DE2046953A1 - Syringe filled through the closure opening and method of filling it - Google Patents

Description

Patent attorneys Dipl.-Ing. F. Weickmann, 2046953

D1PL.-ING. H.Weickmann, Dipl.-Phys. Dr. K. Fincke Dipl.-Ing. F. A-Weickmann, Dipl.-Chem. B. Huber

DMABM g MUNICH 86, DEN

PO Box 860 820

MÖHLSTRASSE 22, CALL NUMBER 48 3921/22

<983921/22>

Sherwood Medical Industries Inc., 1831 Olive Street, St. Iiouis, Mossouri, V.St.A.

Filled syringe and procedure for their filling

The present invention relates to a syringe with a tubular cylinder having a chamber opening axially through the outer end of the cylinder forms and a fastening device at the inner end of the cylinder for a communicating with the chamber Hadel, especially on syringes with plungers.

With conventional plunger syringes, the syringe is filled via the end of the Madeleine. However, this procedure is undesirable if the filled syringe is to be kept, i.e. if the syringes are prefilled acts. In addition, when filling a syringe via the loading process, optimal aseptic conditions can be achieved not achieve. As an example, it has been found that the very small clear width of the needle or the needle connection tip due to the drying drug becomes clogged.

10 9 8 16/1507

2Q46953

To solve this problem, attempts have been made to fill the syringe through the closure end of the barrel remote from the needle. Such pulling of the syringe provides improved storage characteristics as the air between the plunger and the liquid medicament is removed upon insertion of the plunger. To this end, known devices for pulling syringes through the closure end have used needles, rods, valves, conically shaped sockets, etc. in order to vent the air trapped in front of the plunger. These W devices are not only relatively complex and expensive, but it has also been found that they can lead to contamination or even poisoning of the liquid medicament.

The present invention provides an improved syringe assembly that at the piston during insertion deforms the locking end of the cylinder into the position of engagement with the previously filled liquid medicament is used to create a bypass path for ventilation to build. The deformation device can be tubular Contain element that can accommodate the piston under pressure ^ and has a game in the cylinder to a easier movement of the inner end of the element through the locking opening of the cylinder in a side-by-side position Allow position with the liquid medicament, with the trapped air through the space between this element and the cylinder can escape. After reaching the fully deployed position the piston is moved out of its position within the sleeve-shaped end of the element, whereby the piston can expand into sealing, sliding engagement with the cylinder wall. The piston itself can

- 3 109816/1507

attached to the inner end of a rod, which extending outwardly from the piston through the outer end of the cylinder.

In a specific embodiment of the invention The rod extends coaxially through the tubular bushing, the inner bore of which is enlarged radially at the inner end is to form a piston receiving recess. The tubular socket also has a recess at the outer end to receive the thumb piece of the rod. The movement between the rod and the socket can be done manually to selectively deform and To effect release of the piston.

Notwithstanding this embodiment mentioned above, the piston can or the like by a rib. on the inside End of the sleeve are deformed, this rib extending along the piston to deform an outer wall portion of the piston radially inwardly and thereby a bypass path for venting the cylinder to create during the insertion of the piston. Break if desired, a plurality of such ribs can also be provided in order to create a plurality of such bridging paths which makes it easier to ventilate when the piston is inserted.

In addition, the present invention encompasses a method of julling a syringe with a liquid Medicament, which is characterized by the following steps: introduction of the liquid medicament through the Needle remote locking end of the syringe barrel, insertion of a compliant plunger through the locking end with simultaneous deformation by a bridging

9 '; 1 H / 1 RO 7

Kungspfad to form from the inside of the piston to the closing end, so that "when moving the piston after allowing the drug to air out of the cylinder and eventually canceling the plunger deformation this reaches the liquid medicament so that the piston comes into sliding sealing engagement with the cylinder. The syringe can be pulled to obtain a pre-filled syringe unit that can be used at a later date will be annulled. In such a case, the needle end of the syringe is kept tightly sealed. in the other case, i.e. if the syringe is not used for later purposes If the syringe is to be filled and stored, the syringe will be in the one indicated above at the time of use Way filled over the breech end.

On the basis of the exemplary embodiments shown schematically in the figures of the drawing, the invention is to be explained in more detail below with further features. It shows:

1 shows an enlarged partial front view of a syringe according to the invention, in which individual areas are broken open are to facilitate the illustration of the features of the invention,

FIG. 2 is a view similar to FIG. 1, in which the arrangement of the syringe during the insertion of the Piston is shown,

3 shows an exploded view, partially broken away, of a syringe according to the invention, in which the plunger

the

and the deformation-serving bushing according to the invention are shown prior to insertion into the syringe barrel,

- 5.109818 / 1507

4 shows a view of a first embodiment of such a bush,

Pig. 5 a view of the arrangement according to Pig, 4,

Pig. Figure 6 is a partially broken away front view of a second embodiment of a bushing for deformation of the piston for ventilation purposes,

Pig. 7 a bottom view of the socket after Pig. 6,

Pig. 8 is a partially broken away front view of a third embodiment of a deformation bushing; and

Pig. 9 a bottom view of the Pig socket. 8th.

In the embodiment of the invention according to the Pig. 1 to 3 includes one indicated generally at 10 Syringe has a usually tubular barrel 11 which has an axially opening through an outer end 13 Chamber 12 forms. The inner end 14 of the cylinder 11 is provided with an outlet opening 15 which in a connecting part 16 leads to the attachment of a needle, e.g. the more conventionally designed needle 17, which is in a fluid connection with the inner end of the cylinder. In the illustrated embodiment, the connector contains a common locking connector, it should be understood that any suitable needle connector in connection with the present Invention can be used. Before the needle 17 is inserted into the connecting piece 16, it can be turned into usually be closed by a known zap 18, which is in the Pig. 2 and 3 is shown.

- 6 10981R / 15 07

The syringe 10 may contain a prefilled syringe, in which a liquid, for example a liquid Medicament 19, is present in part 20 of chamber 12 within piston 21. In the illustrated embodiment, the liquid 19 is over the outer end filled into the chamber 12. Subsequently, the piston 21 is introduced through the outer end of the chamber 12, in order to intervene in the liquid 19 in the manner shown in FIG. To enable the piston to be inserted, is around the piston a from the inner chamber portion 20 to the outer opening 13 extending bridging path 22 is provided by a vent the chamber 12, while this moves down into the position of FIG.

The invention comprises providing the vent passage 22 with the aid of a tubular element or bush 23, the outer diameter of which is slightly smaller than the inner diameter of the cylinder 11. The bore 24 of the bush 23 is stepped in the region 25 to form a radially enlarged inner end region 26 form, which can receive the piston 21 in the manner shown in FIG. The piston 21 is preferably made of a resilient material, such as neoprene rubber, for example, in order to allow the necessary compression for introducing the piston into the bore section 26 (FIG. 3). The piston is attached to the end connection portion 27 of a rod 28 which has an outer thumb piece 29. The rod 28 extends coaxially through the bore 24 of the socket 23. As shown in Figure 2, the transverse dimension of the rod 28 is slightly smaller than the diameter of the bore 24, thus allowing rapid coaxial movement of the rod 28 through that bore will. IN THE

- T -

1 0 9 8 1 R / 1 B 0 7

To facilitate a relative movement between the rod 28 and the bushing 23 as well as between the bushing 23 and the cylinder 11, the outer end of the bushing 23 is provided with a flange 30. The pad 30 is spaced outwardly from the usually provided outwardly curved pad 31 of the cylinder to enable the user to bring his pingers under the pad 30 while the thumb rests on the thumb piece 29 to thereby quickly release the plunger 21 to be able to move inward from the bore section 26 _o One therefore holds, as in Pig. I, the piston 21 in contact with the liquid medicament 19 and forcing the sleeve 23 outwardly, the lower end of the sleeve is withdrawn from the piston allowing it to expand radially so that it is in sliding sealing engagement with the cylinder wall arrives in the bore section 20, and thereby enables a subsequently controlled ejection of the liquid medicament through the needle 17.

The flange 30 of the socket 23 has 32 in its surface a recess 35, the size and Porm is chosen so that it receives the thumb piece 29 of the rod 28 when $ the rod is pushed completely into the socket 23. When moving the rod 28 relative to the socket 23 out of position after Pig..2 in the position after Pig. I got that Thumb piece 29, / the recess 35 »so that the appearance of a one-piece piston is obtained.

In normal use, the piston 21 can be in its retracted position within the bore section 20 according to Pig. 3 are held so that the movement of the nested piston with the socket 23 in the

1 0 9 a 1 R / 1 R Π 7

Cylinder 11 is facilitated. Notwithstanding this, however, the piston at the rod end 27 can be inside the socket, (the arrangement according to Pig. 1) and inserted into the open end 13 of the cylinder 11. The piston is then introduced into the bore section 26 by a combination of forces resulting from the compressive forces the user's finger on the surface 32 of the flange 30 and the fluid pressure within the bore 12 consist on the piston 21 such that the piston moves axially into the socket at the end 26. Is once the piston is fully received in the bore end 26, so the further movement of the assembly discussed above Manner, since the bushing and the piston are now in the arrangement shown in FIG. This method, in order to bring the piston into the bore end 26 during assembly, it is advantageous if the piston 21 consists of a material that could stick or seize if it has been in the bushing for a long time 24 would be included.

The syringe 10 thus provides an improved arrangement that permits a prior filling of the syringe below optimal allows aseptic conditions in the form of a filling through the closure end with the liquid medicament. As already mentioned above, the liquid medicament can be dispensed by the subsequent introduction of the piston 21 be retained in the prefilled syringe in the manner described above with the plunger engaged with the surface of the liquid can be brought by moving the piston in one with simultaneous venting movement made by the cylinder is shifted, so that the aseptic conditions of the over the syringe filled with the cap side.

1 0 9 Π 1 R / 1 R η 7

If the syringe is to be used, the cap 18 is removed and the needle 17 is inserted into the connecting piece 16 is usually introduced and the liquid medicament is pressed out through the needle by the fingers of the The user engages in the splash 31 and the thumb piece 29 in order to push the rod 28 inwards to push.

Generally speaking, the invention includes providing means for deforming piston 21 during its insertion through the bore 22 to form a bridging path through which the bore 22 to the Facilitate the movement of the piston to the position shown in FIG. 2 to vent. As discussed above, is in one embodiment this device for forming a bridging path with a device for Receiving the piston under pressure at one end of a tubular sleeve 23 is provided. The socket construction is shown in Figs. As will be readily apparent to any person skilled in the art, other forms of piston deforming devices can also be used can be used without therefore departing from the scope of the present invention. Illustratively, a bush 123 is shown in FIG. 4, which is constructed similarly to the bush 23, but in a large number of end prongs 133 that are objected in the initial direction which effectively deflect the piston when it is withdrawn into space 126 radially inward of the pins. In the exemplary embodiment according to FIG. 4, three such prongs are offset from one another by 120 °, about the axis the socket arranged. 8 and 9 show a further modified form of a socket 223, which has a single drooping claw or prong 233 with a radially inwardly protruding rib 234

- 10 -

1 0 9 B 1 R / 1 Fi 0 7

ίο -

has, Äie the piston forming an air passage deformed to deflate the cylinder when the piston is inserted.

Each of the bushings 23, 123 and 223 is similar to the others constructed and work in a similar manner with the exception of the specifically listed differences. With everyone Embodiment, devices are provided to the piston during ^ Insertion into the cylinder bore deform to thereby form a vent passage. The deformation devices are of an elongated Supported element which extends outwardly from the cylinder and for separating the deformation devices is used by the piston after it has reached the desired fully retracted position in which it is in the normal way inside the cylinder works. In this context, too, it is clear to the person skilled in the art that the elements supporting the deformation devices can have other configurations than those shown tubular sockets. The individual parts of the invention Syringes can be made of suitable materials, such as plastic, for their sterilization to facilitate. The syringes can also be prefilled syringes which can only be used once.

- patent claims -

- 11 -

1Q981R / 1R07

Claims (14)

- ii - PATENT CLAIMS l.j syringe with a tubular cylinder, which is a. "" Chamber opening axially through the outer end of the cylinder "and a fastening device on the inner end of the cylinder for a communicating with the chamber Needle, characterized by a resilient piston (21) which has a sealing sliding fit in the chamber (20) Has cylinder (11), an actuating device extending outwardly from the piston (21) through the outer end (13) (28) for the piston and one extending outward from the interior of the chamber through the outer end (13) Control device (23, 123, 223) and selectively either a) a relief channel (22) bridging the piston (21) for venting the one located inside the piston To form chamber section (20), or b) to bring the piston (21) into sealing sliding engagement with the cylinder (11), so that when on the inner End of the chamber (20) directed movement of the piston a fluid medium (19) from the chamber through the fastening device (16) is pressed for the needle (17). 2. Syringe according to claim 1, characterized in that the control device (23, 123) has a tubular interior End (26, 126) which detachably receive the piston (21) can and means to move the piston axially inward therefrom, and that between control means and cylinder (11) forming a bridging path for the fluid medium to the outer end of the cylinder Space (22) consists " - 12 - 1 0 9 8 1 R / 1 R η 7 3. Syringe after. Claim. 2, characterized in that the Control device extending outwardly from the tubular inner end through the outer end (13) of the cylinder Pipe part (23, 123,) contains, and that the KoI benbetsteuereinrichtung a rod (28) attached to the piston (21) and projecting coaxially through the control device (23, 123). 4. A syringe according to claim 2 or 3, characterized in that the control device has an axially inwardly directed Shoulder forms so that the piston after its displacement axially from the tubular inner end remains within this end and cannot move back by itself. 5. Syringe according to one of claims 2 to 4, characterized in that that the position of the inner end of the control device by outside the outer end (13) of the cylinder arranged devices (23, 30) is adjustable. 6. Syringe according to one of claims 1 to 5, characterized in that that the control device (123, 223) is removable along the piston (21) between this and the cylinder (11) extending deformation devices (133; 233, 234) contains, by deformation of the Kolbeas (21), a bridging path between pistons and forming cylinders to the outer end (13) of the cylinder. 7. Syringe according to claim. 6, characterized in that that the control device (123) a plurality of coaxially spaced, a plurality of bridging paths constituting elements (133). - 13 10981R / 1S07 8. A syringe according to claim 6, characterized in that the deformation device (223) has a radial cash contains inwardly projecting rib (234). 9 · Syringe according to claim 6, characterized in that the control device is a tubular element (23) with an axial bore, which is enlarged in the axial direction inner, which the piston having receiving tubular inner end forming portion (26). 10. Syringe according to one of claims Ϊ to 9 »characterized in that that the control device at the outer end is provided with a recess (35) splash (30) has, in which the thumb part (29) of the actuating device is received when the piston (21) in sealing There is sliding engagement with the cylinder (11). 11. Syringe according to one of claims 1 to 10, characterized by a closure (18) "in order to prevent the fluid medium from escaping through the jacket fastening device (16) and prevent a liquid medicament (19) in the chamber section located inside the piston (21) (20), which is held therein by the piston (21) engaging sealingly in the cylinder. 12. Method of! Filling a syringe with a liquid Medicament, characterized by the following steps: introduction of the liquid medicament through that remote from the needle Locking end of the syringe barrel, insert a resilient plunger through the locking end underneath simultaneous defamation to create a bridging path from the inside of the plunger to the end of the closure, so that when the plunger is moved onto the medication - 14 1 0 9 8 1 R / 1 S 0 7 2041 to air can escape from the cylinder and cancel the basket deformation after this liquid medicament is reached so that the piston comes into sliding sealing engagement with the cylinder, 13. The method according to claim 12, characterized in that during the inserting step, the entire piston is deformed avoiding contact with the cylinder . will. 14. The method according to claim 12, characterized in that only part of the piston during the insertion step is deformed while avoiding contact with the cylinder. 10981 Blank page