Patent Description:
Packages may be used to house medical supplies in a sterile environment. In addition to helping to protect the medical supplies from damage that may be caused by handling or storage, packages may help preserve the sterility of medical supplies up to the time of use. For example, a package may house a medical device or another medical supply within a sealed space, and the medical package, including the medical device or other medical supply, may be sterilized prior to distribution. Thus, the package may maintain the sterility of medical supplies within a sealed environment prior to use of the medical device or other medical supply. At the time of use, a clinician may retrieve the medical device or other medical supply from the package by opening the package in a sterile environment to help preserve the sterility of the medical supplies. Documents <CIT> and <CIT> relate to packages having seals.

After a medical device and/or medical supply is sterilized within a sealed package, the sealed package is shipped or transported to a user and there is a risk that the sealed package may be damaged during transport thereof. More particularly, there is a risk that energy transferred to the sealed package during transportation may be transferred directly to the seal of the sealed package. If the seal of the sealed package is twisted or bent, the seal may be broken or breached, and the contents of the sealed package would no longer be contained in a sterile environment.

Embodiments hereof relate to a sealed package that includes improvements for protecting the seal of the sealed package during transport thereof.

Embodiments hereof relate to a package configured for the sterility of medical supplies. The package includes a tray and a cover. The tray has at least one side wall defining an open end of the tray, a base panel opposite the open end, and a flange extending about a periphery of the at least one side wall at the open end of the tray. The cover is configured to seal the open end of the tray when the cover is assembled onto the tray. A continuous barrier seal is formed between the flange and the cover when the cover is assembled onto the tray, and a discontinuous sacrificial seal is also formed between the flange and the cover when the cover is assembled onto the tray. The discontinuous sacrificial seal is configured to absorb stress applied to the flange. The continuous barrier seal is disposed closer to an inner periphery of the flange than the discontinuous sacrificial seal.

Examples hereof also relate to a package including a tray and a cover removably assembled onto the tray. The cover is configured to seal an open end of the tray when the cover is assembled onto the tray. The tray has at least one side wall defining the open end of the tray, a base panel opposite the open end, and a flange extending about a periphery of the at least one side wall at the open end of the tray. The flange includes a planar top surface and the cover includes a peripheral underside surface configured to mate with the planar top surface of the flange of the tray. A continuous barrier seal is formed between the planar top surface of the flange and the peripheral underside surface of the cover when the cover is assembled onto the tray. A discontinuous sacrificial seal is formed between the planar top surface of the flange and the peripheral underside surface of the cover when the cover is assembled onto the tray. The discontinuous sacrificial seal is configured to absorb stress applied to the flange. The continuous barrier seal is disposed closer to the at least one side wall of the tray than the discontinuous sacrificial seal.

Examples hereof also relate to a package including a tray and a cover. The tray has at least one side wall defining an open end of the tray, a base panel opposite the open end, and a flange extending about a periphery of the at least one side wall at the open end of the tray. The cover is configured to seal the open end of the tray when the cover is assembled onto the tray. The flange includes a planar top surface and the cover includes a peripheral underside surface configured to mate with the planar top surface of the flange of the tray. A continuous barrier seal is formed between the planar top surface of the flange and the peripheral underside surface of the cover when the cover is assembled onto the tray. The continuous barrier seal is configured to provide a bacterial barrier when the cover is assembled onto the tray. A discontinuous sacrificial seal is also formed between the planar top surface of the flange and the peripheral underside surface of the cover when the cover is assembled onto the tray. The discontinuous sacrificial seal is configured to absorb stress applied to the flange. At least one hole is formed on the planar top surface of the flange. The at least one hole is spaced apart from the discontinuous sacrificial seal. The continuous barrier seal is disposed closer to an inner periphery of the flange than the discontinuous sacrificial seal and is disposed closer to the inner periphery of the flange than the at least one hole.

Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements.

Embodiments hereof relate to packages that may be used to house and protect one or more medical supplies before use. Such packages often include a hermetic or barrier seal that maintains sterility and integrity of the medical supplies.

More particularly, embodiments hereof relate to a package <NUM> having a stress-absorbing buffer or crumple zone <NUM> on a flange <NUM> of the package <NUM> that is configured to distribute the stress caused by transportation so that the stress is not concentrated on a continuous barrier seal <NUM> of the package <NUM>. The continuous barrier seal <NUM> is a critical hermetic seal that maintains the sterility and integrity of a medical supply housed within the package <NUM>. The stress-absorbing buffer or crumple zone <NUM> is the peripheral portion or region outside of the continuous barrier seal <NUM>, and provides protection to the continuous barrier seal <NUM> of the package <NUM> and in turn the sterilized medical supplies housed within the package <NUM>. Features of the stress-absorbing buffer or crumple zone <NUM> will be described in more detail herein.

Turning now to the figures, <FIG> is an exploded perspective view of the package <NUM> showing a tray <NUM> and a cover <NUM> that is configured to seal an open end <NUM> of the tray <NUM> when the cover <NUM> is assembled onto the tray <NUM>. <FIG> and <FIG> are perspective and side views, respectively, of the package <NUM> with the cover <NUM> assembled onto the tray <NUM>. <FIG> is a side view of the tray <NUM> without the cover <NUM> assembled thereon. , while <FIG> is a top view of the flange <NUM> of the tray <NUM>. The tray <NUM> has at least one sidewall defining the open end <NUM> of the tray <NUM>, and a base panel <NUM> that is opposite the open end <NUM>. The cover <NUM> is spaced apart from but extends generally parallel to the base panel <NUM>. In an embodiment, the package <NUM> and the tray <NUM> each have a rectangular configuration and the tray <NUM> includes a total of four sidewalls. More particularly, the tray <NUM> includes a first sidewall 104A, a second sidewall 104B opposing the first sidewall 104A, a third sidewall 104C, and a fourth sidewall 104D opposing the third sidewall 104C (collectively referred to as "the sidewalls"). The sidewalls 104A, 104B, 104C, 104D are integrally formed with the base panel <NUM> and extend generally perpendicular from the base panel <NUM> towards the cover <NUM>. "Generally perpendicular" as used herein includes sidewalls that extend perpendicular from the base panel <NUM> or extend in an upward direction or vertically at an angle from the base panel <NUM>. For example, the sidewalls 104A, 104B, 104C, 104D may extend upwards or vertically at an angle between <NUM> and <NUM> degrees from the base panel <NUM>. Further, a different number of sidewalls may be required to enclose the package <NUM> depending on the shape of the base panel <NUM> and the cover <NUM>. For example, when the cover <NUM> and the base panel <NUM> are of a circular or oval shape, a single sidewall may be utilized to enclose the package <NUM>.

The sidewalls 104A, 104B, 104C, 104D and the base panel <NUM> collectively form or define an interior cavity or space <NUM> which receives the medical device or other medical supply to be sterilized. The interior cavity <NUM> of the tray <NUM> may be formed into any suitable shape and size. The shape and size of the interior cavity <NUM> depends upon the shape and size of the medical device or other medical supply that is being housed within the tray <NUM>. In the embodiment shown in <FIG>, the tray <NUM> is generally rectangular in shape and has a generally rectangular shaped interior cavity <NUM>. However, the interior cavity <NUM> may take on any shape or size sufficient for its intended application. In an embodiment, the interior cavity <NUM> of the tray <NUM> may be a custom geometry to accommodate a particular type of medical device or other medical supply.

The tray <NUM> includes the flange <NUM> that extends outwardly from of the sidewalls 104A, 104B, 104C, 104D and extends around or about a periphery of the sidewalls 104A, 104B, 104C, 104D at the open end <NUM> of the tray <NUM>. The flange <NUM> of the tray <NUM> thus surrounds the open end <NUM> of the tray <NUM>. The flange <NUM> is integrally formed with the sidewalls 104A, 104B, 104C, 104D and extends outwardly from the sidewalls 104A, 104B, 104C, 104D in a direction away from the base panel <NUM>. The flange <NUM> includes a planar top surface <NUM>. In an embodiment, the planar top surface <NUM> of the flange <NUM> is spaced apart and parallel to the base panel <NUM> as best shown in the side views of <FIG>. The planar top surface <NUM> of the flange <NUM> however may alternatively be spaced apart but extend at an angle relative to the base panel <NUM>. The flange <NUM> includes an inner periphery <NUM> and an outer periphery <NUM>, and the planar top surface <NUM> extends between the inner and outer peripheries <NUM>, <NUM>. In an embodiment, the flange <NUM> has a rectangular configuration including four edges and four corners integrally formed between the edges. More particularly, the flange <NUM> includes a first edge 114A, a second edge 114B opposing the first edge 114A, a third edge 114C, a fourth edge 114D opposing the third edge 114C. A first corner 116A extends between the first and third edges 114A, 114C, respectively. A second corner 116B extends between the third and second edges 114C, 114B, respectively. A third corner 116C extends between the second and fourth edges 114B, 114D. A fourth corner 116D extends between the fourth and first edges 114D, 114A.

The tray <NUM> is formed as a one-piece component such that the base panel <NUM>, the sidewalls 104A, 104B, 104C, 104D, and the flange <NUM> are integrally formed in a one-piece construction. The tray <NUM> may be formed from an injection molded plastic material such as but not limited to polypropylene, polycarbonate (PC), acrylonitrile butadiene styrene (ABS), a PC/ABS blend, nylon, polyvinyl chloride (PVC), and a polyethylene terephthalate glycol (PETG) material. In an embodiment, the tray <NUM> can be formed from a transparent or clear plastic material such that the medical device or supply housed therein is visible. Further, in an embodiment, the material of the tray <NUM> is substantially impervious or impermeable to one or more of gas, moisture, vapor, fluids, particulates, microorganism, or contaminants.

The cover <NUM> is of a size and shape that is configured to seal the open end <NUM> of the tray <NUM> when the cover <NUM> is assembled onto the tray <NUM>, as best shown on the perspective view of <FIG>. In an embodiment, the cover <NUM> and the base panel <NUM> of the tray <NUM> is of the same shape (e.g., rectangular in the embodiment of <FIG>), although the cover <NUM> may have a different shape so long as it is configured to seal the open end <NUM> of the tray <NUM> when the cover <NUM> is assembled onto the tray <NUM>. In an embodiment, the cover <NUM> is generally the same size and shape (e.g., rectangular in the embodiment of <FIG>) as the outer periphery <NUM> of the flange <NUM>. As best shown in the side view of <FIG>, the cover <NUM> includes a peripheral underside surface <NUM> that is configured to mate with the planar top surface <NUM> of the flange <NUM> of the tray <NUM>. The cover <NUM> encloses the medical device or other medical supply within the interior space <NUM> of the tray <NUM>.

In an embodiment, the cover <NUM> is formed from a sheet material having a breathable membrane that is impermeable to microorganisms but is permeable to gases. The breathable membrane comprises a breathable material through which a gas, such as a sterilizing gas, can be introduced into the interior of the package <NUM>.

More particularly, generally, it is desirable to sterilize medical instruments and devices after packaging and prior to being sent to the end user. Forms of sterilization include irradiation, autoclaving, and treatment with a sterilizing gas, such as ethylene oxide. Typically, treatment with a sterilizing gas is used to sterilize medical supplies. The package <NUM> may be sterilized after the medical supply or supplies are positioned within the interior space <NUM> of the package <NUM>. In an embodiment, the package <NUM> may be sterilized by exposing the package <NUM> (having the cover <NUM> sealingly attached to the tray <NUM> as will be described in more detail herein) to a sterilizing agent. For example, the sterilizing agent may include a gaseous or vapor composition include one or more of a gas, an aerosolized component, a suspended component, droplets, or the like. In some examples, the sterilizing agent includes ethylene oxide gas. The sterilizing gas can be introduced into the interior space <NUM> of the package <NUM> through the breathable membrane of the cover <NUM> for sterilizing the contents (i.e., the medical supplies) of the package.

Suitable materials for the cover <NUM> include any material that is a barrier to microorganisms, but is permeable to gases including oxygen, carbon dioxide, and various sterilization gases. For example, suitable materials for the cover <NUM> may include a nonwoven sheet material such as TYVEK (spun-bond polyethylene), medical grade paper, microbial barrier membranes, and other porous materials that limit the passage of microbes. TYVEK is permeable to sterilizing gases such as vapor phase hydrogen peroxide, ozone, ethylene oxide, and steam, and yet is impermeable to potentially contaminating microorganisms. Similarly, medical grade paper is permeable to sterilizing gases such as ethylene oxide, ozone and steam, yet is impermeable to potentially contaminating microorganisms.

In another embodiment, the material for the cover <NUM> is not required to include a breathable membrane that is a barrier to microorganisms but is permeable to gases. In some applications, sterilization of the contents of the package does not require that a sterilizing gas be introduced into the interior space <NUM> of the package <NUM> through the cover <NUM>. Stated another way, a gas path may not be required for sterilization. For example, ionizing radiation including gamma radiation or electron beam may be utilized as a form of sterilization. Both porous and non-porous materials are compatible with such radiation sterilization methods. As such, the cover <NUM> may be formed from a non-porous plastic material. In an embodiment, the cover <NUM> can be formed from a transparent or clear plastic material such that the medical device or supply housed therein is visible.

When assembled onto the tray <NUM> as shown on <FIG> and <FIG>, the cover <NUM> extends over the open end <NUM> and the peripheral underside surface <NUM> is sealingly attached to the planar top surface <NUM> of the flange <NUM> of the tray <NUM>. More particularly, the continuous barrier seal <NUM> is formed between the flange <NUM> and the cover <NUM> when the cover <NUM> is assembled onto the tray <NUM>. Continuous as used herein means that the barrier seal <NUM> extends around the inner periphery <NUM> of the flange <NUM> without gaps or breaks therein and therefore extends around or about the entire open end <NUM> of the tray <NUM>. The continuous barrier seal <NUM> attaches the cover <NUM> and the tray <NUM> together. For example, in an embodiment, the cover <NUM> may be heat sealed to the tray <NUM> to form the continuous barrier seal <NUM>. In another embodiment, an adhesive may be used to form the continuous barrier seal <NUM>. The continuous barrier seal <NUM> is a hermetic seal such that the environment within the interior space <NUM> of the package <NUM> remains relatively constant. Stated another way, the continuous barrier seal <NUM> ensures that the integrity of the sterile environment within the interior space <NUM> is not compromised.

As stated above, the package <NUM> includes the stress-absorbing buffer or crumple zone <NUM> or region on the flange <NUM> that is configured to distribute the stress caused by transportation so that the stress is not concentrated on the continuous barrier seal <NUM> of the package <NUM>. The stress-absorbing buffer or crumple zone <NUM> includes the peripheral portion or region of the flange <NUM> outside of the continuous barrier seal <NUM>. More particularly, the stress-absorbing buffer or crumple zone <NUM> includes a widened planar surface area that includes a secondary or sacrificial seal <NUM> disposed around the outer periphery <NUM> of the flange <NUM> to absorb stress that would otherwise be transferred to the continuous barrier seal <NUM>. The secondary or sacrificial seal <NUM> functions to cushion the continuous barrier seal <NUM> and reduce twisting and bending motion of the flange <NUM>. The secondary or sacrificial seal <NUM> is best shown on <FIG>.

More particularly, the sacrificial seal <NUM> is a discontinuous seal formed between the flange <NUM> and the cover <NUM> when the cover <NUM> is assembled onto the tray <NUM>. Noncontinuous as used herein means that the sacrificial seal <NUM> does not extend around the entire outer periphery <NUM> of the flange <NUM> but rather includes gaps or breaks therein. The discontinuous sacrificial seal <NUM> is disposed on each of the first edge 114A, the second edge 114B, the third edge 114C, and the fourth edge 114D of the flange <NUM>, but it is not disposed on each of the first corner 116A, the second corner 116B, the third corner 116C, and the fourth corner 116D of the flange <NUM>. More particularly, in this embodiment in which flange <NUM> has a rectangular configuration, the discontinuous sacrificial seal <NUM> includes four generally straight segments 127A, 127B, 127C, 127D. Straight segment 127A is disposed on the first edge 114A of the flange <NUM>, straight segment 127B is disposed on the second edge 114B of the flange <NUM>, straight segment 127C is disposed on the third edge 114C of the flange <NUM>, and straight segment 127D is disposed on the fourth edge 114D of the flange <NUM>.

The straight segments 127A, 127B, 127C, 127D of the discontinuous sacrificial seal <NUM> are disposed relative to each other to resemble a rectangle, with the corners of such a rectangle not including the discontinuous sacrificial seal <NUM>. The corners of such a rectangle that do not include the discontinuous sacrificial seal <NUM> are herein referred to as non-seal portions 130A, 130B, 130C, 130D that are disposed between the straight segments 127A, 127B, 127C, 127D of the discontinuous sacrificial seal <NUM>. These non-seal portions 130A, 130B, 130C, 130D are essentially the gaps, spaces, or breaks that make the sacrificial seal <NUM> discontinuous. The non-seal portions 130A, 130B, 130C, 130D generally are disposed at the corners 116A, 116B, 116C, 116D of the flange <NUM>. More particularly, the non-seal portion 130A extends between straight segments 127A, 127C of the discontinuous sacrificial seal <NUM> and is disposed on the corner 116A of the flange <NUM>. The non-seal portion 130B extends between straight segments 127C, 127B of the discontinuous sacrificial seal <NUM> and is disposed on the corner 116B of the flange <NUM>. The non-seal portion 130C extends between straight segments 127B, 127D of the discontinuous sacrificial seal <NUM> and is disposed on the corner 116C of the flange <NUM>. The non-seal portion 130D extends between straight segments 127D, 127A of the discontinuous sacrificial seal <NUM> and is disposed on the corner 116D of the flange <NUM>.

Each of the discontinuous sacrificial seal <NUM> and the continuous barrier seal <NUM> is disposed on the planar top surface <NUM> of the flange <NUM>. The discontinuous sacrificial seal <NUM> is disposed on or along the outer periphery <NUM> of the flange <NUM> and the continuous barrier seal <NUM> is disposed on or along the inner periphery <NUM> of the flange <NUM>. Stated another way, the continuous barrier seal <NUM> is disposed closer to the side walls 104A, 104B, 104C, 104D of the tray <NUM> (and the inner periphery <NUM> of the flange <NUM>) than the discontinuous sacrificial seal <NUM>. Accordingly, since the discontinuous sacrificial seal <NUM> is disclosed outside of the continuous barrier seal <NUM>, the discontinuous sacrificial seal <NUM> is configured to absorb stress that is applied to the flange <NUM> that would otherwise be transferred to the continuous barrier seal <NUM>. The discontinuous sacrificial seal <NUM> also functions to stiffen the area outside the continuous barrier seal <NUM>. When stress is applied to the flange <NUM>, deformation of the flange <NUM> occurs at the stress-absorbing buffer or crumple zone <NUM> which is the peripheral portion or region of the flange <NUM> outside of the continuous barrier seal <NUM>. The discontinuous sacrificial seal <NUM> is configured to preferentially break or peel such that the continuous barrier seal <NUM> is thereby protected and remains intact. Lastly, the non-seal portions 130A, 130B, 130C, 130D that are disposed between the straight segments 127A, 127B, 127C, 127D of the discontinuous sacrificial seal <NUM> provide access points for the user to remove or peel away the cover <NUM> from the tray <NUM> when it is desired to open the package <NUM>.

In addition to the discontinuous sacrificial seal <NUM>, the stress-absorbing buffer or crumple zone <NUM> also includes a plurality of holes 128A, 128B, 128C, 128D (collectively referred to herein as holes <NUM>) disposed at strategic locations on the flange <NUM> to permit controlled deflection or deformation of the package <NUM>. In an embodiment, the holes <NUM> are cutouts that extend through the entire thickness of the flange <NUM>. In an embodiment hereof, each hole <NUM> has an oblong or rectangular configuration and is formed on the flange. However, in another embodiment hereof, each hole <NUM> may have a different configuration such as circular, zigzag, triangular, trapezoidal, or any other configuration suitable to permit controlled deflection or deformation of the package <NUM>. In an embodiment, a hole <NUM> is positioned on each of the first corner 116A, the second corner 116B, the third corner 116C, and the fourth corner 116D of the flange <NUM>. The holes <NUM> are spaced apart from the straight segments 127A, 127B, 127C, 127D of the discontinuous sacrificial seal <NUM>. More particularly, the holes <NUM> are formed on the non-seal portions 130A, 130B, 130C, 130D that are disposed between the straight segments 127A, 127B, 127C, 127D of the discontinuous sacrificial seal <NUM>.

Each hole <NUM> is angled between the corresponding edges of the flange <NUM>. More particularly, the hole 128A is angled between the first edge 114A and the third edge 114C of the flange <NUM>. The hole 128B is angled between the third edge 114C and the second edge 114B of the flange <NUM>. The hole 128C is angled between the second edge 114B and the fourth edge 114D of the flange <NUM>. The hole 128D is angled between the fourth edge 114D and the first edge 114A of the flange <NUM>. Each pair of adjacent edges of the flange <NUM> form approximately a ninety degrees angle, and each hole extends at approximately a forty-five degree angle Θ as shown on <FIG>. Approximately as used herein includes a tolerance of five degrees.

The holes <NUM> are configured to control deflection and/or deformation of the flange <NUM> outside the continuous barrier seal <NUM>. More particularly, the continuous barrier seal <NUM> is disposed closer to the side walls 104A, 104B, 104C, 104D of the tray <NUM> than the holes <NUM>. The holes <NUM> bias or control deformation of the flange <NUM> outside the continuous barrier seal <NUM> because the flange <NUM> is configured to deform or deflect at the holes <NUM> rather than along the continuous barrier seal <NUM>. Although the discontinuous sacrificial seal <NUM> stiffens the flange <NUM> outside the continuous barrier seal <NUM>, the flange <NUM> is more flexible at the corners 116A, 116B, 116C, 116D thereof that do not include the discontinuous sacrificial seal <NUM> and thus these corners may flex and deform without interfering with the integrity of the continuous barrier seal <NUM> when stress is applied to the flange <NUM>.

Claim 1:
A package (<NUM>) configured for the sterility of medical supplies, the package comprising:
a tray (<NUM>) having at least one side wall defining an open end of the tray, a base panel opposite the open end, and a flange (<NUM>) extending about a periphery of the at least one side wall at the open end of the tray, wherein the flange includes a planar top surface (<NUM>);
a cover (<NUM>) configured to seal the open end of the tray when the cover is assembled onto the tray;
a continuous barrier seal (<NUM>) formed between the flange and the cover when the cover is assembled onto the tray, wherein the cover includes a peripheral underside surface configured to mate with the planar top surface of the flange of the tray; and
a discontinuous sacrificial seal (<NUM>) formed between the flange and the cover when the cover is assembled onto the tray, the discontinuous sacrificial seal configured to absorb stress applied to the flange, wherein the continuous barrier seal is disposed closer to an inner periphery of the flange than the discontinuous sacrificial seal,
characterized in that at least one hole (<NUM>) is formed on the planar top surface of the flange, the at least one hole being spaced apart from the discontinuous sacrificial seal and the continuous barrier seal being disposed closer to the inner periphery of the flange than the at least one hole.