Medical device packaging system

Abstract

Packaging systems are used for medical devices. For example, this specification describes packaging systems for implantable medical devices such as, but not limited to, artificial heart valves that can be delivered in a minimally invasive manner using a catheter system. Some embodiments of the packaging systems described herein are designed to facilitate the preparation process that clinicians perform to prepare implantable medical devices.

Description

Technical Field

[0001] This specification relates to packaging systems for medical devices and methods of using them. For example, this specification relates to a packaging system for implantable medical devices, such as artificial heart valves, that can be delivered in a minimally invasive manner by using a catheter system.

Background Art

[0002] Packaging systems for medical devices often serve several important purposes. For example, such packages can protect the medical device contained therein from damage during shipping, storage, and handling. Such protection can help maintain the integrity of expensive medical devices and can also help ensure patient safety. Additionally, many medical devices need to be maintained in a sterile or aseptic condition. Some packaging systems are specifically designed to facilitate the sterilization process and then maintain the medical device in a sterile state during transportation, storage, and handling.

[0003] Some implantable medical devices require one or more preparation processes after the device is removed from the package and before it is actually used. For example, some artificial heart valves and delivery systems must be prepared for use by medical personnel who can perform processes such as flushing the catheter, rinsing the artificial heart valve in a solution, and crimping or attaching the artificial heart valve onto a delivery catheter that covers an expandable balloon.

Summary of the Invention

[0004] This specification describes packaging systems for medical devices and methods of using them. For example, this specification describes a packaging system for implantable medical devices, such as but not limited to artificial heart valves, that can be delivered in a minimally invasive manner by using a catheter system.

[0005] In one embodiment, the disclosure relates to a medical device system including an implantable device delivery system comprising (i) a handle device and (ii) one or more catheters coupled to and extending from the handle device. The medical device system also includes a packaging system configured to house the implantable device delivery system. The packaging system includes (i) a first tray and (ii) a second tray detachably coupled to the handle device.

[0006] In another embodiment, the disclosure covers medical device systems. Such a medical device system includes an implantable device delivery system comprising (i) a handle device and (ii) one or more catheters coupled to and extending from the handle device. The medical device system also includes a packaging system configured to house the implantable device delivery system. The packaging system includes (i) a first tray and (ii) a catheter support member that can be detachably coupled to one or more catheters. The catheter support member is movable relative to the first tray to raise one or more catheters relative to the first tray.

[0007] In another embodiment, the disclosure relates to another medical device system. Such a medical device system includes an implantable device delivery system comprising (i) a handle device and (ii) one or more catheters coupled to and extending from the handle device. The medical device system also includes a packaging system configured to house the implantable device delivery system. The packaging system includes (i) a tray and (ii) a plurality of separate rinsing tanks detachably coupled to the tray.

[0008] In another embodiment, the disclosure relates to a medical device container. Such a medical device container includes a glass bottle having a threaded opening end and a lid. The lid includes (i) a first end that can be detachably coupled to the threaded opening end of the glass bottle, and (ii) a second end that is attached to the first end. The second end is at least partially transparent. An open internal space is formed between the first end and the second end.

[0009] In another aspect, the disclosure relates to a method for preparing an implantable artificial heart valve. The method includes opening a packaging system that includes a medical device comprising a handle and one or more catheters extending from the handle. The packaging system includes a first tray and a second tray that is detachably coupled to a handle device. The second tray is slidably coupled to the first tray. The method also includes sliding the second tray against the first tray such that the distal ends of one or more catheters extend beyond the packaging system, while the handle device remains coupled to the second tray. The method also includes coupling a medical device to the distal ends of one or more catheters, while the distal ends of one or more catheters extend beyond the packaging system.

[0010] Specific embodiments of the present invention described herein can be implemented to achieve one or more of the following advantages. In some embodiments, the packaging systems described herein are advantageously designed to serve a dual purpose, for example, to function as conventional packaging, and secondly, to facilitate the preparation of implantable medical devices for use. For example, some embodiments of the packaging system have special structural features that enable an implantable device delivery catheter to be connected to an artificial valve compression device. Such features can help physicians prepare implantable medical devices for use in a convenient, controlled, precise, and easier-to-implement process than conventional processes. In some embodiments, the packaging systems described herein are advantageously designed to require less space in a medical treatment room environment. Furthermore, some embodiments of the packaging systems described herein include other instruments typically used during the preparation of medical devices. For example, some embodiments include a tank for receiving a catheter cleaning agent and / or a separate tank for rinsing the medical device in preparation for use. Furthermore, some embodiments of the packaging systems described herein advantageously include holders for one or more other devices used during the preparation of medical devices (e.g., syringes, balloon end inflator devices, etc.).

[0011] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which the present invention pertains. Methods and materials similar to or identical to those described herein may be used to carry out the present invention, but suitable methods and materials are described herein. All publications, patent applications, patents, and other references referenced herein are incorporated in their entirety by reference. In case of any conflict, including definitions, this specification shall prevail. In addition, materials, methods, and examples are illustrative and not intended to limit the invention.

[0012] Details of one or more embodiments of the present invention are described in the accompanying drawings and this description. Other features, purposes, and advantages of the present invention will become apparent from the description and drawings, as well as from the claims.

[0013] Similar reference numbers represent corresponding parts throughout the whole. [Brief explanation of the drawing]

[0014] [Figure 1] This is an exploded view of an exemplary medical device packaging system according to some embodiments provided herein. [Figure 2] Figure 1 is an exploded view of a part of the medical device packaging system. [Figure 3] Figure 2 shows the step of opening a portion of the medical device package. [Figure 4] Figure 2 shows another step in opening the medical device package. [Figure 5] Figure 2 shows the steps for preparing the medical device package for use during the preparation process of an implantable medical device. [Figure 6] The steps for preparing an implantable medical device using the medical device package shown in Figure 2 are illustrated. [Figure 7] Another step is shown using the medical device package in Figure 2 to prepare the implantable medical device. [Figure 8] Another step is shown using the medical device package in Figure 2 to prepare the implantable medical device. [Figure 9] This specification shows exemplary implantable medical device containers according to several embodiments provided herein. [Figure 10] Figure 9 is an exploded view of a portion of an implantable medical device container. [Figure 11] This specification provides several embodiments of another exemplary implantable medical device container. [Figure 12] Shows a part of the implantable medical device container of FIG. 11. [Figure 13] Shows another exemplary implantable medical device container according to some embodiments provided herein. [Figure 14] Shows a part of the implantable medical device container of FIG. 13. [Figure 15] Shows another exemplary implantable medical device container according to some embodiments provided herein. [Figure 16] Shows a part of the implantable medical device container of FIG. 15. **MODE FOR CARRYING OUT THE INVENTION**

[0015] This specification describes packaging systems for medical devices and methods of using them. For example, this specification describes a packaging system for implantable medical devices, such as, but not limited to, artificial heart valves, that can be delivered in a minimally invasive manner using a system of a catheter and a control handle. Some embodiments of the packaging systems described herein are designed to facilitate the preparation process that a clinician performs to prepare an implantable medical device.

[0016] FIG. 1 is an exploded view of a medical device packaging system 10 including an outer box 20 and an inner packaging system 100. During shipping, the packaging system 100 is housed within the outer box 20. In some embodiments, the packaging system 100 is housed within a sealed pouch (not shown), and the combination of the packaging system 100 and the pouch is housed within the outer box 20. In some such embodiments, the pouch serves to maintain the sterility of the medical device(s) housed within the packaging system 100.

[0017] In the illustrated embodiment, the outer box 20 is preferably designed to open as shown. That is, by pivoting open the cover 22 of the box 20, a clinician can access and remove the inner packaging system 100. In this embodiment, one of the long edges of the cover 22 is attached to the lower portion 24 of the box 20 and is pivotable relative to the lower portion 24 of the box 20 as shown. This design of the outer box 20 with a cover 22 that opens as shown is convenient in that the packaging system 100 can be removed within the range that would require pulling / sliding the packaging system 100 out of a small end of the box 20 (which would require a physical space about twice as long as the length of the box 20). In a congested environment in a treatment room, it may be difficult to secure such space.

[0018] Figure 2 shows an exploded view of the packaging system 100, an exemplary medical device 200, and an artificial valve crimping device 300. In this example, the medical device 200 is packaged within the packaging system 100, but the valve crimping device 300 is not packaged. Instead, the valve crimping device 300 is a separate device that can be used during the pre-operative preparation of the medical device 200, as further described below.

[0019] The exemplary medical device 200 includes a handle device 210 and one or more catheters 220 that are coupled to and extend from the handle device 210. In the example shown, by way of non-limitation, the medical device 200 is illustrated as an implantable medical device delivery system 200 for a transcatheter delivery of an artificial heart valve (e.g., a TAVR valve). It should be understood that the packaging system 100 can also be used with / for other types of medical devices.

[0020] The packaging system 100 includes a first tray 110 and a cover 120 that fits into the first tray 110 to define an internal space therein. The medical device 200 and the other parts of the packaging system 100 are housed within the area of ​​the internal space defined between the first tray 110 and the cover 120 until they are unpacked by a clinician.

[0021] In the illustrated embodiment, the packaging system 100 also includes other useful instruments housed within the area of ​​the internal space defined between the first tray 110 and the cover 120. These instruments may be particularly useful for clinicians preparing implantable medical devices for placement in patients using the implantable medical device delivery system 200. For example, in the illustrated embodiment, the packaging system 100 includes useful instruments such as a second tray 130, a third tray 140, one or more rinse tanks 150, a catheter support member 160, and a catheter lavage fluid tank 170. Each of these instruments may or may not be included in each embodiment of the packaging system 100. That is, some embodiments of the packaging system 100 may include all of the illustrated instruments, namely the second tray 130, the third tray 140, the rinse tank 150, the catheter support member 160, and the catheter lavage fluid tank 170. Alternatively, in some embodiments, the packaging system 100 includes one or more of the illustrated instruments, namely the second tray 130, the third tray 140, the rinsing tank 150, the catheter support member 160, and / or the catheter irrigation fluid tank 170. Any and all such permutations / combinations of the illustrated instruments may be included in the various embodiments of the packaging system 100 described herein.

[0022] In the illustrated embodiment, the second tray 130 is slidably coupled to the first tray 110. That is, the second tray 130 can be manually slid relative to the first tray 110 along the longitudinal direction of the first tray 110. The second tray 130 is configured to detachably receive and couple with the handle device 210. That is, the second tray 130 has structural features that are complementary to the outer casing of the handle device 210 in order to securely engage with the handle device 210.

[0023] In the illustrated embodiment, the third tray 140 can be detachably fitted to the second tray 130 (to accommodate a handle device 210 between them). In the illustrated embodiment, the third tray 140 is pivotally coupled to the second tray 130 so that the second tray 130 and the third tray 140 open like a clamshell. Alternatively, in some embodiments, the third tray 140 is detachably and removable from its engagement with the second tray 130. In yet another embodiment, there is no third tray 140 included in the packaging system 100. The third tray 140 may be configured to detachably receive a device such as a balloon endo-inflator device, but is not limited to this.

[0024] In the illustrated embodiment, the packaging system 100 also includes one or more rinse tanks 150. The one or more rinse tanks 150 may be nested together and detachably coupled (as in the illustrated embodiment) to a second tray 130, or a first tray 110, or another area of ​​the packaging system 100.

[0025] In the illustrated embodiment, the packaging system 100 also includes a catheter support member 160. The catheter support member 160 is movable relative to the first tray 110 so that the catheter support member 160 can be raised relative to the first tray 110. In the illustrated embodiment, the catheter support member 160 is pivotable relative to the first tray 110. Alternatively, the catheter support member 160 may be movable relative to the first tray 110 by other means, but not limited to, extending and retracting, or by manually reversing it 90° and sliding it to engage with the first tray 110.

[0026] In the illustrated embodiment, the packaging system 100 also includes a cleaning fluid reservoir 150. The cleaning fluid reservoir 150 may be detachably coupled to the first tray 110 (as in the illustrated embodiment). Alternatively, in some embodiments, the cleaning fluid reservoir 150 is attached to the first tray 110 or formed integrally with the first tray 110.

[0027] Figures 3 to 8 are a series of diagrams illustrating the unpacking of the implantable medical device delivery system 200 from the packaging system 100 and the preparation steps of the implantable medical device delivery system 200 using the packaging system 100.

[0028] Figure 3 shows the removal of the cover 120 from its engagement with the first tray 110. The third tray 140, the catheter support member 160, and the rinsing fluid reservoir 170 become visible when the cover 120 and the first tray 110 are removed from each other, as shown in the figure. The medical device 200 is not shown in this figure. The second tray 130 and one or more rinsing reservoirs 150 are not visible in this figure.

[0029] In Figure 4, the second tray 130 and the third tray 140 are open to show the implantable medical device delivery system 200 housed between them. In this embodiment, one or more rinse tanks 150 are also shown detachably coupled to the second tray 130.

[0030] Figure 5 shows one or more rinse tanks 150 after they have been removed from their home positions in the second tray 130. In the illustrated embodiment, there are three rinse tanks 150. In some embodiments, one, two, four, five, six, seven, or more than seven rinse tanks 150 are included in the packaging system 100.

[0031] One or more rinse tanks 150 are liquid-containing tanks that can be used for a variety of purposes, including, but not limited to, rinsing implantable medical devices, keeping implantable medical devices hydrated, and various other purposes desired by the medical team.

[0032] In Figure 6, the catheter support member 160 is manually operated to an upward orientation (thus raising one or more catheters 220). In this upward orientation, the catheter support member 160 extends transversely upward relative to the first tray 110. In the illustrated embodiment, the clinician can manually pivot the catheter support member 160 to the upward orientation relative to the first tray 110 (e.g., from about 80° to about 100°) as shown (for clarity, compare the parallel orientation of the catheter support member 160 in Figure 5, where the catheter support member 160 is placed parallel to the first tray 110, with the upward orientation of the catheter support member 160 in Figure 6). In the illustrated embodiment, the catheter support member 160 is snapped into place in the upward orientation as shown. That is, a mechanical latch holds the catheter support member 160 in a releaseable position in the upward orientation as shown.

[0033] As illustrated, the catheter support member 160 in an upward orientation elevates the distal end portion of one or more catheters 220. In some embodiments, the catheter support member 160 has a top surface molded to detachably engage with and support one or more catheters 220. For example, in the illustrated embodiment, the top surface of the catheter support member 160 has a groove on which one or more catheters 220 rest when the catheter support member 160 is in the upward position as shown in Figure 6. In the illustrated embodiment, the groove is V-shaped. The illustrated height of the distal end portion of one or more catheters 220 is advantageous for further preparation of the medical device 200, as will be further described below.

[0034] In Figure 7, the second tray 130 is manually slid (translated) relative to the first tray 110. That is, the second tray 130 is manually slid toward the catheter support member 160 along the longitudinal orientation of the first tray 110. To further clarify this changed orientation, compare the orientation of the second tray 130 relative to the first tray 110 as shown in Figure 6 with the orientation of the second tray 130 relative to the first tray 110 as shown in Figure 7. Since the handle device 210 is detachably coupled to the second tray 130, this translation of the second tray 130 also translates the handle device 210 and one or more catheters 220. Thus, the elevated distal end portions of one or more catheters 220 here extend beyond the end of the first tray 110.

[0035] Here, with the lifted distal end portions of one or more catheters 220 extending beyond the end of the first tray 110, the distal end portions of one or more catheters 220 are accessible for further processing by a clinician. For example, in some cases, an artificial heart valve can be crimped (compressed) onto the balloon portion of the distal end of one or more catheters 220 by using a crimping device 300 (see Figure 2).

[0036] In the illustrated embodiment, the third tray 140 and the second tray 130 are attached to each other, and therefore move together. However, in some embodiments, the third tray 140 and the second tray 130 are not attached to each other when in the open state as illustrated.

[0037] Figure 8 shows the second tray 130 after it has been slid (horizontally moved) back to its original position relative to the first tray 110. At this point, the clinician can remove the implantable medical device delivery system 200 from the packaging system 100 and then provide it to the physician for use in treating the patient.

[0038] Figures 9 to 16 show various embodiments of medical device containers that can be used to store and transport implantable medical devices in liquids (e.g., propylene oxide, aldehyde solutions, glutaraldehyde solutions, formaldehyde-based solutions, saline solutions, etc.). In the illustrated embodiments, the exemplary medical device is an artificial heart valve.

[0039] Figure 9 shows an exemplary medical device container 400. The medical device container 400 is configured to contain a liquid and a medical device (an artificial heart valve in this non-limiting example). Broadly speaking, the medical device container 400 includes a bottle 410 and a lid 420. The bottle 410 and lid 420 are attachable to each other to form a leak-proof internal space in which the liquid and medical device reside. The bottle 410 and lid 420 are also detachable from each other so that a clinician can access the medical device when desired.

[0040] The liquid in the medical device container 400 can serve to maintain the medical device in a desired state (for example, hydrating, stabilizing, and biocompatible the tissue of the medical device (e.g., bovine pericardium or other type of tissue)). In the illustrated embodiment, the medical device is held in a fixed position within the medical device container 400. Alternatively, in some embodiments, the medical device may be able to move freely within the liquid contained in the medical device container 400. The medical device container 400 may be configured for sterilization.

[0041] In the illustrated embodiment, the bottle 410 is made of glass and has a threaded opening end. The lid 420 has a compatible threaded end that can be screwed onto and engaged with the bottle 410, thereby forming an openable and closable yet leak-proof connection.

[0042] Figure 10 shows an exploded view of the lid 420. However, it should be understood that the lid 420 is constructed as a single, integrated component not intended to be disassembled. The components of the lid 420 may be joined to each other using a variety of techniques, including, but not limited to, heat riveting, the use of adhesives, ultrasonic welding, screwing, and combinations thereof.

[0043] In this non-limiting example, the lid 420 includes a first end 422, a second end 424, and an optional band 426. The first end 422 includes a female thread that allows for screw engagement between the lid 420 and the bottle 410. In some embodiments, the liquid-contacting side of the first end 422 is coated with a biocompatible material, thereby preventing the material constituting the first end 422 from migrating into the liquid. Such a coating can also serve to enhance the liquid-tight seal between the lid 420 and the bottle 410.

[0044] The second end 424 is at least partially or completely visually transparent. An open interior space is formed between the first end 422 and the second end 424. Since the second end 424 is at least partially visually transparent, the open interior space is visually apparent and visually appealing. In some embodiments, the side of the first end 422 facing the second end 424 may include a brand or other image, and the transparency of the second end 424 allows the user to view such a brand or image.

[0045] In this embodiment, the lid 420 includes an optional band 426. The band 426 can help to join the first end 422 and the second end 424 together. In addition, the band 426 can add visual appeal to the bottle 410 and provide a good place for branding and / or other labeling.

[0046] Figure 11 shows another type of medical device container 500. The medical device container 500 is configured to contain a liquid and a medical device (an artificial heart valve in this non-limiting example). The medical device is freely movable in the liquid in this example. The bottle 510 provides a leak-proof internal space in which the liquid and the medical device reside. The bottle 510 is also openable so that a clinician can access the medical device when desired. The medical device container 500 is configured to be sterilized.

[0047] Broadly speaking, the medical device container 500 includes a bottle 510 (including a lid in this example) and a sleeve 520. The sleeve 520 can be permanently attached to the bottle 510, for example, by adhesive. The sleeve 520 provides, for example, cushioning to protect the bottle 510 from impact. Therefore, the sleeve 520 may be made of a suitable elastic / flexible rubber-like material. The sleeve 520 can also provide an enhanced grip for the clinician when handling and / or opening the medical device container 500. Therefore, in some embodiments, the sleeve 520 can be manufactured to have a textured outer surface.

[0048] Figure 12 shows the sleeve 520 separated from the bottle 510. The sleeve 520 includes several openings so that the medical device is visible inside the medical device container 500 (as shown in Figure 11). For example, in this embodiment, the sleeve 510 defines an open bottom 522, two windows 524, and two open side regions 526 that are unbounded at the top. These open regions may have any type of shape. In this example, the open bottom 522 is circular, the two windows 524 are quadrilateral, and the two open side regions 526 are triangular.

[0049] Figures 13 and 14 show another embodiment of the medical device container 600, which is similar to the medical device container 500 except that the sleeve 620 does not include two windows. The sleeve 620 defines an open bottom 622 and two open side regions 626 with no boundary at the top.

[0050] Figures 15 and 16 show yet another embodiment of the medical device container 700. This is similar to the medical device container 500, except that the sleeve 720 does not include two open side regions without a boundary at the top, and the two windows 724 are elongated openings which are elliptical in this example.

[0051] This specification includes many specific implementation details, which should not be construed as limitations on the scope of any invention or claim, but rather as descriptions of features that may be specific to a particular embodiment of a particular invention. Certain features described herein in the context of separate embodiments may be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may be implemented separately in multiple embodiments or in any suitable subcombination. Furthermore, features are described herein as acting in a combination, and may even be initially claimed as such, but in some cases one or more features from a claimed combination may be removed from the combination, and the claimed combination may cover a partial combination or a variation of a partial combination.

[0052] Similarly, although the operations are shown in the drawings in a specific order, this should not be understood as requiring that such operations be performed in the specific order shown or sequentially, or that all illustrated operations be performed, in order to achieve the desired result. In certain situations, multitasking and parallel processing may be advantageous. Furthermore, the separation of various system modules and components in the embodiments described herein should not be understood as requiring such separation in all embodiments, and it should be understood that the components and systems described can generally be integrated together in a single product or packaged in multiple products.

[0053] Specific embodiments of the present invention have been described. Other embodiments are within the scope of the following claims. For example, the actions described in the claims can still achieve the desired results even if they are performed in a different order. As an example, the process shown in the accompanying drawings does not necessarily require the specific order or sequence shown to achieve the desired results.

Claims

1. A medical device system, An implantable device delivery system comprising (i) a handle device, and (ii) one or more catheters coupled to and extending from the handle device, A packaging system configured to house the embedded device delivery system, comprising: (i) a first tray; and (ii) a second tray detachably coupled to the handle device; The system wherein the second tray is slidably coupled to the first tray.

2. The system according to claim 1, further comprising a catheter support member movably coupled to the first tray.

3. The system according to claim 2, wherein the catheter support member is movable between (i) a first position in which the catheter support member is positioned parallel to the first tray and (ii) a second position in which the catheter support member is separated from the first tray and extends transversely upward.

4. The system according to claim 3, wherein the catheter support member latches at the second position.

5. The system according to claim 2, wherein the catheter support member is pivotably coupled to the first tray.

6. The system according to claim 2, wherein the catheter support member defines a groove for detachably supporting one or more catheters.

7. The system according to claim 1, further comprising a third tray configured to cover the second tray.

8. The system according to claim 7, wherein the third tray is pivotably coupled to the second tray such that the second tray and the third tray can be opened like a clamshell.

9. The system according to any one of claims 1 to 8, wherein the second tray is configured to detachably receive the handle device and is slidable along the longitudinal axis of the first tray.

10. The system according to claim 1, further comprising a plurality of separate rinsing tanks detachably coupled to the second tray.

11. A medical device system, An implantable device delivery system comprising (i) a handle device, and (ii) one or more catheters coupled to and extending from the handle device, A packaging system configured to house the implantable device delivery system, comprising: (i) a first tray; and (ii) a catheter support member detachably connectable to one or more catheters; The catheter support member is movable upward relative to the first tray to an upward orientation so as to raise one or more catheters relative to the first tray.

12. The system according to claim 11, further comprising a latch mechanism, wherein the catheter support member is held in the upward orientation by the latch mechanism.

13. The system according to claim 11, wherein the catheter support member is pivotably coupled to the first tray.

14. The system according to claim 11, wherein the catheter support member defines a groove for detachably supporting one or more catheters in the upward orientation.

15. The system according to any one of claims 11 to 14, further comprising a second tray that detachably houses the handle device and is slidable longitudinally along the longitudinal axis of the first tray.

16. The system according to claim 15, further comprising a third tray configured to detachably cover the second tray.

17. A medical device system, An implantable device delivery system comprising (i) a handle device, and (ii) one or more catheters coupled to and extending from the handle device, A packaging system configured to accommodate the embedded device delivery system, comprising: (i) a first tray; (ii) a second tray; and (iii) a plurality of separate rinsing tanks detachably coupled to the first tray or the second tray.

18. The system according to claim 17, wherein the second tray detachably houses the handle device and is slidable longitudinally along the longitudinal axis of the first tray.

19. The system according to claim 17, wherein the plurality of separate rinsing tubs are nested together in the second tray.

20. The system according to any one of claims 17 to 19, further comprising a catheter support member that is movable upward to an upward orientation relative to the first tray so as to raise one or more catheters relative to the first tray.

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