US5084040A
Expired / Lapsed
US
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Lyophilization device
Assignee: West Pharmaceutical Services Inc
•
Filing: 1990-01-25
•
Granted: 1992-01-28
•
Expires: 2010-01-25
Abstract
Abstract A lyophilization container device comprising a top end having at least one lyophilization port axially extending upward and defining a generally polygonally oval shape. The device includes a bottom end having generally the same shape as the top and having preferably a substantially flat bottom. Also included is a wall portion sealed to the top and bottom end to define the container, with the wall portion having an inside surface which is drug compatible and has sufficient buckle strength to withstand vertical force during stopper seating.
Inventors
- 👤 Steven T. Sutter
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-01 22:54
CPC Classifications
A; A61; A61J; A61J1/00; A61J1/05; B; B65; B65D; B65D51/00; B65D51/24; B65D51/241; A61M; A61M2207/00; Y; Y10; Y10T; Y10T428/00; Y10T428/13; Y10T428/1352
Claims Analysis
Total Claims: 62
Claim 1
Independent Claim
82 words
A lyophilization device, for a stopper comprising: a top end having at least one lyophilization port axially extending upward, said top end defining a non-round shape; a bottom end having generally the same shape as said top; and a non-glass wall portion between said top and bottom ends defining a container, said wall portion having an inside surface which is drug compatible and having a predetermined buckle strength to withstand vertical force during insertion of a stopper, said non-round shape being oval.
Claim 2
Dependent Claim
82 words
A lyophilization device, for a stopper comprising: a top end having at least one lyophilization port axially extending upward, said top end defining a non-round shape; a bottom end having generally the same shape as said top; and a non-glass wall portion between said top and bottom ends defining a container, said wall portion having an inside surface which is drug compatible and having a predetermined buckle strength to withstand vertical force during insertion of a stopper, said non-round shape being oval.
Claim 3
Dependent Claim
14 words
The device of claim 1 where said bottom end includes a substantially flat bottom.
Claim 4
Dependent Claim
33 words
The device of claim 1 wherein said wall portion is formed from a multilaminar film in which the inner layer is drug compatible and the outer layer contributes substantially to the buckle strength.
Claim 5
Dependent Claim
15 words
The device of claim 3 wherein said inner layer and ends are formed form polyolefin.
Claim 6
Dependent Claim
16 words
The device of claim 1 wherein said bottom end includes means for attaching an IV hook.
Claim 7
Dependent Claim
11 words
The device of claim 1 which further includes a lyophilization stopper.
Claim 8
Dependent Claim
32 words
The device of claim 6 wherein said stopper and said port include cooperative means for positioning said stopper in a first position for lyophilization and a second position for seating said stopper.
Claim 9
Dependent Claim
82 words
A lyophilization device, for a stopper comprising: a top end having at least one lyophilization port axially extending upward, said top end defining a non-round shape; a bottom end having generally the same shape as said top end; and a wall portion between said top and bottom ends defining a container, said wall portion formed from a multilaminar film wherein the inner layer is drug compatible and the outer layer contributes substantially to the buckle strength and is formed from polyethylene teraphthalate.
Claim 10
Dependent Claim
82 words
A lyophilization device, for a stopper comprising: a top end having at least one lyophilization port axially extending upward, said top end defining a non-round shape; a bottom end having generally the same shape as said top end; and a wall portion between said top and bottom ends defining a container, said wall portion formed from a multilaminar film wherein the inner layer is drug compatible and the outer layer contributes substantially to the buckle strength and is formed from polyethylene teraphthalate.
Claim 11
Dependent Claim
92 words
A lyophilization device, for a stopper comprising: a top end having at least one lyophilization port axially extending upward, said top end defining a non-round shape; a bottom end having generally the same shape as said top end; and a wall portion between said top and bottom ends defining a container, said wall portion being formed from a multi-laminar film wherein the inner layer is drug compatible, the outer layer contributes substantially to the buckle strength, and the middle layer having an increased punctured resistance made of a linear low density polyethylene.
Claim 12
Dependent Claim
92 words
A lyophilization device, for a stopper comprising: a top end having at least one lyophilization port axially extending upward, said top end defining a non-round shape; a bottom end having generally the same shape as said top end; and a wall portion between said top and bottom ends defining a container, said wall portion being formed from a multi-laminar film wherein the inner layer is drug compatible, the outer layer contributes substantially to the buckle strength, and the middle layer having an increased punctured resistance made of a linear low density polyethylene.
Claim 13
Dependent Claim
122 words
A lyophilization device, for a stopper comprising: a top end having at least one lyophilization port axially extending upward, said top end defining a non-round shape; a bottom end having generally the same shape as said top end; a non-glass wall portion between said top and bottom ends defining a container, said wall portion having an inside surface which is drug compatible and having a predetermined buckle strength to withstand vertical force during stopper insertion; and a lyophilization stopper; said port and stopper including cooperative means for positioning said stopper in a first position for lyophilization and a second position for sealing said port comprising a partial or continuous annular ring and groove assembly aligned to define the first and second positions.
Claim 14
Dependent Claim
122 words
A lyophilization device, for a stopper comprising: a top end having at least one lyophilization port axially extending upward, said top end defining a non-round shape; a bottom end having generally the same shape as said top end; a non-glass wall portion between said top and bottom ends defining a container, said wall portion having an inside surface which is drug compatible and having a predetermined buckle strength to withstand vertical force during stopper insertion; and a lyophilization stopper; said port and stopper including cooperative means for positioning said stopper in a first position for lyophilization and a second position for sealing said port comprising a partial or continuous annular ring and groove assembly aligned to define the first and second positions.
Claim 15
Dependent Claim
123 words
A lyophilization device, for a stopper comprising: a top end having at least one lyophilization port axially extending upward, said top end having a predetermined cross sectional shape; a bottom end having generally the same cross sectional shape as said top end, and having a substantially flat bottom; and a flexible, pliable wall portion between said top and bottom ends to define a container, said wall portion having an inside surface which is drug compatible and a predetermined buckle strength to withstand vertical force during stopper seating; said wall portion being multilaminar, wherein at least the inner layer is drug compatible and the outer layer contributes substantially to the buckle strength; and said shape being polygonal including three sets of generally parallel sides.
Claim 16
Dependent Claim
123 words
A lyophilization device, for a stopper comprising: a top end having at least one lyophilization port axially extending upward, said top end having a predetermined cross sectional shape; a bottom end having generally the same cross sectional shape as said top end, and having a substantially flat bottom; and a flexible, pliable wall portion between said top and bottom ends to define a container, said wall portion having an inside surface which is drug compatible and a predetermined buckle strength to withstand vertical force during stopper seating; said wall portion being multilaminar, wherein at least the inner layer is drug compatible and the outer layer contributes substantially to the buckle strength; and said shape being polygonal including three sets of generally parallel sides.
Claim 17
Dependent Claim
136 words
A lyophilization device, for a stopper comprising: a top end having at least one lyophilization port axially extending upward, said top end having a predetermined cross sectional shape; a bottom end having generally the same cross sectional shape as said top end, and having a substantially flat bottom; and a flexible, pliable wall portion between said top and bottom ends to define a container, said wall portion having an inside surface which is drug compatible and a predetermined buckle strength to withstand vertical force during stopper seating of a stopper; said wall portion being multilaminar, wherein at least the inner layer is drug compatible and the outer layer contributes substantially to the buckle strength; and at least said inner layer and said ends being formed from polyolefin and said outer layer being formed from polyethylene teraphthalate.
Claim 18
Dependent Claim
136 words
A lyophilization device, for a stopper comprising: a top end having at least one lyophilization port axially extending upward, said top end having a predetermined cross sectional shape; a bottom end having generally the same cross sectional shape as said top end, and having a substantially flat bottom; and a flexible, pliable wall portion between said top and bottom ends to define a container, said wall portion having an inside surface which is drug compatible and a predetermined buckle strength to withstand vertical force during stopper seating of a stopper; said wall portion being multilaminar, wherein at least the inner layer is drug compatible and the outer layer contributes substantially to the buckle strength; and at least said inner layer and said ends being formed from polyolefin and said outer layer being formed from polyethylene teraphthalate.
Claim 19
Dependent Claim
16 words
The device of claim 12 wherein said bottom end includes means for attaching an IV hook.
Claim 20
Dependent Claim
11 words
The device of claim 12 which further includes a lyophilization stopper.
Claim 21
Dependent Claim
32 words
The device of claim 14 wherein said stopper and said port include cooperating means for positioning said stopper in a first position for lyophilization and a second position for sealing said port.
Claim 22
Dependent Claim
23 words
The device of claim 12 wherein said top and bottom ends and said wall portion are molded together in a one step process.
Claim 23
Dependent Claim
159 words
A lyophilization device, for a stopper comprising: a top end having at least one lyophilization port axially extending upward, said top end having a predetermined cross sectional shape; a bottom end having generally the same cross sectional shape as said top end, and having a substantially flat bottom; and a flexible, pliable wall portion between said top and bottom ends to define a container, said wall portion having an inside surface which is drug compatible and a predetermined buckle strength to withstand vertical force during stopper seating of a stopper; said wall portion being multilaminar, wherein at least the inner layer is drug compatible and the outer layer contributes substantially to the buckle strength; and a lyophilization stopper; and said port including cooperating means for positioning said stopper and a first position for lyophilization and a second position for sealing said port comprising a partial or continuous annular ring and groove assembly aligned to define first and second positions.
Claim 24
Dependent Claim
159 words
A lyophilization device, for a stopper comprising: a top end having at least one lyophilization port axially extending upward, said top end having a predetermined cross sectional shape; a bottom end having generally the same cross sectional shape as said top end, and having a substantially flat bottom; and a flexible, pliable wall portion between said top and bottom ends to define a container, said wall portion having an inside surface which is drug compatible and a predetermined buckle strength to withstand vertical force during stopper seating of a stopper; said wall portion being multilaminar, wherein at least the inner layer is drug compatible and the outer layer contributes substantially to the buckle strength; and a lyophilization stopper; and said port including cooperating means for positioning said stopper and a first position for lyophilization and a second position for sealing said port comprising a partial or continuous annular ring and groove assembly aligned to define first and second positions.
Claim 25
Dependent Claim
102 words
A lyophilization container comprising: a top member having a lyophilization port for mounting a sealing closure; a bottom member; an elongated body member between the top and bottom members, at least said body member being made of a flexible, pliable material and said members being of a predetermined configuration whereby the container has a predetermined buckle strength to withstand a vertical sealing force seating a stopper in said port and sufficient flexibility to allow gravity drainage of contents; and said body portion being formed from a multilaminar film wherein the inner layer is a polyethyelene and the outer layer is polyethylene teraphthalate.
Claim 26
Dependent Claim
102 words
A lyophilization container comprising: a top member having a lyophilization port for mounting a sealing closure; a bottom member; an elongated body member between the top and bottom members, at least said body member being made of a flexible, pliable material and said members being of a predetermined configuration whereby the container has a predetermined buckle strength to withstand a vertical sealing force seating a stopper in said port and sufficient flexibility to allow gravity drainage of contents; and said body portion being formed from a multilaminar film wherein the inner layer is a polyethyelene and the outer layer is polyethylene teraphthalate.
Claim 27
Dependent Claim
32 words
The device of claim 18 wherein said body member defines large planar side walls adapted to confront and engage adjacent sidewalls when a plurality of said devices are placed proximate one another.
Claim 28
Dependent Claim
11 words
The device of claim 18 which further includes a lyophilization stopper.
Claim 29
Dependent Claim
32 words
The device of claim 20 wherein said stopper and said port include cooperating means for positioning said stopper in a first position for lyophilization and a second position for sealing said port.
Claim 30
Dependent Claim
125 words
A lyophilization container comprising: a top member having a lyophilization port for mounting a sealing closure; a bottom member; an elongated body member between the top and bottom members, at least said body member being made of a flexible, pliable material and said members being of a predetermined configuration whereby the container has a predetermined buckle strength to withstand a vertical sealing force seating a stopper in said port and sufficient flexibility to allow gravity drainage of contents; and a lyophilization stopper, said port and stopper including cooperating means for positioning said stopper in a first position for lyophilization and a second position for sealing said port including a partial or continuous annular ring and groove assembly aligned to define said first and second positions.
Claim 31
Dependent Claim
125 words
A lyophilization container comprising: a top member having a lyophilization port for mounting a sealing closure; a bottom member; an elongated body member between the top and bottom members, at least said body member being made of a flexible, pliable material and said members being of a predetermined configuration whereby the container has a predetermined buckle strength to withstand a vertical sealing force seating a stopper in said port and sufficient flexibility to allow gravity drainage of contents; and a lyophilization stopper, said port and stopper including cooperating means for positioning said stopper in a first position for lyophilization and a second position for sealing said port including a partial or continuous annular ring and groove assembly aligned to define said first and second positions.
Claim 32
Dependent Claim
84 words
A lyophilization device, for a stopper comprising: a top end defining a non-round shape and having at least one lyophilization port for a stopper; a bottom end having generally the same shape as said top end; and a non-glass wall portion between said top and bottom ends defining a container, said wall portion having an inside surface which is drug compatible and having a predetermined buckle strength to withstand vertical force during stopper insertion, the cross sectional shape of said device being generally arcuate.
Claim 33
Dependent Claim
84 words
A lyophilization device, for a stopper comprising: a top end defining a non-round shape and having at least one lyophilization port for a stopper; a bottom end having generally the same shape as said top end; and a non-glass wall portion between said top and bottom ends defining a container, said wall portion having an inside surface which is drug compatible and having a predetermined buckle strength to withstand vertical force during stopper insertion, the cross sectional shape of said device being generally arcuate.
Claim 34
Dependent Claim
85 words
A lyophilization device for a stopper, comprising: a top end having at least one lyophilization port defining a non-round cross section; a bottom end having generally the same cross section as said top; and a non-glass wall portion between said top and bottom ends defining a container, said wall portion having an inside surface which is drug compatible and having a predetermined buckle strength to withstand vertical force during insertion of a stopper, said non-round shape being polygonal including three sets of generally parallel sides.
Claim 35
Dependent Claim
85 words
A lyophilization device for a stopper, comprising: a top end having at least one lyophilization port defining a non-round cross section; a bottom end having generally the same cross section as said top; and a non-glass wall portion between said top and bottom ends defining a container, said wall portion having an inside surface which is drug compatible and having a predetermined buckle strength to withstand vertical force during insertion of a stopper, said non-round shape being polygonal including three sets of generally parallel sides.
Claim 36
Dependent Claim
88 words
A lyophilization device, comprising: a top end having at least one lyophilization port axially extending upwardly, said top end defining a non-round shape; a bottom end having generally the same shape as said top end; and a non-glass wall portion between said top and bottom ends defining a container, said wall potion having an inside surface which is drug compatible and having a predetermined buckle strength to withstand vertical force during insertion of a stopper, said non-round shape being oval and including three sets of generally parallel sides.
Claim 37
Dependent Claim
88 words
A lyophilization device, comprising: a top end having at least one lyophilization port axially extending upwardly, said top end defining a non-round shape; a bottom end having generally the same shape as said top end; and a non-glass wall portion between said top and bottom ends defining a container, said wall potion having an inside surface which is drug compatible and having a predetermined buckle strength to withstand vertical force during insertion of a stopper, said non-round shape being oval and including three sets of generally parallel sides.
Claim 38
Dependent Claim
107 words
A lyophilization device, comprising: a top end having at least one lypohilization port axially extending upwardly, said top end defining a non-round shape; a bottom end having generally the same shape as said top end; and a non-glass wall portion between said top and bottom ends defining a container, said wall portion having an inside surface which is drug compatible and having a predetermined buckle strength to withstand vertical force during insertion of a stopper, said non-round shape being oval, said wall portion defining large planar side walls adapted to confront and engage adjacent side walls when a plurality of said devices are placed proximate one another.
Claim 39
Dependent Claim
107 words
A lyophilization device, comprising: a top end having at least one lypohilization port axially extending upwardly, said top end defining a non-round shape; a bottom end having generally the same shape as said top end; and a non-glass wall portion between said top and bottom ends defining a container, said wall portion having an inside surface which is drug compatible and having a predetermined buckle strength to withstand vertical force during insertion of a stopper, said non-round shape being oval, said wall portion defining large planar side walls adapted to confront and engage adjacent side walls when a plurality of said devices are placed proximate one another.
Claim 40
Dependent Claim
116 words
A lyophilization device, comprising: a top end having at least one lyophilization port axially extending upwardly, said top end defining a non-round shape and formed of polyethylene; a bottom end having generally the same shape as said to end and formed of polyethylene; and a non-glass wall potion between said top and bottom ends defining a container, said wall portion having an inside surface which is drug compatible and having a predetermined buckle strength to withstand vertical force during insertion of a stopper, said non-round shape being oval, said wall portion being formed from a multilaminar film including a drug compatible inner layer formed of polyethylene and an outer layer contributing substantially to the buckle strength.
Claim 41
Dependent Claim
116 words
A lyophilization device, comprising: a top end having at least one lyophilization port axially extending upwardly, said top end defining a non-round shape and formed of polyethylene; a bottom end having generally the same shape as said to end and formed of polyethylene; and a non-glass wall potion between said top and bottom ends defining a container, said wall portion having an inside surface which is drug compatible and having a predetermined buckle strength to withstand vertical force during insertion of a stopper, said non-round shape being oval, said wall portion being formed from a multilaminar film including a drug compatible inner layer formed of polyethylene and an outer layer contributing substantially to the buckle strength.
Claim 42
Dependent Claim
107 words
A lyophilization device, comprising: a top end having at least one lyophilization port axially extending upwardly, said top end defining a non-round shape; a bottom end having generally the same shape as said top end; and a non-glass wall portion between said top and bottom ends defining a container, said wall portion having an inside surface which is drug compatible and having a predetermined buckle strength to withstand vertical force during insertion of a stopper, said non-round shape being oval, said wall portion defining large planar side walls adapted to confront and engage adjacent side walls when a plurality of said devices are place proximate one antoher.
Claim 43
Dependent Claim
107 words
A lyophilization device, comprising: a top end having at least one lyophilization port axially extending upwardly, said top end defining a non-round shape; a bottom end having generally the same shape as said top end; and a non-glass wall portion between said top and bottom ends defining a container, said wall portion having an inside surface which is drug compatible and having a predetermined buckle strength to withstand vertical force during insertion of a stopper, said non-round shape being oval, said wall portion defining large planar side walls adapted to confront and engage adjacent side walls when a plurality of said devices are place proximate one antoher.
Claim 44
Dependent Claim
64 words
A lyophilization device, comprising: a top end having at least one lyophilization port; a bottom end; and a non-glass wall portion between said top and bottom ends defining a container of a generally oval shape, said wall portion having an inside surface, which is drug compatible, and said wall portion having a predetermined buckle strength to withstand vertical force during insertion of a stopper.
Claim 45
Dependent Claim
64 words
A lyophilization device, comprising: a top end having at least one lyophilization port; a bottom end; and a non-glass wall portion between said top and bottom ends defining a container of a generally oval shape, said wall portion having an inside surface, which is drug compatible, and said wall portion having a predetermined buckle strength to withstand vertical force during insertion of a stopper.
Claim 46
Dependent Claim
15 words
The device of claim 29 wherein said shape includes three sets of generally parallel sides.
Claim 47
Dependent Claim
14 words
The device of claim 29 where said bottom end includes a substantially flat bottom.
Claim 48
Dependent Claim
33 words
The device of claim 29 wherein said wall portion defines large planar side walls adapted to confront and engage adjacent side walls when a plurality of said devices are placed proximate one another.
Claim 49
Dependent Claim
33 words
The device of claim 29 wherein said wall portion is formed from a multilaminar film in which the inner layer is drug compatible and the outer layer contributes substantially to the buckle strength.
Claim 50
Dependent Claim
14 words
The device of claim 33 including a middle layer having an increased puncture resistance.
Claim 51
Dependent Claim
14 words
The device of claim 34 wherein said middle layer is linear low density polyethylene.
Claim 52
Dependent Claim
15 words
The device of claim 33 wherein said inner layer and ends are formed from polyolefin.
Claim 53
Dependent Claim
15 words
The device of claim 36 wherein said inner layer and ends are formed from polyethylene.
Claim 54
Dependent Claim
13 words
The device of claim 33 wherein said outer layer is formed from polyethylene.
Claim 55
Dependent Claim
16 words
The device of claim 29 wherein said bottom end includes means for attaching an IV hook.
Claim 56
Dependent Claim
11 words
The device of claim 29 which further includes a lyophilization stopper.
Claim 57
Dependent Claim
32 words
The device of claim 40 wherein said stopper and said port include cooperative means for positioning said stopper in a first position for lyophilization and a second position for seating said port.
Claim 58
Dependent Claim
27 words
The device of claim 41 wherein said cooperating means includes a partial or continuous annular ring and groove assembly aligned to define said first and second positions.
Claim 59
Dependent Claim
88 words
A lyophilization device, comprising: a top end having at least one lyophilization port axially extending upwardly, said top end defining a non-round shape; a bottom end having generally the same shape as said top end; and a wall portion between said top and bottom ends defining a container, said wall portion being formed from a multilaminar film including a drug compatible inner layer, an outer layer contributing substantially to the buckle strength, and a middle layer having an increased punctured resistance made of a linear low density polyethylene.
Claim 60
Dependent Claim
88 words
A lyophilization device, comprising: a top end having at least one lyophilization port axially extending upwardly, said top end defining a non-round shape; a bottom end having generally the same shape as said top end; and a wall portion between said top and bottom ends defining a container, said wall portion being formed from a multilaminar film including a drug compatible inner layer, an outer layer contributing substantially to the buckle strength, and a middle layer having an increased punctured resistance made of a linear low density polyethylene.
Claim 61
Dependent Claim
96 words
A lyophilization device for use with a closure, comprising: a top end having at least one lyophilization port for a stopper; a bottom end; and a non-glass wall portion between said top and bottom ends defining a container, said wall portion having an inner layer of a drug compatible material bonded directly to an outer layer having a predetermined buckle strength to withstand vertical force during closure application, the cross sectional shape of said device being generally non-round wherein there are no substantial interstitial spaces when a plurality of devices are positioned in close nest array.
Claim 62
Dependent Claim
96 words
A lyophilization device for use with a closure, comprising: a top end having at least one lyophilization port for a stopper; a bottom end; and a non-glass wall portion between said top and bottom ends defining a container, said wall portion having an inner layer of a drug compatible material bonded directly to an outer layer having a predetermined buckle strength to withstand vertical force during closure application, the cross sectional shape of said device being generally non-round wherein there are no substantial interstitial spaces when a plurality of devices are positioned in close nest array.
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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) | 1995-01-27 | 1995-07-29 | 1996-01-28 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1999-01-27 | 1999-07-29 | 2000-01-28 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2003-01-27 | 2003-07-29 | 2004-01-28 | $7700.00 | Window Closed / Lapsed |