Ampoule for a medical, in particular ophthalmological, liquid

Abstract

The present invention relates to an ampoule (10) for a medical, in particular ophthalmological, liquid, comprising: a trunk part (5) for receiving the medical liquid; a foot part (6) for arranging a label (9), wherein the foot part (6) adjoins the trunk part (5) below the trunk part; a shoulder part (4) which adjoins the trunk part (5) above the trunk part; a neck part (3) which adjoins the shoulder part (4) above the shoulder part; a head part (2) which adjoins the neck part (3) above the neck part, with an applicator opening (2a) for removing the medical liquid from the ampoule (10); and a twist-off part (1) as a closure, which in an initial state of the ampoule (10) is connected to the head part (2) via an predetermined breaking point (1a) and seals the applicator opening (2a) in a fluid-tight manner. The ampoule is characterised in that the head part (2) is designed as an ellipsoidal portion, preferably as a spherical portion, with at least one upper base face in which the applicator opening (2a) is located.

Description

[0001] Ampoule for a medicinal, particularly an ophthalmic, liquid

[0002] Description

[0003] The invention relates to an ampoule for a medical fluid, in particular for an ophthalmological fluid, according to the preamble of patent claim 1.

[0004] Ampoules are used for storing, preparing, and / or transporting medical fluids and can be available in various sizes, for example, with a volume between 5 ml and 30 ml. The medical fluid contained in such an ampoule can be, for example, a medicinal agent, such as a medication, or another fluid used for medical purposes. Such an ampoule generally comprises an ampoule body for holding the medical fluid and a snap-off or twist-off part, which, in its initial state, seals the opening through which the fluid is withdrawn in a fluid-tight manner.

[0005] Conventional ampoules are manufactured using the so-called blow-fill-seal (BFS) process. The blow-fill-seal process is a method that is particularly used for the production of containers for holding liquids. In the blow-fill-seal process, a container is formed, filled, and sealed in a continuous process in a closed environment within a machine, without any intervention by an operator. In the blow-fill-seal process, a plastic material is typically extruded vertically to produce a tubular section, which is then formed and filled in a tool and finally sealed. Due to the formation of the container, especially in a low-germ environment, the blow-fill-seal process is particularly suitable for the production of ampoules for holding medical liquids.

[0006] Ampoules are also used in ophthalmology. There they generally have a smaller volume, for example from 0.1 to 5 ml. They contain an ophthalmic fluid or solution which is applied into one eye. There they are often used as a single-use or single-dose applicator. The fluid is usually a saline-based solution or emulsion which contains or can contain a medication for the treatment of an eye condition. In some cases the fluid may not contain any medication and instead serve solely as a lubricant and / or tear substitute. An example of such an ampoule is described in document EP 3 471 685 B1. There it is simply described that a blunt applicator tip is advantageous in order to avoid scratching the patient's cornea during application.

[0007] There is a need for ampoules for ophthalmic applications that reduce the risk of eye injury during application and enable better dosing.

[0008] Therefore, the present invention is particularly based on the object of providing an ampoule for ophthalmic applications which reduces the risk of eye injury during application and enables better dosing.

[0009] This object is achieved by the subject matter having the features according to the independent patent claims. Advantageous embodiments are the subject of the description, the figures, and the dependent claims.

[0010] In general, the invention is described by an ampoule, which in particular comprises an improved geometry in the head portion, which houses the applicator opening through which the liquid to be withdrawn is withdrawn. According to the invention, the head portion is designed as an ellipsoidal section, preferably as a spherical section, with at least one upper base surface in which the applicator opening is located. This allows for improved dosing or a defined dropper ball to be achieved, while simultaneously forming a blunt top of the ampoule, thus reducing the risk of eye injury during application.In detail, the present invention is described by an ampoule for a medical, in particular ophthalmic, liquid, comprising a body part for holding the medical liquid, a shoulder part which adjoins the body part above, a neck part which adjoins the shoulder part above, a head part which adjoins the neck part above and has an applicator opening for removing the medical liquid from the ampoule, and a twist-off part as a closure which, in an initial state of the ampoule, is connected to the head part via a predetermined breaking point and closes the applicator opening in a liquid-tight manner. The head part is designed according to the invention or preferably as an ellipsoidal section, preferably as a spherical section, with at least one upper base surface in which the applicator opening is located. The ampoule is preferably an eye drop ampoule.

[0011] According to the invention or in particular, the head part is designed as an ellipsoidal section, preferably as a spherical section, with at least one upper base surface in which the applicator opening is located, and with a cross-section that increases starting from the neck part and / or decreases in the direction of the applicator opening. The head part preferably has a bulge. Preferably, the interior of the neck part is delimited by the curved wall of the ellipsoidal section or the spherical section. In one embodiment, the head part is designed as a hollow spherical ring, wherein the wall of the head part is provided or formed by the spherical layer of the spherical ring.

[0012] The twist-off part provides a tamper-evident closure for the ampoule. In a preferred embodiment, the twist-off part is arranged entirely above the head part and is connected to the head part only via the predetermined breaking point, which is preferably annular. This enables a defined twist-off behavior with a defined geometry of the predetermined breaking point. The number of edges and / or burrs after removing or twisting off the twist-off part is also reduced.

[0013] Preferably, the predetermined breaking point is located in the upper base surface of the ellipsoidal section, preferably the spherical section. After removal of the twist-off part, the base surface is provided as a flat base surface, with the applicator opening being delimited by a surrounding, flat circular ring, which forms the predetermined breaking point.

[0014] In one embodiment, the twist-off part provides a gripping part on at least one side, preferably on both sides, with a flat contact surface and a contact edge for a fingertip. The twist-off part preferably comprises a cap or closure cap that closes the applicator opening in the initial state. The closure cap forms the underside of the twist-off part and is formed integrally with the gripping part. The gripping part wraps around the cap and provides a lever for removing the twist-off part.

[0015] In one embodiment, the ellipsoidal section, preferably the spherical section, comprises not only an upper base surface but also a lower base surface. This allows for a defined transition to the neck portion.

[0016] In one embodiment, the ellipsoidal section, preferably the spherical section, has a diameter of 4 to 7 mm, preferably 5 mm. This allows a defined amount to be achieved in the dropper ball for ophthalmic applications. The head section preferably provides a volume of 0.3 to 0.5 ml for a dropper ball to be applied via the applicator opening.

[0017] In one embodiment, the neck portion has a cross-section that tapers from the shoulder portion toward the head portion. In another embodiment, the shoulder portion also has a cross-section that tapers from the body portion toward the neck portion. Thus, the neck portion and the shoulder portion together form a funnel or a type of funnel. This can improve the flow of the liquid.

[0018] In a preferred embodiment, the ampoule additionally comprises a foot part for arranging a label, wherein the foot part adjoins the body part below. The foot part can have a constant cross-section. Preferably, a label, for example with product information, is glued to the foot part. In a further embodiment of the ampoule, the body part has a cross-section that tapers from the shoulder part towards the foot part. Alternatively, the body part can also have a substantially uniform cross-section. Preferably, a company identification and / or optionally also product information is arranged, preferably embossed, on at least one wall of the body part.

[0019] Preferably, the ampoule is a single-dose applicator. In one embodiment, the ampoule is designed to hold a volume of 0.1 ml to 3.0 ml, preferably 0.3 ml to 2.0 ml, preferably 0.8 ml to 1.5 ml.

[0020] The ampoule is manufactured using BFS and is preferably a single-piece design. Suitable materials for the ampoule include PE (polyethylene) and / or PP (polypropylene).

[0021] The shape and size of the ampoule are determined by the shape and size of the mold. Therefore, the invention also encompasses a (blow-fill-seal) BFS system comprising an extruder and a mold with a mold, wherein the mold comprises at least one cavity for forming an ampoule according to the invention.

[0022] In an ampoule arrangement with multiple ampoules, the ampoules are preferably integrally connected to one another via connecting webs. A connecting web is located between every two ampoules. Additional ampoules can be arranged on either side of each ampoule, so that two connecting webs can be arranged diametrically opposite each other on each ampoule, via which additional ampoules are connected to the ampoule body on either side of the ampoule. Therefore, the invention also encompasses an ampoule arrangement with at least two ampoules, wherein the at least two ampoules are integrally connected to one another via a connecting web.

[0023] The present invention will be explained in detail using the following exemplary embodiments. Reference is made to the accompanying drawings containing schematic representations. The same reference numerals in the individual drawings refer to the same parts.

[0024] Fig. 1a to 1c show an embodiment of the ampoule according to the invention in the closed initial state in a perspective view (Fig. 1a), a front view (Fig. 1b) and a side view (Fig. 1c);

[0025] Fig. 2.a to 2.c show an embodiment of the ampoule according to the invention with the twist-off part removed in a perspective view (Fig. 2.a), a front view (Fig. 2.b) and a side view (Fig. 2.c);

[0026] Fig. 3 shows an embodiment of the ampoule according to the invention in the state of use without twist-off part in a perspective view;

[0027] Fig. 4. a to 4.c show an embodiment of the ampoule according to the invention in the closed initial state with dimensions in a front view (Fig. 4.a), a side view (Fig. 4.b) and a bottom view (Fig. 4.c);

[0028] Fig. 5 shows an embodiment of an inventive

[0029] Ampoule arrangement with several ampoules, each of which is integrally connected to one another via a connecting web;

[0030] Fig. 6 shows an embodiment of an ampoule arrangement according to

[0031] Leaving the mold.

[0032] Figures 1a to 1c show an embodiment of the ampoule 10 according to the invention in its sealed initial state, ie, after production and before use. The closure part 1, which here is designed as a twist-off part, is still firmly connected to the ampoule body and to the other components of the ampoule 10.

[0033] Ampoule 10 is an eye drop ampoule. The medicinal fluid it contains is therefore an ophthalmic fluid or solution. Any fluid suitable for use in the eye is considered an ophthalmic solution. The fluid is usually a saline-based solution or emulsion that contains, or can contain, a medication for treating an eye condition. In some cases, the fluid may not contain any medication and instead serve solely as a lubricant and / or tear substitute.

[0034] The ampoule 10 is preferably designed as a single-use applicator. Resealing the ampoule 10 after opening by removing, twisting, or tearing off the twist-off part 1 is not possible.

[0035] The volume of the ampoule 10 can also be selected so that only a single dose can be withdrawn. In this embodiment, the ampoule 10 is a single-dose applicator. For example, the eye drop ampoule 10 is designed to hold a volume of 0.8 ml to 1.5 ml.

[0036] The ampoule 10 is manufactured using a BFS process. Preferred materials for manufacturing the ampoule 10 include PE and / or PP. The eye drop ampoule 10 is formed in one piece. The ampoule 10 is essentially mirror-symmetrical, defined by the plane defined by the axes h and b.

[0037] The illustrated ampoule 10 comprises a body section 5 for holding the medicinal fluid. Below the body section 5 is a foot section 6 for arranging a label 9 (see Figure 4.a). Above the body section 5 is a shoulder section 4. In addition, a neck section 3 is attached above the shoulder section 4. The removal or application section of the ampoule 10 is formed by a head section 2, which is attached above the neck section 3. The head section 2 provides the applicator opening 2a (see Figures 2.a to 3) for removing the medicinal fluid from the ampoule 10.

[0038] In the initial state, the applicator opening 2a is closed with a cap 1d. The cap 1d is a component of the so-called twist-off part 1, which can be removed from the head part 2 by tearing or twisting it off for use with the ampoule 10. The twist-off part 10 is connected to the head part 2 via a predetermined breaking point 1a. In the example shown, only the cap 1d of the twist-off part provides the predetermined breaking point. In the initial state, the applicator opening 2a is sealed in a liquid-tight manner with or by the twist-off part 1. In detail, only the cap 1d of the twist-off part 1 closes the applicator opening 2a. The twist-off part 1 provides a tamper-evident closure. The plate-shaped part of the twist-off part 1 extends essentially in the plane defined by the width axis b and the height axis h.

[0039] The twist-off part 1 provides a grip on both sides with a flat contact surface 1a and a contact edge 1c for a fingertip. This allows the twist-off part 1 to be securely gripped, for example with the thumb and index finger, and removed from the ampoule 10 by twisting. The grip is formed integrally with the cap 1d. The grip extends downwards on two sides in a column-like manner around the cap 1d. The twist-off part 1 is preferably arranged completely above the head part 2. The twist-off part 1 extends exclusively above the head part 2. It does not extend laterally axially along one side of the head part 2. The twist-off part 1 is only connected to the top of the head part 2 via its underside. In detail, the twist-off part 1 is only connected to the top of the head part 2 via its cap 1d. The twist-off part 1, in particular its cap 1d, is connected to the head part 2 via a preferably annular predetermined breaking point 1a.The head part 2 is not part of the turning part 1.

[0040] The head part 2 is designed here as a spherical section with at least one upper base surface, which provides the applicator opening 2a. The predetermined breaking point 1a is located in the upper base surface of the spherical section and is designed as a ring. Further details regarding the head part 2 are explained in connection with Figures 2a to 3.

[0041] The head part 2 merges, in particular via a step, for example an edge, into the axially extending neck part 3, which connects the body part 5 to the head part 2 via the shoulder part 4. In the example shown, the neck part 3 has a cross-section that tapers from the shoulder part 4 toward the head part 2. The neck part 3 is a tube with a cross-section that increases toward the underside.

[0042] The neck part 3 merges downwards into the shoulder part 4. The cross-section of the ampoule 10 widens in the shoulder region via a step, e.g., an edge or curve. The wall of the shoulder part 4 has a smaller gradient compared to the wall of the neck part 3 and with respect to the longitudinal axis of the ampoule 10. The shoulder part 4 thus has a cross-section that increases more sharply, starting from the neck part 3, toward the body part 3. Conversely, the shoulder part 4 has a cross-section that tapers, starting from the body part 5, toward the neck part 2.

[0043] The neck part 3 and the shoulder part 4 together form a kind of funnel. Their funnel-shaped design positively influences the flow of the liquid from the ampoule.

[0044] The body part 5 has a cross-section that tapers from the shoulder part 4 towards the base part 6. At least the body part 5 of the ampoule 10 has a greater width (along the axis b) than depth (along the axis t). This is particularly evident by comparing Figures 1b and 1c. This also applies in particular to the twist-off part 1, the neck part 2 and the base part 6. This allows the ampoule 10 to be held securely during application and the body part 5 to be compressed in a defined manner in order to apply the medicinal liquid into an eye. A marking or logo of the company is arranged on one wall of the body part 5, preferably embossed during the manufacturing process.

[0045] The foot part 6 is located beneath the body part 5. The underside of the foot part 6 forms the underside of the ampoule 10. The foot part 6 represents a kind of tail that adjoins the body part 5. The foot part 6 is plate-shaped here. For example, it is formed by a rectangle. The foot part 6 has a uniform width in the plane defined by the axes h and b and a uniform depth in the plane defined by the axes h and t. For example, a label 9, preferably with product information, can be affixed to the foot part 6 (see Figure 4.a).

[0046] Figures 2a to 3 show an embodiment of the ampoule 10 according to the invention with the twist-off part 1 removed. The inventive design of the head part 2 with the applicator opening 2a is particularly evident. Generally, the ampoule 10 can be designed such that the head part 2 is formed as an ellipsoidal section with at least one upper base surface, which provides the applicator opening 2a. In the illustrated embodiment, the head part 2 is essentially rotationally symmetrical. Here, the head part 2 is formed as a spherical section with at least one upper base surface, which provides the applicator opening 2a.

[0047] After removing the twist-off part 1, a flat base surface is provided, with the applicator opening 2a being defined by a surrounding, flat circular ring. The circular ring preferably forms the area of ​​the predetermined breaking point 1a.

[0048] The head part 2 has a cross-section that initially increases upwards from the neck part 3 and then decreases again. This creates a bulge in the head part 2. The head part 2 has a bulge. The head part 2 sits on the neck part 3 like a ball or sphere, with the upper and / or lower tips of the ball or sphere being removed.

[0049] The spherical section of the head part 2 can have only an upper base surface and be completely spherical in the direction of the neck part 3. In the illustrated embodiment, the spherical section has both an upper and a lower base surface in order to provide the transition to the neck part 3. The head part 2 thus has the shape of a spherical ring in its external view. However, the internal volume formed in the head part 2 is preferably not cylindrical, but spherical or at least partially spherical. The internal volume or the interior of the head part 2 is essentially completely provided by the curved wall of the head part 2. The shape of the interior of the head part 2 essentially corresponds to the shape of the wall of the head part 2. The head part is designed as a hollow spherical ring. In the external design of a spherical ring, the interior of the head part 2 is limited or enclosed by its spherical layer, which provides the wall.formed.

[0050] The special design of the head section 2, especially in conjunction with the twist-off part 1, enables precise dosing of the eye drops and reduces the risk of injury to the user during application. The ball section preferably provides a volume of 0.3 to 0.5 ml for a dropper ball to be applied via the applicator opening.

[0051] As previously described, the predetermined breaking point la is located in the upper base of the spherical section. The predetermined breaking point la is defined there by the circular ring surrounding the applicator opening 2a.

[0052] Figures 4.a to 4.c show the ampoule according to the invention once again in its sealed initial state, but now with the dimensions marked and with a label 9 applied, in particular glued, to the base part 6. The dimensions are listed below. They can be used individually or combined in their entirety:

[0053] - The ampoule 10 has a total height of 40 to 60 mm and / or a maximum width of 17 to 27 mm, preferably 22 mm and / or a maximum depth of 5.4 mm to 9.4 mm, preferably 7.4 mm.

[0054] - The turning part 1 has a height of 10.5 to 20.5 mm, preferably

[0055] 15.5 mm, and / or a width of 8.5 mm to 12.5 mm, preferably

[0056] 10.5 mm, and / or a depth in the plate part of 1.6 to 2.6 mm, preferably 2.1 mm and / or a diameter in the cap Id of 3.6 to 7.6 mm, preferably 5.6 mm.

[0057] - The head part 2, in particular the spherical section, has a diameter of 4 to 7 mm, preferably 5 mm.

[0058] - The upper base surface of the spherical section of the head part 2 is at a radial height of 2 mm.

[0059] - The total height of the head part 2, the neck part 3, the shoulder part 4 and the torso part 5 is 19 to 29 mm, preferably 24 mm.

[0060] - The hull part 5 has (in width) an opening angle of 0° to 15° or greater than 0° to 15°, and / or (in depth) an opening angle of 5° to 15°, preferably 10°.

[0061] The base section 6 has a width of 13 to 23 mm, preferably 18 mm, and / or a depth of 0.3 mm to 1.4 mm, preferably 0.4 mm. Figure 5 shows an embodiment of an ampoule arrangement 100 according to the invention with several ampoules 10 arranged in a row. As an example, five ampoules 10 are arranged in a row. The ampoules 10 are each integrally connected to one another via a connecting web 101.

[0062] Finally, Figure 6 shows an embodiment of an ampoule assembly during or after its production after leaving the mold. The ampoules 10 are produced here in a BFS system (not shown), which includes an extruder and a downstream mold. The ampoules 10 are preferably produced continuously in a type of belt 110.

[0063] By way of example, eight ampoules 10 are arranged in a row to form an ampoule arrangement 100, each of which is integrally connected to one another in the row via a connecting web 101 (not all of which are provided with reference symbols). The molding tool here thus comprises a mold with eight cavities.

[0064] Furthermore, two further rows of ampoules 10 are arranged here by way of example. The formed matrix is ​​embedded in a type of continuously running belt 110. The ampoule arrangements 100 are preferably produced continuously and guided away via the belt 110. The arrows indicate the direction of the continuous belt 110. The individual ampoule arrangements 100 are then removed from the belt 110 (not shown in the figures).

[0065] It will be apparent to those skilled in the art that the described embodiments are to be understood as examples. The invention is not limited to these, but can be varied in many ways without departing from the essence of the invention. Features of individual embodiments and the features mentioned in the general part of the description can each be combined with one another or with one another.

[0066] Reference symbol:

[0067] 1 closure part or twist-off part or twist-off cap la predetermined breaking point or predetermined breaking edge

[0068] 1b Contact surface for the finger

[0069] 1c Contact edge for the finger

[0070] ID cap

[0071] 2 headboard

[0072] 2a Applicator opening

[0073] 3 Neck part

[0074] 4 shoulder part

[0075] 5 fuselage section

[0076] 6 Foot part or label part

[0077] 8 Corporate symbol

[0078] 9 Label or product label

[0079] 10 ampoules or eye drop ampoules

[0080] 100 ampoule arrangement

[0081] 101 connecting bridge

[0082] 110 ampoule band

Claims

Patent claims:

1. Ampoule (10) for a medical, in particular ophthalmic, liquid, comprising a body part (5) for receiving the medical liquid, a shoulder part (4) which adjoins the body part (5) above, a neck part (3) which adjoins the shoulder part (4) above, a head part (2) which adjoins the neck part (3) above, with an applicator opening (2a) for removing the medical liquid from the ampoule (10), and a twist-off part (1) as a closure, which in an initial state of the ampoule (10) is connected to the head part (2) via a predetermined breaking point (1a) and closes the applicator opening (2a) in a liquid-tight manner, characterized in that the head part (2) is designed as an ellipsoidal section, preferably as a spherical section, with at least one upper base surface in which the applicator opening (2a) is located, and with a, starting from the neck part (3),increasing cross-section and decreasing cross-section in the direction of the applicator opening (2a).

2. Ampoule (10) according to the preceding claim, characterized in that the twist-off part (1) provides a tamper-evident closure, wherein the twist-off part (1) is arranged completely above the head part (2) and is connected to the head part (2) only via the predetermined breaking point, which is preferably annular.

3. Ampoule (10) according to one of the preceding claims, characterized in that the predetermined breaking point (1a) is located in the upper base surface of the ellipsoidal section, preferably the spherical section, and, after removal of the twist-off part (1), the base surface is provided as a flat base surface, wherein the applicator opening (2a) is delimited by a surrounding, flat circular ring which forms the predetermined breaking point (1a).

4. Ampoule (10) according to one of the preceding claims, characterized in that the ellipsoidal section, preferably the spherical section, forms a lower base surface in the transition region to the neck part (3).

5. Ampoule (10) according to one of the preceding claims, characterized in that the neck part (3) has a cross-section tapering from the shoulder part (4) in the direction of the head part (2).

6. Ampoule (10) according to one of the preceding claims, characterized in that the shoulder part (4) has a cross-section tapering from the body part (5) in the direction of the neck part (2).

7. Ampoule (10) according to one of the two preceding claims, characterized in that the neck part (3) and the shoulder part (4) together form a funnel.

8. Ampoule (10) according to one of the preceding claims, characterized by a foot part (6) for arranging a label (9), wherein the foot part (6) adjoins the body part (5) below.

9. Ampoule (10) according to the preceding claim, characterized in that the base part (6) has a substantially constant cross-section and / or that a label (9), preferably with product information, is glued to the base part (6).

10. Ampoule (10) according to one of the preceding claims, characterized in that the body part (5) has a cross-section tapering from the shoulder part (4) towards the foot part (6) or that the body part (5) has a substantially constant cross-section.

11. Ampoule (10) according to one of the preceding claims, characterized in that product information and / or a company identification is arranged, preferably embossed, on a wall of the body part (5).

12. Ampoule (10) according to one of the preceding claims, characterized in that the ampoule is a single-dose applicator and is preferably designed to accommodate a volume of 0.1 ml to 3.0 ml, preferably 0.3 ml to 2.0 ml, preferably 0.8 ml to 1.5 ml.

13. Ampoule (10) according to one of the preceding claims, characterized in that the ampoule (10) is produced by means of BFS and / or the ampoule (10) is formed in one piece and / or the ampoule (10) is formed from a material which comprises PE and / or PP.

14. Ampoule arrangement (100) with at least two ampoules (10) according to one of the preceding claims, characterized in that the at least two ampoules (10) are integrally connected to one another via a connecting web (101).

15. BFS system comprising an extruder and a molding tool with a mold, wherein the mold comprises at least one cavity for forming an ampoule (10) according to one of the preceding claims.

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