Flow-regulating urinary catheter

Abstract

A urinary catheter (1) comprising a slide valve (8) provided with a tube (3) and a moving element (2) having a relief (5) at the end face closest to the stenosis (13), the tube (3) being provided with another relief (6), both reliefs being at the same end of the slide valve (8) and adjacent to each other. The valve also has a curved surface (7) adapted to allow a finger to hold the urinary catheter (1) firmly, naturally and ergonomically and to press the moving element (2).

Description

[Technical field]

[0001] The present invention is in the field of devices for removing agent substances from the body, more specifically catheters or hollow catheter Regarding.

[0002] The primary object of the present invention is a urinary catheter that is inserted through the urethra or through a surgical opening that connects it to the bladder, incorporating as part of its design a valve at the opposite end that allows the user to regulate the drainage of urine to drain this fluid from the bladder, kidneys or ureters, reducing the force required to actuate the valve incorporated in the device. [Background technology]

[0003] 2. Background of the Invention As medical advances increase life expectancy, the number of factors that can cause patients to suffer from acute urinary retention is also increasing. It is estimated that at least 10% of people over the age of 65 suffer from benign prostatic hyperplasia, which can lead to acute urinary retention.

[0004] Urinary retention resulting from trauma does not always have the same causes. In the past, the reasons (falling off a horse, wounds on the battlefield, or other causes) may have been completely different from those that cause this medical problem today, but the result was ultimately the same as today: acute or chronic urinary retention. When the bladder is full, the pain felt by the patient is so intense that it makes life impossible for the patient, which probably led to the use in different cultures of devices to relieve the pain by emptying the bladder.

[0005] The main reasons for needing urinary catheterization are: • Allowing urination in patients with neurological conditions causing bladder dysfunction; • Managing urinary incontinence in patients with cognitive deficits; • Minimizing skin deterioration and pressure sores in paralyzed, comatose or terminally ill patients; ● Bladder irrigation; ● Administration of chemotherapy; • Assistance in urological surgery and other procedures on adjacent structures; ● Obtaining accurate measurements of urinary output in critically ill and postoperative patients; ● Emptying the bladder during delivery; and ● Perform urodynamic tests (pressure measurements, etc.).

[0006] The first documented historical record of a bladder catheter is attributed to Galen and his algalia or fistula aenea. We do not know whether this corresponds to an original invention or a modification of an existing prototype, but we know that it was made of metal, long and curved for men, and straight, half the length for women. This type of catheter lasted for longer than the 10th century. In the Islamic period, it was made of silver and was lighter and more delicate. Throughout the Renaissance, it persisted with some minor variations. In the 17th and 18th centuries, there were no major changes, apart from the production of some glass models in different countries.

[0007] Over time, advancements in this device were initially focused on patient comfort, but since the invention of the Foley catheter as we know it today, the interest has become more focused on reducing bladder catheter-related infections, and therefore most of the innovations in this field that have reached the market have been coatings and materials that inhibit biofilm and bacterial growth.

[0008] Bladder drainage is usually accomplished by passing a Foley or intermittent catheter through the natural urethra (called transurethral catheterization) or by creating an artificial pathway between the lower abdominal wall and the bladder (suprapubic catheterization).

[0009] However, these bladder catheters have some drawbacks. During insertion, urine leakage usually occurs, and since urine is often accompanied by blood, biological contamination accidents sometimes occur that affect the professionals who insert them. Bladder catheters usually require connection to a urine collection bag through which the flow passes through a tube. This bag must be replaced or emptied at certain intervals, and when it is filled, it is accompanied by an increase in the weight of the bag, which limits the patient's mobility. In addition, accidental disconnection of the collection bag can occur, as can happen with other accessories such as plugs and independent valves. On the other hand, the constant flow of urine into the collection bag leads to the generation of biofilms in the catheter tube, increasing the risk of infection and blockages, which lead to more frequent visits of the patient to the emergency department or to the doctor to solve these problems, which usually require the insertion of a new catheter. In addition, the long-term connection of the bladder catheter to the collection bag reduces the bladder reflex and causes inconvenience in the patient's life when it is removed.

[0010] Separate valves such as catheter caps and other devices are used as accessories to facilitate emptying the bladder and dispense with a collection bag. Valves require greater handling by patients and professionals, as they need to be replaced regularly and can be subject to accidental disconnection. Furthermore, they are not easy to use for all patients.

[0011] Commonly owned European Patent No. EP2872194A1 discloses an improved urinary catheter comprising a flexible tube with an insertion section enabling it to be inserted through the urethra into the bladder, the flexible tube having a connection section for connecting a connecting element, fluid can be discharged from the urethra via the insertion section, and a closeable valve is arranged between the insertion section and the connection section such that it can prevent the discharge of fluid from the connection section while the valve is closed. The valve is configured as a slide valve and has three switching positions; closed (not allowing the passage of fluid), open (allowing the passage of fluid and air), and a third position which allows the passage of only air and no fluid.

[0012] After testing prototypes and receiving comments received from users on the previous catheter of EP 2 872 194 A1, a new catheter was created with improvements to reduce the forces required for its operation and to reduce the risks arising from the use, assembly and / or transportation of the product. Summary of the Invention

[0013] The device object of the invention is constituted by a urinary catheter provided with a valve, the surface of which is curved so that the force required for its actuation is significantly reduced. The catheter is connected to the bladder by being inserted through the urethra or through a surgical opening and at the opposite end has a connection cone for connecting elements such as a collection bag, a plug, a valve, etc. Furthermore, at the end opposite the bladder connection zone, the catheter is provided with a valve making it possible to regulate the evacuation of fluids through the connection section, said valve being constituted as a slide valve.

[0014] The slide valve allows for the regulation of urine passage without intermediate positions. The valve allows three possible positions to be selected by the user (professional or patient): • “Membrane position”, allowing 100% of the air flow to pass and preventing the total passage of the urine flow.

[0015] ● “Open position”, allows 100% of urine and air flow to pass through.

[0016] • "Closed position," total passage of urine and air flow is prevented.

[0017] Depends on the type of user and usage time: ● Healthcare professionals can avoid urine contamination during the insertion process, and the sequence of use is as follows: With the slide valve of the device in the "membrane position", the device is inserted through the furthest part of said valve until it accesses the bladder, then urine starts to flow along the conduit of the device and pushes out the air contained therein, so that when the air and urine reach the position of the slide valve, at the end opposite to that located in the bladder, only the air can pass through the valve to the outside, while the urine is retained and occupies the entire volume and length of the catheter conduit.

[0018] o The medical professional then moves the slide valve to the "open position" to allow the controlled release of urine which can then be collected in a container provided for this purpose for sampling, in addition to ensuring that all air has been expelled from the conduit. Whatever the motivation for opening the slide valve, it should always be done when and in the manner desired, i.e. in a controlled manner, avoiding accidental splashing which could pose a risk due to contamination.

[0019] Finally, the medical professional moves the slide valve to the "closed position," preventing urine from draining, and the device remains implanted in the patient, waiting to be used as part of their daily life or as an auxiliary device during hospitalization.

[0020] ● Thanks to the controlled opening of the slide valve that allows to regulate the passage of fluid, the patient can naturally drain urine from the bladder in his daily life, when he feels the need or at time intervals defined by a medical professional. This allows to reduce blockages that frequently occur with bladder catheters, since urine can accumulate in the bladder and carry with it the biofilm that may be generated in the tube when it is released. This means that the patient does not need a collection bag and can connect it to the urinary catheter subject of the invention when necessary. Not depending on a collection bag means a significant improvement in the quality of life of the patient, since said bag needs to be changed or emptied at certain intervals and, when it is filled, it means an increase in its weight, thereby limiting the patient's mobility. Furthermore, being able to do without a collection bag prevents accidental disconnection from it, which can also occur with other accessories such as plugs or independent valves. The quality of life of the patient is also significantly improved in the medium to long term, because by not creating a constant flow of urine into the collection bag, the development of biofilm on the inside of the tube is avoided, reducing the risk of infection and blockages, and reducing the number of emergency department and doctor visits by the patient to solve these problems that would normally require the insertion of a new catheter. Finally, by not incurring a prolonged connection of the bladder catheter to the collection bag, a weakening of the bladder reflex is avoided, thereby avoiding the inconvenience of the patient's life when the catheter is removed.

[0021] The urinary catheter subject of the present invention includes a body made from silicone or an equivalent plastic material having similar qualities and properties, and which is usually transparent, so that the urine flow therethrough can be viewed.

[0022] The body has an appearance similar to a Foley urethral catheter, so that, like this type of catheter, it comprises a tube with an opening at one end for urine collection and a balloon that, once inflated inside the bladder, prevents the catheter from coming out through the urethra. At the opposite end, the tube comprises two lumens, one for urine drainage and one for balloon inflation.

[0023] The slide valve of the invention is provided with curved surfaces which make it easier to grip and reduce the force required to actuate it.

[0024] The body incorporates, at the urine outlet end, a hollow or channel, preferably of elliptical cross section, which intersects with the conduit through which the urine circulates, its axis being preferably perpendicular to the urine flow conduit and which is open at both ends. In this hollow or channel, a tube, preferably of elliptical cross section, hollow and made of a rigid material, preferably of the plastic type, is arranged, fitted together without the possibility of movement. The tube incorporates a lumen through which the fluid can always pass freely, since the regulation of the passage of the fluid is the function of the moving element of the slide valve. Inside this hollow tube moves the moving element of the slide valve, which allows the passage of the fluid / urine to be regulated.

[0025] The moving element of the valve is the element that finally regulates the passage of the fluid and is composed of an elongated part, preferably of elliptical cross section, made of a rigid material, preferably plastic. It is a length with a lumen, the opening of which coincides with the urine flow path when the moving element is moved by pushing through one of its ends. One of the two ends of the moving element is always visible and accessible by protruding from one of the ends of a rigid tube housed in the body. Furthermore, the moving element has a constriction in its longitudinal section so that when the moving element is pushed and this constriction coincides with the urine flow path, it leaves a free passage for the fluid, whether it is urine or air. The lumen has an attachment element, a flexible membrane, which allows only the passage of air when both fluids flow through the body duct, but not the passage of urine coming from the bladder and seeking an outlet to the outside.

[0026] The moving element comprises two chromatically differentiated parts, preferably one red and one green. Each coloured part covers approximately half the length of the element, so that, depending on the position, we have the following situations: ● "Open position", the movable element at its green end is visible and fully accessible by one of the ends of the rigid tube that traverses the body, while the red end is visible but not accessible, in this state 100% of the flow of urine and air can pass through.

[0027] ● "Closed position", in which the movable element at its red end is fully accessible and visible by one of the ends of the rigid tube that traverses the body, while the green end is visible but not accessible, and in this position the entire passage of urine and air is blocked.

[0028] There is a third position that occurs only early in the device's use, when inserted by the healthcare professional into the patient: the so-called "membrane position," which allows 100% of the air flow but prevents the entire urine flow from passing through. InsertDuring the insertion process, if the medical professional allows air to escape from the duct, the urine will be retained without the possibility of uncontrolled escape and will occupy the entire volume and length of the catheter conduit. The medical professional then moves the slide valve, first passing through the "open position" and finally, as he continues to press, the slide valve will move until it is in the "closed position". From the moment the closed position is reached, it is not feasible to return the slide valve to the "membrane position", which will remain ineffective for the life of the device, so that there is no possibility of visual confusion between the "closed position" and the "membrane position", since only the "closed position" and the "open position" are possible and accessible under normal conditions of use during the life of the device.

[0029] The tube, preferably of oval cross section, hollow, made of a rigid material, preferably plastic, and located inside the hollow of the body, has two ends which are always visible and at one of them has a relief which allows visual and tactile identification of said end of the element.

[0030] The moving slide valve has a relief at the end which, when viewed, corresponds to the "open position" and which is preferably green in colour, visually and tactilely identifying said end of the element.

[0031] When the valve is inserted into the tube, the reliefs of the sliding valve and the rigid tube must be next to each other on the same side.

[0032] The urinary catheter object of the present invention is a rigid plastic, preferably made of a plastic material. Gu and Equipped with the said platform Gu is At the end of the hollow elliptical cross-section tube, a moving element is Raw and Kiss B's Both fit at the end opposite the end with the relief. Gu is The entire length of the tube is fitted inside the tube, except for the part that is outside the body of the tube, because B's Prevents forward movement on the inside. GuWhen in the tube, the slide valve is prevented from moving involuntarily and the "membrane position" remains fixed in the urinary catheter subject of the present invention, assuring the medical professional that only air and never the liquid contents of the bladder pass through the duct. [Brief description of the drawings]

[0033] To complete this description, and for a better understanding of the characteristics of the invention according to its preferred and practical embodiments, said description is accompanied, as an integral part thereof, by a set of drawings in which the following are represented in an illustrative and non-limiting manner: [Figure 1] FIG. 1 shows a perspective view of a possible embodiment of the device according to the invention. [Diagram 2] FIG. 2 shows a detailed front view of the embodiment of the device of FIG. 1 with the slide valve in the "closed position." [Diagram 3] FIG. 3 shows a detailed rear view of the embodiment of the device of FIG. 1 with the slide valve in the "closed position." [Figure 4] FIG. 4 shows a detailed side view of one of the embodiments of the apparatus of FIG. [Diagram 5] FIG. 5 shows another detailed side view of the embodiment of the device of FIG. 1, in which the relief is visible in the preferably elliptical, hollow cross-section tube and in the moving element of the slide valve. [Figure 6] Figure 6 shows a detailed top view of the embodiment of the device of Figure 1. In this figure, the top view of the moving element 2 is not represented. [Figure 7] FIG. 7 shows some views of possible embodiments of the moving elements of the slide valve. [Figure 8] FIG. 8 shows some views of possible embodiments of a tube of hollow cross section, preferably oval. [Figure 9] FIG. 9 shows a detail of a possible embodiment of a protrusion or relief on the moving element of the slide valve and preferably on the tube of oval hollow cross section. [Figure 10]FIG. 10 shows some views of possible embodiments of plugs making it possible to fix the "membrane position" of the device according to the invention. [Figure 11] FIG. 11 shows a rear view and cross section of a possible embodiment of a device according to the invention, with the sliding valve in the "membrane position" and the plug in place, preventing possible movement of the moving elements of the sliding valve, thereby giving the user assurance that the valve is in the "membrane position". [Figure 12] Figure 12 shows a view and a cross section of a possible embodiment of the device according to the invention, with the slide valve in the "membrane position" and the device held so that the thumb rests on its pad against the end of the moving element of the slide valve. In a preferred embodiment, this end is green in colour and has at least one protrusion or relief that distinguishes it from the opposite end, which is red in colour. The index finger and middle finger hold the body in such a position that, when pressed by the thumb, they exert an equal and opposite force, which moves the moving element of the slide valve to the "open position" and then to the "closed position". [Figure 13] Figure 13 shows a rear view and a cross section of a possible embodiment of the device according to the invention, with the sliding valve in the "closed position" and the device held so that the thumb rests on its pad against the end of the moving element of the sliding valve. In a preferred embodiment, this end is red in colour to distinguish it from the opposite green end. The index and middle fingers hold the body in such a position that when pressed by the thumb, they exert equal and opposite forces, thereby causing the moving element of the sliding valve to move towards the "open position". [Figure 14]Figure 14 shows a rear view and cross section of a possible embodiment of the device according to the invention, with the slide valve in the "open position" and the device held so that the thumb rests on its pad against the end of the moving element of the slide valve. In a preferred embodiment, this end is green in colour to distinguish it from the opposite red end. The index and middle fingers hold the body in a position such that when pressed by the thumb they exert an equal and opposite force, thereby moving the moving element of the slide valve towards the "closed position". [Figure 15] FIG. 15 shows the end of the urinary catheter that connects to the bladder, with a deflated balloon on the left that helps to retain the catheter within the bladder, and with the same balloon already inflated on the right. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] Preferred embodiments of the invention In light of the figures previously described and illustrated, and in accordance with the numbering schemes adopted, examples of preferred embodiments of the invention can be seen therein, which include the parts and elements shown and described below.

[0035] Thus, as seen in FIG. 1, the urinary catheter (1) of the invention has an end for connection to the bladder. Department and and a slide valve (8) consisting of the following elements: ● Figure 7As seen in FIG. 1, the moving element (2) is made of a rigid material, preferably plastic, of elongated, preferably elliptical cross section, which has a constriction (13) in its longitudinal section and a lumen (15). The lumen (15) is preferably circular in cross section and traverses the entire moving element (2) according to an axis preferably parallel to the minor axis of the ellipse constituting the cross section of the moving element (2). At one of the ends of the lumen (15) there is a surface on which is accommodated an adhesive element, a membrane (14), which is a flexible sheet that allows only the passage of air but not urine. The moving element (2) has a relief (5) on its end face closest to the constriction (13). The moving element (2) can be two-colored in a preferred embodiment, for example green in the half including from the constriction (13) to the end with the relief, while the remaining half is another different color, for example red.

[0036] ● The tube (3) is 8 As can be seen in FIG. 1, the device is made of an elongated element, preferably of elliptical cross section, hollow and made of a rigid material, preferably made of plastic. 8 As can be seen in Fig. 1, the tube has a lumen (16) which allows the free passage of fluids at all times. Moreover, it has at one of its ends, the one closest to the lumen (16), a relief ( 6 ).

[0037] In a preferred embodiment, the moving element (2) is arranged inside the tube (3), whereby 9 As can be seen in Figs. 1 and 2, the relief (5) of the moving element (2) and the relief (6) of the tube (3) are at the same end of the slide valve (8). Figures 3, 11, 12, 13 and 14 As can be seen in the figure, the moving element (2) always leaves one of its ends in view, while the remaining volume remains inside the tube (3). The relief is shown as a point in the figure, but it may also have the shape of a bold curve.

[0038] In order to reduce the forces acting on the moving element (2) of the slide valve (8) by distributing the necessary forces on three points, one favorable for the movement of the moving element and two others in the direction opposite to its displacement, the slide valve is completed with surfaces (7) which, due to their curved shape, allow the fingers, for example the index and middle fingers, to grip the urinary catheter (1) firmly, naturally and ergonomically in the area corresponding to the slide valve (8). In this way, the movement of the moving element is favored by a 3° lever. In a preferred embodiment, as shown in FIG. 11 As can be seen in FIG. 1, the urinary catheter (1) of the present invention comprises a plug-shaped part (4) (FIG. 2) made of a rigid material and preferably made of a plastic material. 10 ), said plug-shaped part (4) is attached to the end of the tube (3) opposite to the one with the relief (6) so that its entire length is inside the tube, except for the protrusion that prevents its advancement into the tube when this plug is attached to the bottom. The plug (4) prevents the slide valve from moving involuntarily and keeps the "membrane position" fixed in the urinary catheter (1) subject of the present invention. This is the situation in which the medical professional finds the device during its first use, just before inserting it into the urethra of a patient. In this way, the "membrane position" is guaranteed for the patient, and therefore the insertion procedure can begin with all the guarantees regarding its correct deployment according to the steps described in the previous paragraph.

[0039] In a preferred embodiment, as can be seen mainly in FIG. 1, the urinary catheter (1) that is the subject of the present invention has an appearance very similar to that of the Foley type and therefore has elements common to this type of device, such as, for example: ● Figures 1 to 6 and Figure 1 1 to As can be seen, a connection cone (9) at the distal end of the connection area with the urethra, which allows urine to drain when the slide valve (8) is in the "open position" and allows for the connection of elements such as collection bags, plugs and valves if necessary.

[0040] ● A conduit (10) for the inflation of a balloon (18), as seen in figures 1, 2, 4, 5 and 6. Said balloon is located at the end that is connected to the bladder, next to an orifice for the collection of urine from the bladder and its subsequent transmission to the body (17) via a conduit (11), passing through a slide valve (8), which, when said valve is in the "open position", exits the patient's body via a cone (9).

Claims

1. A urethral catheter (1) comprising a body (17) provided with a slide valve (8) at an end opposite to the bladder connection area (12), wherein the slide valve comprises a tube (3) constituted by an elongated element which is hollow and made of a rigid material and has a lumen (16), and a moving element (2) located inside the tube (3), the moving element (2) comprising two color - distinguishable parts and being constituted by an elongated part, a constriction (13) and a lumen (15) being provided in the longitudinal section, the lumen (15) traversing the entire cross - section of the moving element (2), and at one of the ends of the lumen (15), there is a surface accommodating a membrane (14) constituted by a flexible sheet allowing only the passage of the air flow and not allowing the passage of the urine flow, and one of the two ends of the moving element (2) is always visible and accessible by protrusion from one of the ends of the tube (3), and the moving element (2) is longer than the tube (3). The urethral catheter is: - A relief (5) is provided at an end of the moving element (2) corresponding to the open position of the slide valve (8) when visible, and another relief (6) is provided in the tube (3), both reliefs being at the same end of the slide valve (8) and being close to each other in the closed position of the slide valve (8), and - The slide valve (8) is provided with a curved surface (7) adapted to allow the index finger and the middle finger to hold the body and perform a firm, natural and ergonomic grip of the urethral catheter (1), while the thumb presses the moving element (2) to move the moving element (2) to the open position or the closed position of the slide valve (8). A urethral catheter (1), characterized by the above.

2. At an end opposite to the end where the reliefs (5, 6) are located, it includes a portion in the form of a rigid plug (4) made of plastic material, configured and arranged to fit the end of the tube (3), whereby the plug (4) prevents the slide valve (8) from moving unintentionally and the membrane position of the slide valve (8) is fixed to the urethral catheter (1). The urethral catheter (1) according to claim 1.

3. The elongated portion of the moving element (2) includes an elliptical cross-section, the elongated portion of the moving element (2) is movably provided inside the elongated element of the tube (3), the elongated element of the tube (3) also has an elliptical cross-section, and the lumen (15) having the membrane (14) has a circular cross-section and traverses the entire cross-section of the moving element (2) along an axis parallel to the minor axis of the ellipse constituting the cross-section of the moving element (2). The urethral catheter according to claim 1.

4. The body is made of a transparent silicone or equivalent plastic material that allows the urine flow to be visible. The urethral catheter (1) according to any one of claims 1 to 3.

5. Half of the moving element (2) has a portion distinguished by a first color, and the other half of the moving element (2) has a portion distinguished by a second color. The urethral catheter (1) according to claim 1.

6. - In the open position of the slide valve (8), the constriction (13) coincides with the urine flow path. - In the membrane position of the slide valve (8), the lumen (15) having the membrane (14) coincides with the urine flow path, whereby it allows the flow of air and blocks the flow of urine through the lumen (15). - In the closed position of the slide valve (8), the moving element (2) blocks the urine flow path, whereby it blocks the flow of urine and air through the urinary tract. In such a way that the moving element (2) is movably provided with respect to the body. The urethral catheter (1) according to any one of claims 1 to 3.

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