Source: https://patents.google.com/patent/EP0957883B1/en
Timestamp: 2020-01-19 22:05:45
Document Index: 695873240

Matched Legal Cases: ['art 2', 'art 2', 'art 1', 'art 1', 'art 1', 'art 2']

EP0957883B1 - Adapter for extracting a liquid from a container closed with a stopper - Google Patents
EP0957883B1
EP0957883B1 EP19960945696 EP96945696A EP0957883B1 EP 0957883 B1 EP0957883 B1 EP 0957883B1 EP 19960945696 EP19960945696 EP 19960945696 EP 96945696 A EP96945696 A EP 96945696A EP 0957883 B1 EP0957883 B1 EP 0957883B1
EP19960945696
EP0957883A2 (en
1995-10-20 Priority to DE19540476 priority
1996-10-18 Application filed by Bayer Pharma AG filed Critical Bayer Pharma AG
1999-11-24 Publication of EP0957883A2 publication Critical patent/EP0957883A2/en
2003-03-05 Publication of EP0957883B1 publication Critical patent/EP0957883B1/en
239000007788 liquids Substances 0 abstract claims title 6
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. To do this, 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. 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.
In the event that from an infusion bottle, for example a partial quantity is to be drawn onto a syringe no adapter used. Rather, a cannula is placed on the syringe with which the stopper of the infusion bottle is attached is punctured. This procedure requires one certain routine and a steady hand. The suction is also carried out the liquid through the cannula is relatively slow because the free cannula cross-section is very small.
It is particularly difficult to wind up medical devices Preparations whose active ingredients are available as lyophilisates. For example 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.
When doing so, he must make sure that the saline solution is not direct strikes the lyophilisate, otherwise a lump is inevitable is. The solution of saline and lyophilisate after shaking the second infusion bottle taken to be finally administered.
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 problem is solved by the features of the characterizing part of claim 1.
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. There are three or inside the sleeve four individual, protruding locking elements in one arranged parallel to the base plate. The distance between the base plate and the locking element level is slight greater than the height of the 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. 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.
Instead of a sleeve with the molded locking elements can also individual cantilever arms arranged on the base element are used become. 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.
Furthermore, the 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.
Furthermore, 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. By applying 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. For filling the syringe or to empty the respective infusion bottle 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.
For easier or ergonomic handling of the adapter 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. To the 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. With 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. With 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.
Furthermore, instead of the simple inner cone in the funnel base an inner cone with locking, e.g. a luer lock inner cone, be integrated.
Further details of the invention result from the exemplary embodiment described below and shown schematically.
Adapter in a partially sectioned side view, a bottom view and a container on which the adapter is placed;
Top view of the adapter;
Front view of thorn, enlarged, with two cuts.
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. 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.
The 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. In the here 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).
To influence the jet direction of the nozzles (13), the Because of the hole (12) have different shapes. For example a blasting at approx. 45 ° to the adapter center line if desired, 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 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. Approximately at half the height of each cantilever (25) 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).
On the outer contour, 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.
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. Between the funnel (33) and the base plate (21) are the four stiffening ribs along the inner cone element (32) (34) arranged. They 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).
Container, infusion bottle R2
Crimp cap, aluminum crimp cap
Handle element, handle plate
Centering and gripping part, cantilever arms
Locking elements, locking lugs
Inner cone element
Adaptor for withdrawing a liquid from a receptacle (1) sealed with a stopper or for filling such a receptacle (1) sealed by means of a stopper (2) fixed in place by a crimped-on cap (3), having at its forward end at least one partially hollow spike (11) provided with at least one nozzle (13), having at its rear end a connecting portion (31) comprising an internal cone, and having in the region located therebetween a flat gripping element (21) comprising a base plate, there being arranged on that gripping element (21), towards the forward end of the adaptor, a resilient engaging-around portion (25), the internal contour of which corresponds approximately to the external contour of the crimped-on cap (3) at least in some regions and which has locking elements (26), which engage behind the crimped-on cap (3) at least partly and are located spaced apart from the base plate by at least the height of the crimped-on cap (3), the forward edge of the engaging-around portion (25) projecting beyond the spike (11),
the locking elements (26) are located in the region behind the tip of the spike (11);
a funnel (33) open towards the rear end is arranged on the connecting portion (31); and
the forward edge of the engaging-around portion (25) extends beyond the locking element (26) and is so shaped as to centre the adaptor when it is being placed on the receptacle (1).
Adaptor according to claim 1, characterised in that each nozzle (13) incorporated in the spike (11) has a jet direction that departs by at least 30° from the centre-line of the adaptor.
Adaptor according to claim 1, characterised in that the upper edge of the funnel (33) is spaced apart from the gripping element (21) by 2/3 of the average distal index finger width of a male adult according to DIN 33 402 Part 2.
Adaptor according to claim 1, characterised in that the external contour of the gripping element (21) and/or of the funnel (33) is not round.
Adaptor according to claim 1, characterised in that it consists of one piece.
EP19960945696 1995-10-20 1996-10-18 Adapter for extracting a liquid from a container closed with a stopper Expired - Lifetime EP0957883B1 (en)
EP0957883A2 EP0957883A2 (en) 1999-11-24
EP0957883B1 true EP0957883B1 (en) 2003-03-05
EP19960945696 Expired - Lifetime EP0957883B1 (en) 1995-10-20 1996-10-18 Adapter for extracting a liquid from a container closed with a stopper
ES2351950T3 (en) 2011-02-14 Multidosis flask mounting and adapters for such assemblies.
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