Catheter valve for controlling the fluid flow of a medium

Description

[0001] The invention relates to a catheter valve for controlling the fluid flow of a medium, in particular a self-closing catheter valve, wherein a base body has an inlet and an outlet, a flexible tube and a longitudinally movable slide as a cover, as well as a stepped ratchet at the inlet of the catheter valve for connecting a supply line.

[0002] Urinary incontinence is a common condition that can arise from a variety of causes, such as illness, injury, or exhaustion. A urinary incontinence condition is typically characterized by weakness or complete absence of function in the muscles that control the expansion and contraction of the urethral sphincter. To date, no surgical procedures are known that satisfactorily correct a urinary incontinence condition to such an extent that bladder control is essentially restored.

[0003] Attempts to improve incontinence include the use of passive devices, such as a collection bag worn by the user to collect urine from the urethra. A disadvantage of this solution is that the bladder continuously empties into the bag without the user having any control over urine release. Another drawback is that the collection bag must accompany the user, thus hindering their activities.

[0004] Catheter valves used in urology are increasingly being used for chronic patients. Particularly in geriatrics, patients often have to use catheter valves for years. This fact has received little attention to date.

[0005] To meet these conditions, both design aspects and constructive aspects, which are partly dictated by the design, must be taken into account.

[0006] Attempts to solve problems such as the lack of control, large volume, inconvenience, and prevention of activity have led to the development of valved incontinence control devices. These devices eliminate the need for external collection systems and allow the user to manually control urine drainage from the urethra. Examples of such devices are described in US Patents 35,034,000, 39,398,211, and 40,248,555.

[0007] Also known is US patent 37 31 670, in which a bistable magnetic valve element requires an initial magnetic actuation from the closed position back to an open position.

[0008] Although such a device allows the user some control over the drainage, it is not sufficiently reliable. For example, if the valve is initially actuated to an open position and the drainage stops, the user may forget to perform a second actuation and return the valve to a closed position while it is still in the open position. If the valve is unintentionally left in the open position, an unexpected drainage may occur.

[0009] The risk of unintentional opening remains even with a catheter valve as described in WO 93 / 24173. In this type of valve, a spring element normally closes off the flow through a flexible section of tubing. An actuating element, in the form of a button, which must be pressed against the force of the spring element, releases the closure and opens the valve. However, even with this design, the actuating element can be relatively easily subjected to pressure exerted by a bump or accidental contact, meaning that this valve, too, has the disadvantage of potentially causing unintentional opening.

[0010] Furthermore, catheter valves are known that do not compress the flexible tube section to close it, but rather kink it. EP 0 088 871 A1 operates on this principle. Here, a section of the flexible tube is attached to a sleeve, so that a displacement of the sleeve relative to a housing in which another section of the flexible tube is attached leads to a shortening of the flexible tube and a resulting kink in the tube, as part of the tube moves laterally. A spring holds the sleeve in a position in which the tube is kinked as described, thus closing off the flow through the tube.

[0011] The multiple kinks in the tubing, however, lead to new problems. The continuous kinking and deformation of the tubing damages the tubing wall, necessitating frequent valve checks and potentially even frequent valve replacement. Furthermore, even with the described design, it is not guaranteed that unintentional displacement of the sleeve, and thus an opening of the flow, is adequately prevented. Moreover, such a catheter valve is in need of improvement because its construction is unnecessarily complicated.

[0012] US Patent 21,979,995 discloses a so-called pinch valve in which, in one illustrated embodiment, two independently actuated shut-off elements act on a flexible pipe section to control the flow. Each of the shut-off elements is individually movable. In this embodiment, the shut-off elements are arranged opposite each other, and the action of the shut-off elements on the flexible pipe section occurs at opposite points along the flexible pipe section.

[0013] Furthermore, EP 3 247 450 B1 discloses a catheter valve for controlling fluid flow, which has a movable closing element that can assume different positions. The closing element can be actuated by a magnetically driven valve actuator.

[0014] The disadvantages of all the aforementioned solutions are: Complex design, expensive manufacturing, complicated operation, difficult cleaning and sterilization, many components required, magnetic body / force indirectly controls locking elements, no (one-)handed operation possible, no permanent position / opening possible

[0015] From DE 10 2019 100 509 B4, a catheter valve for adjusting the flow rate of a medium exchangeable via a catheter is known. This valve comprises a valve housing structure that partially delimits the interior of the catheter valve and has a bottom wall designed to support the catheter valve, an upper wall opposite the bottom wall, and at least one side wall connecting the bottom wall and the upper wall. The catheter valve also includes a conduit element for guiding the medium, which extends through the interior of the catheter valve in the longitudinal direction of the valve housing structure, a closure device for blocking and releasing the flow of the medium through the conduit element, and an actuating element that is movably mounted relative to the valve housing structure and by means of which the closure device can be adjusted between a closed position and a released position.The actuating element is slidably arranged on or in the upper wall. Another aspect of the invention relates to a locking device for the catheter valve.

[0016] This solution has the following disadvantages: Potential material fatigue of the spring arm elements and the O-ring spring element with repeated actuation can lead to leakage of the catheter valve; high force is required to hold the opening; the valve tube does not open fully due to the design, resulting in a low flow rate and therefore a long emptying time; complex operation; a permanent position / opening of the valve must be activated by cumbersome actuation of the slider; risk of forgetting to deactivate the permanent position on the valve when removing the urine bag, thus possible unintentional urine leakage; large overall size due to long spring arm elements impairs patient comfort; consists of many individual components; the small distance between the actuating element and the valve outlet increases the risk of urine flowing over the patient's hand or fingers (hygiene).Unintentional disconnection or dislodgement of the catheter is possible.

[0017] US Patent 4,243,034 describes a generic catheter valve for controlling the fluid flow of a medium. Further catheter valves are known from EP 3,679,978 A1 and US Patent 2018 / 245699 A1.

[0018] Finally, a cannula or catheter assembly is known from DE 29 41 278 A1, which has a hose section and a movable pressure body, wherein a slide mounted on the outside of the wall surrounding the channel is movable back and forth in the longitudinal direction of the channel and has an inclined surface facing the pressure body which, when the slide is moved, repositions the pressure body between the two bearings.

[0019] This solution has the following disadvantages: No self-closing function is provided, as the slider must be actuated to close the valve. To open the valve, the slightly flexible hose must push the pressure elements apart. This means that the hose material must possess a certain stiffness. With continuous use, this can lead to material fatigue and thus increase the risk of malfunction. Furthermore, a stiffer material can compromise the seal. The seal is radial around a cannula, rather than completely compressing the flexible hose. The pressure elements are spherically shaped and would therefore not achieve a reliable seal on the hose if compressed without a cannula.

[0020] DE 10 2013 012 158 A1 describes a pinch valve having a tubular valve element enclosed by an annular actuating element and flanked on opposite sides by pinch elements. The pinch elements are movable relative to the valve element by an actuating movement of the actuating element and selectively either open or close a valve channel of the valve element.

[0021] The disadvantages of this solution are: The pinch elements move at a specific angle in the axial longitudinal direction towards the flexible hose. With frequent use of the valve, this can lead to material abrasion on the hose and compromise a reliable seal. Additionally, an axial longitudinal force acts on the loosely positioned hose, which can cause it to shift. This can lead to malfunctions or leaks in the valve. Opening and holding the valve in position requires pushing against a spring force, meaning the user must exert a relatively high force when emptying the bladder. The spring is an additional component, resulting in higher material and assembly costs.

[0022] Finally, another pinch valve is known from DE 10 2007 002 765 B3, which in its embodiment is a combination of the two previously mentioned DE 29 41 278 A1 and DE 10 2013 012 158 A1. The disadvantages of this solution are essentially the same as already mentioned above.

[0023] The invention is based on the objective of developing a catheter valve which: 1. It is ergonomically well-designed so that the patient can become accustomed to it even if they are bedridden for a long time; 2. Since care costs are particularly significant for long-term patients, the catheter valve must be extremely inexpensive; 3. Since geriatric patients often have reduced motor skills, this necessitates that the catheter valve be extremely easy to operate with one hand; 4. Since long-term use is common, this requires that the entire valve can be flushed and sterilized without difficult disassembly; 5. Unintentional detachment of the catheter from the catheter valve must be prevented, thus avoiding the risk of infection.

[0024] The problem is solved by a catheter valve having the features of claim 1 and by a catheter valve having the features of claim 2. Advantageous embodiments are specified in the dependent claims.

[0025] The problem is solved according to the invention by the fact that the base body (1), which has two opposing discharge slopes, has two inclined, opposing chambers (12a; 13a) for actuating and guiding two vertically movable magnets (10; 11) which are arranged on two opposite sides of the valve tube (6) and selectively close or open its flow, wherein an adapter (17) is to be inserted and attached to the outlet (3) of the catheter valve, which – in addition to the longitudinally movable slide (7) – results in a permanently open position of the catheter valve. Sliding the adapter (17) causes a longitudinal displacement of the slide (7) into its open position.

[0026] In a further embodiment of the solution according to the invention, the catheter valve, within the base body (1) which has two laterally opposing vertical chambers (12b; 13b), has a drain slope (8) and an inclined chamber (12a) on the longitudinally movable slide (7) for actuating and guiding a vertically movable magnet (10), which is arranged on one side of the valve tube (6) and selectively closes or opens its flow. An adapter (17) is to be inserted and attached to the outlet of the catheter valve, which—in addition to the longitudinally movable slide (7)—results in a permanently open position of the catheter valve. Sliding the adapter (17) also results in a longitudinal displacement of the slide (7) into its open position.

[0027] An integrated or double-sided attachable safety device is arranged on the stepped grid of the catheter valve inlet.

[0028] The safety device is designed as a U-shaped double-sided clamp.

[0029] The adapter preferably has a locking ring that engages over or into a notch on the outlet of the catheter valve, or is designed to fit flexibly and firmly over the outlet of the catheter valve.

[0030] According to the invention, the catheter valve can also be constructed in such a way that, instead of the longitudinally movable slide, a push button arranged on one or both sides is installed for actuating the two magnets.

[0031] Removing the adapter from the catheter valve receptacle causes the magnets, and thus the tube, to close automatically. Preferably, this closure is effected solely by the magnetic force, which provides the restoring force. Optionally, but less preferably, this closure could be assisted by an additional spring force.

[0032] The catheter valve serves as an interface between the catheter or catheter funnel in the patient and the urine bag. It can be manually opened to allow urine flow. For continuous urine flow, it can be set to the permanent position at night. It is suitable for long-term use (>30 days) and for bladder training.

[0033] Special advantages of the invention: Automatic opening and continuous flow by inserting the adapter, automatic valve closure by removing the adapter, thus eliminating the need for additional operation, ergonomically advantageous design for very easy use even by bedridden patients, cost-effective manufacturing due to a small number of individual parts and simple assembly, easy cleaning and sterilization, minimal effort required to hold the slide in the open position, full opening volume for rapid urine drainage, compact design for improved wearing comfort, double-sided safety clamp to prevent accidental disconnection of the catheter and catheter valve, short slide opening stroke for easy operation.

[0034] A special feature is the special design of the catheter valve through the inventive interaction of the very innovatively designed, longitudinally displaceable slider with its integrated two discharge slopes and the integrated two inclined chambers as well as the two vertical chambers of the base body for vertical movement of the two magnets that close or open the valve tube.

[0035] As already described, an embodiment according to the invention is also possible with a magnet. In this case, the base body has a metallic plate with magnetic properties at its base, at the level of the magnet, as a counterpart.

[0036] The two vertical chambers define a vertical guide in which the two magnets, or the single magnet, are movably guided. Longitudinal displacement of the slide causes the magnet(s) to move along the ramps and away from each other while guided in the vertical guide. When the adapter is removed, the magnetic attraction causes the catheter valve to return to its initial state. If this magnetic force is sufficiently strong, the catheter valve automatically returns to the closed state as soon as the adapter (17) is removed. Example of implementation

[0037] The invention will be explained in more detail below using an exemplary embodiment.

[0038] This shows Figure 1 - the catheter valve in isometric view with closed magnets and double-sided clamp Figure 2- the catheter valve in isometric view and the base body in sectional view with closed magnets Figure 3 - the catheter valve in cross-section with closed magnets Figure 4 - the catheter valve in isometric view and open magnets Figure 5 - the catheter valve in cross-section with open magnets Figure 6 - the catheter valve in isometric view with the slide lifted, double-sided clamp and valve tubing Figure 7 - the catheter valve in the closed state Figure 8 - the catheter valve in the open state Figure 9 - the magnets closed Figure 10 - the magnets opened Figure 11 - the catheter valve with double-sided clamp, adapter and catheter in side view Figure 12 - the catheter valve in cross-section with double-sided clamp, adapter and catheter in side view Figure 13 - the catheter valve with catheter and attached adapter in side view Figure 14- the catheter valve with attached adapter in cross-section and catheter Figure 15 - Double-sided clamp in isometric view Figure 16 - Double-sided clamp in front view with pointed geometry Figure 17 - Double-sided clamp in side view Figure 18 - Catheter valve with attachable catheter safety device Figure 19 - Catheter valve with integrated catheter safety device

[0039] The catheter valve has a base body 1 with an inlet 2 and an outlet 3 ( Figure 1, 2, 3, 4, 5 , 6, 7, 8, 9, 10At the inlet 2, there is a stepped grid 4 for receiving the catheter 5 from the patient. The valve tube 6 is guided through the base body 1. A longitudinally movable slide 7 is arranged on the base body 1, on which two opposing ramps 8; 9 are located inside the base body 1. By moving the slide 7 longitudinally, the two magnets 10; 11 are moved vertically up or down over the ramps 8; 9, thereby closing or opening the cross-section of the valve tube 6. The two magnets 10; 11 move upwards or downwards in two inclined chambers 12a; 13a against two vertically moving chambers 12b; 13b.

[0040] A groove 14 is arranged on the stepped grid 4 towards the base body 1, into which one side of the double-sided clamp 15 engages ( Figure 7). The other side of the double-sided clamp 15 engages the stepped grid 4 and the catheter 5, which is pushed onto the stepped grid 4.

[0041] The double-sided clamp 15 has a special pointed geometry 16 with preferably three points on the side facing the catheter 5, which ensures that the three points engage in the silicone material of the catheter 5 under tensile load and thus prevent unintentional disconnection ( Figures 11 and 12 , 15, 16, 17, 18 ).

[0042] ( Figure 19 Figure 1 shows an integrated embodiment in which the double-sided clamp and the base body 1 are formed from a single component.

[0043] The adapter 17 is attached to the outlet 3 of the base body 1, to which the urine bag connection is attached ( Figures 13, 14 ). When the adapter 17 is attached, the slider 7 is moved in a longitudinal direction, which pushes it into the open position.

[0044] When the adapter 17 is removed, the catheter valve should preferably close automatically. This can be achieved by ensuring that the magnetic force exerted on each other by the magnets 10, 11 is sufficiently dimensioned so that the magnets 10, 11 move towards each other along the ramps 8, 9 and guided in the vertical guide formed by the vertical chambers 12b, 13b, thereby pushing the longitudinally movable slide 7 back into its starting position and closing and compressing the valve tube 6 located between the two magnets 10, 11. List of reference symbols used

[0045] 1 - Base body 2 - Inlet 3 - Outlet 4 - Stepped indexing 5 - Catheter 6 - Valve tubing 7 - Longitudinally movable slider 8 - Bevel 9 - Bevel 10 - Magnet 11 - Magnet 12a - Angled chamber 13a - Angled chamber 12b - Vertical chamber 13b - Vertical chamber 14 - Groove 15 - Double-sided clamp 16 - Pointed geometry 17 - Adapter

Claims

1. A catheter valve for controlling the fluid flow of a medium, in particular a self-closing catheter valve, wherein a main body (1) has an inlet (2) as well as an outlet (3), a flexible valve tube (6) and, as a cover, a slider (7) which is movable in a longitudinal direction, as well as a stepped ratchet (4) at the inlet (2) of the catheter valve for the incorporation of a catheter (5), and inside the main body (1), which has two laterally opposing vertical chambers (12b; 13b), the catheter valve has two counteractive drainage inclines (8; 9) on the longitudinally movable slider (7), characterized in that the main body (1) having two counteractive drainage inclines has two counteractive inclined chambers (12a; 13a) for actuating and guiding two vertically movable magnets (10; 11) which are disposed on two opposite sides of the valve tube (6) and which selectively close or open the passage thereof, wherein the insertion and attachment of an adapter (17) at the outlet of the catheter valve - in addition to the longitudinally movable slider (7) - will result in a permanently open position of the catheter valve.

2. A catheter valve for controlling the fluid flow of a medium, in particular a self-closing catheter valve, wherein a main body (1) has an inlet (2) as well as an outlet (3), a flexible valve tube (6) and, as a cover, a slider (7) which is movable in a longitudinal direction, as well as a stepped ratchet (4) at the inlet (2) of the catheter valve for the incorporation of a catheter (5), and the main body (1) has inside it two laterally opposing vertical chambers (12b, 13b), characterized in that the main body (1) has a drainage incline (8) as well as an inclined chamber (12a) on the longitudinally movable slider (7) for the actuation and guidance of a vertically movable magnet (10), which is disposed on one side of the valve tube (6) and selectively closes or opens the passage thereof, wherein the insertion and attachment of an adapter (17) at the outlet of the catheter valve - in addition to the longitudinally movable slider (7) - will result in a permanently open position of the catheter valve.

3. The catheter valve as claimed in claim 2, characterized in that the main body has a metallic plate with magnetic properties on its bottom, against which the magnet strikes.

4. The catheter valve as claimed in claim 1 or claim 2, characterized in that a safety device which is integrated or which can be attached to both sides is disposed on the stepped ratchet (4) of the inlet (2) of the catheter valve as well as on the catheter (5).

5. The catheter valve as claimed in claim 4, characterized in that the safety device is constructed as a U-shaped double-sided clamp (15).

6. The catheter valve as claimed in claim 1 or claim 2, characterized in that the adapter (17) is engaged over a ratchet of the outlet of the catheter valve, or is flexibly push-fitted over it, via a retaining ring.

7. The catheter valve as claimed in claim 1 or claim 2, characterized in that a removal of the adapter (17) from the catheter valve receptacle results in an automatic closure of the magnets (10; 11) and therefore of the valve tube (6).

8. The catheter valve as claimed in claim 7, characterized in that the adapter (17) can be moved in longitudinal directions during attachment of the slider (7).