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EP-4734905-A1 - AMPOULE FOR A MEDICAL, IN PARTICULAR OPHTHALMOLOGICAL, LIQUID

EP4734905A1EP 4734905 A1EP4734905 A1EP 4734905A1EP-4734905-A1

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.

Inventors

  • BRANDENBURGER, TORSTEN
  • SEIDEL, Janine

Assignees

  • Fresenius Kabi Deutschland GmbH

Dates

Publication Date
20260506
Application Date
20240629

Claims (15)

  1. 1. Ampoule (10) for a medical, in particular ophthalmological, 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 (la) and closes the applicator opening (2a) in a liquid-tight manner, characterized in that the head part (2) is designed as an ellipsoid section, preferably as a spherical section, with at least one upper base surface in which the applicator opening (2a) is located, and with a cross-section which increases starting from the neck part (3) and in The cross-section decreases in the direction of the applicator opening (2a).
  2. 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 only connected to the head part (2) via the predetermined breaking point, which is preferably annular.
  3. 3. Ampoule (10) according to one of the preceding claims, characterized in that the predetermined breaking point (la) is located in the upper base surface of the ellipsoid 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 (la).
  4. 4. Ampoule (10) according to one of the preceding claims, characterized in that the ellipsoid section, preferably the spherical section, forms a lower base surface in the transition region to the neck part (3).
  5. 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. 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. 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. 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. 9. Ampoule (10) according to the preceding claim, characterized in that the foot part (6) has a substantially constant cross-section and/or that a label (9), preferably with product information, is glued to the foot part (6).
  10. 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. 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. 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. 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. 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. 15. BFS system which has an extruder and a mold with a mold, wherein the mold comprises at least one cavity for forming an ampoule (10) according to one of the preceding claims.

Description

AMPOULE FOR A MEDICAL, PARTICULARLY OPHTHALMOLOGICAL, LIQUID Description The invention relates to an ampoule for a medical fluid, in particular for an ophthalmological fluid, according to the preamble of patent claim 1. Ampoules are used to store, prepare and/or transport medical fluids and can be available in different sizes, for example with a volume between 5 ml and 30 ml. A medical fluid contained in such an ampoule can be, for example, a medical agent, such as a drug or another fluid used for medical purposes. Such an ampoule generally comprises an ampoule body for holding the medical fluid and a break-off or twist-off part which seals the opening through which the fluid is removed in a fluid-tight manner in the initial state. Conventional ampoules are manufactured using the so-called blow-fill-seal (BFS) process. The blow-fill-seal process is a process that is used in particular for producing containers for holding liquids. In the blow-fill-seal process, a container is formed, filled and sealed in an uninterrupted process in a closed environment within a machine, without the need for operator intervention. In the blow-fill-seal process, a plastic material is usually extruded vertically to produce a tubular section, which is then formed and filled in a tool and then sealed. Due to the formation of the container, in particular in a low-germ environment, the blow-fill-seal process is particularly suitable for producing ampoules for holding medical liquids. 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 liquid or solution that is applied to an eye. They are often used as a single-use or single-dose applicator. The liquid is usually a saline-based solution or emulsion that contains or can contain a medication to treat an eye disease. In some cases, the liquid may not contain any medication and instead may only serve as a lubricant and/or tear substitute solution. An example of such an ampoule is described in the document EP 3 471 685 Bl. There, only an applicator tip with a blunt tip is described as advantageous in order to avoid scratches in the patient's cornea during application. There is a need for ampoules for ophthalmic applications that reduce the risk of eye injury during application and enable better dosing. Therefore, the present invention is based in particular on the object of providing an ampoule for ophthalmic applications which reduces the risk of eye injury during application and enables better dosing. This object is achieved by the objects having the features according to the independent patent claims. Advantageous embodiments are the subject of the description, the figures and the dependent claims. In general, the invention is described by an ampoule which in particular has an improved geometry in the head part, which includes the applicator opening through which the liquid to be removed is removed. According to the invention, the head part is designed as an ellipsoid section, preferably as a spherical section, with at least one upper base surface in which the applicator opening is located. This makes it possible to achieve improved dosing or a defined dropper ball, while at the same time forming a blunt upper side of the ampoule, so that the risk of eye injury during application is reduced. In detail, the present invention is described by an ampoule for a medical, in particular ophthalmological, liquid comprising a body part for receiving the medical liquid, a shoulder part that adjoins the body part above, a neck part that adjoins the shoulder part above, a head part that adjoins the neck part above, with 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 ellipsoid 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. According to the invention or in particular, the head part is designed as an ellipsoid 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. The interior of the neck part is preferably delimited by the curved wall of the ellipsoid 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. The twist-off part provides a tamper-evident closure for the ampoule. In a preferred embodiment, the twis