MEDICAL APPLICATION ORDER FOR APPLYING A LIQUID TO A SKIN SURFACE

DE502019014440D1Active Publication Date: 2026-03-26B BRAUN MELSUNGEN AG
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Patent Information

Authority / Receiving Office
DE · DE
Patent Type
Patents
Current Assignee / Owner
Filing Date
2019-03-22
Publication Date
2026-03-26

AI Technical Summary

Technical Problem

Existing medical application devices using glass ampoules face issues with breakage-related splintering, necessitating the use of filter elements and lacking adaptability to liquid properties, and require complex designs to ensure shelf life and usability.

Method used

A multi-layered plastic ampoule with a barrier and support layer, manufactured via coextrusion and blow-fill-seal processes, is used, featuring a ductile breaking point and a metering element for controlled liquid release, eliminating the need for glass and simplifying the design.

Benefits of technology

The solution prevents splintering, enhances shelf life through barrier properties, ensures mechanical robustness, and allows for precise dosing and safe application, facilitating environmentally friendly disposal.

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Description

[0001] The invention relates to a medical application arrangement according to the preamble of claim 1.

[0002] Such an application device is known from US 6,439,789 B1, wherein its ampoule can be made of, for example, glass, aluminum, plastic, or combinations of these materials. To release a liquid contained within the ampoule, the ampoule has a seal that can be pierced with a hollow spike. When the hollow spike is pierced, the seal shears away from the ampoule. A metering element is provided for dispensing the released liquid.

[0003] Another application arrangement is known from US 2013 / 108352 A1, in which the ampoule can be made of multilayered plastic. To release a liquid contained within the ampoule, the ampoule has a predetermined breaking point. When the ampoule is screwed into a receiving body, the predetermined breaking point is sheared off, at least partially, from the ampoule by the influence of a torque applied by means of an actuating element. This allows the liquid contained within the ampoule to be released.

[0004] Another application device is known from US Patent 2016 / 0199631 A1 and is designed for applying an antiseptic to a patient's skin. This known application device can be used, for example, in preparation for a surgical procedure. The known application device comprises an ampoule containing the antiseptic. The ampoule is secured in a receiving cavity of a receiving body. Furthermore, the known application device includes an actuating element connected to the ampoule, which projects obliquely from the receiving body like a lever. The ampoule can be broken to release the antiseptic by manually pressing the actuating element. At one end of the receiving body, a sponge-like application element is provided to receive the released antiseptic, which can be brought into contact with the skin area to be moistened.In the known application arrangement, the ampoule is preferably made of glass. The ampoule has a smooth-walled cylindrical shell which breaks at an unspecified point under the influence of the actuating element.

[0005] The object of the invention is to create an application arrangement of the type mentioned above which has improved properties compared to the prior art and in particular enables improved applicability.

[0006] The problem underlying the invention is solved by an application arrangement with the features of claim 1. The solution according to the invention makes it possible, firstly, to dispense with a glass ampoule. With such glass ampoules, breakage-related splintering is often unavoidable. Consequently, in known application arrangements, a filter element may be necessary to filter out splinters from the released liquid. According to the invention, such a filter element can be dispensed with, thus enabling a simplified design of the application arrangement. Furthermore, the multilayered wall of the ampoule, as described in the invention, allows for improved adaptation to specific requirements and / or properties of the liquid. The wall of the ampoule has at least a first and a second layer. However, more than two, in particular three or four, layers can also be provided.For example, a first wall layer can be tailored to the chemical composition of the liquid with regard to its material properties and, in particular, be designed to be impermeable to oxygen, carbon dioxide, and / or water vapor. This can, in particular, improve the liquid's shelf life within the ampoule. For example, a second wall layer can be tailored to the desired mechanical properties of the ampoule, such as its strength, elasticity, or similar characteristics, with regard to its material properties and / or dimensions. This can prevent the ampoule from breaking. Ultimately, this allows for improved usability of the application device. The ampoule can be manufactured using generally known processes in plastics engineering, such as thermoforming, injection molding, or blow molding.It is possible for the ampoule to initially be manufactured with a single-layer wall structure, onto which at least one further layer is applied, for example, by means of a coating process. The ampoule is preferably positively locked to the receiving body. Alternatively or additionally, the ampoule can be positively locked to the receiving body. The actuating element can, for example, be arranged directly on the ampoule, preferably integrally formed with it, or arranged on the receiving body, preferably integrally formed with it. The actuating element can be designed in the form of a manually operable pull, push, bend, and / or rotary actuating element. The ampoule can thus be opened by means of a tensile, push, bend, and / or torsional stress exerted by the actuating element.The actuating element can cause a surface, line, or approximately point-like stress on the ampoule. Preferably, the ampoule has a substantially cylindrical basic shape. Preferably, the wall of the ampoule is entirely multi-layered.

[0007] In an embodiment of the invention, the wall comprises at least one barrier layer, in particular containing ethylene-vinyl alcohol copolymer (EVOH) or polyvinyl alcohol (PVOH). The barrier layer primarily serves to prevent undesirable environmental influences on the liquid contained in the ampoule. This allows for improved shelf life of the liquid. The barrier layer is preferably essentially impermeable to oxygen, carbon dioxide, and / or water vapor. Preferably, the barrier layer consists of ethylene-vinyl alcohol copolymer, the barrier properties of which are generally known, at least in the field of food packaging. Alternatively, the barrier layer can consist of polyvinyl alcohol. The barrier layer can, for example, be extruded and bonded to a further layer of the wall.Alternatively, the barrier layer and another layer of the wall can be co-extruded. Another alternative is that the barrier layer can, for example, be laminated onto another layer of the wall.

[0008] In a further embodiment of the invention, the wall comprises at least one support layer, in particular containing polyethylene (PE) or polypropylene (PP). The support layer primarily serves to ensure specific mechanical properties of the ampoule. For example, the support layer can be dimensioned such that the ampoule is sufficiently robust against external transport and / or storage influences, thus preventing unintentional opening or breakage. The support layer can, for example, be extruded and bonded to another layer of the wall. Alternatively, the support layer can be co-extruded with one or more further layers of the wall. It is, of course, also possible for the support layer to be manufactured using other methods commonly used in plastics engineering and / or bonded to one or more further layers of the wall.

[0009] In a further embodiment of the invention, the ampoule is formed by means of plastic coextrusion. Plastic coextrusion is a well-known process in the field of plastics engineering for the production of, for example, pipes, profiles, or the like. Using plastic coextrusion, the multi-layered wall of the ampoule can be formed particularly easily and with consistent quality. This is a particularly cost-effective embodiment of the invention.

[0010] In a further embodiment of the invention, the ampoule is aseptically formed using a blow-fill-seal process. Blow-fill-seal processes are generally known in the field of plastics processing and represent a special form of extrusion blow molding. In this process, molten plastic is forced through an annular die by means of an extruder screw, resulting in a tubular semi-finished product. This is transferred to a blow mold and shaped to the inner contour of the mold by means of internal pressure. The internal pressure is applied using injection needles, simultaneously injecting the liquid, for example, an antiseptic. The injection needles are then withdrawn from the inflated semi-finished product, and the molding process is completed in a generally known manner. The blow-fill-seal process takes place in a sterile section of a plastics processing machine.This embodiment of the invention allows the required aseptic properties of the ampoule to be ensured in a particularly simple and reliable manner.

[0011] In a further embodiment of the invention, the ampoule has at least one elastically compliant wall section. Preferably, the ampoule has a cylindrical base shape. The wall section is preferably elastically compliant in the radial direction. Thus, after opening the ampoule, the volume flow of the liquid from the ampoule can be controlled by manually applying pressure to the wall section. This allows, in particular, improved dosing of the liquid. This embodiment of the invention results in a particularly easy-to-use application arrangement.

[0012] In a further embodiment of the invention, the receiving body, the application element, and the actuating element are made of plastic. Since the ampoule is also made of plastic according to the invention, this embodiment allows for simplified and environmentally friendly disposal of the application assembly. Preferably, the entire application assembly is made exclusively of plastic.

[0013] Furthermore, according to the invention, a metering element is provided, associated with the ampoule and / or the application element, by means of which a volumetric flow of liquid released from the ampoule can be metered. The solution according to the invention allows for improved metering of the liquid released after opening the ampoule. The metering element is preferably designed such that, in any case, unimpeded flow of the released liquid from the ampoule is prevented. For this purpose, the metering element can, for example, form a constriction of a fluid-carrying lumen of the application arrangement, such as a lumen of the receiving body or the application element, or itself have a fluid-carrying lumen that is provided with a constriction. This, in particular, prevents overdosing of the liquid.This approach allows for improved usability and, in particular, enhanced application safety. The latter is achieved because excessive wetting of the skin area to be treated with liquid can be avoided. The metering element can be fixed to the receiving body by form-fitting, force-fitting, and / or material-fitting means. Preferably, the metering element is arranged in a fluid-carrying passage or lumen of the receiving body.

[0014] Furthermore, according to the invention, the metering element can be moved between at least a first metering position and a second metering position depending on the liquid pressure. The liquid pressure can be generated, for example, by manually applying pressure to the ampoule. Preferably, the metering element is deformed by the liquid pressure and thus moved between the first metering position and the second metering position. Preferably, the first metering position is a closed position in which the flow of the released liquid is essentially completely stopped. Preferably, the second metering position is an open position in which the flow of the released liquid is allowed. It is advantageous if the metering element can be moved continuously between the first metering position and the second metering position.This allows for stepless dosing of the liquid.

[0015] In a further embodiment of the invention, the metering element comprises a rubber-elastic membrane that is pressure-dependent in its permeability. The rubber-elastic membrane is preferably in the form of a circular cylindrical disc membrane. To achieve pressure-dependent permeability of the membrane, it can have at least one fluid passage that can be opened, closed, constricted, and / or expanded depending on the fluid pressure. The membrane can be made, for example, of a naturally or synthetically produced elastomer, a thermoplastic elastomer, silicone, or the like.

[0016] In a further embodiment of the invention, the membrane has at least one slit. The slit forms a fluid passage for the liquid released from the ampoule. The slit is preferably designed and / or arranged such that opening and / or closing of the slit is effected by means of a fluid pressure-induced deflection of the membrane.

[0017] Furthermore, according to the invention, the ampoule has a predetermined breaking point element operatively connected to the actuating element. The predetermined breaking point element forms a predetermined breaking point and / or a predetermined breaking section of the ampoule. The predetermined breaking point element is designed such that it fails in a controlled manner when the actuating element is actuated as intended under a structurally predetermined stress. The solution according to the invention thus prevents locally undefined breakage of the ampoule and therefore enables improved opening of the ampoule. This results in improved release of the liquid and ultimately improved usability of the application device.

[0018] In a further embodiment of the invention, the predetermined breaking element is designed to be ductile and breakable. Accordingly, under stress, the predetermined breaking element does not fail by forming a brittle fracture, but rather by forming a deformation fracture. This prevents splintering when opening the ampoule. Furthermore, improved haptic feedback can be achieved when actuating the actuator, since the ampoule does not break abruptly and brittlely, but rather a certain deformation path, and thus an actuation path of the actuator, is required first.

[0019] Furthermore, according to the invention, the actuating element is operatively connected to the shear element in a torque-transmitting manner, wherein the ampoule is designed such that the shear element shears off from the ampoule at least section by section under the influence of a specific torque applied by means of the actuating element. The actuating element can be operatively connected to the shear element either directly or indirectly in a torque-transmitting manner. It has been shown that the rotary mechanism for opening the ampoule achieved in this way is particularly ergonomically advantageous.

[0020] Furthermore, according to the invention, the predetermined breaking element is designed as a toggle at a distal end of the ampoule. Optionally, the actuating element, preferably at a proximal end of the ampoule, is designed as a rotary actuating element. The distal end of the ampoule is understood to be the end that, during intended use of the application device, faces the skin surface to be treated. Accordingly, the proximal end of the ampoule is understood to be the end that faces away from the skin surface. The toggle and the rotary actuating element are preferably arranged coaxially with each other. The toggle is positively locked to a complementary receiving section of the receiving body. The rotary actuating element can be directly connected to the proximal end of the ampoule and may, for example, be designed as a section of the ampoule's outer casing.To facilitate handling, the rotary actuator can be designed in a wing-like shape, similar to a wing nut. Alternatively, the rotary actuator can form a type of plug, sealing the ampoule fluid-tight at its proximal end. It is also possible for the rotary actuator to be a component manufactured separately from the ampoule and connected to it. For example, the rotary actuator can be connected to the proximal end of the ampoule by means of a plug-in, screw, adhesive, or other connection. Preferably, the rotary actuator is fitted onto the end face of the ampoule and / or the receiving body in the form of a cap.

[0021] Further advantages and features of the invention will become apparent from the claims and from the following description of a preferred embodiment of the invention, which is illustrated with reference to the drawings. Fig. 1 shows in a schematic, partially cut-away side view an embodiment of an application arrangement according to the invention, which has an ampoule made of plastic, Fig. 2 shows in a schematic, partially cut-away side view the ampoule of the application arrangement according to Fig. 1 , Fig. 3 in an enlarged detail view a top view of a metering element of the application arrangement according to Fig. 1 , Fig. 4 the metering element according to Fig. 3 in a schematic cross-section IV and Fig. 5 in an enlarged schematic detail view a wall of the ampoule according to Fig. 2 in an area V according to Fig. 2 .

[0022] A medical application order 1 according to Fig. 1 The application device 1 is designed for applying a liquid F to a skin surface H. The application device 1 comprises an ampoule 2 containing the liquid F, which is fixed to a receiving body 3. As can be seen in particular from the following: Fig. 2 As can be seen, ampoule 2 has a substantially cylindrical shape. The ampoule forms a fluid-tight cavity R in which the liquid F is contained. Of course, it is also possible for the ampoule to form several fluid-tight cavities, each containing a different liquid. In this way, the ampoule can form a multi-chamber system that allows for the application and / or mixing of several different liquids.

[0023] The receiving body 3 is in the form of an elongated hollow cylinder. In a properly assembled state of the application arrangement 1 ( Fig. 1 The ampoule 2 is inserted into the receiving body 3 through a proximal opening (not shown in detail) and secured to it in a manner that will be described in more detail below. The application arrangement 1 further comprises an actuating element 4 operatively connected to the ampoule 2. As will be described in more detail below, the actuating element 4 serves to open the ampoule 2 and release the liquid F. In this case, the actuating element 4 is arranged at a proximal end of the receiving body 3. Furthermore, an application element 5 is arranged at an end face of the receiving body 3 opposite the actuating element 4. The application element 5 is designed for applying liquid F released from the ampoule 2 and is, in this case, in the form of a sponge made of a plastic material. In an embodiment not shown in detail below, a microfiber cloth made of PET is provided instead of a sponge.Alternatively, the application element can also be designed in the form of a swab. In principle, the application element can be absorbent or non-absorbent. In the present case, an approximately wedge-shaped connecting element 6 is provided in the axial direction of the receiving body 3 between the application element 5 and the receiving body 3, although this is not strictly necessary. The connecting element 6 creates a firm connection between the application element 5 and the receiving body 3, so that the latter projects obliquely upwards from the application element 5 like a stem. In an embodiment not shown, no connecting element is provided, so that the application element is oriented approximately perpendicular to the receiving body, which allows for perpendicular application to the surface to be wetted.

[0024] As particularly evident Fig. 2 As can be seen, the ampoule 2 has a predetermined breaking element 7 operatively connected to the actuating element 4. The predetermined breaking element 7 is arranged at a distal end 8 of the ampoule 2. The actuating element 4 is arranged at a proximal end 9 of the ampoule 2. In this case, the actuating element 4 is integrally formed with the ampoule 2 and thus integrally connected to it, although this is not mandatory. In an embodiment not shown, the actuating element 4 can also be manufactured separately from the ampoule 2 and operatively connected to the proximal end 9 of the ampoule. In this case, the actuating element 4 can be attached to the end face of the ampoule 2 and / or to the end face of the receiving body 3, similar to a lid.

[0025] The predetermined breaking element is designed in the form of a toggle 7, which is integrally molded onto the ampoule 2. The toggle 7 forms a tapered end face of the cross-section of the ampoule 2, which is otherwise smooth-walled. As shown by Fig. 1 As can be seen, the toggle 7 is fixed in a rotationally fixed position on a complementary receiving section 8 of the receiving body 3 in a suitably assembled state of the application arrangement 1. The toggle 7 is positively engaged with the receiving section 8 in the circumferential direction of the ampoule 2, so that the ampoule 2 – at least in an intact state of the predetermined breaking element 7 – is torque-resistant to the receiving body 3 in the area of ​​the predetermined breaking element 7. Otherwise, at least in the circumferential direction, no fixed connection is provided between the ampoule 2 and the receiving body 3.

[0026] The ampoule 2 is designed such that the predetermined breaking element 7 shears off from the ampoule 2 at least section by section under the influence of a specific torque applied by means of the actuating element 4. For this purpose, the actuating element is connected to the predetermined breaking element 4 in a torque-transmitting manner and is designed in the form of a rotary actuating element 4.

[0027] In a non-inventive embodiment, the predetermined breaking element can be designed in the form of a piercing section, to which a piercing mandrel can be assigned for piercing into the piercing section and thus releasing the liquid F.

[0028] To apply the liquid F to the skin surface H, the application arrangement 1 is used as shown in the diagram. Fig. 1 The applicator is positioned in a visible orientation relative to the skin surface H. For this purpose, an operator (whose identity is not shown) grasps the stem-like section of the receiving body 3 and places the applicator 5 onto the skin surface H to be moistened. In this state, the ampoule 2 is sealed fluid-tight, and the liquid F is contained in the cavity R. To open the ampoule 2 and thus release the liquid F, the operator preferably grasps the actuating element 4 with their thumb and forefinger and applies a torque D acting along a longitudinal axis L of the ampoule 2. Since the actuating element 4 is operatively connected to the predetermined breaking element 7 in a torque-transmitting manner, and the latter is fixed in the receiving section 8 in a rotationally fixed manner, the predetermined breaking element 7 is subjected to torque. The predetermined breaking element 7 is thus...A cross-section Q of the ampoule 2 adjacent to the predetermined breaking element 7 is dimensioned such that the predetermined breaking element 7 shears off from the ampoule 2 at least section by section under a predetermined, defined torque load. This opens the ampoule 2, and the liquid F can flow out of the ampoule 2 through a failure point formed in the region of the cross-section Q. Due to gravity, the liquid F flows – with respect to the plane of the drawing. Fig. 1 The liquid F flows downwards and reaches the application element 5 via, among other things, a passage 10 in the receiving body 3 and a passage in the connecting element 6 (not shown in detail). The application element 5 absorbs the liquid F in a sponge-like manner. The operator then guides the application device manually along the skin surface H using the stem-like section of the receiving body 3, thus applying the liquid F. In an embodiment not shown in detail, a fluid-permeable body impregnated with an additive is arranged in the passage 10. In this way, the additive can be dosed into the liquid as it flows through the passage. This additive could be a dye, a substance with a sporicidal effect, or the like.

[0029] The predetermined breaking element 7 is designed to be ductile and therefore does not shear brittlely, but only after a certain degree of plastic deformation from the ampoule. This design of the predetermined breaking element 7 can be achieved by selecting a suitable material for the ampoule 2.

[0030] Ampoule 2 is made of plastic K. The material properties of plastic K are selected such that the predetermined breaking element 7 breaks ductilely under stress with torque D in the manner described above. This prevents splintering when opening ampoule 2. Further details will be provided below. Fig. 2 combined with Fig. 5 As can be seen, the ampoule 2 has a multilayered wall 11. The wall 11 has at least one barrier layer 12. The barrier layer 12 serves to protect the liquid F from undesirable environmental influences and can, in particular, be designed to be impermeable to oxygen, carbon dioxide, and / or water vapor. In this embodiment, the barrier layer 12 consists of ethylene-vinyl alcohol copolymer. In an alternative embodiment, the barrier layer 12 can, for example, consist of polyvinyl alcohol. In this embodiment, the barrier layer 12 forms an inner surface of the ampoule 2 and is therefore in direct contact with the liquid F.

[0031] What next based on Fig. 5 As can be seen, the wall 12 has at least one support layer 13. The support layer 13 primarily serves to ensure the mechanical properties of the ampoule 2. In this embodiment, the support layer 13 consists of polyethylene. In an alternative embodiment, the support layer 13 consists of polypropylene. In this embodiment, the support layer 13 forms an outer surface of the ampoule 2. The ampoule 2 thus has a two-layer wall structure. In principle, more than two layers can also be provided.

[0032] The ampoule 2, more precisely the wall 11, is formed by means of plastic coextrusion. In this process, both the plastic material of the barrier layer 12 and the plastic material of the support layer 13 are softened and extruded together through a die using an extruder screw in a generally known manner. For the aseptic formation of the ampoule 2, a so-called blow-fill-seal process is used, which is a special form of blown-fill extrusion and is generally known in the field of plastics processing.

[0033] The ampoule 2 has at least one elastically flexible wall section 14 ( Fig. 1 The wall section 14 is arranged approximately centrally in the longitudinal direction L of the ampoule 2 and is designed to be flexible in the radial direction. In the following Fig. 1 In the intended, assembled state of the application arrangement 1, the wall section 14 is positioned within a recess 15 of the receiving body 3. Accordingly, the wall section 14 is manually accessible and can be pressed by the operator, for example, by means of a thumb positioned in the area of ​​the recess 15. After opening the ampoule 2, the flow of the liquid F can thus be controlled by pressing the wall section 14.

[0034] In this case, in addition to the ampoule 2, the receiving body 3, the actuating element 4, the application element 5, and the connecting element 6 are also made of plastic. Therefore, the entire application assembly 1 is made of plastic, which can facilitate disposal after a single use and potentially make it more environmentally friendly.

[0035] What next based on Fig. 1 As can be seen, a metering element 16 is provided, associated with the ampoule 2 and / or the application element 5, by means of which a volume flow of liquid F released from the ampoule 2 can be metered. The metering element 16 is arranged longitudinally L of the ampoule 2 between the predetermined breaking element 7 and the opening 10 of the receiving body 3 and is fixed to the receiving body 3 at its edge in the region of the opening 10 in a manner not shown in detail. As can be seen from the Fig. 3, 4 As can be seen, the dosing element 16 has a membrane 17. The membrane 17 is provided with a slot 18. The slot 18 extends longitudinally between a top surface 19 and a bottom surface 20 of the membrane 17, essentially parallel to the longitudinal direction L of the ampoule 2. In the radial direction, the slot 18 extends over approximately two-thirds of the diameter of the membrane 17, which in this case is designed in a disc shape and thus has a circular cylindrical basic form. Based on Fig. 4 One dimension of the thickness of membrane 17 is greatly exaggerated for graphical reasons alone. Contrary to the simplified graphical representation of the Fig. 4 The membrane 17 is indeed designed to be thin-walled. As a result of this design, the membrane 17 can be switched between at least one first metering position S1 and a second metering position S2 depending on the liquid pressure of the liquid F. These two metering positions S1 and S2 are schematically represented by Fig. 3 As indicated. In the first dosing position S1, radially opposite, unspecified side walls of the slot 18 are in contact with each other, so that the passage from the top 19 to the bottom 20 of the membrane 17 is essentially closed. When the membrane 17 is pressurized, for example by manually pressing the wall section 14 of the ampoule, the membrane 17 is deformed. The resulting deformed state of the membrane 17 is shown by Fig. 3This is illustrated by the dashed line shown. The slot 18 is widened radially so that its side walls are spaced apart. This opens the passage from the top 19 to the bottom 20 of the membrane 17, allowing any liquid F already released to pass through the slot 18 into the passage 10 of the receiving body 3 and from there to the application element 5.

Claims

1. Medical applicator (1) for applying a liquid (F) to a skin surface (H), comprising an ampoule (2) containing the liquid (F), a receiving body (3) to which the ampoule (2) is secured, an actuation element (4) operatively connected to the ampoule (2) for opening the ampoule (2) and releasing the liquid (F), and an application element (5) arranged at one end of the receiving body (3) for applying liquid (F) released from the ampoule (2), wherein a dosing element (16) assigned to the ampoule (2) and / or to the application element (5) is provided, by means of which dosing element a volumetric flow of liquid (F) released from the ampoule (2) can be dosed, wherein the dosing element (16) can be transferred between at least a first dosing position (S1) and a second dosing position (S2) depending on a liquid pressure of the liquid (F), wherein the ampoule (2) has a predetermined breaking element (7) operatively connected to the actuation element (4), wherein the actuation element (4) is operatively connected to the predetermined breaking element (7) in a torque-transmitting manner, and wherein the ampoule (2) is designed in such a way that the predetermined breaking element (7) shears away from the ampoule (2) at least in sections under the effect of a specific torque load brought about by means of the actuation element (4), characterized in that the ampoule (2) is produced from plastic (K) and has a wall (11) which is of a multi-layer design at least in sections, and in that the predetermined breaking element is integrally formed on the ampoule (2), in the form of a toggle (7) at a distal end (8) of the ampoule (2), wherein the toggle (7) forms an end-side tapering of a cross section of the ampoule (2), and wherein the toggle (7) is joined in a form-fitting manner in the circumferential direction of the ampoule (2) to a complementary receiving portion (8) of the receiving body (3), such that the ampoule (2) - at any rate in an intact state of the toggle (7) - is connected to the receiving body (3) fixedly in terms of torque in the region of the toggle (7).

2. Medical applicator (1) according to Claim 1, characterized in that the wall (11) has at least one barrier layer (12), in particular comprising ethylenevinyl alcohol copolymer or polyvinyl alcohol.

3. Medical applicator (1) according to Claim 1 or 2, characterized in that the wall (11) has at least one carrier layer (13), in particular comprising polyethylene or polypropylene.

4. Medical applicator (1) according to any one of the preceding claims, characterized in that the ampoule (2) is formed by means of plastic coextrusion.

5. Medical applicator (1) according to any one of the preceding claims, characterized in that the ampoule (2) is formed aseptically by means of a blow-fill-seal process.

6. Medical applicator (1) according to any one of the preceding claims, characterized in that the ampoule (2) has at least one elastically flexible wall portion (14).

7. Medical applicator (1) according to any one of the preceding claims, characterized in that the receiving body (3), the application element (5) and the actuation element (4) are produced from plastic.

8. Medical applicator (1) according to any one of the preceding claims, characterized in that the dosing element (16) has a rubber-elastic membrane (17) which is designed to be permeable in a pressure-dependent manner.

9. Medical applicator (1) according to Claim 8, characterized in that the membrane (17) has at least one slit (18).

10. Medical applicator (1) according to any one of the preceding claims, characterized in that the toggle (7) is designed to be breakable with a ductile fracture.

11. Medical applicator (1) according to any one of the preceding claims, characterized in that the actuation element, preferably at a proximal end (9) of the ampoule (2), is in the form of a rotary actuation element (4).