Device for fixing a pressure sensor to a container

Abstract

The invention relates to a single-use device (1) for fixing a pressure sensor (2) to a container (20). A first end region (2a) of the pressure sensor (2) is provided with a pressure-sensitive measuring diaphragm (3) via which the pressure of a medium (21) located in the container (20) can be determined, wherein a tubular component (4) is provided which can be coupled to the container (20) and which has a neck (5) whose inner surface (7) is provided with a radial stop edge (9). A flexible membrane (10) is mounted on the radial stop edge (9), which flexible membrane (10) seals the neck (5) in an air-tight manner and a cup-shaped mount (11) is provided in which a second end region (2b) of the pressure sensor (2) can be placed, said second end region facing away from the pressure-sensitive measuring diaphragm (3). The cup-shaped mount (11) and the neck (5) can be locked via corresponding fixing means (12) and the cup-shaped mount (11) and the neck (5) are designed such that the pressure-sensitive measuring diaphragm (3) of the pressure sensor (2) is in direct proximity to the flexible membrane (10) in the mounted state.

Description

Technical Field

[0001] This invention relates to a device for securing a pressure sensor to a containment (e.g., a container), particularly a single-use device, such as a single-use adapter. Preferably, the pressure sensor is reusable, and the containment is preferably a single-use containment. Background Technology

[0002] Single-use technologies are used in an increasing number of measurements in many industrial processes in the fields of pharmaceuticals, biology, biochemistry, or biotechnology. Flexible containers, such as bags, hoses, or fermenters, are used as containment structures or bioreactors. Supply and discharge lines are provided on single-use containers, and these lines are implemented as flexible hoses; however, alternatively, non-flexible fittings may also be used in these supply and discharge lines.

[0003] The above process takes place in a system isolated from the environment. Single-use technology offers the advantage that the single-use containers used are discarded after the process is completed. In this way, complex and even crucial cleaning and sterilization procedures are avoided. Furthermore, the use of single-use containers eliminates the risk of cross-contamination, thereby increasing process safety.

[0004] To monitor processes operating within single-use containers, the most diverse physical and / or chemical process variables of the media used are recorded. Preferably, sensors known in the prior art are used. Sensors applied in the field of single-use technology can be broadly classified into two categories—invasive sensors and non-invasive sensors. Invasive sensors are positioned within the single-use container and at least the measuring element is in direct contact with the medium to be measured, while non-invasive sensors are externally coupled to the single-use container and isolated from the medium.

[0005] In the case of invasive sensors, coupling to the medium is generally easier to achieve than in the case of non-invasive sensors. However, invasive sensors do need to be discarded or radioactively sterilized after use. Since the sensor's memory is often erased or even the electronics are damaged during radioactive sterilization, at least the software must be reinstalled. In the case of non-invasive sensors, sterilization can be avoided; therefore, they can be iteratively used for multiple processes running in single-use containers without much effort.

[0006] In the case of non-invasive sensors, the problem lies in attaching the sensor to a single-use container. This single-use container is typically made of flexible plastic with low mechanical shape stability. Therefore, releasably attaching a compact sensor to a flexible single-use container to obtain reproducible measurement results is not directly achievable.

[0007] A solution known from US 10,836,990 B2 couples a reusable pressure sensor to a single-use container, such as a single-use bioreactor, via an interface. This interface includes a shape-stable polymer flange capable of engaging with the wall of the single-use container. The polymer flange consists of sidewalls and an interface configured to accommodate a separate, deflectable polymer membrane. Furthermore, a region is provided for hermetically coupling with the polymer flange. This region is configured to enable coupling of the reusable measuring device. As proposed in that US patent, the interface for coupling the measuring device to the bioreactor consists of multiple separate components and is therefore quite complex. Summary of the Invention

[0008] The object of this invention is to provide a simple device for connecting a non-invasive pressure sensor to a single-use container, thus providing a single-use safety housing. Furthermore, the object of this invention is to provide a simple method for manufacturing the device of this invention.

[0009] This objective is achieved by means of a device for securing a pressure sensor to a containment, particularly a single-use device, wherein the pressure sensor is provided with a pressure-sensitive diaphragm in a first end region, via which the pressure of the medium located within the containment can be determined. Furthermore, a hose-shaped component is provided, capable of coupling with the containment. The hose-shaped component includes a neck with radial ridges provided on its inner surface. A flexible diaphragm is located on the radial ridges, hermetically sealing the neck. A cap-shaped retainer is provided, wherein the pressure-sensitive diaphragm can be positioned away from a second end region of the pressure sensor. The retainer and the neck can be connected to each other via corresponding securing mechanisms, wherein the connection is preferably releasable. Furthermore, the neck and retainer are configured such that the pressure-sensitive diaphragm of the pressure sensor is arranged adjacent to the flexible diaphragm in the assembled state.

[0010] Preferably, the pressure-sensitive measuring diaphragm is a ceramic measuring diaphragm. A wide variety of sensors with ceramic measuring diaphragms are developed, manufactured, and marketed by Endress+Hauser.

[0011] High-quality pressure sensors are relatively expensive. Therefore, a reusable pressure sensor is provided, which is removed from the containment via a releasable retaining mechanism after the process is complete. Because the sensor is arranged to be isolated from the process operating in the containment during measurement / monitoring, subsequent radioactive sterilization, which would otherwise result in the aforementioned drawbacks of erasing memory or damaging electronics, can be omitted.

[0012] An advantageous embodiment of the device of the present invention provides an annular lip seal which, in the assembled state, is located between the outer surface of the first end region of the pressure sensor and the corresponding inner surface of the neck.

[0013] The lip seal is implemented to achieve pressure equalization in the event of excessive pressure between the pressure-sensitive diaphragm and the annular lip seal. This occurs periodically during assembly when the cap-shaped retainer with the pressure sensor is fixed to the neck. If excess air cannot escape, excessive pressure is created between the flexible diaphragm and the measuring diaphragm, masking the actual pressure present during the process. With the application of the annular lip seal, the solution according to the invention allows excess air to escape automatically, preventing unwanted excessive pressure from being recorded by the measuring diaphragm. This is crucial because pressure at the measuring diaphragm that is not from the process will inevitably lead to measurement errors.

[0014] Preferably, the annular lip seal is implemented to prevent pressure equalization in the event of negative pressure between the pressure-sensitive measuring diaphragm and the annular lip seal. Therefore, no air is drawn from the outside into the intermediate space between the measuring diaphragm, the flexible membrane, and the lip seal to achieve pressure equalization. In this way, the present invention can measure both excess and negative pressure using a non-invasive pressure sensor.

[0015] Embodiments of the device of the present invention provide an annular lip seal including an upwardly curved portion in its edge region, the upwardly curved portion pointing away from the pressure-sensitive measuring element. Preferably, the upwardly curved portion of the annular lip seal tapers gradually towards the outer edge. By forming a gap between the edge region of the annular lip seal and the inner surface of the neck, excess air can escape without problems under excessive pressure, while preventing air from being drawn in under negative pressure, because in this case, the outer peripheral region of the lip seal tightly abuts against the inner surface of the neck.

[0016] A further development of the device of the present invention provides that the neck and retainer are implemented such that the pressure-sensitive measuring diaphragm of the pressure sensor contacts the flexible membrane in the assembled state with substantially no force transmission. Alternatively, the neck and retainer are provided such that the pressure-sensitive measuring diaphragm of the pressure sensor has a gap of at most 1 mm with the pressure-sensitive measuring diaphragm in the assembled state. The flexible membrane is preferably implemented such that the measurement error—which arises from the fact that the pressure of the medium can only be correctly measured by the pressure sensor when the flexible membrane is in contact with the pressure-sensitive measuring diaphragm—is located in the measurement error region of the pressure measuring device.

[0017] Furthermore, in another development of the device of the present invention, the retainer and the neck are provided to be connected to each other via a cap-shaped retainer and a fastening element on the neck. This fastening element can be, for example, a circumferential snap-fit ​​groove and a corresponding snap. Another option is a threaded closure. Other connections are known to those skilled in the art. Preferably, the cap-shaped retainer is fastened to the neck in such a way that it can be performed with one hand.

[0018] Furthermore, a flexible tube-shaped component is provided with connecting elements at both ends for connecting to a flexible tube, such as a containment vessel. The containment vessel is preferably a single-use containment vessel, which is properly discarded after the process is terminated. In this way, complex cleaning and sterilization processes are avoided in a given situation.

[0019] One embodiment of the device of the present invention provides that the components of the device are preferably made of a biocompatible material, such as polyethylene.

[0020] Furthermore, the object of the present invention is achieved by a method for producing the apparatus as described above in various embodiments. The method steps are as follows: ● A flexible membrane is mounted on a radial ridge located on the inner surface of the neck of the hose-shaped component, wherein this pressure sealing assembly is irreversible; ● The modified tubular component is welded into the bag and sterilized by means of radioactive radiation.

[0021] Preferably, the installation of the flexible membrane on or against the radial protrusions includes a welding process or an adhesive bonding process. Attached Figure Description

[0022] The invention will now be explained in more detail with reference to the accompanying drawings, which are shown below: Figure 1 Longitudinal cross-section of an embodiment of the device of the present invention, Figure 2 A perspective view of an embodiment of a lip seal that can be used in conjunction with the device of the present invention, and Figure 3 according to Figure 2 The cross-section of the lip seal with cutting plane III-III. Detailed Implementation

[0023] Figure 1 A longitudinal cross-section is shown of an embodiment of the disposable device 1 of the present invention for coupling the pressure sensor 2 to the containment 20. The pressure sensor 2 is preferably a ceramic pressure sensor 2, which is pressure-tightly sealed in a first end region 2a by a pressure-sensitive diaphragm 3. Ceramic materials suitable for producing the pressure-sensitive diaphragm are well known in the prior art.

[0024] Pressure sensor 2 determines the pressure of medium 21 located in containment 20 via pressure-sensitive diaphragm 3. Figure 1 The containment vessel 20 is shown schematically. Figure 1 The supply and discharge lines for coupling the containment 20 to the device 1 of the present invention are not shown.

[0025] The device 1 of the present invention includes a flexible hose-shaped component 4 having fixing elements 6a and 6b in the edge region. The flexible hose-shaped component 4 is connected via fixing elements 6a and 6b and corresponding fixing elements of the supply and discharge lines of the containment 20. Figure 1 (Not shown in the image) is connected to containment 20.

[0026] The flexible tube component 4 includes a neck 5 on which a radially and circumferentially extending ridge 9 is provided on the inner surface 7. This ridge 9 is formed, for example, by milling or casting the neck 5. In the illustrated case, a flexible membrane 10 is placed on the radial ridge 9, which hermetically seals the neck 5.

[0027] Furthermore, a cap-shaped retainer 11 is provided, wherein the pressure-sensitive measuring diaphragm 3 can be positioned away from the second end region 2b of the pressure sensor 2. The cap-shaped retainer 11 and the neck 5 can be connected to each other via fastening mechanisms 12a, 12b. In the illustrated case, the fastening mechanisms 12a, 12b are circumferential snaps 12b on the inner surface 18 of the lower edge region of the cap-shaped retainer 11. In the case of assembly, the snaps 12b engage in corresponding snap grooves 12a on the outer surface 8 of the neck 5. Alternatively, this connection can also be achieved, for example, via a threaded connection. Preferably, the connection of the two components 11, 5 is implemented such that it can be performed manually.

[0028] The neck 5 and the cap-shaped retainer 11 are implemented such that the pressure-sensitive measuring diaphragm 3 of the pressure sensor 2 is arranged close to the flexible membrane 10 in the assembled state. In conjunction with the solution of the present invention, "closely" preferably means that the flexible membrane 10, in the assembled state, only contacts the pressure-sensitive measuring diaphragm 3 of the pressure sensor 2 without introducing any significant stress into the diaphragm, or that the two are spaced no more than 1 mm apart.

[0029] Furthermore, an annular lip seal 13 is provided, which, in the assembled state, is located between the outer surface 17 of the first end region 2a of the pressure sensor 2 and the corresponding inner surface 7 of the neck 5. The annular lip seal 13 is implemented such that pressure equalization is achieved in the event of excess pressure between the pressure-sensitive diaphragm 3, the flexible membrane 10, and the annular lip seal 13, because excess air 5 can escape through the gap between the lip seal 13 (bent upward in the edge region 15) and the inner surface 7 of the neck. The annular lip seal 13 behaves differently when negative pressure occurs: if negative pressure exists in the intermediate space between the pressure-sensitive diaphragm 3, the flexible membrane 10, and the annular lip seal 13, the upwardly bent section 15 of the lip seal 13 pushes against the inner surface 7 of the neck 5, thereby effectively preventing pressure equalization. Therefore, in the event of negative pressure, no air is drawn from the outside into the space enclosed by the flexible membrane 10 and the lip seal 13. Figure 2 The upward curve 15 and tapered portion 16 of the lip seal in its outer edge region are described in detail.

[0030] Figure 2 An advantageous embodiment of the lip seal 13 is shown in perspective. Figure 3 Showing according to Figure 2 The cross-section of the lip seal 13 with cutting planes III to III.

[0031] List of reference numerals

[0032] 1. Disposable device, disposable adapter

[0033] 2. Pressure sensor

[0034] 2a First end region of the pressure sensor

[0035] 2b Second end region of the pressure sensor

[0036] 3. Pressure-sensitive measuring diaphragm

[0037] 4. Flexible hose components

[0038] 5. Neck

[0039] 6a First coupling region

[0040] 6b Second coupling region

[0041] 7. Inner surface of the neck

[0042] 8. Outer surface of the neck

[0043] 9. Radial and circumferential protrusions

[0044] 10 Flexible membrane

[0045] 11. Cap-shaped retainer

[0046] 12 Fixed mechanisms

[0047] 12a Buckle Groove

[0048] 12b buckle

[0049] 13. Annular lip seal

[0050] 14. Outer peripheral area of ​​the annular lip seal

[0051] 15. Upward curvature of the lip seal

[0052] 16. The tapered portion of the lip seal

[0053] 17. Outer surface of the pressure sensor

[0054] 18. Inner surface of the cap-shaped retainer

[0055] 19 Cables

[0056] 20 Containers / Containment

[0057] 21 Medium

Claims

1. A disposable device (1) for securing a pressure sensor (2) to a containment (20), wherein, The pressure sensor (2) is provided with a pressure-sensitive diaphragm (3) in the first end region (2a), through which the pressure of the medium (21) located in the containment (20) can be determined. The system includes a flexible hose-shaped component (4) that is capable of coupling with the containment vessel (20). The hose-shaped component (4) includes a neck (5) on which a radial ridge (9) is provided on the inner surface (7) of the neck. The flexible membrane (10) is located on the radial protrusion (9), and the flexible membrane (10) airtightly seals the neck (5). The device includes a cap-shaped retainer (11) in which a pressure-sensitive diaphragm (3) can be positioned away from the second end region (2b) of the pressure sensor (2). The cap-shaped retainer (11) and the neck (5) can be locked together via a corresponding fixing mechanism (12). The neck (5) and the cap-shaped retainer (11) are configured such that the pressure-sensitive measuring diaphragm (3) of the pressure sensor (2) is arranged adjacent to the flexible membrane (10) in the assembled state.

2. The apparatus according to claim 1, in, An annular lip seal (13) is provided, which, in the assembled state, is located between the outer surface (17) of the first end region (2a) of the pressure sensor (2) and the corresponding inner surface (7) of the neck (5).

3. The apparatus according to claim 2, in, The annular lip seal (13) is configured such that, in the event of excessive pressure between the pressure-sensitive diaphragm (3) and the annular lip seal (13), the annular lip seal (13) achieves pressure equalization.

4. The apparatus according to claim 2 or 3, in, The annular lip seal (13) is configured to prevent pressure equalization when there is negative pressure between the pressure-sensitive diaphragm (3) and the annular lip seal (13).

5. The apparatus according to claim 2, 3 or 4, in, The annular lip seal (13) includes an upwardly curved portion (15) in its edge region (14), the upwardly curved portion (15) pointing away from the pressure-sensitive measuring element (3).

6. The apparatus according to one or more of the preceding claims, in, The upwardly curved portion (15) of the annular lip seal (13) has a tapered portion (16) toward its outer edge.

7. The apparatus according to one or more of the preceding claims, in, The pressure-sensitive measuring diaphragm (3) is a ceramic measuring diaphragm.

8. The apparatus according to one or more of the preceding claims, in, The neck (5) and the cap-shaped retainer (11) are configured such that the pressure-sensitive measuring diaphragm (3) of the pressure sensor (2) contacts the flexible membrane (10) in the assembled state with substantially no force transmission.

9. The apparatus according to one or more of claims 1-7, in, The neck (5) and the cap-shaped retainer (11) are configured such that the pressure-sensitive measuring diaphragm (3) of the pressure sensor (2) has a gap of up to 1 mm with the pressure-sensitive measuring diaphragm (3) in the assembled state.

10. The apparatus according to one or more of the preceding claims, wherein, The cap-shaped retainer (11) and the neck (5) can be connected to each other via fastening elements (12a, 12b) of the cap-shaped retainer (11) and the neck (5).

11. The apparatus according to one or more of the preceding claims, in, The hose-shaped component (4) has connecting elements (6a, 6b) in its two end regions.

12. The apparatus according to one or more of the preceding claims, in, The components (4, 5, 10, 11) of the single-use device (1) are made of biocompatible materials, such as polyethylene.

13. The apparatus according to one or more of the preceding claims, in, The pressure sensor (2) is a reusable pressure sensor (2).

14. The apparatus according to one or more of the preceding claims, in, The containment vessel (20) is a single-use container (20).

15. A method for producing an apparatus according to at least one of claims 1-14, comprising the following method steps: The flexible membrane (10) is mounted on the radial protrusion (9), which is located on the inner surface (7) of the neck (5) of the tubular component (4). The modified tubular components (4, 10) were welded into the bag and sterilized by means of radioactive radiation.

16. The method according to claim 15, in, The installation of the flexible membrane (10) on the radial protrusion (9) occurs via a welding process or an adhesive bonding process.

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