Syringe body

Description

[0001] The invention relates to a syringe body for a pharmaceutical or cosmetic syringe, comprising a cylindrical cavity with a first base surface with a cone, a second, open base surface for inserting a piston, and with a finger flange arranged in the region of the circumference of the open base surface, wherein the finger flange has an anti-slip element on the side facing the cone to prevent a finger from slipping during the injection process, as well as a method for applying a pharmaceutical or cosmetic.

[0002] A syringe is a medical instrument used to administer (inject) liquid or fluid medications or cosmetics - so-called injectables - which are generally also referred to as fluids in the context of the present disclosure. A syringe usually comprises a syringe body with a cylindrical cavity and a piston moving therein. A cone, possibly with a screw thread, is usually arranged on one base of the cylinder, to which a cannula or tube is connected. The opposite side, i.e. the other base of the cylinder, is open so that the piston is inserted on this side, with which the syringe can be drawn up, i.e. by pulling out the piston a fluid pharmaceutical or cosmetic can be sucked in through the cone, and the pharmaceutical or cosmetic can also be administered.

[0003] Alternatively, the syringe can already be filled with a pharmaceutical or cosmetic by the manufacturer, especially in a sterile manner, so that there is no need to draw up the pharmaceutical or cosmetic before its application.

[0004] Furthermore, the syringe bodies disclosed herein and the syringes comprising them can be used in both human and veterinary medicine.

[0005] To administer the fluid pharmaceutical or cosmetic from the cylindrical hollow body, the plunger is pushed in, forcing the contents through the cone. To allow this process to be performed with one hand, a finger flange is usually arranged around the circumference of the open base, i.e., around the opening into which the plunger is inserted. This provides a grip for holding the syringe body against the pressure on the plunger. Typically, the syringe body is held by the finger flange with the index and middle fingers, and the plunger is pressed into the syringe body with the thumb.

[0006] To prevent a finger from slipping during the injection process, especially with larger syringes (approximately 20 ml and above), an anti-slip element is often arranged on the finger support surface, i.e., on the side of the finger flange facing the cone. Raised cross struts are often provided for this purpose, which are aligned at tangential intervals.

[0007] The document US 4 994 012 B shows a corresponding syringe body which has tungsten for radiation shielding, as well as a syringe having this.

[0008] US 6 004 299 B discloses a syringe with a syringe body made of glass, which defines lateral finger support surfaces which appear to form longitudinal ribs.

[0009] US 2012 / 0041388 A shows a gripping device for a syringe body that can be almost completely enclosed by the fingers of one hand, except for the thumb. However, due to the inherent size of the gripping device into which the syringe body is to be inserted, the respective syringe body becomes less easy to handle, as the more sensitive movement of the respective fingers operating the syringe is no longer available, but rather only movements of the entire hand are available. Furthermore, it appears cumbersome to first attach the gripping device to the syringe body in order to then be able to use the syringe.

[0010] The document US 2013 / 0178737 A also shows a gripping device for a syringe body, in which it appears to be cumbersome to first attach the gripping device to the syringe body in order to then be able to use the syringe.

[0011] The US patent application US 2009 / 171297 A1 describes a one-piece syringe body with a finger flange, which, however, does not include an anti-slip element.

[0012] It has been found that, for example, designs with longitudinal ribs can lead to storage problems for the syringe bodies: Syringe bodies cast according to the principle described above tend to tilt when placed on a flat surface on the flange surface.

[0013] It is therefore an object of the invention to provide a syringe body of the type mentioned at the outset which can be stored particularly stably.

[0014] This object is achieved according to the invention with a syringe body according to claim 1.

[0015] The invention is based on the idea that particularly stable mounting could be achieved by preventing the syringe body from tipping when placed on the flange surface. It was recognized that the tilting is due to an irregular surface that apparently arises during the casting of the flange. In particular, it was recognized that sink marks arise in the form of depressions that correspond in extent to the cross struts described above. Raised structures to increase grip therefore lead to sink marks on the opposite side and thus to an irregular surface. Based on the further recognition that these sink marks are caused by a local accumulation of material caused by the shape of the cross struts, such an accumulation of material should be avoided.However, in order to maintain grip and slip resistance, an alternative design of the anti-slip element should be provided that does not lead to local accumulation of material.

[0016] For this purpose, a uniformly roughened surface should be used to avoid localized material accumulation. However, to ensure grip, a sufficiently high surface roughness is required.

[0017] In tests, a mean roughness value of more than 5 µm has proven suitable to ensure the desired slip resistance.

[0018] According to the invention, the anti-slip element is designed as a surface with an arithmetic mean roughness value between 5 and 50 µm.

[0019] The finger flange forms a plane with the open base, meaning the opening for inserting the syringe plunger lies in the flat finger flange. As described above, such syringe bodies are particularly prone to tipping when placed on the plane of the flange, so the above-described design of the anti-slip element offers particular advantages.

[0020] Furthermore, the flange is advantageously designed to be mirror-symmetrical with respect to a surface containing the axis of the cylindrical cavity. Such a flange thus has two symmetrical extensions on either side of the piston opening, providing a suitable support surface for the index and middle fingers. Accordingly, an anti-slip element is provided on both support surfaces.

[0021] In a further advantageous embodiment, a labeling surface is arranged on the side of the finger flange facing away from the cone. In such a configuration, the above-described design of the anti-slip element offers additional advantages: The syringe body is usually made of a transparent material. This allows the anti-slip element to shine through the back of the labeling surface. The cross braces described above impair the legibility of the labeling due to refraction and reflection effects. A rough surface, on the other hand, as described above, significantly improves the legibility of the labeling.

[0022] In an even further advantageous embodiment, the anti-slip element covers more than 60%, preferably more than 80%, of the surface of the finger flange. This ensures sufficient to particularly good slip resistance.

[0023] Furthermore, the surface advantageously has a regular geometric structure, i.e. a repeating pattern, or an irregular statistical structure, i.e. a random distribution of raised and depressed areas.

[0024] Furthermore, the anti-slip element is advantageously spaced from the outer surface 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 shortly before (e.g., more than 1 mm) and transitions into a smooth surface, which then extends to and adjoins the cylindrical part. This ensures that the cavity is in contact with the smooth surface during the casting process, thus preventing particle formation.

[0025] The syringe body—that is, the wall surrounding the cavity, the cone, and the finger flange—is advantageously formed as a single piece, e.g., directly manufactured by injection molding. The problem of sink marks described above is particularly evident in syringe bodies manufactured by injection molding. With glass syringes, however, it can be advantageous to use separate, attachable finger flanges that are attached to the wall, since non-cylindrically symmetrical finger flanges are difficult to manufacture from glass.

[0026] In an advantageous embodiment, the syringe body is made of a plastic, in particular a cycloolefin polymer or copolymer. Such syringe bodies, in particular, are advantageously formed in one piece.

[0027] A pharmaceutical syringe advantageously comprises a syringe body as described and a movable piston arranged in the cylindrical cavity.

[0028] The advantages achieved by the invention are in particular that by using a rough surface with an arithmetic mean roughness of more than 5 µm as an anti-slip element on the finger flange of a

[0029] This provides a particularly good grip for the syringe, while also providing a particularly smooth surface on the flange on the opposite side, preventing tipping during storage. This type of surface also improves the legibility of any labeling.

[0030] In everyday laboratory medicine or clinical practice, substances are often used in the preparation and application of corresponding preparations, especially during their injection, which pose a high risk of contamination for the respective user and also for the patient.

[0031] These may, for example, be substances in the preparation to be administered that emit ionising radiation or contain biologically active substances, which also pose a high risk of harm to medical personnel, particularly if, for example, a syringe body is not handled properly. This can happen, for example, if the syringe body is not positioned precisely during handling or if it requires increased force, for example when applying highly viscous fluids.

[0032] In these cases, if the syringe slips off the syringe body during handling, such a substance can leak out and come into undesirable contact with both the patient and the medical staff.

[0033] However, a less correctly positioned injection can also be detrimental to the patient, for example if, during an intramuscular depot delivery, a vessel, such as a blood or lymph vessel, is exposed to the substance to be delivered.

[0034] This situation is usually made even more difficult if, for example, protective gloves are worn during the handling mentioned above.

[0035] In this case, the syringe disclosed herein with its syringe body proves to be extremely helpful, because the anti-slip element disclosed herein with its surface, which is designed with an arithmetic mean roughness value between 0.8 µm and 150 µm, significantly improves handling.

[0036] On the one hand, the probability of slipping is greatly reduced and, on the other hand, more precise handling, for example when positioning the injection to be performed, is considerably improved.

[0037] These advantages are particularly evident when using the syringe disclosed herein with its syringe body in a medical or cosmetic procedure, comprising Injecting or applying a medical preparation in oral surgery, in particular the injection of an anesthetic in the oral cavity of a patient and / or injecting or applying a medical preparation in ophthalmology, in particular for suppressing eyelid reflexes or for dilating the pupils of a patient and / or injecting or applying a medical preparation in nephrology, in particular for applying marker substances to track fluid dynamic processes and / or injecting or applying a medical preparation in nuclear medicine for applying radioactively emitting isotopes, preferably for tumor treatment, and / or injecting or applying a cosmetic preparation, such as hyaluronic acid or a Botox-based preparation.

[0038] These advantages are even more pronounced when, for example, a fluid is injected or applied using protective gloves, especially disposable gloves that comply with DIN EN 455 "Medical gloves for single use".

[0039] For example, a fluid can be injected or applied which comprises a patent-individualized preparation which contains a genetically modified substance, and / or comprises a biologically or microbiologically produced or propagated preparation and / or comprises a patient-individualized tumor-specific marker substance.

[0040] A further advantageous use of the syringe with its syringe body is in a method in which a fluid is injected or applied, which is applied with protective gloves, in particular with protective gloves against ionizing radiation and radioactive contamination, in particular with protective gloves according to DIN EN 421.

[0041] In this case, for example, a fluid can be injected or applied with significantly increased safety, which generates ionizing radiation, which in particular comprises a radioactive patient-individualized tumor marker substance and / or a preparation containing radioactive patient-individualized gene sequences.

[0042] Although commercial aspects are not the immediate focus of the desired improvements, it should nevertheless be noted for the sake of completeness that the above-mentioned preparations, in particular patient-individualized preparations, can generate very considerable costs in their production, which become apparent in particular when an incorrect application leads to at least partial loss of the preparation.

[0043] The frequency of such cases can also be reduced with the method disclosed here.

[0044] Embodiments of the invention are explained in more detail with reference to drawings, in which FIG 1 a schematic representation of a pharmaceutical syringe, FIG 2 an anti-slip element on the finger flange of the syringe in three-dimensional representation, and FIG 3 an improved anti-slip element with representations of various rough surfaces.

[0045] Identical parts are provided with the same reference numerals in all drawings.

[0046] The FIG 1 shows a schematic representation of a syringe body 1 with a piston 2, which together form a pharmaceutical syringe 4. The syringe body 1 is made of a transparent plastic, in exemplary embodiments a cycloolefin polymer or copolymer. It comprises a cavity 6 with a circular cylindrical wall. This is essentially closed at a first base surface 8, but the liquid in the cavity 6 can be forced out there through a cone 10. This is achieved by pushing in the piston 2, so that the piston base 12, which is circular and lies flush with the wall of the cavity 6, exerts pressure on the liquid.

[0047] To insert the piston 2 into the cavity 6, the latter is open at the second base surface of the cylinder. To push the piston 2 in, it has a pressure surface 14 on the side opposite the piston crown 12, which is typically actuated with the user's thumb. To counteract this, a collar-shaped finger flange 16 is cast around the circular opening of the cavity 6. This forms a flat surface around the opening, the normal to which is the axis of the cylindrical cavity 6.

[0048] In the exemplary embodiment, the wall of the cavity 6, the cone 10, and the finger flange 16 are formed as a single piece. Since the syringe body 1 in the exemplary embodiment is made of a plastic, this can be achieved, for example, by producing the syringe body 1 using an injection molding process. In an alternative embodiment, however, the wall and the cone 10 can be made of glass. In this case, the finger flange 16 is designed as a separate, attachable part.

[0049] The design of the finger flange 16 is described in more detail below. FIG 2shows a three-dimensional, partially cutaway view of a syringe body 1 in the area of ​​the finger flange 16 according to the prior art. The finger flange 16 is constructed mirror-symmetrically with respect to a plane through the axis of the cylindrical cavity 6. It has a trapezoidal outer contour on each of the symmetrical sides, with the long base area of ​​the trapezoid being only slightly larger than the outer diameter of the cylinder.

[0050] This creates two wings of the finger flange 16, one of which can be grasped by the index finger and the other by the middle finger of the user, while the thumb presses down the piston 2 as described above. To prevent the index and middle fingers from slipping, anti-slip elements 18 are arranged on each of the wings of the finger flange 16 on the side facing the cone 10. These are known in the prior art according to FIG 2as three clearly raised cross struts each extending parallel to the base of the trapezoid of the wing.

[0051] This results in the problem that the syringe body 1 in the FIG 1 shown position, namely when it stands on the finger flange 16, is not stable but tilts.

[0052] The cause is sagging on the side of the finger flange opposite the cross braces. Furthermore, the cross braces impede the reading of text located on the side opposite the finger flange 16.

[0053] To solve these problems, the anti-slip elements 18 are used as shown in FIG 3 shown, which are only based on their differences to FIG 2 described. FIG 3 The left half of the image shows the finger flange 16 in plan view. The cross braces of the anti-slip elements 18 have been omitted.

[0054] Instead, the surface is roughened in the hatched area, which makes up more than 80% of the finger flange 16. In the preferred embodiment, an arithmetic mean roughness value between 10 and 50 µm is provided. To determine this measured value, the surface is scanned over a defined measuring section, and all height and depth differences of the rough surface are recorded. After calculating the definite integral of this roughness profile over the measuring section, this result is finally divided by the length of the measuring section to obtain the arithmetic mean roughness value.

[0055] The roughened surface is created by the appropriate design of the casting mold. The right half of the image of the FIG 3shows exemplary possibilities for the formation of the rough surface of the anti-slip element, for example through a chaotic, statistical roughening of the surface (left), or a regular geometric pattern (right).

[0056] In addition, FIG 3 In the left half of the image it can be seen that the hatched area of ​​the anti-slip element 18 designed in this way does not reach the outer diameter of the cavity 6, but a smooth transition area remains between the anti-slip element 18 and the outer surface of the cavity 6. List of reference symbols

[0057] 1 Syringe body 2 Piston 4 Syringe 6 Cavity 8 Base 10 Cone 12 Piston bottom 14 Pressure surface 16 Finger flange 18 Anti-slip element

Claims

1. A syringe body (1) for a pharmaceutical syringe (4), comprising a cylindrical cavity (6) which has a first end face (8) with a cone (10); a second, open end face for inserting a plunger (2); and a finger flange (16) provided around the circumference of the open end face; wherein the finger flange (16) has an anti-slip element (18) on the surface facing the cone (10), for preventing a finger from slipping off during an injection process; wherein said finger flange (16) defines a plane together with the open end face, and wherein the finger flange (16) is smooth on the surface of the finger flange (16) facing away from the cone (10); characterized in that the anti-slip element (18) as a surface exhibits an arithmetic mean roughness value between 5 µm and 50 µm, wherein the syringe body (1) is formed in one piece.

2. The syringe body (1) according to claim 1, wherein the anti-slip element (18) as a surface exhibits an arithmetic mean roughness value between 10 µm and 50 µm.

3. The syringe body (1) according to any one of the preceding claims, wherein the finger flange (16) has a mirror-symmetrical shape with respect to a surface containing the axis of the cylindrical cavity (6).

4. The syringe body (1) according to any one of the preceding claims, wherein a labelling area is provided on the surface of the finger flange (16) facing away from the cone (10).

5. The syringe body (1) according to any one of the preceding claims, wherein the anti-slip element (18) covers more than 60 %, preferably more than 80 % of the surface of the finger flange (16).

6. The syringe body (1) according to any one of the preceding claims, wherein the surface has a regular geometric texture or an irregular random texture.

7. The syringe body (1) according to any one of the preceding claims, wherein the anti-slip element (18) is spaced apart from the lateral surface of the cylindrical cavity (6).

8. The syringe body (1) according to any one of the preceding claims, made of a plastics material, in particular a cyclic olefin polymer or cyclic olefin copolymer.

9. A pharmaceutical or cosmetic syringe (4), comprising a syringe body (1) according to any one of the preceding claims, and a movable plunger (2) disposed inside the cylindrical cavity (6).

10. The syringe according to claim 9, comprising a fluid for injection or application, which is applied with protective gloves, in particular with protective gloves for single use according to DIN EN 455 "Medical gloves for single use".

11. The syringe according to claim 9, comprising a fluid for injection or application which a. comprises a patient-individualized preparation that contains a genetically modified substance; or b. comprises a biologically or microbiologically produced or propagated preparation; or comprises a patient-individualized tumour-specific marker substance.

12. The syringe according to claim 9, comprising a fluid for injection or application, which is applied with protective gloves against ionizing radiation and radioactive contamination, in particular with protective gloves according to DIN EN 421.

13. The syringe according to claim 9, comprising a fluid for injection or application, which generates ionizing radiation.

14. The syringe according to claim 9, comprising a fluid for injection or application, which contains a radioactive patient-individualized tumour marker substance or a radioactive preparation containing patient-individualized gene sequences.