Reservable probe device

Abstract

The invention relates to a probe device (20) and the use thereof, the probe device comprising:-a gasket (21a) dividing the probe device (20) into a contaminated region (22) and a sterile region (23) and sealingly isolating the contaminated region (22) from the sterile region (23); a probe (24) having a probe tip (31); a probe chamber (29) having a probe inlet (30), in which a probe tip (31) of the probe (24) is fixedly arranged; wherein:-the probe arrangement further comprises a switch member (25) movable relative to the detection chamber (29) and having a fluid inlet (80) and two positions: a first position (27) and a second position (28); -the switching member (25) is configured to close the detection inlet (30) of the detection chamber (29) in its first position (27) and to open the detection inlet (30) in its second position (28) such that the detection inlet (30) of the detection chamber (29) is in fluid communication with the fluid inlet (80); and-the sterile region (23) accommodates the detection chamber (29) and the switching means (25).

Description

Reusable probe device Technical Field

[0001] This disclosure relates to the field of reserviceable probe devices that allow for multiple uses under sterile conditions, and methods of using such probe devices. Background Technology

[0002] Probe devices are known in the art and can take many forms. Some probe devices are designed for specific purposes and require some type of maintenance, such as cleaning or calibration. For example, electrochemical sensor devices are used to measure a variety of electrochemical parameters, examples of which include pH sensor devices for measuring the pH of a medium, redox sensor devices for measuring the redox potential of a system, and pCO2 sensor devices for measuring the CO2 concentration in a medium. Some of these sensor devices are known to require calibration. Therefore, disposable sensor devices are configured to allow only one such calibration. Reusable sensor devices are configured to allow multiple such calibrations, but the number of calibrations is limited, as discussed in detail below with the example of a pH sensor device. Other examples of probe devices include sampling devices for extracting a portion of a medium's volume, in some cases where sampling must be performed in a sterile environment, such as in biological processes, for example, through a sterile barrier (filter material). Typically, they can be used multiple times without any maintenance. However, in some cases, they include filters to remove unwanted particles (e.g., biological materials such as cells, bacteria, viruses, or biocontaminants). In these situations, the filter may become clogged at some point and become unusable without maintenance (i.e., cleaning or unclogging the filter). However, some sensor devices may also benefit from the possibility of cleaning the sensor.

[0003] For illustration, background art is discussed below for examples of probe devices. The selected examples relate to pH sensor devices, which, as mentioned above, are well known in the art and can be calibrated.

[0004] Figures 1 through 4 illustrate an example of such a pH sensor device. This pH sensor device 1 includes a tubular portion 3 and a movable tubular electrode holder 2 for receiving an electrode, the electrode holder being movable within and along the tubular portion 3 between a calibration position and a measurement position.

[0005] The tubular portion 3 has a bag port 4 at one end for connecting to a bag containing a solution for measuring pH value.

[0006] The electrode holder 2 has a measuring chamber 12 at one end (the tip end), an inlet 5 leading to the measuring chamber 12 (through which calibration solution can be supplied), and an outlet 6 for flushing the solution out of the measuring chamber 12 after the electrode 7 has been calibrated. When the electrode holder 2 is in its calibration position, it does not protrude outside the tubular portion 3 into the bag, and the measuring chamber is sealed by the wall of the tubular portion 3. When the electrode holder 2 is in its measuring position, it protrudes beyond the length of the measuring chamber from the tubular portion 3, and the measuring chamber 12 is exposed to the contents of the bag.

[0007] Three gaskets are provided on the outer surface of the electrode holder 2: - A first gasket 10 is configured to prevent the contents of the bag from seeping into the space between the electrode holder and the tubular portion when the electrode holder is in its calibration position, and is located at the tip of the electrode holder 2; - A second gasket 9 is configured to prevent the contents of the bag from seeping into the space between the electrode holder and the tubular portion when the electrode holder is in its measurement position, and is located at the other end of the measurement chamber; and - A third gasket 8 is configured to prevent contaminants from the external environment of the pH sensor device from seeping into the space between the electrode holder and the tubular portion, thereby maintaining the sterility of the bag contents, and is located between the second gasket 9 and the other end of the electrode holder, further away from the bag.

[0008] The sequences shown in Figures 1 to 4 illustrate the diffusion of the contaminated area after two calibrations.

[0009] Figure 1 shows the pH sensor device 1 in its unused state in the calibration position. In this position, three gaskets divide the inner surface of the tubular portion 3 into three parts: the outer portion furthest from the bag port, the middle portion, and the inner portion closest to the bag port. A third gasket 8 divides the pH sensor device into contaminated and sterile portions, particularly the contaminated area 11 between the tubular portion and the electrode holder, which is in direct contact with the surrounding air. In this case, the contaminated area 11 includes the outer portion of the tubular portion 3. The pH sensor device 1 can be connected to the bag through its bag port. In this calibration position, the pH sensor device 1 can be calibrated before measuring the pH of the solution in the bag. For this purpose, rinsing solution is injected into the closed measuring chamber through the inlet, and then pushed out through the outlet using a buffer solution. Once the measuring chamber is filled with buffer solution, calibration can be performed. A first gasket 10 prevents the contents of the bag from entering the measuring chamber.

[0010] When it is necessary to measure the pH of the reactor contents, push the electrode holder to the measurement position shown in Figure 2. The contaminated area 11 is restricted by the third gasket 8, but as the electrode holder is pushed toward the bag, the third gasket 8 also moves, thus increasing the size of the contaminated area 11: the middle portion of the tubular section 3 is contaminated.

[0011] At some point while using the pH sensor device 1, it may be necessary to recalibrate the device. For this purpose, the electrode holder is brought back to the calibration position shown in Figure 3. When the electrode holder is brought back to this position, the second gasket 9 contacts the contaminated middle portion of the tubular part 3, and is itself contaminated. Furthermore, in this position, a portion of the outer surface of the electrode holder faces the contaminated middle portion, thus this portion of the electrode holder is also contaminated. The contaminated area now extends to the second gasket 10.

[0012] After calibration, the electrode holder 2 is pushed back into the measurement position shown in Figure 4. The second washer 9 contacts and contaminates the inner portion of the tubular part 3: the contaminated area 11 has extended to the inner portion of the inner surface of the tubular part 3.

[0013] If another calibration is desired and the electrode holder 2 is brought back to its calibration position, the first gasket 10 will come into contact with the inner portion and become contaminated. Furthermore, the outer surface portion of the electrode holder between the first and second gaskets will also become contaminated. If the electrode holder 2 is then brought back to its measurement position, the contaminated first gasket and the outer surface portion of the electrode holder between the first and second gaskets will come into contact with and contaminate the contents of the bag.

[0014] Therefore, as described above, due to the movement of the gasket, this type of pH sensor device 1 only allows for two calibrations without contaminating the contents of the bag.

[0015] The contamination issue also applies to other types of probe devices, such as sampling devices. Indeed, in the example above, a pH sensor could be replaced with a sampling probe. In this case, the calibration location is the service location (or the location within the probe device where samples are retrieved), for example, for cleaning, while the measurement location is the sampling location, where the sampling probe is immersed in the liquid to be sampled. Similar to multiple calibrations, multiple samplings require bringing the probe device back to the service location, which results in contamination of the first gasket and the outer surface of the probe device between the first and second gaskets. If the probe device is then brought to its sampling location, the contaminated first gasket and the portion of the outer surface of the probe device between the first and second gaskets will come into contact with and contaminate the contents of the bag. Summary of the Invention

[0016] This disclosure improves upon this situation.

[0017] This invention relates to a reusable probe device comprising: - a gasket that divides the probe device into a contaminated area and a sterile area and seals and isolates the contaminated area from the sterile area; - a probe having a probe tip; - a probe chamber having a probe inlet, wherein the probe tip is fixedly disposed; characterized in that: - the probe device further comprises a switch component movable relative to the probe chamber, the switch component having a fluid inlet and having a first position and a second position; - the switch component is configured to close the probe inlet of the probe chamber in its first position and open the probe inlet in its second position, such that the probe inlet of the probe chamber is in fluid communication with the fluid inlet; and - a sterile area accommodating the probe chamber and the switch component.

[0018] This probe device allows for more than two uses without contaminating the bag's contents. Therefore, users are not at risk of contaminating the bag's contents due to misuse or error. The probe device is no longer limited to two uses; it can handle multiple uses.

[0019] In the case of pH sensor devices, this recalibrable pH sensor device allows the electrode to be calibrated more than twice without contaminating the contents of the bag. Therefore, the user is not at risk of contaminating the bag contents due to misuse or error. The number of operations for this pH sensor device is no longer limited to two calibrations.

[0020] The switching component can be configured such that, in its second position, the opening of the switching component faces the detection entrance of the detection chamber, while in its first position, the wall of the switching component faces the detection entrance of the detection chamber.

[0021] The probe device may include a guide member configured to switch between a first position and a second position of the switching member.

[0022] Because of the guide components, there is no need for gaskets to define the contaminated area and prevent its spread, ensuring that the first and second positions remain within the sterile area.

[0023] The guide member can be configured to convert rotational motion into translational motion, specifically, the rotational motion of the guide member relative to the switch member is converted into the translational motion of the switch member.

[0024] The guide member may have an inner ramp, and the switch member may have an outer mating part that engages with the outer ramp, such that rotation of the guide member relative to the switch member is converted into relative translation between the switch member and the guide member, thereby allowing the switch member to move between its first position and its second position.

[0025] The movement of the ramp relative to the outer mating part between the first and second positions provides safe movement within a sterile area.

[0026] The mating component may include two parallel ribs spaced apart from each other in the longitudinal direction of the switching component, thereby forming a gap of the same size as the ramp width.

[0027] This type of fitting is easy to implement and can reduce the cost of probe devices.

[0028] The guide member may have an inner mating part, and the switch member may have an outer ramp that mates with the outer mating part, such that rotation of the guide member relative to the switch member is converted into relative translation between the switch member and the guide member, thereby allowing the switch member to move between its first position and its second position.

[0029] The movement of the ramp relative to the outer mating part between the first and second positions provides safe movement within a sterile area.

[0030] The guide component may include two parallel ribs spaced apart from each other in the longitudinal direction of the guide component, thereby forming a gap of the same size as the ramp width.

[0031] The combination of two parallel ribs and a ramp is an effective and simple method to convert translational motion into rotational motion.

[0032] The guide component may have a bag port for securing the probe device to the bag, the bag port being a radially outwardly extending flange.

[0033] The switch component may have a generally tubular shape, having a first end portion without openings, a second intermediate portion with one or more openings, and a third end portion without openings, with ramps or mating parts disposed in the third end portion.

[0034] The probe device may include a feed component, in which a probe chamber is formed and has a probe inlet, a service inlet, and a service outlet.

[0035] The service inlet and service outlet of the feed components allow for the safe delivery of service fluids, such as cleaning fluids, flushing fluids, wetting fluids, injection fluids, protective fluids, calibration fluids, activation fluids, or passivation fluids.

[0036] The feed component may have a first end portion having a generally tubular shape and having a detection chamber and a detection inlet, and a second end portion having a generally truncated conical shape, with the apex of the corresponding cone in the detection chamber and its bottom in the contaminated area.

[0037] The probe assembly may include a probe holder comprising a feed component and a probe housing component, the probe housing component being configured to support the probe such that its tip is fixedly placed in the probe chamber, the feed component and the probe housing component being two separate components or a single piece.

[0038] The present invention relates to a method of using a probe device of the above type, the method comprising the following steps, while a switching component is in its first position: - providing a service fluid; - injecting service fluid through the service inlet while the probe inlet is closed; - immersing the probe tip in the service fluid; - rinsing the service fluid through the service outlet.

[0039] This method can be used n times, where n is an integer of 2 or greater. It is easy to operate.

[0040] This invention relates to the use of the above-described type of probe device, wherein the probe device is used more than twice. Attached Figure Description

[0041] Other features, details and advantages will be shown in the following detailed description and figures, wherein: Figures 1 to 4 are schematic diagrams of a pH sensor device according to the prior art, showing the contaminated area during operation up to two calibrations.

[0042] Figure 5 is a 3D exploded view of an example of a pH sensor device according to the present invention.

[0043] Figure 6 is a three-dimensional view of the assembled pH sensor device shown in Figure 5.

[0044] Figure 7 is a bottom perspective view of the pH sensor device in Figure 6.

[0045] Figure 8 is a 3D cross-sectional view of the pH sensor device of Figure 6 when the switching component is in its calibration position.

[0046] Figure 9 is a 3D cross-sectional view of the pH sensor device of Figure 6 when the switching component is in its measuring position.

[0047] Figure 10 is a 3D cross-sectional view of the electrode housing components and electrodes of the pH sensor device shown in Figure 6.

[0048] Figure 11 is a perspective view of the electrode housing component of Figure 10.

[0049] Figure 12 is another perspective view of the electrode housing component of Figure 10.

[0050] Figure 13 is a perspective view of the feed component of the pH sensor device in Figure 6.

[0051] Figure 14 is a 3D cross-sectional view of the feed component in Figure 13.

[0052] Figure 15 is another perspective view of the feed component in Figure 13.

[0053] Figure 16 is a perspective view of the guide component of the pH sensor device in Figure 6.

[0054] Figure 17 is a 3D cross-sectional view of the guide component in Figure 16.

[0055] Figure 18 is a perspective view of the guide component in Figure 16 and the feed component in Figure 13.

[0056] Figure 19 is a perspective view of the switching component of the pH sensor device in Figure 6.

[0057] Figure 20 is a side perspective view of the switching component of the pH sensor device in Figure 6.

[0058] Figure 21 is another perspective view of the switching component of the pH sensor device in Figure 6.

[0059] Figure 22 is a perspective view of the external holding component of the pH sensor device in Figure 6.

[0060] Figure 23 is a 3D cross-sectional view of the external holding and guiding components of the pH sensor device in Figure 6.

[0061] Figure 24 is another perspective view of the external holding component of the pH sensor device in Figure 6.

[0062] Figure 25 is a perspective view of the external holding component together with the guiding component and the feeding component.

[0063] Figure 26 is a perspective view of the electrode housing component with electrodes shown in Figure 10.

[0064] Figure 27 is a 3D exploded view of the electrode housing component with electrodes.

[0065] Figure 28 is another perspective view of the electrode housing component with electrodes shown in Figure 10.

[0066] Figure 29 is a 3D exploded view of the electrode housing component with electrodes and seals.

[0067] Figures 30 and 31 are schematic diagrams of two exemplary sampling probe devices according to the present invention. Detailed Implementation

[0068] In the following text, the term "service" and its derivatives relate to actions performed on a probe within a probe assembly to bring it into a usable state. These actions can include cleaning, rinsing, wetting, perfusing, protecting, calibrating, activating, and even passivating the probe. These actions can be provided by one or more service fluids; for example, cleaning fluids, rinsing fluids, wetting fluids, perfusing fluids, protecting fluids, calibrating fluids, activating fluids, and passivating fluids. Each service fluid can be a service solution or a service gas.

[0069] In the following text, “outward,” “inward,” and their derivatives are used in conjunction with “radial” and “longitudinal.” For “radial,” the reference point is the longitudinal axis of the probe device; “outward” and its derivatives mean “away from the longitudinal axis,” and “inward” and its derivatives mean “towards the longitudinal axis.” For “longitudinal,” the reference point is the bag port; “outward” and its derivatives mean “away from the bag port,” and “inward” and its derivatives mean “towards the bag port.”

[0070] In the following text, when "service fluid," "calibration fluid," etc., are mentioned, it does not mean that the service fluid contains only one type of surfactant, but rather that it may contain a mixture of multiple surfactants. Sometimes, only the injection of service fluid is mentioned; however, this also includes cases where multiple service fluids are injected consecutively.

[0071] Referring to Figures 5 to 29, the present invention relates to a maintainable probe device 20, comprising: - a gasket 21 that divides the probe device 20 into a contaminated area 22 and a sterile area 23 and seals and isolates the contaminated area 22 from the sterile area 23; - a probe 24 having a probe tip 31; - a probe chamber 29 having a probe inlet 30, wherein the probe tip 31 of the probe 24 is fixedly placed.

[0072] The probe device 20 also includes a switch element 25 movable relative to the probe chamber 29, the switch element having a fluid inlet 80 and a first position 27 and a second position 28. The switch element 25 is configured to close the probe inlet 30 of the probe chamber 29 in its first position 27 and open the probe inlet 30 in its second position 28, such that the probe inlet 30 of the probe chamber 29 is in fluid communication with the fluid inlet 80. A sterile area 23 accommodates the probe chamber 29 and the switch element 25.

[0073] Contaminated area 22 refers to a non-sterile area that is in contact with the surrounding air. In contrast, sterile area 23 refers to a sterile area whose internal surfaces are not in contact with the surrounding air. Since any moving parts are located within sterile area 23, the extent of contaminated area 22 does not increase.

[0074] The probe 24 has a longitudinal axis X corresponding to the longitudinal axis of the probe assembly 20. The probe 24 preferably has a cylindrical body 244. The probe 24 can be received by a probe holder of the probe assembly 20, the probe holder being configured to receive and hold the probe 24, with its tip 31 held within the probe chamber 29. The probe holder may include a receiving space whose shape is complementary to at least a portion of the probe 24. For example, when the probe 24 has a cylindrical body 244, the receiving space is cylindrical.

[0075] The probe device 20 can be sterilized using gamma rays.

[0076] The probe 24 may include a probe service inlet, allowing the service fluid to be injected directly into the probe 24. In this case, the probe 24 may also include a probe service outlet, particularly at its tip, allowing the service fluid to drain into the probe chamber 29 and reach the service outlet 62.

[0077] The switch component 25 shown in Figure 16 may have a generally tubular shape and a wall 81 with an opening 80. The switch component 25 may be configured in its second position 28, with the opening 80 facing the detection inlet 30 of the detection chamber 29; and in its first position 27, with the wall facing the detection inlet 30 of the detection chamber 29.

[0078] The detection chamber 29 may have n detection inlets (not shown), where n is an integer equal to 2 or greater, and the switching component 25 may have n openings (not shown). The detection inlets and openings are positioned such that in a second position of the switching component, all openings face their respective detection inlets, and all detection inlets face their respective wall portions of the switching component. The detection inlets may be angularly spaced from each other, for example, at a spacing of (360 / n)°; the openings may also be angularly spaced from each other, for example, at a spacing of (360 / n)°.

[0079] The switch component 25 may have a generally tubular shape, having a first end portion 82 without openings, a second intermediate portion 83 with one or more openings, and a third end portion 84 without openings.

[0080] Preferably, the switch component 25 and the probe 24 are configured to be fixed at an angle to each other. However, a slight gap may exist between these components.

[0081] The probe chamber 29 may be formed in the probe holder. The probe holder may be divided into a feed member 60 and a probe housing member 70. The probe chamber 29 is generally formed in the feed member 60, which has a probe inlet 30, a service inlet 61, and a service outlet 62.

[0082] The feed component 60 shown in Figures 13 to 15 may have a first end portion 63 having a generally tubular shape and including a detection chamber 29 and a detection inlet 30, and a second end portion 64 having a generally truncated conical shape, with the apex of the cone in the detection chamber 29 and its base in the contaminated area 22. The angle of the apex of the cone is generally 20° to 30°, preferably 25°. The service inlet 61 of the feed component 60 may be a pipe (inlet pipe) extending along a generally conical sidewall. The inlet pipe may have one end leading to the detection chamber 29 and the other end having a pipe fitting. The service outlet 62 of the feed component may be a pipe (outlet pipe) extending along a generally conical sidewall. The outlet pipe may have one end leading to the detection chamber 29 and the other end having a pipe fitting. The inlet pipe and the outlet pipe may be radially opposite each other.

[0083] The feed member 60 may have a flange 65 extending radially outward at its end away from the probe chamber 29. The flange 65 may have a cross-shaped cross-section. In some cases, two overlapping flanges 65 may be provided. The flange 65 may serve as a handle for operating the probe device 1.

[0084] The feed member 60 may include a connector 66 configured to guide the translation of the switching member 25. The same connector 66 may be configured to prevent rotation of the switching member 25 relative to the feed member 66, such that the switching member 25 and the probe 24 are fixed at an angle to each other. In this case, the switching member 25 also includes a corresponding connector 86. The connector 66 may be one or more sliders, such as a first slider 67a and a second slider 67b, and the switching member 25 may include corresponding guide rails 86 for receiving sliders 67a, 67b. The number of sliders may be more than two. In this case, they may be radially spaced apart from each other, preferably spaced at equal angular distances. Each slider may be a protrusion. An example of such a protrusion includes a first portion 68a extending radially outward from the sidewall of the feed member 60, a second portion 68b extending longitudinally inward from the first portion 68a, and a stop element 68c extending between the outer wall of the feed member 60 and the second portion 68b. Each guide rail of the switching member 25 may extend longitudinally on the inner wall of the switching member 25, for example, from a third end portion 84 to a second intermediate portion 83. The guide rail 86 may be a groove whose thickness extends radially outward from the outer surface of the sidewall of the switch component 25.

[0085] The feed member 60 and the probe housing member 70 are configured such that the probe housing member 70 can be mounted on the feed member 60 by inserting the probe housing member 70 into the feed member 60 along the longitudinal axis of the probe device 20. The feed member 60 may include an opening 69 for securing the probe housing member 70, thereby preventing the probe housing member 70 from moving in a direction opposite to the insertion direction. Therefore, the probe housing member 70 may include a corresponding fastener 73, such as one or more hooks.

[0086] The opening 69 of the feed component 60 and the fastener 73 of the probe housing component 70 can form a snap-fit ​​joint. For example, the opening 69 of the feed component 60 can be an opening in the side wall of the feed component 60, and the fastener 73 of the probe housing component 70 can be a hook configured to snap into the opening. The opening 69 can be located on the upper part of the feed component 60, and the hook can be located in a corresponding position on the probe housing component 70. The opening 69 can have a generally rectangular shape.

[0087] The probe housing component 70 may include a radially outwardly extending plate 72. When one or more hooks are provided, hooks or hooks 73 may be connected to the plate 72 via a longitudinally inwardly extending beam 71. The probe housing component 70 may include an annular housing 241 for retaining a seal 242 between the probe 24 and the feed component 60. The seal 242 may have a rotatable shape. The seal 242 ensures that the contaminated area 22 does not extend to the probe tip 31. The probe 24 may include an anti-rotation system 243 capable of preventing the probe 24 from rotating about its longitudinal axis. The anti-rotation system 243 may be of a complementary shape type or a snap-fit ​​type. For example, the anti-rotation system 243 may include one or more planes on the originally cylindrical outer surface of the probe 24. A corresponding anti-rotation system is then provided on the probe housing component 70, such as a hole having a shape complementary to the cross-sectional shape of the probe 24, wherein one or more planes are located. In another example, the anti-rotation system 243 may have a snap-fit ​​flange extending longitudinally outward from the outer surface of the probe 24 at an acute angle. The probe 24 may include multiple guiding elements configured to facilitate insertion of the probe 24 into the probe housing component 70.

[0088] The feed component 60 and the probe housing component 70 can be two different components or a single piece.

[0089] The probe device 20 may include a guide member 50 configured to switch the switching member 25 between a measurement position and a calibration position. The guide member 50 may be configured to convert rotational motion into translational motion, specifically, the rotational motion of the guide member 50 relative to the switching member is converted into translational motion of the switching member 25.

[0090] The guide member 50 may have an inner ramp 53, and the switch member 25 may have an outer mating member 540 that mates with the ramp 53, such that rotation of the guide member 50 relative to the switch member 25 is converted into relative translation between the switch member 25 and the guide member 50, thereby allowing the switch member 25 to move between its first position 27 and its second position 28. Typically, the ramp 53 may be configured to allow the switch member 25 to translate a distance of 10 mm to 30 mm, preferably 14 mm to 19 mm, more preferably 18.5 mm, when rotated by an angle of 20° to 180°, preferably 60° to 120°. The inner ramp 53 may be helical, such as a thread. For example, the inner ramp 53 may be a rib formed on the inner surface of the guide member 50, and the mating member may be two protrusions on the outer surface of the switch member 50, spaced apart to form a gap 57, such that they are positioned close to both sides of the rib. The mating member 540 may include two parallel ribs 550, 560, spaced apart from each other in the longitudinal direction of the switching member 25, thereby forming a gap 57 of the same size as the width of the ramp 53.

[0091] Alternatively, the inner ramp 53 may be a groove formed on the inner surface of the guide member 50, and the mating parts 550 and 560 may be protrusions on the outer surface of the switch member 50 and received in the groove.

[0092] The number of ramps and mating parts is not limited to one. When there are more than one, the ramps and mating parts are preferably angularly spaced from each other, and preferably still regularly spaced. For example, the guide member 50 may have n ramps 53, where n is 2 or more, and the switch member 25 may have n external mating parts 540, wherein the ramps 53 may be angularly spaced from each other by (360 / n)°, and the mating parts 540 may be angularly spaced from each other by (360 / n)°.

[0093] The positions of the ramp and mating parts can be interchanged between the guide part 50 and the switch part 25.

[0094] The guide member 50 may have a bag port 51 for securing the probe device 20 to the bag. The bag port 51 may be a radially outwardly extending flange 52.

[0095] The probe assembly 20 may include a limiter 54 for limiting rotation of the probe holder when it is fixed at an angle to the switching member 25. The limiter 54 may be disposed on the guide member 50. The limiter 54 typically has two stops 541, 542 and a track 543 between them. The track may be a notch in the upper portion 58 of the guide member 50, particularly at the radially outer end of the guide member 50. However, the track may also be provided in different forms, such as a groove. The guide member 50 may include two limiters 54. The guide member may include n travel limiters 54, where n is an integer equal to or greater than 2. The travel limiters 54 may be angularly spaced from each other, for example, spaced 360 / n° apart.

[0096] To cooperate with the limiter 54, the probe device 20 may have a slider 55. The slider may be formed on the feed member 60, for example, moving between two stops 541, 542 in a track 543. In operation, as the probe holder rotates, the slider 55 of the probe holder slides along the limiter 54. Therefore, the rotation of the probe holder is limited to two angles corresponding to the positions where the slider 55 abuts against each stop 541, 542. The pH sensor device 20 may include an external retaining member 40. The external retaining member 40 holds the feed member 60 and the guide member 50 together, particularly fixing them to each other. The external retaining member 40 preferably has a generally cylindrical shape. The retaining member 40 may include an inward stop to prevent the guide member 50 from separating from the feed member 60 in a longitudinally inward direction. For example, the inward stop 41 is a shoulder provided thereon. In this case, the guide member 50 may include a support surface 56 configured to abut against the shoulder 41 of the external retaining member 40. The support surface 56 may be an annular protrusion, for example having a triangular cross-section, abutting against the shoulder 41, for example having a triangular cross-section.

[0097] The outer retaining member 40 may further include an outward stop 42 for preventing the feed member 60 from separating from the guide member 50 in the longitudinal outward direction. For example, the outward stop 42 is a snap-fit ​​hook, preferably an annular snap-fit ​​hook at one end of the generally cylindrical outer retaining member. The snap-fit ​​hook may engage with a support surface of the feed member 60. In one embodiment, this support surface may be the surface 551 of the slider 55. As shown in FIG25, the outer retaining member 40 may abut against the edge surface 551 of the slider 55 to maintain a functional clearance. A gap may be provided between the edge surface 551 of the slider 55 and the snap-fit ​​hook of the outer retaining member 40. Therefore, the slider 55 may have two functions: limiting rotation and preventing translation by retaining and preventing the feed member 60 from separating from the guide member 50.

[0098] The outward stop 42 can also cooperate with the upper part 58 of the guide member 50 on one or both sides of the limiter 54 to secure the guide member 50 to the external retaining member 40.

[0099] Referring to Figures 8 and 9, a gasket 21a (referred to as the first gasket 21) that divides the probe device 20 into a contaminated area 22 and a sterile area 23 may be located between the guide member 50 and the probe housing member 70, so that contaminants cannot enter the sterile area through the space between these members 50 and 70.

[0100] The second gasket 21b may be located next to the first gasket 21a but closer to the bag port 51. The second gasket 21b serves as a safety gasket to enhance the seal between contaminated and sterile areas.

[0101] When the probe device 20 is in its first position, two gaskets 21c and 21d are provided to isolate the probe chamber 29 from the contents of the bag. They are typically located at both ends of the probe chamber 29 in the longitudinal direction.

[0102] When the probe holder is formed of two separate components, one or two gaskets 21e, 21f may be provided to prevent contaminants from entering and to prevent liquid from leaking from the probe chamber 29 through the space between the two components.

[0103] The sequences shown in Figures 8 and 9 illustrate the non-spread of contaminated areas after service.

[0104] Figure 8 shows the probe device 20 in the first position 27. In this position, the wall of the switching component faces the detection inlet 30 of the detection chamber 29, so the contents of the bag cannot enter the detection chamber 29, and the detection chamber is ready to receive the service fluid. Furthermore, in this position, the contaminated portion is restricted by the first gasket 21.

[0105] Figure 9 shows the probe device 20 in the second position 28. In this position, the opening 80 faces the detection inlet 30 of the detection chamber 29, allowing the contents of the bag to enter the detection chamber 29. As in the first position, the contaminated portion is restricted by the first gasket 21.

[0106] To move from the first position 27 to the second position 28, the user operates the flange 65 of the probe holder (by rotating the latter) while holding the outer holding member 40, thereby causing the switching member 25 to rotate and translate relative to the guide member 50. Since the probe holder is rotationally fixed to the switching member 25, the switching member 25 rotates with the probe holder. The rotation of the probe holder is limited by the limiter 54. During rotation, the inner ramp 53 of the guide member 50 forces the mating part 540 of the switching member 25 toward the bag port 51 in the longitudinal direction, thereby forcing the switching member 25 to translate. The translation of the switching member 25 is guided by the translation guide 86 of the switching member 25. Simultaneously, the opening 80 of the switching member 25 aligns with the probe inlet 30. Therefore, the contents of the bag can flow into the probe chamber 29. Furthermore, during rotation, no part of the probe device 20 moves from the contaminated area 22 to the sterile area 23, thereby keeping the two areas separate: contamination does not diffuse downwards into the sterile area 23.

[0107] When the probe device 20 needs servicing (e.g., calibration or cleaning), the user operates the flange 65 of the probe holder (by rotating the latter in opposite angular directions) while holding the external holding member 40, causing the switching member 25 to rotate and translate relative to the guide member 50. Since the probe holder is rotationally fixed to the switching member 25, the switching member 25 rotates with the probe holder. The rotation of the probe holder is again limited by the limiter 54. During rotation, the inner ramp 53 of the guide member 50 forces the mating part 540 of the switching member 25 away from the bag port 51 in the longitudinal direction, thereby forcing the switching member 25 to translate. Simultaneously, the probe inlet 30 is closed by the wall of the switching member 25, thereby isolating the probe chamber 29 from the contents of the bag. Similarly, during rotation, no part of the probe device 20 moves from the sterile area 23 to the contaminated area 22, nor from the contaminated area 22 to the sterile area 23, thus keeping the two areas separated: contamination again does not diffuse downwards into the sterile area 23.

[0108] One example of such a probe device 20 is a pH sensor device. In this case, the invention enables the pH sensor device to be calibrated multiple times using a calibration solution as a service fluid. More specifically, the above description should be read with modifications as follows: probe 24 is an electrode, measuring tip is an electrode tip, probe chamber 29 is a measuring chamber (i.e., where pH measurement is performed), probe inlet 30 is a measuring inlet (i.e., an opening in which the solution in the bag enters the measuring chamber), a first position is a calibration position (the electrode tip is in a position where calibration can be performed), a second position is a measuring position (the electrode tip is in a position where pH measurement can be performed in the measuring chamber), service inlet 61 is a calibration inlet (e.g., an inlet for the calibration solution to enter the feed component), service outlet 62 is a calibration outlet (e.g., an outlet for the calibration solution to exit the feed component), probe holder is an electrode holder (e.g., it holds the electrode in place), and probe housing component 70 is an electrode housing component (e.g., it houses the electrode). Preferably, electrode 24 has a cylindrical body 244.

[0109] Another example of such a probe device 20 is a sampling device. In this case, the invention allows for multiple samplings of the bag contents by using a cleaning solution as a service fluid to clean the sampling probe. More specifically, the above description should be read with the following modifications: probe 24 is a sampling probe, measuring tip is a sampling tip, probe chamber 29 is a sampling chamber (i.e., the place where sampling is performed), probe inlet 30 is a sampling inlet (i.e., the opening in which the solution in the bag enters the sampling chamber), a first position is a cleaning position (the sampling tip is in a position where cleaning can be performed), a second position is a sampling position (the sampling tip is in a position where the contents of the bag can be sampled), service inlet 61 is a cleaning inlet (e.g., an inlet for the cleaning solution to enter the feed component), service outlet 62 is a cleaning outlet (e.g., an outlet for the cleaning solution to exit the feed component), a probe holder holds the sampling probe 24 in place, and a probe housing component 70 accommodates the sampling probe 24.

[0110] An example of sampling probe 24 is shown in Figure 30. Sampling probe 24 typically includes a cylindrical hollow body 244 with a sampling tip for receiving sampling fluid. Sampling probe 24 also includes a sample outlet in fluid communication with the interior of the cylindrical hollow body 244, through which the sampling fluid can be recovered, for example, in batches or continuously.

[0111] The sampling tip may include a filter portion 245. The filter portion 245 may be configured to filter out unwanted particles, such as biological materials, such as cells, bacteria, viruses, or biological contaminants. The filter portion 245 may be made of a variety of inert materials, such as porous ceramics, porous polymers, sintered metals, sintered glass, etc. Preferably, the pore size of the filter portion 245 is no more than 1 µm, more preferably 0.1 to 0.5 µm. This material may be provided as a filter membrane.

[0112] The filter section 245 preferably has a cylindrical shape and a longitudinal axis. The liquid to be sampled enters the cylinder perpendicular to the longitudinal axis. The area of ​​the filter section 245 can be 500 to 2000 mm², preferably 100 to 1500 mm².

[0113] The cylindrical hollow body 244 may include a shaft 246 such that the end of the sampling tip is located deeper into the bag during operation. The shaft 246 is preferably cylindrical, and preferably has the same diameter as the filter portion 245. For example, the diameter is 5 to 20 mm, preferably 7.5 to 10 mm. The shaft 246 is preferably made of an inert material. The length of the shaft 246 can reach 1000 mm, preferably 100 to 500 mm. In this case, the collection chamber may extend to at least a portion of the shaft 246.

[0114] This invention is not limited to the pH sensor device or sampling device described above, but is applicable to various types of sensor devices, such as electrochemical sensor devices for measuring various electrochemical parameters. Examples include pH sensor devices for measuring the pH value of a medium, redox sensor devices for measuring the redox potential of a system, and pCO2 sensor devices for measuring the CO2 concentration in a medium. Other probe devices include optical probe devices, photochemical sensor devices, enzyme-catalyzed probe devices, and electrical probe devices.

[0115] This invention relates to a method for maintaining the aforementioned probe device. The method includes the following steps, while the switching component 25 is in its first position: - providing service fluid; - injecting service fluid through the service inlet 61 while the probe inlet 30 is closed, thereby immersing the tip of the probe 24 into the service fluid; - rinsing the service fluid through the service outlet 62.

[0116] For the pH sensor device 20 described above, the method includes the following steps, while the switching component 25 is in its calibration position: - providing a calibration solution; - injecting the calibration solution through the calibration inlet 61 while the measurement inlet 30 is closed, thereby immersing the tip of the electrode 24 into the calibration solution; - calibrating the pH sensor device 20; - rinsing the calibration solution through the calibration outlet 62.

[0117] The switch component 25 may already be in its calibrated position (typically when the pH sensor device is new), or may be brought into this position, for example, by operating the feed component.

[0118] This invention relates to the use of the above-described type of pH sensor device, wherein the pH sensor device is calibrated more than twice.

[0119] For the above-described sampling device 20, the method includes the following steps, while the switching component 25 is in its clean position: - providing a cleaning solution; - injecting the cleaning solution through the cleaning inlet 61 while the sampling inlet 30 is closed, thereby immersing the tip of the sampling probe 24 into the cleaning solution; - rinsing the cleaning solution through the cleaning outlet 62.

[0120] Rinsing with the cleaning solution can be done simultaneously with injecting the cleaning solution to achieve a rinsing effect. Alternatively, rinsing with the cleaning solution can be done after a waiting period following the injection of the cleaning solution to achieve a soaking effect.

[0121] The switching component 25 may already be in its clean position, or may be brought into this position, for example, by operating the feed component. In the case of the sampling device, cleaning is not necessarily performed before each consecutive sampling, but rather when the filter section 245 becomes clogged.

[0122] In the case of an optical probe device having an optical probe with an optical window, the method includes the following steps, while the switching component is in its first position: - providing a cleaning solution; - injecting the cleaning solution through the service inlet while the measurement inlet is closed, thereby immersing the tip of the optical probe in the cleaning solution; - rinsing the cleaning solution through the service outlet; thereby cleaning the optical window.

[0123] In the case of a photochemical sensor device having a photochemical probe comprising a transducer and a dye-coated surface, the method includes the following steps while a switching component is in its first position: - providing a perfusion solution; - injecting the perfusion solution through a service inlet while the measurement inlet is closed, thereby immersing the probe tip in the perfusion solution to perfuse / wet the probe; - rinsing the perfusion solution through a service outlet.

[0124] For the case of an enzyme-catalyzed probe device (e.g., using glucose oxidase for enzymatic glucose measurement), the method includes the following steps, while the switching component is in its first position: - providing an activation solution; - injecting the activation solution through the service inlet while the measurement inlet is closed, thereby immersing the probe tip in the activation solution to activate the enzyme; - rinsing the activation solution through the service outlet.

[0125] The method may alternatively or additionally include the following steps, while the switching component is in its first position: - providing a calibration solution; - injecting the calibration solution through the service inlet while the measurement inlet 30 is closed, thereby immersing the probe tip in the calibration solution; - calibrating the probe; - rinsing the activation solution through the service outlet.

[0126] The activation and calibration methods for these enzyme-catalyzed probe devices are particularly needed after the probes have been treated with gamma.

[0127] For electrical probe devices (such as impedance probe devices, conductivity probe devices, etc.), the method includes the following steps, while the switching component is in its first position: - providing a cleaning solution; - injecting the cleaning solution through the service inlet while the measurement inlet is closed, thereby immersing the probe tip in the cleaning solution; - rinsing the probe with the cleaning solution through the service outlet; thereby cleaning the probe.

Claims

1. A probe device (20), comprising: - A gasket (21a) that divides the probe device (20) into a contaminated area (22) and a sterile area (23) and seals and isolates the contaminated area (22) from the sterile area (23); - A probe (24) having a probe tip (31); - A probe chamber (29) having a probe inlet (30) in which the probe tip (31) of the probe (24) is fixedly placed; characterized in that: - The probe device further includes a switch member (25) movable relative to the probe chamber (29), the switch member having a fluid inlet (80) and having two positions: a first position (27) and a second position (28); - The switch member (25) is configured to close the probe inlet (30) of the probe chamber (29) in its first position (27) and open the probe inlet (30) in its second position (28), such that the probe inlet (30) of the probe chamber (29) is in fluid communication with the fluid inlet (80); and - The sterile area (23) houses the detection chamber (29) and the switching component (25).

2. The probe device according to claim 1, characterized in that, The switch component (25) is configured in its second position (28) with its opening (80) facing the detection entrance (30) of the detection chamber (29), and in its first position (27) with its wall (81) facing the detection entrance (30) of the detection chamber (29).

3. The probe device according to any one of the preceding claims, characterized in that, The probe device includes a guide member (50) configured to switch between first and second positions (27, 28) of the switching member (25).

4. The probe device according to claim 3, characterized in that, The guide member (50) is configured to convert rotational motion into translational motion, specifically, the rotational motion of the guide member (50) relative to the switch member is converted into the translational motion of the switch member (25).

5. The probe device according to claim 3 or 4, characterized in that, The guide member (50) has an inner ramp (53), and the switch member (25) has an outer mating member (540) that engages with the ramp (53), such that rotation of the guide member (50) relative to the switch member is converted into relative translation of the switch member (25) and the guide member, thereby moving the switch member between its second position (28) and its first position (27).

6. The probe device according to claim 5, characterized in that, The mating member (540) includes two parallel ribs (550, 560) spaced apart from each other in the longitudinal direction of the switch member (25), thereby forming a gap (57) of the same size as the width of the ramp (53).

7. The probe device according to claim 3 or 4, characterized in that, The guide member (50) has an inner mating member, and the switch member (25) has an outer ramp that mates with the mating member, such that rotation of the guide member (50) relative to the switch member is converted into relative translation of the switch member (25) and the guide member, thereby moving the switch member between its second position (28) and its first position (27).

8. The probe device according to claim 7, characterized in that, The guide member (50) includes two parallel ribs spaced apart from each other in the longitudinal direction of the guide member (50), thereby forming a gap of the same size as the width of the ramp.

9. The probe device according to any one of the preceding claims, characterized in that, The guide member (50) has a bag port (51) for securing the probe holder to the bag, the bag port (51) being a radially outwardly extending flange (52).

10. The probe device according to any one of claims 5 to 8, characterized in that, The switch component (25) has a generally tubular shape, having a first end portion (82) without openings, a second intermediate portion (83) with one or more openings, and a third end portion (84) without openings, wherein a ramp or mating part (540) is provided in the third end portion (84).

11. The probe device according to any one of the preceding claims, characterized in that, The probe device includes a feed component (60) in which a detection chamber is formed and has a detection inlet, a service inlet (61) and a service outlet (62).

12. The probe device according to claim 10, characterized in that, The feed component (60) has a first end portion (63) having a generally tubular shape and having a detection chamber (29) and a detection inlet (30), and a second end portion (64) having a generally truncated conical shape, with the apex of the corresponding cone in the detection chamber (29) and its bottom in the contaminated area (22).

13. The probe device according to claim 10 or 11, characterized in that, The probe device includes a probe hub comprising a feed component and a probe housing component configured to support the probe, such that its tip (31) is fixedly placed in the probe chamber (29), the feed component and the probe housing component being two separate components or a single piece.

14. The probe device according to any one of claims 1 to 13, characterized in that, The probe includes a service entry point.

15. The probe device according to any one of claims 1 to 14, characterized in that, The probe device is a pH sensor device, and the probe is an electrode.

16. The probe apparatus according to any one of claims 1 to 14, characterized in that, The probe device is a sampling device, and the probe is a sampling probe.

17. The probe device according to claim 16, characterized in that, The sampling probe includes a sample outlet.

18. A method of using the probe device according to any one of claims 1 to 17, the method comprising the steps of, while the switching component (25) is in its first position: - providing service fluid; - injecting service fluid through the service inlet (61) or one of the service inlets while the probe inlet (30) is closed; - immersing the probe tip in the service fluid to maintain the probe tip; - flushing the service fluid through the service outlet.

19. A method for calibrating the probe device according to claim 15, characterized in that, The service fluid is a calibration solution, and the process of calibrating the pH sensor device includes immersing the probe tip in the calibration solution.

20. A method for cleaning the probe device according to claim 16 or 17, characterized in that, The service fluid is a cleaning solution.

21. The use of the probe apparatus according to any one of claims 1 to 17, characterized in that, The probe device with the probe was maintained more than twice.

22. The use of the probe device according to claim 15, characterized in that, The pH sensor device was calibrated more than twice.

23. The use of the probe device according to claim 16 or 17, characterized in that, The sampling device was cleaned more than twice.

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