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 (12) for connecting a functional unit (14) to a flexible wall (10) of a disposable container, the disposable port device (12) comprising a flange (16) to be connected to the flexible wall (10) of the disposable container and an insert (18) for providing or receiving the functional unit (14). The flange (16) and the insert (18) are separate parts made of different materials having different material properties. A method of manufacturing such a disposable port device (12) comprises the steps of: producing the flange (16) from a first material; producing the insert (18) from a different second material, the first material and the second material having different material properties; and connecting the insert (18) to the flange (16).

Description

Technical Field

[0001] The present invention relates to a disposable port device for connecting a functional unit to the flexible wall of a disposable container. The present invention also relates to a method of manufacturing a disposable port device. Background Art

[0002] Especially in the pharmaceutical and biotech industries, for the production, storage, and use of fluids (liquids and gases), disposable containers with flexible walls are used instead of the previously more common rigid tanks and barrels made of, for example, stainless steel. For simplicity, such disposable or single-use containers will be referred to herein as bags. As in the case of rigid containers, it is necessary to sample the fluid in the bag and monitor various parameters of the fluid. To this end, it is known to use sensors that project through a window portion in the bag wall into the interior of the bag.

[0003] For example, DE 10 2015 122 745B3 discloses a bag having a housing of an optical measurement unit projecting into the interior of the bag. The measurement unit housing has a measurement gap defined by two side surfaces facing each other at a certain distance and a connecting surface connecting the side surfaces. Each side surface has an optical window portion, and optical fibers are respectively mounted in front of the window portions. The measurement unit housing has an accommodation channel for receiving the optical fibers upstream of the window portions. The accommodation channel can then be fitted with optical fibers from the outside. The measurement unit housing having the window portions and the accommodation channel is firmly connected to the wall of the bag.

[0004] For cost and disinfection reasons, the sensor or at least the part of the sensor that interacts with or is affected by the fluid to be monitored is formed as a disposable element, which is delivered to the customer firmly connected to the bag. Thus, the bag and the sensor (part) can be disinfected together by the manufacturer before delivery or by the customer before actual use. After being used, the bag and the sensor (part) are disposed of together.

[0005] To attach a sensor or other component to the bag, a suitable port needs to be integrally incorporated into the flexible wall of the bag. However, the pressure of the fluid in the bag can cause the curvature of the bag foil and possibly the curvature of the port, resulting in material stress. Summary of the Invention

[0006] The object of the present invention is to overcome the deficiencies and drawbacks of previous achievements, especially considering on the one hand the easy manufacture and high reliability of the connection between the port and the bag, and on the other hand the high flexibility with respect to the type of sensor to be used.

[0007] The present invention provides a disposable port device. Advantageous and alternative embodiments of the disposable port device according to the present invention are apparent from the description of the present application.

[0008] The disposable port device according to the present invention is intended for connecting a functional unit to the flexible wall of a disposable container. The disposable port device includes a flange to be connected to the flexible wall of the disposable container and an insert for providing or receiving the functional unit. The flange and the insert are separate parts made of different materials having different material properties.

[0009] For the purposes of the present invention, "disposable" is intended for single use. A person skilled in the art of biotechnology can distinguish between single-use components and common multi-use components, such as stainless steel tanks. Single-use components are typically made of sterilizable plastic materials, and multi-use components are reused after being cleaned and sterilized.

[0010] The present invention is based on the finding that using two different materials enables the port device according to the present invention to meet different high requirements, particularly on the one hand regarding avoiding material stress in the area where the port is connected to the flexible wall of the disposable container, and on the other hand providing a rigid and reliable support for any functional unit. This will be explained in more detail below.

[0011] The foil of the disposable container (bag) is flexible and assumes a curved shape when filled with fluid. If a rigid material is used for the port in the foil, the shape of the port will not easily follow the curvature of the foil. Therefore, relative material stress may cause tearing of the foil or cracking of the port, resulting in leakage. Thus, a flexible material may be beneficial for the joint between the port and the bag. However, the functional unit employed at the port typically requires a robust material that does not change its geometry when the bag is filled. Additionally, in most cases, the port is attached to the bag surface by welding, and there are only few materials that can be properly welded to the bag foil. Unfortunately, these materials are generally not suitable for other manufacturing techniques and / or these materials cannot be used under special conditions. For example, polyethylene (PE) can be welded, but polyethylene (PE) is not easily adhesively bonded or used for rapid prototyping.

[0012] The present invention provides a solution to the above problems without making compromises. The basic idea of the present invention is to divide the port into two separate components made of different materials with different material properties. Although the outer flange of the port device according to the present invention can be made of a fusible material for welding to the bag foil or a material suitable for gluing to the bag foil, the insert can be made of a more rigid material in order to provide proper support for the functional unit. The material of the insert can be freely selected because the insert does not have to meet the requirements of the port flange. Conversely, the material of the port flange can be freely selected because the port flange does not have to meet the requirements of the insert.

[0013] The port device according to the present invention can be used as a universal port for applying different functional units. The flange can always have the same design and be pre-attached to the bag wall. The flange can receive different inserts or inserts with different functional units as long as the connection between the flange and the insert is universal. This reduces the need for qualification whenever the same platform is used for newly developed sensors or other functional units. Only the insert has to be suitable for the corresponding functional unit.

[0014] To meet the common requirements of the above ports, it is recommended to select different materials such that the material of the insert is harder than the material of the flange.

[0015] A preferred flange material is polyethylene, especially low-density polyethylene, due to its flexibility and weldability.

[0016] Preferred insert materials are as follows: metals, thermoplastics, thermosetting polymers, resins.

[0017] According to a preferred embodiment of the present invention, the flange is substantially annular and the insert is substantially disc-shaped, and the shape of the flange is adapted to receive the insert. Thus, the insert with the functional unit is completely surrounded by the flange. In this context, "substantially annular" and "substantially disc-shaped" should cover designs with axial protrusions.

[0018] There are various options for connecting the insert to the flange. One of the preferred options is a clamping mechanism. The advantage of the clamping mechanism is that no material connection such as welding, gluing or bonding is required.

[0019] The clamping mechanism can include a retaining ring that, when fixed, presses the flange against the insert or presses the insert against the flange. For example, in the case of an integrated clamping function, a friction fit and / or when a satisfactory connection is achieved or at least the pressure exerted on the insert by the fluid in the container is supported against the flange, the retaining means can be omitted.

[0020] Proper sealing of the port device is important. For this purpose, it is preferred to provide both a radially acting gasket and an axially acting gasket.

[0021] The radially acting washer may be formed by a first O-ring disposed between opposing radial surfaces of the flange and the insert.

[0022] The axially acting washer may be formed by a second O-ring disposed between opposing axial surfaces of the flange and the insert.

[0023] The functional unit to be attached to the disposable container may be any useful device or part of such device, and the functional unit may include at least one of the following or at least a relevant part of at least one of the following: a sensor, a sensor assembly, a fluid transfer unit, a sampling unit, a hose barb, a baffle, a membrane, an analysis interface.

[0024] According to a particular embodiment of the invention, the functional unit is an optical sensor unit including a partially transmissive material, preferably a material transmissive in the wavelength range of 190 nm to 2500 nm. Such materials include, for example, fused silica and borosilicate glass (BK7).

[0025] The partially transmissive material may also be sapphire. Thus, the optical sensor unit may actually include a sapphire disk.

[0026] Generally, the functional unit is not limited to a single function. The functional unit may also provide more than one function simultaneously or provide the same kind of function multiple times.

[0027] The invention also provides a disposable container including a flexible wall and a disposable port device as described above, the port device being integrally incorporated into the flexible wall.

[0028] Due to the existence of established and recognized techniques for connecting certain flange materials to foils and the like, the flange of the port device should be directly attached to, preferably welded or glued to, the flexible wall.

[0029] The invention also provides a method of manufacturing a disposable port device according to the invention. The method includes the steps of producing a flange from a first material; producing an insert from a different second material, the first material and the second material having different material properties; and connecting the insert to the flange.

[0030] The insert of the port device may be produced by 3D printing, machining or molding. Each of these forming methods is accurate enough and suitable for mass production.

[0031] According to a particular aspect of the invention, the flange and the insert may be produced from different materials by the same technique, preferably in the same process.

[0032] The flange can be produced from a first material by injection molding, and the insert can be produced from a second material by 3D printing or by injection molding or overmolding.

[0033] In the case where the flange and the insert are produced independently and the flange is first attached to the flexible container wall, the insert is preferably installed from the inside of the disposable container onto the flange. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Other features and advantages of the present invention will become apparent from the following description and the accompanying drawings, in which:

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

[0036] - Figure 2 shows Figure 1 an exploded view of the port device;

[0037] - Figure 3 shows Figure 1 a bottom view of the port device;

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

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

[0040] - Figure 6 shows Figure 5 an enlarged view of detail C; and

[0041] - Figure 7 shows Figure 5 an enlarged view of detail Y. DETAILED DESCRIPTION

[0042] A portion of the flexible wall 10 of the disposable container is shown in Figure 1 . For simplicity, the disposable container will be referred to herein as a bag. The flexible wall 10 is typically made of foil and surrounds at least a portion of the interior of the bag. The disposable port device 12 is integrally incorporated into the flexible wall 10 and houses the functional unit 14. In the embodiment shown in the drawings, the functional unit 14 is a sensor unit, particularly an optical sensor unit for spectroscopy. However, as will be further described below, the functional unit 14 can provide other functions, can provide more than one function simultaneously, or can provide the same function multiple times.

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

[0044] The outer annular flange 16 of the port device 12 is made of a fusible material for welding to the flexible wall 10 of the bag, particularly for welding to the edge of the window portion provided in the flexible wall 10. Considering the preferred welded connection, the preferred material for the flange 16 is PE (polyethylene), particularly LDPE (low-density polyethylene). As an alternative, the flange 16 can be adhesively bonded or otherwise mechanically attached to the flexible wall 10.

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

[0046] The insert 18 is designed to provide a certain function or to receive a separate functional unit 14. Typical examples of the functional unit 14 include various sensors or sensor assemblies, particularly sensors or sensor assemblies 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 for spectroscopy or other analytical techniques. As previously mentioned, the functional unit 14 can provide a single function, can have more than one function simultaneously or can provide the same type of function multiple times. In the context of the present invention, the term "functional unit" should also cover the relevant parts of functional devices or components, such as the detection elements of sensor assemblies.

[0047] The insert 18 is manufactured by 3D printing, machining, molding or other suitable shaping techniques. The preferred materials for the insert 18 are metals, thermoplastics, thermosetting polymers, resins. In most applications, the insert 18 is less ductile (i.e., harder) than the flange 16.

[0048] Generally, the same techniques, possibly the same processes, can be used to manufacture the flange 16 and the insert 18. For example, 3D printing allows the use of two or more materials in the same printing process. Multi-component injection molding or overmolding are also possible options for co-manufacturing the flange 16 and the insert 18.

[0049] As shown in Figure 4 ,Figure 5 and Figure 6 As can be observed in Figure 6 , the insert 18 is connected to the flange 16 via a first O-ring 20 forming a radially acting washer, a second O-ring 22 forming an axially acting washer, and a retaining ring 24 forming a clamping mechanism for holding the main components of the port device 12 together. During assembly, the insert 18 is mounted from the inside of the bag to the flange 16 already connected to the flexible wall 10 of the bag, such that the top side of the insert 18 faces the inside of the bag and the bottom side faces the outside of the bag.

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

[0051] With the above-described separable 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 figures, the arrangement and sealing of the optical sensor unit are apparent from Figure 1 and Figure 7 The sapphire disk 26 is held in place by a locking ring 32. When the O-ring 28 facing the measurement gap of the optical sensor unit is received behind the circular protrusion of the insert 18, the O-ring 30 located on the other side of the sapphire disk 26 is exposed to the pressure of the fluid in the bag. Thus, the sapphire disk 26 is clamped between the O-ring 28 and the O-ring 30 and is well-sealed.

[0053] The main application of the separable port device 12 is to provide a suitable port for bioreactors (with or without agitation or rocking motion equipment), mixing bags, or any other single-use container with a flexible wall that require a sensor or another functional unit.

[0054] List of reference numerals

[0055] 10 Bag wall

[0056] 12 Port device

[0057] 14 Functional unit

[0058] 16 Flange

[0059] 18 Insert

[0060] 20 O-ring

[0061] 22 O-ring

[0062] 24 Retaining ring

[0063] 26 Sapphire disc

[0064] 28 O-ring

[0065] 30 O-ring

[0066] 32 Locking ring

Claims

1. A method of manufacturing a disposable port device (12) for connecting a functional unit (14) to a flexible wall (10) of a disposable container, wherein the disposable port device (12) includes a flange (16) to be connected to the flexible wall (10) of the disposable container and an insert (18) for providing or receiving the functional unit (14), and the flange (16) and the insert (18) are separate parts made of different materials having different material properties, the method comprising the steps of: producing the flange (16) from a first material; producing the insert (18) from a different second material, the first material and the second material having different material properties; and connecting the insert (18) to the flange (16), wherein the insert (18) is mounted to the flange (16) from the inside of the disposable container, and wherein the flange (16) is configured for mounting to the inside of the disposable container.

2. The method according to claim 1, characterized in that, The insert (18) is produced by 3D printing, machining or molding.

3. The method according to claim 1 or 2, characterized in that, The flange (16) and the insert (18) are produced from different materials by the same technique.

4. The method according to claim 3, characterized in that, The flange (16) and the insert (18) are produced by the same process.

5. The method according to claim 1 or 2, characterized in that, The flange (16) is produced from a first material by injection molding, and the insert (18) is produced from a second material by 3D printing or by injection molding or overmolding.

6. The method according to any one of claims 1, 2, and 4, characterized in that, The material of the insert (18) is harder than the material of the flange (16).

7. The method according to any one of claims 1, 2, and 4, characterized in that, The material of the flange (16) is polyethylene.

8. The method according to claim 7, wherein The material of the flange (16) is low density polyethylene.

9. The method according to any one of claims 1, 2, and 4, characterized in that, The material of the insert (18) includes at least one of the following: metal, thermoplastic, thermosetting polymer, resin.

10. The method according to any one of claims 1, 2, and 4, characterized in that, The flange (16) is substantially annular, and the insert (18) is substantially disc-shaped, and the shape of the flange (16) is adapted to receive the insert (18).

11. The method according to any one of claims 1, 2, and 4, characterized in that, The functional unit (14) includes at least one of the following or at least a relevant part of at least one of the following: sensor, sensor assembly, fluid transfer unit, sampling unit, hose barb, baffle, membrane, analysis interface.

12. The method according to claim 11, wherein The functional unit (14) is an optical sensor unit including a partially transmissive material.

13. The method according to claim 12, wherein The functional unit (14) is an optical sensor unit including a material that is transmissive in the wavelength range of 190 nm to 2500 nm.

14. The method according to claim 12 or 13, characterized in that, The partially transmissive material is sapphire.

15. The method according to claim 14, characterized in that, The optical sensor unit includes a sapphire disc.

16. The method according to any one of claims 1, 2, and 4, characterized in that, The functional unit (14) provides a single function or provides more than one function simultaneously or provides the same type of function multiple times.

17. A method of manufacturing a disposable container, the disposable container including a flexible wall (10) and a disposable port device (12) manufactured by the method according to any one of claims 1 to 16, the method comprising the steps of: The port device (12) is integrally incorporated into the flexible wall (10) of the disposable container by directly attaching the flange (16) of the port device (12) to the flexible wall (10) of the disposable container, wherein the flange (16) is mounted to the interior of the disposable container.

18. The method according to claim 17, characterized in that, The flange (16) of the port device (12) is welded or glued to the flexible wall (10).

19. A disposable port device (12) manufactured by the method according to any one of claims 1 to 16 and mounted to the interior of a disposable container.

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