Syringe body

Abstract

To provide a syringe body (1) for a pharmaceutical syringe (4).SOLUTION: A syringe body (1) has a cylindrical hollow chamber (6). The hollow chamber (6) has: a first basal plane (8) having a cone (10); a second basal plane opened for inserting a piston (2); and a finger flange (16) disposed in a surrounding area of the open basal plane. The finger flange (16) has an antislip member (18) for preventing slip-down of the finger during injection process on the side facing the cone (10). The antislip member (18) is formed as a surface having 0.8 μm to 150 μm arithmetic mean roughness value.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to a syringe body for a pharmaceutical or cosmetic syringe, which has a cylindrical hollow chamber, which has a first base surface with a cone, a second base surface open for inserting a piston, and a finger flange arranged in the peripheral area of ​​the open base surface, the finger flange having a non-slip member on the side facing the cone to prevent the finger from slipping off during the injection process, as well as to a method for administering a drug or cosmetic product. Within the framework of this disclosure, a medical device used for administering (injecting) liquid or fluid drugs or cosmetics, so-called injectable substances, also generally referred to as fluids for short, is called a syringe. A syringe usually includes a syringe body with a cylindrical hollow chamber and a piston moving inside the syringe body. In this case, a cone, possibly also equipped with a screw thread, is usually arranged on one base surface of the cylinder, to which a cannula or a hose is connected. On the opposite side of the cylinder, i.e., on the other base surface, the cylinder is open and a piston is inserted into this side, with which the syringe can also be pulled up; that is, by withdrawing the piston, a fluid medicine or cosmetic can be sucked in through the cone and the medicine or cosmetic can be administered.

[0002] Alternatively, the syringe may already be filled with the drug or cosmetic product in a particularly sterile condition by the manufacturer, so that there is no need to draw up the drug or cosmetic product prior to administration.

[0003] Furthermore, the syringe body and the syringe including the syringe body disclosed in the present invention can be used in both veterinary and human medicine. To administer a fluid drug or cosmetic from the cylindrical hollow body, the piston is pushed, which forces the contents through the cone. To allow this process to be performed with one hand, finger flanges are generally arranged around the area around the open base surface, i.e., around the opening through which the piston is inserted. The finger flanges are gripping means for supporting the syringe body against pressure on the piston. Typically, the syringe body is supported at the finger flanges by the index and middle fingers, and the thumb presses the piston into the syringe body.

[0004] In this case, in order to prevent the finger from slipping off during the injection process, particularly in the case of relatively large syringes of about 20 ml or more, a non-slip element is often arranged on the finger support surface, i.e., the finger flange, on the side facing the cone. For this purpose, a number of spaced, tangentially oriented raised cross members are often provided. [Background technology]

[0005] The publication US Pat. No. 4,994,012 describes a corresponding syringe body having tungsten for radiation shielding, as well as a syringe having this syringe body.

[0006] The syringe disclosed in US Pat. No. 6,004,299, which has a glass syringe body, defines lateral finger support surfaces which are believed to form longitudinal ribs.

[0007] The gripping device for a syringe body described in US20120041388 can be encompassed by almost all the fingers of one hand, except the thumb. However, due to the size of the gripping device according to the above principle, into which the syringe body is fitted, the syringe body cannot be manipulated very well, since the relatively delicate movements of the fingers to manipulate the syringe are no longer provided, but only the movements of the whole hand. Moreover, it is considered troublesome to first attach the gripping device to the syringe body in order to be able to use the syringe later.

[0008] Also, in the case of the gripping device for a syringe body described in publication US20130178737, it would be cumbersome to first attach the gripping device to the syringe body in order to be able to use the syringe at a later time.

[0009] For example, it has been found that a structure having vertical ribs can lead to support problems for the syringe body: when a syringe body molded according to the principles described above is stood on a flat base with its flange surface, the syringe body has a tendency to tilt. Summary of the Invention [Problem to be solved by the invention]

[0010] SUMMARY OF THE DISCLOSURE The object of the invention is therefore to provide a syringe body of the type mentioned at the outset which can be supported in a particularly stable manner. [Means for solving the problem]

[0011] In the present invention, this problem is solved by forming the anti-slip member as a surface having an arithmetic mean roughness value of 0.8 μm to 150 μm.

[0012] In this case, the invention starts from the consideration that a particularly stable support can be achieved by avoiding tilting of the syringe body when standing on the flange surface. It was realized that the tilting can be caused by an irregular surface, which obviously occurs during the molding of the flange. In particular, it was realized that recesses in the form of depressions occur, the extent of which corresponds to the cross member mentioned at the beginning. In other words, the raised structure for increasing the gripping ability leads to a recess on the opposite side and thus to an irregular surface. Based on the further realization that these recesses are caused by local material accumulations which occur due to the shape of the cross member, it is desirable to avoid such material accumulations. In order to nevertheless maintain gripping ability and slip resistance, it is desirable to provide an alternative configuration of the anti-slip element which does not lead to local material accumulations.

[0013] For this purpose, it is advisable to use a uniformly roughened surface which avoids localized material accumulation, but in order to ensure grippability, it is advisable to ensure a correspondingly high roughness of the surface.

[0014] Tests have shown that average roughness values ​​above 0.8 μm are adequate to ensure the desired slip-off safety.

[0015] In this case, the anti-slip member is preferably formed as a surface having an arithmetic mean roughness value of 5 μm to 100 μm, more preferably 10 μm to 50 μm.

[0016] In an advantageous configuration, the finger flange forms a plane together with the open base surface, i.e. the opening for inserting the syringe piston is located in the flat finger flange. As mentioned above, it is precisely in such syringe bodies that the problem of tilting occurs when standing on the plane of the flange, so that the above-mentioned configuration of the anti-slip member provides a special advantage.

[0017] Furthermore, the flange is preferably formed mirror-symmetrically with respect to a plane containing the axis of the cylindrical cavity, i.e., such a flange has two symmetrical extensions on both sides of the opening for the piston, thereby providing suitable support surfaces for the index finger and the middle finger. Both support surfaces are provided with anti-slip elements accordingly.

[0018] In another advantageous configuration, the writing surface is arranged on the side of the finger flange facing away from the cone. In this configuration, the above-mentioned configuration of the anti-slip element provides an additional advantage: the syringe body is usually manufactured from a transparent material, so that the anti-slip element on the rear side of the writing surface is visible. In this case, the cross member mentioned at the beginning reduces the readability of the writing due to refraction and reflection effects. In contrast, a rough surface - as described above - significantly improves the readability of the writing.

[0019] In a further significantly more advantageous configuration, the anti-slip elements cover more than 60%, preferably more than 80%, of the area of ​​the finger flange, which ensures a sufficient to particularly good slip-off safety.

[0020] Furthermore, the surface preferably has a regular geometric structure, ie a repeating pattern, or an irregular statistical structure, ie a random distribution of irregularities.

[0021] Moreover, the anti-slip element is advantageously spaced from the peripheral wall of the cylindrical cavity, in other words, the rough surface of the anti-slip element does not extend to the cylindrical part of the syringe body, but ends just before it (e.g., more than 1 mm before) and then transitions to a smooth surface that extends to and connects to the cylindrical part, thereby preventing the formation of particles due to the porosity coming into contact with the smooth surface during the molding process.

[0022] Advantageously, the syringe body, i.e. the wall surrounding the cavity, the cone and the finger flange are formed in one piece, i.e. are produced directly, for example, by injection molding. It is precisely in the case of syringe bodies produced in this way by injection molding that the problem of the recesses mentioned at the outset is particularly evident. In contrast, in the case of glass injection, it may be advantageous to use separate finger flanges that are fitted over the wall and can be slipped over, since it is difficult to produce finger flanges that are not cylindrically symmetrical from glass.

[0023] In a preferred embodiment, the syringe body is made of plastic, in particular a cycloolefin polymer or a cycloolefin copolymer, and in particular such a syringe body is preferably made in one piece.

[0024] The pharmaceutical syringe preferably comprises said syringe body and a movable piston disposed within the cylindrical cavity.

[0025] The advantage achieved by the invention is in particular that by using a rough surface with an arithmetic mean roughness value of more than 0.8 μm as anti-slip element on the finger flange of the syringe, on the one hand a particularly good gripping is achieved and on the other hand a particularly smooth surface of the flange is achieved on the opposite side, which prevents tilting when supported. Moreover, such a surface also improves the readability of any characters present.

[0026] In laboratory medicine or clinical routine, substances are often used that have a high contamination risk for the respective user and patient when preparing and administering the corresponding medicines, especially when injecting them, which may be, for example, ionizing radiation-emitting or biologically active substances of the medicine to be administered, which also have a high risk of damage for medical personnel, especially if, for example, the syringe body is not handled properly, which may occur, for example, if the syringe body is not positioned correctly during handling or if it requires an increased expenditure of force, for example when administering highly viscous fluids.

[0027] In each of these instances, when handling the syringe, the syringe body may slip off, causing such materials to spill and come into inconvenient contact with both the patient and medical personnel.

[0028] Also, for example in intramuscular depot delivery, a poorly positioned injection when the substance to be delivered is delivered to a vessel, such as a vessel conducting blood or lymph, can be harmful to the respective patient. This situation is usually made even more difficult when, for example, protective gloves are worn during handling as described above.

[0029] Here, the syringe and its syringe body disclosed by the present invention have been found to be particularly useful, since the handling is significantly improved by the non-slip member disclosed by the present invention, which has a surface formed to have an arithmetic mean roughness value of 0.8 μm to 150 μm.

[0030] On the one hand, the probability of slipping off is significantly reduced and on the other hand, more precise handling, for example when positioning the injection to be performed, is significantly improved.

[0031] These advantages are especially -Injection or administration of medicines in oral surgery, in particular injection of anesthetics into the patient's oral cavity and / or - the injection or administration of medicinal products in ophthalmology, particularly to suppress the eyelid reflex or to dilate the pupils of a patient; and / or - injection or administration of medicinal products in nephrology, in particular for administering marker substances for tracking hydrodynamic processes; and / or - injection or administration of medicinal agents in nuclear medicine, preferably for the administration of radioisotopes for tumor therapy and / or - Injection or administration of cosmetic products, for example products based on hyaluronic acid or Botox This occurs when using the syringe disclosed in the present invention and its syringe body in medical or cosmetic procedures, including

[0032] Said advantages are even more pronounced, for example, when the administered fluids are injected or administered using protective gloves, in particular protective gloves for single use that correspond to DIN EN 455 "Medical gloves for single use".

[0033] In this case, fluids that may be injected or administered include: - Patient-specific drugs containing genetically engineered substances are included and / or - contains biologically or microbiologically produced or grown agents and / or -Includes tumor-specific markers specific to each patient.

[0034] One further advantageous use of the syringe and its syringe body is in a method for injecting or administering a fluid which is administered using protective gloves, in particular protective gloves against ionizing radiation and radioactive contamination, in particular protective gloves corresponding to DIN EN 421.

[0035] In this case, for example, fluids that generate ionizing radiation can be injected or administered with significantly increased safety, said fluids including, in particular, radioactive patient-specific tumor marker substances and / or drugs carrying radioactive patient-specific gene sequences.

[0036] Although commercial aspects have not been at the forefront of the targeted improvements, it is noted for the sake of completeness that the abovementioned drugs, in particular patient-specific drugs, can be very expensive to produce, which is especially evident when incorrect administration leads to at least partial losses, the frequency of such cases can also be reduced by the method disclosed according to the invention. [Brief description of the drawings]

[0037] The present invention will now be described in more detail with reference to the accompanying drawings, in which: FIG. [Figure 1] FIG. 1 is a schematic diagram showing a pharmaceutical syringe. [Diagram 2] 1 is a three-dimensional view showing an anti-slip member provided on a finger flange of a syringe. FIG. [Diagram 3] 1A-1C show improved anti-slip members with various rough surfaces. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0038] In all the drawings, the same elements are given the same reference numerals.

[0039] In Fig. 1 a syringe body 1 with a piston 2 is shown diagrammatically, which together form a pharmaceutical syringe 4. The syringe body 1 is made of a transparent plastic, in the example a cycloolefin polymer or cycloolefin copolymer, and has a hollow chamber 6 with a cylindrical wall. The cylindrical wall is substantially closed at a first base face 8, except that the liquid in the hollow chamber 6 can be forced out through a cone 10 there. This is done by pushing in the piston 2, where a circular piston bottom 12, which conformably abuts against the wall of the hollow chamber 6, pressurizes the liquid.

[0040] To insert the piston 2 into the hollow chamber 6, the second cylindrical base surface of the hollow chamber 6 is open. To press the piston 2, the piston 2 has a pressing surface 14 on the side opposite the piston bottom 12, which is typically operated by the thumb of the user. For support, a collar-shaped finger flange 16 is molded around the circular opening of the hollow chamber 6. The finger flange 16 forms a flat surface around the opening, the normal of which is the axis of the cylindrical hollow chamber 6.

[0041] In the present exemplary embodiment, the wall of the cavity 6, the cone 10 and the finger flange 16 are formed in one piece. This can be achieved, for example, by producing the syringe body 1 by an injection molding process, since in the present exemplary embodiment the syringe body 1 is made of plastic. In an alternative embodiment, however, the wall and the cone 10 can also be made of glass. In this case, the finger flange 16 is formed as a separate component that can be slipped on.

[0042] The configuration of the finger flange 16 will now be explained in more detail. Figure 2 shows a three-dimensional view of the syringe body 1, partially cut away, in the region of the finger flange 16 according to the prior art. The finger flange 16 is formed mirror-symmetrically with respect to a plane passing through the axis of the cylindrical cavity 6 and has a trapezoidal outer contour in each symmetrical plane, the longer base surface of which only slightly exceeds the outer diameter of the cylinder.

[0043] This results in the formation of two wings of the finger flange 16, one of which can be gripped by the index finger and the other by the middle finger of the user while the thumb presses down on the piston 2 as described above. In this case, in order to avoid slipping off the index and middle fingers, each wing of the finger flange 16 is arranged with a number of anti-slip elements 18 on the side facing the cone 10. These anti-slip elements 18 are formed in the prior art shown in Figure 2 as three highly raised cross members, which run parallel to the trapezoidal base surface of the wing.

[0044] In this case, the problem arises that the syringe body 1 is not stable in the position shown in Figure 1, i.e. in the position where the syringe body 1 is resting on the finger flange 16, and tilts. This is caused by a depression of the finger flange on the side opposite the cross member. Moreover, the cross member prevents the reading of the characters arranged on the opposite side of the finger flange 16.

[0045] To solve this problem, a non-slip member 18 is formed as shown in Fig. 3, and only the differences from Fig. 2 will be described. In Fig. 3, the finger flange 16 is shown from above in the left half of the figure. The cross member of the non-slip member 18 is eliminated.

[0046] Instead, the surface is roughened over more than 80% of the area of ​​the parallel lines of the finger flange 16. In this case, in a preferred embodiment, an arithmetic mean roughness value of 10 to 50 μm is assumed. To determine this measurement, a defined measurement section of the surface is scanned and all height differences of the rough surface are recorded. The definite integral of this roughness characteristic line over the measurement section is calculated and finally this result is divided by the length of the measurement section to obtain the arithmetic mean roughness value.

[0047] The roughened surface is produced by correspondingly forming the mold. In the right half of Fig. 3, exemplary possibilities for forming the rough surface of the anti-slip element are shown, for example by random statistical roughening of the surface (left) or by regular geometric patterns (right). Furthermore, in the left half of Fig. 3, it can be seen that the parallel line surface of the anti-slip element 18 formed in this way does not reach the outer diameter of the cavity 6, but a smooth transition area is left between the anti-slip element 18 and the peripheral wall of the cavity 6. [Explanation of symbols]

[0048] 1 Syringe body 2 Pistons 4 syringe 6 Hollow chamber 8 Basal plane 10 Cone 12 Piston bottom 14 Pressing surface 16 Finger flange 18 Anti-slip material

Claims

1. A syringe body (1) for a pharmaceutical syringe (4), The syringe body (1) has a cylindrical hollow chamber (6), and the hollow chamber (6) is A first base surface (8) having a cone (10), The second base surface is opened for inserting the piston (2), A finger flange (16) is positioned in the region surrounding the open base surface, It is equipped with, The finger flange (16) together with the open base surface forms a single plane. The finger flange (16) has an anti-slip member (18) on the side facing the cone (10) to prevent the finger from slipping during the injection process, while the surface of the finger flange (16) on the opposite side of the cone (10) is smooth. The anti-slip member (18) is formed as a surface having an arithmetic mean roughness value of 5 μm to 50 μm. The syringe body (1) is formed integrally, Syringe body (1).

2. The anti-slip member (18) is formed as a surface having an arithmetic mean roughness value of 10 μm to 50 μm. The syringe body (1) according to claim 1.

3. The finger flange (16) is formed in a mirror-image symmetric manner with respect to a plane containing the axis of the cylindrical hollow chamber (6), Syringe body (1) according to claim 1 or 2.

4. A lettering surface is provided on the side of the finger flange (16) opposite to the cone (10). A syringe body (1) according to any one of claims 1 to 3.

5. The anti-slip member (18) covers more than 60%, preferably more than 80%, of the area of ​​the finger flange (16). A syringe body (1) according to any one of claims 1 to 4.

6. The surface has a regular geometric structure or an irregular statistical structure. A syringe body (1) according to any one of claims 1 to 5.

7. The anti-slip member (18) is separated from the peripheral wall of the cylindrical hollow chamber (6), A syringe body (1) according to any one of claims 1 to 6.

8. The syringe body (1) is made of plastic, in particular a cycloolefin polymer or a cycloolefin copolymer. A syringe body (1) according to any one of claims 1 to 7.

9. A syringe (4) for pharmaceutical or cosmetic use, comprising a syringe body (1) according to any one of claims 1 to 8, and a movable piston (2) disposed within the cylindrical hollow chamber (6), Syringe (4).

10. The syringe is, - Injection or administration of pharmaceuticals in oral surgery, particularly injection of anesthetics into the oral cavity of patients and / or - In particular, the injection or administration of ophthalmic drugs to suppress the eyelid reflex or dilate the pupils of patients and / or - In particular, the administration of marker substances in nephrology for tracking fluid dynamic processes, and / or the infusion or administration of pharmaceuticals. - Preferably, for administering radioisotopes for tumor treatment, infusion or administration of pharmaceuticals in nuclear medicine and / or, - For example, injection or administration of cosmetic drugs such as hyaluronic acid or Botox-based drugs. Used in medical or cosmetic procedures, including The syringe according to claim 9.

11. In particular, injecting or administering a fluid to be administered using protective gloves, especially protective gloves for single use corresponding to DIN EN 455 "Medical gloves for single use", A syringe according to claim 9 for using the method according to claim 10.

12. A fluid is injected or administered, and the fluid is - Contains patient-specific medications containing genetically modified substances and / or - Contains and / or chemicals manufactured or grown biologically or microbiologically. - Contains patient-specific tumor-specific marker substances, A syringe according to claim 9, particularly for using the method described in claim 11.

13. A fluid is injected or administered using protective gloves, particularly protective gloves against ionizing radiation and radioactive contamination, particularly protective gloves corresponding to DIN EN 421. A syringe according to claim 9, particularly for using the method described in claim 10.

14. A fluid that generates ionizing radiation is injected or administered, which includes a radioactive patient-specific tumor marker substance and / or a drug having a radioactive patient-specific gene sequence. A syringe according to claim 9, particularly for using the method described in claim 13.

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