APPLICATOR SYRINGE CONTAINING A STERILE SOLUTION HAVING A MEDICAL ACTIVE SUBSTANCE, AND METHOD FOR PREPARATION OF SAME

Abstract

An applicator syringe (1) is disclosed containing a sterile solution having a medical active substance, in particular for introducing the solution containing the active substance via a urinary tract and/or bladder catheter into the bladder of a patient. The applicator syringe (1) includes a cylindrical jacket (2), which is closed by a syringe cover (3), which is integrally formed with the jacket (2) and includes an outlet opening (5) and is formed from a cycloolefin copolymer (COC). The applicator syringe (1) furthermore comprises a plunger tip made of an isobutene-isoprene rubber, which is halogenated in particular. The sterile solution containing the medical active substance is arranged in a cavity (6) delimited by the cylindrical jacket (2) having syringe cover (3) and the plunger tip.

Claims

1. An applicator syringe containing a sterile solution having a medical active substance for introducing the sterile solution containing the medical active substance via a urinary tract or bladder catheter into a bladder of a patient, wherein the applicator syringe comprises: a cylindrical jacket formed from a cycloolefin copolymer (COC); a cavity defined by the cylindrical jacket; a syringe cover integrally formed with the jacket, wherein one side of the cylindrical jacket is closed by the syringe cover; an outlet opening defined by the syringe cover, said outlet opening being in fluid communication with the cavity; and a plunger made of an isobutene-isoprene rubber, said plunger being movably received within the cavity; wherein the sterile solution containing the medical active substance is received in the cavity delimited by the cylindrical jacket having syringe cover and the plunger.

2. The applicator syringe as claimed in claim 1, wherein a parasympatholytic agent is contained in the sterile solution as the medical active substance.

3. The applicator syringe as claimed in claim 2, wherein the parasympatholytic agent is contained in the sterile solution at a proportion of 0.01 to 1.0 wt. %.

4. The applicator syringe as claimed claim 1, wherein the sterile solution containing the medical active substance is an NaCl solution containing oxybutynin hydrochloride.

5. The applicator syringe as claimed in claim 4, wherein the sterile solution containing the medical active substance is an isotonic NaCl solution containing oxybutynin hydrochloride.

6. The applicator syringe as claimed in claim 1, wherein the outlet opening is formed in a stepped cone, which is integrally formed with the jacket and the syringe cover and the stepped cone has at least two cylindrical sections having different diameters which become smaller toward a tip of the stepped cone.

7. The applicator syringe as claimed in claim 6, wherein the stepped cone includes ten to fifteen cylindrical sections having different diameters which become smaller toward the tip of the stepped cone.

8. The applicator syringe as claimed in claim 1, wherein the plunger tip is made of a bromobutyl rubber that is able to be autoclaved.

9. The applicator syringe as claimed in claim 1, wherein the sterile solution contains oxybutynin hydrochloride as the parasympatholytic agent, and the sterile solution is of a volume of 1 to 50 mL in the cavity.

10. The applicator syringe as claimed in claim 1, wherein the outlet opening is closed using a closure element made of an isobutene-isoprene rubber.

11. The applicator syringe as claimed in claim 1, wherein the applicator syringe is packaged in a sterilized manner.

12. A method for providing an applicator syringe containing a medication for the introduction of the medication via a urinary tract or bladder catheter into the bladder of the patient, as claimed in claim 1, wherein the method has the following steps: providing the sterile applicator syringe, which includes the cylindrical jacket that is closed on the one side by the syringe cover, which is integrally formed with the jacket and includes the outlet opening, and the applicator syringe is formed from the cycloolefin copolymer (COC), and the plunger made of isobutene-isoprene rubber; providing a solution containing oxybutynin hydrochloride as a medication to form the sterile solution containing the medical active substance; filling the cavity of the applicator syringe delimited by the cylindrical jacket having the syringe cover and the plunger using the solution containing oxybutynin hydrochloride; closing the outlet opening of the applicator syringe using the closure element made of isobutene-isoprene rubber; and steam pressure sterilizing the applicator syringe filled with the solution containing oxybutynin hydrochloride and closed using the closure element in an autoclave.

13. The method as claimed in claim 12, wherein the step of providing the sterile applicator syringe further comprises integrally forming a stepped cone with the jacket and the syringe cover and providing at least two cylindrical sections in the stepped cone, wherein the at least two cylindrical sections have different diameters which become smaller toward a tip of the stepped cone.

14. The method as claimed in claim 12, wherein the steam pressure sterilizing is carried out in the autoclave for at least 10 minutes, at at least 115° C.

15. The method as claimed in claim 12, further comprising the step of packaging the applicator syringe, which is steam pressure sterilized, is filled with the solution containing oxybutynin hydrochloride, and is closed using the closure element.

16. The applicator syringe as claimed in claim 1, wherein the plunger is made of a halogenated isobutene-isoprene rubber.

17. The applicator syringe as claimed in claim 2, wherein the parasympatholytic agent is oxybutynin hydrochloride.

18. The applicator syringe as claimed in claim 3, wherein the parasympatholytic agent is contained in the sterile solution at a proportion of 0.05 to 0.5 wt. %.

19. The applicator syringe as claimed in claim 6, wherein the stepped cone has at least three cylindrical sections having different diameters which become smaller toward the tip of the stepped cone.

20. The applicator syringe as claimed in claim 9, wherein the sterile solution contains oxybutynin hydrochloride as the parasympatholytic agent, and the sterile solution is of a volume of 5 to 25 mL in the cavity.

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0037] Further advantages and features of the invention result from the following description of an exemplary embodiment on the basis of the appended figures. In the figures:

[0038] FIG. 1 shows a three-dimensional view of an applicator syringe according to the invention (without the plunger rod with plunger tip);

[0039] FIG. 2 shows a sectional illustration of the applicator syringe shown in FIG. 1 (again without the plunger rod with plunger tip); and

[0040] FIG. 3 shows an enlarged view of the region identified by III in FIG. 2.

DETAILED DESCRIPTION

[0041] A possible exemplary embodiment of an applicator syringe according to the invention is shown in schematic illustrations in the figures. The figures are not to scale and also do not include all elements illustrated required for the formation of an applicator syringe. In particular, a plunger rod having the plunger tip arranged thereon is not shown in the figures, as is part of the applicator syringe. Such a plunger rod is sufficiently known in its shaping to a person skilled in the art, however, so that reference can be made to the known designs. The special feature of the applicator syringe according to the invention is also not the shaping, but rather the material of the plunger tip.

[0042] An applicator syringe (shown as mentioned without the plunger rod with plunger tip) is generally identified in the figures with the reference sign 1. This applicator syringe 1 includes a jacket 2, with which a syringe cover 3 is integrally formed. Furthermore, a stepped cone 4, which is composed from a plurality of cylindrical sections 8 placed on one another having diameters each becoming smaller starting from the syringe cover 3 up to a tip of the stepped cone 4, is integrally formed on the syringe cover 3 in the exemplary embodiment shown. In the exemplary embodiment shown, these are a total of twelve such sections 8, which merge integrally via a neck into the syringe cover 3.

[0043] This stepped cone 4 integrally formed on the syringe cover 3 and thus connected to the material 2 permits connecting of the applicator syringe 1 to conical connection openings of catheters, for example those for emptying bladders, having very different shapes.

[0044] The special feature of the applicator syringe 1 according to the invention is that it is manufactured, for example injection molded, on the one hand, integrally with the jacket 2, the syringe cover 3, and the stepped cone 4 and from a special material, namely a cycloolefin copolymer (COC), and includes a plunger tip (not shown in the figures, inserted in a typical way into the jacket 2 from a rear end 7) made of a special rubber, namely an isobutene-isoprene rubber, which is halogenated in particular, for example a bromobutyl rubber that can be autoclaved. Furthermore, it is a special feature that this applicator syringe 1 contains, in a cavity 6 formed in the jacket 2 and delimited by the jacket 2, the syringe cover 3, and the plunger tip (not shown in greater detail), a sterile solution containing a medical active substance, in particular a solution containing a parasympatholytic agent, such as oxybutynin hydrochloride in particular, in particular an NaCl solution containing oxybutynin hydrochloride, in particular an isotonic NaCl solution containing oxybutynin hydrochloride is filled. In the course of the preparation, the applicator syringe 1 according to the invention, the outlet opening 5 of which has been closed in particular beforehand by a cap, which is placed on the stepped cone 4 and consists of an isobutene-isoprene rubber, which is halogenated in particular, preferably of bromobutyl rubber that can be autoclaved, has been sterilized in particular in a final step, in particular in a steam pressure sterilization in an autoclave, for example for 20 minutes at 121° C. The special material selection for the material of the jacket 2 with integrally formed syringe cover 3 and stepped cone 4 and also for the material of the plunger tip (and of the optionally usable closure in the form of a closure cap) enables no change of the active substance contained in the cavity 6, in particular with respect to its concentration in the sterile solution, to take place during this final sterilization process. The selected materials do not absorb this active substance, for example a parasympatholytic agent, for example oxybutynin hydrochloride, from the solution even at the temperatures set during the steam pressure sterilization and do not absorb it, so that no change occurs of the active substance concentration of the active substance in the solution, which is to be observed in known applicator syringe is from the prior art.

[0045] The concentration of a sterile solution containing a parasympatholytic agent, for example oxybutynin hydrochloride, in the cavity 6 can in particular be between 0.01 wt. % and 1.0 wt. %. In the exemplary embodiment described here, it is preferably 0.1 wt. %. The volume of the sterile solution received in the cavity 6 can be in particular between 1 mL and 50 mL and is preferably 10 mL in the exemplary embodiment shown.

[0046] The advantage that the stepped cone 4 is integrally formed with the syringe cover 3 is that at this point a leak to be observed in known applicator syringe is from the prior art cannot occur, so that influencing of the solution located in the cavity 6, in particular of the medical active substance dissolved therein, for example in the form of a parasympatholytic agent, such as oxybutynin hydrochloride, also cannot take place here in the final steam pressure sterilization step.

[0047] It is also clear once again from the above description of the exemplary embodiment which special advantages accompany the design according to the invention, in that this in particular enables a final sterilization of the applicator syringe 1 filled with the solution containing the medical active substance in a steam pressure sterilization step in an autoclave, without this resulting in an impairment of the solution filled in the applicator syringe 1 and the active substance dissolved therein.

LIST OF REFERENCE SIGNS

[0048] applicator syringe [0049] jacket [0050] syringe cover [0051] stepped cone [0052] outlet opening [0053] cavity [0054] rear end [0055] cylindrical section