DISPOSABLE PORT DEVICE FOR CONNECTING A FUNCTIONAL UNIT TO A FLEXIBLE WALL OF A DISPOSABLE CONTAINER AND METHOD OF MANUFACTURING A DISPOSABLE PORT DEVICE

Abstract

A disposable port device for connecting a functional unit to a flexible wall of a disposable container includes a flange to be connected to the flexible wall of the disposable container and an insert providing or receiving the functional unit. The flange and the insert are separate parts made from different materials with different material characteristics. A method of manufacturing such a disposable port device includes the steps of producing the flange from a first material, producing the insert from a different second material, the first and second materials having different material characteristics, and connecting the insert to the flange.

Claims

1. A disposable port device for connecting a functional unit to a flexible wall of a disposable container, the disposable port device comprising a flange to be connected to the flexible wall of the disposable container and an insert providing or receiving the functional unit, the flange and the insert being separate parts made from different materials with different material characteristics.

2. The disposable port device according to claim 1, characterized in that the material of the insert is harder than the material of the flange.

3. The disposable port device according to claim 1, characterized in that the material of the flange is low-density polyethylene.

4. The disposable port device according to claim 1, characterized in that the material of the insert includes at least one of the following: metal, thermoplastic, thermosetting polymer, resins.

5. The disposable port device according to claim 1, characterized in that the flange is ring-shaped and the insert is disc-shaped, the shape of the flange being adapted to receive the insert.

6. The disposable port device according to claim 1, characterized in that the functional unit includes at least one of the following or at least a relevant portion thereof: a sensor, a sensor assembly, a fluid transfer unit, a sampling unit, a hose barb, a baffle, a membrane, an analytical interface.

7. The disposable port device according to claim 6, characterized in that the functional unit is an optical sensor unit including a partially transmissive material.

8. The disposable port device according to claim 7, characterized in that the partially transmissive material is sapphire.

9. The disposable port device according to claim 1, characterized in that the functional unit provides a single functionality or more than one functionality at the same time or multiple times the same kind of functionality.

10. A disposable container, comprising a flexible wall and a disposable port device according to claim 1, the port device being integrated into the flexible wall.

11. The disposable container according to claim 10, characterized in that the flange of the port device is directly attached to the flexible wall.

12. A method of manufacturing a disposable port device according to claim 1, the method comprising the steps of: producing the flange from a first material; producing the insert from a different second material, the first and second materials having different material characteristics; and connecting the insert to the flange.

13. The method according to claim 12, characterized in that the insert is produced by 3D printing, machining or molding.

14. The method according to claim 12, characterized in that the flange and the insert are produced by the same technique from different materials.

15. The method according to claim 12, characterized in that the flange is produced by injection molding from a first material, and the insert is produced by 3D printing or by injection molding or overmolding from a second material.

16. The method according to claim 12, characterized in that the insert is mounted to the flange from the inside of the disposable container.

17. A method of manufacturing a disposable container according to claim 10, the method comprising the steps of: manufacturing the disposable port device by producing the flange from a first material, producing the insert from a different second material, the first and second materials having different material characteristics, and connecting the insert to the flange; and directly attaching the flange of the port device to the flexible wall of the disposable container.

18. The disposable port device according to claim 7, wherein the partially transmissive material is transmissive in a wavelength range of 190 to 2500 nm.

19. The disposable port device according to claim 8, wherein the optical sensor unit includes a sapphire disc.

20. The disposable container according to claim 11, wherein the flange of the port device is welded or glued to the flexible wall.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Further features and advantages of the invention will become apparent from the following description and from the accompanying drawings to which reference is made. In the drawings:

[0035] FIG. 1 shows a perspective view of a disposable port device according to the invention for connecting a functional unit to a flexible wall of a disposable container;

[0036] FIG. 2 shows an exploded view of the port device of FIG. 1;

[0037] FIG. 3 shows a bottom view of the port device of FIG. 1;

[0038] FIG. 4 shows a sectional view of the port device along intersection line A-A of FIG. 3;

[0039] FIG. 5 shows a sectional view of the port device along intersection line B-B of FIG. 3;

[0040] FIG. 6 shows an enlarged view of detail C of FIG. 5; and

[0041] FIG. 7 shows an enlarged view of detail Y of FIG. 5.

DETAILED DESCRIPTION OF THE INVENTION

[0042] A portion of a flexible wall 10 of a disposable container is shown in FIG. 1. The disposable container will be referred to here as bag for the sake of simplicity. The flexible wall 10 is typically made of a foil and surrounds at least a portion of the interior of the bag. A disposable port device 12 is integrated into the flexible wall 10 and accommodates a functional unit 14. In the embodiment shown in the drawings the functional unit 14 is a sensor unit, in particular an optical sensor unit for spectroscopy. However, as will be explained further below, the functional unit 14 can provide other functionalities, more than one functionality at the same time or multiple times the same functionality.

[0043] The individual components of the port device 12 and the optical sensor unit are apparent from the exploded view of FIG. 2. The main components of the port device 12 are a ring-shaped flange 16 and a separate insert 18. Further components of the port device 12 are two O-rings 20, 22 and a retaining ring 24. The optical sensor unit includes two sets of the following components: a sapphire disc 26, two O-rings 28, 30, and a locking ring 32.

[0044] The outer ring-shaped flange 16 of the port device 12 is made of a meltable material for welding to the flexible wall 10 of the bag, in particular to an edge of a window provided in the flexible wall 10. The preferred material for the flange 16 in view of the preferred welding connection is PE (polyethylene), especially LDPE (low-density polyethylene). As an alternative, the flange 16 may be glued or otherwise mechanically attached to the flexible wall 10.

[0045] The inner shape of the flange 16 is adapted to receive the basically disc-shaped insert 18. A first side of the insert 18, which is visible in FIGS. 1 and 2, will be referred to as the top side, while the opposite second side, which is visible in FIG. 3, will be referred to as the bottom side.

[0046] The insert 18 is either designed to provide a certain functionality or designed to receive a separate functional unit 14. Typical examples of the functional unit 14 include a variety of sensors or sensor assemblies, especially for measuring pH, dO (dissolved oxygen), temperature, capacitance, conductivity, as well as fluid transfer units, sampling units (ports for extracting samples), hose barbs, baffles, membranes and interfaces to spectroscopy or other analytical techniques. As mentioned before, the functional unit 14 can provide a single functionality, more than one functionality at the same time or multiple times the same kind of functionality. In the context of the present invention, the term “functional unit” shall also encompass a relevant portion of a functional device or assembly, e.g. a detection element of a sensor assembly.

[0047] The insert 18 is manufactured by 3D printing, machining, molding or another suitable forming technique. Preferred materials for the insert 18 are metals, thermoplastics, thermosetting polymers, resins. In most applications the insert 18 is less flexible (i.e. harder) than the flange 16.

[0048] It is generally possible to manufacture the flange 16 and the insert 18 using the same technique, potentially in the same process. For example, 3D printing allows usage of two or more materials within the same printing process. Multi-component injection molding or overmolding are also possible options for jointly manufacturing the flange 16 and the insert 18.

[0049] As can be seen in FIGS. 4, 5 and 6, the insert 18 is connected with the flange 16 via the first O-ring 20 forming a radially acting gasket, the second O-ring 22 forming an axially acting gasket, and the retaining ring 24 forming a clamping mechanism for keeping the main components of the port device 12 together. In the assembling process, the insert 18 is mounted to the flange 16, which is already connected to the flexible wall 10 of the bag, from the inside of the bag so that the top side of the insert 18 faces the bag interior and the bottom side faces the bag exterior.

[0050] The insert 18 may be mounted to the flange 16 without a retaining ring. In this case it is the pressure of the fluid inside the bag that presses the insert 18 against the axially acting gasket (second O-ring 22) and prevents detachment of the insert 18 from the flange 16. Generally, a higher pressure improves the functionality of the gaskets and the strength of the connection. Other options of a clamping mechanism for fixing the insert 18 to the flange 16 include a system of clamps and/or snap/latch locks or a bayonet mount.

[0051] With the above-explained split concept of the port device the design of the flange 16 can remain unchanged while the design of the insert 18 can be adapted to the design of the functional unit 14 to be received.

[0052] Regarding the specific optical sensor unit employed in the embodiment shown in the drawings, the setup and the sealing of the optical sensor unit is apparent from FIGS. 1 and 7. The sapphire discs 26 are held in place by the locking rings 32. While the O-rings 28 facing the measuring gap of the optical sensor unit are received behind a circular protrusion of the insert 18, the O-rings 30 on the other sides of the sapphire discs 26 are exposed to the pressure of the fluid in the bag. Thus, the sapphire discs 26 are clamped between the O-rings 28 and 30 and are sealed well.

[0053] The main application of the split port device 12 is to provide an appropriate port for bioreactors (with or without stirring or rocking motion equipment), mixing bags, or any other single-use container having a flexible wall where a sensor or another functional unit is required.

LIST OF REFERENCE NUMERALS

[0054] 10 bag wall [0055] 12 port device [0056] 14 functional unit [0057] 16 flange [0058] 18 insert [0059] 20 O-ring [0060] 22 O-ring [0061] 24 retaining ring [0062] 26 sapphire disc [0063] 28 O-ring [0064] 30 O-ring [0065] 32 locking ring