Conduit including combination valve and sensor

By integrating a measurement system, including a valve element and a sensor element, into an intermittent urinary catheter, the problem of being unable to measure pressure in the prior art is solved, the practicality and convenience of pressure measurement are achieved, and the reuse of a signal processing device is supported.

CN114007503BActive Publication Date: 2025-09-19COLOPLAST AS
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Patent Information

Application Number
CN202080046339.9
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2019-06-26
Filing Date
2020-06-25
Publication Date
2025-09-19
Estimated Expiration
2040-06-25

AI Technical Summary

Technical Problem

Existing intermittent urinary catheters cannot effectively measure the pressure in the pipe and/or the space connected to the pipe, and lack practicality and convenience.

Method used

A measuring system is integrated into an intermittent urinary catheter, comprising a valve element and a sensor element, for measuring pressure changes in a pipeline, and performing data processing through a signal processing device.

Benefits of technology

The invention provides the ability to measure the pressure in the pipeline and/or the space connected to the pipeline, increases the practicality and convenience of the user, and allows the signal processing device to be reused, thereby reducing resource waste.

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Abstract

An intermittent urinary catheterization assembly (1) includes an intermittent urinary catheter (3) including a conduit (11) extending longitudinally within a body of the conduit. The assembly further includes a measurement system (4) configured to measure at least the pressure in the conduit and / or in a space connected to the conduit. The measurement system includes at least one valve element (37) that is in fluid communication with the conduit when a signal processing device is fixed relative to the intermittent urinary catheter. A shutoff element (41) is configured to switch from a closed state to an open state. The measurement system further includes at least one sensor element configured to measure a parameter indicative of the pressure applied to the shutoff element when the shutoff element switches from the closed state to the open state.
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Description

Technical Field

[0001] The present invention relates to the field of alleviating urinary retention and intermittent urinary catheterization. Background Art

[0002] Intermittent urinary catheters of the prior art typically include a catheter body and a conduit. The catheter body includes an insertable portion intended for insertion into a user's urethra, a non-insertable portion not intended for insertion into the user's urethra, and a connecting portion mounted to the non-insertable portion. The conduit extends longitudinally within the body and defines at least a portion of a flow path from the distal insertion end of the catheter to its proximal outlet end. It is desirable to provide a measurement system configured to measure pressure in the conduit and / or in a space connected to the conduit. Summary of the Invention

[0003] An embodiment provides an intermittent urinary catheterization assembly, comprising an intermittent urinary catheter, the intermittent urinary catheter including a connecting portion integral with or mounted to a non-insertable portion. The intermittent urinary catheter further comprises a conduit extending longitudinally within the conduit body and defining at least a portion of a flow path from a distal insertion end of the catheter to a proximal outlet end thereof. The intermittent urinary catheterization assembly further comprises a measurement system configured to measure at least the pressure in the conduit and / or a space connected to the conduit. The measurement system comprises at least one valve element in fluid communication with the conduit when the signal processing device is fixed relative to the intermittent urinary catheter. The at least one valve element comprises a shutoff element configured to switch from a closed state, which prohibits the flow of liquid in the conduit, to an open state, which permits the flow of liquid in the conduit, in response to pressure applied to the shutoff element by liquid in the conduit. The measurement system further comprises at least one sensor element configured to measure a parameter indicative of the pressure applied to the shutoff element when the shutoff element switches from the closed state to the open state. The measurement system is configured to detect a change in state of the shut-off element from the closed state to the open state. In one aspect, the signal processing device includes a housing with an engagement mechanism for removably securing the signal processing device relative to a connection portion of the intermittent urinary catheter. In another aspect, the measurement system including the signal processing device is securely connected to or integral with the non-insertable portion of the catheter tubing. BRIEF DESCRIPTION OF THE DRAWINGS

[0004] The accompanying drawings are included to provide a further understanding of the embodiments and are incorporated into and constitute a part of this specification. The accompanying drawings illustrate the embodiments and, together with the description, serve to explain the principles of the embodiments. Other embodiments and many of the expected advantages of the embodiments will be readily apparent as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals indicate corresponding similar parts.

[0005] Figures 1 to 3 Schematic cross-sectional views of various embodiments of an intermittent urinary catheter assembly having an intermittent urinary catheter and a measurement system are shown.

[0006] Figure 4 A schematic cross-sectional view of an exemplary intermittent urinary catheter is shown. DETAILED DESCRIPTION

[0007] Intermittent catheters are usually inserted by the user themselves and are only located in the urethra and bladder for the time it takes to empty the bladder, for example, about 5-10 minutes. Intermittent catheters are used every 4-6 hours to empty the bladder, which roughly corresponds to the time interval between people who do not have urinary problems and usually go to the bathroom. Intermittent catheters are usually more rigid than indwelling catheters because they must be inserted by the user themselves and because they do not need to be located in the urethra for several days or weeks. The important feature of intermittent catheters is that they are easy to insert into the urethra. This is accomplished by providing an intermittent catheter with a low-friction surface. Non-limiting examples of this type are hydrophilic coated catheters, which can then be wetted with a swelling medium to form a low-friction surface, or wetted with an oil or water-based gel applied to the catheter before insertion into the urethra.

[0008] Intermittent urinary catheters can be provided with a hydrophilic coating that requires wetting before use and thereby absorbs a large amount of fluid. This hydrophilic coating provides a very slippery surface with very low friction when the catheter is inserted. Hydrophilic-coated catheters that absorb a large amount of fluid to create a low-friction surface (swelling > 100%) are not suitable for use as indwelling catheters because, if left in the body for extended periods, the hydrophilic surface coating can become sticky in the urethral mucosa due to the transition from a highly slippery coating when fully wetted to a sticky coating when the coating's hydration level decreases.

[0009] The present invention relates to an intermittent urinary catheter that can be provided with a hydrophilic coating of the type that is wetted before use to absorb large amounts of liquid and provide a very slippery surface.

[0010] Catheters commonly used as urinary drainage devices come in sizes 8 FR to 18 FR. FR (or French size or Charriere (Ch)) is the standard gauge of catheters and roughly corresponds to the outer circumference (in mm). More precisely, the outer diameter (in mm) of a catheter corresponds to FR divided by 3. Therefore, 8 FR corresponds to a catheter with an outer diameter of 2.7 mm, and 18 FR corresponds to a catheter with an outer diameter of 6 mm.

[0011] The typical range for intermittent urinary catheters is CH 8 to CH 16.

[0012] Intermittent urinary catheters are primarily used for self-catheterization by the user.

[0013] Embodiments provide an intermittent urinary catheter assembly and an intermittent urinary catheter capable of measuring pressure to increase utility and convenience for a user.The intermittent urinary catheter assembly and the intermittent urinary catheter provide a sensor element configured to measure a parameter indicative of pressure.

[0014] In a first aspect, an embodiment provides an intermittent urinary catheterization assembly comprising:

[0015] - an intermittent urinary catheter, comprising:

[0016] o a catheter tube comprising an insertable portion intended for insertion into the urethra of a user, a non-insertable portion not intended for insertion into the urethra of the user, and a connecting portion integral with or mounted to the non-insertable portion; and

[0017] a conduit extending longitudinally within the body and defining at least a portion of a flow path from the distal insertion end of the catheter to the proximal outlet end thereof;

[0018] a measuring system configured to measure at least the pressure in the pipeline and / or in a space connected to the pipeline, wherein the measuring system comprises:

[0019] o a signal processing device comprising a housing having an engagement mechanism for removably securing the signal processing device relative to the connection portion of the catheter;

[0020] o at least one valve element in fluid communication with the tubing when the signal processing device is fixed relative to the intermittent urinary catheter, the at least one valve element comprising a shutoff element configured to switch from a closed state that inhibits the flow of liquid in the tubing to an open state that permits the flow of liquid in the tubing in response to pressure applied to the shutoff element by liquid in the tubing; and

[0021] o at least one sensor element configured to measure a parameter indicative of a pressure applied to the shut-off element when the shut-off element switches from the closed state to the open state,

[0022] Therein, the measuring system is configured to detect a state change of the shut-off element from the closed state to the open state.

[0023] In a second aspect, an embodiment provides an intermittent urinary catheterization assembly, comprising:

[0024] - an intermittent urinary catheter, comprising:

[0025] o a catheter tubing comprising an insertable portion intended for insertion into the urethra of a user, a non-insertable portion not intended for insertion into the urethra of the user; and

[0026] a conduit extending longitudinally within the body and defining at least a portion of a flow path from the distal insertion end of the catheter to the proximal outlet end thereof;

[0027] a measuring system, securely connected to or integral with the non-insertable portion of the catheter tube, for determining at least the pressure in the duct and / or in a space communicating with the duct, wherein the measuring system comprises:

[0028] oSignal processing device;

[0029] o at least one valve element in fluid communication with the conduit, the at least one valve element comprising a shutoff element configured to switch from a closed state that inhibits flow of liquid in the conduit to an open state that permits flow of liquid in the conduit in response to pressure applied to the shutoff element by liquid in the conduit; and

[0030] o at least one sensor element configured to measure a parameter indicative of a pressure applied to the shut-off element when the shut-off element switches from the closed state to the open state,

[0031] The measuring system is configured to detect whether the shut-off element changes from the closed state to the open state.

[0032] The provision of a measuring system comprising at least one valve element and at least one sensor element enables a user of an exemplary intermittent urinary catheter assembly to at least determine the pressure in the tubing and / or in a space connected to the tubing. In an embodiment, the measuring system determines the pressure in the tubing and / or in a space connected to the tubing based on measured parameters.

[0033] In the embodiment of the first aspect, the connection portion of the intermittent urinary catheter is combined with the engagement mechanism to allow the signal processing device to be detachably fixed relative to the catheter body. Accordingly, the intermittent urinary catheter can be discarded after each intermittent catheterization, while the signal processing device can be used multiple times, thereby more efficiently utilizing resources.

[0034] In an embodiment of the first aspect, fluid communication between the conduit and the at least one valve element is permitted when the connecting portion and the engagement mechanism are suitably secured relative to each other.

[0035] In an embodiment, the coupling mechanism of the connecting portion of the catheter tube body and the measuring device in an embodiment of the first aspect comprises corresponding, mutually cooperating coupling elements. In one embodiment, the coupling mechanism comprises a resilient member configured to engage and at least partially surround a groove at the outer circumference of, for example, the connecting portion of the catheter tube body, which can provide improved tactile feedback for, for example, a user with a physical impairment. The coupling mechanism and the connecting portion can also be implemented as, for example, a pair of easily manufactured removable latches, easily attached mutually attractive magnets (easy to attach due to the attraction of the magnets acting at a certain distance), or a friction coupling (in which a protruding connecting portion of the catheter tube body is forced into a receiving portion of the coupling mechanism or vice versa).

[0036] Since in embodiments of the second aspect a measuring system is provided which is securely connected to or integral with the non-insertable portion of the catheter tube, a user is able to determine at least one fluid parameter without having to establish a connection between the catheter tube and the measuring system prior to use.

[0037] In this context, the terms "upstream" and "downstream" refer to a flow path directed from the distal insertion end of an intermittent urinary catheter toward the proximal outlet end of the intermittent urinary catheter. These terms apply similarly to extensions of the flow path that are in fluid communication with the flow path. Accordingly, upstream refers to a flow direction toward the distal insertion end of the intermittent urinary catheter, while downstream refers to a flow direction away from the distal insertion end of the intermittent urinary catheter.

[0038] When the shutoff element is closed and the intermittent urinary catheter is connected to the signal processing device, the flow of liquid in the pipeline is inhibited, and the pressure in the pipeline and upstream of the shutoff element becomes constant. Accordingly, the pressure applied to the shutoff element will correspond to the pressure in the pipeline and / or in a space connected to the pipeline (such as the bladder). This allows the signal processing device to determine the pressure in the pipeline and / or in the space connected to the pipeline based on the measured parameters.

[0039] In an embodiment, the measuring system is configured to change the state of the shut-off element from the open state to the closed state after a predetermined amount of time after detecting the change of state of the shut-off element from the closed state to the open state. This allows for repeated measurement of the pressure in the pipeline and / or in a space connected to the pipeline.

[0040] In an embodiment, at least one of the at least one sensor element is included in the signal processing device. This allows the at least one sensor element in the signal processing device to be reused, while the intermittent urinary catheter according to the first aspect can be conveniently disposed of. In one embodiment, the signal processing device includes a wired or wireless connection device for connecting to and transmitting data to another electronic device, such as a portable electronic device (e.g., a smartphone or laptop) or a stationary computer or server. In one embodiment, the signal processing device includes a data output device, such as those described above.

[0041] In an embodiment, the intermittent urinary catheter is disposable.

[0042] In some embodiments, the intermittent urinary catheter assembly further includes an air outlet upstream of the at least one valve element, configured to disallow the passage of liquid. The air outlet allows air to escape from the tubing and improves the propagation of liquid toward the at least one valve element in the closed state until the liquid reaches the at least one valve element in the closed state. This allows for more direct application of pressure from the liquid in the tubing to the at least one valve element and can achieve greater measurement accuracy. In some embodiments, the air outlet is integrated into the at least one valve element, in which case the at least one valve element allows air, but not liquid, to pass through when closed.

[0043] In an embodiment, the at least one valve element is configured and controllable to:

[0044] o applying a force to the shutoff element to inhibit the flow of fluid in the tubing when the signal processing device is fixed relative to the intermittent urinary catheter; and

[0045] o gradually reducing the force applied to the shut-off element,

[0046] The parameter, measurable by the at least one sensor element and indicative of the pressure applied to the shut-off element when the shut-off element switches from the closed state to the open state, indicates the force applied to the shut-off element. The force applied to the shut-off element by the fluid pressure in the pipeline will be equal to or slightly higher than the force applied to the shut-off element by the at least one valve element during switching. Accordingly, the parameter indicative of the force applied to the shut-off element can be readily used to determine the pressure in the pipeline and / or in a space connected to the pipeline. Furthermore, the parameter indicative of the force applied to the shut-off element is straightforward to determine, as it can conveniently be a control parameter of a signal processing device.

[0047] In an embodiment, at least one of the at least one sensor element is configured to measure the presence of liquid downstream of the at least one valve element for reliably detecting a change of the shut-off element from the closed state to the open state.

[0048] In an embodiment, the shut-off element comprises a ferromagnetic valve member and at least one electromagnet, the at least one electromagnet being configured to apply a variable force to the ferromagnetic valve member. Such an embodiment allows precise and remote variation of the force applied by the at least one valve element to the shut-off element.

[0049] In an embodiment, at least one sensor element is configured to measure the amount of current conducted through the electromagnet. This allows for the precise measurement of a parameter indicative of the force applied to the shut-off element. The measurement can be made indirectly, by applying a known current through the electromagnet. The measurement can also be made directly, allowing for the measurement of a current generated in the electromagnet, for example, due to movement of a ferromagnetic valve member relative to the electromagnet. This movement occurs when the shut-off element switches from a closed state to an open state, and the measurement system can detect the change in state of the shut-off element based on the measured amount of current passing through the electromagnet.

[0050] In an embodiment, the measurement system is configured to determine a fluid flow rate based at least on a measured amount of current conducted through an electromagnet. This is achieved by correlating different vibration modes of a ferromagnetic valve member with different fluid flow rates. The different vibration modes can produce measurable differences in the amount and rate of current conducted through the electromagnet, and the fluid flow rate is determined based on these measurable differences.

[0051] In an embodiment, the measuring system is configured to detect said change of state of the shut-off element when the parameter or its derivative exceeds a predetermined threshold value, thereby simply detecting the change of state.

[0052] In the examples:

[0053] - the valve element further comprises a restriction element upstream of the shut-off member;

[0054] - the shut-off member is displaceable relative to the limiting element;

[0055] The shut-off element is configured to be sealably connected to the restriction element in the closed state of the valve element. Accordingly, the closed state can be achieved by applying a force to the shut-off element in the direction of the restriction element. Pressure exerted by at least the liquid in fluid communication with the conduit then pushes the shut-off element away from the restriction element.

[0056] In the examples:

[0057] The at least one valve element further comprises a retaining element downstream of the restriction element; wherein the retaining element is configured to retain the shut-off element in the open state of the valve element. Accordingly, the shut-off element is retained even in the open state and can be pushed against the restriction element again for further measurements.

[0058] In an embodiment, the intermittent urinary catheter is configured to remain in the user's urethra for a period of no more than 15 minutes. This allows the intermittent urinary catheter to include, for example, coatings that do not allow the duration of catheterization required for indwelling catheterization to be extended.

[0059] In an embodiment, at least the outer surface of the insertable portion of the catheter tubing includes a hydrophilic surface coating. This hydrophilic coating allows for particularly convenient intermittent urinary catheterization. In an embodiment, the intermittent urinary catheterization assembly includes a packaging assembly that encapsulates the catheter tubing and the signal processing device and includes a quantity of a liquid swelling medium for activating the hydrophilic surface, thereby rendering the intermittent urinary catheter assembly ready for use when the packaging assembly is in a stored state.

[0060] The hydrophilic coating may be provided only on the insertable portion of the catheter. The hydrophilic surface coating is of a type that, when hydrated or swollen with a swelling medium, reduces friction on the catheter surface area corresponding to the insertable portion of the catheter intended for insertion into the urinary tract of a user.

[0061] Intermittent hydrophilic catheters also differ from indwelling catheters in that the hydrophilic surface coating of such catheters is not suitable for indwelling use because, if left in the body for periods exceeding 5-20 minutes, the surface coating tends to stick to the urethral mucosa due to the hydrophilic coating's transition from being highly slippery when fully wetted (95% by weight water) to becoming sticky when the coating's hydration level is reduced (<75% by weight water).

[0062] In an embodiment, the catheter tubing is a single lumen tubing in which the tubing forms the only passageway between the distal insertion end and the proximal exit end of an intermittent urinary catheter. Such single lumen catheters are generally not suitable for indwelling use due to the lack of a passageway for introducing air to the balloon of an indwelling urinary catheter or a Foley urinary catheter.

[0063] In an embodiment, the signal processing device is configured to determine a flow rate of the fluid in the conduit based on measurements performed by the at least one sensor element.

[0064] In an embodiment, at least the tubing of the intermittent urinary catheter has a predefined characteristic pressure drop, wherein the signal processing device is configured to determine the fluid flow rate based on at least the predefined characteristic pressure drop and a parameter indicating the pressure applied to the shut-off element when the shut-off element switches from a closed state to an open state. The predefined characteristic pressure drop is used to determine a characteristic pressure drop / fluid flow rate correlation, thereby allowing the fluid flow rate to be determined. The predefined characteristic pressure drop can be predetermined based on a reference measurement on an exemplary intermittent urinary catheter, or the exemplary intermittent urinary catheter can be a standardized intermittent urinary catheter, wherein the predefined characteristic pressure drop is based on a reference measurement on another standardized intermittent urinary catheter.

[0065] Figure 1 A schematic cross-sectional view of an exemplary intermittent urinary catheter assembly 1 having an intermittent urinary catheter 3 and a measuring system 4 is shown. The intermittent urinary catheter 3 comprises a catheter tube 5. The catheter tube 5 comprises an insertable portion 7 intended for insertion into the urethra of a user, a non-insertable portion 9 not intended for insertion into the urethra of a user, and a connecting portion 10 integral with the non-insertable portion 9. The intermittent urinary catheter 3 further comprises a conduit 11 extending longitudinally within the catheter tube 5. The conduit 11 defines a flow path 12 from a distal insertion end 13 of the catheter 3 to a proximal outlet end 15 thereof. Only the non-insertable portion 9 and the connecting portion 10 of the catheter tube 5 and the proximal outlet end 15 of the intermittent urinary catheter 3 are shown, while the insertable portion 7 and the distal insertion end 13 of the catheter tube 5 extend to the proximal outlet end 15 of the intermittent urinary catheter 3. Figure 1 Outside the area shown.

[0066] Figure 1The intermittent urinary catheter assembly 1 further includes a measuring system 4 for determining at least the pressure in the flow path 12 and / or in a space connected to the flow path 12. In the illustrated embodiment, the measuring system 4 comprises an electronic valve element 37. An electromagnet comprising a coil 39 is wound around a portion of the signal processing device 19 to interact with a shut-off element 41 in the form of a ferromagnetic valve member 41 (e.g., a ball) disposed between a restriction element 43a and a retaining element 43b. By controlling the current in the coil 39, the ferromagnetic valve member 41 can be urged against the restriction element 43a, in which case the valve 37 shuts off the flow of liquid, or can be urged toward the retaining element 43b, allowing liquid to pass through the valve element 37. The amount of current applied to the coil 39 is measured and gradually reduced to reduce the force applied to the ferromagnetic valve member 41 when the shut-off member 41 is in the closed state. When the ferromagnetic valve member 41 is pushed away from the retaining element 43b by the pressure exerted thereon by the liquid in communication with the pipe 5, the valve element 37 is released from the closed state ( Figure 1 39). The movement of the ferromagnetic valve member 41 relative to the coil 39 induces a measurable current in the coil 39. The measurement system 4 detects the change in state from the closed state to the open state based on the induced current in the coil 39. The retaining element 43b holds the ferromagnetic valve member 41 in the signal processing device 19 while allowing liquid to pass to the signal processing device outlet 36. When the change in state is detected, the amount of current applied by the measurement system 4 through the coil 39 is measured. This measured current indicates the pressure applied to the shut-off element 41 when it switches from the closed state to the open state.

[0067] The signal processing device 19 comprises a housing 21. The housing 21 has an engagement mechanism 23 which can detachably fix the signal processing device 19 relative to the connecting portion 10 of the intermittent urinary catheter 3. Figure 1 In the embodiment of FIG. 1 , the engagement mechanism 23 is detachably fixed to the connecting portion 10 by firmly inserting the protruding engagement mechanism 23 into the receiving cavity of the connecting portion 10 .

[0068] In one embodiment, the intermittent urinary catheter 3 is configured to reside in the user's urethra for a period of no more than 15 minutes, and at least the outer surface of the insertable portion 7 of the catheter tubing 5 includes a hydrophilic surface coating. The illustrated catheter tubing 5 is a single lumen tubing in which tubing constitutes the only passageway between the distal insertion end 13 and the proximal exit end 15.

[0069] In an embodiment, the signal processing device 19 comprises a data processing unit 35 and a power source, such as a battery or a photovoltaic system.

[0070] Figure 2 and Figure 3 A schematic cross-sectional view of an exemplary intermittent urinary catheter assembly 1 is shown having an intermittent urinary catheter 3 and a measurement system 4. Figure 1 A variation of the measurement system. Figure 2 and Figure 3 In the embodiment, the valve element 37 is in the form of a push rod 47, which is combined with a flexible valve membrane 49 to form a shut-off member 41, and the flexible valve membrane allows the valve element 37 to be in an open state, wherein the flexible valve membrane 49 does not restrict the flow, such as Figure 2 The flexible membrane 49 also allows the valve element 37 to be in a closed state by pushing the push rod 47 downward to force the flexible valve membrane 49 to shut off the flow of liquid through the valve 37, as shown in FIG. Figure 3 As shown in FIG. Push rod 47 is pushed downward by an electric motor (not shown), which is driven by a continuously measured amount of current. The amount of current measured when push rod 47 is pushed toward the open state by the pressure caused by the liquid connected to pipe 5 indicates the pressure in pipe 5. The pressure in the pipe is determined based on the measured current. When push rod 47 moves from the closed state, an electrical contact (not shown) is activated. Based on the activation of the electrical contact, measurement system 4 detects the change from the closed state to the open state.

[0071] Figures 1 to 3 The first aspect has been illustrated and described above. As with the embodiment of the fourth aspect, variations of the illustrated embodiment are also contemplated in which the measurement system 4 is securely connected to or integrally formed with the non-insertable portion 9 of the catheter tube 5. In these variations, the connection portion 10 and the engagement mechanism 23 are replaced with a permanently fixed connection (otherwise, the connection portion 10 and the engagement mechanism 23 would be removably connected), or the catheter tube 5 and the signal processing device 19 are integrally formed (otherwise, the connection portion 10 and the engagement mechanism 23 would be removably connected).

[0072] Figure 4 A schematic cross-sectional view of an exemplary intermittent urinary catheter 3 is shown. The intermittent urinary catheter 3 includes a catheter tube 5. The catheter tube 5 includes an insertable portion 7 intended for insertion into the user's urethra, a non-insertable portion 9 not intended for insertion into the user's urethra, and a connecting portion 10 integral with the non-insertable portion 9. The intermittent urinary catheter 3 further includes a conduit 11 extending longitudinally within the catheter tube 5. The conduit 11 defines a flow path 12 from the distal insertion end 13 of the catheter 3 to its proximal outlet end 15. The catheter tube 5 includes an eyelet 56 in the distal insertion end 13. The eyelet 56 allows liquid to enter the conduit 11.

Claims

1. An intermittent urinary catheterization assembly, comprising: - an intermittent urinary catheter, comprising: o a catheter tube comprising an insertable portion intended for insertion into the urethra of a user, a non-insertable portion not intended for insertion into the urethra of the user, and a connecting portion integral with or mounted to the non-insertable portion; and a conduit extending longitudinally within the body and defining at least a portion of a flow path from the distal insertion end of the catheter to the proximal outlet end thereof; a measuring system configured to measure at least the pressure in the pipeline and / or in a space connected to the pipeline, wherein the measuring system comprises: o a signal processing device comprising a housing having an engagement mechanism for removably securing the signal processing device relative to the connection portion of the catheter; o at least one valve element in fluid communication with the tubing when the signal processing device is fixed relative to the intermittent urinary catheter, the at least one valve element comprising a shutoff element configured to switch from a closed state that inhibits the flow of liquid in the tubing to an open state that permits the flow of liquid in the tubing in response to pressure applied to the shutoff element by liquid in the tubing; and o at least one sensor element configured to measure a parameter indicative of a pressure applied to the shut-off element when the shut-off element switches from the closed state to the open state, wherein the measuring system is configured to detect a change in state of the shut-off element from the closed state to the open state, Wherein, the at least one valve element is configured and controllable to: o applying a force to the shutoff element to inhibit the flow of fluid in the tubing when the signal processing device is fixed relative to the intermittent urinary catheter; and o gradually reducing the force applied to the shut-off element, And wherein the parameter measurable by the at least one sensor element, which is indicative of a pressure applied to the shut-off element when the shut-off element switches from the closed state to the open state, is indicative of a force applied to the shut-off element.

2. The intermittent urinary catheterization assembly according to claim 1, further comprising: An air outlet is located upstream of the at least one valve element, the air outlet being configured to not allow liquid to pass therethrough.

3. The intermittent urinary catheterization assembly according to claim 1 or 2, wherein: At least one of the at least one sensor element is configured to measure the presence of liquid downstream of the at least one valve element.

4. The intermittent urinary catheterization assembly according to claim 1 or 2, wherein: The shut-off element comprises a ferromagnetic valve member and at least one electromagnet configured to apply a variable force to the ferromagnetic valve member.

5. The intermittent urinary catheterization assembly according to claim 4, wherein: The at least one sensor element is configured to measure an amount of current conducted through the electromagnet.

6. The intermittent urinary catheterization assembly according to claim 1 or 2, wherein: The measurement system is configured to detect the change in state of the shut-off element when the parameter or its derivative exceeds a predetermined threshold.

7. The intermittent urinary catheterization assembly according to claim 1 or 2, wherein: - the valve element further comprises a restriction element upstream of the shut-off element; - the shut-off element is displaceable relative to the limiting element; The shut-off element is configured to be sealably connected to the restriction element in the closed state of the valve element.

8. The intermittent urinary catheterization assembly according to claim 7, wherein: - The at least one valve element further comprises a holding element downstream of the restriction element; wherein the holding element is configured to hold the shut-off element in the open state of the valve element.

9. The intermittent urinary catheterization assembly according to claim 1 or 2, wherein: The intermittent urinary catheter is configured to remain in the user's urethra for a period of time not exceeding 15 minutes.

10. The intermittent urinary catheterization assembly according to claim 1 or 2, wherein: At least the outer surface of the insertable portion of the catheter tubing includes a hydrophilic surface coating.

11. The intermittent urinary catheterization assembly according to claim 1 or 2, wherein: The catheter tubing is a single lumen tubing, wherein the tubing constitutes the only passageway between the distal insertion end and the proximal exit end of the intermittent urinary catheter.

12. The intermittent urinary catheterization assembly according to claim 1 or 2, wherein: The signal processing device is configured to determine a fluid flow rate in the conduit based on measurements performed by the at least one sensor element.

13. An intermittent urinary catheterization assembly comprising: - an intermittent urinary catheter, comprising: o a catheter tubing comprising an insertable portion intended for insertion into the urethra of a user, a non-insertable portion not intended for insertion into the urethra of the user; and a conduit extending longitudinally within the body and defining at least a portion of a flow path from the distal insertion end of the catheter to the proximal outlet end thereof; a measuring system, securely connected to or integral with the non-insertable portion of the catheter tube, for determining at least the pressure in the duct and / or in a space communicating with the duct, wherein the measuring system comprises: oSignal processing device; o at least one valve element in fluid communication with the conduit, the at least one valve element comprising a shutoff element configured to switch from a closed state that inhibits flow of liquid in the conduit to an open state that permits flow of liquid in the conduit in response to pressure applied to the shutoff element by liquid in the conduit; and o at least one sensor element configured to measure a parameter indicative of a pressure applied to the shut-off element when the shut-off element switches from the closed state to the open state, wherein the measuring system is configured to detect whether the shut-off element changes from the closed state to the open state, Wherein, the at least one valve element is configured and controllable to: o applying a force to the shutoff element to inhibit the flow of fluid in the tubing when the signal processing device is fixed relative to the intermittent urinary catheter; and o gradually reducing the force applied to the shut-off element, And wherein the parameter measurable by the at least one sensor element, which is indicative of a pressure applied to the shut-off element when the shut-off element switches from the closed state to the open state, is indicative of a force applied to the shut-off element.

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