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EP0957883B1 - Adaptateur utile pour prelever un liquide dans un recipient ferme par un bouchon - Google Patents

Adaptateur utile pour prelever un liquide dans un recipient ferme par un bouchon Download PDF

Info

Publication number
EP0957883B1
EP0957883B1 EP96945696A EP96945696A EP0957883B1 EP 0957883 B1 EP0957883 B1 EP 0957883B1 EP 96945696 A EP96945696 A EP 96945696A EP 96945696 A EP96945696 A EP 96945696A EP 0957883 B1 EP0957883 B1 EP 0957883B1
Authority
EP
European Patent Office
Prior art keywords
adaptor
adapter
plug
container
funnel
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
Application number
EP96945696A
Other languages
German (de)
English (en)
Other versions
EP0957883A2 (fr
Inventor
Werner Mrotzek
Bernd GRÄF
Ingoberth SCHÖNKE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer Intellectual Property GmbH
Original Assignee
Schering AG
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Schering AG filed Critical Schering AG
Publication of EP0957883A2 publication Critical patent/EP0957883A2/fr
Application granted granted Critical
Publication of EP0957883B1 publication Critical patent/EP0957883B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • 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
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/10—Coring prevention means, e.g. for plug or septum piecing members

Definitions

  • the present invention relates to an adapter for removal a liquid from a sealed with a stopper Container or for filling this container, which means a stopper fixed by a crimp cap is, with at least one partially hollow, with at least one Nozzle provided at the front end for piercing the Plug, a connecting part with an inner cone on the rear End for coupling medical devices and a flat Handle element to facilitate the adaptation process in between lying area.
  • Such adapters or withdrawal cannulas cf. EP 0 499 481 A1 and WO 93/24095 - which forms the basis of the preamble of claim 1 - are used in the medical field, to i.a. commercially available infusion sets on infusion bottles to be able to connect.
  • the adapters usually have a lockable taper connection according to DIN 13 090 part 2. Das Connect the infusion sets to the infusion bottles is done by trained personnel who have no problems the stopper of the infusion bottles with the adapter to pierce and connect the cutlery to the adapter. However, it is very difficult for an inexperienced person to use the infusion bottle to couple to the adapter.
  • the thorn With an adapter that with the help of locking elements the crimp cap of the infusion bottle reaches behind, the thorn must stop the rubber plug at that moment pierce, in which the locking elements on the edge of Crimp cap come to rest to be pushed outwards. Especially in the initial phase of puncturing, if so a lot of power is needed to find the right one aligning adapter and infusion bottle the spread locking elements quite unstable on the upper outer edge the crimp cap. Even if the Operator gets lost between adapter and container. As a result, at least one locking element extends far outwards bent, possibly under cancel, while usually at least one locking element returns to its starting position and further postponement prevented by tilting.
  • Preparations whose active ingredients are available as lyophilisates.
  • motor-impaired MS patients need such Preparations for self-medication.
  • Such a drug is stored in two size R2 infusion bottles.
  • the first infusion bottle contains saline while the second infusion bottle contains the lyophilisate.
  • the patient so far taken with a disposable syringe with attached Cannulae the saline solution from the first infusion bottle.
  • the He injects the contents of the syringe into the second infusion bottle.
  • An aid for placing the disposable syringe on the infusion bottle offers an adapter known from WO 95/07066.
  • This adapter is used as a guide for the disposable syringe on the Infusion bottle attached.
  • the cannula of the disposable syringe pierces the straight when inserted into the adapter Closure of the infusion bottle.
  • An inexperienced in handling syringes or a motor-impaired patient finds it difficult to use the single-use syringe not to tilt when inserted into the adapter. On Tilting will break the cannula. Even if the cannula is correctly inserted into the infusion bottle Lyophilisates still have the above-mentioned risk of clumping.
  • the present invention is therefore based on the problem to create an adapter with the help of which a liquid via a standardized syringe and one with a stopper Container removed as well as filled can.
  • the transfer process should also be done by an inexperienced person fast, reliable, without any risk of injury and without greater effort can be performed. Furthermore should the risk of contamination should be as small as possible. Moreover are those known from the prior art Disadvantages are avoided.
  • the elastic centering and gripping part is for example a thin-walled sleeve that emerges directly from the basic element.
  • the inside diameter of the sleeve is slightly larger than the outside diameter of the stopper on the infusion bottle fixing crimp cap.
  • the pod itself is several Extended millimeters beyond the locking elements. she is included - also to minimize the risk of injury - a few millimeters longer than the mandrel of the adapter. consequently the sleeve centers the adapter when it is placed on the infusion bottle cap.
  • the sleeve Only when the sleeve is the crimp cap the mandrel tip is almost completely surrounded or covered on the stopper. As soon as the tip of the mandrel pierces the stopper has, the locking elements on the top of the Crimp cap. If the adapter is pushed open further the locking elements pushed outwards. This deforms the thin-walled sleeve elastic. Reached in the locking element level they have a polygonal cross-section during sliding open. After fully sliding open the Locking elements the lower edge of the crimp cap, the sleeve returns to its cylindrical shape.
  • the one-part or multi-part centering and gripping part can also be designed so that after complete at least partially put on the infusion bottle is plastically deformed.
  • centering and gripping part can be extended so far be that it is the cylindrical outer surface of the corresponding Infusion bottle partially covered or that the infusion bottle completely disappears into it.
  • the whole serves here Bottle body as a centering aid.
  • the infusion bottle can also be attached and pre-latched adapter so that when Preparation and administration of the preparation, putting on and There is no need to center the adapter.
  • the one arranged on the other side of the grip element an inner cone equipped connecting part enables a easy coupling with an outer cone as a connecting part provided syringe.
  • the syringe's outer cone slides along the inner funnel contour in the on the Funnel connecting standardized inner cone.
  • a low axial force creates a tight cone connection.
  • the syringe forms together with the infusion bottle via the adapter a cohesive by positive and positive locking Unit that is stable in every position.
  • the unit can only be held by the syringe barrel be brought into the winding position.
  • the emptying or The infusion bottle is filled due to the large bore and nozzle cross sections in the adapter quickly with little Effort.
  • Each nozzle integrated in the mandrel has a jet direction, that deviates from the center line of the adapter by at least 30 °. This prevents the saline solution when injected directly into the second infusion bottle meets the lyophilisate. It is usually attached to the and / or sprayed inside the bottle. Depending on the infusion bottle position it flows along there or drips from there down. In this way it is prevented that the lyophilisate partially clumps.
  • the funnel sits on the handle element so that its Top edge of the handle element is a length away that about 2/3 of the middle, distant index finger width of one male adults according to DIN 33 402 Part 2.
  • the patient stops, for example, by piercing the sealing plug the adapter with the infusion bottle positioned underneath in the area between the funnel and the handle element between the index and middle fingers, with the spine on the inside of the hand shows.
  • the thumb of the same hand on the ground of the infusion bottle, it pushes in a kind of Forceps move the infusion bottle and the adapter onto each other to.
  • this design the patient is not forced to the adapter by placing your fingers on the sterile Connect the funnel to the infusion bottle.
  • the edge design also serves for easier handling of the grip element and / or the funnel. At least one of the Parts are flattened in the edge area, for example. This will make the adapter sterile after removing it Packing a roll away on a slightly inclined Level prevented.
  • the adapter is made, for example, by injection molding made of clear, transparent plastic. Preferably it consists of one piece. Depending on the purpose there may be a vent duct with or without a particle filter contain.
  • an inner cone with locking e.g. a luer lock inner cone, be integrated.
  • Figure 1 shows the adapter in the middle in a side view.
  • the adapter is shown enlarged by a factor of two and cut on one side. It is suitable for a liquid with the aid of a syringe, for example a disposable syringe according to DIN 13098 part 1 with outer cone, without injection cannula from a closed injection bottle according to DIN ISO 8362 Take part 1.
  • a syringe for example a disposable syringe according to DIN 13098 part 1 with outer cone
  • Such an injection bottle (1) see. FIG. 1, lower drawing, is closed with a stopper (2), by an aluminum crimp cap (3) on the Injection bottle (1) is held.
  • the injection bottle shown (1) has a volume of approx. 4 ml.
  • the adapter has one in its middle area Handle plate (21) aligned vertically. centric a mandrel (11) is arranged below the handle plate (21). With it, the plug (2) when putting on the Push the adapter through the injection bottle (1). To the Mandrel (11) around, parallel to it, four cantilever arms (25) in Circle arranged, which protrude from the handle plate (21) down. The cantilever arms (25) facilitate as a centering aid one placing the adapter on the corresponding injection bottle (1) and secondly they reach for the completely push the lower edge of the crimp cap. On the handle plate (21) is a funnel-shaped connecting part (31) arranged after the insertion of the outer cone DIN 13090 part 1 of the disposable syringe facilitated and a tight Establishes connection between disposable syringe and adapter.
  • connection part (31) below the handle plate (21) concentrically arranged mandrel (11) has one circular cross section, at least in the front area tapered towards a tip, see Figure 3.
  • Detail “Z” shown at the bottom right is the mandrel (11) the adapter center line by 90 ° compared to the illustration in Figure 1 shown rotated.
  • the mandrel (11) has a central bore (12) in the upper part. in the middle of the mandrel in two perpendicular to the adapter center line arranged nozzles (13) merges.
  • the diameter the bore (12) corresponds approximately to the bore diameter from the outer cone of the standardized disposable syringe.
  • the opposing nozzles (13) have approximately one rectangular opening cross-section. Each nozzle (13) opens out into one aligned in the mandrel (11) parallel to the adapter center line Groove (14). Located immediately below each nozzle (13) a lip (15), the outer contour of which is in the nozzle area corresponds approximately to the contour of the bore (12) and thereby rises above the bottom of the groove. The lip (15) prevents i.a. on Blocking of the nozzles (13) lying above them during the piercing the plug, for example made of rubber (2).
  • the Because of the hole (12) have different shapes.
  • the bore (12) is provided with a bottom, which has the shape of a gable roof, with each roof side is facing a nozzle.
  • the lower edges of the roof form the lower edges of the nozzle openings.
  • Each of the four cantilever arms arranged around the mandrel (11) (25) has a cross-section over its entire length that approximately corresponds to the shape of a circular ring section.
  • the inner diameter of the circular ring sections is slightly larger than the outside diameter of the crimp cap (3) of the injection bottle (1).
  • Has the outer contour of the circular ring section approx. the length of 1/8 of the circumference.
  • the not curved ones Side surfaces of the cantilever arms (25) form planes around the Half the cantilever width offset parallel to the center line of the adapter run.
  • a detent (26) is arranged on the inside thereof.
  • each Latch (26) has a trapezoidal cross section and extends across the entire width of each cantilever (25).
  • the nose flank oriented towards the grip plate (21) is inclined by approx. 30 ° to the horizontal. In the The direction of the nose is aligned with the Horizontal an angle of approx. 41 °.
  • the Lugs (26) rise approx. 0.7 mm above the inner contour of the cantilever arms (25).
  • each cantilever arm (25) has the handle plate in the upper one (21) oriented area a parallel to the adapter center line and stiffening rib aligned centrally to the cantilever width (27). It has a semicircular cross section. About the appropriate dimensioning of the cross section and the length of the individual stiffening rib (27) can affect the bending stiffness of each cantilever (25) become.
  • the handle plate carrying the mandrel (11) and the cantilever arms (25) (21) is a flat, substantially circular Plate. Missing in the areas between two cantilever arms (25) each have a circular section with, for example, 0.9 mm arc height to the full circle.
  • the flats (22) prevent rolling of the adapter on one slightly against the horizontal inclined, inclined plane.
  • Connection part (31) On the base plate (21) is concentric to the mandrel (11) Connection part (31) formed. It consists of a funnel (33), an inner cone element (32) and four stiffening ribs (34).
  • the inner cone element (32) is directly with the Base plate (21) connected. It is the counterpart to the outer cone the disposable syringe to be coupled. By pushing in the outer cone of the disposable syringe into the inner cone element (32) creates a relatively rigid connection. It is liable the outer cone in the inner cone element (32) via frictional connection.
  • the funnel (33) connects to the inner cone element (32) on. For example, it has an opening angle of 110 °. His maximum outer diameter corresponds to the base plate diameter.
  • the four stiffening ribs along the inner cone element (32) (34) are located in radial planes the adapter center line, cf. Figure 2. There they are in the Top view shown in dashed lines.
  • the individual stiffening ribs (34) are in the middle above the cantilever arms (25) arranged.
  • the depth of the stiffening ribs (34) is chosen, for example, so that the radius of one around the outer edges of the stiffening ribs (34) around the circumference centered between the outer radius of the inner cone element (32) and the maximum radius of the funnel (33).

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Closures For Containers (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
  • Feeding And Controlling Fuel (AREA)

Claims (5)

  1. Adaptateur pour prélever un liquide dans un récipient (1) fermé par un bouchon ou pour remplir ce récipient (1), qui est fermé au moyen d'un bouchon (2) fixé par un capuchon rabattu (3), avec au moins une broche (11) partiellement creuse et pourvue d'au moins une buse (13) sur l'extrémité avant, une pièce de liaison (31) avec cône intérieur sur l'extrémité arrière et un élément de poignée (21) plane avec une plaque de base dans la zone intercalaire, moyennant quoi une pièce de serrage (25) élastique est disposée sur cet élément de poignée (21) en direction de l'extrémité avant de l'adaptateur, pièce dont le contour intérieur correspond au moins par endroits approximativement au contour extérieur du capuchon rabattu (3) et qui présente des éléments d'encliquetage (26), lesquels saisissent par l'arrière au moins par endroits le capuchon rabattu (3) et sont disposés à une distance de la plaque de base égale au moins à la hauteur du capuchon rabattu (3), moyennant quoi le bord avant de la pièce de serrage (25) déborde de la broche (11), caractérisé
    en ce que les éléments d'encliquetage (26) sont disposés dans la zone située à l'arrière de l'extrémité de la broche (11),
    en ce qu'un entonnoir (33) ouvert en direction de l'extrémité arrière est disposé sur la pièce de liaison (31), et
    en ce que le bord avant de la pièce de serrage (25) s'étend au-delà de l'élément d'encliquetage (26) et est conçu pour le centrage de l'adaptateur lors de la pose sur le récipient (1).
  2. Adaptateur selon la revendication 1, caractérisé en ce que chaque buse (13) intégrée dans la broche (11) présente une direction de jet qui s'écarte d'au moins 30° de l'axe central de l'adaptateur.
  3. Adaptateur selon la revendication 1, caractérisé en ce que le bord supérieur de l'entonnoir (33) est éloigné de l'élément de poignée (21) de 2/3 de la largeur d'index moyenne, éloignée du corps d'un homme adulte selon DIN 33 402 partie 2.
  4. Adaptateur selon la revendication 1, caractérisé en ce que le contour extérieur de l'élément de poignée (21) et/ou de l'entonnoir (33) est ovale.
  5. Adaptateur selon la revendication 1, caractérisé en ce qu'il est constitué d'une seule pièce.
EP96945696A 1995-10-20 1996-10-18 Adaptateur utile pour prelever un liquide dans un recipient ferme par un bouchon Expired - Lifetime EP0957883B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19540476 1995-10-20
DE19540476 1995-10-20
PCT/DE1996/002027 WO1997015267A2 (fr) 1995-10-20 1996-10-18 Adaptateur utile pour prelever un liquide dans un recipient ferme par un bouchon

Publications (2)

Publication Number Publication Date
EP0957883A2 EP0957883A2 (fr) 1999-11-24
EP0957883B1 true EP0957883B1 (fr) 2003-03-05

Family

ID=7776218

Family Applications (1)

Application Number Title Priority Date Filing Date
EP96945696A Expired - Lifetime EP0957883B1 (fr) 1995-10-20 1996-10-18 Adaptateur utile pour prelever un liquide dans un recipient ferme par un bouchon

Country Status (9)

Country Link
US (1) US6039093A (fr)
EP (1) EP0957883B1 (fr)
AT (1) ATE233530T1 (fr)
AU (1) AU1765097A (fr)
DE (1) DE59610206D1 (fr)
DK (1) DK0957883T3 (fr)
ES (1) ES2192236T3 (fr)
PT (1) PT957883E (fr)
WO (1) WO1997015267A2 (fr)

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CN113490477B (zh) 2019-01-31 2024-09-27 西医药服务以色列有限公司 移液装置
EP3781113B1 (fr) 2019-04-30 2024-03-20 West Pharma Services IL, Ltd. Dispositif de transfert de liquide avec pointe iv à double lumière
USD956958S1 (en) 2020-07-13 2022-07-05 West Pharma. Services IL, Ltd. Liquid transfer device

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GB9103291D0 (en) * 1991-02-15 1991-04-03 Waverley Pharma Ltd Transfer adaptor
GB9211912D0 (en) * 1992-06-04 1992-07-15 Drg Flexpak Ltd Vial connector system
BR9407390A (pt) * 1993-09-07 1996-11-05 Debiotech Sa Dispositivo de seringa para mistura de dois compostos
EP0692235A1 (fr) * 1994-07-14 1996-01-17 International Medication Systems (U.K.) Ltd. Dispositif mélangeur et distributeur
US5526853A (en) * 1994-08-17 1996-06-18 Mcgaw, Inc. Pressure-activated medication transfer system

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Publication number Publication date
PT957883E (pt) 2003-07-31
DE59610206D1 (de) 2003-04-10
US6039093A (en) 2000-03-21
EP0957883A2 (fr) 1999-11-24
DK0957883T3 (da) 2003-06-30
WO1997015267A2 (fr) 1997-05-01
ATE233530T1 (de) 2003-03-15
ES2192236T3 (es) 2003-10-01
AU1765097A (en) 1997-05-15
WO1997015267A3 (fr) 1997-07-17

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