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US5944709A Expired / Lapsed US ⏱️ 0.0 years remaining

Flexible, multiple-compartment drug container and method of making and using same

Assignee: B Braun Medical Inc
•
Filing: 1997-04-11
•
Granted: 1999-08-31
•
Expires: 2017-04-11
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Abstract

Abstract A flexible container is provided for the storage and mixing together of diluents and medicaments. The container incorporates multiple compartments, separated by peelable seals, in which the diluents and medicaments are stored. The container is constructed of thermoplastic materials having high oxygen and moisture barrier properties which allows the container to be stored for extended periods of time without degrading the contents. The seals are ruptured by manipulation of the container to thereby mix the contents together for delivery through standard IV arrangement to a patient. The seals are constructed to provide a non-linear resistance characteristic to hydraulic pressure, which causes the seal to peel open completely along its length. The container is folded-over along the line of one of the seals and also includes a locking tab and retaining slot to secure the bag in a folded-over condition.

Inventors

  • 👤 Ward W. Barney
  • 👤 Noel Gharibian
  • 👤 Douglas G. Harvey
  • 👤 Mark R. McLonis
  • 👤 Christopher D. Peara
  • 👤 Giuseppe Sacca
  • 👤 Sharilyn J. Sandberg
  • 👤 Steven L. Smith
  • 👤 William V. Walter
  • 👤 Nicholas Chung-Hui Wu
  • 👤 Walter A. York
  • 👤 H. Theodore Young

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-09 01:11
CPC Classifications
A; A61; A61J; A61J1/00; A61J1/14; A61J1/20; A61J1/2093; A61J1/05; A61J1/10; A61J1/1475; A61J1/16; B; B29; B29C; B29C49/00; B29C49/0005; B29C49/02; B29C49/06905; B29C49/0691; B29C65/00; B29C65/02; B29C66/00; B29C66/01; B29C66/05; B29C66/10; B29C66/11; B29C66/112; B29C66/1122; B29C66/13; B29C66/131; B29C66/133; B29C66/20; B29C66/24; B29C66/242; B29C66/50; B29C66/51; B29C66/53; B29C66/532; B29C66/5326; B29C66/53261; B29C66/53262; B29C66/70; B29C66/72; B29C66/723; B29C66/7232; B29C66/72321; B29C66/7234; B32; B32B; B32B15/00; B32B15/04; B32B15/08; B32B27/00; B32B27/06; B32B27/08; B32B27/32; B65; B65B; B65B55/00; B65B55/02; B65B55/12; B65B55/16; B65D; B65D81/00; B65D81/32; B65D81/3261; B65D81/3266; C; C08; C08L; C08L23/00; C08L23/02; C08L23/04; C08L23/08; C08L23/0807; C08L23/0815; C08L23/10; C08L23/14; C08L23/142; C08L23/16; C08L53/00; C08L53/02; C08L53/025; A61J1/2003; A61J1/202; A61J1/2024; A61M; A61M2207/00; B29C2793/00; B29C2793/0027; B29C2793/009; B29C65/18; B29C65/76; B29C66/71; B29C66/72341; B29C66/72343; B29C66/80; B29C66/83; B29C66/832; B29C66/8322; B29K; B29K2023/00; B29K2023/04; B29K2023/06; B29K2023/0608; B29K2023/0641; B29K2023/08; B29K2023/083; B29K2023/086; B29K2023/10; B29K2023/12; B29K2101/00; B29K2101/12; B29K2105/00; B29K2105/0085; B29K2105/0088; B29K2305/00; B29K2305/02; B29K2705/00; B29K2705/02; B29L; B29L2009/00; B29L2009/003; B29L2031/00; B29L2031/712; B29L2031/7148; B31; B31B; B31B2155/00; B31B2155/002; B31B2170/00; B31B2170/20; B31B2241/00; B31B70/00; B31B70/74; B31B70/81; B31B70/84; B31B70/844; B65D75/00; B65D75/52; B65D75/58; B65D75/5861; Y; Y10; Y10T; Y10T428/00; Y10T428/13; Y10T428/1334; Y10T428/1341

Claims Analysis

Total Claims: 90
Claim 1
Independent Claim 162 words
A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising: a flexible rear sheet; a flexible front sheet sealed to the rear sheet along a common peripheral edge; a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent; a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment; a clear high-barrier laminate film separately disposed upon and sealed to the front sheet, the high-barrier laminate film sized to extend over the medicament compartment; and an opaque high-barrier protective film peelably affixed to the clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the medicament compartment.
Claim 2
Dependent Claim 162 words
A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising: a flexible rear sheet; a flexible front sheet sealed to the rear sheet along a common peripheral edge; a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent; a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment; a clear high-barrier laminate film separately disposed upon and sealed to the front sheet, the high-barrier laminate film sized to extend over the medicament compartment; and an opaque high-barrier protective film peelably affixed to the clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the medicament compartment.
Claim 3
Dependent Claim 22 words
A flexible container as defined in claim 1, wherein the front sheet comprises a polypropylene-polyethylene co-polymer blended with styrene ethylene-butylene styrene elastomer.
Claim 4
Dependent Claim 24 words
A flexible container as defined in claim 2, wherein the polypropylene-polyethylene co-polymer is blended with styrene ethylene-butylene styrene elastomer in an about 80%/200% ratio.
Claim 5
Dependent Claim 15 words
A flexible container as defined in claim 1, wherein the medicament is a powdered antibiotic.
Claim 6
Dependent Claim 61 words
A flexible container as defined in claim 3, wherein the rear sheet comprises a multi-layer laminate including: an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer in about an 80%/20% ratio interfacing with the front sheet; an intermediate layer of aluminum foil; and an outer thermoplastic layer having a higher melting point than said inner layer.
Claim 7
Dependent Claim 59 words
A flexible container as defined in claim 1, wherein the opaque high-barrier protective film is peelably affixed over the clear high-barrier laminate film, whereby said opaque high-barrier protective film contacts only a portion of the surface of the clear high-barrier laminate film, the strength of attachment of the opaque film being directly proportional to the area of surface contact.
Claim 8
Dependent Claim 42 words
A flexible container as described in claim 6, wherein the opaque high-barrier protective film is affixed over the clear high-barrier laminate film by a patterned heat seal head, the patterned heat seal head defining a regular array of generally circular non-contact areas.
Claim 9
Dependent Claim 27 words
A flexible container as described in claim 6, wherein the opaque high-barrier protective film is affixed over the clear high-barrier laminate film by a uniform heat seal.
Claim 10
Dependent Claim 27 words
A flexible container as defined in claim 6, wherein the opaque high-barrier protective film is affixed over the clear high-barrier laminate film by a peelable, peripheral seal.
Claim 11
Dependent Claim 46 words
A flexible container as defined in claim 1, wherein the container is folded-over adjacent the first peelable seal such that the folded-over container's outwardly facing surface comprises the multi-layer laminate rear sheet, the flexible container further comprising means for securing the container in a folded-over condition.
Claim 12
Dependent Claim 83 words
A flexible container as defined in claim 10, wherein the means for securing the container in a folded-over condition comprises: a locking tab integrally formed with and extending from a side of the container; and a slot integrally formed with and extending from the same side of the container as the tab, wherein the tab and slot are moved into position for mutual engagement when the container is folded-over adjacent the first peelable seal to thereby secure the container in a folded-over condition.
Claim 13
Dependent Claim 56 words
A flexible container as defined in claim 1, wherein the peelable seals are constructed to provide a uniform resistance characteristic to hydraulic pressure against the seal caused by manipulation of the container, the uniform resistance characteristic causing the seal to peel at an applied pressure in the range of three to five pounds per square inch.
Claim 14
Dependent Claim 177 words
A flexible container for separately storing and mixing liquid diluent and medicament, the container comprising: a multi-layer laminate rear sheet including an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer, an opaque high-barrier intermediate layer, and an outer high temperature resistant mold release layer; a flexible front sheet constructed of a single layer film of a polypropylene-polyethylene co-polymer blended with styrene ethylene-butylene styrene elastomer interfacing with the rear sheet, the front sheet sealed to the rear sheet along a common peripheral edge; at least two peelable seals extending between two parallel sides of the common peripheral edge and separably joining the front and rear sheets to define at least three compartments in the container including a first compartment containing a powdered medicament; a clear high-barrier laminate film sealed to the front sheet, the high-barrier laminate film sealed to extend over the medicament compartment; and an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the medicament compartment.
Claim 15
Dependent Claim 177 words
A flexible container for separately storing and mixing liquid diluent and medicament, the container comprising: a multi-layer laminate rear sheet including an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer, an opaque high-barrier intermediate layer, and an outer high temperature resistant mold release layer; a flexible front sheet constructed of a single layer film of a polypropylene-polyethylene co-polymer blended with styrene ethylene-butylene styrene elastomer interfacing with the rear sheet, the front sheet sealed to the rear sheet along a common peripheral edge; at least two peelable seals extending between two parallel sides of the common peripheral edge and separably joining the front and rear sheets to define at least three compartments in the container including a first compartment containing a powdered medicament; a clear high-barrier laminate film sealed to the front sheet, the high-barrier laminate film sealed to extend over the medicament compartment; and an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the medicament compartment.
Claim 16
Dependent Claim 30 words
A flexible container as defined in claim 13, wherein the polypropylene-polyethylene co-polymer of the front and rear sheets is blended with styrene ethylene-butylene styrene elastomer in an about 80%/20% ratio.
Claim 17
Dependent Claim 15 words
A flexible container as defined in claim 13, wherein the medicament is a powdered antibiotic.
Claim 18
Dependent Claim 58 words
A flexible container as defined in claim 13, wherein the opaque high-barrier protective film is peelably affixed over the clear high-barrier laminate film, whereby said opaque high-barrier protective film contacts only a portion of the surface of the clear high-barrier laminate film, the strength of attachment of the covering being directly proportional to the area of surface contact.
Claim 19
Dependent Claim 42 words
A flexible container as described in claim 16, wherein the opaque high-barrier protective film is affixed over the clear high-barrier laminate film by a patterned heat seal head, the patterned heat seal head defining a regular array of generally circular non-contact areas.
Claim 20
Dependent Claim 53 words
A flexible container as defined in claim 13, wherein the peelable seals are constructed to provide a uniform resistance characteristic to hydraulic pressure against the seal caused by manipulation of the container, the uniform resistance characteristic causing the seal to peel at an applied force in the range of three to five pounds.
Claim 21
Dependent Claim 28 words
A flexible container as defined in claim 16, wherein the opaque high-barrier protective film is affixed over the clear high-barrier laminate film by a peelable, uniform heat seal.
Claim 22
Dependent Claim 28 words
A flexible container as defined in claim 16, wherein the opaque high-barrier protective film is affixed over the clear high-barrier laminate film by a peelable, peripheral heat seal.
Claim 23
Dependent Claim 46 words
A flexible container as defined in claim 13, wherein the container is folded-over adjacent the first peelable seal such that the folded-over container's outwardly facing surface comprises the multi-layer laminate rear sheet, the flexible container further comprising means for securing the container in a folded-over condition.
Claim 24
Dependent Claim 83 words
A flexible container as defined in claim 21, wherein the means for securing the container in a folded-over condition comprises: a locking tab integrally formed with and extending from a side of the container; and a slot integrally formed with and extending from the same side of the container as the tab, wherein the tab and slot are moved into position for mutual engagement when the container is folded-over adjacent the first peelable seal to thereby secure the container in a folded-over condition.
Claim 25
Dependent Claim 160 words
A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising: a flexible front sheet; a flexible rear sheet sealed to the front sheet at a common peripheral edge; a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent; and a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment, wherein the peelable seals are constructed to provide a uniform resistance characteristic to hydraulic pressure against the seal caused by manipulation of the container, the uniform resistance characteristic causing the seal to peel at an applied pressure in the range of from about 3 to about 5 lbs per square inch.
Claim 26
Dependent Claim 160 words
A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising: a flexible front sheet; a flexible rear sheet sealed to the front sheet at a common peripheral edge; a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent; and a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment, wherein the peelable seals are constructed to provide a uniform resistance characteristic to hydraulic pressure against the seal caused by manipulation of the container, the uniform resistance characteristic causing the seal to peel at an applied pressure in the range of from about 3 to about 5 lbs per square inch.
Claim 27
Dependent Claim 15 words
A flexible container as defined in claim 23, wherein the medicament is a powdered antibiotic.
Claim 28
Dependent Claim 28 words
A flexible container as defined in claim 23, wherein the front sheet comprises a single layer film constructed of a polypropylene-polyethylene co-polymer blended with styrene-ethylene butylene styrene elastomer.
Claim 29
Dependent Claim 25 words
A flexible container as defined in claim 25, wherein the polypropylene-polyethylene co-polymer is blended with styrene ethylene-butylene styrene elastomer in about an 80%/20% wt/wt ratio.
Claim 30
Dependent Claim 62 words
A flexible container as defined in claim 23, wherein the rear sheet comprises a multi-layer laminate including: an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer in about an 80%/20% wt/wt ratio interfacing with the front sheet; an intermediate layer of aluminum foil; and an outer thermo-plastic layer having a higher melting point than said inner layer.
Claim 31
Dependent Claim 36 words
A flexible container as defined in claim 27, further comprising a high-barrier protective covering at least a portion of which is separably sealed to the front sheet, the covering sized to extend over the medicament compartment.
Claim 32
Dependent Claim 68 words
A flexible container as defined in claim 28, wherein the high-barrier protective covering comprises: an opaque, peelable, multi-layer laminate including; a modified ethylenevinylacetate polymer layer comprising the inwardly facing surface of said laminate; a polyester polymer layer having a higher melting temperature than said modified ethylenevinylacetate polymer layer, comprising the outwardly facing surface of said laminate; and an aluminum foil layer intermediate the modified ethylenevinylacetate and polyester layers.
Claim 33
Dependent Claim 65 words
A flexible container as defined in claim 29, wherein the high-barrier protective covering further comprises: a clear transparent multi-layer high-barrier film laminate disposed intermediate the front sheet and the opaque, peelable, multi-layer laminate, the transparent high-barrier film laminate including; a polypropylene inner layer adjacent the front sheet; an outer layer comprising polyester; and a clear, transparent high moisture barrier between the inner and outer layers.
Claim 34
Dependent Claim 35 words
A flexible container as defined in claim 30, wherein the clear, transparent multi-layer high-barrier film laminate further comprises a clear, transparent, high oxygen barrier film layer disposed intermediate the polypropylene layer and the polyester layer.
Claim 35
Dependent Claim 35 words
A flexible container as defined in claim 31, wherein the clear, transparent high moisture barrier film layer is a polymer selected from the group consisting of oriented high-density polyethylene, polychlorotrifluoroethylene, and silica deposited polyethylene terephthalate.
Claim 36
Dependent Claim 35 words
A flexible container as defined in claim 31, wherein the clear, transparent high oxygen barrier film layer is a polymer selected from the group consisting of ethylenevinylalcohol, polyvinylidenechloride coated polyethylene terephthalate, and silica deposited polyvinylalcohol.
Claim 37
Dependent Claim 80 words
A flexible container as defined in claim 23, wherein the first and second peelable seals comprise: a first longitudinal portion extending between two parallel sides of the common peripheral edge; a second longitudinal portion extending between two parallel sides of the common peripheral edge; and a transverse portion adjacent one of the two parallel sides of the common peripheral edge, the transverse portion joining the first and second longitudinal portions at one end thereof, to form thereby a U shape.
Claim 38
Dependent Claim 25 words
A flexible container as defined in claim 34, wherein the transverse portion is formed with its entire length partially overlapping the compartment containing a medicament.
Claim 39
Dependent Claim 33 words
A flexible container as defined in claim 23, wherein the first and second peelable seals each comprise a generally rectangular longitudinal seal portion extending between the two sides of the common peripheral edge.
Claim 40
Dependent Claim 46 words
A flexible container as defined in claim 23, wherein the container is folded-over adjacent the first peelable seal such that the folded-over container's outwardly facing surface comprises the multi-layer laminate rear sheet, the flexible container further comprising means for securing the container in a folded-over condition.
Claim 41
Dependent Claim 83 words
A flexible container as defined in claim 37, wherein the means for securing the container in a folded-over condition comprises: a locking tab integrally formed with and extending from a side of the container; and a slot integrally formed with and extending from the same side of the container as the tab, wherein the tab and slot are moved into position for mutual engagement when the container is folded-over adjacent the first peelable seal to thereby secure the container in a folded-over condition.
Claim 42
Dependent Claim 150 words
A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising: a flexible rear sheet; a flexible front sheet sealed to the rear sheet along a common peripheral edge; a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent; a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment; and a third peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby a sacrificial moisture vapor barrier compartment which is intermediate the diluent compartment and the medicament compartment.
Claim 43
Dependent Claim 150 words
A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising: a flexible rear sheet; a flexible front sheet sealed to the rear sheet along a common peripheral edge; a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent; a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment; and a third peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby a sacrificial moisture vapor barrier compartment which is intermediate the diluent compartment and the medicament compartment.
Claim 44
Dependent Claim 32 words
A flexible container as defined in claim 39, wherein the container is folded-over adjacent the first peelable seal, the flexible container further comprising means for securing the container in a folded-over condition.
Claim 45
Dependent Claim 83 words
A flexible container as defined in claim 40, wherein the means for securing the container in a folded-over condition comprises: a locking tab integrally formed with and extending from a side of the container; and a slot integrally formed with and extending from the same side of the container as the tab, wherein the tab and slot are moved into position for mutual engagement when the container is folded-over adjacent the first peelable seal to thereby secure the container in a folded-over condition.
Claim 46
Dependent Claim 60 words
A flexible container as defined in claim 41 further comprising: a clear high-barrier laminate film sealed to the front sheet, the high-barrier laminate film sized to extend over the medicament compartment; and an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the medicament compartment.
Claim 47
Dependent Claim 59 words
A flexible container as defined in claim 42, wherein the opaque high-barrier protective covering is peelably affixed over the clear high-barrier laminate film, whereby said opaque high-barrier protective film contacts only a portion of the surface of the clear high-barrier laminate film, the strength of attachment of the opaque film being directly proportional to the area of surface contact.
Claim 48
Dependent Claim 42 words
A flexible container as described in claim 43, wherein the opaque high-barrier protective film is affixed over the clear high-barrier laminate film by a patterned heat seal head, the patterned heat seal head defining a regular array of generally circular non-contact areas.
Claim 49
Dependent Claim 56 words
A flexible container as defined in claim 39, wherein the peelable seals are constructed to provide a uniform resistance characteristic to hydraulic pressure against the seal caused by manipulation of the container, the uniform resistance characteristic causing the seal to peel at an applied pressure in the range of three to five pounds per square inch.
Claim 50
Dependent Claim 28 words
A flexible container as defined in claim 43, wherein the opaque high-barrier protective film is affixed over the clear high-barrier laminate film by a peelable, peripheral heat seal.
Claim 51
Dependent Claim 80 words
A flexible container as defined in claim 45, wherein the first and second peelable seals comprise: a first longitudinal portion extending between two parallel sides of the common peripheral edge; a second longitudinal portion extending between two parallel sides of the common peripheral edge; and a transverse portion adjacent one of the two parallel sides of the common peripheral edge, the transverse portion joining the first and second longitudinal portions at one end thereof, to form thereby a U shape.
Claim 52
Dependent Claim 25 words
A flexible container as defined in claim 45, wherein the transverse portion is formed with its entire length partially overlapping the compartment containing a medicament.
Claim 53
Dependent Claim 33 words
A flexible container as defined in claim 45, wherein the first and second peelable seals each comprise a generally rectangular longitudinal seal portion extending between the two sides of the common peripheral edge.
Claim 54
Dependent Claim 69 words
A flexible container as defined in claim 42, wherein the opaque, high-barrier protective film comprises: an opaque, peelable, multi-layer laminate including; a modified ethylenevinylacetate polymer layer comprising the inwardly facing surface of said laminate; a polyester polymer layer, having a higher melting temperature than said modified ethylenevinylacetate polymer layer comprising the outwardly facing surface of said laminate; and an aluminum foil layer intermediate the modified ethylenevinylacetate and polyester layers.
Claim 55
Dependent Claim 41 words
A flexible container as defined in claim 42, wherein the clear high-barrier laminate film comprises: a polypropylene inner layer adjacent the container front sheet; an outer layer comprising polyester; and a clear, transparent high-moisture barrier between the inner and outer layers.
Claim 56
Dependent Claim 32 words
A flexible container as defined in claim 51, wherein the clear, high-barrier laminate film further comprises a clear, transparent high oxygen barrier film layer intermediate the polypropylene layer and the polyester layer.
Claim 57
Dependent Claim 35 words
A flexible container as defined in claim 52, wherein the clear, transparent high moisture barrier film layer is a polymer selected from the group consisting of oriented high-density polyethylene, polychlorotrifluoroethylene, and silica deposited polyethylene terephthalate.
Claim 58
Dependent Claim 35 words
A flexible container as defined in claim 53, wherein the clear, transparent high oxygen barrier film layer is a polymer selected from the group consisting of ethylenevinylalcohol, polyvinylidenechloride coated polyethylene terephthalate, and silica deposited polyvinylalcohol.
Claim 59
Dependent Claim 244 words
A flexible container for combined storage and administration of medicaments and diluent for IV solutions, the container comprising: a flexible front sheet; a flexible rear sheet sealed to the front sheet along a common peripheral edge; a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent; a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing medicament which is intermediate the outlet compartment and an diluent compartment, wherein the peelable seals are rupturable by hydraulic pressure against the seal caused by manipulation of the container; an opaque high-barrier protective film separably sealed to the front sheet, the covering sized to extend over the medicament compartment, whereby the opaque high-barrier protective film contacts only a portion of the surface of the medicament compartment, the strength of attachment of the high-barrier protective film being directly proportional to the are of surface contact; a locking tab integrally formed and extending from an edge of the container; and a mating receptacle integrally formed with an extending from the same edge of the container as said locking tab, wherein the container is folded-over adjacent the first peelable seal thereby moving the locking tab into position for engagement with the mating receptacle for securing the container in a folded-over condition.
Claim 60
Dependent Claim 244 words
A flexible container for combined storage and administration of medicaments and diluent for IV solutions, the container comprising: a flexible front sheet; a flexible rear sheet sealed to the front sheet along a common peripheral edge; a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent; a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing medicament which is intermediate the outlet compartment and an diluent compartment, wherein the peelable seals are rupturable by hydraulic pressure against the seal caused by manipulation of the container; an opaque high-barrier protective film separably sealed to the front sheet, the covering sized to extend over the medicament compartment, whereby the opaque high-barrier protective film contacts only a portion of the surface of the medicament compartment, the strength of attachment of the high-barrier protective film being directly proportional to the are of surface contact; a locking tab integrally formed and extending from an edge of the container; and a mating receptacle integrally formed with an extending from the same edge of the container as said locking tab, wherein the container is folded-over adjacent the first peelable seal thereby moving the locking tab into position for engagement with the mating receptacle for securing the container in a folded-over condition.
Claim 61
Dependent Claim 42 words
A flexible container as defined in claim 55, wherein the opaque, high-barrier protective film is peelably affixed over the medicament compartment by a patterned heat seal head, the patterned heat seal head defining a regular array of raised, generally circular, non-contact areas.
Claim 62
Dependent Claim 28 words
A flexible container as defined in claim 55, wherein the front sheet comprises a polypropylene-polyethylene co-polymer blended with styrene ethylene-butylene styrene elastomer in about an 80%/20% wt/wt ratio.
Claim 63
Dependent Claim 62 words
A flexible container as defined in claim 57, wherein the rear sheet comprises a multi-layer laminate including: an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer in about an 80%/20% wt/wt ratio interfacing with the front sheet; an intermediate layer of aluminum foil; and an outer thermoplastic layer having a higher melting point than said inner layer.
Claim 64
Dependent Claim 69 words
A flexible container as defined in claim 58, wherein the opaque, high-barrier protective covering comprises: an opaque, peelable, multi-layer laminate including; a modified ethylenevinylacetate polymer layer comprising the inwardly facing surface of said laminate; a polyester polymer layer, having a higher melting temperature than said modified ethylenevinylacetate polymer layer comprising the outwardly facing surface of said laminate; and an aluminum foil layer intermediate the modified ethylenevinylacetate and polyester layers.
Claim 65
Dependent Claim 39 words
A flexible container as defined in claim 59, further comprising a clear high-barrier laminate film intermediate the opaque, high-barrier protective film, and sealed to the front sheet, the clear, high-barrier laminate film sized to extend over the medicament compartment.
Claim 66
Dependent Claim 41 words
A flexible container as defined in claim 60, wherein the clear high-barrier laminate film comprises: a polypropylene inner layer adjacent the container front sheet; an outer layer comprising polyester; and a clear, transparent high-moisture barrier between the inner and outer layers.
Claim 67
Dependent Claim 32 words
A flexible container as defined in claim 61, wherein the clear, high-barrier laminate film further comprises a clear, transparent high oxygen barrier film layer intermediate the polypropylene layer and the polyester layer.
Claim 68
Dependent Claim 35 words
A flexible container as defined in claim 62, wherein the clear, transparent high moisture barrier film layer is a polymer selected from the group consisting of oriented high-density polyethylene, polychlorotrifluoroethylene, and silica deposited polyethylene terephthalate.
Claim 69
Dependent Claim 35 words
A flexible container as defined in claim 63, wherein the clear, transparent high oxygen barrier film layer is a polymer selected from the group consisting of ethylenevinylalcohol, polyvinylidenechloride coated polyethylene terephthalate, and silica deposited polyvinylalcohol.
Claim 70
Dependent Claim 340 words
A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising: a flexible front sheet comprising a single layer film constructed of a polypropylene-polyethylene co-polymer blended with styrene ethylene-butylene styrene elastomer in an about 80%/20% wt/wt ratio; a flexible rear sheet sealed to the front sheet along a common peripheral edge, the rear sheet constructed of a multi-layer laminate including; an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer in about an 80%/20% wt/wt ratio interfacing with the front sheet; an intermediate layer of aluminum foil; and an outer thermo plastic layer having a higher melting point than said inner layer; a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent; a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment, wherein the peelable seals are rupturable by hydraulic pressure against the seal caused by manipulation of the container; a clear, transparent multi-layer high-barrier film laminate disposed adjacent the medicament compartment, the transparent high-barrier film laminate including; a polypropylene inner layer adjacent the front sheet in the region of the medicament compartment; an outer layer comprising polyester; a clear, transparent high moisture barrier film layer between the inner and outer layers; a clear, transparent high oxygen barrier film layer disposed intermediate the polypropylene layer and the polyester-containing thermoplastic layer; an opaque, peelable, multi-layer laminate separably sealed to the transparent high-barrier film laminate, wherein the opaque multi-layer laminate comprises; a modified ethylenevinylacetate polymer layer comprising the inwardly facing surface of said laminate; a polyester polymer layer having a higher melting temperature than said modified ethylenevinylacetate polymer layer, comprising the outwardly facing surface of said laminate; and an aluminum foil layer intermediate the modified ethylenevinylacetate and polymer layers.
Claim 71
Dependent Claim 340 words
A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising: a flexible front sheet comprising a single layer film constructed of a polypropylene-polyethylene co-polymer blended with styrene ethylene-butylene styrene elastomer in an about 80%/20% wt/wt ratio; a flexible rear sheet sealed to the front sheet along a common peripheral edge, the rear sheet constructed of a multi-layer laminate including; an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer in about an 80%/20% wt/wt ratio interfacing with the front sheet; an intermediate layer of aluminum foil; and an outer thermo plastic layer having a higher melting point than said inner layer; a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent; a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment, wherein the peelable seals are rupturable by hydraulic pressure against the seal caused by manipulation of the container; a clear, transparent multi-layer high-barrier film laminate disposed adjacent the medicament compartment, the transparent high-barrier film laminate including; a polypropylene inner layer adjacent the front sheet in the region of the medicament compartment; an outer layer comprising polyester; a clear, transparent high moisture barrier film layer between the inner and outer layers; a clear, transparent high oxygen barrier film layer disposed intermediate the polypropylene layer and the polyester-containing thermoplastic layer; an opaque, peelable, multi-layer laminate separably sealed to the transparent high-barrier film laminate, wherein the opaque multi-layer laminate comprises; a modified ethylenevinylacetate polymer layer comprising the inwardly facing surface of said laminate; a polyester polymer layer having a higher melting temperature than said modified ethylenevinylacetate polymer layer, comprising the outwardly facing surface of said laminate; and an aluminum foil layer intermediate the modified ethylenevinylacetate and polymer layers.
Claim 72
Dependent Claim 84 words
A flexible container for combined storage and administration of IV solutions, the container comprising: a flexible front sheet; a flexible, rear sheet, the front and rear sheets sealed together at a common peripheral edge so as to define a volume enclosure; and at least one removable sacrificial port interposed a between the front and rear sheets along a common peripheral edge and in communication with the volume enclosure to thereby form a filling path adapted to allow the volume enclosure to be filled aseptically.
Claim 73
Dependent Claim 84 words
A flexible container for combined storage and administration of IV solutions, the container comprising: a flexible front sheet; a flexible, rear sheet, the front and rear sheets sealed together at a common peripheral edge so as to define a volume enclosure; and at least one removable sacrificial port interposed a between the front and rear sheets along a common peripheral edge and in communication with the volume enclosure to thereby form a filling path adapted to allow the volume enclosure to be filled aseptically.
Claim 74
Dependent Claim 79 words
The flexible container according to claim 66, further comprising: a first peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form a first compartment; and a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby a second compartment and a third compartment which is intermediate the second compartment and the first compartment.
Claim 75
Dependent Claim 58 words
The flexible container according to claim 67, the at least one sacrificial port in communication with the first compartment, wherein the flexible container further comprises a second sacrificial port interposed between the front and rear sheets and in communication with the third compartment to thereby form a filling path for allowing the third compartment to be filled aseptically.
Claim 76
Dependent Claim 41 words
The flexible container according to claim 68, wherein the first compartment is adapted to contain a liquid diluent, the third compartment is adapted to contain a powdered medicament, and the second compartment is adapted to form an initially empty outlet compartment.
Claim 77
Dependent Claim 58 words
The flexible container according to claim 67, wherein the peelable seals are constructed to provide a uniform resistance characteristic to hydraulic pressure against the seal caused by manipulation of the container, the uniform resistance characteristic causing the seal to peel at an applied pressure in the range of from about 3 to about 5 pounds per square inch.
Claim 78
Dependent Claim 76 words
The flexible container according to claim 67, wherein the peelable seals comprise: a first longitudinal portion extending between two parallel sides of the common peripheral edge; a second longitudinal portion extending between two parallel sides of the common peripheral edge; and a transverse portion adjacent one of the two parallel sides of the common peripheral edge, the transverse portion joining the first and second longitudinal portions at one end thereof, to form thereby a U shape.
Claim 79
Dependent Claim 173 words
A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising: a flexible rear sheet; a flexible front sheet sealed to the rear sheet along a common peripheral edge; a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent; a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment; an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film including; a modified ethylenevinylacetate polymer layer comprising the inwardly facing surface of said laminate; a polyester polymer layer, having a higher melting temperature than said modified ethylenevinylacetate polymer layer, comprising the outwardly facing surface of said laminate; and an aluminum foil layer intermediate the modified ethylenevinylacetate and polyester layers.
Claim 80
Dependent Claim 173 words
A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising: a flexible rear sheet; a flexible front sheet sealed to the rear sheet along a common peripheral edge; a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent; a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment; an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film including; a modified ethylenevinylacetate polymer layer comprising the inwardly facing surface of said laminate; a polyester polymer layer, having a higher melting temperature than said modified ethylenevinylacetate polymer layer, comprising the outwardly facing surface of said laminate; and an aluminum foil layer intermediate the modified ethylenevinylacetate and polyester layers.
Claim 81
Dependent Claim 187 words
A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising: a flexible rear sheet; a flexible front sheet sealed to the rear sheet along a common peripheral edge; a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent; a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment; a clear high-barrier laminate film sealed to the front sheet, the high-barrier laminate film sized to extend over the medicament compartment, the film comprising a polypropylene inner layer adjacent a container front sheet, an outer layer comprising polyester, and a clear, transparent high-moisture barrier between the inner and outer layers; and an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the medicament compartment.
Claim 82
Dependent Claim 187 words
A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising: a flexible rear sheet; a flexible front sheet sealed to the rear sheet along a common peripheral edge; a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent; a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment; a clear high-barrier laminate film sealed to the front sheet, the high-barrier laminate film sized to extend over the medicament compartment, the film comprising a polypropylene inner layer adjacent a container front sheet, an outer layer comprising polyester, and a clear, transparent high-moisture barrier between the inner and outer layers; and an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the medicament compartment.
Claim 83
Dependent Claim 32 words
A flexible container as defined in claim 73, wherein the clear, high-barrier laminate film further comprises a clear, transparent high oxygen barrier film layer intermediate the polypropylene layer and the polyester layer.
Claim 84
Dependent Claim 35 words
A flexible container as defined in claim 74, wherein the clear, transparent high moisture barrier film layer is a polymer selected from the group consisting of oriented high-density polyethylene, polychlorotrifluoroethylene, and silica deposited polyethylene terephthalate.
Claim 85
Dependent Claim 35 words
A flexible container as defined in claim 75, wherein the clear, transparent high oxygen barrier film layer is a polymer selected from the group consisting of ethylenevinylalcohol, polyvinylidenechloride coated polyethylene terephthalate, and silica deposited polyvinylalcohol.
Claim 86
Dependent Claim 221 words
A flexible container for separately storing and mixing liquid diluent and medicament, the container comprising: a multi-layer laminate rear sheet including an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene butadiene elastomer, an opaque high-barrier intermediate layer, and an outer high temperature resistant mold release layer; a flexible front sheet constructed of a single layer film of a polypropylene-polyethylene co-polymer blended with styrene butadiene elastomer interfacing with the rear sheet, the front sheet sealed to the rear sheet along a common peripheral edge; at least two peelable seals extending between two parallel sides of the common peripheral edge and separably joining the front and rear sheets to define at least three compartments in the container including a first compartment containing a powdered medicament; a clear high-barrier laminate film sealed to the front sheet, the high-barrier laminate film sized to extend over the medicament compartment; and an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the medicament compartment, the opaque film comprising; a modified ethylenevinylacetate polymer layer comprising an inwardly facing surface; a polyester polymer layer, having a higher melting temperature than said modified ethylenevinylacetate polymer layer, comprising the outwardly facing surface; and an aluminum foil layer intermediate the modified ethylenevinylacetate and polyester layers.
Claim 87
Dependent Claim 221 words
A flexible container for separately storing and mixing liquid diluent and medicament, the container comprising: a multi-layer laminate rear sheet including an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene butadiene elastomer, an opaque high-barrier intermediate layer, and an outer high temperature resistant mold release layer; a flexible front sheet constructed of a single layer film of a polypropylene-polyethylene co-polymer blended with styrene butadiene elastomer interfacing with the rear sheet, the front sheet sealed to the rear sheet along a common peripheral edge; at least two peelable seals extending between two parallel sides of the common peripheral edge and separably joining the front and rear sheets to define at least three compartments in the container including a first compartment containing a powdered medicament; a clear high-barrier laminate film sealed to the front sheet, the high-barrier laminate film sized to extend over the medicament compartment; and an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the medicament compartment, the opaque film comprising; a modified ethylenevinylacetate polymer layer comprising an inwardly facing surface; a polyester polymer layer, having a higher melting temperature than said modified ethylenevinylacetate polymer layer, comprising the outwardly facing surface; and an aluminum foil layer intermediate the modified ethylenevinylacetate and polyester layers.
Claim 88
Dependent Claim 32 words
A flexible container as defined in claim 77, wherein the clear, high-barrier laminate film further comprises a clear, transparent high oxygen barrier film layer intermediate the polypropylene layer and the polyester layer.
Claim 89
Dependent Claim 35 words
A flexible container as defined in claim 78, wherein the clear, transparent high moisture barrier film layer is a polymer selected from the group consisting of oriented high-density polyethylene, polychlorotrifluoroethylene, and silica deposited polyethylene terephthalate.
Claim 90
Dependent Claim 35 words
A flexible container as defined in claim 79, wherein the clear, transparent high oxygen barrier film layer is a polymer selected from the group consisting of ethylenevinylalcohol, polyvinylidenechloride coated polyethylene terephthalate, and silica deposited polyvinylalcohol.

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USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2002-08-30 2003-03-01 2003-08-31 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2006-08-30 2007-03-01 2007-08-31 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2010-08-30 2011-03-01 2011-08-31 $7700.00 Window Closed / Lapsed

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