MULTI-LEVEL FLANGE SEALING

Description

RELATED APPLICATIONS

This application claims the benefit of Provisional Application No. 63/680,192, filed on Aug. 7, 2024, which is hereby incorporated by reference in its entirety.

TECHNICAL FIELD

The present disclosure is directed generally to packaging and, more particularly, to seal packaging for medical device equipment.

BACKGROUND

Packaging of medical device equipment can require one or more lids or barrier layers to provide and maintain a sterile barrier and protect the equipment from environmental factors such as moisture (e.g., water) intrusion or air (e.g., oxygen). Prior art packaging uses heat-sealing to apply a single barrier layer or lid (e.g., Tyvek®) to a single planar surface of a container holding the medical device. The barrier layer or lid is applied in a single heat-sealing step. In some embodiments, the barrier layer or lid can be multilayer, comprising a laminate of different material layers applied to the container in a single step.

It is desirable to provide multiple barrier layers or lids to provide redundant protection and/or to provide multiple barrier layers or lids in separate steps to allow for sterilization of the medical device between application of, for example, a first barrier layer permeable to sterilization gases, and a second barrier layer configured to protect the medical device from environmental factors (e.g., moisture and air (e.g., oxygen)).

These prior art packaging designs with multiple barriers, however, have issues with ensuring that each of the multiple barriers is properly sealed. As such, there is a need for a sealing system that ensures sealing is proper for each of the multiple barriers.

SUMMARY

The present disclosure is related to resolving the issues identified above, such that each of the seals of the multiple barriers is properly adhered. Ensuring that both seals are properly adhered, ensures that moisture, debris, and air does not infiltrate the sterile packaging. Numerous interchangeable dies, manufacturing techniques, and packages are discussed that address these adherence issues.

In one aspect, an interchangeable die (hereinafter also referred to as a die or removable die) is provided for attachment to a platen of a heat-sealing apparatus for applying seals to containers having an inner sealing surface configured to receive a first lid and an outer sealing surface configured to receive a second lid. The interchangeable die includes a first side defined by a planar first side surface configured to interface with a planar first sealing surface of the platen, a second side disposed opposite the first side and separated from the first side by a first thickness, and a projection extending outward from the second side and having a planar second sealing surface extending parallel to the first side surface and the first sealing surface. The second sealing surface is configured to apply heat and pressure to the inner sealing surface of the container.

In another aspect, a heat-sealing assembly for applying a first lid to an inner sealing surface of a container and a second lid to and outer sealing surface of the container includes a platen having a first sealing surface configured to apply heat and pressure to the outer sealing surface of the container and an interchangeable die removably attached to the platen and configured to apply heat and pressure to the inner sealing surface of the container.

In yet another aspect, a method of sealing a medical device container having an inner sealing surface disposed in a first plane and an outer sealing surface disposed in a second plane extending parallel to and separated from the first plane includes applying heat and pressure to an inner lid disposed on the inner sealing surface of the container to seal the inner lid to the container and applying heat and pressure to an outer lid disposed on the outer sealing surface of the container to seal the outer lid to the container. Applying pressure to the outer lid is conducted without simultaneously applying pressure to the inner lid.

In yet another aspect, a container for packaging a medical device includes an inner lid sealed to an inner sealing surface and an outer lid sealed to an outer sealing surface. In some embodiments, the outer sealing surface and inner sealing surface are disposed in separate and parallel plane. The described container for packaging the medical device is produced using the interchangeable die, heat-sealing assembly, and/or the methods described herein.

The present summary is provided only by way of example, and not limitation. Other aspects of the present disclosure will be appreciated in view of the entirety of the present disclosure, including the entire text, claims and accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a non-limiting example of a packaging container designed for use with the disclosed heat-sealing assembly.

FIG. 2 is a perspective view of a non-limiting example of an interchangeable die configured for use with the container of FIG. 1.

FIG. 3 is a perspective view of a non-limiting example of a heat-sealing assembly including the interchangeable die of FIG. 2 attached to a platen.

FIG. 4 is a perspective view of another embodiment of an interchangeable die having a projection shaped for sealing an inner lid to an inner sealing surface of a jar.

FIG. 5 is a cross-sectional view of a non-limiting example of a jar arranged in a sealing apparatus and having an inner sealing surface compatible with the interchangeable die of FIG. 4.

FIGS. 6A-6C are cross-sectional views of a non-limiting example of a series of steps in a heat-sealing process performed with the heat-sealing assembly of FIG. 3.

FIGS. 7-9 are schematic side views of a non-limiting example of alternative retention mechanisms for securing an interchangeable die to a platen in a heat-sealing assembly.

FIG. 10 is a schematic side view of a non-limiting example of an alternative heat-sealing assembly.

While the above-identified figures set forth embodiments of the present invention, other embodiments are also contemplated, as noted in the discussion. In all cases, this disclosure presents the invention by way of representation and not limitation. It should be understood that numerous other modifications and embodiments can be devised by those skilled in the art, which fall within the scope and spirit of the principles of the invention. The figures may not be drawn to scale, and applications and embodiments of the present invention may include features, steps and/or components not specifically shown in the drawings.

DETAILED DESCRIPTION

Heat sealing is commonly used to package medical devices in rigid or semi-rigid containers including, for example, trays and jars. The container heat-sealing process joins a flexible lid to a container to enclose a product contained therein. As used herein, the term “lid” refers to any flexible cover, barrier layer, film, or the like capable of being sealed to a container in a heat-sealing process. Lid materials are selected based on the sealing requirements of the product, including, for example, sterile conditions, puncture resistance, moisture control, and prevention of exposure to light. Lid materials can include but are not limited to synthetic fiber sheets such as Tyvek®, laminated foil, thermoplastic films, plastic-coated paper, and combinations thereof. Container materials can also be selected based on the packaging requirements of the product. Container materials can include, for example, rigid or semi-rigid plastic, such as polyethylene terephthalate glycol (PETG) or high-density polyethylene (HDPE).

In the heat-sealing process, a heated platen applies heat and pressure to bond the lid to the container. The temperature of the platen, pressure applied, and sealing time can be finely controlled and adjusted based on the lid material and/or container material and bonding requirements. A hermetic seal can be created to ensure that the packaged product can be stored and shipped under sterile conditions. Medical devices can require packaging that includes a sterilization lid and a moisture barrier. In one non-limiting example, a tray containing the product to be packaged can be sealed with a Tyvek® lid or other material permeable to sterilization gases yet capable of maintaining a sterile barrier. Following sealing, the product can be sterilized by passing sterilization gases, such as ethylene oxide, through the permeable lid to kill any microorganisms contained in the packaging. In a next step, a second lid such as, but not limited to, a moisture barrier or light barrier can be applied to the container over the inner lid. The second lid is applied via the heat-sealing process and can also form a hermetic seal with the container. A hermetic seal ensures that the packaged product can be stored and shipped under acceptable environmental conditions such as moisture level, oxygen level, light, etc.

The materials of the first and second lids can be selected based on the packaging requirements of the medical device and are not limited to particular materials disclosed herein. Each lid can be a single material or laminate. Materials can be selected based on their permeability to particular gases and moisture, porosity, and/or other material characteristics (e.g., non-toxic, compatible with heat-sealing process, etc.). In some embodiments, it may be desirable to include one or more lids that are non-porous and non-permeable to gas and moisture (e.g., foil), non-porous and non-permeable to moisture but permeable to gas (e.g., Teflon®), porous and non-permeable to moisture but permeable to gas (e.g., polytetrafluoroethylene (PTFE), polyethylene, polypropylene).

In some examples, an outer lid can be applied directly over and in the sealing plane as an inner lid with a sealing surface that is coincidental with or outside of a perimeter of a sealing surface of the inner lid. In such an example, heat and pressure is reapplied to the inner lid in application of the outer lid. This can make it difficult to ensure good quality seals on the inner and outer lids (e.g., over-sealing of the inner lid and under-sealing of the outer lid). The present disclosure overcomes the issues of over-sealing and under-sealing by applying the second lid to a sealing surface disposed in a plane outward of the first lid. As disclosed herein, packaging containers can be designed with multiple sealing surfaces disposed in different planes (e.g., stepped surfaces arranged at different depths of the packaging), which can be sealed by a platen with an interchangeable die.

The disclosed heat-sealing assemblies include a removable die that can be attached to a platen of a container heat-sealing apparatus to apply a sealing lid to an inner sealing surface of a package and can be removed from the platen to apply an outer sealing lid to an outer sealing surface, which is not in the same plane as the inner sealing surface of the package. The removable die includes a protruding and mating sealing surface that covers (e.g., substantially covers) and matches a shape of the inner sealing surface. The die can be received in the packaging container to apply pressure to the inner sealing surface. A support can be provided under the inner sealing surface to maintain a position of the inner sealing surface as pressure is applied. Interchangeable dies can be designed with different shapes and sizes to accommodate a wide variety of packing designs. The dies can easily be removed from and added to the platen in the packaging process. Once the die is removed from the platen, the platen can be used according to current packaging practices to apply a lid to the outer sealing surface of the package.

The disclosed interchangeable dies and sealing assemblies can be used with or adapted for use with a variety of commercially available container heat-sealing systems that use a platen for applying heat and pressure to a sealing surface of a packaging container. Applicable systems can include, for example, manual and semi-automated heat-sealing systems, constant heat sealers, and impulse heat sealers. While the disclosure is particularly directed to medical device applications, it will be understood by one of ordinary skill in the art that the disclosed interchangeable dies and sealing assemblies can be used with a wide range of packaging materials and for a wide range of packaging applications (e.g., food packaging).

FIG. 1 is a perspective view of a non-limiting example of a packaging container designed for use with a disclosed heat-sealing assembly. FIG. 1 shows container 10, outer sealing surface 12, inner sealing surface 14, and separating surface 16. Separating surface 16 separates outer sealing surface 12 and inner sealing surface 14. Container 10 is configured to receive two non-contacting lids—one on inner sealing surface 14 and one on outer sealing surface 12—to contain and protect contents disposed in a receptacle of container 10. Container 10 can be configured for containing and protecting any of a variety of contents; however, container 10 may be particularly suitable for medical devices requiring multiple protective lids. Container 10 can have any shape, size, and internal structure suitable for containing, retaining, and/or storing contents.

Container 10 can be formed of a rigid or semi-rigid plastic suitable for heat-sealing applications. For example, container 10 can be formed from PETG or HDPE. Other materials, including, for example, metal and glass, may also be suitable for heat-sealing applications.

Outer sealing surface 12 is an outermost surface of container 10. Outer sealing surface 12 is a planar surface configured to be disposed in a plane parallel to the platen or interchangeable die during the heat-sealing process. Outer sealing surface 12 fully surrounds an opening of container 10 (i.e., opening to the receptacle or storage space) and can define an outermost perimeter of and outermost extent of container 10. Outer sealing surface 12 can be a flange that extends laterally outward from a top edge of container 10. During application of a lid, an underside of outer sealing surface 12 can be supported by a support structure provided under outer sealing surface 12 on an external surface of container 10 to prevent deformation when pressure is applied in the heat-sealing process. As discussed further herein, the support can conform to an exterior shape of a portion of container 10 below outer sealing surface 12 and inner sealing surface 14. Outer sealing surface 12 can have any desired shape. Outer sealing surface 12 has a sealing surface width W_O large enough to securely seal a lid to container 10. Outer sealing surface 12 can have a sealing surface width W_O that extends beyond or outward from a lid disposed thereon.

Inner sealing surface 14 is an inner sealing surface of container 10 configured to receive an inner lid. Inner sealing surface 14 is a planar surface configured to be disposed in a plane parallel to a sealing surface of an interchangeable die during the heat-sealing process. Inner sealing surface 14 can be disposed in a plane parallel to outer sealing surface 12, as shown in FIG. 1, or in a plane angled relative to outer sealing surface 12. Inner sealing surface 14 fully surrounds the opening of container 10, defining a perimeter thereof such that the lid with which inner sealing surface 14 is joined fully surrounds and seals the opening of container 10. Inner sealing surface 14 is disposed inside of an innermost perimeter of outer sealing surface 12, such that the interchangeable die can be received through the opening of outer sealing surface 12 and lowered to meet inner sealing surface 14 during a heat-sealing process. Inner sealing surface 14 can have a shape substantially similar to but smaller than outer sealing surface 12, as shown in FIG. 1, or can have any desired shape.

The depth to which inner sealing surface 14 is disposed relative to outer sealing surface 12 is determined by a height h of separating surface 16 (also shown in FIG. 6A). Separating surface 16 extends from the top or outermost edge of container 10 along outer sealing surface 12 to an outermost perimeter of inner sealing surface 14. Separating surface 16 can extend substantially perpendicular to each of outer sealing surface 12 and inner sealing surface 14. Alternatively, separating surface 16 can slant outward from inner sealing surface 14 to outer sealing surface 12 to limit interference with the interchangeable die when the interchangeable die is lowered onto inner sealing surface 14 during the heat-sealing process. The meeting angles of outer sealing surface 12 and separating surface 16 and inner sealing surface 14 and separating surface 16 can be variable (e.g., greater than or equal to 90 degrees). The height h of separating surface 16 can be selected based on the selection of inner lid material and/or inner lid thickness. Generally, height h is sufficient to prevent adverse re-heating of inner sealing surface 14 during application of the outer lid to outer sealing surface 12.

Inner sealing surface 14 has a sealing surface width W_i large enough to securely seal the inner lid. Inner sealing surface 14 can have a sealing surface width W_i that extends beyond or outward from the inner lid. During application of the inner lid, an underside of inner sealing surface 14 can be supported by a support structure provided under inner sealing surface 14 on an external surface of container 10 to prevent deformation during a sealing process when heat and pressure are applied on inner sealing surface 14 over a period of time. The underside of inner sealing surface 14 can also be supported during application of the outer lid to outer sealing surface 12. As discussed further herein, both outer sealing surface 12 and inner sealing surface 14 can be supported during both inner and outer lid heat-sealing applications.

FIG. 2 is a perspective view of a non-limiting example of an interchangeable die configured for use with container 10 of FIG. 1. FIG. 3 is a perspective view of a non-limiting example of a heat-sealing assembly including the interchangeable die of FIG. 2 attached to a platen. FIGS. 2 and 3 are discussed together herein. FIG. 2 shows interchangeable die 20, retention block 22, projection 24, first surface 26 and second surface 28, sealing surface 30, retention features 32, wall 34, heating elements 36, electrical connection 38, and thicknesses T_B and T_P. FIG. 3 shows assembly 40, interchangeable die 20, retention block 22, projection 24, first and second surfaces 26 and 28, sealing surfaces 30 and 44, retention features 32, platen 42, slots 46, and heating elements 48.

Interchangeable die 20 includes retention block 22 and projection 24. Projection 24 extends outward from retention block 22 and is configured to form a sealing interface with an inner lid disposed on inner sealing surface 14 of container 10. Retention block 22 is configured to interface with and be removably connected to platen 42. Platen 42 is configured to form a sealing interface with an outer lid disposed on outer sealing surface 12 of container 10 when interchangeable die 20 is removed from platen 42. Retention features 32 of interchangeable die 20 are configured to be slidingly received in slots 46 of platen 42 to attach interchangeable die 20 to platen 42. As will be discussed further herein, retention features 32 and corresponding receiving slots 46 are a non-limiting example of a retention mechanism used to secure interchangeable die 20 to platen 42. Platen 42 can include heating elements 48, as known in the art, for heating platen 42. Heating elements 48 are shown schematically. Similar heating elements 36 can be provided in interchangeable die 20 as discussed further herein.

Interchangeable die 20 can be designed for use with commercially available heat-sealing systems. In some embodiments, including that shown in FIGS. 2 and 3, modification of a platen may be required to attach interchangeable die 20 to the platen. Additional modifications may be required for heating and monitoring a temperature of interchangeable die 20.

Interchangeable die 20 can be formed of metal, including but not limited to aluminum, stainless steel, or other alloys that satisfy thermal conductivity and wear resistance requirements. Interchangeable die 20 can be heated by platen 42 via conduction or can include heating elements 36 (shown schematically) like those of platen 42 and known in the art. Interchangeable die 20 heated by heating elements (e.g., resistive heaters) can have an electrical connection 38 configured to receive electrical power. In some embodiments, the placement and concentration of heating elements is dictated by the shape and thickness of the interchangeable die, e.g., thicker areas of the interchangeable die with more thermal mass can be associated with a higher concentration of heating elements. In some embodiments, the platen 42 can be configured to have different heating profiles based on whether the interchangeable die 20 is attached or not and/or the shape and material of the interchangeable die 20. A temperature of interchangeable die 20 can be controlled and monitored during the heat-sealing process to ensure temperature requirements for sealing the inner lid to container 10 are met. In some embodiments, the inner lid and outer lid can have different requirements for ensuring proper seal (e.g., thermal requirements, pressure requirements, etc.). In some embodiments, the interchangeable die 20 comprises a different material than the platen 42, depending on the sealing requirements.

Retention block 22 is configured to secure projection 24 to platen 42 without disrupting a sealing surface of platen 42. Retention block 22 can have any thickness T_B suitable for attachment to platen 42 and operation in a modified heat-sealing assembly. As illustrated in FIG. 3, retention block 22 can have a shape substantially matching a shape of platen 42 and fully covering sealing surface 44 of platen 42. As shown retention block 22 and platen 42 can have equal widths w₁ and lengths l₁. In other embodiments, the width w₁ and/or length l₁ of retention block 22 can be greater than or less than the width w₁ and/or length l₁ of platen 42. The width w₁ of retention block 22 can be selected to position retention features 32 adjacent edges of platen 42 as described further herein. The length l₁ of retention block 22 can be shortened based on the size of projection 24 as discussed further herein.

Retention block 22 includes first surface 26 and second surface 28. First and second surfaces 26 and 28 are disposed on opposite sides of retention block 22. First surface 26 is planar and configured to interface with sealing surface 44 of platen 42. Second surface 28 can be planar. Second surface 28 does not interact with any surface of container 10 or the inner lid during the heat-sealing process. Second surface 28 is spaced from outer sealing surface 12 of container 10 in the heat-sealing process. The distance second surface 28 is spaced from outer sealing surface 12 is determined by the thickness T_P of projection 24.

Projection 24 extends outward from second surface 28 of retention block 22. Projection 24 can be integrally formed with retention block 22. Projection 24 has sealing surface 30. Sealing surface 30 is configured to interface with and apply heat and pressure to an inner lid disposed on inner sealing surface 14 of container 10. Sealing surface 30 has a shape and orientation corresponding or mating with inner sealing surface 14. For example, sealing surface 30 can be planar and oriented parallel to first surface 26 of retention block and sealing surface 44 of platen in embodiments in which inner sealing surface 14 is planar and oriented in a plane parallel to outer sealing surface 12. Sealing surface 30 is configured to overlap a sufficient portion of width W_i on inner sealing surface 14 to seal a lid fully and effectively to inner sealing surface 14. Sealing surface 30 can have a shape substantially matching a shape of inner sealing surface 14 of container 10. Sealing surface 30 can have a shape that differs from a shape of second surface 28.

Projection 24 is configured to be received in container 10 and within the perimeter of outer sealing surface 12. Wall 34 of projection 24 connects second surface 28 of retention block to sealing surface 30. Wall 34 can extend perpendicular to sealing surface 30 to avoid interaction with separating surface 16 of container 10. Wall 34 can have a thickness T_P selected to provide a desired separation between second surface 28 and outer sealing surface 12 of container 10.

First surface 26 of retention block 22 includes retention features 32. Retention features 32 can be bulbous-shaped rails projecting from first surface 26, as shown in FIG. 3, having a smaller neck portion connected to first surface 26 and an expanding bulbous shape extending outward therefrom. Retention features 32 are not limited to the shape shown. Retention features 32 can have any shape suitable for attaching retention block 22 to platen 42, including, for example, L-hooks, T-hooks, and the like. Retention features 32 can extend a full or partial length of retention block 22. Retention features 32 are disposed in locations outside of a sealing area of outer sealing surface 12 of container 10 such that corresponding receiving slots 46 in platen 42 do not disrupt a sealing interface. Retention block 22 can have two retention features 32 disposed adjacent to opposite side edges of retention block 22 as illustrated. Retention features 32 extend parallel to each other.

Platen 42 includes slots 46 configured to receive retention features 32. Slots 46 can have a shape substantially matching a shape of retention features 32 such that retention features 32 and slots 46 have mating shapes. Slots 46 can be larger than retention features 32 for ease of insertion and removal of interchangeable die 20 but can be sized to provide contact between sealing surface 44 of platen 42 and first surface 26 of retention block 22 when assembled. Slots 46 can be open to at least one end wall of platen 42 to allow retention features 32 to be slidingly received in slots 46. Interchangeable die 20 can be inserted and removed from the same side of platen 42 (e.g., front or side) during the heat-sealing process. Slots 46 can extend a partial or full length of platen 42. The length of slots 46 can correspond to a length of retention features 32. Slots 46 are disposed outside of the sealing area of outer sealing surface 12 of container 10, such that slots 46 do not disrupt a sealing interface between platen 42 and an outer lid disposed on outer sealing surface 12.

In some embodiments, a thermal medium is included between the platen 42 and the retention block 22, such that heat from the platen 42 is uniformly distributed along the retention block during sealing (e.g., removing hot spots or cold spots due to inconsistencies in the mating surfaces).

Retention features 32 and corresponding slots 46 can be configured to place first surface 26 of retention block 22 in contact with sealing surface 44 of platen 42 to provide conductive heating of interchangeable die 20. The configurations of retention features 32 and corresponding slots 46 are not limited to those illustrated. For example, retention features 32 and corresponding slots 46 can be configured as keyhole-type attachments, fastener attachments, and receptacles or variations thereof.

Platen 42 has sealing surface 44 configured to seal a lid to outer sealing surface 12 of container 10 when interchangeable die 20 is removed. As previously described, platen 42 includes slots 46 configured to receive retention features 32 of interchangeable die 20. Slots 46 extend along and open to sealing surface 44. As illustrated in FIG. 3, two slots 46 can be disposed adjacent to opposite edges of platen 42 outside of a sealing area of outer sealing surface 12 to ensure that a sealing interface is not disrupted.

Interchangeable die 20 is one example of a die that can be used with platen 42 for sealing a lid to an inner sealing surface of a container. It will be understood by one of ordinary skill in the art that platen 42 can be used to seal lids to outer sealing surfaces of containers of a variety of sizes and shapes. A plurality of interchangeable dies can be formed having uniform retention blocks 22 configured for attachment to platen 42 and varying projections 24 to provide sealing to containers having inner sealing surfaces of different shapes, sizes, and orientations. Each interchangeable die 20 can have a projection and sealing surface uniquely shaped or sized to correspond to a uniquely shaped or sized inner sealing surface of a container.

FIG. 4 is a perspective view of another embodiment of an interchangeable die having a projection shaped for sealing an inner lid to an inner sealing surface of a jar. FIG. 5 is a cross-sectional view of a jar arranged in a heat-sealing apparatus and having an inner sealing surface compatible with the interchangeable die of FIG. 4. FIGS. 4 and 5 are discussed together herein. FIG. 4 shows interchangeable die 50, retention block 52, projection 54, first surface 56, second surface 58, sealing surface 60, retention features 62, and wall 64. FIG. 5 shows jar 70, vessel wall 71, outer sealing surface 72, outer sealing surface plane 73, inner sealing surface 74, inner sealing surface plane 75, separating surface 76, and support 78.

Interchangeable die 50 is substantially similar to interchangeable die 20 of FIGS. 2 and 3 with a modified projection 54. Interchangeable die 50 is configured for use with platen 42 of FIG. 3. Retention block 52, including retention features 62, is substantially the same as retention block 22. Projection 54 is cylindrical having circular sealing surface 60 configured to seal a round lid to inner sealing surface 74 of jar 70. Sealing surface 60 has a shape and orientation corresponding or mating with inner sealing surface 74. Sealing surface 60 of projection 54 can be planar and oriented parallel to sealing surface 44 of platen 42 upon assembly in embodiments in which inner sealing surface 74 is planar and oriented in a plane parallel to outer sealing surface 72. In some embodiments, retention block 52 can have a width w₁ equal to the width w₁ of platen 42 and a length l₂ less than the length l₁ of platen 42 because the additional length is unnecessary to accommodate projection 54.

Outer sealing surface 72 forms an outermost portion of jar 70, defining an opening of jar 70. Inner sealing surface 74 is disposed in jar 70. Outer sealing surface 72 and inner sealing surface 74 of jar 70 are planar. Outer sealing surface 72 is oriented parallel to inner sealing surface 74. Outer sealing surface 72 is disposed in outer sealing surface plane 73. Inner sealing surface 74 is disposed in inner sealing surface plane 75, disposed below outer sealing surface plane 73 in jar 70. Inner sealing surface plane 75 can be parallel to outer sealing surface plane 73 as shown in FIG. 5 or can be disposed at an angle relative to outer sealing surface plane 74. Inner sealing surface 74 is separated from outer sealing surface 72 by separating surface 76. Each of outer sealing surface 72 and inner sealing surface 74 has a width sufficient to provide an effective sealing interface with a lid as described with respect to container 10 of FIG. 1. As illustrated, outer sealing surface 72 is a rim. In other embodiments, outer sealing surface 72 can be a flange that extends laterally outward from the rim of jar 70. As illustrated, inner sealing surface 74 can be formed by bumping out the inner diameter of jar 70 to form an expanded opening. For example, inner sealing surface 74 can extend outward of and perpendicular to vessel wall 71. Inner sealing surface 74 can have a shape and size substantially matching a shape and size of sealing surface 60 of interchangeable die 50. Separating surface 76 can be oriented parallel to vessel wall 72 and perpendicular to or angled outward from inner sealing surface 74 to allow projection 54 of interchangeable die 50 to be received in jar 70 to apply heat and pressure to a lid disposed on inner sealing surface 74.

Jar 70 can be suspended from support 78 during a heat-sealing process. Support 78 can be shaped to conform to an outer surface shape of jar 70 below inner sealing surface 74 and outer sealing surface 72. Support 78 is configured to prevent deflection of inner sealing surface 74 and outer sealing surface 72 during the heat-sealing process.

FIGS. 6A-6C are cross-sectional views of a series of steps of a heat-sealing process performed with heat-sealing assembly 40 of FIG. 3. FIGS. 6A-6C show container 10, outer sealing surface 12, inner sealing surface 14, and support 80. FIG. 6A additionally shows outer sealing surface plane 82 and inner sealing surface plane 84. FIG. 6B additionally shows separating surface 16, assembly 40, interchangeable die 20, retention block 22, projection 24, second surface 26, sealing surface 30, retention features 32, wall 34, platen 42, sealing surface 44, and gap G. FIG. 6C additionally shows platen 42, sealing surface 44, and slots 46.

In a first step, container 10 can be suspended from support 80 in a heat-sealing apparatus. Support 80 is disposed beneath each of inner sealing surface 14 and outer sealing surface 12 to prevent deflection of the sealing surfaces during the heat-sealing process. Support 80 can be designed to conform to a shape of an outer surface of container 10.

An inner lid (not shown) can be applied to inner sealing surface 14. The inner lid can be, for example, a flexible sterilization layer such as Tyvek®. The inner lid can be pre-cut to size and positioned on inner sealing surface 14. The inner lid can be sized and shaped to substantially cover inner sealing surface 14. Once the inner lid is in place, assembly 40, including interchangeable die 20 can be brought in contact with the inner lid in a second step to apply heat and pressure to seal the inner lid onto inner sealing surface 14. The temperature, pressure, and sealing time can be selected based on the material of the inner lid. As illustrated in FIG. 6B, projection 24 of interchangeable die 20 can be lowered into container 10 inside of an inner perimeter of outer sealing surface 12. Sealing surface 30 is brought into contact with the inner lid on inner sealing surface 14. Sealing surface 30 can be sized and shaped to substantially cover the inner lid and inner sealing surface 14. Projection 24 can be sized to provide a small gap between separating surface 16 of container 10 and wall 34 of projection 24 to limit interference therebetween as interchangeable die 20 is lowered into container 10. As previously described, projection 24 can have a thickness sized to provide a gap G between second surface 26 of retention block 22 and outer sealing surface 12 of container 10. Gap G prevents interchangeable die 20 from contacting outer sealing surface 12 during the process of sealing the inner lid to inner sealing surface 14.

As previously described, interchangeable die 20 can be heated by platen 42 by conduction and/or by heating elements disposed in interchangeable die 20. Interchangeable die 20 applies pressure to inner sealing surface 14, which is supported by support 80. Support 80 prevents deflection of inner sealing surface 14 such that inner sealing surface 14 remains oriented parallel to sealing surface 30 of interchangeable die 20 during the heat-sealing process.

Once the inner lid is sealed to inner sealing surface 14, interchangeable die 20 is lifted out of container 10 and removed from platen 42. In some embodiments, the sealed container can be sterilized by radiation or by passing sterilization gases, such as ethylene oxide, through the permeable inner lid to kill any microorganisms contained in container 10.

In a third step, an outer lid is applied to outer sealing surface 12 and platen 42 is brought into contact with the outer lid to seal outer sealing surface 12 as illustrated in FIG. 6C. The outer lid can be, for example, a moisture barrier comprising a plastic-lined paper. The outer lid covers the opening of container 10 above the inner lid. The outer lid can be pre-cut to a size and shape substantially corresponding to the outer perimeter of outer sealing surface 12. The outer lid can extend beyond outer sealing surface 12. Platen 42 can be lowered onto the outer lid disposed on outer sealing surface 12. Support 80 disposed under outer sealing surface 12 prevents deflection of outer sealing surface 12 as platen 42 applies heat and pressure to the outer lid and outer sealing surface 12 during the heat-sealing process. The temperature, pressure, and sealing time can be selected based on the sealing material of the outer lid and can be different from the temperature, pressure, and sealing time applied to the inner lid. As shown in FIG. 6C, slots 46, configured to retain interchangeable die 20, are positioned outward from outer sealing surface 12 to ensure that sealing surface 44 of platen 42 is uninterrupted in the location of outer sealing surface 12.

Platen 42 does not contact inner sealing surface 14 or the inner lid and thereby does not affect the seal of the inner lid in the process of sealing the outer lid.

FIGS. 7-9 are schematic side views of alternative retention mechanisms for securing an interchangeable die to a platen. The retention mechanisms shown in FIGS. 7-9 can replace retention features 32 and corresponding slots 46 in assembly 40 of FIG. 3. The embodiments shown in FIGS. 7-9 are non-limiting examples of alternative retention mechanisms. It will be understood by one skilled in the art that various modifications can be made to the disclosed retention mechanisms without departing from the scope and spirit of the invention.

FIG. 7 shows assembly 90, including interchangeable die 92 and platen 94. Interchangeable die 92 includes retention block 96, having first side surface 97, and projection 98. Platen 94 includes retention hooks 100, slots 102, and sealing surface 104. As illustrated, retention block 96 of interchangeable die 92 is received in slots 102 formed by retention hooks 100 of platen 94.

Interchangeable die 92 can be substantially similar to interchangeable die 20 with a modified retention block 96. In contrast to retention block 22, retention block 96 does not include retention features 32 on first side surface 97. As illustrated, first side surface 97 is completely planar. Retention block 96 is also reduced in width compared to platen 94. As shown, retention block 96 has a width w₂ that is less than a width w₃ of platen 94. Retention block 96 can have a length substantially matching platen 94, however, provided retention block 96 can be securely retained by retention hooks 100, it is not necessary that retention block 96 extend a full length of platen 94. Retention block 96 can have a reduced thickness to minimize an extent to which retention hooks 100 extend from sealing surface 104 of platen 94.

Interchangeable die 92 includes projection 98, which can be integrally formed with retention block 96 as previously described. Projection 98 can be shaped and sized to interface with an inner lid on a corresponding inner sealing surface of a container as previously described.

Platen 94 includes retention hooks 100 configured to receive a portion of retention block 96. Retention hooks 100 can be integrally formed with platen 94. Retention hooks 100 extend downward from sealing surface 104 and under a portion of retention block 96, forming L-shaped hooks with slots 102 open toward each other and retention block 96. Retention hooks 100 can be sized to receive and secure retention block 96 with first side surface 97 disposed in interfacing contact with sealing surface 104 of platen 94. Retention hooks 100 can be disposed on opposite ends of platen 94 and can extend a partial or full length of platen 94. Retention block 96 can be slidingly received in slots 102 and retained by retention hooks 100. Slots 102 are open to at least a first end of platen 94 to receive interchangeable die 92 in assembly. In some embodiments, slots 102 can be open at a forward receiving end and closed at an aft end to restrict further lateral movement of interchangeable die 92 in assembly 90.

Retention hooks 100 are disposed outside of a sealing area of sealing surface 104 during a heat-sealing process. The distance retention hooks 100 extend from sealing surface 104 can be minimized to limit interference between platen 94 and supports and/or a retention platform from which containers are suspended. In some embodiments, a thickness of retention block 96 can be reduced to minimize the extent to which retention hooks 100 must extend to receive retention block 96. In some embodiments, supports such as support 80 of FIGS. 6A-6C can be configured to raise an outer sealing surface of a container. Supports can be positioned on a retention plate configured to receive the containers through openings therein. Supports can be positioned around the perimeter of the containers to elevate the outer sealing surface above the retention platform to provide space for retention hooks 100 when platen 94 is pressed on the outer sealing surface of the container.

FIG. 8 shows assembly 110 having interchangeable die 111 with retention block 112 and projection 113, platen 114, and retention hooks 116. Assembly 110 is substantially similar to assembly 90. In contrast to assembly 90, retention hooks 116 are not integrally formed with platen 114 but instead attached thereto. As shown, retention block 112 can extend a full width of platen 114 to be received in retention hooks 116. As previously described, retention block 112 can extend a full or partial length of platen 114.

Retention hooks 116 can have substantially the same configuration as retention hooks 100. Retention hooks 116 can be secured to platen 114 by any of a variety of known means including, but not limited to, fasteners that extend through retention hooks 116 into platen 114. In some embodiments, retention hooks 116 can include clip portions 118 (shown in phantom) disposed at opposite ends of retention hooks 116 and configured to clip front and back sides of platen 114 therebetween. In some embodiments, retention hooks 116 can be disposed immediately adjacent to platen 114 but attached to a surface of a heat-sealing apparatus. For example, retention hooks 116 can include flange 120 (shown in phantom) at a top end (opposite the hook portion) configured to be secured to a surface of the heat-sealing assembly. Retention hooks 116 can be used to avoid making modifications to a platen in a currently used heat-sealing assembly. Various modifications and variations can be made to retention hooks 116 to accommodate use with existing platens without departing from the scope and spirit of the invention.

FIG. 9 shows assembly 130 including interchangeable die 132 and platen 134. Interchangeable die 132 includes retention block 136, projection 138, and retention hooks 140. Platen 134 includes slot 142 and sealing surface 144. In contrast to assemblies 90 and 110, in assembly 130, retention hooks 140 are each provided on interchangeable die 132 and received in a corresponding slot 142 of platen 134. As previously described, projection 138 can be shaped and sized to interface with a lid on a corresponding inner sealing surface of a container.

Retention block 136 includes retention hooks 140, which extend upward from second surface 137 (opposite projection 138). Retention hooks 140 can be disposed on opposite ends of retention block 136 and can extend a full or partial length of retention block 136. As illustrated in FIG. 9, the addition of retention hooks 140 increases the width w₄ of retention block 136 relative to the width w₅ of platen 134. Retention hooks 140 can be substantially similar to retention hooks 100 (FIG. 7), having L-shaped projections with slots 141 opening toward each other and platen 134. Retention hooks 140 are slidingly received in slots 142 of platen 134. Retention hooks 140 can be sized to secure retention block 136 with second surface 137 disposed in interfacing contact with sealing surface 144 of platen 134.

Platen 134 includes slots 142 configured to receive retention hooks 140. Slots 142 are open to at least a first end of platen 134, as illustrated, to receive interchangeable die 132 in assembly 130. Slots 142 extend along opposite sides of platen 134. Slots 142 can extend a partial or full length of each side. In some embodiments, slots 142 can be open at a forward receiving end and closed at an aft end to restrict further lateral movement of interchangeable die 132 in assembly 130. Slots 142 can be positioned at any height along a thickness dimension of platen 134 suitable for securing retention hooks 140.

In contrast to other embodiments, the sealing surface area available on sealing surface 144 of platen 134 is not limited by retention mechanisms, as no retention features interrupt sealing surface 144. In contrast to assemblies 90 and 110, in assembly 130, sealing surface 144 defines the outermost extent of platen 134. As such, there is no need to raise an outer sealing surface of a container to accommodate retention hooks or features extending outward from sealing surface 144 during a heat-sealing process.

FIG. 10 is a schematic side view of an alternative heat-sealing assembly. FIG. 10 shows heat-sealing assembly 150 including platen 152 and interchangeable die assembly 154. Interchangeable die assembly 154 includes retention block 156 and projection 158. Interchangeable die assembly 154 is substantially similar to interchangeable die 132 of FIG. 9 but includes an interchangeable projection 158. In contrast to other embodiments disclosed herein in which the projection is integrally formed with the retention block, projection 158 is detachable from retention block 156 and retention block 156 is configured for use with a plurality of interchangeable projections.

Retention block 156 can include retention hooks 160 configured to be received in corresponding slots 162 of platen 152 as described with respect to heat-sealing assembly 130 of FIG. 9. In other embodiments, retention block 156 and platen 152 can be secured by other retention features disclosed herein or modifications thereof.

Retention block 156 can further include slots 164 configured to receive corresponding retention features 168 of projection 158. Slots 164 are open to second side 166 of retention block 156. Slots 164 can extend a partial length of retention block 156 to limit lateral movement or lock projection 158 in a desired position. The location of slots 164 on second side 166 can be selected to accommodate a variety of projection shapes and sizes.

Projection 158 can include retention features 168 extending outward from surface 170 opposite sealing surface 172. Retention features 168 can be, for example, bulbous-shaped rails as previously described or other shape suitable for retention and corresponding to a shape of slots 164. Retention features 168 can be slidingly received in slots 164. Retention features 168 can extend a full or partial length of projection 158. Retention features 168 and corresponding slots 164 are configured to retain projection 158 in contact with second side 166 of retention block 156 to provide conductive heat transfer to projection 158.

The disclosed heat-sealing assemblies are designed to seal multiple lids or barrier layers to containers without causing over-sealing and under-sealing of the lids or barrier layers. The disclosed heat-sealing assemblies are particularly suited to medical device packaging applications, which can require application of a first sterilization lid followed by application an addition lid to provide, for example, a barrier to moisture following sterilization of the container. The disclosed interchangeable dies may be used with commercially available heat-sealing systems with minor modification. The interchangeable dies can easily be added to and removed from a platen of a heat-sealing system to seal inner and outer lids in a two-step sealing process.

The embodiments disclosed herein are intended to provide an explanation of the present invention and not a limitation of the invention. The present invention is not limited to the embodiments disclosed. It will be understood by one skilled in the art that various modifications and variations can be made to the invention without departing from the scope and spirit of the invention. Furthermore, it will be understood by one of ordinary skill in the art that features disclosed with respect to one embodiment may be interchangeable with features of other embodiments disclosed herein or may be combined to form embodiments not illustrated herein but within the scope the invention.

Any of the various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise sterilization of the associated system, device, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

Any relative terms or terms of degree used herein, such as “substantially,” “essentially,” “generally,” “approximately” and the like, should be interpreted in accordance with and subject to any applicable definitions or limits expressly stated herein. In all instances, any relative terms or terms of degree used herein should be interpreted to broadly encompass any relevant disclosed embodiments as well as such ranges or variations as would be understood by a person of ordinary skill in the art in view of the entirety of the present disclosure, such as to encompass ordinary manufacturing tolerance variations, incidental alignment variations, transient alignment or shape variations induced by thermal, rotational or vibrational operational conditions, and the like. Moreover, any relative terms or terms of degree used herein should be interpreted to encompass a range that expressly includes the designated quality, characteristic, parameter, or value, without variation, as if no qualifying relative term or term of degree were utilized in the given disclosure or recitation.

Discussion of Detailed Embodiments

The following are non-exclusive descriptions of possible embodiments of the present invention.

In one aspect, an interchangeable die is provided for attachment to a platen of a heat-sealing apparatus for applying seals to containers having an inner sealing surface configured to receive a first lid and an outer sealing surface configured to receive a second lid. The interchangeable die includes a first side defined by a planar first side surface configured to interface with a planar first sealing surface of the platen, a second side disposed opposite the first side and separated from the first side by a first thickness, and a projection extending outward from the second side and having a planar second sealing surface extending parallel to the first side surface and the first sealing surface. The second sealing surface is configured to apply heat and pressure to the inner sealing surface of the container.

The interchangeable die of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations, and/or additional components:

In an embodiment of the preceding interchangeable die, the second side surface can surround a perimeter of the projection.

In an embodiment of any of the preceding interchangeable dies, a shape of the second sealing surface can differ from a shape of the second side surface.

In an embodiment of any of the preceding interchangeable dies, the shape of the second sealing surface can be circular.

In an embodiment of any of the preceding interchangeable dies, the shape of the second sealing surface can be rectangular.

In an embodiment of any of the preceding interchangeable dies, the projection has a second thickness defined between the second side surface and the second sealing surface. The second thickness can be greater than the first thickness.

An embodiment of any of the preceding interchangeable dies can further include a plurality of retention features configured to attach the die to the platen.

In an embodiment of any of the preceding interchangeable dies, the plurality of retention features can include protruding members extending outward from the first side and configured to be slidingly received in corresponding slots of the platen.

In an embodiment of any of the preceding interchangeable dies, the protruding members can be disposed adjacent to opposite edges of the first side and extend a length of the first side.

In an embodiment of any of the preceding interchangeable dies, the protruding members and corresponding slots can have mating shapes.

In an embodiment of any of the preceding interchangeable dies, the plurality of retention features can include hooks configured to be received in corresponding slots of the platen.

In an embodiment of any of the preceding interchangeable dies, the hooks extend outward from the first side along opposite edges of the first side.

In an embodiment of any of the preceding interchangeable dies, the plurality of retention features can include slots disposed in opposite sidewalls between the first and second side surfaces. The slots can be configured to receive retention features of the platen.

In an embodiment of any of the preceding interchangeable dies, the slots can extend a length of the sidewalls.

In an embodiment of any of the preceding interchangeable dies, the first and second sides can define a retention block and the projection is integrally formed with the retention block.

In an embodiment of any of the preceding interchangeable dies, the first and second sides can define a retention block and, in some embodiments, the projection is detachable from the retention block.

In an embodiment of any of the preceding interchangeable dies, the retention block can include a slot configured to receive a corresponding retention feature of the projection.

In an embodiment of any of the preceding interchangeable dies, the retention feature of the projection can be a shaped rail protruding from a surface of the projection opposite the second sealing surface.

An embodiment of any of the preceding interchangeable dies can further include internally disposed electric heating elements and an electrical connection configured to receive a power source connector.

In another aspect, a heat-sealing assembly for applying a first lid to an inner sealing surface of a container and a second lid to and outer sealing surface of the container includes a platen having a first sealing surface configured to apply heat and pressure to the outer sealing surface of the container and an interchangeable die removably attached to the platen and configured to apply heat and pressure to the inner sealing surface of the container.

The heat-sealing assembly of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations, and/or additional components:

In an embodiment of the preceding heat-sealing assembly, the interchangeable die can include a retention block and a projection extending outward from the retention block in which the projection has a second sealing surface configured to apply heat and pressure to the inner sealing surface of the container.

In an embodiment of any of the preceding heat-sealing assemblies, the retention block can include a first side defined by a first surface and configured to contact the first sealing surface of the platen when the interchangeable die is attached to the platen, and a second side opposite the first side and having a second surface from which the projection extends.

In an embodiment of any of the preceding heat-sealing assemblies, the retention block can include a plurality of retention features configured to attach the interchangeable die to the platen.

In an embodiment of any of the preceding heat-sealing assemblies, the plurality of retention features can include a plurality of rails extending outward from the first surface and wherein the platen can include a plurality of corresponding slots configured to receive the plurality of rails.

In an embodiment of any of the preceding heat-sealing assemblies, rails of the plurality of rails can have a shape selected from the shapes consisting of a bulbous shape, a T-shape, and an L-shape.

In an embodiment of any of the preceding heat-sealing assemblies, the plurality of rails can include a first rail disposed adjacent to a first end of the retention block and a second rail disposed adjacent to a second, opposite, end of the retention block.

In an embodiment of any of the preceding heat-sealing assemblies, the plurality of corresponding slots can include a first corresponding slot disposed adjacent to a first end of the platen and a second corresponding slot disposed adjacent to a second, opposite, end of the platen.

In an embodiment of any of the preceding heat-sealing assemblies, the first and second corresponding slots can be open to a front end of the platen adjacent to the first and second ends of the platen and wherein the corresponding slots can be closed at an aft end of the platen.

In an embodiment of any of the preceding heat-sealing assemblies, the plurality of retention features can include a first hook and a second hook, the first and second hooks disposed at opposite ends of the retention block and extending outward from the first surface.

In an embodiment of any of the preceding heat-sealing assemblies, the platen can include a first slot and a second slot, the first and second slots disposed in opposite ends of the platen and configured to slidingly receive the first and second hooks.

In an embodiment of any of the preceding heat-sealing assemblies, the first and second slots can be open to a front end of the platen adjacent to the first and second ends and can be closed at an aft end of the platen.

In an embodiment of any of the preceding heat-sealing assemblies, the first and second hooks can extend a partial length of the retention block.

In an embodiment of any of the preceding heat-sealing assemblies, the platen can include a plurality of retention features configured to be received in the retention block.

In an embodiment of any of the preceding heat-sealing assemblies, the plurality of retention features can include a first hook and a second hook, the first and second hooks disposed on opposite ends of the platen.

In an embodiment of any of the preceding heat-sealing assemblies, the retention block can include a first slot and a second slot, the first and second slots disposed in opposite ends of the retention block and configured to slidingly receive the first and second hooks.

An embodiment of any of the preceding heat-sealing assemblies can further include a first retention hook disposed adjacent a first end of each of the platen and retention block, the first hook extending outward from and under the first sealing surface, and a second retention hook disposed adjacent a second end of each of the platen and retention block, the second end opposite the first end, the second hook extending outward from and under the first sealing surface. The first and second ends of the retention block can be configured to be slidingly received in the first and second retention hooks.

In an embodiment of any of the preceding heat-sealing assemblies, the first and second retention hooks can be attached to the platen.

In an embodiment of any of the preceding heat-sealing assemblies, the projection can be integrally formed with the retention block.

In an embodiment of any of the preceding heat-sealing assemblies, the projection can be removably attached to the retention block.

In an embodiment of any of the preceding heat-sealing assemblies, the retention block can include a slot configured to receive a corresponding retention feature of the projection.

In an embodiment of any of the preceding heat-sealing assemblies, the retention feature of the projection can be a shaped rail protruding from a surface of the projection opposite the second sealing surface.

In an embodiment of any of the preceding heat-sealing assemblies, the interchangeable die can include internally disposed electric heating elements and an electrical connection configured to receive a power source connector.

In yet another aspect, a method of sealing a medical device container having an inner sealing surface disposed in a first plane and an outer sealing surface disposed in a second plane extending parallel to and separated from the first plane includes applying heat and pressure to an inner lid disposed on the inner sealing surface of the container to seal the inner lid to the container and applying heat and pressure to an outer lid disposed on the outer sealing surface of the container to seal the outer lid to the container. Applying pressure to the outer lid is conducted without simultaneously applying pressure to the inner lid.

The method of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations, additional components, and/or steps:

In an embodiment of the preceding method, heat and pressure can be applied to the inner lid with an interchangeable die attached to a platen of a heat-sealing apparatus.

An embodiment of any of the preceding methods can further include removing the interchangeable die from the platen after sealing the inner lid to the container.

In an embodiment of any of the preceding methods, heat and pressure can be applied to the outer lid with the platen.

In an embodiment of any of the preceding methods, removing the interchangeable die from the platen can include sliding retention features out of corresponding slots.

In an embodiment of any of the preceding methods, the retention features can extend outward from the interchangeable die and wherein the corresponding slots are disposed in a sealing surface of the platen, the sealing surface configured to apply heat and pressure to the outer lid.

In an embodiment of any of the preceding methods, the corresponding slots can be disposed outside of a sealing area of the outer lid.

In an embodiment of any of the preceding methods, the retention features can include a first hook and a second hook, the first and second hooks extending outward from the opposite ends of the interchangeable die, and wherein corresponding slots are disposed in opposite ends of the platen.

In an embodiment of any of the preceding methods, removing the interchangeable die can include sliding a retention block portion of the interchangeable die from first and second hooks extending outward from a sealing surface of the platen and under the retention block.

An embodiment of any of the preceding methods can further include heating the interchangeable die via conduction from the platen, wherein a surface of the interchangeable die is disposed in contact with a sealing surface of the platen.

An embodiment of any of the preceding methods can further include heating the interchangeable die with heating elements disposed therein and connected to a power source.

An embodiment of any of the preceding methods can further include reattaching the interchangeable die to the platen to seal an inner lid to an inner sealing surface of another container.

In yet another aspect, a container for packaging a medical device includes an inner lid sealed to an inner sealing surface and an outer lid sealed to an outer sealing surface, wherein the outer sealing surface and inner sealing surface are disposed in separate and parallel planes.

The container of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations, and/or additional components:

In an embodiment of the preceding container, the outer sealing surface can surround a perimeter of the inner sealing surface.

In an embodiment of any of the preceding containers, the outer sealing surface can be separated from the inner sealing surface by a separating surface.

In an embodiment of any of the preceding containers, the separating surface can be oriented perpendicular to the outer sealing surface and the inner sealing surface.

In an embodiment of any of the preceding containers, the outer sealing surface can be a flange disposed at an opening of the container.

In an embodiment of any of the preceding containers, the inner lid can be permeable to a sterilization gas.

In an embodiment of any of the preceding containers, the outer lid can be a moisture barrier.

While the invention has been described with reference to an exemplary embodiment(s), it will be understood by those skilled in the art that various changes may be made, and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment(s) disclosed, but that the invention will include all embodiments falling within the scope of the appended claims.