Catheter valve for controlling fluid flow of a medium

Abstract

The present invention relates to a catheter valve for controlling the fluid flow of a medium, in particular to a self-closing catheter valve, which has a base having an inlet section, an outlet section, a flexible tube, and a longitudinally movable slider as a cover member, the inlet section of the catheter valve has a stepped anti-slip section for attaching a supply line, and the catheter valve has two opposite running inclined sections on the longitudinally movable slider inside the base having two vertical chambers opposite each other on the sides. The objective of the present invention is to develop a catheter valve which: 1. is ergonomically well designed, so that the patient can get used to it even if he is bedridden for a long time; 2. since nursing costs are particularly important for long-term patients, the catheter valve must be extremely inexpensive; 3. since geriatric patients often have a reduced ability to move, due to this the catheter valve must be extremely easy to operate and with one hand; 4. since long-term use is often used, it is assumed that the entire valve can be cleaned and sterilized without difficult disassembly; and 5. unintentional removal of the catheter from the catheter valve must be prevented, thereby avoiding the risk of infection. This is achieved according to the invention in that a base body having two opposing running inclined sections has two opposing oblique chambers for operating and guiding two vertically movable magnets, which are arranged on two opposite lateral sides of the valve hose and selectively close or open the flow through the valve hose, and in the outlet part of the catheter valve an adapter can be inserted and fixed, which, together with a longitudinally movable slider, brings about a continuous open position of the catheter valve.

Description

[Technical Field]

[0001] The present invention relates to a catheter valve for controlling the fluid flow of a medium, and in particular to a self-closing catheter valve, in which a base body has an inlet portion, an outlet portion, a flexible tube, and a longitudinally movable slider as a cover member, and the inlet portion of the catheter valve has a stepped anti-detachment portion for attaching a supply line. [Background technology]

[0002] Urinary incontinence is a frequently confronted condition that can arise for a number of reasons, such as, for example, illness, injury, or debilitation. The urinary incontinence condition is usually characterized by a weakness or complete lack of function of the muscles that control the expansion and contraction of the urethral sphincter. To date, there are no known surgical methods that satisfactorily correct the incontinence condition so that bladder control is substantially restored.

[0003] Attempts to improve incontinence conditions have included the use of passive devices, such as collection bags carried by the user to collect urine discharged from the ureter. A drawback of this solution is that the user urinates continuously into the bag without having any control over urine output. Another drawback of this solution is that the collection bag must be attached to the user, thus interfering with the user's activities.

[0004] Catheter valves used in urology are increasingly used in chronic patients, especially in geriatrics, where patients have to use catheter valves for many years, a situation that has not been taken into account to date.

[0005] To meet these requirements, both design aspects and structural aspects, which are partly determined by the design, must be taken into account.

[0006] Attempts to solve problems such as lack of controllability, large volume, discomfort, and inhibition of activity have led to the development of incontinence control devices with valves. These devices eliminate the need for external collection systems and allow the user to manually control urination through the urethra. Examples of such devices are described in US Pat. No. 3,503,400, US Pat. No. 3,939,821, and US Pat. No. 4,024,855.

[0007] Similarly, US Pat. No. 3,731,670 is known, in which a bistable magnetic valve element requires a first magnetic actuation to return from a closed position to an open position.

[0008] While this type of device allows the user some control over their bowel movements, it is not reliable enough. For example, if the valve is first operated to the open position and bowel movements stop, the user may forget to perform the second operation, i.e., forget to return the valve to the closed position while it is still in the open position. If the valve remains in the open position unintentionally, this may result in unintended bowel movements.

[0009] The risk of unintentional opening also exists in catheter valves such as those described in WO 93 / 24173 A1. In this case, a spring element normally blocks flow through a flexible line segment. An operating element in the form of a button that can be operated against the force of the spring element can release the closed state and open the valve. Even in this device, the operating element is relatively easily exposed to pressure exerted by impact or accidental contact, and as a result, this valve also has the disadvantage of being unable to prevent unintentional opening.

[0010] Further, catheter valves are known that fold rather than crush to close a flexible line segment. The valve disclosed in EP 0 088 871 A1 operates on this principle. A portion of the flexible line is fixed to a sleeve, whereby relative sliding of the sleeve relative to a housing to which the other portion of the flexible line is fixed causes a portion of the line to escape to the side, shortening the flexible line and resulting in bending of the line. A spring holds the sleeve in the bent position, thereby blocking flow through the line.

[0011] However, multiple bending of a line configured as a hose creates new problems. The constant bending deformation of the hose leads to damage to the hose wall and requires frequent maintenance of the valve, and in some cases even frequent replacement of the valve. Furthermore, even the described embodiments do not guarantee sufficient prevention of unintentional sliding of the sleeve and therefore opening of the flow path. Furthermore, this type of catheter valve leaves room for improvement in that its structure is unnecessarily complex.

[0012] From US Pat. No. 2,197,995, a so-called force valve is known, in which, in the illustrated embodiment, two shutoff elements, which can be operated independently of one another, act on a flexible line section to control the flow. Each of the shutoff elements is individually movable. In this embodiment, the shutoff elements are arranged opposite one another, and the actuation of the flexible line section by the shutoff elements takes place at points on the flexible line section that face each other.

[0013] Furthermore, EP 3 247 450 B1 discloses a catheter valve for controlling fluid flow, which has a movable closure element that can assume different positions, the closure element being actuable by a magnetically acting valve actuator.

[0014] The drawbacks of all the above solutions are: - Complex structural configuration - Expensive manufacturing - Complex operability - Difficult to clean and disinfect - Many components required - Magnetic material / magnetic force indirectly controls the closing element - Manual operation (one-hand steering) is not possible - Continuation position / cannot be released

[0015] Patent Document 9 (DE 10 2019 100 509 B4) discloses a catheter valve for regulating the flow rate of an exchangeable medium through a catheter. The catheter valve includes a valve housing structure that defines an internal space of the catheter valve and has a bottom wall configured to support the catheter valve, an upper wall disposed opposite the bottom wall, and at least one side wall connecting the bottom and upper wall. The catheter valve further includes a line element extending through the internal space of the catheter valve in the longitudinal direction of the valve housing structure and for guiding the medium, a closing device for blocking or releasing the flow of the medium through the line element, and an adjusting element movably supported relative to the valve housing structure and capable of adjusting the position of the closing device between a blocking position and an releasing position. The adjusting element is slidably disposed on or within the upper wall. A further aspect of the invention relates to a closing device for the catheter valve.

[0016] This solution has the following drawbacks: - After multiple operations, possible material fatigue of the spring arm elements and of the spring elements configured as O-rings can lead to non-tightness of the catheter valve. - High force is required to maintain the open state. - Due to the structural configuration, the incomplete open volume of the valve hose results in a low flow rate and therefore a long drain time. - Complex operation, the valve's open / close position must be actuated by a tedious operation of a slider. When removing the urine bag, there is a risk that the deactivation of the continue position of the valve may be forgotten, which could result in an unintentional urine leak. The large structural volume due to the long spring arm elements reduces the carrying comfort for the patient. - It is made up of many individual components. - The short distance between the operating element and the valve outlet increases the risk of urine getting onto the patient's hands and fingers (hygiene). - Unintentional detachment or dislodgement of the catheter may occur.

[0017] Furthermore, DE 29 41 278 A1 discloses a cannula or catheter device having a hose member and a movable pressure body, in which a slider is provided on the outer surface of the wall surrounding the flow path and can slide back and forth in the longitudinal direction of the flow path and has an inclined surface facing the pressure body, which switches the pressure body between both supports when the slider slides.

[0018] This solution has the following drawbacks: - There is no self-closing feature as the slider must be operated to close the valve. - To open the valve, the flexible hose must push the pressure bodies apart. This means that the hose material must have a certain stiffness. This also leads to material fatigue in long-term use, thereby increasing the risk of malfunction. In addition, a harder material will result in increased sealing loads. - A radial seal is formed around the cannula, and the flexible hose is not completely crushed. The pressure body is of spherical design, so that in the event of crushing without the cannula, a reliable seal on the hose would not be achieved.

[0019] DE 10 2013 012 158 A1 describes a force valve which has a hose-shaped valve element surrounded by a ring-shaped operating element located on the opposite side of the force valve element, which is movable relative to the valve element by an operating movement of the operating element and selectively opens or closes the valve flow path of the valve element.

[0020] The drawbacks of this solution are: The pressing element moves towards the flexible hose at an angle in the axial longitudinal direction, which leads to material wear on the hose during frequent use of the valve and compromises the reliable sealing. Additionally, longitudinally directed axial forces act on loosely positioned hoses, which can lead to displacement of the hoses, which can result in malfunction or non-tightness of the valve. - To release and hold the position, a push must be made against the spring force, which means that the user has to use a relatively large amount of force when urinating. - The spring is another component that adds significant material and assembly costs.

[0021] Finally, another pressure valve is known from DE 10 2007 002 765 B3, which in its embodiment is a combination of DE 10 2007 002 765 B3 and DE 10 2007 002 765 B3. The drawbacks of this solution are essentially the same as those described above. [Prior art documents] [Patent documents]

[0022] [Patent Document 1] U.S. Patent No. 3,503,400 [Patent Document 2] U.S. Patent No. 3,939,821 [Patent Document 3] U.S. Patent No. 4,024,855 [Patent Document 4] U.S. Patent No. 3,731,670 [Patent Document 5] International Publication No. 93 / 24173 [Patent Document 6] European Patent Application Publication No. 0088871 [Patent Document 7] U.S. Patent No. 2,197,995 [Patent Document 8] European Patent No. 3247450 [Patent Document 9] German Patent No. 102019100509 [Patent Document 10] DE 2941278 A1 [Patent Document 11] German Patent Application Publication No. 102013012158 [Patent Document 12] German Patent No. 102007002765 Summary of the Invention [Problem to be solved by the invention]

[0023] The problem underlying the present invention is to develop a catheter valve which: 1. It is ergonomically designed, allowing patients to become accustomed to the catheter valve even if they are bedridden for a long period of time. 2. Because nursing costs are particularly important for long-term patients, catheter valves must be extremely inexpensive. 3. Geriatric patients often have reduced mobility, and for this reason, catheter valves must be very easy to operate and can be operated with one hand. 4. Since long-term use is often required, it is assumed that the entire valve can be cleaned and sterilized without difficult disassembly. 5. Unintentional removal of the catheter from the catheter valve must be prevented, thereby avoiding the risk of infection. [Means for solving the problem]

[0024] The problem is solved by a catheter valve having the features of claim 1. Solution Advantageous configurations are set forth in the dependent claims.

[0025] The solution to this problem is provided by the present invention in which a base body (1) with two opposing ramps has two opposing oblique chambers (12a, 13a) for operating and guiding two vertically movable magnets (10, 11) arranged on two opposite sides of a valve hose (6) to selectively close or open the flow of the valve hose (6), with an adapter (17) insertable and fixable at the outlet (3) of the catheter valve, which, together with a longitudinally movable slider (7), sets the catheter valve in its open, permanent position. Pressing the adapter (17) causes the slider (7) to slide longitudinally towards its open position.

[0026] According to the present invention R Solution Reference example In the catheter valve, a longitudinally movable slider (7) has a running ramp (8) and an inclined chamber (12a) for operating and guiding a vertically movable magnet (10) within a base (1) having two laterally opposite vertical chambers (12b, 13b). The magnet (10) is disposed on one side of a valve hose (6) and selectively closes or opens the flow of the valve hose (6). An adapter (17) is insertable and fixable at the outlet of the catheter valve, and the adapter (17) positions the catheter valve in a continuous open position alongside the longitudinally movable slider (7). Again, pushing the adapter (17) causes the slider (7) to slide longitudinally toward its open position.

[0027] The stepped stop at the inlet of the catheter valve is provided with a built-in or double-sided insertable retainer.

[0028] The fixator is configured as a double-sided clamp formed in a U-shape.

[0029] The adapter preferably has a retainer ring that is adapted to cover or penetrate a stopper portion of the outlet portion of the catheter valve, or the retainer ring is adapted to be flexibly and fixedly attached to the outlet portion of the catheter valve. Cover The device is configured to be mounted on a support member.

[0030] The catheter valve may also be configured in accordance with the present invention so that instead of a longitudinally movable slider, a push button is provided on one or both sides to operate both magnets.

[0031] Removal of the adapter from the catheter valve receiver results in automatic closure of the magnet and therefore of the tubing. Preferably, this closure is brought about solely by magnetic force, which provides the restoring force. Optionally, but less preferred, this closure could be assisted by an additional spring force.

[0032] The catheter valve serves as an interface between the catheter or catheter funnel located in the patient and the urine bag. To establish urine flow, the catheter valve can be manually opened for urination. For continuous urine flow, the catheter valve can be set to the continuous position overnight. The catheter valve is suitable for long-term use (greater than 30 days) as well as for bladder training.

[0033] Special advantages of this invention: - Inserting the adapter automatically opens the flow to the continuous position. - Removal of the adapter causes the valve to close automatically, so no further action is required. - It has an ergonomically advantageous shape and can therefore be operated very easily even by bedridden patients. - It is inexpensive to manufacture, with few individual parts and simple assembly. - Easy to clean and sterilize. - Only a small force is required to hold the slider in the open position. - Full open volume for rapid urination. - Small configuration size for better carrying comfort. - Safety bilateral clamps are provided to prevent unintentional separation of the catheter and catheter valve. - Short slider opening path for easy operation.

[0034] One particularity is the special structure of the catheter, which, according to the invention, is based on the cooperation of a highly innovatively constructed longitudinally movable slider, which incorporates both running ramps and both oblique chambers, with both vertical chambers in the base for the vertical movement of both magnets that close or open the valve hose.

[0035] As mentioned above, the present invention Reference example It is also possible to use one magnet, in which case the base has at its bottom, at the level of the magnet, a metal plate with magnetic properties as a counter element.

[0036] Both vertical chambers also bound a vertical guide in which one or both magnets are movably guided. The longitudinal sliding of the slider causes one or both magnets, while guided in the vertical guide, to be guided along a ramp and moved away from each other. When the adapter is removed, the magnetic attraction force causes the catheter valve to return to its starting state. If this magnetic force is strong enough, the catheter valve automatically transitions back to its closed state as soon as the adapter (17) is withdrawn again.

[0037] The present invention will be described in detail below based on examples. [Brief explanation of the drawings]

[0038] [Figure 1] FIG. 1 shows an isometric view of a catheter valve with a magnet and double clamps in a closed position. [Figure 2] FIG. 1 shows an isometric view of a catheter valve with the magnet in a closed position and a cross-sectional view of the base. [Figure 3] FIG. 1 shows a cross-sectional view of a catheter valve with the magnet in the closed position. [Figure 4] FIG. 13 shows an isometric view of the catheter valve with the magnet open. [Figure 5] FIG. 10 shows a cross-sectional view of the catheter valve with the magnet open. [Figure 6] FIG. 1 shows an isometric view of a catheter valve with the slider, both clamps, and valve hose removed. [Figure 7] FIG. 1 shows a catheter valve in a closed state. [Figure 8] FIG. 1 shows a catheter valve in an open position. [Figure 9] FIG. 10 is a diagram showing the magnet in a closed state. [Figure 10] FIG. 10 is a diagram showing the magnet in an open state. [Figure 11]FIG. 1 shows a side view of a catheter valve having a bilateral clamp, an adapter, and a catheter. [Figure 12] FIG. 1 shows a cross-sectional side view of a catheter valve having a bilateral clamp, an adapter, and a catheter. [Figure 13] FIG. 1 shows a side view of a catheter valve with a catheter and an adapter inserted. [Figure 14] FIG. 1 illustrates a catheter valve with a catheter and an adapter in an inserted state, the adapter shown in cross section. [Figure 15] FIG. 1 shows an isometric view of a double clamp. [Figure 16] FIG. 10 is a front view of a double-sided clamp having pointed features. [Figure 17] FIG. 10 is a side view of a double clamp. [Figure 18] FIG. 1 shows a catheter valve with an implantable catheter fixator. [Figure 19] FIG. 1 shows a catheter valve with a built-in catheter fixator. DETAILED DESCRIPTION OF THE INVENTION

[0039] The catheter valve has a base body 1 with an inlet 2 and an outlet 3 (Figs. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10). The inlet 2 has a stepped stop 4 for receiving a catheter 5 from a patient. A valve hose (valve tube) 6 is guided through the base body 1. A longitudinally movable slider 7 is arranged on the base body 1 and has two ramps 8 and 9 arranged in opposite directions within the base body 1. The longitudinal movement of the slider 7 moves both magnets 10 and 11 vertically upward or downward via the ramps 8 and 9, thereby closing or opening the cross section of the valve hose 6. In this case, both magnets 10 and 11 move upward or downward within two diagonally arranged chambers 12a and 13a relative to two vertically extending chambers 12b and 13b.

[0040] The stepped anti-slip portion 4 has a groove 14 formed toward the base 1, and one side of a double-sided clamp 15 engages with the groove 14 (FIG. 7). The other side of the double-sided clamp 15 engages with the stepped anti-slip portion 4 and the catheter 5 that is pushed onto the stepped anti-slip portion 4.

[0041] In this case, the bilateral clamp 15 has, on the side facing the catheter 5, a special tip shape 16, preferably with three tips, so that the three tips bite into the silicone material of the catheter 5 under tensile load, thus preventing unintentional separation (Figures 11, 12, 15, 16, 17, 18).

[0042] FIG. 19 shows an embodiment in which the double clamp 15 and the base 1 are one component.

[0043] An adapter 17 is fixed to the outlet portion 3 of the base body 1, and a urine bag connector is connected to the adapter 17 (Figs. 13 and 14). When the adapter 17 is inserted, the slider 7 is moved longitudinally by poking (i.e., by abutting and pushing), and the slider 7 is thereby pushed into the open position.

[0044] When the adapter 17 is removed, the catheter valve should preferably be closed automatically, which is achieved in that the magnetic forces of the magnets 10, 11 exerted towards one another are sufficiently dimensioned so that the magnets 10, 11, guided along the ramps 8, 9 and in the vertical guides formed by the vertical chambers 12b, 13b, move towards one another, pushing the longitudinally movable slider 7 back to its starting position and squeezing the valve hose 6 located between the two magnets 10, 11 to close it. [Explanation of symbols]

[0045] 1 Base 2 Entrance 3 Exit section 4-stage stopper 5 Catheter 6 Valve hose (valve tube) 7. Longitudinal slider 8 Slope 9 Slope 10. Magnets 11 Magnet Room 12a, diagonal Room 13a, diagonal Chamber 12b, vertical Chamber 13b, vertical 14 Groove 15 Double clamp 16 Point shaped part 17 Adapters

Claims

1. 1. A catheter valve for controlling fluid flow of a medium, comprising: The base (1) has an inlet (2), an outlet (3), a flexible valve hose (6), and a slider (7) movable in the longitudinal direction as a cover member, and the inlet (2) of the catheter valve has a stepped stopper (4) for attaching a catheter (5). The catheter valve has two opposing running ramps (8; 9) on the longitudinally movable slider (7) inside the base body (1) which has two laterally opposite vertical chambers (12b; 13b), the base body (1) having two opposing ramps has two opposing oblique chambers (12a; 13a) for operating and guiding two vertically movable magnets (10; 11) arranged on two opposite sides of the valve hose (6) for selectively closing or opening the flow of the valve hose (6); an adapter (17) can be inserted and fixed into the outlet of the catheter valve, which, together with the longitudinally movable slider (7), provides a continuous open position for the catheter valve; A catheter valve comprising:

2. The step-shaped locking portion (4) of the inlet portion (2) of the catheter valve and the catheter (5) are provided with built-in or double-sided insertable locking devices; The catheter valve of claim 1 .

3. The fixator is configured as a U-shaped double clamp (15); The catheter valve of claim 2 .

4. The adapter (17) is engaged with or flexibly placed over the retaining portion of the outlet portion of the catheter valve via a retainer ring; The catheter valve of claim 1 .

5. removal of the adapter (17) from the catheter valve receptacle results in automatic closure of the magnet (10; 11) and therefore of the valve hose (6); The catheter valve of claim 1 .

6. When the adapter (17) is inserted, the slider (7) is movable in the longitudinal direction; The catheter valve of claim 5 .

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