Terminal sterilization packaging

Abstract

Provided herein is a terminally sterilizable package for a medical device including a first flexible web having a proximal end, a distal end and at least one side defining a first perimeter therebetween, and a second flexible web having a proximal end, a distal end and at least one side defining a second perimeter therebetween that at least partially overlaps the first perimeter at one or more seal areas, the second flexible web being removably attached to the first flexible web, the first flexible web and the second flexible web defining a compartment configured to hold the medical device, the one or more seal areas defining a tortuous path fluidly connecting the compartment with an exterior of the package.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 315,786, entitled “PACKAGE FOR TERMINAL STERILIZATION,” filed March 2, 2022, the entire disclosure of which is incorporated herein by reference in its entirety.

[0002] The present invention relates generally to packaging for medical devices and, in certain embodiments or aspects, to terminally sterilizable packaging. [Background technology]

[0003] Medical devices and their packaging require sterilization. The approach is to sterilize the device and its packaging once it is packaged. However, traditional materials used for packaging have shortcomings.

[0004] Specifically, most plastic films, which are transparent or substantially transparent to allow visualization of the medical device within the package, are not gas permeable and therefore cannot be used with gas sterilization methods such as ethylene oxide (EtO), hydrogen peroxide, ozone, nitrous oxide, and steam. To allow gas sterilization methods, materials such as paper or gas permeable materials such as TYVEK are used. However, such materials are typically not transparent and do not allow visualization of the device within the package. To address this issue, packages made of multiple materials have been used, but such packages are typically more expensive and complex to manufacture. Thus, there is a need in the art for end-sterilizable packages for medical devices. Summary of the Invention

[0005] Provided herein is a terminally sterilizable package for a medical device comprising: a first flexible web having a proximal end, a distal end, and at least one side defining a first perimeter between the proximal end and the distal end; and a second flexible web having a proximal end, a distal end, and at least one side defining a second perimeter between the proximal end and the distal end that at least partially overlaps the first perimeter at one or more seal areas, wherein the second flexible web is removably attached to the first flexible web, the first flexible web and the second flexible web defining a compartment configured to hold a medical device, the one or more seal areas defining a tortuous path fluidly connecting the compartment with an exterior of the package.

[0006] According to one embodiment of the invention, the one or more seal areas are disposed between the first flexible web and the second flexible web at the proximal end.

[0007] According to one embodiment of the invention, the one or more seal areas are disposed between the first flexible web and the second flexible web at the distal end.

[0008] According to one embodiment of the invention, the one or more seal areas are disposed between the first flexible web and the second flexible web on one or more of the sides.

[0009] According to an embodiment of the invention, the one or more sealing areas are arranged at two or more locations of the overlap between the first perimeter and the second perimeter.

[0010] According to one embodiment of the invention, the first flexible web and the second flexible web are formed of the same material.

[0011] According to one embodiment of the invention, the material comprises one or more flexible thermoformable plastics.

[0012] According to one embodiment of the invention, the flexible thermoformed plastic includes one or more of a nylon-based film, polyethylene, and / or ethyl vinyl acetate.

[0013] According to an embodiment of the invention, the tortuous path comprises one or more curves.

[0014] According to an embodiment of the invention, the tortuous path includes one or more right angles.

[0015] According to an embodiment of the invention, the serpentine path comprises a honeycomb arrangement.

[0016] According to an embodiment of the invention, the tortuous path fluidly connects the compartment with an exterior of the package at a plurality of locations along the first perimeter and the second perimeter.

[0017] According to an embodiment of the invention, the serpentine path is disposed at substantially all of the overlap between the first perimeter and the second perimeter.

[0018] According to an embodiment of the invention, the first flexible web and the second flexible web include one or more overlapping regions extending radially inwardly into the compartment.

[0019] According to an embodiment of the invention, the tortuous path is disposed in at least the one or more inwardly extending regions.

[0020] Also provided herein is a terminally sterilizable package for a medical device comprising: a tray having a closed distal end, an open proximal end, a sidewall disposed between the closed distal end and the open proximal end, the closed distal end and the sidewall defining a container configured to receive a medical device, and a flange disposed about a periphery of the open proximal end of the tray; and a flexible web disposed at the open proximal end of the tray and at least partially overlapping the flange at one or more seal areas, the one or more seal areas defining a tortuous path fluidly connecting the container with an exterior of the package.

[0021] According to one embodiment of the invention, the one or more sealing areas are disposed at two or more locations of the overlap between the flange and the flexible web.

[0022] According to an embodiment of the invention, the tray and / or the flexible web comprises one or more flexible thermoformed plastics.

[0023] According to an embodiment of the invention, the flexible thermoformed plastic includes one or more of a nylon-based film, polyethylene, and / or ethyl vinyl acetate.

[0024] According to an embodiment of the invention, the tortuous path comprises one or more curves.

[0025] According to an embodiment of the invention, the tortuous path includes one or more right angles.

[0026] According to an embodiment of the invention, the serpentine path comprises a honeycomb arrangement.

[0027] According to an embodiment of the invention, the tortuous path fluidly connects the enclosure with an exterior of the package at a plurality of locations along the periphery of the enclosure.

[0028] According to an embodiment of the invention, the serpentine path is disposed at substantially all of the overlap between the first perimeter and the second perimeter.

[0029] According to an embodiment of the invention, the flange and the flexible web include one or more overlapping regions extending radially inwardly to the open proximal end of the tray.

[0030] According to an embodiment of the invention, the tortuous path is disposed in at least the one or more inwardly extending regions.

[0031] Also provided herein is a terminally sterilizable package for a medical device comprising: a tray having a closed distal end, an open proximal end, a sidewall disposed between the closed distal end and the open proximal end, the closed distal end and the sidewall defining a reservoir configured to receive a medical device; and a flange connected to the sidewall and disposed about a periphery of the open proximal end of the tray, the sidewall and the flange including one or more notches; a flexible web disposed at the open proximal end of the tray and at least partially overlapping the flange; and one or more plugs disposed in the one or more notches in the sidewall and the flange, the one or more plugs defining a tortuous path fluidly connecting the reservoir with an exterior of the package.

[0032] According to an embodiment of the invention, the notch and the plug have a substantially circular cross-sectional shape.

[0033] According to an embodiment of the present invention, the notch and the plug have a substantially rectangular cross-sectional shape.

[0034] According to an embodiment of the invention, the notch and the plug have a substantially rectangular cross-sectional shape.

[0035] According to an embodiment of the invention, the notch and the plug have a substantially trapezoidal cross-sectional shape.

[0036] According to one embodiment of the invention, the tray and / or the flexible web comprises one or more flexible thermoformed plastics.

[0037] According to an embodiment of the invention, the flexible thermoformed plastic includes one or more of a nylon-based film, polyethylene, and / or ethyl vinyl acetate.

[0038] According to an embodiment of the invention, the flexible web overlaps the flange at one or more sealing areas, the one or more sealing areas defining a tortuous path fluidly connecting the containing portion with an exterior of the package.

[0039] According to an embodiment of the invention, the tortuous path comprises one or more curves.

[0040] According to an embodiment of the invention, the tortuous path includes one or more right angles.

[0041] According to an embodiment of the invention, the serpentine path comprises a honeycomb arrangement.

[0042] Also provided herein is a terminally sterilizable package for a medical device comprising: a first flexible web having a proximal end, a distal end, and at least one side defining a first perimeter between the proximal end and the distal end; and a second flexible web having a proximal end, a distal end, and at least one side defining a second perimeter between the proximal end and the distal end that at least partially overlaps the first perimeter at one or more seal areas, the second flexible web being removably attached to the first flexible web, the first flexible web and the second flexible web defining a compartment configured to hold a medical device, wherein one or both of the first flexible web and the second flexible web comprise one or more filters configured to allow entry of sterilizing gas into the compartment.

[0043] According to an embodiment of the invention, the first flexible web and the second flexible web are formed of the same material, and the package is configured to be recycled in a single stream recycle.

[0044] According to an embodiment of the present invention, the material comprises polypropylene or polyethylene.

[0045] According to an embodiment of the invention, the material comprises low density polyethylene or linear low density polyethylene.

[0046] According to an embodiment of the invention, the one or more filters are formed from the same material as the first flexible web and the second flexible web.

[0047] According to an embodiment of the invention, the package is adapted to be sterilized by sterilizing gas and / or irradiation.

[0048] Also provided herein is a terminally sterilizable package for a medical device comprising a flexible web having a proximal end, a distal end, and at least one side between the proximal end and the distal end, defining a first perimeter and a compartment configured to hold the medical device, wherein at least one of the proximal end and the distal end and / or the side defines a seam, the seam defining a tortuous path fluidly connecting the compartment with an exterior of the package.

[0049] According to an embodiment of the invention, the plastic web comprises polypropylene or polyethylene and the package is adapted to be recycled in a single stream recycle.

[0050] According to an embodiment of the present invention, the flexible web comprises low density polyethylene or linear low density polyethylene.

[0051] According to an embodiment of the invention, the tortuous path comprises one or more curves.

[0052] According to an embodiment of the invention, the tortuous path includes one or more right angles.

[0053] According to an embodiment of the invention, the serpentine path comprises a honeycomb arrangement.

[0054] According to an embodiment of the invention, the tortuous path fluidly connects the compartment with the exterior of the package at multiple locations along the seam.

[0055] According to an embodiment of the invention, the package is adapted to be sterilized by sterilizing gas and / or irradiation. [Brief description of the drawings]

[0056] [Figure 1]FIG. 1 is a schematic diagram of a terminally sterilizable package for a medical device, according to a non-limiting embodiment or aspect. [Diagram 2] FIG. 2 is a schematic diagram of a terminally sterilizable package for a medical device, according to a non-limiting embodiment or aspect. [Diagram 3] FIG. 3 is a schematic diagram of a terminally sterilizable package for a medical device, according to a non-limiting embodiment or aspect. [Figure 4] FIG. 4 is a schematic diagram of a terminally sterilizable package for a medical device, according to a non-limiting embodiment or aspect. [Figure 5A] FIG. 5A is a schematic diagram of a terminally sterilizable package for a medical device according to a non-limiting embodiment or aspect. [Figure 5B] FIG. 5B is a schematic diagram of a terminally sterilizable package for a medical device according to a non-limiting embodiment or aspect. [Figure 5C] FIG. 5C is a schematic diagram of a terminally sterilizable package for a medical device according to a non-limiting embodiment or aspect. [Figure 5D] FIG. 5D is a schematic diagram of a terminally sterilizable package for a medical device according to a non-limiting embodiment or aspect. [Figure 5E] FIG. 5E is a schematic diagram of a terminally sterilizable package for a medical device according to a non-limiting embodiment or aspect. [Figure 5F] FIG. 5F is a schematic diagram of a terminally sterilizable package for a medical device according to a non-limiting embodiment or aspect. [Figure 5G] FIG. 5G is a schematic diagram of a terminally sterilizable package for a medical device according to a non-limiting embodiment or aspect. [Figure 5H] FIG. 5H is a schematic diagram of a terminally sterilizable package for a medical device according to a non-limiting embodiment or aspect. [Figure 5I] FIG. 5I is a schematic diagram of a terminally sterilizable package for a medical device according to a non-limiting embodiment or aspect. [Figure 5J]FIG. 5J is a schematic diagram of a terminally sterilizable package for a medical device according to a non-limiting embodiment or aspect. [Figure 5K] FIG. 5K is a schematic diagram of a terminally sterilizable package for a medical device according to a non-limiting embodiment or aspect. [Figure 5L] FIG. 5L is a schematic diagram of a terminally sterilizable package for a medical device according to a non-limiting embodiment or aspect. [Figure 5M] FIG. 5M is a schematic diagram of a terminally sterilizable package for a medical device according to a non-limiting embodiment or aspect. [Figure 6] FIG. 6 is a schematic diagram of a terminally sterilizable package for a medical device, according to a non-limiting embodiment or aspect. [Figure 7A] FIG. 7A is a schematic diagram of a terminally sterilizable package for a medical device according to a non-limiting embodiment or aspect. [Figure 7B] FIG. 7B is a schematic diagram of a terminally sterilizable package for a medical device according to a non-limiting embodiment or aspect. [Figure 7C] FIG. 7C is a schematic diagram of a terminally sterilizable package for a medical device according to a non-limiting embodiment or aspect. [Figure 8] FIG. 8 is a schematic diagram of a terminally sterilizable package for a medical device, according to a non-limiting embodiment or aspect. [Figure 9] FIG. 9 is a graph showing the diffusion distance over time for particles having various diameters. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0057] The following description is provided to enable those skilled in the art to make and use the described embodiments that are intended to practice the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0058] For purposes of description hereinafter, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "longitudinal" and their derivatives refer to the present invention as oriented in the drawings. However, it will be understood that the present invention may be subject to various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the attached drawings and described in the following specification are merely exemplary embodiments of the present invention. As such, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0059] 1-4, a terminally sterilizable package 100 for a medical device according to a non-limiting embodiment or aspect has a proximal end 102, a distal end 104, and one or more sides 106. As used herein, the term "terminally sterilizable" refers to a means of removing or killing microorganisms present on a medical device contained in a package and / or on the surfaces of the package in which the device is contained after the device is sealed in the package to achieve a germ-free or sterile microbial environment. Sterilization can be achieved by applying heat, chemicals, irradiation / radiation, high pressure, filtration, or combinations thereof. Chemical sterilization includes sterilization with gases such as ethylene oxide, hydrogen peroxide gas, ozone, liquids such as chlorine bleach, iodine, glutaraldehyde, formaldehyde, orthophthalaldehyde (OPA), hydrogen peroxide, peracetic acid, sodium hydroxide, silver, cobalt, etc. Radiation sterilization uses radiation such as electron beam (E-beam), x-rays, gamma rays, elementary particles, etc. In non-limiting embodiments or aspects, the terminal sterilization is gas sterilization including EtO, hydrogen peroxide gas, ozone, nitrous oxide, and / or steam. The terminally sterilizable package 100 can be, for example, a blister package. In non-limiting embodiments or aspects, the terminally sterilizable package 100 includes a first flexible web 110 and an optional second flexible web 120 that define a compartment 140 configured to receive a medical device. Each of the webs has a proximal end and a distal end and at least one side defining a respective perimeter therebetween. The first flexible web 110 and the second flexible web 120 at least partially overlap in one or more regions along their respective perimeters. In non-limiting embodiments, the width of the overlap region (shown as A in FIG. 1) is between about 3 / 8 inch and about 1 inch, optionally between about 3 / 8 inch and about 3 / 4 inch, including all values ​​and sub-ranges therebetween. Within these one or more overlapping regions are one or more seal regions 130. In non-limiting embodiments, the seal region 130 can be about 2-7 mm, about 3-6 mm, and / or about 4-5 mm wide, including all values ​​and sub-ranges therebetween.In a non-limiting embodiment, the total length of the perimeter of the sealing area 130 can be at least 300 mm, optionally at least 350 mm, optionally at least 374 mm, including all values ​​and sub-ranges therebetween. In a non-limiting embodiment or aspect, one or both of the first flexible web 110 and the second flexible web 120 include an inwardly projecting section 135 that extends from the respective periphery into the compartment 140. In a non-limiting embodiment or aspect, the one or more sealing areas 130 are positioned to at least partially include such an inwardly projecting section 135. In a non-limiting embodiment or aspect, the one or more inwardly projecting sections 135 are about 3 / 4 inch wide. In a non-limiting embodiment or aspect, one or both of the first flexible web 110 and the second flexible web 120 can include one or more thumb notches 150 that allow a user to separate the webs to access the compartment and the medical device held therein.

[0060] In non-limiting embodiments or aspects, these one or more seal regions 130 define one or more tortuous paths 160 (e.g., as shown in FIGS. 5A-5I ) that fluidly connect the compartment 140 and the exterior of the package 100. The one or more seal regions 130 including the one or more tortuous paths 160 can be located at one or more locations on the periphery of the package, including the proximal end 102, the distal end 104, and / or the sides 106. This fluid connectivity allows sterilizing gases, such as those described herein, to reach the medical device while simultaneously preventing the ingress of microorganisms.

[0061] The first and second flexible webs 110, 120 can be formed of one or more layers of any material known to one of skill in the art to be useful in packaging. In non-limiting embodiments or aspects, the material is substantially or completely transparent. In non-limiting embodiments or aspects, the material is a flexible thermoformed plastic film. In non-limiting embodiments or aspects, the film is multi-layered. In non-limiting embodiments or aspects, the major component of the film is a layer of about 15-30% nylon, while the remaining layers can include materials including, but not limited to, polyethylene. In non-limiting embodiments or aspects, the material is ethylene vinyl acetate (EVA), optionally up to about 30% EVA. In non-limiting embodiments or aspects, the first and / or second flexible webs 110, 120 are formed of a radiation stable material. In non-limiting embodiments or aspects, the first and / or second flexible webs 110, 120 are formed from polyethylene, low density polyethylene, linear low density polyethylene, polypropylene, and / or stabilized polypropylene. In non-limiting embodiments or aspects, the first and second flexible webs 110, 120 are formed from the same or similar materials, and no sealant or adhesive is required or included. In such embodiments, the sheet of material can be fused to itself to create the seams, for example, by heat welding, laser ablation, or other similar techniques known to those skilled in the art. These seams can define one or more tortuous paths (e.g., those shown in Figures 5A-5I) that fluidly connect the compartments with the exterior of the package 100, similar to the seal area 130 described above. Using a single material (or the same type of material) for the first and / or second flexible webs 110, 120 can allow the package 100 to be easily recyclable in a single seam recycle.

[0062] 5A-5M, non-limiting embodiments or aspects of a serpentine path 160 fluidly connecting the compartment 140 of the package 100 with the exterior of the package to allow for the ingress of sterilization gas are shown. The one or more serpentine paths 160 can be of any shape and / or geometry, can have any diameter, and can include one or more curves, right angles, acute angles, and / or oblique angles. In non-limiting embodiments, the one or more serpentine paths 160 have a circular, triangular, and / or rectangular shape, for example, as shown in FIGS. 5J-5M. In non-limiting embodiments, the rectangular shape can be a square or rectangular. In non-limiting embodiments, the serpentine path 160 is disposed on the periphery of the package 100. In non-limiting embodiments, the one or more serpentine paths 160 have a diameter of 1 mm or less, optionally 250 μm or less, optionally 3.0 μm or less, including all values ​​and sub-ranges therebetween. In non-limiting embodiments, for example, as shown in Figures 5J-5M, the serpentine path 160 can have a rectangular (Figure 5J), square (Figure 5K), circular (Figure 5L), and / or triangular (Figure 5M) cross-sectional shape. As previously mentioned, the serpentine path 160 can have any suitable diameter, but in non-limiting embodiments, the serpentine path 160 has a width (x) of about 1 mm and a height (y) of about 0.5 mm, a height (y) of about 1 mm, and / or a diameter (x) of about 0.26 mm.

[0063] In non-limiting embodiments or aspects, the distance between the curves and / or angles (e.g., B in Figures 5B and 5H) can range from 1 mm to 5 mm, optionally about 4.5 mm, including all values ​​and sub-ranges therebetween. In non-limiting embodiments, the one or more serpentine paths include at least one 90° angle, optionally a curved 90° angle. The one or more serpentine paths 160 can be any length, can cross each other any number of times, and / or can open to the compartment 140 and / or to the exterior of the package 100 at one or more locations. In non-limiting embodiments or aspects, the one or more serpentine paths 160 can be configured as a honeycomb. In non-limiting embodiments or aspects, the one or more serpentine paths 160 can include one or more sawtooth regions, for example, as shown in Figure 5F. One of ordinary skill in the art will appreciate that the one or more tortuous paths 160 can include any number and any combination of any arrangement / configuration of paths. Without wishing to be bound by theory, the size of the microorganisms to be prevented from entering may correspond to the length of the one or more tortuous paths 160, with smaller diameter microorganisms requiring longer tortuous paths.See, e.g., Tsuda et al., Particle Transport and Deposition: Basic Physics of Particle Kinetics. Compr. Physiol. 2013, 3 (4): 1437 -1471; Louten, Virus Structure and Classification. ESS. Hum.Virol. 2016,19-29; and Puiet al., Experimental Study of Particle Deposition in Bends of Circular Cross Section. Aero. Sci.& Tech. 1987,3001-315; and Zhang et al., Experimental Measurement and Numerical Study of Particle Deposition in Highly Idealized Mouth - Throat Models. Aero. Sci.& Tech. 2006,5:361-372, the contents of which are incorporated herein by reference in their entireties. 9 shows a graph detailing the diffusion distance of particles of various diameters over a period of years, which supports the tortuous path length mentioned above. One skilled in the art can choose the appropriate length of the tortuous path, knowing the particle diameter and the diffusion coefficient, based on the following formula:

[0064]

number

[0065] Where D = diffusion coefficient (cm 2 / s) and t = time in seconds.

[0066] In non-limiting embodiments, the one or more tortuous paths 160 can have a length of at least 10 mm, at least 20 mm, at least 100 mm, at least 200 mm, at least 300 mm, at least 400 mm, at least 500 mm, at least 600 mm, at least 700 mm, at least 1 cm, at least 5 cm, at least 10 cm, at least 30 cm, including all values ​​and sub-ranges therebetween. In non-limiting embodiments, the one or more tortuous paths 160 have a length of at least 20.5 mm, at least 321 mm, at least 600 mm, at least 10 cm, and / or at least 30 cm. In non-limiting embodiments, a tortuous path length of at least 20.5 mm will prevent the entry of bacteria, a tortuous path length of at least 321 mm will prevent the entry of larger viruses (e.g., greater than 0.05 μm in diameter), and a tortuous path length of at least 600 mm will prevent the entry of viruses with a diameter of 0.05 μm or less. Additionally, a longer tortuous path can increase the amount of time that microorganisms are prevented from entering the compartment 140.

[0067] As will be appreciated by one of ordinary skill in the art, the various characteristics of the tortuous path 160 described above may require different terminal sterilization lengths to ensure that the sterilization medium enters the compartment 140 .

[0068] 6, a terminally sterilizable package 200 for a medical device according to a non-limiting embodiment or aspect has a first web 210 in the form of a tray, optionally formed of a rigid material, having a closed distal end, an open proximal end, and a sidewall 212 disposed therebetween that defines a receptacle 240 configured to receive a medical device. The first web 210 can also include a flange 215 disposed about a periphery of its open proximal end. A second flexible web 220 can be disposed at the open proximal end of the first flexible web 210, at least partially overlapping the flange 215 to create one or more seal areas 230. In a non-limiting embodiment or aspect, one or both of the flange 215 and the second flexible web 220 include an inwardly projecting section (not shown) that extends into the open proximal end of the first web 210. In non-limiting embodiments or aspects, the one or more seal areas 230 are arranged to at least partially include such an inwardly projecting compartment. As described above, these one or more seal areas 230 define one or more serpentine paths 260 that fluidly connect the containment with the exterior of the package. The one or more serpentine paths 260 may have any of the characteristics of the serpentine paths 160 described above. This fluid connectivity allows sterilizing gases, such as those described herein, to reach the medical device while simultaneously preventing the ingress of microorganisms. As described above and shown in the non-limiting embodiments or aspects of Figures 5A-5I, the one or more serpentine paths 260 may assume any useful configuration. The one or more serpentine paths 260 may be any shape and may include one or more curves, right angles, acute angles, and / or oblique angles. The one or more serpentine paths 260 can be of any length, can cross one another any number of times, and / or can open at one or more locations to the housing 240 and / or to the exterior of the package 200. In a non-limiting embodiment or aspect, the one or more serpentine paths 260 can be configured as a honeycomb.In a non-limiting embodiment or aspect, the one or more serpentine paths 260 can include one or more sawtooth regions, for example, as shown in Figure 5F. One skilled in the art will understand that the one or more serpentine paths 260 can include any number and any combination of any arrangement / configuration of paths.

[0069] 7A-7C, a terminally sterilizable package 300 for a medical device according to a non-limiting embodiment or aspect has a first web 310 in the form of a tray, optionally formed of a rigid material, having a closed distal end, an open proximal end, and a sidewall 312 disposed therebetween that defines a receptacle 340 configured to receive a medical device. The first web 310 can also include a flange 315 disposed about a periphery of the open proximal end. A second flexible web 320 can be disposed at the open proximal end of the first flexible web 310, at least partially overlapping the flange 315.

[0070] As shown in FIGS. 7A-7C, in non-limiting embodiments or aspects, the sidewall 312 and / or flange 315 can include one or more notches 370. In non-limiting embodiments or aspects, the package 300 includes one or more plugs 380 disposed within the one or more notches. The one or more plugs 380 can be formed of a resilient and / or porous material, such as foam, and / or a sintered polyolefin material. In non-limiting embodiments or aspects, the one or more plugs 380 define a tortuous path that fluidly connects the housing 340 with the exterior of the package 300. In non-limiting embodiments or aspects, the one or more plugs 380 are larger than the one or more notches 370 and provide a seal between the one or more plugs 380 and the sidewall 312 and / or flange 315. The one or more notches 370 and plugs 380 can assume any useful configuration, but in non-limiting embodiments or aspects can have a circular cross-sectional shape or a quadrangular, e.g., rectangular, square, or trapezoidal cross-sectional shape. One skilled in the art will understand that plugs as described above can be included in any of the other described embodiments, for example, as an alternative and / or in addition to a sealing region (e.g., one that defines a tortuous path as described herein).

[0071] In non-limiting embodiments or aspects, the package 300 can include both the notch 370 and plug 380, as well as one or more serpentine paths (not shown) disposed between the first web 310 and the second flexible web 320 in one or more seal areas 330, as described above with respect to Figures 1-6. A serpentine path useful in the illustrated non-limiting embodiments can have any of the features of the serpentine paths 160, 260 described above.

[0072] Referring to FIG. 8, a non-limiting embodiment or aspect of a package 400 is shown that includes first and second flexible webs 410, 420 that define compartments for holding, for example, medical devices. The package 400 may be terminally sterilized by sterilizing gas and / or irradiation. One or both of the first and second flexible webs 410, 420 may include a window 430 in which a filter 440 is placed. The edges of the first and second flexible webs 410, 420 may be formed of one or more materials as described above and may be melted as described above. In a non-limiting embodiment or aspect, the first and second flexible webs 410, 420 and the filter 440 are formed of similar materials, optionally the same material, allowing single-stream recycling of the package 400. In a non-limiting embodiment or aspect, the first flexible web 410 and the second flexible web 420 at least partially overlap in one or more regions along their respective perimeters, as described above. Within these one or more overlapping regions are one or more sealing regions and / or plugs, as described above. These one or more sealing regions may define one or more tortuous paths (e.g., those shown in Figures 5A-5I) that fluidly connect the compartments with the exterior of the package 400. The tortuous paths useful in the illustrated non-limiting embodiments may have any of the characteristics of the tortuous paths 160, 260 described above.

[0073] The filter 440 may function similarly to the tortuous path and stopcock described above in that it may allow sterilizing gas (e.g., hydrogen peroxide gas, EtO) to pass through the compartment and sterilize its interior, including any medical equipment placed therein. Additionally, the filter 440 may limit the passage of microorganisms, thus maintaining the sterility of the compartment and any medical equipment placed therein after sterilization. The filter 440 may be formed of polypropylene, polyethylene, sintered polyolefin materials, and / or similar materials known to those skilled in the art as useful for filtering air, and may have any useful properties, such as porosity, to maximize the ability of sterilizing gas to pass therethrough while limiting the ingress of microorganisms into the compartment. The use of such materials allows the package 400 to be recycled in a single stream recycle. Although the window 430 and filter 440 are shown in FIG. 8 as being parallelogram shaped, one skilled in the art will understand that any suitable shape and size (including thickness) may be used. The filter 440 may be attached to the first and / or second flexible webs 410, 420 by known techniques such as, for example, heat staking, adhesives, ultrasonic welding, and / or laser welding.

[0074] Also provided is a method of making a terminally sterilizable container as described herein. In a non-limiting embodiment or aspect, the filter 440 is attached to the first and / or second flexible webs 410, 420, e.g., using one or more techniques described herein. The first flexible web 410 and the second flexible web 420 are then attached to each other along one or more, but not all, of any overlapping areas, e.g., using one or more techniques described herein. A medical device is then inserted into the compartment defined by the first and second flexible webs 410, 420, and the final overlapping area(s) are attached to each other, e.g., using one or more techniques described herein. The package 400 is then terminally sterilized as described herein.

[0075] While the present invention has been described in detail for purposes of illustration based on what are currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is for this purpose only, and that the present invention is not limited to the disclosed embodiments or aspects, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. 1. A terminally sterilizable package for a medical device, comprising: a first flexible web having a proximal end, a distal end, and at least one side defining a first perimeter between said proximal end and said distal end; a second flexible web having a proximal end, a distal end, and at least one side defining a second perimeter between the proximal end and the distal end that at least partially overlaps the first perimeter at one or more seal areas, the second flexible web being removably attached to the first flexible web, the first flexible web and the second flexible web defining a compartment configured to hold a medical device; wherein the one or more seal areas define a tortuous path fluidly connecting the compartment with an exterior of the package.

2. 10. The terminally sterilizable package of claim 1, wherein the one or more seal areas are disposed between the first flexible web and the second flexible web at the proximal end.

3. 3. The terminally sterilizable package of claim 1, wherein the one or more seal areas are disposed between the first flexible web and the second flexible web at the distal end.

4. 10. The terminally sterilizable package of claim 1, wherein the one or more seal areas are disposed between the first flexible web and the second flexible web on one or more of the sides.

5. 10. The terminally sterilizable package of claim 1, wherein the one or more seal areas are disposed at two or more locations of overlap between the first perimeter and the second perimeter.

6. 10. The terminally sterilizable package of claim 1, wherein the first flexible web and the second flexible web are formed of the same material.

7. The terminally sterilizable package of claim 6 , wherein the material comprises one or more flexible thermoformed plastics.

8. 8. The terminally sterilizable package of claim 7, wherein the flexible thermoformed plastic comprises one or more of a nylon-based film, polyethylene, and / or ethyl vinyl acetate.

9. 10. The terminally sterilizable package of claim 1, wherein the tortuous path includes one or more curves.

10. 10. The terminally sterilizable package of claim 1, wherein the tortuous path includes one or more right angles.

11. The terminally sterilizable package of claim 1 , wherein the tortuous path comprises a honeycomb configuration.

12. 2. The terminally sterilizable package of claim 1, wherein the tortuous path fluidly connects the compartment with an exterior of the package at a plurality of locations along the first perimeter and the second perimeter.

13. 2. The terminally sterilizable package of claim 1, wherein the tortuous path is disposed at substantially all of the overlap between the first perimeter and the second perimeter.

14. 10. The terminally sterilizable package of claim 1, wherein the first flexible web and the second flexible web include one or more overlap regions extending radially inward into the compartment.

15. 15. The terminally sterilizable package of claim 14, wherein the tortuous path is disposed in at least the one or more inwardly extending regions.

16. 1. A terminally sterilizable package for a medical device, comprising: A tray, a closed distal end; an open proximal end; a sidewall disposed between the closed distal end and the open proximal end, the closed distal end and the sidewall defining a receptacle configured to receive a medical device; a flange disposed about a periphery of the open proximal end of the tray; A tray comprising: a flexible web disposed at the open proximal end of the tray and at least partially overlapping the flange at one or more seal areas; Equipped with A terminally sterilizable package, wherein the one or more seal regions define a tortuous path fluidly connecting the reservoir with an exterior of the package.

17. 17. The terminally sterilizable package of claim 16, wherein the one or more seal areas are disposed at two or more locations of overlap between the flange and the flexible web.

18. 18. The terminally sterilizable package of claim 16 or 17, wherein the tray and / or the flexible web comprise one or more flexible thermoformed plastics.

19. 20. The terminally sterilizable package of claim 18, wherein the flexible thermoformed plastic comprises one or more of a nylon-based film, polyethylene, and / or ethyl vinyl acetate.

20. 17. The terminally sterilizable package of claim 16, wherein the tortuous path includes one or more curves.

21. 17. The terminally sterilizable package of claim 16, wherein the tortuous path includes one or more right angles.

22. 17. The terminally sterilizable package of claim 16, wherein the tortuous path comprises a honeycomb configuration.

23. 17. The terminally sterilizable package of claim 16, wherein the tortuous path fluidly connects the enclosure with an exterior of the package at a plurality of locations along the perimeter of the enclosure.

24. 17. The terminally sterilizable package of claim 16, wherein the tortuous path is disposed at substantially all of the overlap between the first perimeter and the second perimeter.

25. 17. The terminally sterilizable package of claim 16, wherein the flange and the flexible web include one or more overlap regions extending radially inwardly to the open proximal end of the tray.

26. 26. The terminally sterilizable package of claim 25, wherein the tortuous path is disposed in at least the one or more inwardly extending regions.

27. 1. A terminally sterilizable package for a medical device, comprising: A tray, a closed distal end; an open proximal end; a sidewall disposed between the closed distal end and the open proximal end, the closed distal end and the sidewall defining a receptacle configured to receive a medical device; a tray connected to the sidewall and positioned about the open proximal end of the tray, the sidewall and the flange including one or more notches; A tray comprising: a flexible web disposed at the open proximal end of the tray and at least partially overlapping the flange; one or more plugs disposed in one or more of the notches in the sidewall and the flange; Equipped with A terminally sterilizable package, wherein the one or more plugs define a tortuous path fluidly connecting the reservoir with an exterior of the package.

28. 30. The terminally sterilizable package of claim 27, wherein the notch and the plug have a substantially circular cross-sectional shape.

29. 30. The terminally sterilizable package of claim 27, wherein the notch and the plug have a substantially rectangular cross-sectional shape.

30. 30. The terminally sterilizable package of claim 27 or 29, wherein the notch and the plug have a substantially rectangular cross-sectional shape.

31. 30. The terminally sterilizable package of claim 27 or 29, wherein the notch and the plug have a substantially trapezoidal cross-sectional shape.

32. 30. The terminally sterilizable package of claim 27, wherein the tray and / or the flexible web comprise one or more flexible thermoformed plastics.

33. 33. The terminally sterilizable package of claim 32, wherein the flexible thermoformed plastic comprises one or more of a nylon-based film, polyethylene, and / or ethyl vinyl acetate.

34. 28. The terminally sterilizable package of claim 27, wherein the flexible web overlaps the flange at one or more seal areas, the one or more seal areas defining a tortuous path fluidly connecting the reservoir with an exterior of the package.

35. 35. The terminally sterilizable package of claim 34, wherein the tortuous path includes one or more curves.

36. 36. The terminally sterilizable package of claim 34 or 35, wherein the tortuous path includes one or more right angles.

37. 35. The terminally sterilizable package of claim 34, wherein the tortuous path comprises a honeycomb configuration.

38. 1. A terminally sterilizable package for a medical device, comprising: a first flexible web having a proximal end, a distal end, and at least one side defining a first perimeter between said proximal end and said distal end; a second flexible web having a proximal end, a distal end, and at least one side defining a second perimeter between the proximal end and the distal end that at least partially overlaps the first perimeter at one or more seal areas, the second flexible web being removably attached to the first flexible web, the first flexible web and the second flexible web defining a compartment configured to hold a medical device; Equipped with A terminally sterilizable package, wherein one or both of the first flexible web and the second flexible web comprise one or more filters configured to allow entry of a sterilizing gas into the compartment.

39. 40. The terminally sterilizable package of claim 38, wherein the first flexible web and the second flexible web are formed of the same material, and the package is configured to be recycled in a single-stream recycle.

40. 40. The terminally sterilizable package of claim 39, wherein the material comprises polypropylene or polyethylene.

41. 41. The terminally sterilizable package of claim 39 or 40, wherein the material comprises low density polyethylene or linear low density polyethylene.

42. 40. The terminally sterilizable package of claim 38, wherein the one or more filters are formed of the same material as the first flexible web and the second flexible web.

43. 40. The terminally sterilizable package of claim 38, wherein the package is configured to be sterilized by sterilizing gas and / or irradiation.

44. 1. A terminally sterilizable package for a medical device, comprising: a flexible web having a proximal end, a distal end, and at least one side between the proximal end and the distal end, defining a first perimeter and a compartment configured to hold the medical device, wherein at least one of the proximal end and the distal end and / or the side defines a seam; Equipped with A terminally sterilizable package, wherein the seam defines a tortuous path fluidly connecting the compartment with an exterior of the package.

45. 45. The terminally sterilizable package of claim 44, wherein the plastic web comprises polypropylene or polyethylene, and the package is configured to be recycled in a single-stream recycle.

46. 46. ​​The terminally sterilizable package of claim 44 or 45, wherein the flexible web comprises low density polyethylene or linear low density polyethylene.

47. 45. The terminally sterilizable package of claim 44, wherein the tortuous path includes one or more curves.

48. 45. The terminally sterilizable package of claim 44, wherein the tortuous path includes one or more right angles.

49. 45. The terminally sterilizable package of claim 44, wherein the tortuous path comprises a honeycomb configuration.

50. 45. The terminally sterilizable package of claim 44, wherein the tortuous path fluidly connects the compartment with an exterior of the package at a plurality of locations along the seam.

51. 45. The terminally sterilizable package of claim 44, wherein the package is configured to be sterilized by sterilizing gas and / or irradiation.

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