The invention relates to a medical syringe with passive needle protection for administering a dose of medication to a patient, with a hollow body forming the syringe housing and containing the medical active substance, at the distal end of which a hollow needle intended for injecting the active substance is mounted in a bearing sleeve, and in which a displaceable plunger provided at the end with a receiving hole for the hollow needle is arranged.
To avoid or reduce the risk of contamination or injury after the use of medicinal syringes and in particular to avoid multiple use of syringe needles by different users, syringes with so-called retraction or retraction systems for the syringe needle are increasingly used. In such syringes, in particular medical syringes, also known as “tips with passive needle protection”, the syringe needle is retracted into the syringe body after dispensing the active substance held in the syringe and is completely enclosed by the syringe body. Access to the syringe and thus a risk of injury, or even the risk of multiple use of the same needle, can thus be largely excluded.
Such syringes with passive needle protection are known, for example, from EP 1 284 769 B1, EP 0 720 491 B1, EP 0 680 347 B1 or EP 1 764 127 B1.
The invention is now based on the task of further designing a syringe with passive needle protection of the above-mentioned type in such a way that it is possible to deliver the medicament contained in the syringe body as completely and as far as possible, while largely avoiding any residual medication remaining in the syringe body after delivery.
This task is solved according to the invention in that the plunger is made in several parts and, in addition to a needle holder having a retaining clip for the hollow needle, comprises a plunger jacket which is shaped in such a way that, when the needle holder is inserted, it leaves free inflow channels on both sides of the retaining clip into the enclosed end of the hollow needle for the active substance.
The invention is based on the consideration that for the desired reduction or, if possible, complete avoidance of drug residues remaining in the syringe, the dead volumes in the drug chamber and the flow channels for the drug should be kept as small as possible. Particularly in the case of syringes with a retraction system, however, the hollow needle must usually be coupled to the syringe plunger towards the end of the dispensing process so that it can be drawn into the syringe body via the plunger during retraction. This usually requires a mechanical enclosure of the hollow needle, which on the other hand causes the formation of inherently undesirable dead volumes. To counteract this, the syringe plunger is now specifically designed to offer suitable flow paths for the active substance even after contact with the hollow needle, through which it can still be supplied to the needle even in this state.
Advantageously, and for a particularly cost-effective design, the retaining bracket of the needle holder carries a needle bearing which forms the receiving hole and is provided on the inside with a circumferential latching lip which, when the hollow needle is pushed into the needle bearing, engages in a retaining groove arranged on its outer circumference and fixes it in the longitudinal direction.
In order to ensure that during the retraction movement of the plunger the needle is carried along by the plunger towards the interior of the syringe body and thus retracted into the syringe housing, the dimensions of the retaining groove and its associated locking lip in the needle bearing are advantageously selected in such a way, that, taking into account the deformability of the material on the outer circumference of the hollow needle and the material of the needle bearing surrounding it, the holding or breakaway force of the needle thus engaged in the needle bearing is greater in the longitudinal direction than the corresponding holding or breakaway force of a holding groove of the hollow needle in the bearing sleeve.
In order to ensure even further improved reliability and operating safety of the syringe during use, the syringe is in a very particularly preferred embodiment provided with a retraction-triggering spring which, when the needle is retracted into the interior of the syringe body, additionally also displaces the trigger plate provided for actuating the syringe in a direction away from the distal end of the syringe. As a result, the intended retraction or retraction of the syringe needle into the syringe body can be perceived by the user not only visually, but also in other usable ways, in particular by means of haptic perceptibility. In particular, the syringe, coupled to the retraction process of the needle tip, generates a corresponding displacement of its associated trigger plate, which can be felt by the user, for example, via the thumb. In this way, without the user having to actively observe the syringe, the information can be transmitted to the user that the needle has been properly retracted and, above all, that the active substance has been completely administered and the delivery of the active substance has thus ended.
An embodiment of the invention is explained in more detail with reference to a drawing. Therein show:
Identical parts are marked with the same reference signs in all figures.
The medical syringe 1 with passive needle protection according to
The first assembly, i.e. the cartridge or cartridge unit 2, shown in
The needle 12 is surrounded by a removable protective cap 15 to prevent injury or the like, which is removed before the syringe 1 is used. The rear or proximal end 16 of the hollow body 6 forming the syringe housing, on the other hand, is closed by a plunger 18 whose outer dimensions are precisely adapted to the inner contour of the hollow body 6 and which can be moved within the hollow body 6. In the state shown in
The second assembly of the medical syringe 1, i.e. the drive or actuation unit 4, shown in
The medical syringe 1 is provided with a passive needle protection in the form of a retraction system by the components and parts mentioned. The purpose of this is that after use of the syringe 1, i.e. after dispensing the active substance held in the hollow body 6 forming the syringe housing via the needle 12, the latter is drawn into the syringe housing in such a way that it is completely enclosed by the syringe housing. This is intended to keep unintentional contact with the used needle 12, for example by auxiliary or nursing personnel, and thus the risk of injury and contamination particularly low or, if possible, completely excluded.
For this purpose, the following procedure is basically intended for the use and handling of the components mentioned:
Due to the two-component design of the overall system provided in the embodiment example, the cartridge unit 2 and the actuation unit 4 are first suitably connected to each other. For this purpose, on the one hand the coupling element 26 is connected to the piston 18 and on the other hand the coupling plate 30 is connected to the proximal end 16 of the hollow body 6. In the case of an a priori single-component design of the overall system, in which, for example, the actuating plunger 22 could be connected directly to the piston 18 and the coupling plate 30 could be moulded directly onto the proximal end 16 of the hollow body 6, this connection step can naturally be omitted.
After the syringe 1 has been made ready for use in this way, the needle 12 is suitably positioned on the patient for the administration of the medical active substance so that it pierces the patient's skin at a suitable point. The retaining circle of the needle 12 in the bearing sleeve 14 is thereby predetermined, in particular by suitable dimensioning of the components and/or the choice of material pairing, in such a way that the needle 12 remains securely in its position in the bearing sleeve 14 when the operator pierces the needle 12 through the patient's skin by handling it on the hollow body 6.
The actuating plunger 22 is then pressed by the operator so that the piston 18 moves inside the hollow body 6 towards its distal end 8, thereby feeding the medicinal agent to the needle 12 and dispensing it via the latter. Shortly before complete dispensing of the active ingredient, i.e. shortly before complete emptying of the interior of the hollow body 6, the piston 18 reaches the end of the needle 12 projecting into the interior in the vicinity of the distal end 8 of the hollow body 6, so that the needle 12 enters the receiving hole 19 provided for this purpose during further movement. After complete dispensing of the active substance, the piston 18 then reaches its end position directly at the distal end 8 of the hollow body 6 and thereby encloses the part of the hollow needle 12 projecting into the receiving hole 19. This insertion of the corresponding part of the hollow needle 12 into the receiving hole 19 and the connection of the needle 12 with the piston 18 thereby achieved is also referred to herein as “connecting”.
As soon as this point is reached and the piston 18 has arrived at its intended end position, the locking element 32—in the embodiment example via a catch on the actuating plunger 22—is to deform suitably and thereby release the fixing of the spring 34. In the embodiment example, the dimensioning of the corresponding components is thereby selected in such a way that the “connecting” occurs slightly or briefly before the release of the spring 34; this is considered to be independently inventive. In response to this, i.e. to the release of the spring 34, the pre-tensioned spring 34 relaxes and thereby moves the pusher plate 20 of the actuating plunger 22 away from the coupling plate 30 and thus away from the syringe body formed by the hollow body 6. This also entrains the plunger 18, which is connected to the shaft 28 of the actuating plunger 22 via the coupling element 26, and pulls it within the hollow body 6 away from the distal end 8 towards the proximal end 16. In turn, it takes the enclosed needle 12 with it and pulls it into the hollow body 6 so that it is completely positioned inside the hollow body 6 in the final state.
A significant and considered inventive aspect in this respect is that the spring 34 provided for carrying out the retraction movement of the needle 12 into the hollow body 6 is arranged above the coupling plate 30 in the region of the shaft 28 of the actuating plunger 22 and acts on the actuating plunger 22 via the plunger plate 20 thereof. In contrast to conventional retraction systems, in which the retraction spring is arranged in the region of the tip or the distal end of the syringe within the syringe body and acts directly on the needle or its bearing body, the design now provided in accordance with the invention means that the needle 12 is moved together with the actuating plunger 22 and, in particular, its pusher plate 20 during retraction, so that the user or operator can detect the position and, in particular, the change in position of the needle 12 on the basis of the position of the pusher plate 20 relative to the coupling plate 30. This detection is possible visually, but above all also haptically.
In other words, the retraction movement, similar to an actuating button of a biro, produces a movement of the pusher plate 20 that can be felt by the user, for example with the thumb. Thus, the user can conclude from the movement of the pusher plate 20 that can be felt with the thumb, on the one hand, that the needle 12 has now been retracted and thus there is no longer any risk of injury or contamination in the area of the distal end 8 of the syringe 1. On the other hand, he can also conclude from this that the active substance has now been completely administered without having to monitor this visually, for example. The syringe 1 thus enables significantly simplified handling when administering the active substance.
For better clarification, this sequence is shown in the sequence of partial sections in
Starting from this state, the active substance is dispensed—in particular when the needle 12 is inserted into the patient's skin—by moving the plunger 18 from its starting position shown in
When the piston 18 or the actuating plunger 22 reaches the end position shown in
As can be seen from the illustrations in
In order to achieve the mode of operation explained above in a particularly reliable and advantageous manner in several respects, the components are specifically designed in various details, whereby the embodiments described below are each considered to be both independently inventive and inventive in any combination with one another.
For example, the hollow needle 12 is independently inventive according to the following description. As can be seen from the enlarged representation in
The first holding groove 48 is provided for temporarily fixing the needle 12 in the bearing sleeve 14 of the needle holder 10. For this purpose, an associated circumferential locking lip is provided inside the bearing sleeve 14, which engages in the holding groove 48 when the needle 12 is mounted and properly inserted into the bearing sleeve 14 and fixes it in the longitudinal direction. In accordance with an embodiment which is fundamentally considered to be independently inventive, the dimensions of the retaining groove 48 and the latching lip are thereby advantageously selected in such a way that, taking into account the deformability of the material of the plastic sheath 46 and/or any adhesive force due to the material pairing of the material of the plastic sheath 46 and the material of the bearing sleeve 14 surrounding it, the retaining or breakaway force of the needle 12 thus latched in the longitudinal direction is, on the one hand, sufficiently great, so that the needle 12 can be inserted into the patient's skin in accordance with the procedure described above, but on the other hand is also sufficiently small so that the described retraction movement of the needle 12 towards the interior of the hollow body 6 can be carried out. If necessary, the profile of the retaining groove 48 can also be designed accordingly asymmetrically, with a comparatively steep flank angle on its side facing the tip 44 facing the interior and a comparatively flat flank angle on its side facing the exposed tip 42.
The second retaining groove 50, on the other hand, is provided for a corresponding catch in the piston 18. In
As can be seen in
The design of the retaining clip 56 also creates a free space inside the plunger 18 which, in the final phase of dispensing the active substance, when the needle tip 44 has already penetrated the receiving hole 19 and is therefore no longer readily accessible to the active substance, allows the active substance to flow into the needle tube 40 via the needle tip 44 in the manner of a bypass. The inflow can take place on both sides of the retaining clip 56 into the free space.
As already explained, in a further embodiment, which is also considered to be independently inventive, the piston 18 is made of several parts. As can be seen in the enlarged view according to
In order to enable the intended release of the locking element 32 for releasing the pre-tensioned spring 34, a specific design of the shaft 28 of the actuating plunger 22, which is also considered to be independently inventive, is provided. For clarification, this is shown enlarged in
In the ready-to-use state of the syringe 1, the locking element 32, which forms a number of pretensioned legs 68, is pushed onto the shaft 28 in the end region, as shown on the left in
If, as shown in
Furthermore, a notch 72 is also provided in the shaft ribs 62, 64, into which the securing spring 38 arranged in the dome plate 30 can engage when positioned appropriately. This serves to fix the assumed position after retraction of the needle 12 into the interior of the hollow body 6, so that the needle 12 remains secured there.
An alternative embodiment of a medical syringe 1′ with passive needle protection of the type mentioned, which is also considered to be independently inventive, is shown in longitudinal section in
Such a double-chamber system is particularly used for liquid and/or lyophilized (freeze-dried) or powdered medicines that need to be dissolved before administration. Such double-chamber systems are thus a particularly suitable solution for lyophilized/liquid or liquid/liquid drug combinations. The system offers a variety of advantages for sensitive injectable medicines.
The solvent, for example, is kept in the first active substance chamber 84, whereas the actual, e.g. freeze-dried or powdered active substance is located in the second active substance chamber 86. When the active ingredient is administered, the solvent provided in the first active ingredient chamber 84 is first introduced into the second active ingredient chamber 86 by actuating the actuating plunger 4 via a bypass channel 90 arranged in the housing wall of the hollow body 6 and formed by a moulding 88 in the housing jacket, past the further plunger 80. There it dissolves the active substance held there so that it is ready for administration. Subsequently, by further actuation of the actuating plunger 4, the plunger 18 is moved up to the stop against the plunger 80, and then the plungers 18, 80 are moved further together, so that the nummore dissolved active substance located in the second active substance chamber 86 is dispensed via the needle 12.
As soon as the further plunger 80 reaches the needle 12 and the latter penetrates the plunger body, the remaining active substance is dispensed and then, after the position shown in
In this alternative embodiment of the medical syringe 1′, the needle holder 10 could also be made in one piece with the hollow body 6 forming the syringe housing. In the present embodiment example, which is considered to be independently inventive, however, the needle holder 10 is designed as a separate component and can be screwed to the hollow body 6 by means of a thread, in particular a Luer thread 100. Alternatively, the needle holder 10 could also be plugged or attachable to the hollow body 6 or the syringe cone forming the syringe housing.
This application is a national phase of the international application PCT/EP2020/075087, filed Sep. 8, 2020 and titled “MEDIZINISCHE SPRITZE MIT PASSIVEM NADELSCHUTZ” (“MEDICAL SYRINGE WITH PASSIVE NEEDLE GUARD/PROTECTION”), which is hereby incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/EP2020/075087 | 9/8/2020 | WO |