Medical Device Packaging

Abstract

The present invention relates to a package 10 for containing a medical device 100. The package 10 includes a first side 12 and a second side 14 sealed or otherwise secured around its periphery to define multiple edges. An interaction area 24 provides and defines a first contact point for a user of the package 10. The package 10 also includes a tear area 28 that, in use, is at least partially separated from the remainder of the package to form an opening at the top end of the package 10. The tear area 28 includes an interaction point that defines a second contact point for a user of the package 10. A seal arrangement includes first and second seal members 42, 44 that provide a user-sealable seal between the first side 12 and the second side 14 of the package 10.

Description

[Technical Field]

[0001] The present invention relates to packaging for medical devices, particularly single-use medical devices, including, but not limited to, male disposable catheters. [Background technology]

[0002] Medical devices (e.g., disposable medical devices) are commonly individually packaged. Typically, this may take the form of a plastic or paper housing that is sealed in some manner to provide a sealed interior for containing the medical device. Typical requirements for such packages include being sufficiently sealable to maintain a sterile internal environment for the medical device prior to use, being lightweight, being easy (and quick) to open, and allowing the user to interact with the housed device before opening the package. However, such products are typically designed with use in a healthcare environment (e.g., hospitals, nursing homes, etc.) in mind, and therefore little consideration is given to the personal experience when the packaged medical device is used by the patient outside of a healthcare environment, for example, for self-catheterization in a public restroom.

[0003] For example, a package designed for quick and efficient opening may take the form of a pair of sheets of material sealed around their edges to define an interior region for containing a product. The sheets can be pulled apart to access the medical device contained therein. However, once the package is opened, the sheets serve no further purpose, and each sheet and the contained medical device must generally be disposed of separately. Therefore, it would be advantageous to reduce the number of separable components of the package and / or provide a package that can be used to hold used medical devices for subsequent disposal.

[0004] The shape and configuration of prior art packages are generally primarily determined by the shape and configuration of the medical device itself to be housed. Where there are no or few space constraints, this may not be an issue, and in fact may even be beneficial, since the device can be housed without any modifications. However, certain devices (e.g., male urinary catheters, which can exceed 30 cm in length) may make the size and configuration of such packages impractical for users to carry with them for personal use. While the flexibility of some catheters may mean that they can be housed in a coiled / folded configuration, no acceptable solution has been provided to date for such cases. Therefore, it would be advantageous to provide a package that is appropriately configured for user portability (e.g., in a hand, pocket, or bag).

[0005] Furthermore, packaging designed for medical environments generally does not consider discreetness during use, and thus does not consider the noise generated when opening such a package. Similarly, the number of separable components of a package generally is not considered, since in a medical environment, such components are expected to be discarded upon use rather than disposed of elsewhere (which may be the case for individual users outside of such environments). For medical devices that may be used outside of a medical environment (e.g., intermittent urinary catheters), such characteristics may be undesirable to users. Therefore, it would be advantageous to provide packaging for a medical device (e.g., an intermittent urinary catheter) that allows a user to carry, use, and subsequently dispose of the package and the contained device in a discreet manner.

[0006] It is an object of embodiments of the present invention to overcome or at least partially alleviate one or more problems of the prior art. Summary of the Invention

[0007] According to one aspect of the present invention, a package for containing a medical device is provided.

[0008] The package may have first and second sides sealed or otherwise secured around its periphery to define a plurality of edges. The plurality of edges may include one or more of a first major edge, a second major edge, a bottom edge, and a top edge. The first edge may include a first straight edge. The second edge may optionally include a second tapered edge opposite the first edge.

[0009] The package may include an interaction region defining a first contact point for a user of the package. The interaction region may include one or more visual and / or tactile indicators on a first side and / or a second side of the package. The interaction region may be located proximate to a first end or a second end of the package.

[0010] The package may include a tear-away region, which may include a tear line defining a line along which the package can be torn in use to at least partially separate the tear-away region from the remainder of the package and form an opening at the upper edge of the package. The tear-away region may be defined proximate the upper edge of the package. The tear-away region may include an interaction point defining a second contact point for a user of the package. The interaction point may be located at a first end of the tear-away region. The tear-away region may include a tear stop. The tear stop may be located at a second end of the tear-away region. The tear stop may act to prevent or reduce the possibility of the tear-away region being completely separated from the remainder of the package. The tear-away region may be substantially triangular in shape with a beveled upper edge.

[0011] The package may include a seal arrangement including a first seal member and a second seal member operable to provide a user-closeable seal between a first side and a second side of the package. The first seal member and / or the second seal member may be disposed on an inner surface of the first side and / or the second side of the package. For example, the seal arrangement may include a first seal member disposed on an inner surface of the first side of the package and a second seal member disposed on an inner surface of the second side of the package. The seal arrangement may be disposed adjacent to the tear zone.

[0012] At least a portion of the first side and / or second side of the package may comprise a material having a textured surface profile on its interior and / or exterior surface.

[0013] According to one aspect of the present invention, a package for containing a medical device is provided. The package includes first and second sides, an interaction area, a tear area, and a sealing arrangement. The first and second sides are sealed or otherwise secured around their peripheries to define a pair of major edges, a lower end, and an upper end. The pair of major edges include a first straight end and a second tapered end opposite the first end. The interaction area, which defines a first contact point for a user of the package, includes one or more visual and / or tactile indicators on the first and / or second side of the package and is located proximate to the first or second end. The tear region defined adjacent to the top end includes a tear line between a first end and a second end of the tear region that defines a line along which the package can be torn in use to at least partially separate the tear region from the remainder of the package and form an opening at the top end of the package; an interaction point at the first end of the tear region that defines a second contact point for a user of the package; and a tear stop at the second end of the tear region. The tear stop acts to prevent or reduce the possibility of the tear region being completely separated from the remainder of the package. The tear region is substantially triangular in shape with a sloped top end. The seal arrangement includes a first seal member disposed on the inner surface of the first side of the package and a second seal member disposed on the inner surface of the second side of the package. The first and second seal members are operable to provide a user-sealable seal between the first and second sides of the package and are disposed adjacent to the tear region. At least a portion of the first side and / or second side of the package comprises a material having a textured surface profile on its interior and / or exterior surface.

[0014] Advantageously, having a tapered end opposite a straight end of the package can guide a user to hold the package in a particular (e.g., “user-friendly”) orientation. For example, the first straight end may define a leading edge of the package to a user when interacting with the package, e.g., when opening the package. Furthermore, having a tapered end opposite the straight end of the package can advantageously define a shape of the package to fit in the palm of a user's hand and / or form a pocket shape. Furthermore, providing a sealing arrangement in combination with a tear region allows the package to be initially opened by at least partial removal of the tear region before sealing using the first and second sealing members. Having sealing members provided on the inner surface of the side of the package can advantageously reduce the number of individual components provided as part of the package, thereby improving the user experience compared to, for example, packages that include additional sealing tabs. This is particularly beneficial when the package contains a disposable medical device, such as a urinary catheter, which can later be used to contain the used product for disposal, and it is desirable to reduce the number of components and packaging parts that need to be contained within the package after use. The textured surface profile may act to attenuate or otherwise mitigate the propagation of sound waves through the package, thereby reducing the overall sound generated during a user's interaction with the package (e.g., opening the package) or simply carrying the package. This can be particularly advantageous when it is desirable to use and carry the packaged medical product inconspicuously (e.g., when carried in a pants / coat pocket in a public environment, when used in a public restroom at a restaurant, shopping center, etc.).

[0015] Any feature described below may be applied to any aspect of the invention (defined above or below as appropriate).

[0016] The medical device may comprise a catheter. The medical device may comprise a urinary catheter. The medical device may comprise a female urinary catheter, but is preferably a male urinary catheter. The medical device may comprise a disposable medical device. The medical device may comprise an intermittent urinary catheter.

[0017] According to one aspect of the present invention, a package for containing a medical device is provided, the package comprising first and second sides sealed or otherwise secured around a periphery thereof to define a plurality of ends, the plurality of ends including a first straight end and a second tapered end opposite the first end, and an interaction area defining a contact point for a user of the package, the interaction area including one or more visual and / or tactile indicators on the first and / or second sides of the package.

[0018] According to one aspect of the present invention, a package for containing a medical device is provided, the package comprising first and second side surfaces sealed or otherwise secured around its periphery to define a pair of main ends, a lower end, and an upper end, the pair of main ends including a first straight end and a second tapered end opposite the first end, and an interaction area defining a contact point for a user of the package, the interaction area including one or more visual and / or tactile indicators on the first and / or second side surfaces of the package, the interaction area being positioned proximate to at least the first or second main end of the package.

[0019] Advantageously, having a tapered end opposite a straight end of the package can guide a user to hold the package in a particular (e.g., "convenient") orientation. For example, a first straight end may define the front end of the package to a user when interacting with the package, e.g., when opening the package. Furthermore, having a tapered end opposite a straight end of the package can advantageously define the shape of the package to fit in the palm of a user's hand and / or can be pocket-shaped.

[0020] The interaction area is preferably located proximate the first main end of the package. Advantageously, having the interaction area proximate the first straight main end defines a distinct region on the package for a user to grasp, guiding the user to grasp the package at or proximate the "leading edge" of the package.

[0021] In embodiments, the second main end includes a curved, tapered end. Advantageously, having a curved, tapered second main end provides a clearer distinction between the first and second main ends and guides the user's interaction. Additionally, the curved, tapered end better complements the size / shape profile of a user's hand and / or pocket, improving usability of the package.

[0022] The bottom end of the package may include a straight edge that may be substantially perpendicular to the first major edge.

[0023] The top edge of the package may be angled, e.g., not perpendicular, relative to the first and / or second major edges. In such embodiments, the top edge may include a sloped edge. The sloped top edge may be sloped, for example, from the first major edge toward the second major edge or from the second major edge toward the first major edge. The sloped top edge may define a substantially triangular region adjacent the top edge of the package.

[0024] In embodiments, the package includes a tear area. The tear area may be defined proximate a top edge of the package. The tear area may be defined at least in part by one or more of the top edge of the package, at least a portion of the first major edge, at least a portion of the second major edge, and a tear line.

[0025] A tear line may be provided between the first and second ends of the tear region. The tear line may define a line along which the package can be torn to at least partially separate the tear region from the remainder of the package. Tearing the package along the tear line can form an opening in the top end of the package during use. In embodiments where the top end includes a beveled top end, the top end, the first major end or at least a portion thereof, the second major end or at least a portion thereof, and / or the tear line may define a substantially triangular tear region.

[0026] The one or more visual and / or tactile indicators may visually indicate the location of the interaction area. The one or more visual and / or tactile indicators may be visually distinct from the remainder of the first side and / or second side of the package.

[0027] The one or more visual and / or tactile indicators may include one or more visual surface marks. The one or more visual surface marks may include a pattern. The one or more visual surface marks may distinguish the interaction area from the first side and / or the second side of the package. For example, the one or more visual surface marks may be visually distinct from any surface marks on the remainder of the first and / or second side of the package. In a preferred embodiment, the interaction area may include one or more visual surface mark patterns, and the remainder of the first and / or second side of the package may be free of surface marks.

[0028] The one or more visual and / or tactile indicators may include a visual boundary mark. For example, the one or more visual and / or tactile indicators may include a solid or dashed line that defines the boundary of the interaction area. The visual boundary mark may include one or more lines that include substantially the same shape as one or more edges of the package. For example, the visual boundary mark may include a first tapered line that includes substantially the same curvature and / or taper as the second major edge of the package. The visual boundary mark may include a second straight line that is substantially parallel to the bottom edge of the package. The first and second lines of the visual boundary mark may intersect at a radiused corner.

[0029] The tactile indicator may be provided on an exterior surface of the first side and / or the second side of the package. The one or more visual and / or tactile indicators may include a tactile surface profile on the exterior surface of the first side and / or the second side of the package. For example, the one or more visual and / or tactile indicators may include a raised, depressed, or patterned surface profile, such as a tactile surface texture. The tactile surface profile can assist a user in gripping the package at the interaction area.

[0030] In embodiments, the package has a height of, for example, at least 50 mm, or at least 75 mm, or at least 100 mm, or at least 125 mm, or at least 150 mm, or at least 200 mm. The package may have a height of, for example, 100 mm or less, or 125 mm or less, or 150 mm or less, or 200 mm or less, or 250 mm or less. In embodiments, the package has a width of, for example, at most 50 mm, or at most 75 mm, or at most 100 mm, or at least 125 mm, or at most 150 mm. In embodiments, the package has a width of, for example, at least 50 mm, or at least 75 mm, or at least 100 mm, or at least 120 mm, or at least 150 mm. The package may have a width of, for example, 100 mm or less, or 120 mm or less, or 150 mm or less, or 200 mm or less. In some embodiments, the package has outer dimensions of a height of 180 mm or less and a width of 120 mm or less.

[0031] In some embodiments, the first and second sides are sealed around their peripheries, for example, by one or more of a heat seal, a pressure seal, or a weld.

[0032] At least two of the first major end, the second major end, the bottom end, and the top end may be integrally formed with a further end of the package with rounded corners at the end. In some embodiments, each of the ends may be integrally formed with a further end of the package with rounded corners at the end. In embodiments where multiple rounded corners are provided, each rounded corner may include a corner radius equal to the remaining rounded corners of the package. In some embodiments, a first rounded corner of the package may include a larger corner radius compared to one or more further rounded corners of the package. The first rounded corner may be located between the first major end and the top end. The first rounded corner may be located within the interaction area. The first rounded corner may be located as part of the tear area.

[0033] According to one aspect of the present invention, there is provided a package for containing a medical device, the package comprising first and second sides sealed or otherwise secured around a periphery thereof, a tear region defined adjacent to a top end of the package that, in use, is at least partially removed from the remainder of the package to form an opening in the top end of the package, and a seal arrangement including first and second seal members operable to provide a user-sealable seal between the first and second sides of the package at or adjacent the opening in the top end of the package.

[0034] According to another aspect of the present invention, there is provided a package for containing a medical device, the package comprising first and second sides sealed or otherwise secured around its periphery, a tear region defined adjacent to a top end of the package, the tear region including a tear line between the first and second ends of the tear region that, in use, defines a line along which the package can be torn to at least partially separate the tear region from the remainder of the package and form an opening in the top end of the package, and a sealing arrangement including a first seal member disposed on an inner surface of the first side of the package and a second seal member disposed on an inner surface of the second side of the package, the first and second seal members operable to provide a user-sealable seal between the first and second sides of the package at or adjacent to the opening in the top end of the package.

[0035] Advantageously, providing a seal arrangement in combination with a tear area allows the package to be initially opened by at least partial removal of the tear area prior to sealing using the first and second seal members. Having a seal member disposed on the inner surface of a side of the package can advantageously reduce the number of individual components provided as part of the package, thereby improving the user experience, for example, when compared to packages that include additional seal tabs. This is particularly beneficial when the package contains a disposable medical device, such as a urinary catheter, which can later be used to contain the used product for disposal, and it is desirable to reduce the number of components and packaging parts that need to be contained within the package after use.

[0036] The user-closable seal may include a resealable seal.

[0037] The first and second seal members may be configured to provide an adhesive seal between the first and second sides of the package. In such embodiments, one or both of the first and second seal members may include an adhesive applied to the first and / or second sides of the package. For example, in some embodiments, the first seal member may include an adhesive applied to the inner surface of the first side of the package. In such embodiments, the second seal member may include an adhesive applied to the inner surface of the second side of the package. Alternatively, only the first seal member may include an adhesive. In such embodiments, the second seal member may include a region of one side of the package configured to be adhesively secured to the adhesive of the first seal member.

[0038] In some embodiments, the first seal member and the second seal member may form a hook and loop fastener arrangement. In such embodiments, the first seal member may include an area of hook fasteners disposed on a surface of a first side of the package, and the second seal member may include an area of loop fasteners disposed on a surface of a second side of the package. In alternative embodiments, the first seal member and the second seal member may form a double hook and loop fastener arrangement. In such embodiments, the first seal member may include an area of hook fasteners disposed on a surface of a first side of the package, and the second seal member may include an area of hook fasteners disposed on a surface of a second side of the package.

[0039] The first and second sealing members may provide a watertight, or a nearly watertight, or substantially watertight seal at or adjacent the opening in the top end of the package. Advantageously, such an arrangement may be useful when fluid is present in the package before or after use, for example, when the packaged product is a urinary catheter and the package contains a fluid therein, such as a lubricant or wetting fluid, or when traces of urine may be present in a used catheter that is reintroduced into the package for venting.

[0040] In embodiments, the tear area includes an interaction point, which may be located at a first end of the tear area, and which may define a contact point for a user of the package.

[0041] In embodiments, the interaction point includes an opening in the package. The opening may include, for example, a circular opening in the package. The opening may be formed through a first side and a second side of the package. In embodiments, the interaction point may include a rounded corner of the package. The rounded corner may include a first rounded corner of a plurality of rounded corners of the package. The first rounded corner of the package may include a larger corner radius compared to one or more additional rounded corners of the package. The first rounded corner may be formed, for example, between the first major end and the top end.

[0042] The tear region may include a tear stop. The tear stop may be provided at a second end of the tear region. The second end of the tear region may include an end opposite the first end of the tear region. In this manner, a user can interact with an interaction point at the first end of the tear region to tear the package from the first end toward the second end of the tear region. The tear stop may act to reduce the likelihood that the tear region will completely separate from the remainder of the package. Advantageously, preventing the tear region from completely separating from the remainder of the package can reduce the number of separated components of the package after use. This may be beneficial from a user interaction perspective when it is desirable for the used medical device and package components to be contained within, or at least integrally formed or otherwise attached to, a single package that is then discarded.

[0043] In embodiments, the tear stop includes an opening in the tear area, which may be located at or adjacent to the tear line to allow a tear to propagate through the package to the tear stop during use.

[0044] In some embodiments, the tear region includes a tear start. The tear start may be located at a first end of the tear region. The tear start may act to initiate a tear along the tear line, e.g., from the tear start to the tear stop. The tear start may include a notch in the first side and / or the second side of the package. The tear start may be substantially triangular in shape. In such embodiments, the triangular notch includes a sloped upper edge. Optionally, the triangular notch may include a lower edge, e.g., aligned with the tear line and / or perpendicular to the first major edge of the package.

[0045] The tear line may comprise a line of weakness on the first side and / or the second side of the package. Advantageously, providing the tear line as a line of weakness can encourage the tear to propagate in a desired direction, for example, from a first end of the tear region to a second end of the tear region.

[0046] The tear area of the package is at least partially defined by the first and second major edges of the package, the top edge of the package, and the tear line. The top edge of the package may be angled, e.g., not perpendicular, relative to the first and / or second major edges. In such embodiments, the top edge, and thus the tear area, may include an angled top edge. As such, the tear area may be substantially triangular in shape.

[0047] In some embodiments, the beveled top edge may be angled from the interaction point to the tear stop, advantageously encouraging a user to interact with the interaction point to open the package.

[0048] In embodiments, the package may be gas impermeable and may be sealed or otherwise secured around the periphery of the first and second sides of the package to provide a sterile internal environment.

[0049] According to another aspect of the present invention, there is provided a package for containing a medical device, the package having first and second sides sealed or otherwise secured around a periphery thereof, at least a portion of the first and second sides of the package comprising a material having a textured surface profile thereon.

[0050] Advantageously, the textured surface profile may act to attenuate or otherwise mitigate the propagation of sound waves through the package, thereby reducing the overall sound generated during a user's interaction with the package (e.g., opening the package). This may be particularly advantageous when it is desirable to use the packaged medical product discreetly (e.g., in a public place).

[0051] The textured surface profile may be provided on an exterior surface of the first and / or second side of the package. Additionally or alternatively, the textured surface profile may be provided on an interior surface of the first and / or second side of the package. Advantageously, having a textured surface profile on the interior surface of the first and / or second side of the package can provide the above-mentioned benefits without substantially affecting the design of the exterior surface of the package.

[0052] The textured surface profile may comprise a patterned surface profile. In some embodiments, the textured surface profile may comprise an undulating surface profile. In further embodiments, the textured surface profile may comprise an irregular or random surface profile. The package may be embossed or lacquered to form the textured surface profile.

[0053] The package may be formed, at least in part, from one or more of, for example, polypropylene (PP), polyethylene (PET), or oriented polypropylene (OPP). The package may comprise a laminate of two or more layers. The package may include an inner layer and an outer layer. The package may include inner and outer polypropylene layers. The package may include an inner layer of oriented polypropylene and an outer layer of polypropylene. The package may include, for example, an inner layer of polypropylene and an outer layer of polyethylene. The inner and outer layers may have the same thickness. In other embodiments, the inner and outer layers may have different thicknesses. The inner layer may have a thinner thickness than the outer packaging. In embodiments, the inner layer may have a thickness between 5 and 20 microns, or between 10 and 10 microns, or between 10 and 15 microns, and the outer layer may have a thickness between 10 and 50 microns, or between 20 and 40 microns, or between 35 and 45 microns. As an example, the inner layer may have a thickness of approximately 12 microns and the outer layer may have a thickness of approximately 40 microns.

[0054] According to one aspect of the present invention, there is provided a package blank for forming any of the package aspects described herein.

[0055] The package blank may include first and second side panels. The first side panel and / or the second side panel may include any one or more of a first end, a second end, a bottom end, and a top end. The first end of the first side panel and / or the second side panel may include a straight end. The second end of the first side panel and / or the second side panel may include a tapered end. The tapered second end may include a curved tapered end. The bottom end of the first side panel and / or the second side panel may include a straight end. The top end of the first side panel and / or the second side panel may include a beveled end.

[0056] The first and second side panels may be configured to be sealed around their peripheries to other side panels to form a package. The panels may be configured to be sealed to other side panels at or adjacent their first, second, bottom, and / or top edges. The panels may be configured such that the top, bottom, first, and second edges of a first panel are configured to be sealed to the corresponding top, bottom, first, and second edges of a second panel.

[0057] The first and / or second side panels of the package blank may be provided as separate components. Alternatively, the first and / or second side panels may be provided integrally formed with one another. For example, the first and / or second side panels may be integrally formed along their edges, e.g., along the first edges of the first and / or second side panels. The first and / or second side panels may be integrally formed at a fold line along which the package blank can be folded to at least partially form the package.

[0058] The first side panel and / or the second side panel may include one or more openings therein. The openings may be provided to form an interaction point in the formed package, such as an opening in a tear area of the package. The openings may be provided to form a tear stop in the formed package, such as an opening at a tear line. The openings may be provided to form a tear initiation in the formed package, such as a notch in an edge of the formed package.

[0059] The first side panel and / or the second side panel may include a sealing member formed thereon, bonded thereto, sealed, or otherwise secured thereto. For example, the first side panel and / or the second side panel may include a sealing member adhesively secured to a surface of the panel. In some embodiments, the first side panel includes a first sealing member and the second side panel includes a second sealing member. The sealing member may include a strip of material, such as, for example, a strip of adhesive, a strip of hook fasteners, or a strip of loop fasteners.

[0060] According to one aspect of the present invention, there is provided a package blank for forming the above claimed package, the package blank including first and second side panels configured to be sealed about their peripheries to other side panels to form the package.

[0061] The package blank of this aspect of the invention may include any one or more of the features discussed for the previous aspects as desired or appropriate.

[0062] According to one aspect of the present invention, there is provided a method of manufacturing a package of any aspect described herein, the method comprising sealing or otherwise securing first and second sides of the package around a periphery thereof to define an interior volume for containing a medical device.

[0063] The method may include forming a package around the medical device. In such embodiments, the medical device may be disposed on or otherwise associated with one of the first or second sides of the package before the first and second sides are peripherally sealed to encase the medical device.

[0064] In other embodiments, the method may include partially forming a package, introducing a medical device into the partially formed package, and then forming the remainder of the package around the medical device. For example, in some embodiments, the method may include partially sealing or otherwise securing first and second sides of the package around its periphery to partially form a package having an open end for introduction of the medical device. In such embodiments, the method may include introducing the medical device into the package through the open end before subsequently sealing or otherwise securing the remainder of the periphery of the first and second sides to encase the medical device.

[0065] The method may include forming a package from a package blank according to any aspect described herein.

[0066] In order that the invention may be more clearly understood, one or more embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0067] [Figure 1A] FIG. 1 is a front view showing an embodiment of a package according to the present invention. [Figure 1B] Rear view of the package shown in Figure 1A [Figure 2] Further front view of the package shown in the previous figure, with the package partially open [Figure 3] Top view of the package (open) shown in the previous figure [Figure 4] Side cross-sectional view of the package (open) shown in the previous figure [Figure 5] 1 is a diagram showing an embodiment of a package blank according to the present invention; DETAILED DESCRIPTION OF THE INVENTION

[0068] Generally, the present invention relates to a package 10 containing a medical device, shown herein as a medical device in the form of a male intermittent disposable urinary catheter 100.

[0069] 1-4 illustrate an embodiment of a package 10, which in this embodiment is formed from polypropylene. The package 10 includes a first side 12 and a second side 14 that are peripherally sealed, where the first side 12 and the second side 14 are heat-sealed around their peripheries to form an enclosed package 10 for a catheter 100. The peripheral seals of the first side 12 and the second side 14 act to define a pair of opposing main ends 16, 18 and opposing upper and lower ends 20, 22 of the package 10.

[0070] The first major end 16 is substantially straight and defines the front end of the package 10 in use. The second major end 18 is tapered and curves from a top end 22 to a bottom end 20. The bottom end 20 is also straight, while the top end 22 is straight but slopes (downward in the direction shown) from the first major end 16 to the second major end 18. As described herein, the sloped top end 22 partially defines a tear region 28 of the package 10.

[0071] Each of the ends 16, 18, 20, and 22 intersects with its adjacent end at a rounded corner. Specifically, the first major end 18 and the top end 22 intersect at a first rounded corner 37, the top end 22 and the second major end 18 intersect at a second rounded corner 38, the second major end 18 and the bottom end 20 intersect at a third rounded corner 39, and the bottom end 20 and the first major end 16 intersect at a fourth rounded corner 40. The second, third, and fourth rounded corners 38, 39, and 40 each include equal corner radii. In contrast, the first rounded corner 37 includes a larger corner radius. As discussed herein, first rounded corner 37 is provided as part of tear area 28 and serves to define a portion of a secondary interaction point for package 10 .

[0072] Interaction area 24 is provided to define a primary interaction point (e.g., first contact point) for a user of package 10. Interaction area 24 is located proximate the first major end of package 10 and extends midway along first end 16 to top end 22. Interaction area 24 includes a visual indicator in the form of surface markings 26. Surface markings 26 are provided on both first side 12 and second side 14 of package 10 and, in this embodiment, take the form of a series of diamonds. It will be appreciated that the invention is not limited in this sense; rather, interaction area 24 need only be distinguished in some way from the remainder of package 10. This can take the form of a different surface pattern, texture, color, etc. between interaction area 24 and the remainder of the package, or may be defined by a border (see below).

[0073] In the illustrated embodiment, interaction area 24 is bounded by boundary line 25. Boundary line 25 has substantially the same shape as second major end 18 and bottom end 20 of package 10. Specifically, boundary line 25 includes a first tapered line that includes substantially the same curvature and taper as second major end 18 of package 10, and a second straight line that is substantially parallel to bottom end 20 of package 10. The first and second lines of boundary line 25 intersect at a rounded corner.

[0074] Interaction area 24 essentially defines an end area of package 10 that guides a user to grasp package 10 at first end (or "front end") 16 of package 10.

[0075] The package 10 includes a tear region 28 defined adjacent the beveled top edge 22. Specifically, in the illustrated embodiment, the package 10 includes a substantially triangular tear region 28 defined by the top edge 22, a portion of the first major end 16, and a tear line 30 defined between a first end 32 and a second end 34 of the tear region 28. The tear region 28 comprises a portion of the package 10 that can be at least partially removed during use to form an opening at the top end of the package 10 and provide access to the interior of the package 10.

[0076] The tear line 30 is shown as a substantially straight line between a first end 32 and a second end 34 of the tear region 28. At the first end 32, the package is provided with a notch 33 that acts as a tear initiation for initiating a tear along (or at least partially along or adjacent to) the tear line 30. Here, the notch is triangular in shape with a sloped upper end and a flat lower end aligned with the tear line 30, and can act to control the direction of tearing through the package during use, e.g., preferably along the tear line 30. At the second end 34 of the tear region 28, a tear stop in the form of an opening 35 is provided in the package 10. The opening 35 acts to prevent or reduce the likelihood of the tear region 28 being completely removed from the remainder of the package 10. Specifically, the opening prevents (or at least reduces the likelihood of) further propagation of the tear along (or substantially along) the tear line. In this manner, tear region 28 is configured to remain integrally formed at second end 34 with the remainder of package 10 after opening. Advantageously, package 10 remains as a unitary package even after opening, thereby improving ease of use by the user (e.g., in terms of subsequent disposal).

[0077] As discussed herein, a secondary interaction point (e.g., a second contact point for a user) is provided within tear region 28. Specifically, this takes the form of an opening 36 disposed proximate first rounded corner 37 and extending through package 10. Opening 36 is sized to roughly correspond to the typical size of a user's finger / thumb tip for grasping by the user's finger and thumb during use. It also serves as a convenient hanger. Additionally, interaction region 24 extends upward into tear region 28 to define a secondary interaction region 25′ within tear region 28 around opening 36. This further acts to guide the user to grasp package 10 at secondary interaction region 25′ (i.e., proximate opening 36) when opening package 10.

[0078] In use, a user may first grasp the package at interaction area 24 with a first hand, and then grasp tear area 28 at or adjacent opening 36 with a second hand. Tear area 28 and the remainder of package 10 may then be pulled in opposite directions to tear along tear line 30, beginning at notch 33 at first end 32 of tear area 28 and moving toward opening 35 at second end 34 of tear area 28. This is figuratively shown in FIG. 2 .

[0079] The package 10 further includes a seal arrangement in the form of a first seal member 42 disposed on the inner surface of the first side 12 of the package 10 and a second seal member 44 disposed on the inner surface of the second side 14 of the package 10. The first seal member 12 and the second seal member 14 are operable to provide a user-sealable seal between the first side 12 and the second side 14, specifically at the top opening of the package 10 formed by removal of the tear region 28. In the illustrated embodiment, the first seal member 42 and the second seal member 44 each take the form of a strip of hook fastener secured (e.g., by adhesive) to the inner surface of the respective side 12, 14 of the package 10. In this manner, the first seal member 42 and the second seal member 44 form a double hook fastener arrangement for sealing the top opening of the package 10 during use. In this manner, a medical device (e.g., a catheter 100) can be removed from the package 10, used, and then returned to the package 10 for subsequent disposal. Configuring the package 10 to be resealable after opening can be beneficial in situations where fluid may be present (e.g., urine or wetting fluid from the catheter 100) and / or in situations where the user wishes to keep the contents of the package 10 discreet, for example, when exiting the toilet room before disposal.

[0080] As shown in FIG. 4 , each of the first and second sides 12, 14 of the package includes a textured surface profile disposed on its interior surface. Specifically, each of the first and second sides 12, 14 includes an undulating surface profile formed by a series of regions 46, 48 of increasing thickness disposed on the respective sides 12, 14. Advantageously, the textured surface profile acts to attenuate or otherwise mitigate the propagation of sound waves through the package 10. As a result, the overall sound generated during a user's interaction with the package 10 (e.g., rustling in a pocket or upon opening the package 10) can be reduced compared to prior art packages.

[0081] In the illustrated embodiment, package 10 includes an interaction area 24 that includes a series of visual indicators 26. Additionally or alternatively, interaction area 24 may incorporate one or more tactile indicators within interaction area 24. For example, the tactile indicators may include one or more areas within interaction area 24 that have raised (or depressed) surfaces to provide a textured surface profile. Advantageously, this can physically distinguish interaction area 24 from the rest of package 10 and can also assist a user in gripping package 10 during use.

[0082] In the illustrated embodiment, the package 10 includes first and second seal members 42, 44 in the form of strips of hook fasteners adhesively secured to the inner surfaces of the first side 12 and second side 14. However, it will be understood that the seal members 42, 44 may alternatively form a hook-and-loop fastener arrangement, for example, where the first seal member 42 includes a strip of hook fasteners adhesively secured to the first side 12 and the second seal member 44 takes the form of a strip of loop fasteners adhesively secured to the second side 14 of the package 10, or vice versa. Alternatively, the first and second seal members 42, 44 may include an adhesive to provide an adhesive seal between the first side 12 and second side 14 of the package 10.

[0083] FIG. 5 illustrates an embodiment of a package blank 210 for forming the package 10.

[0084] The blank 210 includes a first side panel 212 and a second side panel 214 for forming the first side 12 and the second side 14, respectively, of the package 10. In the illustrated embodiment, the first side panel 212 and the second side panel 214 are integrally formed along a first edge thereof at a fold line 216.

[0085] The first side panel 212 includes a second end 218a, a bottom end 220a, and a top end 222a which, together with the fold line 216, define the perimeter of the first side panel 212. The first side panel 212 also includes a first opening 235a and a second opening 236a extending through the panel 212. A strip of hook fasteners 242 is disposed on the surface of the side panel 212 which forms the first seal member 42 of the package 10.

[0086] The second side panel 214 is constructed in substantially the same manner as the first side panel 212 and includes a second end 218b, a bottom end 220b, and a top end 222b which, together with the fold line 216, define the perimeter of the second side panel 214. The second side panel 214 further includes a first opening 235b and a second opening 236b extending therethrough. A strip of hook fasteners 244 is disposed on the surface of the side panel 214 which forms the second seal member 42 of the package 10.

[0087] A further opening 233 is provided in the fold 216 to form the notch 33 in the package 10 .

[0088] To form package 10, blank 210 is folded along fold line 216 to bring corresponding edges of blank 210 into proximity with one another. Specifically, second end 218a of first side panel 212 is adjacent to second end 218b of second side panel 214, bottom end 220a of first side panel 212 is adjacent to bottom end 220b of second side panel 214, and top end 222a of first side panel 212 is adjacent to top end 222b of second side panel 214. First side panel 212 and second side panel 214 are then sealed around their peripheries, specifically, edges 218a, 220a, 222b are sealed to edges 218b, 220b, 222b, respectively, to form package 10. At this point, a seal may be provided along fold line 216 to strengthen package 10. Furthermore, the first openings 235a, 235b are sealed together around their peripheries to form an opening 35 in the package 10, and the second openings 236a, 236b are sealed together around their peripheries to form an opening 36 in the package 10.

[0089] The catheter 100 may be placed in the panels 212, 214 of the blank 210 prior to forming the package 10. In this case, the blank 210 may be folded and sealed around the catheter 100 to form the package 100 therearound. Alternatively, the catheter 100 may be placed during the forming step. For example, the package 10 may be formed by first sealing one or more of the bottom ends 220a, 220b and second ends 218a, 218b along with the fold line 216 to partially form a package having an opening at the top through which the catheter 100 can be placed. The top ends 222a, 222b of the blank 210 may then be sealed together to enclose the catheter 100 within the package 10. Those skilled in the art will be familiar with fold-fill-seal machinery suitable or compatible for performing these steps.

[0090] In an alternative embodiment, package blank 210 may instead include separate first and second side panels 212, 214. That is, fold line 216 may be omitted, and instead, each of the first and second side panels may include a respective first end. These first ends, as well as second ends 218a, 218b, bottom ends 220a, 220b, and top ends 222a, 222b, may be sealed together to form first main end 16 of package 10.

[0091] Conditional terms such as "can," "could," "might," or "may," unless otherwise specified or understood within the context in which they are used, are 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 the features, elements, and / or steps are in some way required for one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or steps are included in or performed in a particular embodiment, with or without user input or prompting.

[0092] Except in the examples, or where expressly indicated, all numerical quantities in this description specifying amounts of materials, device dimensions, and the like, should be understood to be modified by the term "about."

[0093] Unless otherwise indicated, each chemical or composition referred to herein should be construed as being a commercial grade material that may include isomers, by-products, derivatives, and other such materials normally understood to be included in commercial grades.

[0094] One or more embodiments have been described above by way of example only, and many variations are possible without departing from the scope of protection provided by the appended claims.

Claims

1. A package containing a medical device, first and second side surfaces having peripheries sealed or otherwise secured to define a pair of main ends, a lower end, and an upper end, the pair of main ends including a first straight end and a second tapered end opposite the first straight end; an interaction area defining a first contact point for a user of the package, the interaction area including one or more visual and / or tactile indicators on the first side and / or the second side of the package, the interaction area being positioned proximate the first straight end or the second tapered end; a tear area defined adjacent the top end, the tear area being substantially triangular in shape with a sloped top end, the tear area including: a tear line between a first end and a second end of the tear area defining a line along which the package can be torn in use to at least partially separate the tear area from the remainder of the package and form an opening in the top end of the package; an interaction point at the first end of the tear area defining a second contact point for a user of the package; and a tear stop at the second end of the tear area, the tear stop acting to prevent or reduce the possibility of the tear area being completely separated from the remainder of the package; a sealing arrangement including a first sealing member disposed on an interior surface of the first side of the package and a second sealing member disposed on an interior surface of the second side of the package, the first and second sealing members operable to provide a user-sealable seal between the first and second sides of the package, the sealing arrangement being disposed adjacent to the tear area; Equipped with at least a portion of the first side and / or the second side of the package comprises a material having a textured surface profile on its interior and / or exterior surface; package.

2. the interaction area is located proximate a first main end of the package; The package of claim 1.

3. the second main end includes a curved tapered end; 3. The package of claim 1 or 2.

4. the top end of the package is angled relative to the first major end and / or the second major end to define a substantially triangular region adjacent the top end of the package; 4. The package of claim 2 or 3.

5. a tear area defined adjacent the top end of the package; A package according to any one of claims 2 to 4.

6. the one or more visual and / or tactile indicators include one or more visual surface marks; A package according to any one of claims 1 to 5.

7. the one or more visual and / or tactile indicators include visual boundary marks; A package according to any one of claims 1 to 6.

8. the one or more visual and / or tactile indicators include a tactile surface profile on an exterior surface of the first side and / or the second side of the package; A package according to any one of claims 1 to 7.

9. at least two of the first main end, the second main end, the bottom end, and the top end are integrally formed with a further end of the package with rounded corners at the end; A package according to any one of claims 1 to 8.

10. a first rounded corner of the package including a larger corner radius compared to one or more additional rounded corners of the package; 10. The package of claim 9.

11. the user-closable seal comprises a resealable seal; A package according to any one of claims 1 to 10.

12. the first seal member and the second seal member form a double hook fastener arrangement, the first seal member including an area of hook fasteners disposed on a surface of the first side of the package, and the second seal member including an area of hook fasteners disposed on a surface of the second side of the package; A package according to any one of claims 1 to 11.

13. the first and second sealing members are configured to provide a watertight seal, or a nearly watertight or substantially watertight seal, at or adjacent an opening in the top end of the package; A package according to any one of claims 1 to 12.

14. the interaction point includes an opening in the package; A package according to any one of claims 1 to 13.

15. The upper end of the package is angled relative to the first main end and / or the second main end, thereby defining a sloped upper end of the tear area, the sloped upper end sloping from the interaction point to the tear stop.

15. The package of claim 14.

16. the tear area includes a tear stop; 16. A package according to any one of claims 1 to 15.

17. the tear stop includes an opening in the tear area; 17. A package according to any one of claims 1 to 16.

18. the tear region includes a tear initiation; 18. A package according to any one of claims 1 to 17.

19. the tear initiation includes a notch in the first side and / or the second side of the package; 20. The package of claim 18.

20. the textured surface profile is provided on an inner surface of the first side and / or the second side of the package; 20. A package according to any one of claims 1 to 19.

21. the textured surface profile comprises one or more of a patterned surface profile, an undulating surface profile, and an irregular or random surface profile; 21. A package according to any one of claims 1 to 20.

22. the medical device comprises a catheter; 22. A package according to any one of claims 1 to 21.

23. The medical device includes a male intermittent urinary catheter.

23. The package of claim 22.

24. 24. A package blank for forming a package according to any one of claims 1 to 23, comprising: first and second side panels configured to be sealed at their peripheries to other side panels to form the package; Equipped with Package blank.

25. 24. A method for producing a package according to any one of claims 1 to 23, comprising the steps of: sealing or otherwise securing the first and second sides of the package about a periphery thereof to define an interior volume for containing a medical device; method.

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