Medical device packaging systems

Abstract

A packaging system for a medical device. For example, this document describes a packaging system for an implantable medical device, such as, but not limited to, a prosthetic heart valve that can be delivered in a minimally invasive manner using a catheter system. Some embodiments of the packaging system described in the present document are designed to facilitate a clinician to perform a preparation process to prepare a medical device for implantation.

Description

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202480034833.1 (22) Application Date 2024.05.20 (30) Priority Data 63 / 504,383 2023.05.25 US (85) PCT International Application Entering National Phase Date 2025.11.25 (86) PCT International Application Application Data PCT / US2024 / 030253 2024.05.20 (87) PCT International Application Publication Data WO2024 / 243153 EN 2024.11.28 (71) Applicant: Antares Technologies, Inc. Address: USA (72) Inventors: T. Jimes, P.K. Parmet, M.T. Oswell, A.E. Reid, M.R. Kmelik, J.S. Kruska, W.L. D'Agostino (74) Patent Agency: China Council for the Promotion of International Trade Patent & Trademark Office Co., Ltd. 11038 Patent Attorney: Wang Aihua (51) Int.Cl. A61B 50 / 30 (2006.01) A61B 50 / 33 (2006.01) A61F 2 / 00 (2006.01) A61M 25 / 00 (2006.01) (54) Invention Title: Medical Device Packaging System (57) Abstract: Packaging system for medical devices. For example, this document describes a packaging system for implantable medical devices, such as, but not limited to, prosthetic heart valves delivered in a minimally invasive manner using a catheter system. Some embodiments of the packaging system described in this document are designed to facilitate a preparation process performed by a clinician to prepare a medical device for implantation. Claims 2 pages, Description 7 pages, Drawings 12 pages, CN 121194759 A 2025.12.23 CN 1 21 19 47 59 A 1. A medical device system comprising: an implantable device delivery system including: (i) a handle device and (ii) one or more catheters coupled to and extending from the handle device; and a packaging system configured to include the implantable device delivery system, the packaging system including: (i) a first tray and (ii) a second tray, the second tray being releasably coupled to the handle device, wherein the second tray is slidably coupled to the first tray. 2. The system of claim 1, further comprising a catheter support member movably coupled to the first tray.3. The system of claim 2, wherein the catheter support member is movable between (i) a first position and (ii) a second position, in the first position the catheter support member lies flat parallel to the first tray, and in the second position the catheter support member extends laterally upward and away from the first tray. 4. The system of claim 3, wherein the catheter support member is latched in the second position. 5. The system of claim 2, wherein the catheter support member is pivotally coupled to the first tray. 6. The system of claim 2, wherein the catheter support member defines a recess to releasably support the one or more catheters. 7. The system of claim 1, further comprising a third tray configured to cover the second tray. 8. The system of claim 7, wherein the third tray is pivotally coupled to the second tray such that the second tray and the third tray can open like a clamshell. 9. The system of any one of claims 1 to 8, wherein the second tray is configured to releasably receive the handle device and is slidable along the longitudinal axis of the first tray. 10. The system of claim 1, further comprising a plurality of separate rinsing basins releasably coupled to the second tray. 11. A medical device system comprising: an implantable device delivery system including: (i) a handle device and (ii) one or more catheters coupled to and extending from the handle device; and a packaging system configured to include the implantable device delivery system, the packaging system including: (i) a first tray and (ii) a catheter support member releasably coupled to the one or more catheters, wherein the catheter support member is movable upward relative to the first tray to a raised orientation to raise the one or more catheters relative to the first tray. 12. The system of claim 11, further comprising a latching mechanism by which the catheter support member is held in the raised orientation. 13. The system of claim 11, wherein the catheter support member is pivotally coupled to the first tray. 14. The system of claim 11, wherein the catheter support member defines a recess to releasably support the one or more catheters in the raised orientation. 15. The system of any one of claims 11 to 14, further comprising a second tray releasably receiving the handle device and slidable longitudinally along a longitudinal axis of the first tray. Claims 1 / 2 Page 2 CN 121194759 A 16. The system according to claim 15, further comprising a third tray configured to releasably cover the second tray.17. A medical device system comprising: an implantable device delivery system including: (i) a handle device and (ii) one or more catheters coupled to and extending from the handle device; and a packaging system configured to include the implantable device delivery system, the packaging system including: (i) a first tray, (ii) a second tray, and (iii) a plurality of separate rinse basins releasably coupled to the first tray or the second tray. 18. The system of claim 17, wherein the second tray releasably accommodates the handle device and is capable of sliding longitudinally along a longitudinal axis of the first tray. 19. The system of claim 17, wherein the plurality of separate rinse basins are nested together within the second tray. 20. The system of any one of claims 17 to 19, further comprising a catheter support member movable upward relative to the first tray to an elevation orientation to elevate the one or more catheters relative to the first tray. Claims 2 / 2 Page 3 CN 121194759 A Medical Device Packaging System

[0001] Cross-Reference to Related Applications

[0002] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 504,383, filed May 25, 2023. The disclosure of the prior application is considered part of the disclosure of this application (and is incorporated by reference). Technical Field

[0003] This document relates to packaging systems for medical devices and methods of using them. For example, this document relates to packaging systems for implantable medical devices, such as prosthetic heart valves, which can be delivered in a minimally invasive manner using a catheter system. Background Art

[0004] Packaging systems for medical devices are commonly used for many critical purposes. For example, such packaging can protect the medical device contained therein from damage during transport, storage, and handling. This protection can help maintain the integrity of high-value medical devices and help ensure patient safety. Moreover, many medical devices need to be kept in a sterile or sterilized state. Some packaging systems are specifically designed to facilitate the sterilization process and subsequently maintain the medical device in a sterile state during transport, storage, and handling.

[0005] Some implantable medical devices require one or more preparation processes after removal from packaging and before actual use. For example, some prosthetic heart valves and delivery systems must be prepared for use by medical personnel who can perform processes such as flushing the catheter, resinning the prosthetic heart valve in solution, and coiling or mounting the prosthetic heart valve onto an expandable balloon or delivery catheter. Summary of the Invention

[0006] This document describes packaging systems for medical devices and methods of using them.For example, this document describes a packaging system for implantable medical devices, such as, but not limited to, prosthetic heart valves delivered in a minimally invasive manner using a catheter-based system.

[0007] In one aspect, this disclosure relates to a medical device system comprising an implantable device delivery system including: (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 include the implantable device delivery system. The packaging system includes: (i) a first tray and (ii) a second tray releasably coupled to the handle device. The second tray is slidably coupled to the first tray.

[0008] In another aspect, this disclosure relates to another medical device system. This 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 include the implantable device delivery system. The packaging system includes: (i) a first tray and (ii) a catheter support member releasably coupled to the one or more catheters. The catheter support member is movable relative to the first tray to elevate the one or more catheters relative to the first tray.

[0009] In another aspect, this disclosure relates to another medical device system. Such a medical device system includes an implantable device delivery system, which includes: (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 include the implantable device delivery system. The packaging system includes: (i) a tray and (ii) a plurality of separate rinsing basins releasably coupled to the tray.

[0010] In another aspect, this disclosure relates to a medical device container. Such a medical device container includes a glass jar and a cap having a threaded open end. The cap includes: (i) a first end portion releasably engageable with a threaded opening end of the glass jar, and (ii) a second end portion attached to the first end portion. The second end portion is at least partially transparent. An open interior space is defined between the first end portion and the second end portion.

[0011] In another aspect, this disclosure relates to a method of preparing a prosthetic heart valve for implantation. The method includes opening a packaging system containing a medical device, the medical device including a handle and one or more catheters extending from the handle.The packaging system includes a first tray and a second tray releasably coupled to the handle device. The second tray is slidably coupled to the first tray. The method further includes sliding the second tray relative to the first tray while the handle device remains coupled to the second tray, such that the distal portion of the one or more catheters extends beyond the packaging system. The method further includes coupling the medical device to the distal portion of the one or more catheters while the distal portion of the one or more catheters extends beyond the packaging system.

[0012] Specific embodiments of the subject matter described herein can be implemented to achieve one or more of the following advantages. In some embodiments, the packaging system described herein is advantageously designed for a dual purpose, for example, 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 allow the delivery catheter(s) of the implantable device(s) to dock with a prosthetic valve coiling device. Such features can help medical practitioners prepare implantable medical devices for use in a convenient, controlled, and accurate manner and in a manner easier to perform than conventional procedures. In some embodiments, the packaging system described herein is advantageously designed to require less space in a medical operating room environment. Furthermore, some embodiments of the packaging system described herein include other instruments typically used during the preparation of a medical device. For example, some embodiments include a basin for receiving catheter flushing fluid, and / or a separate basin for rinsing the medical device in preparation for use. Moreover, some embodiments of the packaging system described herein advantageously include a retainer for one or more other devices (such as syringes, balloon inflators, etc.) used during the preparation of a medical device.

[0013] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While similar or equivalent methods and materials to those described herein may be used in the practice of this invention, suitable methods and materials are described herein. All publications, patent applications, patents, and other references mentioned herein are incorporated herein by reference in their entirety. In case of conflict, this specification (including definitions) shall prevail. Additionally, materials, methods, and examples are illustrative only and not restrictive.

[0014] Details of one or more embodiments of the invention are set forth in the accompanying drawings and description herein. Other features, objects, and advantages of the invention will be apparent from the description and drawings and the claims.

[0015] FIG1 is an exploded view of an exemplary medical device packaging system according to some embodiments provided herein.

[0016] FIG2 is an exploded view of a portion of the medical device packaging system of FIG1. ​​

[0017] FIG3 illustrates the steps of opening a portion of the medical device packaging of FIG2.Instruction Manual 2 / 7 Page 5 CN 121194759 A

[0018] Figure 4 illustrates another step in opening the medical device packaging of Figure 2.

[0019] Figure 5 illustrates the steps in preparing the medical device packaging of Figure 2 for use during the implantable medical device preparation process.

[0020] Figure 6 illustrates the steps in preparing an implantable medical device using the medical device packaging of Figure 2.

[0021] Figure 7 illustrates another step in preparing an implantable medical device using the medical device packaging of Figure 2.

[0022] Figure 8 illustrates another step in preparing an implantable medical device using the medical device packaging of Figure 2.

[0023] Figure 9 illustrates an exemplary implantable medical device container according to some embodiments provided herein.

[0024] Figure 10 is an exploded view of a portion of the implantable medical device container of Figure 9.

[0025] Figure 11 illustrates another exemplary implantable medical device container according to some embodiments provided herein.

[0026] Figure 12 illustrates a portion of the implantable medical device container of Figure 11.

[0027] FIG13 shows another exemplary implantable medical device container according to some embodiments provided herein.

[0028] FIG14 shows a portion of the implantable medical device container of FIG13.

[0029] FIG15 shows another exemplary implantable medical device container according to some embodiments provided herein.

[0030] FIG16 shows a portion of the implantable medical device container of FIG15.

[0031] The same reference numerals always denote corresponding parts. Detailed Description

[0032] This document describes packaging systems for medical devices and methods of using them. For example, this document describes a packaging system for implantable medical devices, such as, but not limited to, prosthetic heart valves, which can be delivered in a minimally invasive manner using a catheter system and control handle. Some embodiments of the packaging systems described herein are designed to facilitate preparation procedures performed by clinicians to prepare the medical device for implantation.

[0033] FIG1 is an exploded view of a medical device packaging system 10 including an outer box 20 and an inner packaging system 100. During transport, the packaging system 100 is contained within the outer box 20. In some embodiments, the packaging system 100 is contained within a sealed bag (not shown), and the combination of the packaging system 100 and the bag is contained within an outer box 20. In some such embodiments, the bag is used to maintain the sterility of one or more medical devices contained within the packaging system 100.

[0034] In the depicted embodiment, the outer box 20 is advantageously designed to open, as shown. That is, the lid 22 of the box 20 can be pivotally opened by a clinician to access and remove the inner packaging system 100. In this embodiment, one of the long edges of the lid 22 is attached to and pivotable relative to the lower portion 24 of the box 20, as shown.The design of the outer box 20, whose lid 22 opens as shown in the figure, is convenient because the packaging system 100 can be removed from it without having to pull / slide the packaging system 100 out of the small end of the box 20 (which would require a physical space approximately twice the length of the box 20). Such space may be difficult to achieve in the crowded environment of a medical operating room.

[0035] Figure 2 shows an exploded view of the packaging system 100, the exemplary medical device 200, and the prosthetic valve curling device 300. In this example, the medical device 200 is packaged within the packaging system 100, but the valve curling device 300 is not. Instead, the valve curling device 300 is a separate device that will be used during the preoperative preparation of the medical device 200, as further described below.

[0036] The exemplary medical device 200 includes a handle device 210 and one or more catheters 220 coupled to and extending therefrom the handle device 210. In the depicted example, without limitation, the medical device 200 is illustrated as an implantable medical device delivery system 200, such as for a prosthetic heart valve (e.g., a TAVR valve) that can be delivered via catheter. It should be understood that the packaging system 100 can also be used with / for other types of medical devices.

[0037] The packaging system 100 includes a first tray 110 and a lid 120 that cooperates with the first tray 110 to define an internal space therein. The medical device 200 and other portions of the packaging system 100 are contained within the boundaries of the internal space defined between the first tray 110 and the lid 120 until the clinician performs unpacking.

[0038] In the depicted embodiment, the packaging system 100 also includes other useful instruments contained within the boundaries of the internal space defined between the first tray 110 and the lid 120. In particular, these instruments may be useful to clinicians preparing an implantable medical device for deployment in a patient using the implantable medical device delivery system 200. For example, in the depicted embodiments, the packaging system 100 includes useful appliances such as a second tray 130, a third tray 140, one or more rinsing basins 150, a conduit support member 160, and a conduit flushing fluid receiving basin 170. Each of these appliances may or may not be included in every embodiment of the packaging system 100. That is, some embodiments of the packaging system 100 may include all the depicted appliances, namely, the second tray 130, the third tray 140, the rinsing basin 150, the conduit support member 160, and the conduit flushing fluid receiving basin 170. Alternatively, in some embodiments, the packaging system 100 includes only the specific appliances of the depicted appliances, namely, one or more of the second tray 130, the third tray 140, the rinsing basin 150, the conduit support member 160, and / or the conduit flushing fluid receiving basin 170.Any and all such arrangements / combinations of the depicted apparatus may be included in various embodiments of the packaging system 100 described herein.

[0039] In the depicted 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 releasably receive and engage with the handle device 210. That is, the second tray 130 has structural features complementary to the outer contour of the handle device 210 for fixed engagement with the handle device 210.

[0040] In the depicted embodiment, the third tray 140 can be releasably engaged with the second tray 130 (to enclose the handle device 210 therebetween). In the depicted embodiment, the third tray 140 is pivotally coupled to the second tray 130 such that the second tray 130 and the third tray 140 open like a clamshell. Alternatively, in some embodiments, the third tray 140 can be detached and removed from engagement with the second tray 130. In other embodiments, a third tray 140 is not included in the packaging system 100. The third tray 140 may be configured for releasably receiving a device, such as, but not limited to, an inflator device.

[0041] In the depicted embodiments, the packaging system 100 also includes one or more rinsing basins 150. The one or more rinsing basins 150 may be nested together and removably coupled to a second tray 130 (as in the depicted embodiment) or a first tray 110 or another area of ​​the packaging system 100.

[0042] In the depicted embodiments, the packaging system 100 also includes a conduit support member 160. The conduit support member 160 is movable relative to the first tray 110 such that the conduit support member 160 is elevable relative to the first tray 110. In the depicted embodiments, the conduit support member 160 is pivotable relative to the first tray 110. Alternatively, the conduit support member 160 may be moved relative to the first tray 110 in other ways, such as, but not limited to, extending or retracting it or manually flipping it 90° and sliding it into engagement with the first tray 110.

[0043] In the depicted embodiment, the packaging system 100 further includes a rinsing fluid receiving basin 150. The rinsing fluid receiving basin 150 may be removably coupled to the first tray 110 (as in the depicted embodiment). Alternatively, in some embodiments, the rinsing fluid receiving basin 150 is attached to or integrally formed with the first tray 110.

[0044] Figures 3-8 are a series of illustrations depicting 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.

[0045] Figure 3 depicts the removal of the cap 120 from its engagement with the first tray 110.As shown in the figure, when the cover 120 and the first tray 110 are detached from each other, the third tray 140, the catheter support member 160, and the flushing fluid receiving basin 170 become visible. The medical device 200 is not shown in this figure. The second tray 130 and one or more rinse basins 150 are not visible in this figure. Specification 4 / 7 pages 7 CN 121194759 A

[0046] In Figure 4, the second tray 130 and the third tray 140 have been opened to expose the implantable medical device delivery system 200 contained therein. One or more rinse basins 150 removably coupled to the second tray 130 in this embodiment are also exposed.

[0047] Figure 5 shows one or more rinse basins 150 after being removed from their original position within the second tray 130. In the depicted embodiment, three rinse basins 150 are included. In some embodiments, the packaging system 100 includes one, two, four, five, six, seven, or more than seven rinse basins 150.

[0048] One or more rinse basins 150 are liquid-containing containers that can be used for a variety of purposes, including but not limited to rinsing implantable medical devices, maintaining the hydration of implantable medical devices, and various other purposes required by the medical team.

[0049] In FIG. 6, the catheter support member 160 has been manually manipulated to an elevated orientation (which in turn elevates one or more catheters 220). In this elevated orientation, the catheter support member 160 extends laterally upward relative to the first tray 110. In the depicted embodiment, a clinician can manually pivot the catheter support member 160 (e.g., pivot about 80° to about 100°) to the elevated orientation relative to the first tray 110 as shown (for further clarification, the parallel orientation of the catheter support member 160 in FIG. 5, where the catheter support member 160 is placed parallel to the first tray 110, is compared to the elevated orientation of the catheter support member 160 in FIG. 6). In the depicted embodiment, the catheter support member 160 snaps into place in the elevated orientation as shown. That is, a mechanical latch is used to releasably retain the catheter support member 160 in the elevated orientation as shown.

[0050] As shown, the catheter support member 160 in its elevated orientation elevates the distal portions of one or more catheters 220. In some embodiments, the catheter support member 160 has a top surface shaped to releasably engage with and support one or more catheters 220. For example, in the depicted embodiment, the top surface of the catheter support member 160 has a groove in which one or more catheters 220 rest when the catheter support member 160 is in its elevated arrangement, as shown in FIG6. In the depicted embodiment, the groove is a V-shaped groove. The elevation of the distal portions of the depicted one or more catheters 220 is advantageous for further preparation of the medical device 200, as further described below.

[0051] In FIG. 7, the second tray 130 has been manually slid (translated) relative to the first tray 110. That is, the second tray 130 has been manually slid toward the catheter support member 160 along the longitudinal orientation of the first tray 110. To further illustrate this changed orientation, the orientation of the second tray 130 relative to the first tray 110 shown in FIG. 6 is compared with the orientation of the second tray 130 relative to the first tray 110 shown in FIG. 7. This translation of the second tray 130 also translates the handle device 210 and one or more catheters 220 because the handle device 210 is releasably coupled to the second tray 130. Therefore, the raised distal portion of one or more catheters 220 now extends beyond the end of the first tray 110.

[0052] With the raised distal portion of one or more catheters 220 now extending beyond the end of the first tray 110, the distal portion of one or more catheters 220 is accessible for further clinical intervention. For example, in some cases, the valve coiling device 300 (see FIG. 2) can be used to coil (compress) a prosthetic heart valve onto a balloon component of the distal portion of one or more catheters 220.

[0053] In the depicted embodiment, the third tray 140 has moved together with the second tray 130 because the two are attached to each other. However, in some embodiments, the third tray 140 and the second tray 130 are not attached to each other when they are in the open state as shown.

[0054] FIG. 8 shows the second tray 130 after sliding (translating) 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.

[0055] FIG. 9-16 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 embodiment described on pages 5 / 7 of the specification 8 CN 121194759 A, an exemplary medical device is a prosthetic heart valve.

[0056] Figure 9 illustrates an exemplary medical device container 400. The medical device container 400 is configured to contain a liquid and a medical device (in this non-limiting example, a prosthetic heart valve). Broadly speaking, the medical device container 400 includes a canister 410 and a lid 420. The canister 410 and the lid 420 may be attached to each other to form a leak-proof internal space in which the liquid and the medical device reside. The canister 410 and the lid 420 may also be detached from each other, allowing a clinician to access the medical device when needed.

[0057] The liquid in the medical device container 400 may be used to maintain the medical device in a desired state (e.g., where the tissue of the medical device (e.g., bovine pericardium or other types of tissue) is maintained in a hydrated, stable, and biocompatible state).In the depicted embodiments, the medical device is held in a fixed position within the medical device container 400. Alternatively, in some embodiments, the medical device may be allowed to move freely within the liquid contained within the medical device container 400. The medical device container 400 may also be configured for sterilization.

[0058] In the depicted embodiments, the container 410 is made of glass and has a threaded open end. The cap 420 has a compatible threaded end portion that can be screwed into the container 410 to create an openable but leak-proof connection.

[0059] FIG10 shows an exploded view of the cap 420. However, it should be understood that the cap 420 is constructed as a single integral component not intended to be disassembled. The components of the cap 420 may be joined together using various techniques, such as, but not limited to, heat fusion, the use of adhesives, ultrasonic welding, threaded connections, and combinations thereof.

[0060] In this non-limiting example, the cap 420 includes a first end portion 422, a second end portion 424, and an optional strap 426. The first end portion 422 includes internal threads that allow threaded engagement between the cap 420 and the can 410. In some embodiments, the liquid-facing side of the first end portion 422 is coated with a biocompatible material that prevents the material forming the first end portion 422 from leaking into the liquid. This coating can also be used to enhance the liquid-tight seal between the cap 420 and the can 410.

[0061] The second end portion 424 is at least partially visually transparent or completely visually transparent. An open interior space is defined between the first end portion 422 and the second end portion 424. Because the second end portion 424 is at least partially visually transparent, the open interior space is visually apparent and visually appealing. In some embodiments, a brand or other image may be included on the side of the first end portion 422 facing the second end portion 424, and the transparent nature of the second end portion 424 allows the user to visualize such a brand or image.

[0062] In this embodiment, the cap 420 includes an optional strap 426. The strap 426 can be used to help connect the first end portion 422 and the second end portion 424 to each other. Additionally, the band 426 can increase the visual appeal of the can 410 and can provide a good place for branding and / or other labeling.

[0063] Figure 11 illustrates another type of medical device container 500. The medical device container 500 is configured to contain a liquid and a medical device (in this non-limiting example, a prosthetic heart valve). In this example, the medical device is free to move within the liquid. The can 510 provides a leak-proof internal space in which the liquid and the medical device reside. The can 510 is also openable, allowing clinicians to access the medical device when needed. The medical device container 500 is constructed for sterilization.

[0064] Broadly speaking, the medical device container 500 includes a can 510 (including a lid in this example) and a sleeve 520. The sleeve 520 can be permanently attached to the can 510 by, for example, an adhesive.For example, sleeve 520 provides cushioning to protect canister 510 from impact. Therefore, sleeve 520 can be made of a suitable elastic / compliant rubber-like material. Sleeve 520 can also provide enhanced grip for clinicians when handling and / or opening the medical device container 500. Therefore, in some embodiments, sleeve 520 can be fabricated with a textured outer surface.

[0065] Figure 12 shows sleeve 520 isolated from canister 510. Sleeve 520 includes multiple opening portions that make the medical device visible within the medical device container 500 (as shown in Figure 11). For example, in this embodiment, sleeve 510 defines an opening bottom 522, two windows 524, and two unbounded opening side regions 526 at the top. These opening regions can have any type of shape. In this example, the opening bottom 522 is circular, the two windows 524 are quadrilateral, and the two opening side regions 526 are three-sided.

[0066] Figures 13 and 14 illustrate another embodiment of the medical device container 600. This is similar to the medical device container 500, except that the sleeve 620 does not include two windows. The sleeve 620 does define an opening bottom 622 and two opening side regions 626 that are unbounded at the top.

[0067] Figures 15 and 16 illustrate 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 opening side regions that are unbounded at the top, and the two windows 724 are elongated oval openings in this example.

[0068] While this specification contains numerous details of specific embodiments, these should not be construed as limiting any invention or the scope that may be claimed, but rather as descriptions of features that may be specific to particular embodiments of a particular invention. Certain features described in the context of individual embodiments in this specification may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented individually or in any suitable sub-combination in multiple embodiments. Furthermore, although features may be described herein as functioning in certain combinations and even initially claimed in this way, one or more features from the claimed combinations may be removed from the combinations in some cases, and the claimed combinations may involve sub-combinations or variations thereof.

[0069] Similarly, although operations are depicted in a specific order in the figures, this should not be construed as requiring such operations to be performed in the specific order shown or in a sequential order, or to perform all the operations shown to achieve the desired result. In some cases, multitasking and parallel processing may be advantageous.Furthermore, the separation of various system modules and components in the embodiments described herein should not be construed as requiring such separation in all embodiments, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products.

[0070] Specific embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. For example, the actions recited in the claims may be performed in a different order and still achieve the desired result. As an example, the processes depicted in the drawings do not necessarily require the specific order or sequence shown to achieve the desired result. Instruction manual, page 7 / 7, 10 CN 121194759 A, Figure 1; Instruction manual, Figure 1 / 12, page 11 CN 121194759 A, Figure 2; Instruction manual, Figure 2 / 12, page 12 CN 121194759 A, Figure 3; Instruction manual, Figure 3 / 12, page 13 CN 121194759 A, Figure 4; Instruction manual, Figure 4 / 12, page 14 CN 121194759 A, Figure 5; Instruction manual, Figure 5 / 12, page 15 CN 121194759 A, Figure 6; Instruction manual, Figure 6 / 12, page 16 CN 121194759 A, Figure 7; Instruction manual, Figure 7 / 12, page 17 CN 121194759 A, Figure 8; Instruction manual, Figure 8 / 12, page 18 CN 121194759 A, Figure 9 / 12, page 19 CN 121194759 A, Figure 11; Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 Figure 16 Figure 17 Figure 18

Claims

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

2. The system of claim 1 further includes a catheter support member movably coupled to the first tray.

3. The system of claim 2, wherein the catheter support member is movable between (i) a first position and (ii) a second position, wherein in the first position the catheter support member is laid flat parallel to the first tray, and in the second position the catheter support member extends laterally upward and away from the first tray.

4. The system of claim 3, wherein the conduit support member is latched in the second position.

5. The system of claim 2, wherein the conduit support member is pivotally connected to the first tray.

6. The system of claim 2, wherein the catheter support member defines a groove to releasably support the one or more catheters.

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

8. The system of claim 7, wherein the third tray is pivotally connected 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 releasably receive the handle device and is slidable along the longitudinal axis of the first tray.

10. The system of claim 1, further comprising a plurality of separate rinsing basins releasably coupled to the second tray.

11. A medical device system comprising: An implantable device delivery system comprising: (i) a handle device and (ii) one or more catheters coupled to and extending from the handle device; and A packaging system configured to include the implantable device delivery system, the packaging system comprising: (i) a first tray and (ii) a catheter support member releasably connectable to the one or more catheters. The catheter support member is capable of moving upward relative to the first tray to an elevation orientation to elevate the one or more catheters relative to the first tray.

12. The system of claim 11, further comprising a latching mechanism by which the conduit support member is secured in the elevation orientation.

13. The system of claim 11, wherein the conduit support member is pivotally coupled to the first tray.

14. The system of claim 11, wherein the catheter support member defines a groove to releasably support the one or more catheters in the elevation orientation.

15. The system according to any one of claims 11 to 14, further comprising a second tray releasably receiving the handle device and capable of sliding longitudinally along the longitudinal axis of the first tray.

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

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

18. The system of claim 17, wherein the second tray releasably accommodates the handle device and is capable of sliding longitudinally along the longitudinal axis of the first tray.

19. The system of claim 17, wherein the plurality of individual rinsing basins are nested together within the second tray.

20. The system according to any one of claims 17 to 19, further comprising a catheter support member, the catheter support member being movable upward relative to the first tray to an elevation orientation to elevate the one or more catheters relative to the first tray.

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