EP0897708B1 - Behälter mit einem Luer-Filter zur Verabreichung eines Arzneistoffes - Google Patents
Behälter mit einem Luer-Filter zur Verabreichung eines Arzneistoffes Download PDFInfo
- Publication number
- EP0897708B1 EP0897708B1 EP19980306407 EP98306407A EP0897708B1 EP 0897708 B1 EP0897708 B1 EP 0897708B1 EP 19980306407 EP19980306407 EP 19980306407 EP 98306407 A EP98306407 A EP 98306407A EP 0897708 B1 EP0897708 B1 EP 0897708B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- vial
- luer
- luer tube
- neck
- stopper
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
- 238000012377 drug delivery Methods 0.000 title description 10
- 239000003814 drug Substances 0.000 claims description 52
- 229940079593 drug Drugs 0.000 claims description 52
- 239000012530 fluid Substances 0.000 claims description 10
- 230000001681 protective effect Effects 0.000 claims description 6
- 230000004044 response Effects 0.000 claims description 6
- 238000007789 sealing Methods 0.000 claims description 5
- 239000002904 solvent Substances 0.000 description 26
- 238000003780 insertion Methods 0.000 description 6
- 230000037431 insertion Effects 0.000 description 6
- 239000007788 liquid Substances 0.000 description 6
- 239000000463 material Substances 0.000 description 5
- 239000013536 elastomeric material Substances 0.000 description 4
- 239000012528 membrane Substances 0.000 description 3
- 230000000712 assembly Effects 0.000 description 2
- 238000000429 assembly Methods 0.000 description 2
- 239000012634 fragment Substances 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 230000036541 health Effects 0.000 description 2
- 230000036512 infertility Effects 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 238000000926 separation method Methods 0.000 description 2
- 0 CC(C1C(**)C1)C(F)(F)F Chemical compound CC(C1C(**)C1)C(F)(F)F 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 238000013019 agitation Methods 0.000 description 1
- 239000005391 art glass Substances 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 239000000356 contaminant Substances 0.000 description 1
- 239000006193 liquid solution Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000011236 particulate material Substances 0.000 description 1
- 239000013618 particulate matter Substances 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000005394 sealing glass Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/202—Separating means
- A61J1/2031—Separating means having openings brought into alignment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2048—Connecting means
- A61J1/2055—Connecting means having gripping means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2079—Filtering means
- A61J1/2086—Filtering means for fluid filtration
Definitions
- the invention relates to a resealable vial connector assembly that contributes to sterility, which prevents particulate flow to or from the vial, and which controls unintended splash back from the vial.
- Liquid drugs typically have a shelf life. As a result, liquid drugs typically are stamped with an expiration date, and health care facilities must monitor their inventory to ensure that the drugs are used in a timely manner.
- lyophilized drugs are lyophilized or reduced to a dry powdered form, to increase shelf life and to minimize inventory control problems.
- the lyophilized drug typically is stored in a sealed glass vial.
- a measured amount of a liquid solvent may be mixed with the lyophilized during shortly prior to use to produce a drug solution.
- a selected dose of the drug solution may then be withdrawn from the vial and administered to the patient.
- the prior art has included many structures for sealing glass vials of lyophilized drugs. These prior art structures have attempted to deal with the often conflicting objectives of long term storage and easy access.
- some prior art vials of lyophilized drugs are sealed with a pierceable membrane.
- the sealed vial may be used with an adapter having a double ended needle or double ended spike.
- One end of the needle or spike is urged through the membrane on the vial, and the opposed end is placed in communication with a supply of solvent or with an appropriate drug delivery apparatus.
- This prior art method and apparatus is undesirable in that small fragments of the membrane can separate when the seal is pierced and can be delivered into the patient.
- Some prior art vials have a luer connector rather than a spike or needle.
- the luer connector can be threadedly engaged with a supply of solvent or with an appropriate drug delivery apparatus. However, depending on the pressurization inside the vial, the luer connector may allow some splash back, which is preferably avoided.
- WO91/07160 provides a storage bottle which contains a constituent of a medicinal solution and a transfer device for transferring the solution, once it has been mixed with a solvent, into a final-use container.
- the bottle comprises a constricted neck in which is located, during the storage phase, a sealing device consisting of two elements: a first element consisting of an elastomeric stopper, and a second element consisting of an elastomeric O-ring seal. At least one inlet opens into the space between the first and second elements of the sealing device.
- the invention is directed to a vial connector assembly for use with a vial of a lyophilized drug.
- the vial may be a glass vial having a bottom wall and an upstanding side wall.
- a shoulder may extend inwardly from the upper end of the side wall and a neck may extend upwardly from the shoulder.
- the top end of the neck is opened and defines the access to the vial.
- An enlarged annular rim may extend around the open top end of the neck.
- the connector assembly of the invention includes a luer tube with-opposed proximal and distal ends and a lumen extending continuously therebetween. Portions of the luer tube between the proximal and distal ends may be slidably disposed within the neck of the vial.
- the proximal end of the luer tube is permanently mounted to a rubber stopper which in turn is slidably and sealably engageable within the neck of the vial. Portions of the luer tube adjacent the stopper include apertures or slots that communicate with the lumen through the tube.
- the distal end of the luer tube includes a pair of oppositely directed luer projections for threaded engagement with a luer connector on a syringe or on a fitting for delivering a solvent into the vial and for delivering a drug solution from the vial.
- the luer tube further is provided with a filter securely affixed at a location in the lumen intermediate the proximal and distal ends of the luer tube.
- the filter is selected from known materials that will prevent a flow of solid particulates.
- the filter will act to prevent particulate or contaminants from being transported into or out of the vial and will act to prevent an outflow of undesolved lyophilized drug into the patient.
- the filter also will act to prevent a sufficient impediment to liquid flow for preventing an undesirable splash back of drug solution when the vial is separated from the supply of solvent and/or when the vial is separated from the drug delivery system.
- the filter will permit a flow of solvent under pressure into the vial and similarly will enable an outflow of drug solution from the vial in response to a pressure differential across the filter.
- the connector assembly further includes a collar having opposed proximal and distal ends and a generally annular transverse wall therebetween.
- the luer tube passes through the annular transverse wall of the collar and is securely mounted thereto.
- An inner wall is projects proximally from the transverse wall and is dimensioned for slidable insertion into the opened neck of the vial.
- the inner wall is surrounds portions of the luer tube.
- An outer wall is dimensioned and configured for slidable movement along the outer circumferential surface of the neck of the vial.
- the outer wall may include latches that are engageable with the enlarged annular rim around the open top of the neck to prevent complete removal of the collar from the vial.
- the collar functions to guide the luer tube through a controlled range of movement in the vial.
- One or more ribs is provided between the luer tube and the collar, so as to prevent any unwanted rotation between the two such as may occur, for instance, when a luer syringe is attached to removed from the luer tube.
- a connector assembly in accordance with the subject invention is identified generally by the numeral 10 in Figs. 1, 3, 8 and 9.
- Connector assembly 10 is used with a prior art glass vial 12 having a bottom wall 14.
- a cylindrical side wall 16 extends upwardly and substantially orthogonally from bottom wall 14.
- a shoulder 18 extends inwardly and upwardly from an end of cylindrical side wall 16 remote from bottom wall 14.
- a cylindrical neck 20 with an inside diameter "a” and an outside diameter "b” extends upwardly from shoulder 18.
- Neck 20 terminates at an open top 22 and comprises an annular rim 24 projecting outwardly from neck 20 adjacent top 22.
- Annular rim 24 has an outside diameter "c”.
- Vial 12 contains a drug 26 in dry form, such as a lyophilized drug or a powdered drug, as shown most clearly in Fig. 2.
- Connector assembly 10 functions to protectively seal drug 26 in vial 12 and to permit a solvent to be added to vial 12 for forming a drug solution. Connector assembly 10 further enables connection of vial 12 to a delivery system for administering drug solution 30 to a patient. Connector assembly 10 may then be disconnected from the delivery system and resealed for further use.
- connector assembly 10 may feature a generally tubular collar 32 having a proximal end 34, a distal end 36 and an annular transverse wall 38 between ends 34 and 36.
- Annular transverse wall 38 defines an inside diameter less than inside diameter "a" of neck 20 on vial 12 and an outside diameter greater than inside diameter "a” of neck 20.
- annular transverse wall 38 can be supported on the top end 22 of vial 12.
- Collar 32 comprises further a tubular inner wall 40 extending proximally from transverse wall 38 toward proximal end 34 of collar 32.
- Tubular inner wall 40 defines an outside diameter less than inside diameter "a" of neck 20 on vial 12.
- Proximal portions of tubular inner wall 40 define an outer circumferential step 42 for receiving an O-ring seal as explained further herein.
- Tubular inner wall 40 further defines an inner generally cylindrical surface having an inside diameter "d" as shown in Fig. 4.
- Collar 32 further includes a outer wall 44 projecting proximally from transverse wall 38 to proximal end 34 of collar 32.
- Outer wall 44 includes a plurality of distal notches 46 extending proximally from transverse wall 38 to define a plurality of spaced apart resiliently deflectable segments 48 disposed in a generally cylindrical array around transverse wall 38.
- Outer circumferential portions of segments 48 include detents 50 defining a major outside diameter for collar 32.
- Outer wall 44 is further defined by a plurality of proximal notches 52 extending distally from proximal end 34.
- Proximal notches 52 are offset circumferentially from distal notches 46 to define a plurality of circumferentially spaced resiliently deflectable fingers 54 at proximal end 34 of collar 32.
- Each finger 54 includes an inwardly projecting locking detent 56 having a proximally and inwardly facing cam surface 58 and a distally facing locking surface 60.
- Opposed locking projections 56 define a minor inside diameter for outer wall 44 which is approximately equal to the outside diameter "b" of neck 20 on vial 12. Portions of outer wall 44 distally of locking projections 56 define an inside diameter approximately equal to outside diameter "c" of rim 24 on vial 12.
- Collar 32 further includes a tubular distal wall 62 projecting distally from transverse wall 38.
- Tubular distal wall 62 is diametrically greater than tubular inner wall 40 and smaller than outer wall 44.
- Connector assembly 10 further includes a luer tube 64 as illustrated in Figs. 3, 6 and 7.
- Luer tube 64 has opposed proximal and distal ends 66 and 68 and a passage 70 extending axially therebetween.
- Proximal portions 72 of passage 70 are substantially cylindrical.
- Distal portions 74 of passage 70 taper from a major diameter adjacent distal end 68 to a minor diameter spaced therefrom. The taper on distal portions 74 of passage 70 may be configured to conform to a tip on a hypodermic syringe.
- Passage 70 further includes intermediate portion 76 extending between cylindrical portion 72 and tapered distal end 74. Intermediate portion 76 is tapered in a direction opposite from distal tapered portion 74.
- luer tube 64 further includes a filter 78.
- filter 78 is shown as securely affixed at the region of dimensional change between cylindrical portion 72 and intermediate portion 76.
- filter 78 may be affixed at another location intermediate proximal and distal ends 66 and 68 of the luer tube.
- Filter 78 may be formed from a material that will permit a passage of liquid solutions in response to a pressure differential on opposite sides of filter 78.
- filter 78 acts to substantially prevent movement of particulates and acts to prevent flow of liquid if there is no significant pressure differential on opposite sides of filter 78.
- filter 78 acts to prevent flow of liquid in response to the above described splash back or mere gravitational flow.
- Distal end 68 of luer tube 64 comprises a pair of luer projections 86.
- Luer projections 86 are dimensioned and configured for threaded engagement with a mateable luer connection, such as a luer collar on a hypodermic syringe.
- luer projections 86 enable luer tube 64 of connector assembly 10 to be threadedly, but releasably, engaged with a supply of solvent for mixing with drug 26 and/or for connection to a drug delivery device to enable administration of a drug solution to a patient.
- Luer tube 64 further includes a seal step 90 which cooperates with the step 42 on tubular inner wall 40 of collar 32 for capturing an O-ring seal therebetween.
- Connector assembly 10 further includes an O-ring 92, as illustrated in Figs. 3 and 8-10, which extends between step 42 of tubular inner wall 40 of collar 32 and step 90 on luer tube 64.
- the O-ring is dimensioned to sealingly engage against both tubular inner wall 40 and luer tube 64.
- Outer circumferential portions of O-ring 92 are dimensioned for sliding fluid tight and air tight engagement with the inner circumferential surface of neck 20 on vial 12.
- connector assembly 10 further includes a stopper 94 formed from a resiliently deflectable elastomeric material.
- Stopper 94 is of generally cylindrical shape and includes opposed proximal and distal ends 96 and 98. Outer circumferential surface regions of stopper 94 between proximal and distal ends 96 and 98 comprise a plurality of annular ribs for deflectable sealing engagement with inner circumferential surface regions of tubular neck 20 on vial 12. Proximal end 96 of stopper 94 is substantially continuous entirely thereacross, as shown in Fig. 3, to provide a fluid and air impervious barrier across tubular neck 20 of vial 12.
- Distal end 98 of stopper 94 comprises a short cylindrical recess 100, as shown in Figs. 8 and 9.
- Recess 100 defines a depth which is less than the length "f' of fingers 82 on luer tube 64.
- Recess 100 further defines a diameter approximately equal to the outside diameter "g" on fingers 82 at locations spaced from detents 84.
- proximal end 66 of luer tube 64 can be urged into recess 100 of stopper 94. This insertion of proximal end 66 of luer tube 64 into recess 100 will cause a deformation of the elastomeric material from which stopper 94 is formed and an inward deflection of fingers 32.
- stopper 94 Upon complete insertion, the elastomeric material of stopper 94 will resiliently return toward its undeformed condition around detents 84, such that detents 84 and the elastomeric material of stopper 94 cooperate with one another for securely retaining stopper 94 on fingers 82 of luer tube 64.
- the relative depth of recess 100 and length "f" of fingers 82 ensures that portions of slots 80 between fingers 82 will extend distally beyond stopper 94. Thus, stopper 94 will not impede fluid flow through passage 70 of luer tube 64.
- Connector assembly 10 further includes a protective cap 102, as shown in Fig. 1 and 8.
- Protective cap 102 has a stepped tubular side wall 104 and an end wall 106.
- the relative dimensions of stepped tubular side wall 104 of protective cap 102 are selected to enable releasable frictional engagement with distal wall 66 of collar 32 and with outer circumferential portions of outer wall 44.
- connector assembly 10 are assembled by initially mounting O-ring 92 over proximal end 42 of tubular inner wall 40 of collar 32.
- the relative position of O-ring 92 on inner tubular wall 40 is precisely controlled by step 42 provided on tubular inner wall 40.
- Distal end 68 of luer tube 64 is then inserted distally through the proximal end of tubular inner wall 40.
- step 90 of luer tube 64 will engage against the proximal end of O-ring 92 and will tightly engage within tubular inner wall 40 of collar 32.
- Proximal end 66 of luer tube 64 may then be urged into recess 100 of stopper 94, such that detents 84 at the ends of fingers 82 lockingly secure stopper 94 to luer tube 64.
- One or more ribs "R” is provided between tubular wall 40 of the collar and outer circumferential portions of luer tube 64 engaging tubular wall 40. See Figures 8 and 10.
- the purpose of the ribs is to prevent unwanted rotation between the luer tube and the collar that can result, for instance, when a force is exerted upon the luer tube by a luer syringe as it is being attached to or removed from distal end 68 of the luer tube.
- the ribs can be formed as part of either the collar or luer tube, or both, or they can be separately affixed to either of them.
- the ribs can be formed from plastics, elastomeric materials, or any other material capable of providing this stated function.
- Connector assembly 10 can be moved in proximal and distal directions relative to vial 12. As shown in Fig 2, connector assembly 10 is in its distal position on vial 12. In this position both O-ring 92 and stopper 94 are sealably engaged with inner circumferential surfaces of neck 20 on vial 12. Thus, drug 26 within vial 12 is contained for long term storage. Sterility of luer tube 64 and distal wall 62 of collar 32 can be assured by frictionally retaining protective cap 102 over collar 32.
- protective cap 102 is disengaged from collar 32 by exerting distally directed pulling forces sufficient to overcome the frictional engagement.
- Distal end 68 of luer tube 64 then may be threadedly engaged with a supply of solvent.
- the solvent may be stored in a hypodermic syringe or in some other container that is threadedly engageable with the luer projections 86 on distal end 68 of luer tube 64.
- the solvent can be directed into vial 12 by urging vial 12 and the supply of solvent toward one another. These forces will overcome the frictional engagement of stopper 94 with neck 20 of vial 12 and will urge stopper 94 proximally into vial 12 as shown in Fig. 9.
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- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Claims (4)
- Ampullenanschlußbaugruppe für eine Ampulle (12) mit einer Arzneimittelaufnahmekammer, einem von der Arzneimittelaufnahmekammer vorstehenden röhrenförmigen Hals (20) und einem offenen Oberteil (22), wobei die Baugruppe folgendes umfaßt:einen Stopfen (94), der in der Ampulle (12) angeordnet wird und gleitend im Hals (20) der Ampulle (12) bewegt werden kann,ein Lüer-Rohr (64) mit einem außerhalb der Ampulle (12) angeordneten distalen Ende (68) und einem starr am Stopfen (94) befestigten proximalen Ende (66), wobei das Lüer-Rohr (64) einen Durchgang (70) umfaßt, der durch dasselbe von einer proximalen Position wesentlich angrenzend an den Stopfen (94) zum distalen Ende (68) des Lüer-Rohrs (64) verläuft, wobei das Lüer-Rohr (64) gleitend im Hals (20) der Ampulle (12) bewegt werden kann, zwischen einer distalen Position, in welcher der Stopfen (94) abdichtend mit dem Hals (20) der Ampulle (12) ineinandergreift, und einer proximalen Position, in welcher der Stopfen (94) in der Fluidaufnahmekammer ist derart, daß der Durchgang (70) des Lüer-Rohrs (64) mit der Fluidaufnahmekammer der Ampulle (12) in Verbindung steht, undeinen im Durchgang (70) des Lüer-Rohrs (64) befestigten Filter (78), wobei der Filter (78) als Reaktion auf ein Druckgefälle auf den gegenüberliegenden jeweiligen Seiten des Filters (78) einen Fluidstrom durch denselben ermöglicht, wodurch der Filter (78) wirkt, um einen Teilchenstrom zu oder von der Ampulle (12) zu verhindern, unddie Baugruppe außerdem einen Bund (32) mit einer röhrenförmigen Innenwand (40), die das Lüer-Rohr (64) sicher in Eingriff nimmt, und einer Außenwand (44), gleitend im Eingriff um den Hals (20) der Ampulle (12), mit einer O-Ring-Dichtung (92) dichtend im Eingriff um das Lüer-Rohr (64) und dichtend im Eingriff innerhalb des Halses (20) der Ampulle (12), wobei die O-Ring-Dichtung (92) in distaler Richtung vom Stopfen (94) angeordnet wird, in einer Position zum gleitenden Dichteingriff mit dem Hals (20) der Ampulle (12) bei allen Gleitpositionen des Lüer-Rohrs (64) im Verhältnis zur Ampulle (12), dadurch gekennzeichnet, daßdie Baugruppe eine oder mehrere Rippen (R) zwischen dem Lüer-Rohr (64) und der röhrenförmigen Innenwand (40) des Bundes (32) umfaßt, um eine unerwünschte Rotation zwischen dem Lüer-Rohr (64) und dem Bund (32) zu verhindern.
- Baugruppe nach Anspruch 1, die außerdem eine Schutzkappe (102) umfaßt, lösbar im Eingriff über dem Bund (32) und über dem Oberteil der Ampulle (12).
- Baugruppe nach Anspruch 1, bei welcher der Filter (78) an einer Stelle im Durchgang (70) des Lüer-Rohrs (64) zwischen dem proximalen und dem distalen Ende (66, 68) des Lüer-Rohrs (64) angeordnet wird.
- Baugruppe nach Anspruch 3, bei welcher der Durchgang (70) durch das Lüer-Rohr (64) eine Abmessungsdiskontinuität (76) des Durchmessers einschließt, wobei der Filter (78) an der Abmessungsdiskontinuität (76) im Durchgang befestigt wird.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US90960097A | 1997-08-12 | 1997-08-12 | |
US909600 | 1997-08-12 |
Publications (3)
Publication Number | Publication Date |
---|---|
EP0897708A2 EP0897708A2 (de) | 1999-02-24 |
EP0897708A3 EP0897708A3 (de) | 1999-11-10 |
EP0897708B1 true EP0897708B1 (de) | 2003-10-29 |
Family
ID=25427529
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP19980306407 Expired - Lifetime EP0897708B1 (de) | 1997-08-12 | 1998-08-11 | Behälter mit einem Luer-Filter zur Verabreichung eines Arzneistoffes |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP0897708B1 (de) |
JP (1) | JPH11104215A (de) |
DE (1) | DE69819254T2 (de) |
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US8998875B2 (en) | 2009-10-01 | 2015-04-07 | Medimop Medical Projects Ltd. | Vial assemblage with vial and pre-attached fluid transfer device |
US12171716B2 (en) | 2016-08-15 | 2024-12-24 | Genentech, Inc. | Vial assembly with luer fitting |
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Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2791254B1 (fr) * | 1999-03-25 | 2001-06-08 | Pierre Frezza | Ampoule pour le conditionnement d'un liquide a usage medical |
DE102004005435B3 (de) * | 2004-02-04 | 2005-09-15 | Haindl, Hans, Dr. | Medizinisches Transfergerät |
US20080300536A1 (en) * | 2004-12-16 | 2008-12-04 | Xinming Wang | Drug Mixing and Delivery Device |
IL202070A0 (en) | 2009-11-12 | 2010-06-16 | Medimop Medical Projects Ltd | Inline liquid drug medical device |
JP4638553B1 (ja) * | 2010-08-09 | 2011-02-23 | 株式会社アルテ | 二室式容器兼用注射器の製造方法及びフロントストッパー |
IL209290A0 (en) | 2010-11-14 | 2011-01-31 | Medimop Medical Projects Ltd | Inline liquid drug medical device having rotary flow control member |
IL215699A0 (en) | 2011-10-11 | 2011-12-29 | Medimop Medical Projects Ltd | Liquid drug reconstitution assemblage for use with iv bag and drug vial |
USD720451S1 (en) | 2012-02-13 | 2014-12-30 | Medimop Medical Projects Ltd. | Liquid drug transfer assembly |
USD737436S1 (en) | 2012-02-13 | 2015-08-25 | Medimop Medical Projects Ltd. | Liquid drug reconstitution assembly |
IL219065A0 (en) | 2012-04-05 | 2012-07-31 | Medimop Medical Projects Ltd | Fluid transfer device with manual operated cartridge release arrangement |
IL221634A0 (en) | 2012-08-26 | 2012-12-31 | Medimop Medical Projects Ltd | Universal drug vial adapter |
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CA2006584C (en) * | 1988-12-27 | 1998-11-10 | Gabriel Meyer | Storage and transfer bottle for storing a component of a medicinal substance |
DK0453555T3 (da) * | 1989-11-13 | 1994-01-31 | Becton Dickinson France | Flakon til opbevaring af et lægemiddelstof |
US5685845A (en) * | 1995-07-11 | 1997-11-11 | Becton, Dickinson And Company | Sterile resealable vial connector assembly |
-
1998
- 1998-08-07 JP JP22499098A patent/JPH11104215A/ja active Pending
- 1998-08-11 EP EP19980306407 patent/EP0897708B1/de not_active Expired - Lifetime
- 1998-08-11 DE DE1998619254 patent/DE69819254T2/de not_active Expired - Lifetime
Cited By (2)
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US12171716B2 (en) | 2016-08-15 | 2024-12-24 | Genentech, Inc. | Vial assembly with luer fitting |
Also Published As
Publication number | Publication date |
---|---|
DE69819254T2 (de) | 2004-07-29 |
DE69819254D1 (de) | 2003-12-04 |
EP0897708A2 (de) | 1999-02-24 |
JPH11104215A (ja) | 1999-04-20 |
EP0897708A3 (de) | 1999-11-10 |
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