Medical device packaging with sterile moisture barrier

Abstract

A packaging assembly for receiving a medical device can comprise a tray comprising lateral and bottom wall portions defining a recess configured to receive the medical device, and a top rim extending laterally around a portion of the lateral wall portion. A first sealing lid can be configured to be disposed over the recess and sealed to the top rim to provide a lid over the recess, the first sealing lid comprising a gas-permeable material portion and a gas- impermeable material portion.

Description

MEDICAL DEVICE PACKAGING WITH STERILE MOISTURE BARRIERCROSS REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims the benefit of U.S. Patent Application No. 63 / 552,584, filed February 12, 2024, the disclosure of which is hereby expressly incorporated by reference herein in its entirety for all purposes.BACKGROUND

[0002] The integrity of medical devices needs to be maintained during their storage and / or transport, such as from the manufacturing facility into the operating room. Medical devices are typically disposed within a packaging assembly to provide protection against physical damage and preserve sterility of the medical devices.SUMMARY

[0003] Described herein are methods and devices relating to packaging assemblies for medical devices. In some instances, a packaging assembly can comprise a tray and a first sealing lid including a gas-permeable material portion and a gas-impermeable material portion. The first sealing lid can be configured to be sealed to the tray. A second sealing lid comprising a gas-impermeable and moisture-resistant lid can be configured to be disposed over and sealed to the first sealing lid. The packaging assembly can comprise a oneway valve coupled to the second sealing lid to allow release of gas from within the sealed tray. In some instances, a packaging assembly can comprise the jar and a gas-permeable sealing lid configured to seal the jar. A cap can be configured to be disposed over the gas- permeable sealing lid and engaged with the jar. The packaging assembly can comprise a sealing ring circumferentially received around a portion the jar and configured to engage with respective portions of the cap to facilitate sealing of the jar. In some instances, a packaging assembly can comprise a pouch having a gas -impermeable pouch portion and a gas- permeable header. The gas-permeable header can be removed to provide a pouch comprising at least a part of remaining portions of the gas-impermeable pouch portion.

[0004] Methods and structures disclosed herein for treating a patient also encompass analogous methods and structures performed on or placed on a simulated patient, which is useful, for example, for training; for demonstration; for procedure and / or device development; and the like. The simulated patient can be physical, virtual, or a combination ofphysical and virtual. A simulation can include a simulation of all or a portion of a patient, for example, an entire body, a portion of a body (e.g. , thorax), a system (e.g. , cardiovascular system), an organ (e.g., heart), or any combination thereof. Physical elements can be natural, including human or animal cadavers, or portions thereof; synthetic; or any combination of natural and synthetic. Virtual elements can be entirely in silico, or overlaid on one or more of the physical components. Virtual elements can be presented on any combination of screens, headsets, holographically, projected, loud speakers, headphones, pressure transducers, temperature transducers, or using any combination of suitable technologies.

[0005] For purposes of summarizing the disclosure, certain aspects, advantages, and novel features have been described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular example. Thus, the disclosed examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Various examples are depicted in the accompanying drawings for illustrative purposes and should in no way be interpreted as limiting the scope of the inventions. In addition, various features of different disclosed examples can be combined to form additional examples, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements. However, it should be understood that the use of similar reference numbers in connection with multiple drawings does not necessarily imply similarity between respective examples associated therewith. Furthermore, it should be understood that the features of the respective drawings are not necessarily drawn to scale, and the illustrated sizes thereof are presented for the purpose of illustration of inventive aspects thereof. Generally, certain of the illustrated features may be relatively smaller than as illustrated in some examples or configurations.

[0007] Figures 1A and IB provide a perspective view and side cross-sectional view, respectively, of a packaging assembly configured to receive a medical device, in accordance with one or more examples.

[0008] Figure 2 provides an exploded perspective view of a packaging assembly configured to receive a medical device, in accordance with one or more examples.

[0009] Figure 3 provides a perspective view of a tray configured to receive a medical device, in accordance with one or more examples.

[0010] Figures 4A, 4B, 4C, 4D, 4E and 4F provide various views of a packaging assembly comprising ajar configured to receive a medical device, in accordance with one or more examples.

[0011] Figure 5 provides an exploded perspective view of a packaging assembly comprising ajar and an inner receptacle configured to receive a medical device, the inner receptacle being configured to be disposed within the jar, in accordance with one or more examples.

[0012] Figures 6A, 6B and 6C provide a first plan view, a second plan view and a perspective view, respectively, of a packaging assembly comprising a pouch configured to receive a medical device, in accordance with one or more examples.

[0013] Figure 7 A provides a plan view of the packaging assembly described with reference to Figures 6A, 6B and 6C in a sealed state in accordance with one or more examples.

[0014] Figure 7B provides a plan view of a packaging assembly resulting from removing a portion of the packaging assembly described with reference to Figures 6A, 6B and 6C, in accordance with one or more examples.DETAILED DESCRIPTION

[0015] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0016] Although certain preferred examples are disclosed below, inventive subject matter extends beyond the specifically disclosed examples to other alternative examples and / or uses and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular examples described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain examples; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various examples, certain aspects and advantages of these examples are described. Not necessarily all such aspects or advantages are achieved by any particular example. Thus, for example, various examples may be carried out in a manner that achievesor optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0017] Certain standard anatomical terms of location are used herein to refer to the anatomy of animals, and namely humans, with respect to the preferred examples. Although certain spatially relative terms, such as “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms, are used herein to describe a spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationship between element(s) / structures(s), as illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of the element(s) / structures(s), in use or operation, in addition to the orientations depicted in the drawings. For example, an element / structure described as “above” another element / structure may represent a position that is below or beside such other element / structure with respect to alternate orientations of the subject patient or element / structure, and vice-versa.|0018| Providing packaging assemblies for medical devices that can prevent damage to the medical devices while allowing desired sterilization of the medical devices received within the packaging assemblies can be challenging. Packaging assemblies need to be able to maintain a sterile environment. Some medical devices can be sensitive to moisture, requiring packaging assemblies to provide protection against moisture ingress during at least a portion of the storage and / or transport of the medical devices.

[0019] Described herein are methods and devices relating to packaging assemblies for medical devices, where the packaging assemblies can allow sterilization of the medical devices received within the packaging assemblies while providing a sterile barrier for the medical devices. In some instances, the packaging assemblies can be subsequently sealed to provide a gas-impermeable and moisture-resistant enclosure for the medical devices. In some instances, a packaging assembly can comprise a tray and a first sealing lid including a gas-permeable material portion and a gas-impermeable material portion. The first sealing lid can be configured to be sealed to the tray. A second sealing lid comprising a gas- impermeable and moisture-resistant lid can be configured to be disposed over and sealed to the first sealing lid. In some instances, the packaging assembly can comprise a one-way valve coupled to the second sealing lid to allow release of gas from within the sealed tray. In some instances, a packaging assembly can comprise the jar and a gas-permeable sealing lid configured to seal the jar. A cap can be configured to be disposed over the gas-permeablesealing lid and engaged with the jar. The packaging assembly can comprise a sealing ring circumferentially received around a portion the jar and configured to engage with respective portions of the cap, such as to seal the jar. In some instances, a packaging assembly can comprise a pouch with a gas-impermeable pouch portion and a gas-permeable header. The gas-permeable header can be subsequently removed to provide a pouch comprising at least a part of remaining portions of the gas-impermeable pouch portion.[00201 The gas-permeable material portion of the first sealing lid, gas-permeable sealing lid and / or gas-permeable header of the pouch can allow passage therethrough of sterilization gases, such as ethylene oxide (ETO), for sterilizing the medical device within the respective receptacle. Subsequently sealing of the receptable can provide a sterile enclosure for the medical device that provides desired resistance to gas and moisture ingress, and / or prevent damage to the medical device. For example, the tray can comprise a gas-impermeable and moisture resistant material. The jar and the cap can comprise a gas-impermeable and moisture resistant material. In some instances, the gas-permeable header can be removed after completion of the gaseous sterilization process such that a pouch is formed using at least a portion of the remaining gas-impermeable pouch portion. Sealing the second sealing lid to the tray, engaging the cap and the jar, and / or removing the gas-permeable header can provide an enclosure that serves as a moisture barrier while allowing sterility of the medical device to be maintained.

[0021] It will be understood that one or more packaging assemblies described herein can be used in combination with one or more of the other packaging assemblies. For example, a packaging assembly described herein can be disposed within one or more of the other packaging assemblies described herein. In some instances, a sealed and / or capped jar can be configured to be disposed within a pouch, such as sealed within the pouch. In some instances, a sealed tray can be configured to be disposed within a pouch, such as sealed within the pouch. In some instances, a sealed pouch can be disposed within ajar and / or tray, including a sealed and / or capped jar, and / or a sealed tray. In some instances, the medical devices can comprise an implantable medical device, including for example prosthetic heart valves, such as heart valves configured to be delivered using minimally invasive transcatheter procedures. In some instances, the prosthetic heart valves can comprise prosthetic aortic heart valves, prosthetic mitral valves, and / or prosthetic tricuspid valves. In some instances, the medical devices can comprise one or more other devices configured to replace and / or for repair of a heart valve. In some instances, the one or more prosthetic heart valves and / or medical devices can be sensitive to moisture. For example, the prosthetic heart valves and / ormedical devices configured to replace and / or for repair of heart valves can comprise animal tissue, including bovine tissue, such as pericardial bovine tissue.

[0022] Figures 1A and IB provide a perspective view and side cross-sectional view of an example of a packaging assembly 100 configured to receive a medical device (not shown). The packaging assembly 100 can comprise a tray 110. The tray 110 can define a recess 112 configured to receive the medical device. For example, the tray 110 can comprise a lateral wall portion 120 and bottom wall portion 130 that define the recess 112. A top portion 122 of the lateral wall portion 120 can define a top opening 114 of the recess 112. A bottom portion 124 of the lateral wall portion 120 can be coupled to the bottom wall portion 130, for example extending upwardly from the bottom wall portion 130. In some instances, the tray 110 can be a unitary piece. In some instances, the tray 110, including the lateral and bottom wall portions 120, 130 can be formed using a unitary piece of material. In some instances, a process for manufacturing the tray 110 can comprise a lamination process. In some instances, the tray 110 can comprise a gas-impermeable material. In some instances, the tray 110 can comprise a moisture-resistant material. For example, the tray 110, including the lateral and bottom wall portions 120, 130, can be gas-impermeable and / or moisture-resistant. The packaging assembly 100 can comprise a first sealing lid 150 configured to provide a lid over the recess 112. For example, the first sealing lid 150 can be configured to be disposed over the recess 112 and coupled to the tray 110, including being directly coupled to the tray 110. The first sealing lid 150 can be coupled to the tray 110 to provide a sealed recess, for example directly sealed to the tray 110. In some instances, the first sealing lid 150 can comprise a tab 150a to facilitate removal of the first sealing lid 150. The tab 150a can comprise a portion of the first sealing lid 150 that extends and / or protrudes beyond adjacent portions of the first sealing lid 150 to facilitate user engagement for removing the first sealing lid 150. The tab 150a can extend and / or protrude beyond respective edge portion of the tray 110. In some instances, the first sealing lid 150 can comprise a gas-permeable material portion 160 and a gas-impermeable material portion 162. The gas-permeable material portion 160 can be configured to be allow passage therethrough of gas, including sterilization gas for sterilizing the medical device received within the recess 112 sealed by the first sealing lid 150. In some instances, the gas-permeable material portion 160 can allow passage therethrough of one or more purging gases. Although the first sealing lid 150 is described with one gas-permeable material portion 160, it will be understood that a first sealing lid can comprise more than one gas-permeable material portions. The gas-impermeable material portion 162 can be impermeable or substantially impermeable to gas and moisture.

[0023] In some instances, the recess 112 can comprise a shape and / or size based at least in part on a shape and / or size of the medical device. For example, the lateral wall portion 120 and / or bottom wall portion 130 can each comprise one or more indentations along at least a portion thereof. In some instances, the shape and / or size of the recess 112 can be configured to conform or substantially conform to the shape and / or size of the medical device. In some instances, the lateral and / or bottom wall portions 120, 130 can define a recess 112 having an oblong shape. For example, the top portion 122 of the lateral wall portion 120 can define a top opening 114 having an oblong shape, including a rectangular or substantially rectangular shape. In some alternative instances, the lateral and / or bottom wall portions 120, 130 can define a recess 112 having a rounded configuration. For example, the top portion 122 of the lateral wall portion 120 can define a top opening 114 having circular or substantially circular shape. In some alternative instances, the top portion 122 can define a top opening 114 having a square or substantially square shape.

[0024] In some instances, a top rim 140 can extend laterally from the top portion 122 of the lateral wall portion 120, including a top edge 126, that defines the top opening 114 of the recess 112. The top edge 126 can at least partially define the top opening 114. In some instances, the top rim 140 can extend circumferentially around the top portion 122, including the top edge 126, of the lateral wall portion 120. For example, the top rim 140 can extend around a rectangularly or substantially rectangularly shaped top opening. In some instances, the top rim 140 can assume a rectangular or substantially rectangular shape, for example an outer edge of the top rim 140 forming the rectangular shape. In some instances, an edge portion 156 of the first sealing lid 150 can be coupled to the tray 110, such as the top rim 140, including sealing circumferentially around the top rim 140. A first surface 152 of the first sealing lid 150 can be oriented toward the recess 112, including a first surface 142 of the top rim 140. A second surface 154 of the first sealing lid 150 can be opposingly oriented away from the recess 112. The first surface 152 on at least a portion of the edge portion 156 of the first sealing lid 150 can be sealed to one or more portions of the top rim 140. For example, the first surface 142 of the top rim 140 can have an upward orientation. The first sealing lid 150 can be configured to be sealed to at least a portion of the first surface 142 of the top rim 140. In some instances, the first sealing lid 150 and the top rim 140 can form a continuous seal around the top opening 114, such as to enclose the medical device within the recess 112.

[0025] The gas -impermeable material portion 162 of the first sealing lid 150 can be sealed to the tray 110, such as the top rim 140, for example so as to seal the recess 112 against gas permeation through edge portions 156 of the first sealing lid 150. In someinstances, sealing of the gas-impermeable material portion 162 to the tray 110 can reduce or prevent moisture ingress and / or permeation through any edge portion 156 the first sealing lid 150 sealed to the tray 110. For example, rather than having any portion of the gas-permeable material 160 exposed along any edge portion of the first sealing lid 150, the edge portion 156 of the first sealing lid 150 sealed to the tray 110 can be gas-impermeable and / or moisture- resistant. In some instances, the gas-impermeable material portion 162 can surround the gas- permeable material portion 160. In some instances, the edge portion 156 of the first sealing lid 150 can comprise the gas impermeable material portion 162, such as to facilitate coupling the gas-impermeable portion 162 to the top rim 140. In some instances, the gas-permeable material portion 160 can be centered on the first sealing lid 150. For example, a central portion 158 of the first sealing lid 150 can comprise the gas-permeable material portion 160. Alternatively, the gas-permeable material portion 160 can be off-centered.

[0026] Referring again to Figures 1A and IB, the packaging assembly 100 can comprise a second gas-impermeable and moisture-resistant sealing lid 170 configured to be disposed over the first sealing lid 150 to provide a sealed recess that is gas-impermeable and / or moisture-resistant. The second gas-impermeable and moisture-resistant sealing lid 170 can be impermeable or substantially impermeable to gas and moisture. The second gas- impermeable and moisture-resistant sealing lid 170 can comprise a first surface 172 configured to be oriented toward the recess 112, including toward the first sealing lid 150 disposed over the recess 112. A second surface 174 can be configured to be oriented away from the first sealing lid 150. At least a portion of the first surface 172 of the second gas- impermeable and moisture-resistant sealing lid 170, such as an edge portion 176 of the second gas-impermeable and moisture-resistant sealing lid 170, can be configured to be coupled to the first sealing lid 150. For example, the first surface 172 of the second gas- impermeable and moisture-resistant sealing lid 170, such as an edge portion 176 of the first surface 172, can be configured to be coupled to respective portions of the second surface 154 of the first sealing lid 150. The edge portion 176 of the first surface 172 can be coupled to the first sealing lid 150 along the edge portion 156 of the second surface 154 of the first sealing lid 150. In some instances, the first sealing lid 150 and the second gas-impermeable and moisture-resistant sealing lid 170 can have the same or similar size and / or shape. A continuous seal, including a circumferential seal, can be formed between the first sealing lid 150 and the second gas-impermeable and moisture-resistant sealing lid 170, such as around respective edge portions of the lids 150, 170. Sealing the second gas-impermeable and moisture-resistant sealing lid 170 to the first sealing lid 150 can seal the recess 112 againstgas permeation. The recess 112 can be provided in an air-tight and / or sterile condition. In some instances, the second gas-impermeable and moisture-resistant sealing lid 170 can comprise a tab 170a to facilitate its removal. The tab 170a can comprise a portion of the second gas-impermeable and moisture-resistant sealing lid 170 that extends and / or protrudes beyond adjacent portions of the sealing lid 170 to facilitate user engagement. The tab 170a can extend and / or protrude beyond respective edge portion of the tray 110. Figure 1 A shows the tabs 150a, 170a being aligned with one another. Aligning the tabs 150a, 170a can facilitate removal of both lids 150, 170 together. In some instances, the tabs 150a, 170a can extend from a comer portion of the respective sealing lid 150, 170. As described herein, the top opening 114 and / or top rim 140 can have a rectangular shape. In some instances, the shape and / or size of the first sealing lid 150 and / or second gas-impermeable and moistureresistant sealing lid 170 can be the same or similar to that of the top opening 114 and / or top rim 140. For example, the first sealing lid 150 and / or second gas-impermeable and moisture- resistant sealing lid 170 can be rectangular or substantially rectangular. In some instances, the tabs 150a, 170a can extend from a corner of the rectangle. Alternatively, the tabs 150a, 170a can extend from another portion of the respective sealing lid 150,170. In some alternative instances, the first sealing lid 150 can comprise the tab 150a while the second gas- impermeable and moisture-resistant sealing lid 170 does not, such that pulling off the first sealing lid 150 also removes the second gas-impermeable and moisture-resistant sealing lid 170.

[0027] In some instances, the first sealing lid 150 can be sealed onto the tray 110 after the medical device is placed into the recess 112. The tray 110 can subsequently be subjected to one or more sterilization processes, including one or more sterilization processes for sterilizing the medical device. In some instances, one or more sterilization gases can be allowed to pass through the gas-permeable material portion 160 such that the medical device received within the recess 112 sealed by the first sealing lid 150 can be sterilized. After the sterilization is complete, the second gas-impermeable and moisture-resistant sealing lid 170 can be sealed onto the first sealing lid 150 to provide the recess 112 in the air-tight and / or sterile condition.

[0028] In some instances, the recess 112 sealed by the second gas-impermeable and moisture-resistant sealing lid 170 can be provided under a partial vacuum. The partial vacuum can prevent rupture of the seal between the second gas -impermeable and moistureresistant sealing lid 170 and the tray 110, including the first sealing lid 150 coupled to the tray 110, under high altitude conditions. In some instances, the recess 112 sealed by thesecond gas-impermeable and moisture-resistant sealing lid 170 can be provided at about 50% to about 95% of the atmospheric pressure, such as the surrounding atmospheric pressure, including surrounding atmospheric pressure at the manufacturing facility, including about 70% to about 95%, about 70% to about 90%, about 70% to about 85%, and about 75% to about 80%.

[0029] In some instances, the packaging assembly 100 can comprise a one-way valve 180 configured to be coupled to the second gas-impermeable and moisture-resistant sealing lid 170 to allow release and / or escape of gas from within the sealed tray. The one-way valve 180 can allow release and / or escape of gas from within the sealed tray while preventing entry of gas and / or moisture into the sealed tray. In some instances, the one-way valve 180 can be triggered, for example assume an open state, to allow release and / or escape of gas from within the sealed tray once a target pressure differential is reached. For example, the one-way valve 180 can remain in a closed state while pressure external of the sealed tray is higher than that within the sealed tray. The one-way valve 180 can assume the open state to allow degassing of gas from within the sealed tray while pressure external of the sealed tray is less than the pressure within the sealed tray. The one-way valve 180 can reduce or prevent gas buildup within the sealed tray, thereby reducing or preventing ballooning of the second gas-impermeable and moisture-resistant sealing lid 170, which can lead to rupture and / or failure of the sealed tray.

[0030] The one-way valve 180 can comprise at least a portion disposed over an externally oriented surface, such as the second surface 174 of the second gas-impermeable and moisture-resistant sealing lid 170. The second gas-impermeable and moisture-resistant sealing lid 170 can comprise one or more openings (not shown) extending therethrough and in fluid communication with, such as aligned with, the one-way valve 180 to allow gas from within the sealed tray to pass therethrough and out through the one-way valve 180. For example, the one or more openings can be disposed below at least a portion of the one-way valve 180. The one-way valve 180 and one or more openings in the second gas-impermeable and moisture-resistant sealing lid 170 can be at any number of different locations on the second gas-impermeable and moisture-resistant sealing lid 170. In some instances, the oneway valve 180 and one or more openings can be on a central portion 178 of the second gas- impermeable and moisture-resistant sealing lid 170.

[0031] In some instances, the one-way valve 180 can have a patch configuration. For example, the one-way valve 180 can comprise a first surface 182 configured to be coupled to the second surface 174 and a second surface 184 configured to be oriented awayfrom the second surface 174. At least a portion of the first surface 182 can comprise a glue and / or adhesive such that the first surface 182 can be disposed over and coupled to the second gas-impermeable and moisture-resistant sealing lid 170. For example, application of the oneway valve 180 to the second surface 174 of the second gas-impermeable and moisture- resistant sealing lid 170 can comprise a peel- and- stick method.

[0032] In some instances, a packaging assembly can comprise more than one oneway valve. Each one-way valve can be in fluid communication with, such as aligned with, one or more respective openings. The one-way valves and respective openings can be at similar or different locations on a second gas-impermeable and moisture-resistant sealing lid.

[0033] The gas-permeable material portion 160 can comprise any number of porous materials configured to maintain a sterile barrier while allowing gas to pass therethrough. In some instances, the gas-permeable material portion 160 of the first sealing lid 150 can comprise polyolefin fibers and / or filaments, including polyethylene fibers and / or filaments, such as high-density polyethylene (HDPE) (e.g., TYVEK® 2FS, 1059B and / or 1073B, from DuPont de Nemours, Inc. of Wilmington, Delaware). In some instances, the gas-permeable material portion 160 can comprise a spunbonded olefin sheet. In some instances, the gas-impermeable material portion 162 of the first sealing lid 1 0 can be moisture-resistant. In some instances, the gas -impermeable material portion 162 and / or the second gas-impermeable and moisture-resistant sealing lid 170 can comprise foil, including an aluminum foil. For example, the first sealing lid 150 and / or the second gas-impermeable and moisture-resistant sealing lid 170 can comprise a foil layer. In some instances, the second moisture-resistant sealing lid 170 can be heat sealed to the first sealing lid 150. Alternatively, or in combination, one or more other sealing methods can be used. In some instances, the second moisture-resistant sealing lid 170 can be sealed to the first sealing lid 150 using one or more of induction sealing and laser sealing. In some instances, the tray 110 can comprise a gas-impermeable and moisture-resistant material. In some instances, the tray 110 can comprise a cyclic olefin copolymer (COC), including a laminated structure comprising one or more cyclic olefin copolymer (COC) layers. In some instances, the laminated structure can comprise one or more layers comprising another polymer, including for example polychlorotrifluoroethylene (PCTFE). In some instances, the first sealing lid 150 can be heat sealed to the tray 110. Alternatively, or in combination, one or more other sealing methods can be used. In some instances, the first sealing lid 150 can be sealed to the tray 110 using one or more of induction sealing and laser sealing. For example, sealing the second gas- impermeable and moisture-resistant sealing lid 170 to the first sealing lid 150 can provide amoisture barrier and sterile environment for the medical device. As described herein, the second gas-impermeable and moisture-resistant sealing lid 170 can be sealed to the edge portion 156 of the first sealing lid 150, such as the portion of the first sealing lid 150 comprising the gas-impermeable material portion 162. In some instances, sealing of the tray 110 to the gas-impermeable material portion 162 can reduce or prevent moisture ingress and / or permeation through the material of the first sealing lid 150, such as any exposed portions of a gas-permeable material.

[0034] Figure 2 provides an exploded perspective view of another example of a packaging assembly 200 configured to receive a medical device. The packaging assembly 200 can comprise an outer tray 210 and an inner tray 280. In some instances, use of both the outer tray 210 and inner tray 280 can facilitate aseptic transfer of the sterile medical device disposed within the inner tray 280 into a sterile field, such as in an operating room. The inner tray 280 can define a recess 288 configured to receive the medical device. For example, the inner tray 280 can comprise a lateral wall portion 282 and a bottom wall portion 286 that define the recess 288. The lateral wall portion 282 can be coupled to the bottom wall portion 286, for example extending upwardly from the bottom wall portion 286. In some instances, the inner tray 280 can be a unitary piece, for example being formed using a unitary piece of material. The inner tray 280 can have one or more features of the outer tray 210 as described herein. An inner sealing lid 294 can be configured to be coupled to the inner tray 280 to seal the recess 288. As described in further detail herein, the inner sealing lid 294 can comprise a gas-permeable material to facilitate passage therethrough of gas. For example, the gas- permeable material can allow passage therethrough of sterilization gas for sterilization of the medical device. In some instances, the gas-permeable material can allow passage therethrough of a purging gas. In some instances, a top rim 290 can extend from a top end 284 of the lateral wall portion 282. The inner sealing lid 294 can form a seal with the top rim 290, for example, forming a continuous seal around the top rim 290, including a circumferential seal. Respective portions of a first surface 296 of the inner sealing lid 294 can be configured to be oriented toward and sealed to the top rim 290, including a first surface 292 of the top rim 290 oriented toward the inner sealing lid 294. The inner sealing lid 294 can have a second surface 298 oriented away from the top rim 290. The inner tray 280 can be configured to be received within the outer tray 210. For example, the sealed inner tray 280 can be disposed within the recess 212 of the outer tray 210.

[0035] The outer tray 210 can comprise one or more features of the tray 110 described with reference to Figures 1A and IB. In some instances, the outer tray 210 canhave the same features as the tray 110 described with reference to Figures 1A and IB. For example, the outer tray 210 can comprise a lateral wall portion 220 and bottom wall portion 230 that define a recess 212 configured to receive the medical device. A top portion 222 of the lateral wall portion 220 can define a top opening 214 of the recess 212. A first outer sealing lid 250 can be disposed over the top opening 214 and coupled to the outer tray 210 to seal the recess 212. A top rim 240 can extend laterally from the top portion 222, including a top end 224, of the lateral wall portion 220. In some instances, an edge portion 256 of the first outer sealing lid 250 can be coupled to the outer tray 210, such as the top rim 240, for example forming a circumferential seal with the outer tray 210. The first outer sealing lid 250 can comprise a first surface 252 configured to be oriented toward a first surface 242 of the top rim 240, and a second opposingly oriented surface 254. At least a portion of the first surface 252 on the edge portion 256 of the first outer sealing lid 250 can be configured to be sealed to one or more portions of the top rim 240.

[0036] In some instances, the first outer sealing lid 250 can comprise a gas- permeable material portion 260 and a gas-impermeable material portion 262. The gas- impermeable material portion 262 can be impermeable to gas and / or moisture. The gas- permeable material portion 260 can be configured to be allow passage therethrough of gas, including sterilization gas for sterilizing the medical device received within the recess 212 sealed by the first outer sealing lid 250. In some instances, the gas-permeable material portion 260 can comprise a plurality of discrete portions. The discrete portions can have any number of shapes. In some instances, the gas-permeable material portion 260 can comprise a plurality of circular portions. Alternatively, the discrete gas-permeable material portions can have one or more different shapes, including oval, rectangular and / or square. The discrete gas- permeable material portions may or may not have the same shape. Figure 2 shows the gas- permeable material portion 260 of the first outer sealing lid 250 comprising three circular portions. In some instances, the plurality of discrete portions can be arranged on a center portion 258 of the first outer sealing lid 250. In some instances, the three circular gas- permeable material portions 260a, 260b, 260c can be arranged along a line on the center portion 258 of the first outer sealing lid 250.

[0037] Alternatively or in combination, a plurality of discrete gas-permeable material portions can comprise a non-circular shape, including a rectangular and / or oval shape. The plurality of discrete gas-permeable material portions can be off-centered on a sealing lid and / or comprise a non-linear arrangement on the sealing lid. In some instances, the plurality of discrete gas-permeable material portions can be arranged on the sealing lid suchthat a gas-impermeable material portion forms an edge portion of the sealing lid. The gas- impermeable material portion on the edge portion of the sealing lid can facilitate sealing of the sealing lid to the tray.

[0038] A second outer sealing lid 270 can be configured to be disposed over the first outer sealing lid 250 to provide a sealed recess that is gas -impermeable and / or moistureresistant. The second outer sealing lid 270 can be gas-impermeable and / or moisture-resistant. A first surface 272 of the second outer sealing lid 270 can be configured to be oriented toward and coupled to the first outer sealing lid 250. For example, an edge portion 276 of the first surface 272 can be configured to be coupled to respective portions of the second surface 254 of the first outer sealing lid 250. The edge portion 276 of the first surface 272 can be coupled to the first outer sealing lid 250 along the edge portion 256 of the second surface 254 of the first outer sealing lid 250, for example forming a circumferential seal around the edge portion 256 of the first outer sealing lid 250. Sealing the second outer sealing lid 270 to the first sealing lid 250 can seal the recess 212 against gas permeation to provide the recess 212 in an air-tight and / or sterile condition.|0039| In some instances, the inner sealing lid 294 can be sealed onto the inner tray 280 after the medical device is placed into the recess 288. The inner sealing lid 294 can comprise a gas-permeable material. In some instances, the inner sealing lid 294 can be entirely or substantially gas-permeable. In some instances, sealed inner tray 280 can be placed into the outer tray 210. The first outer sealing lid 250 can be sealed to the outer tray 210 after the inner tray 280 is placed into the outer tray 210. For example, the first surface 252 of the outer sealing lid 250 can be oriented toward the second surface 298 of the inner sealing lid 294. In some instances, the sealed outer tray 210 can be subjected to one or more sterilization processes, including sterilization process for sterilizing the medical device. The gas-permeable material portion 260 of the first outer sealing lid and the gas-permeable inner sealing lid 294 can allow passage therethrough of the sterilization gas. After the inner sealing lid 294 is sealed to the inner tray 280, the sealed tray can be subjected to one or more sterilization processes, including sterilization process for sterilizing the medical device. In the alternative or combination, the sealed inner tray 280 can be subjected to one or more sterilization processes prior to being placed into the outer tray 210. In some instances, the outer tray 210 can sealed and subsequently be subjected to one or more additional sterilization processes. After the sterilization process is complete, the second outer sealing lid 270 can be sealed to the first outer sealing lid 250.

[0040] The packaging assembly 200 can comprise one or more other features of the packaging assembly 100 described with reference to in Figures 1A and IB. For example, the recess 212 sealed by the second outer sealing lid 270 can be provided under a partial vacuum. In some instances, the recess 212 sealed can be provided at about 50% to about 95% of the atmospheric pressure, such as the surrounding atmospheric pressure, including surrounding atmospheric pressure at the manufacturing facility, including about 70% to about 95%, about 70% to about 90%, about 70% to about 85%, and about 75% to about 80%. In some instances, the packaging assembly 200 can comprise a one-way valve coupled to the second outer sealing lid 270 to facilitate release of gas from within the sealed outer tray 210. For example, the second outer sealing lid 270 can comprise one or more openings aligned with the one-way valve to allow release of the gas to prevent rupture of the seal between the outer tray 210 the second outer sealing lid 270.

[0041] Figure 3 is a perspective view of an example of a tray 300 for a packaging assembly configured to receive a medical device. In some instances, the tray 300 can be used as a part of a packaging assembly described herein, including one or more of packaging assemblies 100, 200 described with reference to in Figures 1A, IB, and 2. For example, the tray 300 can replace the tray 110 in the packaging assembly 100 described with reference to in Figures 1A and IB, and / or the outer tray 210 in the packaging assembly 200 described with reference to in Figure 2. The tray 300 can comprise a lateral wall portion 310 and bottom wall portion 320 that define a recess 302. A top portion 312 of the lateral wall portion 310, such as a top edge 316, can define a top opening 304 of the recess 302. A top rim 330 can extend laterally from the top portion 312, such as the top edge 316, of the lateral wall portion 310. The top rim 330 can extend circumferentially around the top portion 312, such as the top edge 316. In some instances, an edge portion of a first sealing lid can be coupled to the top rim 330. The first sealing lid can comprise one or more features of the first sealing lid 150 described with reference to Figures 1A and IB, and / or the first outer sealing lid 250 described with reference to Figure 2. The top rim 330 can comprise a first circumferential sealing surface 340 and a second circumferential sealing surface 342. For example, the top rim 330 can comprise a first surface 332 having an upward orientation. The first surface 332 can comprise the first circumferential sealing surface 340 extending around the top rim 330. The second circumferential sealing surface 342 can extend around the first circumferential sealing surface 340 on the first surface 332. The second circumferential sealing surface 342 can be spaced from the first circumferential sealing surface 340. For example, the first surface 332 can comprise a first protruding surface portion, such as a first upwardlyprotruding surface portion, forming the first circumferential sealing surface 340, and a second protruding surface portion, such as a second upwardly protruding surface portion, forming the second circumferential sealing surface 342. A groove and / or recess 344 can extend around the circumference of the top rim 330 between the first and second circumferential sealing surfaces 340, 342. In some instances, the first circumferential sealing surface 340 can comprise a flat or substantially flat surface extending along the entire or substantially entire circumference of the top rim 330. The second circumferential sealing surface 342 can comprise a flat or substantially flat surface extending along the entire or substantially entire circumference of the top rim 330.

[0042] The first and second circumferential sealing surfaces 340, 342 can be configured to seal to respective circumferential portions of the first sealing lid. The first sealing lid can be disposed over the top opening 304 and coupled to the tray 300 to provide a seal for the recess 302. For example, a first surface of the first sealing lid can be oriented toward the recess 302, including the first surface 332 of the top rim 330. The first surface on at least a portion of the edge portion of the first sealing lid can be sealed to the first and second circumferential sealing surfaces 340, 342. Two circumferential seals can thereby form between the first sealing lid and the tray 300.

[0043] In some instances, a top rim having two circumferential sealing surfaces can prevent premature rupturing of sealing for the tray, including under conditions at higher altitudes. Increased pressure within the recess 302 relative to an external pressure, such as at higher altitudes, can contribute to undesired rupturing of the seal for the tray, thereby compromising the sterility of the recess 302. A tray comprising two circumferential seals can provide a sacrificial seal, such as an inner circumferential seal. An outer circumferential seal can maintain the integrity of the sterility of the recess 302 after an inner circumferential seal ruptures. For example, sealing between the tray 300 and the first sealing lid can be maintained so long as either the seal between the first sealing lid and the first circumferential sealing surface 340 or the seal between the first sealing lid and the second circumferential sealing surface 342 is intact. In some instances, an intact seal between the first sealing lid and the second circumferential sealing surface 342 can maintain a sealed recess 302 even if the seal between the first sealing lid and the first circumferential sealing surface 342 is compromised.

[0044] The tray 300 can comprise one or more other features of the trays 110, 210 described with reference to Figures 1A and IB, and 2. For example, a bottom portion 314 of the lateral wall portion 310 can be coupled to the bottom wall portion 320, for exampleextending upwardly from the bottom wall portion 320. The tray 300 can comprise a gas- impermeable and / or moisture-resistant material. The recess 302 can comprise a shape and / or size based at least in part on a shape and / or size of the medical device, including one or more indentations along at least a portion of the lateral and / or bottom wall portions 310, 320.

[0045] Figures 4A, 4B, 4C, 4D, 4E and 4F show various views of an example of a packaging assembly 400 configured to receive a medical device, where the packaging assembly 400 comprises ajar 402. Figure 4 A provides an exploded perspective view of the packaging assembly 400. The packaging assembly 400 can comprise the jar 402 defining a space 404 configured to receive the medical device. The jar 402 can comprise a bottom and lateral wall portion 410, 420 at least partially defining the space 404 configured to receive the medical device. A gas-permeable sealing lid 450 can be configured to be disposed over a top opening 406 of the jar 402 and be coupled to the jar 402 to provide a lid over the space 404. A cap 470 can be configured to be threadedly engaged with the jar 402. A sealing ring 494, such as an O-ring, can be circumferentially received around a portion of the jar 402. At least a portion of the sealing ring 494 can be configured to engage with respective portions of the cap 470 while the cap 470 is threadedly engaged with the jar 402, such as to facilitate providing an air-tight seal between the cap 470 and jar 402. Figures 4B, 4C and 4D are a perspective, side view, and side cross-sectional view, respectively, of the jar 402. Figures 4E and 4F are a perspective and side cross-sectional view, respectively, of the cap 470.

[0046] The gas-permeable sealing lid 450 can be configured to be disposed over the top opening 406 and couple to the jar 402, such as forming a seal, including a continuous seal, with portions of the jar 402 at least partially defining the top opening 406 to provide the space 404 in a sealed state. For example, the gas-permeable sealing lid 450 can form a circumferential seal with portions of the jar 402 at least partially defining the top opening 406. In some instances, the gas-permeable sealing lid 450 can be entirely or substantially entirely gas-permeable. The gas-permeable sealing lid 450 can be configured to allow passage therethrough of any number of gases, including sterilization gas for sterilizing the medical device received within the space 404 while the space 404 is sealed by the gas- permeable sealing lid 450. In some instances, the gas-permeable sealing lid 450 can allow passage therethrough of one or more purging gases. In some instances, an edge portion 452 of the gas-permeable sealing lid 450 can be configured to form the seal with the jar 402. A first surface 454 of the gas-permeable sealing lid 450 can be configured to be oriented toward the jar 402, such as the space 404. A second surface 456 can be oriented away from the jar 402.In some instances, the first surface 454, such as along the edge portion 452, can form the seal with the jar 402.

[0047] In some instances, the gas-permeable sealing lid 450 can comprise a tab 458. The tab 458 can extend from the edge portion 452, for example forming a protrusion along a portion of the edge portion 452. The tab 458 can facilitate user engagement of the gas-permeable sealing lid 450, such as for its removal. In some instances, the tab 458 can be in a folded configuration to facilitate positioning of the cap 470 over the gas-permeable sealing lid 450. For example, the tab 458 can be folded back over remaining portions of the gas-permeable sealing lid 450 such that the second surface 456 of the tab 458 can be oriented toward remaining portions of the second surface 456 of the of the gas-permeable sealing lid 450.

[0048] In some instances, the packaging assembly 400 can optionally comprise a medical device holder 460. The medical device holder 460 can be configured to engage with the medical device to maintain a position of the medical device within the jar 402, including for prevention or reduction of movement along a longitudinal and / or lateral dimension of the jar 402. In some instances, the medical device holder 460 can comprise a first circumferential member 462 and a second circumferential member 464 that are longitudinally spaced from and aligned with one another. For example, the first circumferential member 462 can be oriented toward the top opening 406 and the second circumferential member 464 can be oriented toward the bottom wall portion 410. A plurality of elongate rods 466 can couple the first and second circumferential members 462, 464 to one another. The plurality of elongate rods 466 can be distributed around and coupled to respective portions of each of the first and second circumferential members 462, 464, including respective portions of an outer edge portion of the first and second circumferential members 462, 464. In some instances, the first and second circumferential members 462, 464 can each comprise a ring configuration. At least a portion of the medical device can be received within the opening of each of the first and second circumferential members 462, 464. In some instances, a size and / or shape of the medical device holder 460 can be selected based on a size and / or shape of the space 404 of the jar 402. For example, one or more portions of the first and second circumferential members 462, 464 and / or plurality of elongate rods 466 can be configured to engage with portions of an inwardly oriented surface 432 of the jar 402. In some instances, each of the first and second circumferential members 462, 464 can comprise a straight portion 462a, 464a configured to align, engage and / or mate with a flat portion 420a of the lateral wallportion 420 of the jar 402. It will be understood that, in alternative instances, a packaging assembly may not use a medical device holder.

[0049] Referring to Figures 4B, 4C and 4D, the bottom wall portion 410 and lateral wall portion 420 of the jar 402 can at least partially define the space 404 configured to receive the medical device. For example, inwardly oriented surfaces 432, 412 of the lateral and bottom wall portions 420, 410 can define the space 404. A top end portion 422 of the lateral wall portion 420 can define the top opening 406. A bottom portion 424 of the lateral wall portion 420 can be coupled to the bottom wall portion 410. The lateral wall portion 420 can extend upwardly from the bottom wall portion 410, including from an edge portion 414 of the bottom wall portion 410.

[0050] As described in further detail herein, the cap 470 can be threadedly engaged with the jar 402. In some instances, the jar 402 can comprise a plurality of threads 434 configured to engage with complementary threads of the cap 470. The top end portion 422 of the lateral wall portion 420 can comprise the plurality of threads 434 to mate with reciprocal threads of the cap 470. In some instances, the plurality of threads 434 can be configured to allow engaging, including fully and / or completely engaging, and / or removing, including fully and / or completely removing, the cap 470 after rotating the cap 470 about 2.5 turns relative to the jar 402. The cap 470 can be engaged with the jar 402 while the gas- permeable sealing lid 450 is coupled to the jar 402. Respective portions of the first surface 454 of the gas-permeable sealing lid 450 can be coupled to, such as form a seal with, a top surface 426 of the top end portion 422 of the lateral wall portion 420.

[0051] In some instances, the packaging assembly 400 can comprise a sealing ring 494, such as an O-ring, configured to be received by a circumferential recess 428 of the jar 402. The circumferential recess 428 can be disposed around a circumference of the lateral wall portion 420. For example, a portion of an externally oriented surface 430 of the lateral wall portion 420 can define the circumferential recess 428. A portion of the sealing ring 494 can be received within the circumferential recess 428. At least a portion of the sealing ring 494 protruding from the circumferential recess 428 can be configured to engage with respective portions of the cap 470 while the cap 470 is threadedly engaged with the jar 402, such as to facilitate providing an air-tight seal, between the cap 470 and the jar 402. In some instances, the sealing ring 494 can comprise a fluoropolymer elastomer and synthetic rubber compound (e.g. , Viton™, The Chemours Company of Wilmington, Delaware). In some instances, the sealing ring 494 can comprise a synthetic rubber. In some instances, the sealing ring 494 can comprise ethylene propylene diene monomer rubber (EPDM).

[0052] A position of the circumferential recess 428 along a height of the lateral wall portion 420 can be selected to provide desired engagement between the sealing ring 494 and the cap 470, and / or ease of screwing on and / or off of the cap 470. In some instances, the circumferential recess 428 can be disposed above the plurality of threads 434 of the lateral wall portion 420. In some instances, the circumferential recess 428 can be distanced from a top of the lateral wall portion 420, such as the top surface 426. In some instances, an outer diameter of the top end portion 422 comprising the recess 428 can be smaller than that comprising the plurality of threads 434. In some instances, the top end portion 422 can comprise a step transition between the wider and narrower portions. In some instances, the reduced outer diameter of the portion of the lateral wall portion 420 comprising the recess 428 can facilitate desired engagement between the sealing ring 494 and the cap 470 while providing ease of screwing on and / or off of the cap 470.

[0053] In some instances, the lateral wall portion 420 can comprise a flat portion 420a extending at least partially along a height of the lateral wall portion 420. For example, the lateral wall portion 420 can comprise a flat portion 420a extending at least partially along a longitudinal axis, such as a height, of the jar 402. In some instances, at least a portion of the externally oriented surface 430 and / or at least a portion of the inwardly oriented surface 432 of the lateral wall portion 420 can be flat. In some instances, the inwardly oriented surface 432 of the flat portion 420a can be flat along an entire or substantially entire height of the lateral wall portion 420. In some instances, remaining portions of the lateral wall portion 420 can be arcuate. In some instances, a cross section along a plane perpendicular or substantially perpendicular to the longitudinal axis, such as the height, of the jar 402 can comprise a segment of an oval, including a segment of a circle. In some instances, the inwardly oriented surface 432 of the flat portion 420a can facilitate engagement with the medical device holder 460 and / or medical device to reduce relative movement of the medical device holder 460 and / or medical device. In some instances, the externally oriented surface 430 of the of the flat portion 420a can facilitate user engagement with the jar 402, such as providing ease of gripping by the user. In some instances, a lateral wall portion can comprise more than one flat portion. For example, a lateral wall portion can comprise more than one flat portion between respective adjacent arcuate portions.

[0054] The jar 402 can comprise a lateral rim 440 extending circumferentially from the lateral wall portion 420. In some instances, the lateral rim 440 can extend from a position on the lateral wall portion 420 below the plurality of threads 434. As described in further detail herein, the lateral rim 440 of the jar 402 can be configured to engage with alower rim 488 of the cap 470 to facilitate desired engagement between the cap 470 and the jar 402.

[0055] Referring to Figures 4E and 4F, a perspective view and a side cross- sectional view, respectively, of the cap 470 are shown. The cap 470 can comprise a lateral cap portion 472 and a top cap portion 474. A first surface 480, such as an inwardly oriented surface, of the cap 470 can be configured to be oriented toward the jar 402, such as while the cap 470 is disposed over the jar 402. A second surface 482, such as an externally oriented surface, of the cap 470 can be configured to be oriented away from the jar 402. The lateral cap portion 472 can extend, such as downwardly, from the top cap portion 474. For example, an upper end portion of the lateral cap portion 472 can extend downwardly from around an edge portion 486 of the top cap portion 474. The first surface 480, such as a portion of the first surface 480 on the lateral cap portion 472, can comprise a plurality of threads 484 configured to threadedly engage with the plurality of threads of the jar 402.

[0056] The top portion 474 can be configured to be at least partially disposed over the top opening 406 of the jar 402. In some instances, a portion of the first surface 480 of the top portion 474 can be disposed over and / or in contact with the gas-permeable sealing lid 450.

[0057] In some instances, a circumferential portion of the first surface 480 can engage with respective portions of the sealing ring 494 to facilitate sealing of the jar 402. The circumferential portion of the first surface 480 can be above the portion of the first surface 480 comprising the plurality of threads 484. In some instances, an inner lateral dimension, such as an inner diameter, of the cap 470 at the circumferential portion can be smaller than that at the portion of the first surface 480 comprising the plurality of threads 484. For example, an upper end portion 476 of the cap 470 can have an inner lateral dimension smaller than that of a lower end portion 478 of the cap 470. In some instances, the smaller diameter can facilitate engagement between the sealing ring and the cap 470 to provide the air-tight seal.

[0058] In some instances, the cap 470 can comprise a plurality of indentations 492 circumferentially disposed on the second surface 482. In some instances, the plurality of indentations 492 can be on the top and / or lateral cap portions 472, 474. The plurality of indentations 492 can be configured to facilitate user engagement with the cap 470, such as to screw the cap 470 onto or off from the jar 402. In some instances, the plurality of indentations 492 can be evenly distributed around the second surface 482.

[0059] In some instances, the cap 470 can comprise a lower rim 488 configured to engage with the lateral rim 440 of the jar 402. The lower rim 488 can extend laterally from a lower end portion 478 of the lateral cap portion 472. For example, the lower rim 488 can comprise a lower surface 490 configured to be oriented toward the lateral rim 440 of the jar 402. The lower surface 490 can contact an upper surface 442 of the lateral rim 440 while the cap 470 is screwed onto the jar 402. For example, screwing on of the cap 470 can be stopped after contact is made between the lower surface 490 and the lateral rim 440.

[0060] In some instances, the jar 402 can be a unitary piece. In some instances, the jar 402, including the lateral and bottom wall portions 420, 410 can be formed using a unitary piece of material. For example, the jar 402 can be integrally formed. In some instances, the cap 470 can be a unitary piece. For example, the cap 470 can be integrally formed. In some instances, the jar 402 and / or cap 470 can each comprise a polymeric material. For example, the jar 402 and / or cap 470 can be formed using injection molding. In some instances, the jar 402 and / or cap 470 can comprise a gas-impermeable material. In some instances, the jar 402 and / or cap 470 can comprise a moisture-resistant material. For example, the jar 402, including the lateral and bottom wall portions 420, 410, can be gas-impermeable and / or moisture-resistant. The cap 470, including the lateral and top cap portions 472, 474, can be integrally formed. Screwing on of the cap 470 onto the jar 402 can prevent gas and moisture from entering space 404. In some instances, the gas-permeable sealing lid 450 can seal the space 404 after the medical device is positioned into the space 404. The jar 402 comprising the gas-permeable sealing lid 450 thereon can be subjected to one or more gaseous sterilization processes, including processes for sterilizing the medical device. After sterilization is completed, the cap 470 can be screwed onto the jar 402 such that the space 404 can be maintained in the sterile condition while also preventing undesired moisture ingress. In some instances, the sealed jar 402 can be placed into another packaging receptacle, and / or be further sterilized, providing a double sterile barrier.

[0061] The gas-permeable material sealing lid 450 can comprise any number of porous materials configured to maintain a sterile barrier while allowing gas to pass therethrough. In some instances, the gas-permeable sealing lid 450 can comprise polyolefin fibers and / or filaments, including polyethylene fibers and / or filaments, such as high-density polyethylene (HDPE) (e.g., TYVEK® 2FS, 1059B and / or 1073B, from DuPont de Nemours, Inc. of Wilmington, Delaware). In some instances, the gas-permeable sealing lid 450 can comprise a spunbonded olefin sheet. The jar 402 and / or cap 470 can be gas-impermeable and / or moisture-resistant. In some instances, the jar 402 and / or cap 470 can comprise a gas-impermeable and moisture-resistant material, including a cyclic olefin copolymer (COC). In some instances, the jar 402 and / or cap 470 can be injection molded members comprising one or more cyclic olefin copolymers (COC). In some instances, the gas-permeable sealing lid 450 can be heat sealed to the jar 402. Alternatively, or in combination, one or more other sealing methods can be used, including induction sealing and / or laser sealing.

[0062] Figure 5 is an exploded perspective view of an example of a packaging assembly 500 comprising ajar 502 and an inner receptacle 560 configured to be disposed within the jar 502, where a medical device is configured to be disposed within the inner receptacle 560. In some instances, use of both the jar 502 and inner receptacle 560 can facilitate aseptic transfer of the sterile medical device disposed within the inner receptacle 560 into a sterile field, such as in an operating room. The jar 502 can have a space 504 configured to receive the inner receptacle 560. In some instances, a bottom and lateral wall portion 510, 520, including a flat portion 520a of the lateral wall portion 520, of the jar 502 can at least partially define the space 504. The inner receptacle 560 can define a space 566 configured to receive the medical device. In some instances, the inner receptacle 560 can comprise lateral and bottom wall portions 562, 564 that define at least in part the space 566. In some instances, the inner receptacle 560 can be a unitarily formed, for example being made from a unitary piece of material. The inner receptacle 560 be gas-impermeable and / or moisture-resistant material. In some instances, the inner receptacle 560 can comprise one or more gas-impermeable and / or moisture-resistant materials described herein. In some instances, the lateral wall portion 562 can comprise a flat portion 562a configured to align, engage and / or mate with the flat portion 520a of the jar 502. An inner gas-permeable sealing lid 568 can be configured to be disposed over and coupled to the inner receptacle 560 to provide a lid over the space 566, for example forming a circumferential seal with the corresponding portions of the inner receptacle 560. An outer gas-permeable sealing lid 550 can be configured to be disposed over the top opening 506 and coupled to the jar 502, including a top surface 526 of the lateral wall portion 520, to provide a lid over the space 504. In some instances, the inner gas-permeable sealing lid 568 and / or the outer gas-permeable sealing lid 550 can be entirely or substantially entirely gas-permeable. In some instances, the outer gas-permeable sealing lid 550 can be used to seal the space 504 after the inner receptacle 560 is placed therein. In some instances, after the outer gas-permeable sealing lid 550 is sealed to the jar 502, a cap 570 can be configured to be threadedly engaged with the jar 502.

[0063] The packaging assembly 500 can comprise one or more other features of the packaging assembly 400 describe with reference to Figures 4A through 4E. In some instances, the jar 502, outer gas-permeable sealing lid 550 and / or cap 570 can comprise one or more features of the jar 402, gas-permeable sealing lid 450, and / or cap 470 of the packaging assembly 400 described with reference to Figures 4A through 4E. For example, the outer gas-permeable sealing lid 550 can comprise a tab 558 extending from an edge portion 552 of the gas-permeable sealing lid 550. A first surface 554 of the gas-permeable sealing lid 550 can be oriented toward and coupled to the jar 502. The cap 570 can be disposed over a second surface 556 of the gas-permeable sealing lid 550. A sealing ring 594 can be configured to be received in a recess 528 on a top end portion 522 of the lateral wall portion 520 of the jar 502, the sealing ring 594 being configured to engage with the cap 570 to facilitate sealing of the jar 502. An inwardly oriented surface 580 of the cap 570 can comprise a plurality of threads to engage with threads 534 of the jar 502. The cap 570 can comprise a plurality of indentations 592 circumferentially disposed on an externally oriented surface 582. In some instances, the plurality of indentations 592 can be on the top and / or lateral cap portions 572, 574. The cap 570 can comprise a lower rim 588 configured to engage with the lateral rim 540 of the jar 502. In some instances, the jar 502, outer gas- permeable sealing lid 550, sealing ring 494 and / or cap 570 can be the same as the jar 402, gas-permeable sealing lid 450, sealing ring 494 and / or cap 470 of the packaging assembly 400 described with reference to Figures 4A through 4E. In some instances, the packaging assembly 500 can optionally comprise a medical device holder 544. The medical device holder 544 can comprise one or more features of the medical device holder 460 described with reference to Figures 4A through 4E. The medical device holder 544 can be disposed within the space 566 of the inner receptable 560.

[0064] In some instances, the inner gas-permeable sealing lid 568 can be sealed onto the inner receptacle 560 after the medical device is placed into the space 566. In some instances, sealed inner receptacle 560 can be placed into the jar 502. The outer gas-permeable sealing lid 550 can be sealed to the jar 502 after the inner receptacle 560 is placed into the jar 502. In some instances, the sealed jar 502 can be subjected to one or more sterilization processes, including sterilization process for sterilizing the medical device. The outer and inner gas-permeable sealing lids, 550, 568 can allow passage therethrough of gases, including the sterilization gas. In the alternative or combination, the sealed inner receptacle 560 can be subjected to one or more sterilization processes prior to being placed into the jar 502. In some instances, the jar 502 can be sealed and subsequently be subjected to one or more additionalsterilization processes. In some instances, outer and inner gas-permeable sealing lids, 550, 568 can allow passage therethrough of one or more purging gases. After the sterilization process is complete, the cap 570 can screwed onto the jar 502.

[0065] In the alternative or in combination, a packaging assembly can comprise a gas-impermeable and moisture-resistant sealing lid to facilitate sealing of ajar. In some instances, the gas-impermeable and moisture-resistant sealing lid can be disposed over and sealed to a sealing lid comprising a gas-permeable material portion. For example, the sealing lid comprising the gas-permeable material portion can be sealed to the jar. The sealing lid comprising the gas-permeable material portion can have one or more gas-permeable material portions surrounded by a gas -impermeable and moisture-resistant material portion. For example, the gas-impermeable and moisture-resistant material portion can be sealed to the jar. In some instances, the gas-impermeable and moisture-resistant sealing lid can be used in place of a cap for the jar.

[0066] In some instances, additional inner receptacles can be utilized. For example, one or more receptacles can be in a nested configuration within the inner receptacle. The medical device can be disposed within the innermost receptacle. Use of additional receptacles can facilitate transport of the medical device into a sterile environment, such as that of an operating room.

[0067] Figures 6A, 6B and 6C show various views of an example of a packaging assembly 600 configured to receive a medical device, where the packaging assembly 600 assumes a pouch configuration. Figures 6A and 6B provide a first side plan view and a second side plan view, respectively, of the packaging assembly 600. For example, Figure 6A shows a top view and Figure 6B shows a bottom view. Figure 6C shows a perspective view of an end portion of the packaging assembly 600. Figures 6A, 6B and 6C show the packaging assembly 600 comprising an open end and a closed end. For example, the packaging assembly 600 can comprise a first end portion 602 and a second end portion 604. The first end portion 602 is shown as comprising an opening 608 at the open end and the second end portion 604 is shown as comprising a seal 616 at the closed end. The packaging assembly 600 can comprise a gas-impermeable portion and a gas-permeable portion. In some instances, the packaging assembly 600 can comprise a gas-impermeable pouch portion 610 and a gas- permeable header 670. The gas-permeable header 670 can form a portion of the first end portion 602, for example being coupled to the gas-impermeable pouch portion 610 and forming a portion of the open end of the packaging assembly 600.

[0068] In some instances, the packaging assembly 600 can comprise a rectangular shape. For example, the first and second end portions 602, 604 can be opposingly oriented. Alternatively, or in combination, other shapes may be suitable. The gas-impermeable pouch portion 610 can comprise a first gas-impermeable pouch end portion 612 and a second gas- impermeable pouch end portion 614. The open end is shown as comprising the first gas- impermeable pouch end portion 612 and the second gas-impermeable pouch end portion 614. For example, the first gas-impermeable pouch end portion 612 and the second gas- impermeable pouch end portion 614 can be oriented toward the open end. In some instances, the gas-permeable header 670 can be coupled to the second gas-impermeable pouch end portion 614. For example, the first gas-impermeable pouch end portion 612 can extend beyond and / or overlap with the second gas-impermeable pouch end portion 614. The gas- permeable header 670 can be configured to form a seal with the first gas-impermeable pouch end portion 612 to allow enclosure of a space 606 configured to receive the medical device. The gas-permeable header 670 can allow passage of gas therethrough, including one or more sterilization gases and / or purging gases, The gas-permeable header 670 can allow passage of gas therethrough such that gaseous sterilization of the medical device can be performed while the medical device is received within the space 606.

[0069] In some instances, the gas-impermeable pouch portion 610 can comprise a first gas-impermeable sheet 630 and a second gas -impermeable sheet 650. The first gas- impermeable sheet 630 can be coupled to the second gas-impermeable sheet 650. For example, respective portions of the first and second gas-impermeable sheets 630, 650 can be coupled to one another. In some instances, the first and second gas -impermeable sheets 630, 650 can each have a rectangular or substantially rectangular shape. In some instances, the gas-permeable header 670 can have a rectangular or substantially rectangular shape. Respective portions of the first and second gas-impermeable sheets 630, 650 and gas- permeable header 670 can be coupled to one another to form a packaging assembly 600 have a rectangular or substantially rectangular shape. For example, a first edge portion 632, second edge portion 634, and third edge portion 636 of the first gas-impermeable sheet 630 can be coupled, such as form a continuous seal with, to respective portions of the first edge portion 652, second edge portion 654, and third edge portion 656 of the second gas-impermeable sheet 650.

[0070] The first gas-impermeable sheet 630 can comprise the first gas- impermeable pouch end portion 612. The second gas-impermeable sheet 650 can comprise the second gas -impermeable pouch end portion 614. For example, the first gas-impermeablesheet 630 can have a length longer than that of the second gas-impermeable sheet 650 such that a fourth edge portion 638 of the first gas-impermeable sheet 630 can extend beyond a fourth edge portion 658 of the second gas-impermeable sheet 650. The gas-permeable header 670 can be coupled to the fourth edge portion 658 of the second gas-impermeable sheet 650. For example, a first edge portion 672 and third edge portion 676 of the gas-permeable header 670 can be coupled to, such as form a continuous seal with, respective portions of the first and third edge portions 632, 636 of the first gas-impermeable sheet 630. A second edge portion 674 of the gas-permeable header 670 can be coupled to, such as forming a continuous seal with, the fourth edge portion 658 of the second gas-impermeable sheet 650. A fourth edge portion 678 of the gas-permeable header 670 and a fourth edge portion 638 of the first gas-permeable sheet 630 can define the opening 608 at the first end portion 602.

[0071] After placement of the medical device within the packaging assembly 600, the packaging assembly 600 can be closed such that the medical device can be enclosed within the packaging assembly 600. For example, the medical device can be placed within the space 606 defined by the first and second gas-impermeable sheets 630, 650 and the gas- permeable header 670. Subsequently, a fourth edge portion 678 of the gas-permeable header 670 can be coupled to, such as form a continuous seal with, a fourth edge portion 638 of the first gas-impermeable sheet 630. As described in further detail herein, the medical device can be sterilized while received within the space.

[0072] In some instances, the second end portion 604 can comprise a chevronshaped seal to provide the closed end. For example, the second edge portion 634 of the first gas-impermeable sheet 630 and the second edge portion 654 of the second gas-impermeable sheet 650 can be coupled to, such as form a continuous seal with, one another to provide the closed end of the gas-impermeable pouch portion 610. The seal formed between the second edge portions 634, 654 can have a chevron shape. In some instances, the first and second gas- impermeable sheets 630, 650 can each comprise a portion extending beyond the seal, for example providing loose ends. A user can engage with the loose ends to break the seal, such as prior to insertion of the medical device into a patient. In some instances, the chevron shape can facilitate breaking of the seal, including while maintaining the integrity of the remainder of the packaging assembly 600.

[0073] In some instances, the closed end of the packaging assembly 600 can comprise a plurality of tack seals 680. For example, the tack seals 680 can be configured to couple the loose ends of the first and second gas -impermeable sheets 630, 650 to one another.Figures 6A and 6B show two tack seals 680 coupled to the closed end. It will be understood that more or fewer tack seals can be used.

[0074] The gas-permeable header 670 can comprise any number of porous materials configured to maintain a sterile barrier while allowing gas to pass therethrough. In some instances, the gas-permeable header 670 can comprise polyolefin fibers and / or filaments, including polyethylene fibers and / or filaments, such as high-density polyethylene (HDPE) (e.g., TYVEK® 2FS, 1059B and / or 1073B, from DuPont de Nemours, Inc. of Wilmington, Delaware). In some instances, the gas-permeable header 670 can comprise a spunbonded olefin sheet. In some instances, the gas-impermeable pouch portion 610 can comprise foil, including an aluminum foil. In some instances, the gas-impermeable pouch portion 610 can comprise a layered configuration. For example, the gas-impermeable pouch portion 610 can comprise a layer of foil between two or more other material layers, including polymeric layers. In some instances, the gas-impermeable pouch portion 610 can comprise a layer of foil between polyamide, including biaxially oriented polyamide, polyethylene and / or polypropylene. The gas-impermeable pouch portion 610 can be moisture-resistant.|0075| Figures 7A provides a plan view of the packaging assembly 600 described with reference to Figures 6 A, 6B, 6C in a sealed state, and Figure 7B provides a plan view of a packaging assembly 700 resulting from removing a portion of the packaging assembly 600. Figure 7 A shows a seal 690 formed between the fourth edge portion 678 of the gas- permeable header 670 and the fourth edge portion 638 of the first gas-impermeable sheet 630. The seal 616 at the second end portion 604 and the first seal 690 at the first end portion 602 can provide the space 606 receiving the medical device in a sealed state. The packaging assembly 600 in the sealed state can be subjected to one or more sterilization processes, including sterilization processes for the medical device. The gas-permeable header 670 can allow passage of gas therethrough into the space 606 such that gaseous sterilization of the medical device can be performed while the medical device is received within the space 606. In some instances, after sterilization of the medical device, the gas-permeable header 670 can be removed to provide a sterilized space that is impermeable to gas.

[0076] Figure 7B shows removal of the gas-permeable header 670 and a corresponding portion of the gas-impermeable pouch portion 610. For example, the gas- permeable header 670 and an opposing portion of the first gas-impermeable sheet 630 can be removed to provide the packaging assembly 700. The packaging assembly 700 can comprise a remaining portion of the gas-impermeable pouch portion 610. The packaging assembly 700 can be a gas-impermeable pouch defining a space 704 receiving the medical device that isimpermeable or substantially impermeable to gas. The space 704 can be a sealed sterile space that is impermeable or substantially impermeable to gas and / or moisture.

[0077] Opposing edge portions of a remaining gas -impermeable pouch portion can be configured to be sealed to one another to form the packaging assembly 700 comprising the space 704 receiving the medical device. For example, a second seal 702 can be formed between corresponding portions of the first and second gas-impermeable sheets 630, 650, such as opposing loose portions of the first and second gas -impermeable sheets 630, 650. Remaining portions of the first and second gas-impermeable sheets 630, 650 can define the space 704. In some instances, the second seal 702 can comprise a heat seal. Alternatively, or in combination, one or more other sealing methods can be used, including induction sealing and / or laser sealing.Additional Description of Examples

[0078] Provided below is a list of examples, each of which may include aspects of any of the other examples disclosed herein. Furthermore, aspects of any example described above may be implemented in any of the numbered examples provided below.

[0079] Example 1: A packaging assembly for receiving a medical device, the packaging assembly can comprise a tray comprising lateral and bottom wall portions defining a recess configured to receive the medical device, and a top rim extending laterally around a portion of the lateral wall portion. The packaging assembly can include a first sealing lid configured to be disposed over the recess and sealed to the top rim to provide a lid over the recess, the first sealing lid comprising a gas-permeable material portion and a gas- impermeable material portion.

[0080] Example 2: The assembly of any example herein, in particular example 1, wherein the gas-impermeable material portion surrounds the gas-permeable material portion and is configured to be sealed to the rim.

[0081] Example 3: The assembly of any example herein, in particular example 1 or 2, wherein the gas-impermeable material portion comprises foil.

[0082] Example 4: The assembly of any example herein, in particular example 1, wherein the gas-permeable material portion is centered on the first sealing lid.

[0083] Example 5: The assembly of any example herein, in particular examples 1 to 4, wherein the gas-permeable material portion comprises a plurality of discrete portions.

[0084] Example 6: The assembly of any example herein, in particular example 5, wherein the gas-permeable material portion comprises a plurality of circular portions.

[0085] Example 7 : The assembly of any example herein, in particular examples 1 to 6, wherein the gas-permeable material portion comprises high-density polyethylene filaments.

[0086] Example 8: The assembly of any example herein, in particular examples 1 to 7, wherein top the rim comprises a first circumferential sealing surface and a second circumferential sealing surface spaced from and extending around the first circumferential sealing surface, the first and second circumferential sealing surfaces being configured to seal to respective circumferential portions of the first sealing lid.

[0087] Example 9: The assembly of any example herein, in particular examples 1 to 8, further comprising a second gas-impermeable and moisture-resistant sealing lid configured to be disposed over the first sealing lid to provide a sealed recess that is moistureresistant.

[0088] Example 10: The assembly of any example herein, in particular example 9, wherein the sealed recess is provided with a partial vacuum.

[0089] Example 11: The assembly of any example herein, in particular example 9 or 10, further comprising a one-way valve coupled to the second gas-impermeable and moisture-resistant sealing lid to allow degassing of the sealed recess.

[0090] Example 12: A packaging assembly for receiving a medical device, the packaging assembly comprising ajar having bottom and lateral wall portions defining a space configured to receive the medical device, a top end portion of the lateral wall portion defining a top opening. The packaging assembly can include a gas-permeable sealing lid configured to be disposed over the top opening and coupled to the jar to provide a lid over the space configured to receive the medical device, and a cap configured to be disposed over the top opening and gas-permeable sealing lid, and threadedly engage with the jar.

[0091] Example 13: The assembly of any example herein, in particular example12, further comprising a sealing ring configured to be received by a circumferential recess disposed around the lateral wall portion of the jar, the sealing ring being configured to engage with the cap while the cap is threadedly engaged with the jar.

[0092] Example 14: The assembly of any example herein, in particular example13, wherein the circumferential recess is disposed above a plurality of threads of the lateral wall portion of the jar configured to engage with reciprocal threads of the cap.

[0093] Example 15: The assembly of any example herein, in particular example14, wherein the circumferential recess is distanced from a top of the lateral wall portion of the jar.

[0094] Example 16: The assembly of any example herein, in particular examples 12 to 15, wherein the lateral wall portion comprises a flat portion extending at least partially along a longitudinal dimension of the lateral wall portion.

[0095] Example 17: The assembly of any example herein, in particular example 16, wherein a cross section along a plane perpendicular to a longitudinal axis of the jar comprises a segment of a circle.

[0096] Example 18: The assembly of any example herein, in particular examples 12 to 17, wherein the cap comprises a plurality of indentations circumferentially disposed on an externally oriented surface portion.

[0097] Example 19: The assembly of any example herein, in particular examples 12 to 18, further comprising an inner receptacle configured to be disposed within the space of the jar, the inner receptacle defining a second space being configured to receive the medical device, and an inner gas-permeable sealing lid configured to be coupled to the inner receptacle to provide a lid for the second space.

[0098] Example 20: The assembly of any example herein, in particular example 19, wherein the inner receptacle comprises a flat lateral wall portion configured to mate with a corresponding flat portion of the lateral wall portion of the jar.

[0099] Example 21: A packaging assembly for receiving a medical device, the packaging assembly comprising a gas-impermeable pouch portion comprising an open end and a closed end, the open end comprising a first gas-impermeable pouch end portion extending beyond a second gas-impermeable pouch end portion. The packaging assembly can include a gas-permeable header coupled to the second gas-impermeable pouch end portion, the gas-permeable header being configured to seal with the first gas -impermeable pouch end portion to allow enclosure of a space configured to receive the medical device and gaseous sterilization of the medical device received within the space.

[0100] Example 22: The assembly of any example herein, in particular example 21, wherein the closed end comprises a chevron-shaped seal.

[0101] Example 23: The assembly of any example herein, in particular example 21 or 22, wherein the gas-impermeable pouch portion comprises a first gas-impermeable sheet and a second gas-impermeable sheet coupled to the first gas-impermeable sheet, the first gas-impermeable sheet comprising the first gas-impermeable pouch end portion and the second gas-impermeable sheet comprising the second gas-impermeable pouch end portion.

[0102] Example 24: The assembly of any example herein, in particular example 23, wherein corresponding edge portions of the first gas-impermeable sheet and second gas-impermeable sheet are coupled to one another to form a seal and provide the closed end of the gas-impermeable pouch portion, the corresponding edge portions of the first and second gas-impermeable sheets each comprising a portion extending beyond the seal to provide loose ends.

[0103] Example 25: The assembly of any example herein, in particular example 24, furthering comprising a plurality of tack seals coupling the loose ends to one another.

[0104] Example 26: The assembly of any example herein, in particular examples 21 to 25, wherein the gas-permeable header and opposing gas-impermeable pouch portion are configured to be removed after sterilization of the medical device, and opposing edge portions of a remaining gas-impermeable pouch portion are configured to be sealed to one another to form a gas-impermeable pouch receiving the medical device.

[0105] Example 27: The assembly of any example herein, in particular examples 21 to 26, wherein the gas-permeable header portion comprises high-density polyethylene filaments.

[0106] Example 28: The assembly of any example herein, in particular examples 21 to 27, wherein the gas-impermeable material comprises foil.

[0107] Depending on the example, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, may be added, merged, or left out altogether. Thus, in certain examples, not all described acts or events are necessary for the practice of the processes.

[0108] Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended to convey that certain examples include, while other examples do not include, certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that features, elements and / or steps are in any way required for one or more examples or that one or more examples necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular example. The terms “comprising,” “including,” “having,” and the like are synonymous, are used in their ordinary sense, and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase“at least one of X, Y and Z,” unless specifically stated otherwise, is understood with the context as used in general to convey that an item, term, element, etc. may be either X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain examples require at least one of X, at least one of Y and at least one of Z to each be present.

[0109] It should be appreciated that in the above description of examples, various features are sometimes grouped together in a single example, Figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and / or described in a particular example herein can be applied to or used with any other example(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each example. Thus, it is intended that the scope of the inventions herein disclosed and claimed below should not be limited by the particular examples described above, but should be determined only by a fair reading of the claims that follow.|01101 It should be understood that certain ordinal terms (e.g., “first” or “second”) may be provided for ease of reference and do not necessarily imply physical characteristics or ordering. Therefore, as used herein, an ordinal term (e.g., “first,” “second,” “third,” etc.) used to modify an element, such as a structure, a component, an operation, etc., does not necessarily indicate priority or order of the element with respect to any other element, but rather may generally distinguish the element from another element having a similar or identical name (but for use of the ordinal term). In addition, as used herein, indefinite articles (“a” and “an”) may indicate “one or more” rather than “one.” Further, an operation performed “based on” a condition or event may also be performed based on one or more other conditions or events not explicitly recited.

[0111] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which example examples belong. It be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0112] The spatially relative terms “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms, may be used herein for ease of description to describe the relations between one element or component and another elementor component as illustrated in the drawings. It be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, in the case where a device shown in the drawing is turned over, the device positioned “below” or “beneath” another device may be placed “above” another device. Accordingly, the illustrative term “below” may include both the lower and upper positions. The device may also be oriented in the other direction, and thus the spatially relative terms may be interpreted differently depending on the orientations.

[0113] Unless otherwise expressly stated, comparative and / or quantitative terms, such as “less,” “more,” “greater,” and the like, are intended to encompass the concepts of equality. For example, “less” can mean not only “less” in the strictest mathematical sense, but also, “less than or equal to.”

Claims

WHAT IS CLAIMED IS:

1. A packaging assembly for receiving a medical device, the packaging assembly comprising: a tray comprising lateral and bottom wall portions defining a recess configured to receive the medical device, and a top rim extending laterally around a portion of the lateral wall portion; and a first sealing lid configured to be disposed over the recess and sealed to the top rim to provide a lid over the recess, the first sealing lid comprising a gas- permeable material portion and a gas-impermeable material portion.

2. The assembly of claim 1, wherein the gas-impermeable material portion surrounds the gas-permeable material portion and is configured to be sealed to the rim.

3. The assembly of claim 2, wherein the gas-permeable material portion comprises a plurality of discrete portions.

4. The assembly of any one of claims 1 to 3, wherein the top rim comprises a first circumferential sealing surface and a second circumferential sealing surface spaced from and extending around the first circumferential sealing surface, the first and second circumferential sealing surfaces being configured to seal to respective circumferential portions of the first sealing lid.

5. The assembly of any one of claims 1 to 3, further comprising a second gas- impermeable and moisture-resistant sealing lid configured to be disposed over the first sealing lid to provide a sealed recess that is moisture-resistant.

6. The assembly of claim 5, wherein the sealed recess is provided with a partial vacuum.

7. The assembly of claim 5, further comprising a one-way valve coupled to the second gas-impermeable and moisture-resistant sealing lid to allow degassing of the sealed recess.

8. A packaging assembly for receiving a medical device, the packaging assembly comprising:ajar comprising bottom and lateral wall portions defining a space configured to receive the medical device, a top end portion of the lateral wall portion defining a top opening; a gas-permeable sealing lid configured to be disposed over the top opening and coupled to the jar to provide a lid over the space configured to receive the medical device; and a cap configured to be disposed over the top opening and gas-permeable sealing lid, and threadedly engage with the jar.

9. The assembly of claim 8, further comprising a sealing ring configured to be received by a circumferential recess disposed around the lateral wall portion of the jar, the circumferential recess being disposed above a plurality of threads of the lateral wall portion of the jar configured to engage with reciprocal threads of the cap, and the sealing ring being configured to engage with the cap while the cap is threadedly engaged with the jar.

10. The assembly of claim 9, wherein the circumferential recess is distanced from a top of the lateral wall portion of the jar.

11. The assembly of any one of claims 8 to 10, wherein the lateral wall portion comprises a flat portion extending at least partially along a longitudinal dimension of the lateral wall portion.

12. The assembly of claim 11, wherein a cross section along a plane perpendicular to a longitudinal axis of the jar comprises a segment of a circle.

13. The assembly of any one of claims 8 to 10, further comprising: an inner receptacle configured to be disposed within the space of the jar, the inner receptacle defining a second space being configured to receive the medical device; and an inner gas-permeable sealing lid configured to be coupled to the inner receptacle to provide a lid for the second space.

14. The assembly of claim 13, wherein the inner receptacle comprises a flat lateral wall portion configured to mate with a corresponding flat portion of the lateral wall portion of the jar.

15. A packaging assembly for receiving a medical device, the packaging assembly comprising: a gas-impermeable pouch portion comprising an open end and a closed end, the open end comprising a first gas-impermeable pouch end portion extending beyond a second gas-impermeable pouch end portion; and a gas-permeable header coupled to the second gas-impermeable pouch end portion, the gas-permeable header being configured to seal with the first gas- impermeable pouch end portion to allow enclosure of a space configured to receive the medical device and gaseous sterilization of the medical device received within the space.

16. The assembly of claim 15, wherein the closed end comprises a chevron -shaped seal.

17. The assembly of claim 15 or 16, wherein the gas-impermeable pouch portion comprises a first gas -impermeable sheet and a second gas-impermeable sheet coupled to the first gas-impermeable sheet, the first gas -impermeable sheet comprising the first gas- impermeable pouch end portion and the second gas-impermeable sheet comprising the second gas-impermeable pouch end portion.

18. The assembly of claim 17, wherein corresponding edge portions of the first gas-impermeable sheet and second gas-impermeable sheet are coupled to one another to form a seal and provide the closed end of the gas-impermeable pouch portion, the corresponding edge portions of the first and second gas-impermeable sheets each comprising a portion extending beyond the seal to provide loose ends.

19. The assembly of claim 18, furthering comprising a plurality of tack seals coupling the loose ends to one another.

20. The assembly of claim 15 or 16, wherein the gas-permeable header and opposing gas-impermeable pouch portion are configured to be removed after sterilization of the medical device, and opposing edge portions of a remaining gas-impermeable pouch portion are configured to be sealed to one another to form a gas-impermeable pouch receiving the medical device.

Images