Three barrier closure system for medical liquid container

Claim 2

In a thermoplastic steam sterilizable medical liquid container, having a flange on a neck portion and an inner closure and an outer closure, the improvement of: a tube on the inner closure with a passage therethrough; a first hermetic seal closing the passage; a second hermetic seal closing the passage externally of the first hermetic seal; said outer closure encloses the first and second hermetic seals; said outer closure having an outwardly extending brim fused to said flange and includes a vent that equalizes pressure inside and outside the outer closure, so that the outer closure is relieved of differential pressure stresses.

Claim 3

The combination as set forth in claim 1, wherein the first hermetic seal remains closed when subjected to a pressure differential of 10 psi (0.70 Kg/cm) exerted across the first hermetic seal.

Claim 4

The combination as set forth in claim 1, wherein the second hermetic seal remains closed when subjected to a pressure differential of 10 psi (0.70 Kg/cm2) exerted across the second hermetic seal.

Claim 5

The combination as set forth in claim 1, wherein the vent is a tortuous passage through the outer closure.

Claim 6

The combination as set forth in claim 1, wherein the outer closure has a manually frangible section for opening the outer closure to gain access to the first and secoind hermetic seal means on the inner closure.

Claim 7

The combination as set forth in claim 5, wherein the manually frangible section includes an annular venting opening about the outer closure with one or more frangible webs integral with the outer closure and extending across the vent opening.

Claim 8

The combination as set forth in claim 1, wherein the tube is a dispensing outlet tube and includes a spike gripping tubular sleeve.

Claim 9

The combination as set forth in claim 7, wherein the spike gripping sleeve has an inner wall that tapers inwardly toward an interior of the container.

Claim 10

The combination as set forth in claim 8, wherein the spike gripping sleeve is laterally expandable for grippingly receiving a tubular administration spike.

Claim 11

The combination as set forth in claim 9, wherein the first hermetic seal in puncturable thermoplastic diaphragm formed integrally with and closing off a passage through the tubular spike gripping sleeve.

Claim 12

The combination as set forth in claim 10, wherein the spike gripping sleeve has an integral annular rib extending below the diaphragm.

Claim 13

The combination as set forth in claim 10, wherein the tube includes an annular support section with the spike gripping sleeve disposed within and integrally formed with this annular support section.

Claim 14

The combination as set forth in claim 12, wherein the tube includes an annular space between the annular support section and the spike gripping sleeve disposed therein.

Claim 15

The combination as set forth in claim 1, wherein the second hermetic seal is a manually peelable thermoplastic-metal foil bonded to an outer end of the tube.

Claim 16

The combination as set forth in claim 1, wherein the outer closure is a cap having a diameter substantially greater than a diameter of the tube section, whereby forces to open the first and second hermetic seals are cOncentrated in areas substantially smaller than the outer closure.

Claim 17

The combination as set forth in claim 1, wherein the tube is an outlet tube and the inner closure also includes an additive port closed by a puncturable resealable diaphragm separate from the outlet tube and additive medication can be added to the container through this additive port.

Claim 18

The combination as set forth in claim 16, wherein the puncturable resealable diaphragm is externally sealed off by a hermetic barrier disposed within the outer closure.

Claim 19

The combination as set forth in claim 17, wherein the puncturable resealable diaphragm is disposed in an additive tube integrally formed with the inner closure.

Claim 20

The combination as set forth in claim 18, wherein the additive tube section has hermetic barrier external of the puncturable resealable diaphragm.

Claim 21

The combinationn as set forth in claim 19, wherein the hermetic barrier is a thermoplastic-metal foil.

Claim 22

The combination as set forth in claim 1, wherein the outer closure is a thermoplastic cap and is secured to the container by a plurality of webs each of which has a cross-sectional area less than 0.0004 in2 (0.0026 cm2) for easy manual breakage by twisting or cocking the outer cap relative to the container.

Claim 23

The combination as set forth in claim 1, wherein the inner closure has an additive tube, the first hermetic barrier is a puncturable resealable diaphragm, and the second hermetic barrier is a metal-thermoplastic laminate foil, both of which are sealed to the additive tube.

Claim 24

For handling and dispensing a sterile medical liquid the combination of: a thermoplastic bottle having a neck with an outlet passage therethrough; an integral thermoplastic flange integral with this neck; an inner closure permanently sealed to the container neck; said inner closure having an outlet tube formed by an annular support section and a spike gripping tubular sleeve integral with and disposed within the annular support section; a puncturable diaphragm integrally formed with the spike gripping sleeve and forming a first hermetic barrier to a dispensing passage that extends through the spike gripping sleeve; a thermoplastic-metal foil having a thermoplastic surface bonded to an outer end of the dispensing tube forming a second hermetic barrier across the dispensing passage through the spike gripping sleeve; an additive tube integrally formed with the inner closure; a puncturable resealable diaphragm sealing off a passage through the additive tube through which additive medications can be injected into the bottle; a hermetic seal across the additive tube externally of the puncturable resealable diaphragm, said hermetic barrier being a thermoplastic-metal foil; a third barrier in the form of a cap having a top wall, a tubular sidewall, and a laterally extending brim fitting over and enclosing both the outlet tube and the additive tube; said cap brim being permanently bonded to the bottle neck flange and supporting the outer cap''s top wall a distance above the thermoplastic-metal foil; said outer closure having a tortuous vent at a juncture between the tubular side wall and the cap brim; and a series of manually frangible web sections connecting the sidewall to the flange of the outer closure.

Claim 25

For handling and dispensing a sterile medical liquid the combination of: a thermoplastic bottle having a neck with an outlet passage therethrough; an integral thermoplastic flange integral with this neck; an inner closure permanently sealed to the container neck; said inner closure having an outlet tube formed by an annular support section and a spike gripping tubular sleeve integral with and disposed within the annular support section; a puncturable diaphragm integrally formed with the spike gripping sleeve and forming a first hermetic barrier to a dispensing passage that extends through the spike gripping sleeve; a thermoplastic-metal foil having a thermoplastic surface bonded to an outer end of the dispensing tube forming a second hermetic barrier across the dispensing passage through the spike gripping sleeve; an additive tube integrally formed with the inner closure; a puncturable resealable diaphragm sealing off a passage through the additive tube through which additive medications can be injected into the bottle; a hermetic seal across the additive tube externally of the puncturable resealable diaphragm, said hermetic barrier being a thermoplastic-metal foil; a third barrier in the form of a cap having a top wall, a tubular sidewall, and a laterally extending brim fitting over and enclosing both the outlet tube and the additive tube; said cap brim being permanently bonded to the bottle neck flange and supporting the outer cap''s top wall a distance above the thermoplastic-metal foil; said outer closure having a tortuous vent at a juncture between the tubular side wall and the cap brim; and a series of manually frangible web sections connecting the sidewall to the flange of the outer closure.