the shaft, substantially between the delivery sheath 416 and the nose piece 412. One end of the prosthetic valve 10 can be compressed and contained within the delivery sheath 416, and the remainder of the prosthetic valve 10 can be provided outside of the delivery sheath 416 and extend distally from the delivery sheath 416.

Compressing and containing one end of the prosthetic valve 10 within the delivery sheath 416 facilitates loading of the prosthetic valve 10 within the delivery sheath 416. In one embodiment, a portion of the inflow end 14 is compressed and contained within the delivery sheath 416, and the outflow end extends distally from the delivery sheath 416. In another embodiment, a portion of the outflow end 16 is compressed and contained within the delivery sheath 416, and the inflow end extends distally from the delivery sheath 416.

Loading of the prosthetic valve 10 within the delivery sheath 416 can be accomplished in a variety of ways. In one embodiment, the prosthetic valve 10 is loaded within the delivery sheath 416 by moving the prosthetic valve 10 in a proximal direction. In another embodiment, the prosthetic valve 10 is loaded within the delivery sheath 416 by moving the delivery sheath 416 in a distal direction.

As shown in fig. 1-6, the entire prosthetic valve 10 and its associated delivery system 400 can be secured and housed within the tray 100. The prosthetic valve 10 can be maintained in a compressed state around the distal portion 410 of the delivery system 400 by a valve cover 600 coupled to the prosthetic valve 10. As shown in fig. 9 and 10, the lock 300 can be secured to the valve cover 600 to protect the prosthetic valve 10 from damage caused by movement along the delivery system 400. In one embodiment, the lock 300 can be positioned and configured to prevent the nose piece 412 from sliding into the prosthetic valve 10 and thus prevent the nose piece 412 from damaging the delicate leaflet tissue 14.

Returning to the components of the tray 100, the tray 100 may include a cavity 110, the cavity 110 having an open end 112, a floor 114, and a peripheral sidewall 120 defining a depth of the cavity 110. The cavity 110 can be sized and shaped to receive the prosthetic valve 10 and a valve cover 600 coupled to the prosthetic valve 10. A cover 200 may be provided to partially close the open end 112 of the cavity 110. As shown in fig. 2 and 3, the cover 200 may be detachably coupled to the tray 100, and may define an opening 210 of the cavity 110 when it is coupled to the tray 100. When the lid 200 is coupled to the tray 100, the first moisturizing fluid can be injected into the cavity 110 through the opening 210. The cavity 110 can contain a volume of the first moisturizing fluid sufficient to completely submerge the prosthetic valve 10, as indicated by a fill indicator or line 122 disposed from the peripheral sidewall 120 between the floor 114 and the open end 112. The fill line 122 can also be positioned a distance from the mouth end 112 to contain a volume of additional second moisturizing fluid used to flush the delivery system 400 when the prosthetic valve 10 is contained within the cavity 110 (see fig. 11G). The first and second moisturizing fluids can be the same or they can be different. In one embodiment, the first and second moisturizing fluids are saline solutions.

In one embodiment, the prosthetic valve 10 can be stored within the cavity 110 without a liquid preservative solution. The prosthetic valve 10 can be stored without air (i.e., vacuum sealed). The prosthetic valve 10 can also be stored in air, nitrogen, argon, or any other non-reactive gas. It will be appreciated that the biological tissue comprising the flexible leaflet section 14 is treated, which allows it to be stored without a liquid preservative solution or in a substantially dry state. Similarly, it should be understood that the entire delivery system 400 can be stored in a similar manner as the prosthetic valve 10.

The lid 200 and tray 100 are removably coupled together by a plurality of resilient mating pairs 130, 230. In the embodiment shown in fig. 1-3, the lid 200 is depicted as including a plurality of projections 230 and the tray 100 is depicted as including a plurality of corresponding recesses 130. Airflow channels 132 may be provided from the recess 130 and a portion of the airflow channels 132 may extend beyond a portion of the tray 100 covered by the lid 200 to ensure airflow and sterilization of the packaging tray 100 and its contents when the lid 200 is coupled to the tray 100.

Fig. 9 and 10 depict an embodiment of a valve cover 600 that can be used to house the prosthetic valve 10 and that can also be used to facilitate loading of the prosthetic valve 10 within the delivery sheath 416. The valve cover 600 can include a nose cone 610 configured to receive the nose piece 412, a central chamber 620 having a tapered inner cavity that receives the prosthetic valve 10 in a first compressed state, and a mating portion (mated portion)630 that couples the valve cover 600 to the delivery system 400.

The tapered inner cavity of the central chamber 620 maintains at least a portion of the prosthetic valve 10 in a first compressed state having a diameter that is less than the diameter of the prosthetic valve 10 when the prosthetic valve 10 is deployed by the delivery system 400 and implanted in a patient (fig. 7). The inner cavity may have a tapered surface with a diameter that tapers to the delivery sheath 416. When the prosthetic valve 10 is loaded into the delivery sheath 416, the tapered surface can help guide and sufficiently crimp the prosthetic valve 10 to a second diameter within the delivery sheath 416 that is less than the first diameter within the inner lumen of the delivery sheath 416.

The mating portion 630 is depicted as containing three interlocking pieces (interlocking pieces)630a, 630b, 630c, where the interlocking pieces 630a and 630b mate together to provide frictional engagement with the delivery sheath 416 and the mating portion 630 is held together by sliding 630c over the interlocking mating pair (mating pair)630a, 630b and twisting 630c in the locked position. It should be appreciated that the frictional engagement of the mating portion 630 is not so tight as to prevent the delivery sheath 416 from slidably moving axially or distally relative to the mating portion 630.

The valve cover 600 can further include wings 625 that extend laterally from opposite sides of the valve cover 600 to couple the mounting surface 116 in the cavity 110 of the tray 100. The wings 625 can contain apertures shaped to resiliently engage the mounting surface 116 to stabilize and prevent the valve cover 600 from moving or rotating during storage, transport, and loading of the prosthetic valve 10 within the delivery sheath 416.

In the embodiment depicted in fig. 1-6, the mounting surface 116 is depicted as a pair of thermoformed projections formed by the cavity floor 114 that are shaped to resiliently engage corresponding recesses or openings formed in the wings 625. The cavity floor 114 may further include a shaped recess 118 to conform to the outer contour of the valve cover 600 facing the floor 114 to further stabilize the valve cover 600 against movement or rotation. Although the mounting surface 116 is depicted as a protrusion, it should be understood that the mounting surface 116 may be one of a pair of protrusions or a pair of recesses or openings configured to mate with corresponding features of the wings 625. The corresponding feature of the wing 625 may be the other of the pair of projections or the pair of recesses or openings. Preferably, the wings 625 and the mounting surface 116 are in resilient snap-fit engagement.

A lock 300 may optionally be provided to engage the valve cover 600. As further depicted in fig. 9 and 10, the locking member 300 can be coupled to the valve cover 600. In one embodiment, the locking member 300 may include a first end 310 and a second end 320.

The first end 310 of the lock 300 may include a first pair of prongs 312 configured to be inserted into an opening 612 between the nose cone 610 and the ventricle 620 and a second pair of prongs 314 configured to engage the surrounding exterior of the valve cover 600. The first pair of prongs 312 prevents the nose piece 412 from sliding into the prosthetic valve 10 and thus serves to substantially maintain the nose piece 412 within the nose cone 610. The first pair of prongs 312 can also be positioned to maintain separation between the nose piece 412 and the prosthetic valve 10. Stabilizing the nose piece 412 relative to the prosthetic valve 10 prevents the nose piece 412 from sliding into and damaging the delicate leaflets 14 of the prosthetic valve 10. In one embodiment, the first pair of prongs 312 may be provided between the second pair of prongs 314. The second pair of prongs 314 are resiliently secured to the exterior of the valve cover 600.

As shown in fig. 2, the second end 320 of the lock 300 may be configured to protrude outside of the cavity 110 and through the aperture 220 disposed on the cover 200. The second end 320 may be sized and/or shaped to prevent it from passing through the aperture 220, such as by providing the second end 320 larger than the aperture 220. Alternatively, the second end 320 may be fixed to the cap 200 or integrated with the cap 200. Regardless, the second end 320 is configured to cooperate with the cover 200 such that removal of the cover 200 will also remove the first end 310 of the lock 300 from the valve cover 600 and the elongate delivery system 400.

Returning to the components of the tray 100 in fig. 1-6, an engagement surface 140 may be provided on the exterior or periphery of the cavity 110. At least a portion of the engagement surface 140 may be elevated above the cavity floor 114, and a ramp 150 may be provided to extend between the engagement surface 140 and the cavity 110. In one embodiment, a ramp 150 extends downwardly from the engagement surface 140 and enters the cavity 110 through an opening 152 defined in the peripheral sidewall 120 and adjacent the cavity floor 114. In another embodiment, the ramp 150 extends downward from the engagement surface 140 to the floor of the cavity 110. As shown in fig. 6, the angle □ of the ramp 150 may be from about 4 degrees to about 10 degrees relative to a horizontal plane bisecting the tray 100. The angle □ of the ramp 150 is selected to prevent any fluid contained in the cavity 110 from leaking out of the tray 100.

The engagement surface 140 and the ramp 150 are configured to secure at least a portion of the delivery system 400 to the exterior of the cavity 110. One or both of the engagement surface 140 and the ramp 150 can include a channel 142 formed in the tray 100 and shaped to accommodate a portion of the delivery system 400 (such as the main conduit 418), along a portion of its length or along its entire length extending outside of the cavity 110. The engagement surface 140 may also include a plurality of protrusions 144, the plurality of protrusions 144 configured to resiliently engage portions of the delivery system 400 or the main conduit 418 within the channel or to the tray 100.

As shown in fig. 2, the engagement surface 140 may include curved portions 160A, 160B and at least one straight portion 162 on opposite sides of the tray 100 to maintain an elongated delivery system 400 and thus provide more compact storage. The delivery system 400 may be positioned and maintained in this configuration by a plurality of projections 144.

As shown in fig. 4, the linear portion 162 may contain a space 170 where the delivery system 400 is not in direct contact with the tray 100. Space 170 is provided around free section 470 of elongated delivery system 400 outside of cavity 110 to allow a user's hand to grasp free section 470 and lift at least a portion of elongated delivery system 400 on both sides of free section 470 out of engagement with tray 100 and without causing the remainder of delivery system 400 to disengage from tray 100.

As shown in fig. 5, proximal portion 420 of delivery system 400 is engaged within the perimeter of tray 100 in formed recesses 145A, 145B, and 145C, recesses 145A, 145B, and 145C being shaped to accommodate the outer profile of proximal portion 420. As shown in fig. 11E, when the proximal portion 420 is disengaged from the tray 100 and extends out of the tray 100, a support surface 164 can be provided to maintain the proximal portion 420 of the delivery system 400 in a position for coupling with the handle 80.

In one embodiment, the packaging system 1 containing the prosthetic valve 10 and its associated delivery system 400 (both maintained with the tray 100) is packaged within a sterile bag 70 (fig. 11C) and then sterilized by gas, such as by ethylene oxide or by gamma or electron beam irradiation. In one embodiment, the sterile pouch 70 is gas impermeable and may contain Tyvek material from DuPont. After sterilization, the sterile bag 70 is then placed within the second bag 60 (fig. 11B). The second pouch 60 may be moisture-proof, air-tight, or both (e.g., a foil pouch). A second bag 60 containing sterile bag 70 and packaging system 1 can then be provided within box 50 for shipment (fig. 11A).

Fig. 11A-11I depict exemplary steps for preparing and assembling the prosthetic valve 10 and the delivery system 400 using the packaging system 1. Fig. 11A-11C depict a sequence for removing the packaging tray 100 from its outer packaging.

In a first step shown in FIG. 11A, once the cartridge 50 is received, the temperature sensor 52 is referenced to determine if the cartridge 50 has been subjected to an unacceptable temperature excursion (temperature excursions). In one embodiment, the temperature sensor 52 will indicate whether the cassette 50 has been subjected to a temperature excursion outside of the range of from about-18 ℃ to about 45 ℃. If the cassette 50 has been subjected to temperatures outside of an acceptable range, the prosthetic valve 10 and delivery system 400 cannot be used to implant the heart valve 10 into a patient.

However, if the cassette 50 is not subject to unacceptable temperature excursions outside of acceptable ranges, the foil pouch 60 is removed from the cassette 50. Fig. 11B depicts the foil pouch 60 opened along tear line 62. The foil pouch 60 is gas impermeable and is provided to protect the packaging system 1 from moisture. Once the foil pouch 60 is torn along the tear line 62, another pouch 70 containing the packaging system 1 is removed. It should be understood that the processing of the cassette 50, foil pouch 60 and pouch 70 may be performed in a non-sterile area of an operating room.

The steps in fig. 11C illustrate the transfer of the packaging system 1 from the non-sterile area to the sterile area and require one person in the non-sterile area to open and handle the bag 70 and another person in the sterile area to handle and transfer the packaging system 1 to the sterile area. In one embodiment, the steps in fig. 11C may be performed by a single person by simply opening pouch 70 and sliding packaging system 1 from a non-sterile area to a sterile area. In one aspect of this embodiment, the person opening the pouch 70 is in a non-sterile area and avoids any direct physical contact with the packaging system 1 as it is slid or otherwise transferred to, for example, a table in the sterile area. In another embodiment, the steps in fig. 11C may be performed by two people, one who handles and opens the bag 70 in a non-sterile area, and another who receives and removes the packaging system 1 from the bag 70 in a sterile area. According to one aspect of this embodiment, the cavity does not contain a liquid or preservative solution.

The steps exemplified by fig. 11D to 11I are understood to be performed in the sterile area of the operating room.

In fig. 11D, the first moisturizing fluid 1000 is injected into the cavity 110 up to the fill line 122 to completely submerge the prosthetic valve 10. While the heart valve 10 is wet, the handle 80 can be prepared and attached to the proximal portion 420 of the delivery system 400.

In fig. 11E, the proximal portion 420 of the delivery system 400 is removed from secure engagement with the trays 145A, 145B, 145C and allowed to resiliently extend beyond the perimeter of the tray 100, supported by the support surface 164 for engagement with the handle 80.

In fig. 11F, the cover 200 can be removed from the tray 100, and removal of the cover 200 can also remove the lock 300 from the valve cover 600. The integration of the lock 300 with the cover 600 ensures that the lock 300 is removed prior to loading the heart valve 10 within the delivery sheath 416, as failure to remove the lock 300 prior to loading would likely result in damage to the leaflet structure of the heart valve 10.

A rinsing step may be performed to remove any bubbles C from within the delivery system 400. In fig. 11G, the second moisturizing fluid 2000 is injected into the handle 80, and the second moisturizing fluid 2000 passes through the proximal portion 420, through a lumen extending through the delivery system 400, and exits at the distal portion 410. Injection of the second moisturizing fluid 2000 through the delivery system 400 can be performed to flush out any air bubbles C that may be present within the delivery system 400, and when the air bubbles C are no longer released from the distal portion 410 of the delivery system 400, it can be concluded that injection of the second moisturizing fluid 2000 through the delivery system 400 is complete.

After flushing is complete, the heart valve 10 can be loaded within the delivery sheath 416. Fig. 11H depicts the prosthetic valve 10 being loaded within the delivery sheath 416. Loading of the heart valve 10 within the delivery sheath 416 may be accomplished by the handle 80, causing actuation of the delivery sheath 416 over the heart valve and toward the nose piece 412. Actuation of the delivery sheath 416 may involve both axial movement in the distal direction as well as rotational movement that creates a large torque force. Fig. 8A and 8B depict actuation of the delivery sheath 416 from an unloaded configuration (fig. 8A) to a loaded configuration in which the heart valve 10 is contained within the delivery sheath 416 (fig. 8B). The prosthetic valve 10 can be loaded within the delivery sheath while the valve cover 600 is attached to the delivery system 400 and the wings 625 resiliently engage the mounting surface 116. This allows the heart valve 10 and its associated delivery system 400 to be stabilized from torsional forces applied when the delivery sheath 416 is advanced distally over the heart valve 10.

The wings 625 of the valve cover 600 can be configured to extend laterally from opposite sides of the valve cover 600 to couple with the mounting surface 116 disposed from the cavity floor 114. The wings 625 can contain apertures shaped to resiliently engage the mounting surface 116, providing the mounting surface 116 on the tray 100 to stabilize and prevent the valve cover 600 from moving or rotating during storage, transport, and loading of the prosthetic valve 10 within the delivery sheath 416. Additionally, the cavity floor 114 may further include a shaped recess 118 to conform to the outer contour of the valve cover 600 facing the floor 114 to further stabilize the valve cover 600 against movement or rotation.

Once the prosthetic valve 10 is loaded within the delivery sheath 416, the valve cover 600 can be removed from the distal portion 410 of the delivery system 400 by first twisting and removing the interlocks 630c to allow disassembly of the interlocks 630a and 630 b. See fig. 10. This will allow the distal portion 410 of the delivery system 400 to slide out of the remainder of the valve cover 600.

Fig. 11I depicts removal of the delivery system 400, with the prosthetic valve 10 loaded within the delivery sheath 416 and the valve lock 600 removed from the distal portion 410. The delivery system 400 may be removed from the tray 100 by grasping the free segment 470 in the space 170 of the tray 100 and removing the delivery system 400 from engagement with the tray 100. The free section 470 of the delivery system 400 may be a portion of the delivery system 400 that is not in direct contact with the tray 100. The space 170 may have a width that allows a hand to grasp the circumference of the free section 470 to pull at least a portion of the delivery system 400 out of engagement with the tray 100. The other hand may (but need not) support the proximal end 420 of the delivery system 400.

Fig. 12-19 depict another embodiment of a packaging system 1000 that can be used to store, transport, and prepare replacement heart valves with their associated delivery systems 1200 for use in an operating room. The replacement heart valve (not shown) may be the same as the heart valve 10 described above with reference to fig. 7. Similarly, the delivery system 1200 that may be packaged in the packaging system 1000 may be the same as the delivery system 400 described above with reference to fig. 8A and 8B. The differences between the packaging system 1000 described with reference to fig. 12-19 reside in the structure of the tray 1100, the valve cover 1210 that houses the replacement heart valve and a portion of the distal end of the delivery system 1200. As described more fully below, these differences alter certain aspects of the steps of preparing and assembling a replacement heart valve as described above with reference to fig. 11A-11I.

As shown in fig. 12, 13, 14A, 14B, and 19, the tray 1100 can store and transport a delivery system 1200, the delivery system 1200 including a prosthetic valve (not shown) housed within a valve cover 1210. While the valve cover 1210 remains secured (affixed) to the tray 1100, the valve cover 1210 is removably associated with the delivery system 1200. The tray 1100 is also configured to store and transport a handle 1230 associated with the delivery system 1200. In the embodiment depicted in fig. 12, 13, 14A, and 14B, the handle 1230 can be stored within a tray 1100 that is attached to the delivery system 1200. In another embodiment (not depicted), the handle 1230 can be stored within a (destaged) tray 1100 that is separate from the delivery system 1200.

The tray 1100 can be made of any material that can be formed to securely and removably attach at least the valve cover 1210 and the handle 1230 from movement during storage and transport. The tray 1100 is sized such that the catheter portion 1220 of the delivery system 1200 can be arranged or affixed to the tray 1100 in a single curve or U-bend manner in order to reduce the torque required during the loading operation of the delivery system 1200, wherein the valve is loaded within the delivery sheath prior to implantation. The catheter portion 1220 between the valve cover 1210 and the handle 1230 can be secured within the tray by one or more resilient tabs 1128 to provide a snap-fit engagement of the catheter portion 1220 within a slot or recess disposed within the tray 1100. Fig. 14B depicts a pair of resilient tabs 1128 disposed on only one side of the tray 1100.

The tray 1100 includes a cavity 1130 formed to receive the valve cover 1210. The valve cover 1210 houses a prosthetic valve that is mounted on the distal portion of the delivery system 1200. As described above, the prosthetic valve can be partially contained within the delivery sheath at one end and adjacent to the nose cone at the other end. The floor of the cavity 1130 can include a mounting surface 1112, the mounting surface 1112 being formed to resiliently engage at least a portion of an exterior surface of the valve cover 1210 to prevent movement of the valve cover 1210 during storage, transport, preparation, and loading of the prosthetic valve within the delivery sheath. The mounting surface 1112 may comprise a contoured surface to substantially conform to a portion of the exterior surface of the valve cover 1210 and thus provide an engagement and resilient fit that prevents movement of the valve cover 1210 within the cavity 1130.

As depicted in fig. 12, 14A, and 14B, the structure of the valve cover 1210 differs in some respects from the valve cover 600 described above with reference to fig. 9 and 10. In the embodiment depicted in fig. 12, 14A, and 14B, the valve cover 1210 can include a flared end 1212 that allows entry of the prosthetic valve's moisturizing fluid and an opposing fixed end 1214 that provides an attachment point for the distal end of the delivery system 1200.

As depicted by the double arrow in fig. 12, the valve cover 1210 may further include a lock ring 1216, which lock ring 1216 may be slidable between a locked position and an unlocked position. In the locked position, the lock ring 1216 exerts a radially inward force around the fixed end 1214 of the valve cover 1210 to fixedly secure the valve cover 1210 to the delivery system 1200. In the unlocked position, after the prosthetic valve is moisturized, flushed, and loaded, the radially inward force applied by the locking rings 1216 around the fixed end 1214 of the valve cover 1210 is released to allow the delivery device 1200 to be removed from the valve cover 1210.

As can be seen in fig. 12 and 14B, a spaced region 1116 is provided within the mounting surface 1112 at the floor of the cavity 1130 to allow the lock ring 1216 to slide freely between a locked position and an unlocked position around the securing end 1214 while the valve cover 1210 itself remains secured to the mounting surface 1112. Thus, it is not necessary to remove the valve cover 1210 from the tray 1100 to perform the steps required to prepare the prosthetic valve for implantation and the delivery system 1200.

The cavity 1130 can be sized to contain at least a volume of moisturizing fluid sufficient to submerge a prosthetic valve contained within the valve cover 1210. The expanded open end 1212 of the valve cover 1210 is also configured to allow the prosthetic valve to be submerged in a moisturizing fluid. When the cavity 1130 is filled with a sufficient volume of the moisturizing fluid to submerge the prosthetic valve, further filling of the cavity 1130 with the moisturizing fluid will cause the fluid to fill the adjacent reservoir 1135, the adjacent reservoir 1135 being in fluid communication with the cavity 1130. The container 1135 may thus perform two functions-providing a clear visual indication and containing excess moisturizing fluid when a sufficient volume of moisturizing fluid is provided in the cavity 1130.

In addition to the cavity 1130, a ramp 1129 may be provided in a similar manner as described above with respect to fig. 1-6, wherein the ramp 1129 may extend downwardly from the upper surface 1120 of the tray 1100 and downwardly through an opening defined in a peripheral sidewall adjacent a floor of the cavity 1130. The corners of the ramps 1129 may be similarly provided to prevent spilled fluids from leaking out of the tray 1100.

A handle 1230 can be provided within the tray 1100, either attached to the delivery system 1200 or detached from the delivery system 1200. Fig. 12, 13, 14A, 14B, and 19 depict a handle 1230 attached to the delivery system 1200. An advantage of providing handle 1230 in an attached state is that it eliminates the step of preparing the valve for implantation in an operating room. In one embodiment, the handle 1230 is battery powered, and a battery (not shown) can be provided separate from the handle 1230 and can also be stored within the space 1160 within the tray 1100.

The tray 1100 also includes an engagement surface 1134, the engagement surface 1134 providing a contoured and engaging fit with the handle 1230 so as to secure it within the tray 1100 from movement during storage, transport, preparation, and loading operations of the prosthetic valve. Handle 1230 contains side port 1232 and end port 1234 to allow injection of moisturizing fluids through the catheter lumen and guidewire lumen of delivery system 1200, respectively. The tray 1100 can include side hole engagement surfaces 1132 to secure the side holes 1232 during storage and transport. The engagement surface 1134 of the tray 1100 can further include a channel and an opening in the raised sidewall 1110 of the tray 1100 to allow access to the end hole 1234 of the handle 1230 without removing the handle 1230 from the tray 1100. Thus, a syringe containing a moisturizing fluid can be coupled to the end holes 1234 of the handle 1230 without disengaging or removing the handle 1230 from the engagement surface 1134 of the tray 1100.

Fig. 12, 13 and 14A depict providing a lid 1300 in combination with a packaging system 1000. The cover 1300 can cover substantially the entire upper surface 1120 and sidewalls 1110 of the tray 1100 to enclose the cavity 1130, the container 1135, and the delivery system 1200 removably secured to the tray 1100. The lid 1300 may include a plurality of gas passages 1322 formed on a surface 1320 of the lid. Lid 1300 may also include a plurality of protrusions 1332 to mate with corresponding recesses 1122 disposed on tray 1100.

In one embodiment, the lid 1300 may include a contoured upper surface 1320 and sidewalls 1310 to provide a conformal fit (conforming fit) with a majority of the upper surface 1120 and sidewalls 1110, respectively, of the tray 1100. In one aspect of this embodiment, the cover 1300 is easily removable and does not frictionally engage the tray 1100 and/or the delivery system 1200.

The processing of the packaging system 1000 containing the prosthetic valve and associated delivery system 1200 can be the same as described above with reference to fig. 11A-11C. It should be understood that the packaging system 1000 is provided in a sterile bag and then sterilized by gas (such as by ethylene oxide) or by gamma irradiation or electron beam irradiation, as described above and depicted in fig. 11C. The sterile pouch may be gas impermeable and may contain Tyvek material from DuPont. As depicted in fig. 11B, the packaging system 1000 contained with a sterile pouch may be provided in a second pouch, which may be moisture-resistant, air-impermeable, or both (e.g., a foil pouch). The packaging system 1000 provided in two pouches may then be provided in a box, as depicted in fig. 11A for shipping. According to one aspect of this embodiment, the cavity does not contain a liquid or preservative solution.

As indicated above, the exemplary steps for preparing and assembling the prosthetic valve and delivery system 1200 using the packaging system 1000 are different than the steps described above with reference to fig. 11D-11I.

As described with reference to fig. 11A-11C, after the packaging tray 1000 is removed from its outer packaging (i.e., sterile bag, second bag, and cassette) and transferred from the non-sterile area to the sterile area, the lid 1300 is removed from the tray 1100. After removal of the lid 1300, the hydrating fluid is injected into the cavity 1130 until the hydrating fluid begins to spill into the adjacent container 1135 to indicate complete filling of the cavity 1130 and submersion of the valve contained in the delivery capsule 1210. If desired, the handle 1230 is removed from the engagement surface 1134 to install a battery (not shown). The handle 1230 is then replaced onto the engagement surface 1134 of the tray 1100.

Fluid can then be injected into the side hole 1232 of the handle 1230 to flush the catheter lumen of the delivery system 1200. In one embodiment, fluid may be injected into side aperture 1232 by a syringe containing the fluid. Once the flushing of the catheter lumen is complete, loading of the heart valve can be performed by pressing button 1236 to actuate loading of the heart valve within the delivery sheath. After loading is complete, fluid can be injected into the end hole 1234 of the handle 1230 to flush the guidewire lumen of the delivery system 1200. As can be seen in fig. 19, the end holes 1234 of the handle 1230 are accessible by a syringe without removing the handle 1230 from the tray 1100. Thus, it should be appreciated that the delivery capsule 1210 and handle 1230 may remain secured within the tray 1100 during flushing and loading operations.

After the flushing and loading operations have been completed, the delivery system 1200 may be finally removed from the tray 1100. Removal of the delivery system 1200 may be accomplished by disengaging the handle 1230 from the engagement surface 1134, sliding the lock ring 1216 from the locked position to the unlocked position to release the radial pressure of the securing end 1214 on the catheter portion 1220, and sliding the distal end of the delivery system 1200 out of the valve cover 1210.

In all embodiments described herein and in one optional aspect, the delivery system is packaged within a tray and the cavity does not contain a liquid or preservative solution until a moisturizing solution is added during the process of preparing the valve for implantation. Thus, the valve contained within the cavity can be stored and transported in dry storage.

It should be understood, that the detailed description and specific examples, while indicating preferred embodiments of the disclosure, are given by way of illustration and not limitation. Many changes and modifications may be made within the scope of the present disclosure without departing from the spirit thereof, and the invention includes all such modifications.