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EP-4740994-A1 - A SMALL-BORE FEMALE CONNECTOR FOR ENGAGING A FLEXIBLE TUBE

EP4740994A1EP 4740994 A1EP4740994 A1EP 4740994A1EP-4740994-A1

Abstract

A small-bore female connector suitable for being inserted into a flexible tube, wherein the small-bore female connector comprises a hollow body part, a first removable part, and a second removable part, wherein the hollow body part comprises a device-side part comprising a small-bore female connector part having a small-bore female opening, and a tube-side part comprising a tube engaging part having a fluid receiving opening, wherein the first removable part forms a tube-side connection to the tube-side part of the hollow body part, thereby breakably closing the fluid receiving opening, and wherein the second removable part forms a device-side connection to the device-side part of the hollow body part, thereby breakably closing the small-bore female opening.

Inventors

  • Vallotton, Raphael

Assignees

  • B. Braun Melsungen AG

Dates

Publication Date
20260513
Application Date
20241112

Claims (15)

  1. A small-bore female connector suitable for being inserted into a flexible tube, wherein the small-bore female connector comprises - a hollow body part (1), - a first removable part (2), and - a second removable part (3), wherein the hollow body part (1) comprises - a device-side part (4) comprising a small-bore female connector part (5) having a small-bore female opening (6), and - a tube-side part (7) comprising a tube engaging part (8) having a fluid receiving opening (9), wherein the first removable part (2) forms a tube-side connection (10) to the tube-side part (7) of the hollow body part (1), thereby breakably closing the fluid receiving opening (9), and wherein the second removable part (3) forms a device-side connection (11) to the device-side part (4) of the hollow body part (1).
  2. The small-bore female connector according to claim 1, wherein the second removable part (3) forming a device-side connection (11) to the device-side part (4) of the hollow body part (1) results in breakably closing the small-bore female opening (6).
  3. The small-bore female connector according to any of the preceding claims 1 or 2, wherein the tube engaging part (8) comprises an engaging section (8a) for engaging with the tube and a tapered, preferably conical, section (8b) for centering the tube, wherein the engaging section (8a) connects the tube engaging part (8) to the hollow body part (1), and wherein the tapered part (8b) connects the engaging section (8a) with the first removable part (2).
  4. The small-bore female connector according to any of the preceding claims 1 to 3, wherein the hollow body part (1) further comprises a radially extending flange (12).
  5. The small-bore female connector according to claim 4, wherein the radially extending flange (12) is positioned at a connection between the tube-side part (7) and the device-side part (4).
  6. The small-bore female connector according to any of the preceding claims 1 to 5, wherein the hollow body part (1) comprises a hole (13) extending through the hollow body part (1) connecting the small-bore female opening (6) and the fluid receiving opening (9).
  7. The small-bore female connector according to any of the preceding claims 1 to 6, wherein the first removable part (2) comprises at least two lateral extensions (14).
  8. The small-bore female connector according to claim 7, wherein the breadth of the at least two lateral extensions (14) decreases along the lateral dimension of the at least two lateral extensions (14) from the tube-side part (7) towards an end of the first removable part (2).
  9. The small-bore female connector according to claims 7 or 8, wherein the second removable part (3) comprises at least two lateral extensions (15) for gripping said second removable part (3) and applying force or torque to twist it off.
  10. The small-bore female connector according to any of the preceding claims 1 to 9, wherein the small-bore female connector further comprises a retaining string (17), wherein the retaining string (17) is connected to the second removable part (3) and the hollow body part (1), preferably the flange (12) of the hollow body part (1).
  11. The small-bore female connector according to any of the preceding claims 1 to 10, wherein the small-bore female connector further comprises a cap (18) suitable for being placed on the small-bore female connector part (5) after twisting off the second removable part (3).
  12. The small-bore female connector according to claim 11, wherein the cap (18) is connected to the second removable part (3).
  13. Use of the small-bore female connector according to any of the preceding claims 1 to 12 in a pharmaceutical product, preferably as a port in a pharmaceutical product, more preferably as a port in a bag comprising an active pharmaceutical ingredient.
  14. Process for preparing a small-bore female connector according to any of the preceding claims 1 to 12, wherein the process comprises the steps of: - injection molding the small-bore female connector thereby shaping the tube-side connection (10) and the device-side connection (11); - closing the twist-off opening (15) of the second removable part (3).
  15. The process according to claim 14, wherein the step of closing of the twist-off opening (16) comprises the step of inserting a plug into the twist-off opening (16) or the step of sealing, preferably thermally sealing, most preferably heating, flattening and welding, the twist-off opening (16).

Description

Technical Field of the Invention The present invention relates to a small-bore female connector, in particular a small-bore female connector which can be inserted into a flexible tube, and which has a simple, easy to manufacture design. Furthermore, the present invention relates to the use of such a small-bore female connector in a pharmaceutical product and a process for preparing such a small-bore female connector. Background of the Invention Pharmaceutical ingredients have an intended application purpose, for which they need to be inserted in specific downstream devices. Hence, pharmaceutical ingredients and solutions thereof are commonly stored prior to use and are transferred to respective downstream devices or storage containers shortly before usage. Typically, such pharmaceutical solutions are stored in glass or plastic vials, glass or plastic ampoules, or plastic pouches. Historically, vials, glass bottles, and plastic pouches were accessed through elastomeric stoppers using needles, spikes, or other types of sharp transfer devices for puncturing said elastomeric stoppers. Accessing vials, ampoules or pouches and transferring the pharmaceutical solution using needles has the drawback of potential risks using sharp devices, such as piercing of the container walls, creation of fragments of elastomeric stopper or plastic membrane, needle-stick injuries, and general difficulty of pushing the needle through the elastomeric stopper. To overcome the problem of handling the solution with a needle, other kinds of containers such as glass ampoules and later plastic ampoules were developed over the years, which provide access to their content through an open neck after breaking off an ampoule head. Such ampoules can be accessed using a needle, similar to those used to pierce elastomeric stoppers, or blunt needles. In addition, also plastic needles of transfer devices, as well as semi-flexible straws could be used to transfer the pharmaceutical solution. Moreover, for withdrawing the content of glass ampoules, needles or straws are typically equipped or combined with inline filters to prevent glass particles from being directed into the withdrawing devices and later being administered to the patient. Needle-free connectors have been developed to overcome the above-mentioned problems, cf. WO 9600556 A1. The most common needle-free connector for intravenous application is the LUER connector, as currently defined in ISO 80369-7. This connector allows liquid-tight connection of two devices and transfer of a pharmaceutical solution in between these devices. Likewise, an example for a connector for neuraxial application is the NRFit® connector, as currently defined in ISO 80369-6. It is generally a desire to provide needle-free connectors having a sealing function. In this way, complicated designs including further means for sealing the connection could be avoided. However, generally, female LUER or NRFit connectors have a small fluid conduit, wherein the diameter of this conduit is in the range of a few millimeters. Such small diameters make it difficult to position an elastomeric resealing member to achieve a sealing function. While LUER-activated valves are known from the prior art, the design of some features of such LUER-activated valves deviates from the dimensions stated in ISO 80369-7 in order to give enough room for the elastomeric and its deformation (i.e. the threads supporting diameter and its axial extend, as well as the 'functional' inner taper of the LUER cone receiving the male mating connector). This is in particular true for the length of the outer threaded portion and the depth of the tapered female portion (cf. AAMI CN27). These modifications can have a negative impact on the seat of the male connector in the female connector and generally on the connection strength and tightness. NRFit connectors have an even smaller inner diameter of the fluid conduit, which makes it hardly possible to place an elastomeric member therein. Hence, even larger deviations from nominal dimensions as stated in ISO 80369-6 would be necessary to achieve an NRFit-activated valve. Summary of the Invention Hence, the small-bore female connector activated valves known from the prior art have the disadvantage that they deviate from the standards risking problems of the connection, i.e. reduced strength and tightness. On the other hands, standard-conform small-bore female connectors known from the prior art have the disadvantage that they require additional means for sealing. Hence, the object of the present invention is to find a small-bore connector, in particular a female small-bore connector, which allows for sealing of a conduit until a used defined opening event and which allows for completely fulfilling the standards for said small-bore connector. Furthermore, it is another object of the present invention to find a small-bore connector, in particular a female small-bore connector, which ensures that an inner cavity or