Sterile air feedthrough packaging system for testing hydrocephalus shunt valves

Claim 2

A sealed, sterile packaging system having air communication means for connecting a source of pressurized air located externally of said packaging system to a device positioned in an interior compartment of the packaging system for the air pressure testing of valves of such a device comprising: an inner package defining a first sterilizable interior compartment and having a peripheral seal which can be broken for opening said inner package; an outer package defining a second sterilizable interior compartment that holds said inner package therein, said outer package having a peripheral seal which can be broken for opening said outer package; means for sealing the peripheries of said inner and outer packages; and air communication means comprising a sterile connector assembly positioned within and across a portion of the sealed periphery of the inner and outer packages, for allowing pressurized air to flow therethrough to the interior of the device in the inner package from the external source of pressurized gas without compromising the sterility of the device.

Claim 3

The packaging system of claim 1 wherein said connector assembly comprises a cylindrical connector housing, one end of which is capable of being connected to the interior of the device within the first interior compartment of said packaging system and the other end of which is capable of receiving a connector of an air pressure testing device thereon.

Claim 4

The packaging system of claim 2 wherein said connector housing has a bacteriostatic filter extending acrosss a lumen thereof.

Claim 5

The packaging system of claim 3 wherein said bacteriostatic filter is made of a coated polyolefin.

Claim 6

The packaging system of claim 4 wherein said coated polyolefin is air-permeable.

Claim 7

The packaging system of claim 2 wherein said connector housing is made of a bacteriostatic material.

Claim 8

The packaging system of claim 6 wherein said connector housing is made of steel.

Claim 9

The packaging system of claim 6 wherein said connector housing is made of polyethylene.

Claim 10

The packaging system of claim 1 wherein said inner and outer packages are substantially the same and comprise a planar bottom wall and a molded upper wall.

Claim 11

The packaging system of claim 9 wherein the upper wall of each package is made of polyvinylchloride.

Claim 12

The packaging system of claim 9 wherein the bottom wall of each package is made of a coated polyolefin.

Claim 13

The packaging system of claim 11 wherein said coated polyolefin is air-permeable.

Claim 14

The packaging system of claim 11 wherein said connector housing is made of polyvinylchloride.

Claim 15

The packaging system of claim 1 wherein said means for sealing the peripheries of said inner and outer packs comprise a heat activated sealant.

Claim 16

The packaging system of claim 14 wherein said sealing means further include a bead of silastic positioned around the area of the periphery of each package through which said connector assembly passes.

Claim 17

The packaging system of claim 9 wherein said upper molded wall and planar bottom wall of each package are formed to be capable of being separated from each other by pulling them apart from a periphery thereof.

Claim 18

A sterile connector assembly that transmits pressurized air or other gaseous substance from an externally located source to a device located within an interior compartment defined within a peripherally sealed packaging system for air pressure testing of valves of the device, said connector assembly comprising: a cylindrical connector housing having a first end thereof located within the interior of the packaging system, a second end located exterior of the packaging system, and an intermediate portion disposed within a portion of the sealed peripheral region of the packaging system, said connector housing having a lumen extending therethrough; a filter centrally disposed within and across said lumen of said sterile connector housing in such a manner as to allow molecules of pressurized air or other pressurized gaseous material to pass therethrough while sealing or plugging said connector housing against entry of particles which are larger than molecules of gas, such as bacterial contaminants; sealing means for sealing said connector housing within the sealed peripheral portion of the packaging system, said sealing means being capable of maintaining said seal during periods when stress is placed on said connector housing to ensure integrity of the seal; and connecting means associated with said connector housing for connecting said first interior end of said connector housing with the interior of the device positioned within the sealed packaging system to provide a passageway through which pressurized air entering the connector assembly can be shunted into the interior of the device for air pressure testing of the valves of the device; said connecting means comprising a cannula or tube extending from said first or interior end of said connector housing to and into one end of the device packaged within the packaging system.

Claim 19

A sterile connector assembly that transmits pressurized air or other gaseous substance from an externally located source to a device located within an interior compartment defined within a peripherally sealed packaging system for air pressure testing of valves of the device, said connector assembly comprising: a cylindrical connector housing having a first end thereof located within the interior of the packaging system, a second end located exterior of the packaging system, and an intermediate portion disposed within a portion of the sealed peripheral region of the packaging system, said connector housing having a lumen extending therethrough; a filter centrally disposed within and across said lumen of said sterile connector housing in such a manner as to allow molecules of pressurized air or other pressurized gaseous material to pass therethrough while sealing or plugging said connector housing against entry of particles which are larger than molecules of gas, such as bacterial contaminants; sealing means for sealing said connector housing within the sealed peripheral portion of the packaging system, said sealing means being capable of maintaining said seal during periods when stress is placed on said connector housing to ensure integrity of the seal; and connecting means associated with said connector housing for connecting said first interior end of said connector housing with the interior of the device positioned within the sealed packaging system to provide a passageway through which pressurized air entering the connector assembly can be shunted into the interior of the device for air pressure testing of the valves of the device; said connecting means comprising a cannula or tube extending from said first or interior end of said connector housing to and into one end of the device packaged within the packaging system.

Claim 20

The assembly of claim 17 wherein said connector housing is made of a bacteriostatic material.

Claim 21

The connector assembly of claim 18 wherein said connector housing is made of steel.

Claim 22

The connector assembly of claim 19 wherein said connector housing is made of polyvinylchloride.

Claim 23

The connector assembly of claim 18 wherein said connector housing is made of polyethylene.

Claim 24

The connector assembly of claim 17 wherein said bacteriostatic filter is made of a coated polyolefin.

Claim 25

The connector assembly of claim 22 wherein said coated polyolefin is air-permeable.

Claim 26

The assembly of claim 17 wherein said cannula is made of a suitable plastic material.

Claim 27

The connector of claim 24 wherein said plastic material is a bacteriostatic silicone rubber.

Claim 28

The connector or claim 17 wherein the connection of said cannula to said device is air-tight.