Microbial barrier vented package for sterile medical devices and method of packaging
First Claim
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1. A foil outer package for medical device packages, comprising:
- a first substantially planar member comprising a foil, said planar member having at least two cavities formed therein for receiving a medical device in each cavity, wherein said planar member has an outer periphery, an outer side and an inner side;
a second substantially flat planar member comprising a foil, said second planar member having an outer periphery, an outer side and an inner side, said second member also having at least one vent opening therein, each said opening having a periphery;
a gas permeable microbial barrier membrane mounted to the second planar member about the periphery of each vent opening;
wherein the first planar member is mounted to the second planar member such that the outer peripheries are substantially in alignment, the inner surface of the first planar member being bonded to the inner surface of the second planar member adjacent to the outer peripheries of the planar members to form a gas impermeable peripheral seal, and the inner surface of the first planar member being further bonded to the inner surface of the second inner surface about each cavity to form a gas impermeable side seal adjacent to each cavity, said side seals having a first end and a second end, wherein the first end of each seal intersects the peripheral seal and the second end extends at least partially between adjacent cavities, thereby forming a manifold such that each cavity is in communication with the vent opening.
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Abstract
A package for sterilized, absorbable medical devices is disclosed. The package has a plurality of cavities in communication with a vent, wherein the vent is preferably centrally located. After sterilization, the package is sealed adjacent to the vent thereby providing individual hermetically sealed sterile cavities which are cut away from the package to form unitary packages.
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Citations
45 Claims
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1. A foil outer package for medical device packages, comprising:
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a first substantially planar member comprising a foil, said planar member having at least two cavities formed therein for receiving a medical device in each cavity, wherein said planar member has an outer periphery, an outer side and an inner side; a second substantially flat planar member comprising a foil, said second planar member having an outer periphery, an outer side and an inner side, said second member also having at least one vent opening therein, each said opening having a periphery; a gas permeable microbial barrier membrane mounted to the second planar member about the periphery of each vent opening; wherein the first planar member is mounted to the second planar member such that the outer peripheries are substantially in alignment, the inner surface of the first planar member being bonded to the inner surface of the second planar member adjacent to the outer peripheries of the planar members to form a gas impermeable peripheral seal, and the inner surface of the first planar member being further bonded to the inner surface of the second inner surface about each cavity to form a gas impermeable side seal adjacent to each cavity, said side seals having a first end and a second end, wherein the first end of each seal intersects the peripheral seal and the second end extends at least partially between adjacent cavities, thereby forming a manifold such that each cavity is in communication with the vent opening. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 36, 37, 38, 39, 40, 41, 42, 43)
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18. A foil outer package for medical device packages, comprising:
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a first substantially planar member comprising a foil, wherein said planar member has an outer periphery, an outer side and an inner side; a second substantially flat planar member comprising a foil, said second planar member having an outer periphery, an outer side and an inner side, said second member also having at least one vent opening therein, each said opening having a periphery; a gas permeable membrane mounted to the second planar member about the periphery of each vent opening; wherein the first planar member is mounted to the second planar member such that the outer peripheries are substantially in alignment, the inner surface of the first planar member being bonded to the inner surface of the second planar member adjacent to the outer peripheries of the planar members to form a gas impermeable peripheral seal, and the inner surface of the first planar member being further bonded to the inner surface of the second inner surface to form at least two compartments bounded by gas impermeable side seals adjacent to each compartment, said side seals having a first end and a second end, wherein the first end of each seal intersects the peripheral seal and the second end extends at least partially between adjacent compartments, thereby forming a manifold such that each compartment is in communication with the at least one vent opening. - View Dependent Claims (33, 34)
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35. A foil outer package for a medical device package, comprising:
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a first substantially planar member comprising a foil, said planar member having a cavity formed therein for receiving a medical device, wherein said planar member has an outer periphery, an outer side and an inner side; a second substantially flat planar member comprising a foil, said second planar member having an outer periphery, an outer side and an inner side, said second member also having an interior vent opening therein, each said opening having a periphery; a gas permeable membrane mounted to the second planar member about the periphery of the vent opening; wherein the first planar member is mounted to the second planar member such that the outer peripheries are substantially in alignment, the inner surface of the first planar member is bonded to the inner surface of the second planar member adjacent to the outer peripheries of the planar members to form a gas impermeable peripheral seal such that the cavity is in communication with the vent opening.
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44. A method of packaging a medical device in an outer foil package, said method comprising:
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providing a first substantially planar member, said member having an inner side, an outer side and an outer periphery; forming a plurality of cavities in said first planar member, said cavities suitable for receiving a surgical suture package, said cavities formed on the inner side of the planar member; inserting a medical device in each cavity; providing a second substantially planar member having an outer periphery, an outer side and a top side; cutting a hole having an outer periphery into the second planar member, said hole centrally located therein; mounting a gas permeable member over the opening, and sealing the member about the periphery of the opening, thereby providing a central vent; aligning the first and second planar members such that the outer peripheries are substantially in registration; sealing the inner sides of the planar members to form an outer gas impervious outer seal, and sides seals adjacent to each cavity, such that each cavity has an opening in communication with the central vent; sealing off the openings in each cavity such that the cavity is bounded by gas impervious seals thereby hermetically sealing each cavity; and
,forming hermetically sealed unitary suture packages from the multicavity package by cutting the package adjacent to each cavity such that each unitary package comprises a cavity bounded by gas impervious seals.
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45. A method of packaging a medical device in an outer foil package, said method comprising:
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providing a first substantially planar member, said member having an inner side, an outer side and an outer periphery; locating a plurality of compartments in said first planar member, said compartments suitable for receiving a surgical suture package inserting a medical device in each compartment; providing a second substantially planar member having an outer periphery, an outer side and a top side; cutting a hole having an outer periphery into the second planar member, said hole centrally located therein; mounting a gas permeable member over the opening, and sealing the member about the periphery of the opening, thereby providing a central vent; aligning the first and second planar members such that the outer peripheries are substantially in registration; sealing the inner sides of the planar members to form an outer gas impervious outer seal, and sides seals adjacent to each compartment, such that each compartment has an opening in communication with the central vent; sealing off the openings in each compartment such that each compartment is bounded by gas impervious seals thereby hermetically sealing each compartment; and
,forming hermetically sealed unitary suture packages from the multicompartment package by cutting the package adjacent to each compartment such that each unitary package comprises a compartment bounded by gas impervious seals.
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Specification