Medical device packaging with microbial-resistant channels

Abstract

The devices, systems, and / or methods discussed herein relate to medical device packaging that facilitates sterilization or other processing of medical devices disposed within the packaging. For example, the medical device packaging may include a gas-permeable channel configured to allow gas to enter / exit the packaging in which the medical device is located while preventing microorganisms from entering / exiting the packaging. The gas-permeable channel may be implemented within / as part of a seal of the packaging, a surface of the packaging, and / or elsewhere. The gas-permeable channel may include a tortuous path or a path longer than a predetermined threshold to inhibit / prevent microorganisms from contaminating the medical device.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 370,150, filed August 2, 2022, entitled MEDICAL DEVICE PACKAGING WITH MICROORGANISM RESISTANT CHANNELS, and to U.S. Provisional Patent Application No. 63 / 500,764, filed May 8, 2023, entitled MEDICAL DEVICE PACKAGING WITH MICROORGANISM RESISTANT CHANNELS, the entire disclosures of which are incorporated herein by reference in their entireties. [Background technology]

[0002] The present disclosure relates generally to the field of medical device packaging.

[0003] Description of Related Art Medical devices are often packaged in containers to protect the device and / or maintain its sterility during manufacturing / shipping / use or other times. For example, packaging a medical device in a container for sterilization can prevent the medical device from becoming contaminated with microorganisms (e.g., bacteria, viruses, pathogens, etc.) and / or from being damaged while being transported from one location to another. Summary of the Invention

[0004] Described herein are devices, methods, and / or systems for packaging medical devices in a manner that facilitates gas or other forms of sterilization of the medical devices within the packaging and inhibits / prevents the entry / transmission of microorganisms.

[0005] For purposes of summarizing the present disclosure, certain aspects, advantages, and / or features are described. It is to be understood that not all such advantages may necessarily be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein, without necessarily achieving other advantages that may be taught or suggested herein. [Brief explanation of the drawings]

[0006] Various embodiments are illustrated in the accompanying drawings for purposes of example. In addition, various features of different disclosed embodiments may be combined to form additional embodiments that are part of the present disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondence between referenced elements.

[0007] [Figure 1] FIG. 1 illustrates a package including a gas-permeable seal to facilitate gas sterilization or another gas process for treating a medical device placed therein, according to one or more embodiments. [Figure 2] FIG. 2 illustrates details of the gas-permeable seal of FIG. 1 that may be implemented in accordance with one or more embodiments. [Figure 3] FIG. 3 illustrates a configuration / implementation of the gas-permeable seal of FIG. 1 having multiple paths / channels, according to one or more embodiments. [Figure 4] FIG. 4 illustrates a configuration / implementation of the gas-permeable seal of FIG. 1 having a single path / channel through the gas-permeable seal, according to one or more embodiments. [Figure 5] FIG. 5 illustrates a configuration / implementation of the gas-permeable seal of FIG. 1 having a path through the seal that is at least partially parallel to the top edge of the package, according to one or more embodiments. [Figure 6] FIG. 6 illustrates a configuration / implementation of the gas-permeable seal of FIG. 1 including openings positioned on different sides / edges of the package according to one or more embodiments. [Figure 7A]FIG. 7A illustrates a package including pores / holes configured in an offset manner on multiple packaging members / membranes to facilitate channels that allow gas ingress and inhibit microbial ingress into the package, according to one or more embodiments. [Figure 7B] FIG. 7B illustrates a package including pores / holes configured in an offset manner on multiple packaging members / membranes to facilitate channels that allow gas ingress and inhibit microbial ingress into the package, according to one or more embodiments. [Figure 8] FIG. 8 illustrates a package implemented with a pouch and tray, according to one or more embodiments. [Figure 9A] FIG. 9A illustrates a perspective view of the cross-sectional views of FIGS. 9B-1 and 9B-2, according to one or more embodiments. [Figure 9B-1] FIG. 9B-1 illustrates a cross-sectional view of an implementation of the packaging of FIG. 9A in which multiple packaging members / films are fused / bonded together to form a seal, according to one or more embodiments. [Figure 9B-2] FIG. 9B-2 illustrates a cross-sectional view of an implementation of the packaging of FIG. 9A in which multiple packaging members / membranes are linked / joined together by interlocking features to form a seal, according to one or more embodiments. [Figure 10] FIG. 10 illustrates a process flow diagram for forming gas permeable channels in medical device packaging and treating medical device packaging with a gas, according to one or more embodiments. [Figure 11] FIG. 11 illustrates a package including a single track seal with a non-serpentine channel, according to one or more embodiments. [Figure 12] FIG. 12 illustrates a package including a single track seal with a serpentine channel, according to one or more embodiments. [Figure 13] FIG. 13 illustrates various dimensions of channels formed in the seal of a package according to one or more embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0008] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the subject matter.

[0009] Although specific examples are disclosed below, the subject matter extends beyond the specifically disclosed examples to other alternative examples and / or applications, as well as modifications and equivalents thereof. Therefore, the scope of claims that may arise from this specification is not limited by any of the examples described below. In any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular order. Although various operations may be described sequentially as multiple discrete operations in a manner that may be helpful in understanding a particular embodiment, the order of description should not be construed as implying that these operations are order-dependent. Additionally, structures, systems, and / or devices described herein may be embodied as integrated or separate components. For purposes of comparing various embodiments, specific aspects of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular example. Thus, for example, the various examples may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0010] Certain reference numbers are reused across different figures throughout the present disclosure for convenience with respect to devices, components, systems, features, and / or modules having characteristics that may be similar in one or more respects. However, with respect to any examples disclosed herein, the reuse of a common reference number in a figure does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, context may inform one skilled in the art of the extent to which the use of a common reference number may imply similarity between the referenced subject matter. The use of a particular reference number in the context of a description of a particular figure may relate to the device, component, aspect, feature, module, or system identified in that particular figure, and may not necessarily relate to any device, component, aspect, feature, module, or system identified with the same reference number in another figure. Furthermore, aspects in separate figures identified with a common reference number may share characteristics or be construed as being entirely independent of one another.

[0011] When an alphanumeric reference identifier is used that includes a numeric portion and an alphabetic portion (e.g., "10a," where "10" is the numeric portion and "a" is the alphabetic portion), a reference in the written description to the numeric portion (e.g., "10") can refer to any feature identified in a figure using such a numeric portion (e.g., "10a," "10b," "10c," etc.), even if such feature is identified using a reference identifier that connects the numeric portion with one or more alphabetic characters (e.g., "a," "b," "c," etc.). That is, a reference in the present disclosure to feature "10" can refer, by way of example, to feature "10a" identified in a particular figure of the present disclosure, or to either the identifier "10" or "10b" in the same or another figure.

[0012] Certain spatial relationship terms, such as "outer," "inner," "upper," "lower," "lower," "upper," "vertical," "horizontal," "top," "bottom," and similar terms, are used herein to describe the spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure; these terms are used herein for ease of description to describe the positional relationships between elements / structures illustrated in the figures. Spatial relationship terms are intended to encompass different orientations of elements / structures during use or operation in addition to the orientation generally depicted in the figures. For example, an element / structure described as "above" another element / structure can represent a position that is below or lateral to such other element / structure, and vice versa, with respect to the intended patient or alternative orientations of the element / structure. Spatial relationship terms, including those listed above, can be relative to the illustrated orientation of each of the referenced figures.

[0013] The present disclosure relates to devices, methods, and / or systems for packaging medical devices in a manner that facilitates sterilization or other processing of medical devices placed within the packaging and prohibits the entry / transmission of microorganisms. For example, medical device packaging may include gas-permeable channels / paths configured to allow the entry / exit of gases into / from the packaging while preventing / minimizing the entry / exit of microorganisms into / from the packaging in which the medical device is located. In implementations, medical devices are placed within the packaging for protection and / or delivery and undergo a gas sterilization process to sterilize or otherwise prepare the medical device. The gas-permeable channels may be implemented within / as part of the seals, surfaces, and / or other locations of the packaging. The gas-permeable channels may be tortuous or non-tortuous paths that inhibit / prevent microorganisms or other pathogens from contaminating the medical device. Furthermore, in implementations, the gas-permeable channels include paths to prevent the entry of microorganisms and to provide ventilation of the packaging (e.g., air escape from the inside to the outside and / or from the outside to the inside of the packaging) or other functions. Here, the packaging may be subjected to another form of sterilization, such as gas sterilization and / or irradiation (seals may not be used for gas sterilization introduction). In implementations, the packaging includes multiple parts formed of the same material. This can provide various sustainability benefits, such as allowing the packaging to be recycled or disposed of without complete separation of the packaging parts. Additionally, in implementations, the packaging includes one or more transparent sections so that the medical device can be identified / inspected from the outside of the packaging.

[0014] Any of the embodiments of the methods and structures disclosed herein for treating a patient also encompass similar methods and structures performed on or placed on a simulated patient, which is useful, for example, for training, demonstration, treatment and / or device development, and the like. The simulated patient can be physical, virtual, or a combination of physical and virtual. The simulation may include simulation of all or a portion of a patient, such as the whole body, a body part (e.g., the chest), a system (e.g., the cardiovascular system), an organ (e.g., the heart), or any combination thereof. The physical elements may be natural, including human or animal cadavers or portions thereof, synthetic, or any combination of natural and synthetic. The virtual elements may be entirely within the silica or may be overlaid on one or more of the physical components. The virtual elements may be presented on any combination of screens, headsets, holographic, projection, loudspeakers, headphones, pressure transducers, temperature transducers, or presented using any combination of suitable technologies.

[0015] Any of the various systems, devices, apparatus, etc. of the present disclosure can be sterilized (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can include sterilization (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of the relevant systems, devices, apparatus, etc.

[0016] FIG. 1 illustrates a packaging / container / package 102 (also referred to as a “medical device packaging 102”) configured to facilitate gas sterilization or another gas process for treating the packaging 102 and / or a medical device 104 disposed therein, according to one or more embodiments. In this implementation, the packaging 102 includes multiple packaging members / portions / sections 106 connected to each other, for example, via seals 108. The packaging members 106 are sealed to form a cavity / region 110 within the packaging 102 to house / contain the medical device 104. The packaging members 106 can be separate elements / components or a unitary element / component (e.g., the same material / substance comprising multiple portions / segments). The packaging member 106 can be a sheet / layer / component / film material, substance, etc. For ease of illustration / discussion, the packaging 102 is illustrated in various figures with a medical device 104 disposed therein, although the packaging 102 is implemented without the medical device 104 in many embodiments. Additionally, the package 102 may be configured to house other types of devices / items. In Figure 1, the callout on the right illustrates a horizontal cross-sectional view of the seal 108.

[0017] In embodiments, the seal 108 includes one or more segments / portions positioned / shaped to provide one or more channels (also referred to as “one or more pathways or paths”) that facilitate passage through the seal 108. FIG. 1 illustrates exemplary seal segments 108(A)-108(H). Each seal segment can be a portion / section / region of the seal 108 where the packaging members 106(A) and 106(B) are joined / connected together (e.g., in a sealed manner that prevents the passage of gas / vapor). On the other hand, an opening / discontinuity in the seal 108 can be a portion / section / region where the packaging members 106(A) and 106(B) are not joined / connected together or are joined together in a manner that allows the passage of gas / vapor. A group of openings / discontinuities and / or gaps between one or more seal segments can form one or more channels (sometimes referred to as “one or more entry paths”) in the seal 108. The channels and / or seal segments can include one or more straight and / or one or more curved portions / sections. The dimensions (eg, width, depth, length, etc.) of an opening or segment may be the same or different from another opening or segment.

[0018] In embodiments, seal 108 includes one or more channels that form one or more tortuous paths, which may be configured to prevent microorganisms or other pathogens from reaching medical device 104 because microorganisms cannot traverse a tortuous path. Further, in embodiments, seal 108 includes one or more channels having a particular length or other dimension such that the average or minimum / maximum distance traveled from the external environment to internal cavity 110 is above / below a threshold value. For example, a network of channels or a single channel may be formed within seal 108 such that gas must travel at least a predetermined / threshold distance to reach cavity 110 of packaging 102 (e.g., a tortuous or non-tortuous path is longer than a threshold value). This may prevent pathogens from reaching medical device 104, such as where microorganisms may be killed after traveling a particular distance that is less than the predetermined / threshold distance.

[0019] In embodiments such as that shown in FIG. 1 , the seal 108 includes multiple tracks separated from one another by breaks / openings / gap. The term “track” can refer to rows, columns, layers, levels, traces, rings, etc. (often referred to as “rows” or “tracks” for convenience). Each track can include one or more segments arranged within a closed geometric shape / form. The tracks can take on various shapes / forms, including rectangles (as shown in FIG. 1 ), circles, quadrilaterals, lines, etc., when viewed from a top view, such as FIG. 1 , or another view. The tracks can be referenced / defined in relation to the proximity / distance / shape of the track relative to the cavity 110 / medical device 104, the outer edge of the package 102, another feature of the package 102 / medical device 104, etc. FIGS. 1-5 illustrate embodiments of a package 102 having a seal 108 with multiple tracks (also referred to as a “multi-track configuration”).

[0020] To illustrate, in the embodiment of FIG. 1, the seal 108 includes three tracks extending horizontally and vertically around the package 102, each track separated by a distance (which may be the same distance as the other tracks or may be different) relative to the other tracks. In particular, seal segments 108(A), 108(B), and 108(C) form a first track (e.g., segments 108(A), 108(B), and 108(C) are disposed within and / or form the shape of a first rectangular structure / track), seal segments 108(H), 108(F), and 108(D) form a second track (e.g., segments 108(H), 108(F), and 108(D) are disposed within and / or form the shape of a second rectangular structure / track), and seal segments 108(G) and 108(E) form a third track (e.g., segments 108(G) and 108(E) are disposed within and / or form the shape of a third rectangular structure / track). In the embodiment of FIG. 1, the track of seal 108 generally has the same shape as the outer edge of package 102. However, the tracks of the seal 108 may follow other features and / or form other shapes that may or may not follow the features of the package 102. In some cases, for ease of discussion, the tracks may be referred to as rows or columns, even though the tracks extend horizontally and / or vertically. For example, the outermost segments of the seal 108 in FIG. 1 that extend around the package 102 may be part of the same row, even though the row extends horizontally and vertically relative to the orientation of the package 102 shown in FIG. 1.

[0021] Further, in embodiments, seal 108 includes a single row / column / layer / level / ring / track having one or more channels formed therein. For example, seal 108 may include one or more segments arranged within a single closed geometric structure / form, such as those shown in Figures 11 and 12, which are discussed in more detail below.

[0022] In some implementations, one or more segments / portions and / or one or more openings of the seal 108 may be formed / arranged in a pattern to define a predetermined / repeating pattern for one or more channels / segments (also referred to as a "patterned seal"). For example, one or more first segments may have a first dimension and / or be positioned at a first distance relative to one another, and one or more second segments may have a first dimension and / or be positioned at a first distance relative to one another. Furthermore, in some implementations, one or more segments and / or one or more openings of the seal 108 may be formed / arranged in a random configuration to define random / non-repeating channels / segments.

[0023] The seal 108 may include any number of inlet channels / points into the seal 108 and / or any number of outlet channels / points into the cavity 110. In some implementations, such as the one illustrated in FIG. 1 , the seal 108 includes multiple inlet channels / points for entering the seal 108 from the external environment and multiple outlet channels / points for exiting the seal 108 into the cavity 110. Further, in some implementations, the seal 108 includes a single inlet channel / point into the seal 108 and multiple outlet channels / points into the cavity 110. The inlet channel can branch into multiple outlet channels. Moreover, in some implementations, the seal 108 includes multiple inlet channels / points and a single outlet channel / point into the seal 108. The inlet channel can converge into a single outlet channel. Further, in some implementations, the seal 108 includes a single inlet channel / point and a single outlet channel / point. In this manner, one or more sealing portions / segments of seal 108 can take on various forms and / or positions to form a single path to cavity 110 or multiple paths to cavity 110. In some implementations, one or more channels include one or more dead ends, as shown in FIG. 2 and discussed below.

[0024] One or more seal segments / portions and / or one or more openings in the seal 108 can be sized / positioned to create specific characteristics for one or more channels of the seal 108. In the exemplary implementation of FIG. 1 , the seal 108 includes segments having substantially the same thickness and / or spacing relative to one another, creating one or more channels having substantially the same width. However, the seal 108 may include segments / openings / channels having different characteristics, such as different lengths, thicknesses, widths, heights (e.g., the distance between packaging members 106(A) and 106(B)), spacing relative to one another (e.g., perpendicular to FIG. 1 ), spacing relative to the edge of the package 102, etc. For example, the seal 108 may include segments having different thicknesses and / or having different spacing relative to one another.

[0025] In some implementations, the seal 108 is configured / designed so that the average or minimum / maximum distance traveled from the external environment to the internal cavity 110 is above / below a threshold value. For example, a network of channels or a single channel can be formed within the seal 108 such that gas must travel at least a predetermined / threshold distance to reach the cavity 110 of the packaging 102 (e.g., the channel path is longer than the threshold value). This can prevent pathogens from reaching the medical device 104 in cases where microorganisms may die after traveling a certain distance that is shorter than the predetermined / threshold distance, where microorganisms are unable to travel a certain distance along a path that includes a certain number of curves / corners / obstacles / features, where microorganisms are unable to travel a certain distance for other reasons, etc. Furthermore, in some implementations, the seal 108 is designed to include several curves / corners / obstacles / features, the number of which may be greater (or less) than a threshold number associated with inhibiting / preventing microorganisms. Additionally, in some implementations, the seal 108 is designed to include one or more curves / corners / obstacles / features having properties (e.g., angles, orientations, etc.) that are relevant to deterring / preventing microorganisms.

[0026] The seal 108 can be formed in a variety of ways. In some implementations, the packaging 102 can be subjected to an energy source, such as heat, laser, induction, etc., which emits energy / heat / beams to fuse / bond the packaging members 106(A) and 106(B) together to form the seal 108 and / or other interface. Additionally, in some implementations, an adhesive is applied to the packaging members 106(A) and / or 106(B) to adhere / bond the packaging members 106(A) and 106(B) together to form the seal 108 and / or other interface. Furthermore, in some implementations, the packaging member 106(A) includes mating features, such as flanges, detents, indentations, holes, protrusions, edges, etc., configured to mate with opposing mating features on the packaging member 106(B), where the mating features can form the seal 108.

[0027] 1, the seal 108 (and / or other portions of the package 102) includes one or more channels configured to allow gas 112 to enter / exit the package 102 (e.g., cavity 110) and / or prevent / minimize pathogens 114 (e.g., microorganisms) from entering / exiting the package 102. The callouts on the right side in FIG. 1 illustrate exemplary paths the gas 112 may take to reach the medical device 104 contained within the package 102, and exemplary paths the pathogens 114 may take (e.g., before being killed). The gas 112 / pathogens 114 can travel in various ways along any number of paths in an attempt to reach the cavity 110.

[0028] The packaging 102 can be implemented using a variety of materials. In some implementations, the packaging 102 includes multiple components / elements / portions that are each made of the same material (sometimes referred to as "mono-material packaging"). That is, the same type of material can be used for the components / elements / portions of the packaging 102. This can facilitate recycling or disposing of the packaging 102 once the medical device 104 has been removed. For example, packaging members 106(A) and 106(B) can be made of the same material. At the time of use, such as before / during a procedure, a user can partially or fully open the packaging 102, remove the medical device 104, and discard the packaging 102 in the same container. In some cases, making the packaging members 106(A) and 106(B) of the same material allows the packaging 102 to be partially opened to remove the medical device 104 and discard the packaging 102 in the same recycling container (without the user having to completely separate the packaging members 106(A) and 106(B) from one another). This can minimize the effort required by the user to remove the medical device 102 and can be beneficial in many cases, for example, when using a relatively large package to accommodate a relatively large medical device, when the user needs to remove multiple medical devices from the package throughout the day, etc. In other implementations, the package 102 includes different materials in multiple members / elements / portions of the package 102, such as a first material in packaging member 106(A) and a second, different material in packaging member 106(B).

[0029] In embodiments, the packaging 102 includes one or more members / elements / portions formed of a material that is substantially transparent / clear / see-through or opaque (opaque / semi-transparent). In transparent implementations, a user can see into the cavity 110 of the packaging 102 and identify the medical device 104 disposed therein. The transparent / opaque material may include any type of polymeric material. For example, packaging members 106(A) and / or 106(B) may be transparent. In some implementations, the packaging 102 is formed of a single type of transparent material to allow the medical device 104 to be viewed within the packaging 102 and to facilitate recycling of the packaging 102.

[0030] In embodiments, packaging members 106(A) and / or 106(B) and / or other portions of package 102 are implemented without gas-permeable material. That is, packaging members 106(A) and / or 106(B) and / or other portions of package 102 may be implemented using non-porous material. For example, package 102 may not include a gas-permeable sheet of material such as Tyvek®, medical paper, or another gas-permeable sheet. However, in other examples, package 102 may include a gas-permeable sheet of material in addition to or separate from gas-permeable seal 108. The gas-permeable sheet may allow gas to pass directly through the gas-permeable sheet into cavity 110.

[0031] As described above, the package 102 can receive a gas, such as gas 112, to provide a treatment to the medical device 104 located within the package 102. For example, the medical device 104 can be placed / positioned within the package 102, the package 102 sealed with the seal 108, and the package 102 can then receive the gas 112, causing the gas 112 to pass through the seal 108 into the package 102 and into the cavity 110 in which the medical device 104 is located. However, the package 102 can receive the gas 112 without the medical device 104 located therein, for example, if the package 102 is prepared to receive the medical device 104, if the seal 108 is implemented as a resealable / reusable seal, if the package 102 includes another method / means other than the seal 108 for sealing the medical device 104 within the package, etc.

[0032] In some implementations, the package 102 receives a gas, such as gas 112, to perform a sterilization process that sterilizes the medical device 104 placed therein. The gas sterilization process may include treating the package 102 with ethylene oxide (ETO) gas, hydrogen peroxide vapor, nitrous oxide, chlorine dioxide, ozone (gas plasma), steam sterilization, or another gas while the medical device 104 is sealed in the package 102. The gas penetrates through the seal 108 (and / or other portions of the package 102 as discussed herein) and sterilizes the medical device 102 and / or the package 102. In some implementations, a portion / member / membrane of the package 102 is nonporous to some substances and breathable to gases, such as a polymeric material (e.g., polytetrafluoroethylene). Although various examples are discussed in the context of using gas to sterilize the medical device 104, gases may be applied to treat the medical device 104 for other purposes.

[0033] Additionally, in some implementations, the packaging 102 undergoes radiation sterilization, including but not limited to electron beam, gamma ray, x-ray, and the like.

[0034] The package 102 may be implemented in a variety of ways. In some implementations, the package 102 is a pouch / bag / header bag / pouch-style package 102(A) that includes multiple sheets of material (e.g., flexible sheets) of relatively flexible material (also referred to as a "flexible package"). The multiple sheets of material can be subjected to an energy / heat source to seal the multiple sheets together and create a cavity for the medical device. In yet other implementations, the package 102 is a tray / jar / tray-style package 102(B) that includes a relatively rigid structure that may provide more protection / support than a pouch (also referred to as a "rigid package"). Moreover, in some implementations, the package 102 includes a sheet of relatively flexible material (e.g., similar or identical to a pouch sheet) covering a tray. Furthermore, the package 102 may include a tray located within a pouch, or a pouch located within a tray.

[0035] FIG. 2 illustrates details of a seal 108 that may be implemented in accordance with one or more embodiments. The seal 108 is illustrated with multiple segments / portions 202(A)-202(B), which include the features illustrated in FIG. 2 but may be similar or identical to one or more of the segments 108(A)-108(H) of FIG. 1. As discussed above, the segments and / or channels formed by the seal segments may have various features depending on the segment / channel configuration / design, and one or more of the features may be the same or different. FIG. 2 illustrates various exemplary features that may be implemented in various configurations of the seal 108. While these features are illustrated in a single embodiment for ease of discussion, any of these features may be implemented with or without other features of the segments 202. FIG. 2 and other figures illustrate a seal 108 having a channel network. The callout on the right in FIG. 2 illustrates a horizontal cross-sectional view of the seal 108.

[0036] For example, FIG. 2 illustrates thickness T1 (i.e., referring to FIG. 2, the vertical distance of segment 202(C)), where thickness T1 of segment 202(C) is thinner than thickness T2 of segment 202(E). Furthermore, FIG. 2 illustrates length L1 (i.e., referring to FIG. 2, the horizontal distance of segment 202(A)), which is shorter than length L2 of segment 202(E). Moreover, FIG. 2 illustrates spacing S1 between segments 202(A) and 202(B) (i.e., adjacent segments), which is smaller than spacing S2 between segments 202(B) and 202(E).

[0037] FIG. 2 illustrates that segments 202 can include different shapes. For example, segment 202(B) includes multiple subsections joined together to define a non-rectangular shape, while segment 202(A) has a rectangular shape with reference to the cross-sectional view shown in FIG. 2 . Here, segment 202(B) forms a channel including two dead ends 204. Furthermore, segment 202(D) includes a protrusion / angled section 206 that extends angularly outward from a main portion of segment 202(D). Additionally, segment 202(F) includes a curved section 208 that extends outward from an end of segment 202(F). It should be understood that any of segments 202 can include a curved section within any portion of the segment. A segment can be curved to form a curved channel. In this manner, segments 202 can include various shapes to facilitate various configurations / shapes of channels through seal 108.

[0038] The segments 202 may be spaced / positioned such that some segments are located more distal to the cavity 110 (and more proximal to the external environment) and some segments are located more proximal to the cavity 110 (and more distal to the external environment). For example, segment 202(A) is positioned closer / more proximal to the external environment and more distal to the cavity 110 than segment 202(E). In other words, segment 202(E) is positioned farther / more distal to the external environment and more proximal to the cavity 110 than segment 202(A). As discussed herein, the various segments of the seal may be represented / positioned in rows (such as those shown in FIG. 1 or elsewhere), columns (such as those shown in FIG. 5 or elsewhere), and / or other configurations. The rows may form a perimeter / periphery of the cavity 110.

[0039] Figure 3 illustrates a configuration / implementation of a seal 108 of a package 102 having multiple paths / channels through the seal 108 (similar to the configuration / implementation of Figures 1 and 2), according to one or more embodiments. The seal 108 is illustrated having multiple segments / portions 302 / 304, which include the characteristics illustrated in Figure 3, but which may be similar or identical to segments 108(A)-108(H) of Figure 1. The callout on the right in Figure 3 illustrates a top view (e.g., a cross-section through the seal 108) of the exemplary configuration of the seal 108 with the upper packaging member 106(B) removed, leaving the seal 108.

[0040] In the implementation of FIG. 3 , seal 108 includes rows 306 (also referred to as “tracks 306”) that are evenly spaced apart relative to one another. For example, the distance / spacing / offset (e.g., perpendicular distance relative to FIG. 3 ) between rows 306(A) and 306(B) is the same as the distance between rows 306(B) and 306(C), the distance between rows 306(C) and 306(D) is the same as the distance between rows 306(B) and 306(C), and so on. Here, row 306(D) (e.g., a segment of row 306(D)) is positioned / located more proximally to cavity 110 than row 306(C) (e.g., a segment of row 306(C)), row 306(C) is positioned / located more proximally to cavity 110 than row 306(B), and so on. However, the distance / spacing (whether vertical or horizontal) between any number of rows 306 (or segments of rows 306) can vary. In the embodiment of Figure 3 having segments 302, the seal 108 includes four rows 306 of seal segments, while in the embodiment having segments 304, the seal 108 includes six rows. However, any number of rows can be implemented.

[0041] 3 implementation, the segments of the seal 108 are substantially elongated (also referred to as "elongated segments / sections") and oriented parallel to a particular edge of the packaging member 106(A), such as the top edge 308 closest to the seal 108 (e.g., closest to the seal segments exceeding a threshold number). This allows the gas / pathogen to travel substantially longitudinally / orthogonally / vertically relative to the top edge 308 (although it can also travel horizontally) to reach the cavity 110. In embodiments, the package 102 is configured to be opened from the top edge 308 (e.g., the package 102 includes a tab / peelable element at the top edge 308 that the user pulls to expose / remove the medical device 104). However, the seal segments may take other forms and / or be positioned in other ways, such as the configuration shown in FIG. 5 and discussed in more detail below.

[0042] In 310 (the upper implementation shown in FIG. 3 ), each of the rows 306 includes openings that are evenly spaced relative to the openings in adjacent rows. That is, each opening in a first row is horizontally offset by the same amount relative to the openings in the next / adjacent row. For example, the first opening 312 in row 306(A) is located a distance from the second opening 314 in row 306(B), as illustrated by the horizontal distance D1 between the center of opening 312 and the center of opening 314. Furthermore, the second opening 314 in row 306(B) is located the same distance from the third opening 316 in row 306(C), as illustrated by the horizontal distance D2 between the center of opening 314 and the center of opening 316. That is, distance D1 is the same as distance D2. This allows paths / channels to be created through openings 312, 314, and 316. Similarly, the distances between other openings in adjacent rows may also be the same. In the implementation at 310, the segments of the seal 108 are patterned (eg, similarly / identically distributed / positioned and / or similarly / identically sized) to create patterned channels.

[0043] In 318 (the lower implementation shown in FIG. 3 ), row 306 includes at least some openings that are spaced differently relative to openings in adjacent rows. For example, a first opening 320 in row 306(B) is located a distance from a second opening 322 in row 306(C), as illustrated by a horizontal distance D3 between the center of opening 320 and the center of opening 322. The second opening 322 in row 306(C) is located a different distance from a third opening 324 in row 306(D), as illustrated by a horizontal distance D4 between the center of opening 314 and the center of opening 316. That is, distance D3 is different from distance D4. Similarly, the distances between other openings in adjacent rows may also be different (or the same). In the implementation in 318, the segments of seal 108 are distributed more randomly (e.g., less patterned) than in the implementation in 310, creating random / non-patterned channels.

[0044] FIG. 4 illustrates a configuration / implementation of a seal 108 having a single path / channel through the seal 108, according to one or more embodiments. The seal 108 is illustrated having multiple segments / portions 402 / 404, which include the characteristics illustrated in FIG. 4 but may be similar or identical to segments 108(A)-108(H) of FIG. 1. The callout on the right in FIG. 4 illustrates a top view (e.g., a cross-section through the seal 108) of an exemplary configuration of the seal 108 with the upper packaging member 106(B) removed, leaving the seal 108. In some embodiments, the configuration / implementation of FIG. 4 is referred to as a labyrinth path. A labyrinth path may include a single opening (e.g., into the seal 108), a single exit (e.g., from the seal 108 into the cavity 110), and / or a repeating pattern of seal segments / channels.

[0045] At 406 (top implementation of FIG. 4 ), the seal 108 is configured with alternating openings 410 in rows 408. For example, opening 410(A) is positioned on a first side (e.g., the right side) of the package 102, opening 410(B) is positioned on a second side (e.g., the left side) of the package 102, opening 410(C) is positioned on the first side of the package 102, and opening 410(D) is positioned on the second side of the package 102. In this example, openings 410(A) and 410(C) are aligned vertically, and openings 410(B) and 410(D) are aligned vertically. However, the openings 410 may not be aligned vertically. Here, a channel is formed that extends from right to left through an opening in the seal 108 down to the next channel, and then from left to right to the next opening in the seal 108. In this manner, elements can traverse the channel from side to side to reach cavity 110. Each of the channels between adjacent rows includes a dead end. However, openings 410 may be positioned at the end of row 406 to avoid the dead ends. In this implementation, the distance between the right-side openings (i.e., openings 410(A) and 410(C)) and the left-side openings (i.e., openings 410(B) and 410(D)) is the same for each adjacent row. For example, the distance / spacing (e.g., horizontal distance) between openings 410(A) and 410(B) is the same as the distance / spacing between openings 410(B) and 410(C). In an embodiment, the path / channel (e.g., tortuous path) through seal 108 is longer than a threshold value.

[0046] In 412 (the bottom implementation in FIG. 4 ), the seal 108 is configured with openings 414 that gradually move from one side of the package 102 to the other. For example, opening 414(A) is positioned toward the right side of the package 102, opening 414(B) is positioned in the adjacent / upper row toward the left side of the package 102 relative to opening 414(A), and opening 414(C) is positioned even further toward the left side of the package 102 relative to opening 414(B) in the adjacent / upper row. Here, a channel is created that extends from left to right, down through the opening, and then again from left to right, down through the opening. While this embodiment is illustrated in the context of the channel / openings being formed from right to left, they may be implemented alternatively (e.g., from left to right).

[0047] Figure 5 illustrates a configuration / implementation of a seal 108 having a path / channel therethrough that is at least partially parallel to the edge of the package 102, according to one or more embodiments. The seal 108 is illustrated having multiple segments / portions 502, which include the characteristics illustrated in Figure 5, but which may be similar or identical to segments 108(A)-108(H) of Figure 1. In Figure 5, the callout on the right side illustrates a top view (e.g., a cross-section through the seal 108) of the exemplary configuration of the seal 108 with the upper packaging member 106(B) removed, leaving the seal 108.

[0048] 5 , the segments 502 of the seal 108 are substantially elongated and oriented orthogonal / perpendicular to a particular edge of the packaging member 106(A), such as the top edge 504 closest to the seal 108 (e.g., closest to the seal segments exceeding a threshold number). The segments 502 include openings 506 to provide one or more paths / channels to the cavity 110. Here, an element such as a gas or pathogen can enter one or more channels at a first side (e.g., the left side) of the package 102, traverse the seal 108 from left to right through one or more seal segments 502 and openings 506, and exit the seal 108 (entering the cavity 110) at the right side of the package 102. While a single inlet and a single outlet are illustrated, any number of inlets / outlets may be provided.

[0049] 6 illustrates a configuration / implementation of a seal 802 of the package 102, according to one or more embodiments, that includes openings 804 positioned on different sides / edges of the package 102. This provides a channel that extends from one side of the package 102 to the other side of the package 102. The seal 802 includes the features shown in FIG. 6, but is similar or identical to the seal 108 of FIG.

[0050] As shown, the seal 802 includes an opening 804 to define / form seal segments 802(A)-802(D). In this implementation, the seal segment 802(A) (also referred to as the outer track 802(A)) forms the outer segment / seal / perimeter (more distal to the cavity 110), while the seal segments 802(B)-802(D) (also referred to as the inner tracks 802(B)-802(D)) form the inner segment / seal / perimeter (more proximal to the cavity 110). The inner segments 802(B)-802(D) can be positioned / spaced apart from the outer segment 802(A) to form a channel therebetween. While four seal segments are illustrated, with three segments being inner seals, any number of seal segments can be implemented as inner or outer segments. In an embodiment, the seal 802 can extend around the perimeter / edge of the package 102.

[0051] As described above, the openings 804 are positioned on different sides of the package 102 to facilitate a channel extending from one side of the package 102 to the other. In this implementation, the opening 804(A) in the outer segment 802(A) is positioned on a first side (e.g., the left side) of the package 102, while the openings 804(B)-804(D) in the inner segments 802(B)-802(D) are positioned on different sides (e.g., the top, right, and bottom) of the package 102. The openings may be positioned on adjacent or opposite sides of the package 102. For example, the opening 804(B) is positioned adjacent to the opening 804(A), while the opening 804(C) is positioned opposite to the opening 804(A). By positioning the opening on the other side of the package 102, elements such as gases or pathogens are forced to cross from one side of the package 102 to the other side of the package 102 and enter the cavity 110 in which the medical device 102 is located.

[0052] In this implementation, each of the openings 804 is offset from the center of the respective side on which it is located. For example, opening 802(A) is offset relative to the left side / edge 806 of package 102. However, openings 802 may be in the center of each side or positioned at other locations along each side. Additionally, while a particular number of openings is illustrated, any number of openings 804 may be implemented.

[0053] 7A and 7B illustrate a package 702 including pores / holes / perforations 704 arranged in an offset manner on multiple packaging members / portions / sections 706 to facilitate a channel / pass into the package 702, according to one or more embodiments. Here, the packaging members 706 are implemented as a sheet / layer / piece / film of material, although other forms may also be implemented. The package 702 may be similar or identical to package 102, except that the package 702 includes pores 704 implemented on multiple packaging members 706. In some embodiments, the package 702 is referred to as a "vented package."

[0054] As shown, the package 702 includes multiple packaging members 706(A)-706(C), which may be joined together around the perimeter / periphery of the package 102 and / or at other locations. In this example, the package 702 includes three packaging members 706, although any number of packaging members may be implemented. Here, the packaging members 706 may be joined / coupled (e.g., laminated, glued, bonded, interlocked, etc.) together, for example, via seals 708 (which may be gas-permeable seals similar or identical to seals 108, or full / complete / impermeable seals). Thus, in some implementations, the package 706 includes multiple locations / elements through which gas can enter the package. The packaging members 706 may be joined together such that a cavity 710 is formed between packaging members 706(A) and 706(B), and the cavity 710 is configured to house / contain a medical device 712.

[0055] In this implementation, packaging members 706(B) and 706(C) include holes 704 (e.g., apertures, openings, fenestrations, etc.) that are offset / displaced to form one or more channels that lead through packaging members 706(B) and 706(C) into cavity 110. For example, packaging member 706(B) can include holes 704(A) positioned / formed in a first configuration / orientation / pattern, and / or packaging member 706(C) can include holes 704(B) positioned / formed in a second configuration / orientation / pattern that can be the same as or different from the first configuration / orientation / pattern, for example, as shown in FIG. 7B . Packaging members 706(B) and 706(C) can be aligned such that at least a portion of holes 704(A) and 704(B) (or more than a threshold number of holes) are not aligned. That is, the center of hole 704(A) on packaging member 706(B) is generally not aligned with the center of hole 704(B) on packaging member 706(C). Packaging members 706(B) and 706(C) may be positioned adjacent to one another with a small amount of space / channel between them (e.g., positioned on substantially offset / parallel planes, such as during formation, manufacturing, when provided without a medical device therein, or at other times). Such a configuration may provide a channel / path (e.g., a tortuous path) through packaging members 706(B) and 706(C) to allow gas to enter through hole 704(B) in packaging member 706(C), pass through the channel / spacing between packaging members 706(B) and 706(C), and enter cavity 110 through hole 704(A).

[0056] The holes 704 may be positioned throughout the entire packaging 102 or over specific regions / sections. In implementations, the holes 704 are formed in regions of the packaging members 706(B) and / or 706(C) that are sealed (e.g., within seals 708) to form the cavity 110. Additionally, in implementations, the holes 704 are formed in regions of the packaging members 706(B) and / or 706(C) that are above / adjacent to the medical device 712. In some cases, the packaging members 706(B) and 706(C) are sealed together between adjacent holes 704 to allow gas to travel around the seal segments.

[0057] One or more of the holes 704 may have a relatively small diameter / dimension to allow the ingress of gases and minimize / prevent the ingress of other substances, such as pathogens, liquids, etc. For example, each of the holes 704 may have a diameter less than a certain number of microns. In some examples, the holes 704 are referred to as "microholes." The holes 704 may be formed in a variety of ways, which may include forming the holes 704 during the manufacturing of the individual packaging members 706(B) and 706(C).

[0058] In some implementations, the package 702 includes two packaging members / sheets / films mounted on one side of the cavity 110 (e.g., an upper outer / external sheet and an inner sheet) and two packaging members / sheets mounted on the other side (e.g., an outer / external sheet and an inner sheet on the opposite side / lower side of the cavity 110), where holes may be positioned on one side on the outer packaging sheet and holes may be positioned on the inner sheet on the other side of the package 702. Channels between the packaging sheets may be placed / formed / arranged around the cavity 110 such that gas can travel through the outer holes on one side of the package, through the channels between the packaging sheets, and through the holes on the inner sheet on the opposite side of the package 702 to reach the cavity 110.

[0059] 8 illustrates a package 102 implemented with a pouch and tray 802, according to one or more embodiments. Here, a pouch (also referred to in this embodiment as pouch 106) is implemented with packaging members 106(A) and 106(B), which are multiple sheets of material joined together with a seal 108. In this embodiment, a top sheet 106(B) is partially peeled away to expose / emerge / access a medical device 104, which may include multiple components 104(A) and 104(B). An example access sheath 104(A) and catheter 104(B) are shown for illustrative purposes, although any type of medical device or other device may be placed therein.

[0060] Gas-permeable seals 108 may be implemented on pouches 106 and / or trays 802, for example, to enable gas sterilization of medical devices 104, where seals 108 are implemented between sheets of pouches 106. Additionally, in implementations, a set of gas-permeable holes may be implemented on pouches 106 and / or trays 802.

[0061] In implementations, the pouch 106 is formed of a flexible material, while the tray 802 is formed at least in part of a rigid material (e.g., more rigid than the pouch 106), which can provide structure for holding and / or protecting the medical device 104. However, in some cases, the pouch 106 can be more rigid than the tray 802. The tray 802 can include grooves / recesses / cavities for receiving / securing the medical device 104. In examples, the tray 802 includes multiple pieces that can be joined together, such as an upper tray / component and a lower tray component configured to couple together around the medical device 104 by mating features.

[0062] 9A, 9B-1, and 9B-2 illustrate configurations / implementations for forming seal 108, according to one or more embodiments. For ease of discussion / illustration, the features of FIGS. 9A, 9B-1, and 9B-2 are discussed / illustrated in the context of seal 108 of package 102, although such features may additionally or alternatively be implemented with respect to seal 708 of package 702 and / or other seals discussed herein.

[0063] FIG. 9B-1 illustrates a cross-sectional view of an implementation of a package 102 in which multiple packaging members 106(A) and 106(B) are fused / bonded together (e.g., laminated, melted, pressed, etc.) to form a seal 108, according to one or more embodiments. For example, an energy source (e.g., a heat source, a laser, etc.) can be configured to irradiate energy (e.g., heat, a beam of light, etc.) at specific locations to fuse / bond the packaging members 106(A) and 106(B) to one another and form seal segments 902 and 904 (e.g., gas-impermeable segments). Alternatively or additionally, pressure can be applied to specific locations to fuse / bond the packaging members 106(A) and 106(B) to one another and form seal segments 902 and 904. Areas where the packaging members 106(A) and 106(B) are not fused / bonded can form channels / gaps through which gas can pass through the seal 108, such as the area / gaps 906 illustrated in FIG. 9B-1.

[0064] 9B-2 illustrates a cross-sectional view of an implementation of a package 102 in which multiple packaging members 106(A) and 106(B) are coupled / joined together by mating features to form a seal 108, according to one or more embodiments. For example, the packaging member 106(A) may include a first mating feature 902(A) (e.g., a male feature) configured to mate / interlock with a second mating feature 902(B) (e.g., a female feature) located on the packaging member 106(B) to form the seal segment 902. Additionally, the packaging member 106(A) may include a third mating feature 904(A) (e.g., a male feature) configured to mate / interlock with a fourth mating feature 904(B) located on the packaging member 106(B) to form the seal segment 904. The mating feature may include a flange, a detent, an indentation, a hole, a protrusion, a lip, etc.

[0065] In implementations, packaging members 106(A) and 106(B) are bonded / fused together after being connected via mating features. Additionally, in implementations (in the context of the features of either FIG. 9B-1 or FIG. 9B-2), packaging members 106(A) and 106(B) are joined / connected together by adhesive, for example, at seal segments 902 and 904.

[0066] 10 illustrates a flow diagram of a process 1000 for forming gas permeable channels in medical device packaging and treating the medical device packaging with a gas, according to one or more embodiments. For ease of illustration, the process 1000 will be discussed in the context of the exemplary medical device packaging 102 / 702, although the process 1000 may be implemented to form other medical device packaging.

[0067] At block 1002, the process 1000 includes providing a plurality of packaging members for packaging a medical device. For example, one or more packaging members 106 / 706 can be provided. As discussed herein, the one or more packaging members 106 / 706 can be formed of the same material or different materials. In embodiments, the one or more packaging members 106 / 706 include a transparent material.

[0068] At block 1004, the process 1000 includes providing a medical device. For example, the medical device 104 / 712 may be provided for packaging in a medical device package 102 / 702.

[0069] At block 1006, the process 1000 includes joining / connecting multiple packaging members together. In one embodiment, packaging member 106(A) is joined / connected to packaging member 106(B) in a manner that forms a seal 108 (e.g., a gas-permeable seal) and / or a cavity 110 between members 106(A) and 106(B). This may include radiating energy using an energy source (e.g., in specific areas to form seal segments), pressing packaging members 106(A) and 106(B) together (e.g., applying force in specific areas to form seal segments), associating / connecting mating features, or otherwise performing a process that connects / joins packaging members 106(A) and 106(B) to form the seal 108.

[0070] In another embodiment, packaging members 706(A)-706(C) may be joined / connected together to provide a gas permeable path and / or a gas permeable seal between adjacent packaging members. For example, packaging members 706(B) and 706(C) may be positioned and connected together in a particular orientation / positioning such that holes 704(A) and 704(B) are offset to provide a path through multiple layers of packaging members 706(B) and 706(C).

[0071] In implementation, the medical device 104 / 712 is placed / positioned on or otherwise associated with one or more packaging members 106 / 706 such that the medical device 104 / 712 is sealed in the medical device packaging 102 / 702 when the packaging members 106 / 706 are connected / joined together.

[0072] At block 1008, the process 1000 includes treating the medical device packaging with a gas. For example, the medical device packaging 102 / 702 can be treated with ethylene oxide (ETO) gas or another gas while the medical device 104 / 712 is disposed / sealed in the medical device packaging 102 / 702. The gas can penetrate the medical device packaging 102 / 702 and reach the medical device 104 / 712 through gas permeable channels, such as gas permeable seal 108, holes 704, seal 708, etc., where the gas permeable channels prevent pathogens from reaching the medical device 104 / 712 inside the medical device packaging 102 / 702. In this manner, the gas permeable channels can provide a barrier to microorganisms and other pathogens.

[0073] Any of the various systems, devices, apparatus, etc. in the present disclosure may be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use on patients, and / or the methods described herein may include sterilization (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of the associated systems, devices, apparatus, etc.

[0074] 11 and 12 illustrate an embodiment of a package 102 having a seal 108 implemented with a single track. In contrast to other embodiments discussed herein, such as FIG. 1 , which includes multiple tracks in the seal 108, the package 102 of FIGS. 11 and 12 includes a single track for the seal 108 with one or more channels (also referred to as “one or more paths or pathways”) to facilitate passage through the seal 108, such as allowing gases / vapors to enter the package 102 by passing through the single track. As mentioned above, a channel can be an opening / discontinuity in the seal 108 even when the packaging members 106(A) and 106(B) are not joined / connected together or are joined together in a manner that allows the passage of gases / vapors. As also discussed herein in the context of other embodiments, the track of the seal 108 may include the same shape as the outer edge of the package 102, may follow other features, or may form other shapes, which may or may not be the same as the shapes of the features of the package 102. The exemplary packaging 102 of Figures 11 and 12 can include any of the features discussed herein for other packaging.

[0075] While the embodiments of Figures 11 and 12 illustrate a single channel through the seal 108 in a single track, the seal 108 may include multiple channels around the seal 108, each of which may include an entry point and an exit point. Furthermore, in some single-track embodiments, the seal 108 includes multiple entry channels / points for entering the seal 108 from the external environment and multiple exit channels / points for exiting the seal 108 into the cavity 110. Moreover, in some single-track embodiments, the seal 108 includes a single entry channel / point into the seal 108 and multiple exit channels / points into the cavity 110. The entry channel can branch into multiple exit channels. Moreover, in some single-track embodiments, the seal 108 includes multiple entry channels / points into the seal 108 and a single exit channel / point. The entry channels can converge into a single exit channel.

[0076] FIG. 11 illustrates a package 102 having a non-tortuous channel 1102 through the seal 108, where the non-tortuous channel 1102 is longer than a predetermined distance. The channel 1102 may be straight / substantially straight, curved, or take another form. In some embodiments, a non-tortuous channel includes turns / bends less than a threshold, curves less than a threshold, curves / bends less than a certain amount / degree, segments / sections less than a threshold between adjacent turns / obstacles / features, or other features. Exemplary non-tortuous channel 1102(A) illustrates a slightly curved path, while exemplary non-tortuous channel 1102(B) illustrates a straight path. While channel 1102(B) is referred to as a non-tortuous path, in some embodiments, a slight curve in the channel (as shown) may be a tortuous path. A non-tortuous channel may have a length, width, or other dimension that exceeds a threshold / predetermined distance, such that microorganisms or gases must travel a distance / extent to reach the interior cavity 110. The threshold distance may be greater than the distance a microorganism can travel without adhering to a host / entity, or may be a distance based on experimental information indicating the average / longest / shortest distance a microorganism can travel without adhering to a host / entity. This may prevent the microorganism from reaching the medical device 104 within the packaging 102, such as when the microorganism dies after traveling a certain distance less than the threshold distance. As shown in FIG. 11 , length L3 represents the length of channel 1102, which may refer to the distance through channel 1102 (e.g., the distance traveled through channel 1102).

[0077] The non-serpentine channel 1102 can include various configurations and / or can be located in various positions. In embodiments, the non-serpentine channel 1102 can form a curved path on one side of the seal 108, such as that shown at 1102(A). Further, in embodiments, the non-serpentine channel 1102 can form a diagonal path within the seal 108, such as that shown at 1102(B). Moreover, in embodiments, the non-serpentine path 1102 can travel through the seal 108 from one side of the package 102 to the other side of the package 102 (e.g., from the right side of the seal 108 to the top side of the seal 108) around corners / curves within the seal 108. Further, in embodiments, the non-serpentine channel 1102 can be oriented relatively perpendicular to the seal 108 (e.g., the channel 1102 can be perpendicular to the longitudinal axis of the seal 108).

[0078] In embodiments, the entry and / or exit points of the non-serpentine channel 1102 may be positioned relative to a feature of the package 102 and / or a feature of the medical device 104 disposed therein. A feature may include any attribute or characteristic of the package 102 / medical device 104, such as a corner, an edge / side, a distal end / proximal end, etc. For example, the entry point (e.g., an opening through which gas can enter the channel from the external environment) may be positioned at or within a predetermined proximity / distance relative to a first corner of the package 102, and the exit point (e.g., the opening of the channel into the cavity 110) may be positioned at or within a predetermined proximity / distance relative to a center of the package 102, a second corner of the package 102, or another location on the package 102. Here, the channel 1102 may move diagonally, linearly, or in a curved manner.

[0079] In embodiments, the length L3 of the channel 1102 is related to / proportional to a dimension of the packaging 102, a dimension of the seal 108, a dimension of the medical device 104, etc. In one example, the length L3 of the channel 1102 exceeds a predetermined threshold (e.g., the length L3 is at least a minimum length), where the predetermined threshold is proportional to a dimension of the packaging 102 / seal 108 / medical device 104, where the length L3 can be a quarter, a third, a half, three-quarters, etc., of the length, width, or other dimension of the packaging 102 / seal 108 / medical device 104. In some embodiments, the length L3 of the channel 1102 is based on the width of the channel, e.g., the length-width ratio or width-length ratio is a particular ratio, less than a threshold ratio, greater than a threshold ratio, etc.

[0080] FIG. 12 illustrates a package 102 having a tortuous channel 1202 through the seal 108. The tortuous channel may include turns / bends or other features such that the path through the tortuous channel is not linear (e.g., not straight). In some embodiments, the tortuous channel includes more than a threshold number of turns, more than a threshold number of curves or other obstacles / features, more than a certain amount / degree of curves / bends, more than a threshold number of segments / sections between adjacent turns / obstacles / features, or other features. In some cases, the tortuous channel includes features in a specific pattern, while in other examples, the tortuous channel includes features positioned / oriented more randomly along the path. Microorganisms or other pathogens generally cannot travel / migrate through a tortuous path, or at least a tortuous path that includes enough turns, obstacles, or other features to allow them to travel around. Thus, packaging 102 may be implemented with a tortuous channel 1202 and / or tortuous channel 1202 may be implemented with particular features to prevent microorganisms or other pathogens from reaching medical devices 104 disposed within cavity 110. Tortuous channel 1202 may include the same or similar features as other tortuous channels discussed herein or elsewhere.

[0081] Additionally, in some embodiments, the serpentine channel 1202 is designed with specific dimensions to provide additional protection against the ingress of microorganisms. For example, as also described above with reference to the package 102 shown in FIG. 12 , the length, width, or other dimension may exceed a threshold / predetermined distance. The threshold distance may be greater than the distance a microorganism can travel without adhering to a host / entity, which may be a distance based on empirical information indicating the average / longest / shortest distance a microorganism can travel without adhering to a host / entity. This may prevent microorganisms from reaching the medical device 104 within the package 102, such as when the microorganisms die after traveling a specific distance that is less than the threshold distance.

[0082] Serpentine channel 1202 can include various configurations and / or can be located in various positions. In embodiments, serpentine path 1202 can travel through seal 108, around corners / curves in seal 108, from one side of package 102 to the other side of package 102 (e.g., from the right side of seal 108 to the top side of seal 108). Further, in embodiments, serpentine channel 1202 can be oriented relatively perpendicular to seal 108 (e.g., a line between the entry and exit points of channel 1202 can be perpendicular to the longitudinal axis of seal 108).

[0083] In embodiments, the entry and / or exit points of the non-tortuous channel 1102 may be positioned relative to a feature of the package 102 and / or a feature of the medical device 104 disposed therein. As discussed above, a feature may include any attribute or characteristic of the package 102 / medical device 104, such as a corner, an edge / side, a distal end / proximal end, etc. For example, the entry point of the serpentine channel 1102 (e.g., an opening through which gas can enter the channel from the external environment) may be positioned at or within a predetermined proximity / distance relative to a first corner of the package 102, and the exit point of the serpentine channel 1102 (e.g., the opening of the channel into the cavity 110) may be positioned at or within a predetermined proximity to a center of the package 102, a second corner of the package 102, or another location on the package 102.

[0084] In embodiments, the length of the channel 1202 is related / proportional to a dimension of the packaging 102, a dimension of the seal 108, a dimension of the medical device 104, etc. In one example, the length of the channel 1202 exceeds a predetermined threshold (e.g., the length is at least a minimum length), where the predetermined threshold is proportional to a dimension of the packaging 102 / seal 108 / medical device 104. Here, the length of the channel 1202 can be a quarter, a third, a half, three-quarters, etc., of the length, width, or other dimension of the packaging 102 / seal 108 / medical device 104. In some embodiments, the length of the channel 1202 is based on the width of the channel, e.g., a length-to-width ratio or width-to-length ratio that is a particular ratio, less than a threshold ratio, greater than a threshold ratio, etc. Additionally, in some embodiments, the length of the channel 1202 is based on or otherwise related to any number of bends / turns in the channel 1202 / seal 108. Similarly, any number of bends / turns in the channel 1202 may be based on or otherwise associated with the length of the channel 1202 / seal 108.

[0085] FIG. 13 illustrates various dimensions of a channel 1302 formed in the seal 108 of the package 102. The channel 1302 can represent any of the channels discussed herein. In this example, the channel 1302 includes multiple sections / portions, each having dimensions 1304, 1306, and 1308. However, the channel 1302 may include a single section / portion and / or other features, as discussed herein. For ease of discussion / illustration, each section is substantially straight. Each of the dimensions 1304, 1306, and 1308 represents the length / distance of the respective section of the channel 1302 (e.g., the distance that a microorganism must travel through that section of the channel 1302) (sometimes referred to as the "travel distance"). In an example, one or more of the dimensions 1304, 1306, and / or 1308 are at least 0.1 microns long (1×10 -7meter), 1 micron long, 2 microns long, 5 microns long, 10 microns long, 20 microns long, etc. In one example, each of dimensions 1304, 1306, and 1308 is at least 0.1 micron long, 1 micron long, 2 microns long, 5 microns long, 10 microns long, 20 microns long, etc. In another example, the total length of channel 1302 (e.g., all dimensions of 1304, 1306, and 1308 added together) is at least 0.1 micron long, 1 micron long, 2 microns long, 5 microns long, 10 microns long, 20 microns long, etc.

[0086] FIG. 13 also shows dimension 1310 of channel 1302, which may represent the diameter, the largest cross-sectional dimension of channel 1302, the smallest cross-sectional dimension of channel 1302, the cross-sectional width of channel 1302, the cross-sectional height of channel 1302, the average cross-sectional dimension of channel 1302, etc. Dimension 1310 may be uniform throughout the length of channel 1310, e.g., from opening to exit, or may be non-uniform. In embodiments, dimension 1310 may be at least 0.1 microns, 0.2 microns, 0.3 microns, 0.4 microns, etc. Further, in embodiments, dimension 1310 (e.g., diameter) may be in the range of 0.1-0.4 microns, 0.1-0.3 microns, 0.1-0.2 microns, etc. In embodiments, the cross-sectional area of channel 1302 may be at least 7.8×10 -12 In an embodiment, the cross-sectional area of the channel 1302 is 7.8×10 -12 Square meter ~ 1.26 x 10 -11 square meters (e.g., 0.1 micron diameter to 0.4 micron diameter) (e.g., for any of the lengths shown above). In any of the above embodiments, the sections of channel 1302 can have lengths of at least 0.1 micron, at least 0.4 micron, in the range of 0.1 to 0.4 micron, in the range of 0.1 to 0.3 micron, or in the range of 0.1 to 0.2 micron. In any of the above embodiments, the sections can have a total length of less than 10 cm.

[0087] Although discussed in the context of seal 108, channel 1302 may be formed in multiple packaging members / portions / sections, for example, in the embodiments discussed in Figures 7A and 7B or elsewhere.

[0088] (Additional Description of the Examples) Below is provided a list of examples, each of which may include aspects of any of the other examples disclosed herein. Furthermore, aspects of any of the examples described above may be implemented in any of the numbered examples provided below.

[0089] Example 1: A medical device package comprising a first packaging member and a second packaging member joined to the first packaging member with a gas-permeable seal, wherein the first packaging member and the second packaging member form an interior cavity configured to accommodate a medical device, the gas-permeable seal comprising a channel configured to permit the passage of gas through the gas-permeable seal and to prevent the ingress of microorganisms into the interior cavity, the channel comprising at least one of 1) a tortuous path, or 2) a path longer than a predetermined threshold, and at least one of the first packaging member or the second packaging member being substantially transparent.

[0090] Example 2: A medical device package as described in any example herein, particularly as described in Example 1, wherein the first packaging member and the second packaging member are each substantially transparent.

[0091] Example 3: A medical device package as described in any example herein, particularly as described in Example 1 or Example 2, wherein the first packaging member and the second packaging member are formed of the same material.

[0092] Example 4: A medical device packaging as described in any example herein, particularly as described in Examples 1-3, wherein the gas permeable seal includes at least a first seal segment and a second seal segment spaced apart from the first seal segment, the second seal segment being located closer to the inner cavity than the first seal segment.

[0093] Example 5: A medical device packaging as described in any example herein, particularly as described in Example 4, wherein the first seal segment includes a first opening and the second seal segment includes a second opening located a first distance from the first opening.

[0094] Example 6: A medical device packaging as described in any example herein, particularly as described in Example 5, wherein the gas permeable seal includes a third seal segment spaced from the second seal segment, the third seal segment being located proximal to the inner cavity than the second seal segment, and the third seal segment includes a third opening located a second distance from the second opening.

[0095] Example 7: A medical device packaging as described in any example herein, particularly as described in Example 6, wherein the spacing between the first seal segment and the second seal segment is different from the spacing between the second seal segment and the third seal segment.

[0096] Example 8: A medical device packaging as described in any example herein, particularly as described in Example 6, wherein the spacing between the first seal segment and the second seal segment is substantially the same as the spacing between the second seal segment and the third seal segment.

[0097] Example 9: A medical device packaging as described in any example herein, particularly as described in Example 6, wherein the first distance between the first opening and the second opening is different from the second distance between the second opening and the third opening.

[0098] Example 10: A medical device packaging as described in any example herein, particularly as described in Example 6, wherein the first distance between the first opening and the second opening is substantially the same as the second distance between the second opening and the third opening.

[0099] Example 11: A medical device packaging as described in any example herein, particularly as described in Example 5, wherein the first opening is located on a first side of the medical device packaging and the second opening is located on a second side of the medical device packaging.

[0100] Example 12: A medical device packaging as described in any example herein, particularly as described in Example 4, wherein the first seal segment is an elongated segment positioned substantially parallel to the edge of the medical device packaging.

[0101] Example 13: A medical device packaging as described in any example herein, particularly as described in Example 4, wherein the first seal segment is an elongated segment positioned substantially perpendicular to the edge of the medical device packaging.

[0102] Example 14: A medical device packaging as described in any example herein, particularly as described in Example 4, wherein the first seal segment is an inner track around the perimeter of the medical device packaging and the second seal segment is an outer track around the perimeter.

[0103] Example 15: The predetermined threshold of the channel path is at least 1×10 -7 10. A medical device package as described in any example herein, particularly as described in Examples 1-14, that is meter (0.1 micron) long.

[0104] Example 16: The cross-sectional area of the channel path is 7.8 x 10 -12 Square meter ~ 1.26 x 10 -11 Range is square meters and / or 7.8 x 10 -12 Square meter ~ 1.26 x 10 -11 Passes with cross-sectional areas in the range of square meters are at least 1 x 10 -7 A medical device packaging as described in any example herein, particularly as described in examples 1-15, extending in length over a meter.

[0105] Example 17: A medical device package as described in any example herein, particularly as described in Examples 1-16, wherein the first packaging member and the second packaging member are each formed from a non-porous material.

[0106] Example 18: A medical device packaging as described in any example herein, particularly as described in Examples 1-17, wherein the gas permeable seal comprises at least one of a fused seal or a bonded seal.

[0107] Example 19: A medical device packaging as described in any example herein, particularly as described in Examples 1-18, wherein the gas permeable seal comprises a first mating feature on the first packaging member and a second mating feature on the second packaging member configured to mate with the first mating feature.

[0108] Example 20: The medical device packaging of any example herein, particularly examples 1-19, wherein the first packaging member comprises one or more first holes, the medical device packaging further comprises a third packaging member disposed adjacent to the first packaging member, the third packaging member comprising one or more second holes offset from the one or more first holes, and the first packaging member and the third packaging member form a serpentine channel that connects to the interior cavity through the one or more first holes, the space between the first packaging member and the third packaging member, and the one or more second holes.

[0109] Example 21: A medical device packaging as described in any example herein, particularly as described in Examples 1-20, which is a flexible package.

[0110] Example 22: A medical device packaging as described in any example herein, particularly as described in Examples 1-21, which is a rigid package.

[0111] Example 23: A medical device packaging as described in any of the examples herein, particularly as described in Examples 1-22, wherein the gas permeable seal is implemented as a single track seal having one or more seal segments positioned on a single track.

[0112] Example 24: A medical device packaging as described in any of the examples herein, particularly as described in Examples 1-23, wherein the gas-permeable seal comprises at least one seal segment mounted on a first track and at least one seal segment mounted on a second track, the first track being closer to the inner cavity than the second track.

[0113] Example 25: A medical device packaging as described in any of the examples herein, particularly as described in Examples 1-24, wherein the channel comprises a path that is longer than a predetermined threshold, and the path is substantially straight.

[0114] Example 26: A medical device packaging as described in any example herein, particularly as described in Examples 1-25, wherein the channel comprises a path longer than a predetermined threshold, and the predetermined threshold is related to a dimension of the medical device packaging.

[0115] Example 27: A medical device packaging as described in any example herein, particularly as described in Examples 1-26, wherein the channel comprises a path longer than a predetermined threshold, the predetermined threshold being proportional to the length of the gas-permeable seal.

[0116] Example 28: A medical device packaging comprising: a first sheet of material including one or more first holes; a second sheet of material positioned adjacent to the first sheet of material including one or more second holes offset from the one or more first holes to form a serpentine channel configured to allow gas to pass through the first sheet of material and the second sheet of material; and a third sheet of material joined to at least one of the first sheet of material or the second sheet of material, wherein the second sheet of material and the third sheet of material form a cavity configured to receive a medical device.

[0117] Example 29: A medical device packaging as described in any example herein, particularly as described in Example 28, wherein the first sheet of material and the second sheet of material are sealed to one another around the one or more first holes and second holes.

[0118] Example 30: A medical device packaging as described in any example herein, particularly as described in Example 28 or Example 29, wherein at least one of the first sheet of material, the second sheet of material, or the third sheet of material is substantially transparent.

[0119] Example 31: A medical device packaging as described in any example herein, particularly as described in Examples 28-30, wherein the first sheet of material, the second sheet of material, and the third sheet of material are each substantially transparent.

[0120] Example 32: A medical device packaging as described in any example herein, particularly as described in Examples 28-31, wherein the first sheet of material, the second sheet of material, and the third sheet of material are the same material.

[0121] Example 33: A medical device packaging as described in any example herein, particularly as described in Examples 28-32, wherein the second sheet of material and the third sheet of material are joined with a gas-permeable seal, the gas-permeable seal including at least one path configured to allow gas to enter the cavity and prevent the ingress of microorganisms into the cavity.

[0122] Example 34: A medical device packaging as described in any example herein, particularly as described in Example 33, wherein the gas permeable seal includes at least a first seal segment and a second seal segment spaced apart from the second seal segment and positioned closer to the cavity than the first seal segment.

[0123] Example 35: The medical device packaging as described in any example herein, particularly example 34, wherein the first seal segment comprises a first opening, the second seal segment comprises a second opening located a first distance from the first opening, and at least one pass comprises the first opening and the second opening.

[0124] Example 36: A medical device packaging as described in any example herein, particularly as described in Example 35, wherein the gas permeable seal includes a third seal segment spaced apart from the second seal segment and positioned closer to the cavity than the second seal segment, and the third seal segment includes a third opening positioned a second distance from the second opening.

[0125] Example 37: A medical device packaging as described in any example herein, particularly as described in Example 35, wherein the spacing between the first seal segment and the second seal segment is different from the spacing between the second seal segment and the third seal segment.

[0126] Example 38: A medical device packaging as described in any example herein, particularly as described in Example 36, wherein the spacing between the first seal segment and the second seal segment is substantially the same as the spacing between the second seal segment and the third seal segment.

[0127] Example 39: A medical device packaging as described in any example herein, particularly as described in Example 36, wherein the first distance between the first opening and the second opening is different from the second distance between the second opening and the third opening.

[0128] Example 40: A medical device packaging as described in any example herein, particularly as described in Example 36, wherein the first distance between the first opening and the second opening is substantially the same as the second distance between the second opening and the third opening.

[0129] Example 41: A medical device packaging as described in any example herein, particularly as described in Example 35, wherein the first opening is located on a first side of the medical device packaging and the second opening is located on a second side of the medical device packaging.

[0130] Example 42: A medical device packaging as described in any example herein, particularly as described in Example 34, wherein the first seal segment is an elongated segment positioned substantially parallel to the edge of the medical device packaging.

[0131] Example 43: A medical device packaging as described in any example herein, particularly as described in Example 34, wherein the first seal segment is an elongated segment positioned substantially perpendicular to the edge of the medical device packaging.

[0132] Example 44: At least one tortuous path is at least 1×10 -7 10. A medical device packaging as described in any example herein, particularly as described in Example 33, that is meter (0.1 micron) in length.

[0133] Example 45: A medical device packaging as described in any example herein, particularly as described in Example 33, wherein at least one path is a serpentine path that includes a pattern.

[0134] Example 46: A medical device packaging as described in any example herein, particularly as described in Example 33, wherein the gas permeable seal comprises at least one of a fused seal or a bonded seal.

[0135] Example 47: A medical device packaging as described in any example herein, particularly as described in Example 33, wherein the gas permeable seal includes a first mating feature on the first sheet of material and a second mating feature on the second sheet of material configured to join with the first mating feature.

[0136] Example 48: A medical device packaging as described in any example herein, particularly as described in Examples 28-47, which is a flexible package.

[0137] Example 49: A medical device packaging as described in any example herein, particularly as described in Examples 28-48, which is a rigid package.

[0138] Example 50: A medical device packaging as described in any example herein, particularly as described in Examples 33-49, wherein the gas permeable seal is implemented as a single track seal having one or more seal segments positioned on a single track.

[0139] Example 51: A medical device packaging as described in any example herein, particularly as described in Examples 33-49, wherein the gas-permeable seal comprises at least one seal segment mounted on a first track and at least one seal segment mounted on a second track, the first track being closer to the cavity than the second track.

[0140] Example 52: A medical device packaging as described in any example herein, particularly as described in Examples 33-51, wherein at least one path is longer than a predetermined threshold and at least one path is substantially straight.

[0141] Example 53: A medical device packaging as described in any example herein, particularly as described in Examples 33-52, wherein at least one path is longer than a predetermined threshold, and the predetermined threshold is related to a dimension of the medical device packaging.

[0142] Example 54: A medical device packaging as described in the examples herein, particularly Examples 33-53, wherein at least one path is longer than a predetermined threshold, the predetermined threshold being proportional to the length of the gas permeable seal.

[0143] Example 55: A method of forming a medical device package, comprising: installing a first packaging member; installing a second packaging member; and joining the first packaging member to the second packaging member to form a gas-permeable seal between the first packaging member and the second packaging member, wherein the gas-permeable seal comprises a channel configured to allow the passage of gas into an interior cavity between the first packaging member and the second packaging member and to prevent the ingress of microorganisms into the interior cavity, wherein the channel comprises at least one of a tortuous path or a path longer than a predetermined threshold, and wherein at least one of the first packaging member or the second packaging member is substantially transparent.

[0144] Example 56: The method of any example herein, particularly Example 55, wherein the first packaging member and the second packaging member are each substantially transparent.

[0145] Example 57: The method of any example herein, particularly Example 55 or Example 56, wherein the first packaging member and the second packaging member are formed of the same material.

[0146] Example 58: The method described in any example herein, particularly examples 55-57, wherein the gas-permeable seal includes at least a first seal segment and a second seal segment spaced apart from the first seal segment, the second seal segment being located closer to the inner cavity than the first seal segment.

[0147] Example 59: The method of any example herein, particularly Example 58, wherein the first seal segment includes a first opening and the second seal segment includes a second opening located a first distance from the first opening.

[0148] Example 60: The method of any example herein, particularly example 59, wherein the gas permeable seal includes a third seal segment spaced apart from the second seal segment, the third seal segment being located closer to the inner cavity than the second seal segment, and the third seal segment including a third opening located a second distance from the second opening.

[0149] Example 61: The method of any example herein, particularly example 60, wherein the spacing between the first seal segment and the second seal segment is different from the spacing between the second seal segment and the third seal segment.

[0150] Example 62: The method described in any example herein, particularly Example 60, wherein the spacing between the first seal segment and the second seal segment is substantially the same as the spacing between the second seal segment and the third seal segment.

[0151] Example 63: The method of any example herein, particularly example 60, wherein the first distance between the first opening and the second opening is different from the second distance between the second opening and the third opening.

[0152] Example 64: The method of any example herein, particularly example 60, wherein the first distance between the first opening and the second opening is substantially the same as the second distance between the second opening and the third opening.

[0153] Example 65: The method described in any example herein, particularly Example 59, wherein the first opening is located on a first side of the medical device packaging and the second opening is located on a second side of the medical device packaging.

[0154] Example 66: The method described in any example herein, particularly Example 59, wherein the first seal segment is an elongated segment positioned substantially parallel to the edge of the medical device packaging.

[0155] Example 67: The method described in any example herein, particularly Example 59, wherein the first seal segment is an elongated segment positioned substantially perpendicular to the edge of the medical device packaging.

[0156] Example 68: The method described in any example herein, particularly Example 59, wherein the first seal segment is an inner row around the perimeter of the medical device packaging and the second seal is an outer row around the perimeter.

[0157] Example 69: The channel is at least 1 x 10 -7 meters (0.1 microns) long, or at least 7.8 x 10 -12 The method described in any example herein, particularly examples 55-68, wherein the method has at least one of a cross-sectional area of about 1000 square meters.

[0158] Example 70: The method of any example herein, particularly examples 55-69, wherein the channel comprises a serpentine path that includes a pattern.

[0159] Example 71: The method of any example herein, particularly Examples 55-70, wherein the first packaging member and the second packaging member are each formed of a non-porous material.

[0160] Example 72: The method of any example herein, particularly examples 55-71, wherein the gas permeable seal comprises at least one of a fused seal or a bonded seal.

[0161] Example 73: The method described in any example herein, particularly examples 55-72, wherein the gas permeable seal includes a first mating feature on the first packaging member and a second mating feature on the second packaging member configured to join with the first mating feature.

[0162] Example 74: The method of any example herein, particularly examples 55-73, wherein the first packaging member comprises one or more first holes, and the method further comprises joining a third packaging member to at least one of the first packaging members of the second packaging member, wherein the third packaging member comprises one or more second holes offset from the one or more first holes, and wherein the first packaging member and the third packaging member form a serpentine path leading to the cavity through the one or more first holes, the space between the first packaging member and the third packaging member, and the one or more second holes.

[0163] Example 75: The method described in any example herein, particularly Examples 55-74, wherein the medical device packaging is a flexible package.

[0164] Example 76: The method described in any example herein, particularly Examples 55-75, wherein the medical device packaging is a rigid package.

[0165] Example 77: The method described in any example herein, particularly examples 55-76, wherein the gas permeable seal is implemented as a single track seal having one or more seal segments positioned on a single track.

[0166] Example 78: The method of any example herein, particularly examples 55-76, wherein the gas-permeable seal comprises at least one seal segment mounted on a first track and at least one seal segment mounted on a second track, the first track being closer to the inner cavity than the second track.

[0167] Example 79: The method of any example herein, particularly examples 55-78, wherein the channel comprises a path longer than a predetermined threshold, and the path is substantially straight.

[0168] Example 80: The method described in any example herein, particularly examples 55-79, wherein the channel comprises a path longer than a predetermined threshold, and the predetermined threshold is related to a dimension of the medical device packaging.

[0169] Example 81: The method of any example herein, particularly examples 55-79, wherein the channel comprises a path longer than a predetermined threshold, the predetermined threshold being proportional to the length of the gas-permeable seal.

[0170] Example 82: A method of forming a medical device package, comprising: placing a first sheet of material including one or more first holes; placing adjacent to the first sheet of material a second sheet of material including one or more second holes offset from the one or more first holes to form a serpentine channel for gas to pass through the first sheet of material and the second sheet of material; and joining a third sheet of material to at least one of the first sheet of material or the second sheet of material, wherein the second sheet of material and the third sheet of material form a cavity configured to receive a medical device.

[0171] Example 83: The method of any example herein, particularly Example 82, wherein the first sheet of material and the second sheet of material are sealed to one another around one or more first holes and second holes.

[0172] Example 84: The method described in any example herein, particularly Example 82 or Example 83, wherein at least one of the first sheet of material, the second sheet of material, or the third sheet of material is substantially transparent.

[0173] Example 85: The method of any example herein, particularly Examples 82-84, wherein the first sheet of material, the second sheet of material, and the third sheet of material are each substantially transparent.

[0174] Example 86: The method of any example herein, particularly Examples 82-85, wherein the first sheet of material, the second sheet of material, and the third sheet of material are the same material.

[0175] Example 87: The method described in any example herein, particularly Examples 82-86, wherein the second sheet of material and the third sheet of material are joined with a gas-permeable seal, the gas-permeable seal including at least one path configured to allow gas to enter the cavity and prevent the ingress of microorganisms into the cavity.

[0176] Example 88: A method as described in any example herein, particularly as described in Example 87, wherein the gas-permeable seal includes at least a first seal segment and a second seal segment spaced apart from the second seal segment and positioned closer to the cavity than the first seal segment.

[0177] Example 89: The method described in any example herein, particularly Example 88, wherein the first seal segment includes a first opening, the second seal segment includes a second opening located a first distance from the first opening, and at least one path extends through the first opening and the second opening.

[0178] Example 90: The method of any example herein, particularly example 89, wherein the gas-permeable seal includes a third seal segment spaced apart from the second seal segment and positioned closer to the cavity than the second seal segment, and the third seal segment includes a third opening positioned a second distance from the second opening.

[0179] Example 91: The method of any example herein, particularly example 90, wherein the spacing between the first seal segment and the second seal segment is different from the spacing between the second seal segment and the third seal segment.

[0180] Example 92: The method described in any example herein, particularly example 90, wherein the spacing between the first seal segment and the second seal segment is substantially the same as the spacing between the second seal segment and the third seal segment.

[0181] Example 93: The method of any example herein, particularly Example 90, wherein the first distance between the first opening and the second opening is different from the second distance between the second opening and the third opening.

[0182] Example 94: The method of any example herein, particularly example 90, wherein the first distance between the first opening and the second opening is substantially the same as the second distance between the second opening and the third opening.

[0183] Example 95: The method described in any example herein, particularly Example 89, wherein the first opening is located on a first side of the medical device packaging and the second opening is located on a second side of the medical device packaging.

[0184] Example 96: The method described in any example herein, particularly Example 88, wherein the first seal segment is an elongated segment positioned substantially parallel to the edge of the medical device packaging.

[0185] Example 97: The method described in any example herein, particularly Example 88, wherein the first seal segment is an elongated segment positioned substantially perpendicular to the edge of the medical device packaging.

[0186] Example 98: The method described in any example herein, particularly example 87, wherein at least one path is longer than a threshold.

[0187] Example 99: The method of any example herein, particularly example 87, wherein at least one path comprises a pattern.

[0188] Example 100: The method of any example herein, particularly example 87, wherein the gas permeable seal comprises at least one of a fused seal or a bonded seal.

[0189] Example 101: A method described in any example herein, particularly Example 87, wherein the gas-permeable seal includes a first mating feature on a first sheet of material and a second mating feature on a second sheet of material configured to join to the first mating feature.

[0190] Example 102: The method described in any example herein, particularly Examples 82-101, wherein the medical device packaging is a flexible package.

[0191] Example 103: The method described in any example herein, particularly Examples 82-101, wherein the medical device packaging is a rigid package.

[0192] Example 104: The method described in any example herein, particularly examples 87-103, wherein the gas-permeable seal is implemented as a single track seal having one or more seal segments positioned on a single track.

[0193] Example 105: The method of any example herein, particularly examples 87-103, wherein the gas-permeable seal comprises at least one seal segment mounted on a first track and at least one seal segment mounted on a second track, the first track being closer to the cavity than the second track.

[0194] Example 106: The method of any example herein, particularly examples 87-105, wherein at least one path is longer than a predetermined threshold and at least one path is substantially straight.

[0195] Example 107: The method described in any example herein, particularly examples 87-106, wherein at least one path is longer than a predetermined threshold, and the predetermined threshold is related to a dimension of the medical device packaging.

[0196] Example 108: The method described in the examples herein, particularly Examples 87-106, wherein at least one path is longer than a predetermined threshold, the predetermined threshold being proportional to the length of the gas permeable seal.

[0197] Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein may be performed in a different order, added, combined, and / or omitted entirely. Thus, in a particular embodiment, not all described acts or events may be required to practice a process.

[0198] In particular, conditional language used herein, such as "can," "could," "might," "may," "e.g.," and the like, is intended to have its ordinary meaning unless specifically stated otherwise or understood otherwise within the context of use, and is generally intended to convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any way necessary to one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without authorial input or prompting, whether those features, elements, and / or steps are included in or should be performed in any particular embodiment. Terms such as "comprising," "including," "having," and the like are generally synonymous and used in their ordinary sense, and are used in an inclusive, non-limiting manner and do not exclude additional elements, features, acts, operations, etc. Additionally, the term "or" is used in its inclusive sense (and not its exclusive sense), for example, when used to connect a list of elements, so that the term "or" means one, some, or all of the elements in the list. Connective language such as the phrase "at least one of X, Y, and Z" is understood in context as being used generally to convey that an item, term, element, etc., can be either X, Y, or Z, unless specifically stated otherwise. Thus, such connective language is not generally intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z, each be present.

[0199] In the 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 understanding one or more of the various aspects. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Moreover, any component, feature, or step illustrated and / or described in a particular example herein may be applied to or used in conjunction with any other example. Moreover, no component, feature, step, or group of components, features, or steps is necessarily required or essential to each example. Therefore, it is intended that the scope of the subject matter disclosed and claimed below not be limited by the specific examples described herein.

[0200] Certain sequential terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Thus, as used herein, sequential terms (e.g., "first," "second," "third," etc.) used to modify elements such as structures, components, operations, etc., do not necessarily indicate a priority or order of the element relative to any other elements, but rather may generally distinguish an element from other elements having a similar or identical name (except for the use of sequential terms). Additionally, as used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, 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.

[0201] Unless otherwise defined, terms used herein (including technical and / or scientific terms) may have the same meaning as commonly understood by a person skilled in the art to which the examples belong. Terms, such as those defined in commonly used dictionaries, may be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and unless explicitly defined herein, are not to be interpreted in an idealized or overly formal sense.

[0202] Spatially relative terms such as "outside," "inside," "upper," "lower," "bottom," "upper," "vertical," "horizontal," and similar terms may be used herein for ease of description to describe the relationship between one element or component and another element or component, as shown in the drawings. Spatially relative terms may encompass different orientations of the device during use or operation in addition to the orientation depicted in the drawings. For example, if a device shown in the drawings is turned over, a device positioned "below" or "directly below" another device may be positioned "above" another device. Thus, the exemplary term "below" may include both a lower position and an upper position. Devices may also be oriented in other directions, and thus spatially relative terms may be interpreted differently depending on the orientation.

[0203] Unless expressly stated otherwise, comparative and / or quantitative terms such as "less," "more," "greater than," and the like can encompass equivalent concepts. For example, "less" can mean "less than" as well as "less than" in the strictest mathematical sense.

Claims

1. A medical device package comprising: a first packaging member; a second packaging member joined to the first packaging member with a gas-permeable seal, wherein the first packaging member and the second packaging member define an interior cavity configured to accommodate a medical device, the gas-permeable seal including a channel configured to permit the passage of gas through the gas-permeable seal and to prevent the ingress of microorganisms into the interior cavity, the channel including at least one of 1) a tortuous path, or 2) a path longer than a predetermined threshold; The medical device packaging, wherein at least one of the first packaging member or the second packaging member is substantially transparent.

2. 10. The medical device package of claim 1, wherein the first packaging member and the second packaging member are substantially transparent.

3. 3. The medical device package of claim 1, wherein the first packaging member and the second packaging member are formed from the same material.

4. 4. The medical device packaging of claim 1, wherein the gas-permeable seal includes at least a first seal segment and a second seal segment spaced apart from the first seal segment, the second seal segment being located proximal to the inner cavity than the first seal segment.

5. 5. The medical device packaging of claim 4, wherein the first seal segment includes a first opening and the second seal segment includes a second opening located a first distance from the first opening.

6. 6. The medical device packaging of claim 5, wherein the gas permeable seal includes a third seal segment spaced from the second seal segment, the third seal segment located proximal to the inner cavity than the second seal segment, and the third seal segment includes a third opening located a second distance from the second opening.

7. 7. The medical device packaging of claim 6, wherein a spacing between the first seal segment and the second seal segment is different from a spacing between the second seal segment and the third seal segment.

8. 7. The medical device packaging of claim 6, wherein the spacing between the first seal segment and the second seal segment is substantially the same as the spacing between the second seal segment and the third seal segment.

9. 7. The medical device packaging of claim 6, wherein the first distance between the first opening and the second opening is different from the second distance between the second opening and the third opening.

10. 7. The medical device packaging of claim 6, wherein the first distance between the first opening and the second opening is substantially the same as the second distance between the second opening and the third opening.

11. 6. The medical device packaging of claim 5, wherein the first opening is located on a first side of the medical device packaging and the second opening is located on a second side of the medical device packaging.

12. The medical device package of claim 4 , wherein the first seal segment is an elongated segment positioned substantially parallel to an edge of the medical device package.

13. The medical device package of claim 4 , wherein the first seal segment is an elongated segment positioned substantially perpendicular to an edge of the medical device package.

14. 5. The medical device package of claim 4, wherein the first seal segment is an inner track around a perimeter of the medical device package and the second seal segment is an outer track around the perimeter.

15. The predetermined threshold of the paths of the channel is at least 1×10 －７ 15. The medical device packaging of any preceding claim, which is meter long.

16. The cross-sectional area of the path of the channel is 7.8×10 －１２ Square meter ~ 1.26 x 10 －１１ 16. The medical device packaging of any preceding claim, in the square meter range.

17. 7.8 x 10 －１２ Square meter ~ 1.26 x 10 －１１ The paths having cross-sectional areas in the range of square meters are at least 1×10 －７ 18. The medical device packaging of claim 17, extending a meter in length.

18. The medical device package of any one of claims 1 to 17, wherein the first packaging member and the second packaging member are each formed of a non-porous material.

19. 19. The medical device package of any of claims 1-18, wherein the gas permeable seal comprises a first mating feature on the first packaging member and a second mating feature on the second packaging member configured to mate with the first mating feature.

20. the first packaging member includes one or more first holes, and the medical device package comprises:

20. The medical device packaging of any of claims 1-19, further comprising a third packaging member disposed adjacent to the first packaging member, the third packaging member including one or more second holes offset from the one or more first holes, the first packaging member and the third packaging member forming a serpentine channel leading to the interior cavity through the one or more first holes, a space between the first packaging member and the third packaging member, and the one or more second holes.

21. The medical device packaging according to any one of claims 1 to 20, which is a flexible package.

22. The medical device packaging of any one of claims 1 to 21, which is a rigid package.

23. The medical device packaging of any of claims 1-22, wherein the gas permeable seal is implemented as a single track seal having one or more seal segments positioned on a single track.

24. 24. The medical device packaging of any of claims 1-23, wherein the gas permeable seal includes at least one seal segment mounted on a first track and at least one seal segment mounted on a second track, the first track being closer to the inner cavity than the second track.

25. 25. The medical device packaging of any preceding claim, wherein the channel comprises a path that is longer than a predetermined threshold, and the path is substantially straight.

26. 26. The medical device packaging of any preceding claim, wherein the channel comprises a path longer than a predetermined threshold, the predetermined threshold being related to a dimension of the medical device packaging.

27. 27. The medical device packaging of any preceding claim, wherein the channel comprises a path longer than a predetermined threshold, the predetermined threshold being proportional to the length of the gas-permeable seal.

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