A urinary catheter and a connector with pressure equalization

Abstract

A urinary catheter (100) with pressure equalising means is provided. The pressure equalising means may include a valve (116). Furthermore, the urinary catheter (100) may include a vent tube (110). The urinary catheter (100) may include a flow channel, which is in flow communication with an actuator. A connector with pressure equalizing means is provided. The connector is configured for being connected to a urinary catheter.

Description

[0001] A Urinary Catheter and a Connector with Pressure Equalization The invention relates to a urinary catheter and a connector with pressure equalization means.

[0002] Brief Description of the Drawing

[0003] The accompanying drawings are included to provide a further understanding of embodiments and are incorporated into and a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated 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 designate corresponding similar parts.

[0004] Figure 1 to 3 each illustrates what happens in a urinary catheter of the prior art.

[0005] Figure 4 is a schematic illustration of the layers in mucosal tissue, e.g. in the bladder wall.

[0006] Figure 5 illustrates an example of a urinary catheter with a vent tube.

[0007] Figure 6A- 6C illustrate examples of a connector for a urinary catheter with a vent tube.

[0008] Figure 7 illustrates an example of a urinary catheter with a flow channel.

[0009] Figures 8 to 10D illustrate examples of a urinary catheter with a valve mechanism at the outlet portion.

[0010] Detailed Description

[0011] Examples relate to a urinary catheter comprising:

[0012] - a tip portion in a proximal insertion portion of the urinary catheter,

[0013] - a tubular portion extending from the tip portion and longitudinally to a distal end of the tubular portion, the tubular portion comprising a wall defining an exterior surface and an interior surface defining an interior lumen,

[0014] - drainage openings provided in the tubular portion and traversing the wall providing fluid communication through the wall from the exterior surface to the interior lumen, each drainage opening being provided with an exterior edge atthe exterior surface and an interior edge at the interior lumen and a drainage opening wall extending from the exterior edge to the interior edge, wherein the urinary catheter further comprises pressure equalising means.

[0015] Catheterisation involves insertion of a urinary catheter through the urethra and into the bladder. The urinary catheter may be an intermittent urinary catheter, which is configured for being inserted through the urethra until the tip portion reaches the bladder. An intermittent urinary catheter is configured for being inserted 4 to 6 times a day, empty the bladder (which takes up to 5-10 minutes at the most) and then being removed again. The urinary catheter may also be an indwelling urinary catheter, which is configured for dwelling in the urethra with the tip portion in the bladder for a longer period of time, such as days, weeks or even months. During the indwelling process, the urine continuously flows from the bladder through the catheter and out of the body.

[0016] Irrespectively of the type of catheter used, a pressure difference may occur between the bladder and the ambience outside the body. The pressure difference occurs because of two factors: The abdominal pressure in the body as one factor and the height difference between the inflow into the catheter (through the drainage openings) and the outflow from the catheter, i.e. from the distal end of the catheter as the other factor. The abdominal pressure in the body may be in the order of 30-50 mBar depending on the position of the body (whether the user is standing up or is in a supine position). Furthermore, the height difference between the inlet to the catheter at the drainage openings and the outlet from the catheter outside of the urethra may contribute with around 20m Bar (corresponding to 20 cm height difference) due to liquid column in the interior lumen of the catheter. Thus, the pressure difference may overall be in the order of 50-70 mBar. Such pressure difference may influence tissue in the bladder.

[0017] During catheterisation, the mucosal tissue of the bladder wall may get into proximity of the drainage openings, and the suction pressure from the inflow causes suction at the mucosal tissue, by which the mucosal tissue is sucked towards the drainage opening, thereby potentially blocking further inflow. If all drainage openings of the urinary catheter are blocked by the suction, the urinary catheter will stop draining the urine from the bladder and the drainage is only resumed if the urinary catheter is repositioned, and the drainage openings are released from the mucosal tissue.Thus, during the flow stop caused by the suction, the mucosal tissue can be subjected to mechanical load, mechanical strain and wear. It may occur that the force acting on the mucosal tissue will press and draw the mucosal tissue to abut the drainage openings of the urinary catheter. If the drainage opening is large enough to allow it, the mucosal tissue may be drawn into, and even through, the drainage openings of the urinary catheter. This is, amongst others, caused by the sub-pressure provided by the liquid column standing in the urinary catheter during flow through the urinary catheter.

[0018] An advantage of examples disclosed herein is that because of the pressure equalizing means, there will be a reduction in the sub-pressure caused by the liquid column, and thereby, the mucosal tissue in the bladder will, during micturition, only be subjected to stress and strain at a low level.

[0019] In the following, whenever referring to a proximal end of an element of the invention, the referral is to the end adapted for insertion. Whenever referring to the distal end of an element, the referral is to the end opposite the insertion end. In other words, the proximal end is the end closest to the user, when the catheter is to be inserted and the distal end is the opposite end - the end furthest away from the user when the catheter is to be inserted. The same definitions apply to the package and container - the proximal end is the end storing the proximal end of the catheter and the distal end is the opposite end.

[0020] The longitudinal direction is the direction from the distal to the proximal end. The transverse direction is the direction perpendicular to the longitudinal direction, which corresponds to the direction across the shaft of the catheter.

[0021] A urinary catheter typically comprises a tubular portion with an interior lumen (interior catheter lumen) and drainage openings extending from an exterior surface of the tubular portion to an interior surface of the tubular portion. The interior surface of the tubular portion defines the interior lumen. The drainage openings are each provided with an exterior annular edge and an interior annular edge and a drainage opening wall. The drainage openings are positioned in a proximal portion of the urinary catheter. The urinary catheter is provided with an outlet at a distal end of the catheter; the outlet may be in the form of a connector or a handle or may be coupled to a collecting bag.

[0022] The urinary catheter may be an intermittent urinary or an indwelling urinary catheter.Usually, intermittent urinary catheters are from size 6 FR (or CH6) to size 18 FR (or CH18). FR (or French size or Charriere (CH)) is a standard gauge for catheters approximately corresponding to the outer circumference in mm. More accurately, the outer diameter of the catheter in mm corresponds to FR divided by 3. Thus, 6 FR corresponds to a catheter with an outer diameter of 2 mm, and 18 FR corresponds to a catheter with an outer diameter of 6 mm.

[0023] Indwelling urinary catheter catheters typically are slightly larger in diameter than intermittent urinary catheters. Thus, they are typically from size 12 FR (or CH12) to size 30 FR (or CH30) - corresponding to an outer diameter of 4 mm and 10 mm.

[0024] The urinary catheter described herein is provided with pressure equalising means. The pressure equalising means can be configured for equalising or reducing a pressure difference between the pressure at or in the proximity of the drainage openings of the catheter and the pressure at an outlet from the catheter. The pressure equalising means can be configured to reduce this pressure difference with a predetermined value. As an example, the pressure difference is reduced at least 5 mBar. In a further example, the pressure difference is reduced around 10 mBar, which in this context refers to between 9 and 11 mBar.

[0025] The pressure equalising means can be realised in the form of a vent tube extending from the exterior of the urinary catheter - i.e. outside the body of the user - to a point inside the interior lumen of the tubular portion of the catheter, the point being in the proximity of the drainage openings.

[0026] The pressure equalising means can be realised in the form of a flow channel configured for providing a counter-pressure in the proximity of the drainage openings; the fluid in the flow channel may be in the form of air or liquid.

[0027] The pressure equalising means can be realised in the form of a valve configured to close off the urine drainage path in response to a pressure peak resulting from a blockage (clogging) of the drainage openings.

[0028] In the context of this disclosure, whenever there is a referral to the proximity of the drainage openings, this referral is to a portion of the interior lumen of the tubular portion of the urinary catheter. This portion of the interior lumen is defined as the portion whichextends between 5 mm distally of the distal most point of the exterior edge of the distal most drainage opening and 5 mm proximally of the proximal most point of the exterior edge of the proximal most drainage opening. The proximal most drainage opening may be positioned so close to the proximal end of the interior lumen that the proximal most point of the exterior edge of this proximal drainage opening is less than 5 mm from the proximal end of the interior lumen. In that case, the proximity of the drainage opening is meant to be covering the portion of the lumen which extends to the proximal end of the interior lumen.

[0029] The drainage openings referred to in this disclosure are openings, which extend through the tubular wall and have a closed curved shape as an exterior edge and as an interior edge. They are sometimes also referred to as eyelets. The exterior edge and interior edge may be circular, oval or any other closed curved shape, such as rectangular with rounded corners, star-shaped with rounded points etc.

[0030] Urine flowing from the bladder to the exterior of the urinary catheter is influenced by the difference in pressure in the bladder, P, and the pressure in the ambience (exterior of the catheter) Po. The ambient pressure Po is lower than the pressure in the bladder P. Thus, the pressure in the bladder can be indicated as Po plus the abdominal pressure Pabd:

[0031] P=0 T Pabd

[0032] Pabd is, as mentioned above, typically in the order of 30-50 mBar. During flow of urine from the bladder to the exterior through a urinary catheter, there is a first reduction of pressure at the drainage opening APi and a second reduction of pressure through the catheter, AP2. In some examples described herein, the urinary catheter may be provided with a pressure valve, and in that case, there may in some instances be a third reduction of pressure through the pressure valve, AP3. Finally, the urine leaves the catheter at the ambient pressure, Po. The reduction of pressure through the urinary catheter, AP2, is due to at least two factors. The first factor is the difference in pressure due to the column of liquid (urine) standing in the urinary catheter during flow. The second factor is a resistance to flow due to friction between the urine and the interior surface of the catheter, and this resistance to flow will work against the influence from the water column. However, these two factors together will in the context of this disclosure, be contemplated to provide a reduction of pressure, AP2, which overall contributes to the urine flow through the urinary catheter.During voiding of urine from the bladder a situation may occur, in which the drainage opening(s) of the urinary catheter is blocked by mucosal tissue of the bladder having been sucked towards the drainage opening so as to abut the exterior edge of the drainage opening or even penetrate into the vicinity of the drainage opening. In this situation, the liquid column may still move distally through the urinary catheter and thus provide a rather high sub-pressure at the drainage opening. This sub-pressure has the side-effect of drawing the mucosal tissue in through the drainage opening (provided that the drainage opening has a size allowing this to happen) and provide a (negative) pressure peak. The sub-pressure may have a very short but rather high spike as the drainage opening is closed by the mucosal tissue. It may have a static sub-pressure due to the combination of the abdominal pressure and the sub-pressure arising from the moving liquid column through the lumen. One way of neutralizing the sub-pressure is to move the urinary catheter up and down so as to break the contact between the drainage opening and the mucosal tissue of the bladder. The examples disclosed herein provide pressure equalizing means that will assist in minimizing the problem of stressing the mucosal tissue, for example by lowering the pressure spike and also by lowering the static sub-pressure so as to release the mucosal tissue from the drainage opening.

[0033] Examples relate to the pressure equalising means includes a vent tube. The vent tube connects the interior lumen of the tubular portion in the proximity of the drainage openings with the exterior of the catheter. A vent tube will allow for an equalisation of any subpressure occurring at a proximal portion of the tubular portion of the catheter.

[0034] In examples, the vent tube can be in fluid flow with a valve. The valve can in an example be in a proximal end of the vent tube. The valve can in an example be in the distal end of the vent tube. The valve can be a flap valve, a duckbill valve or any other one-way valve.

[0035] In examples the pressure equalising means includes a connector for a tubular portion of a catheter, the connector comprising a valve in fluid connection with a vent tube. The connector can comprise means for detachably connecting the connector to the tubular portion or the tubular portion and the connector can comprise cooperating means for detachably connecting the connector to the tubular portion. The vent tube can extend proximally beyond the connector and can in examples have a length corresponding largely to the length of the tubular portion. This allows for the vent tube to reach a point in the proximity of the drainage opening. By largely corresponding means that the vent tube has a length which is equal to or 5 % longer or shorter than the tubular portion.Examples relate to the pressure equalizing means including a flow channel with an outlet at a proximal end of the flow channel in the proximity of the drainage openings, and wherein the pressure equalizing means are configured for providing a counter-pressure at the outlet of the flow channel. The counter-pressure can be a result of fluid being pumped or otherwise fed through the flow channel. The fluid can be ambient air or liquid. The pressure equalizing means can further comprise an actuator, which comprises a pump, and at least one pressure sensor. The pressure sensor is advantageously positioned close to a proximal end of the flow channel, such that the sensor senses the pressure at a proximal portion of the tubular portion of the catheter, and thereby as close as possible to determine the pressure at the drainage opening(s), which are positioned in the proximal portion of the catheter. In other examples, the pressure sensor can be positioned at the outlet of the catheter, because the difference between a pressure under regular flow and a pressure flow influenced by partly or fully blockage of the drainage openings will be detectable for the pressure sensor. The pressure equalizing means can further include a chamber configured for holding the fluid, which is to be used in the flow channel, and where the distal end of the flow channel is in fluid flow with this chamber. Alternatively, or additionally, the pressure equalizing means can include a liquid reservoir.

[0036] In examples, the fluid, which is entered into the flow channel of the urinary catheter is ambient air which has passed through a filtering process, such as an antibacterial process. This can be done by providing a filter at the inlet to the flow channel, which is at the distal end of the flow channel. The filter may be a microporous filter, for example made of Tyvek or the like. It can also be hydrophobic or coated with an antibacterial coating. In an example the filter can be an open-celled foam. In case a chamber or a liquid reservoir is used, a filtering process of the fluid can be done at an inlet to the chamber or liquid reservoir.

[0037] Examples relate to the pressure equalising means including a valve configured to close off the urine drainage path in response to a pressure peak occurring in the interior lumen of the urinary catheter, which pressure peak is the result from a blockage (clogging) of the drainage openings. One advantage of this example is that by blocking or partly blocking the outlet of the catheter tubing simultaneously with the blocking of the drainage openings, the urine flow is stopped abruptly. Stopping the urine flow will have the effect of stopping the suction at the mucosal tissue at the drainage openings.In examples, the pressure equalising means includes a pressure valve configured to close off the urine drainage path in response to a pressure peak occurring in the interior lumen. In a related example, the urinary catheter is configured to be provided with pressure equalizing means in the form of separate attachable or connectable pressure valve. The pressure valve may be configured to counteract a pressure peak, which may occur during voiding of urine from the bladder.

[0038] The pressure valve can form part of a connector for a urinary catheter, which is configured to either attach to a urinary catheter or to be permanently attached to a urinary catheter. Alternatively, the pressure valve can be an external unit configured to be attached to a urinary catheter.

[0039] In examples, the tubular portion of the catheter is made of a plastic material, such as Polyvinyl-chloride (PVC), Polyurethane (Pll) or Polyolefin, such as Polyethylene or Polypropylene. Similarly, the vent tube or flow channel may also be provided in any one of these materials. The valves can be provided in silicone or a thermoplastic elastomeric material.

[0040] In an example, the tip portion is a nelaton tip. In an example, the tip portion is a flex tip. By a flex tip is meant that the tip portion comprises a bulb-shaped proximal portion, followed in distal direction by a necked portion and the necked portion transitions over in the tubular portion of the urinary catheter.

[0041] Detailed Description of the Drawing

[0042] Figures 1 and 2 illustrate a prior art catheter 1 sitting in a bladder 10. The bladder is full of urine indicated at 11. The abdominal pressure on the bladder is indicated by the arrows 12. The catheter comprises two rather large drainage openings 2, 3 positioned in a staggered configuration.

[0043] Figure 3 illustrates how the bladder tissue 13 is sucked into the drainage openings due to the abdominal pressure not being equalised. As mentioned above, there are several factors that contribute to establish a pressure difference across the drainage opening(s) and through the catheter. This pressure difference has the upside that it ensures flow through the catheter, but the flipside that it can lead to bladder or urethral tissue being sucked into the drainage openings. In case the tissue is sucked into and through thedrainage openings, the pressure difference may even lead to this bladder / urethral tissue being subjected to large stress and strain.

[0044] Figure 4 illustrates schematically bladder wall tissue 13 comprising the layered tissue with urothelium 14 towards the inside of the bladder, muscle tissue 15 facing outside and connective tissue 16 between those two. If subjected to large stress and strain, the layered tissue may at least partly delaminate and therefore, the layered tissue may be damaged.

[0045] Figure 5 discloses an example of a urinary catheter 100 in a cross-sectional view. The urinary catheter 100 has a proximal portion 101 with a proximal insertion end 102 and a distal outlet portion 103 with a distal end 104. The proximal portion 101 has a number of drainage openings 105 for draining urine from the bladder through the urinary catheter. Only one drainage opening 105 is shown in this cross-sectional view - but more drainage openings may be present in the urinary catheter. The urinary catheter has a tubular portion 106 extending from the proximal portion 101 to the distal outlet portion 103. The tubular portion 106 of the urinary catheter has an interior lumen 107, which comprises a first interior lumen 108 configured for urine flow from the drainage openings 105 to the outlet portion 103 of the urinary catheter.

[0046] The interior lumen 107 further comprises a vent tube 110 with a second interior lumen configured for leading fluid (e.g. air or liquid) into the urinary catheter in a proximity of the drainage openings 105. The vent tube 110 extends from a distal end 111 of the vent tube, which extends distally beyond the distal end 104 of the urinary catheter to a proximal end 112 of the vent tube, which is in the proximity of the drainage openings 105.

[0047] The vent tube 110 is in the illustrated example provided with a first inlet filter 113 in the distal end 111 of the vent tube and a second outlet filter 114 in the proximal end 112 of the vent tube. The first inlet filter 113 and the second outlet filter 114 are provided to reduce the likelihood of contaminating the interior lumen, and potentially the bladder, with bacteria and other potential infectious particles. Therefore, the first inlet filter 113 and the second outlet filter 114 may be provided with a repellent surface, which is able to repel bacteria. It may as an example be in the form of a microporous membrane, for example made of a material such as Tyvek ®.The flow in the catheter is indicated by the arrow 115. In case the drainage opening is suddenly blocked by bladder tissue, the liquid in the catheter may behave like a standing water column, which continues its move towards the distal end 104 of the catheter and thus increase the suction on the bladder tissue. To alleviate or minimise this, the vent tube 110 may be provided with a valve 116, which in the figure is illustrated as a simple flapvalve - the enlargement of the proximal end 112 of the vent tube 110 illustrated in the circle in Fig. 5. The valve 116 is configured to open and allow air to enter into the vent tube 110, once the pressure at the proximal end 112 of the vent tube decreases beyond a threshold limit of the valve 116. The threshold limit can suitably be controlled by a level of flexibility of the flap 117, which in turn is controlled by the material and dimensions of the flap 117.

[0048] An example as illustrated in figure 5 allows for a ventilation of the interior lumen 107. This ventilation will cause an equalising of pressure and thereby allow the urine to resume flowing following a flow-stop. As mentioned above, during a flow-stop, the urine may be in the form of a standing water column, which, as mentioned above, continues its move towards the distal end of the catheter and thus provides a static pressure on the bladder tissue, which is sucked towards the drainage openings 105.

[0049] Figures 6A, 6B illustrate an example of a connector 203, which can be used as a separate outlet portion in connection with a urinary catheter 200 as illustrated in figure 6C. The illustrated connector 203 comprises a valve 216, which is illustrated as a duckbill valve, although other types of valves may also be used. The valve flaps 217 are illustrated in a closed configuration in figure 6A and in an open configuration in figure 6B. The connector 203 includes a vent tube 210 in fluid connection with the valve 216. As illustrated in figure 6A, the vent tube 210 extends proximally beyond the connector, such that it is configured for being inserted into the catheter 200 prior to use - illustrated in dashed lines in figure 6A and 6C. The connector 203 may be detachably attached to the urinary catheter by cooperating means 218, 219, e.g. in the form of threads, bayonet coupling, friction fit of the like. Thus, the user may prior to use insert the vent tube 210 into a urinary catheter 200 and attach the connector 203 to the urinary catheter 200. Thereby the urinary catheter will include a vent tube, which is configured for equalising the pressure, should a flow stop occur as a result of bladder wall tissue being sucked into or abutting a drainage opening 205. Following micturition, the user may detach the connector 203 from the catheter and clean the connector by normal cleaning means and discard the urinary catheter tube 200. The connector 203 does not have to be completely sterile for it to bereusable, because this connector never comes into contact with the tissue of the urethra or the bladder. The connector 203 may therefore be reusable.

[0050] Figure 7 illustrates an example of a urinary catheter 300. In the example illustrated, the urinary catheter 300 has a number of similarities with the urinary catheter shown and described in figure 5. The difference between the two urinary catheters is the second lumen, which in the example in figure 5 is a vent tube 110, and in the example in figure 7 is a flow channel 310 configured for enabling pulsation of a fluid. Other features such as the drainage opening 305 are similar to the drainage opening 105 in figure 5.

[0051] In the example illustrated in figure 7, an actuator 320 is connected to a distal end 311. The actuator 320 comprises a chamber for a fluid 321 and further comprises a pump schematically illustrated at 322, which is integrated in the actuator. The pump 322 may be a small membrane pump, which is well-known in the art of pumps, such as a dosing pump, which is commonly used in laboratories. The pump 322 is configured to react on input from a sensor 323, which is positioned close to a proximal end 312 of the flow channel 310. The sensor 323 reacts to changes in the pressure at the proximal end of the flow channel, and when the pressure reaches a predetermined threshold value, the sensor 323 sends a signal to a controller 324, which is configured to activate the pump 322. The pump 322 will then pump a small amount of fluid, e.g. air or liquid, through the flow channel 310 and out from the outlet 313 at the proximal end 312 of the flow channel and thereby create a counterpressure in the interior lumen 307 of the catheter. This counterpressure will equalise any negative pressure, which may have occurred due to bladder tissue being sucked into or abutting the drainage openings 305. If a liquid is used, then the actuator 320 can be coupled to a liquid reservoir 330, as illustrated in dashed lines in Fig. 7. In case a liquid reservoir 330 is used, then the chamber 321 may be dispensed with.

[0052] Instead of reacting to a signal from sensor 323, the pump 322 can be configured to continuously pulsate a small amount of liquid / air through the flow channel 310. The pulsation may counteract the suction of mucosa towards the drainage opening 305, as each pulse provides a short-term high flow, which is higher (and much shorter in duration) than the inflow through the drainage opening 305. Thus, the change in pressure gradient in the vicinity of the drainage opening, may be impacted more by the pulsating flow than by the suction or inflow through the drainage openings. This will therefore prevent any negative pressure from occurring at the proximal portion of the lumen 307 of the catheter.Figures 8 and 9 illustrate an example of a urinary catheter 400, which comprises pressure equalising means in the form of a pressure valve generally indicated as 430, which is configured to close off the urine draining flow path if a flow-stop occurs at the drainage opening 405. Figure 8 illustrates the urinary catheter 400 with the pressure valve 430 and figure 9 illustrates the urinary catheter 400 with the pressure valve 430 in a situation where it is sitting in a bladder 10. Details of the function of an exemplary pressure valve 430 are illustrated in figures 10A, 10B, 10C and 10D.

[0053] In figure 9, the pressure ratio in the bladder 10, urinary catheter 400 and ambience is illustrated. The pressure in the bladder 10 is indicated as P and the pressure in the ambience is indicated as Po. Furthermore, the figure illustrates APi and AP2, where, as mentioned above, AP1 is a first reduction of pressure at the drainage opening and AP2 is a second reduction of pressure through the catheter. In the example of figures 8 to 10, the urinary catheter is provided with a pressure valve 430 and therefore figure 9 also illustrates a third reduction of pressure through the pressure valve, AP3.

[0054] During normal flow (i.e., undisturbed draining), the urine flows as indicated by the arrows in figures 8, 9, 10A and 10C from the bladder 10, through the drainage opening 405 into the interior lumen 407 of the tubular portion 406 and further through the distal portion 403, which is shown to comprise the pressure valve 430. The urine flows past the open valve element 431 and out through an outlet opening 432 as indicated in fig. 10A and 10C. The valve element 431 may include a closure plate 433 attached to a spring-element 434. As mentioned above, during voiding of the bladder 10, a situation may occur, in which the mucosal tissue of the bladder 10 is sucked towards the drainage opening 405 and it may potentially block the drainage opening and provide a pressure peak in the urinary catheter. This pressure peak may be countered by pressure valve 430, which may either be attached to or attachable to the urinary catheter by known means, such as friction fitted, threaded or bayonet coupling or the like (not shown).

[0055] The pressure valve 430 registers this pressure peak (or flow decrease, or flow stop), for example through a pressure sensor 435, and activates an actuator 436, which, in a construction as illustrated cooperates with closure plate 433 configured for closing an outlet opening 432 (see the plan view of figure 10C) in the connector element. As illustrated in figure 10A and 10B, the closure plate 433 is activated by a membrane 437, which in turn is activated by the actuator 436 and configured to move in a transversal direction of the outlet portion / connector element of the urinary catheter. The cooperationbetween the actuator and the membrane 437 can be established in the form of a rod 438, which is able to translate the movement of the actuator 435 to the membrane 437 as illustrated in figures 8 to 10. The membrane 437 is flexible or at least flexibly attached to the outlet portion as indicated by the suspensions 439a, 439b, and when it is impacted by the rod 438, it will move slightly inwards in the outlet portion and reach the position shown in dashed lines and further as indicated by the arrow in figure 10A. This will cause a shock wave in the urine in that portion of the outlet portion and cause the closure plate 433 to move against the spring-element 434 and close the outlet opening 432 - also indicated by arrows in dashed lines in figure 10A. When the valve-element 431 is closed, the urine flow through the catheter will diminish and eventually stop. This will lead to the pressure inside the catheter increasing again, which in turn will lead to the mucosal tissue being freed from the drainage opening(s) and thus the pressure sensor 435 will no longer detect a negative pressure peak. This will cause the actuator to move backwards (downwards in figures 10A, 10B) and thus release the membrane 437 from being pushed inwards, which allows the membrane to return to its original position - indicated by dashed lines in figures 10B. The movement of the membrane 437 will cause a flow in the urine towards the membrane and thus release the pressure on the closure plate 433. When the pressure on the closure plate 433 is released, the spring-element 434 causes the closure plate 433 to move back to an open position of the valve element (downwards in figures 10A 10B, as indicated by the arrow in figure 10B). The urine will then be able flow through the outlet opening 432 and leave the catheter through the distal opening 440.

[0056] The structure of the outlet portion is in the illustrated example divided into a number of partition walls. The outer wall 450 (Fig. 10B-10D) is traversed by the membrane 437 as illustrated in figures 10A, 10B. Inside the outlet portion, the distal end is partly closed by a first partition wall 451. Furthermore, the structure includes two longitudinally extending partition walls, a second partition wall 452, which extends from the first partition wall 451 and inwards to close off a portion of the outlet portion. A third partition wall 453 extends transversely to the second partition wall 452. In the illustrated example this third partition wall 453 functions as a control for the closure plate 433, so as to ensure that the closure plate 433 moves in the correct direction. A fourth partition wall 454 extends longitudinally from the third partition wall 453 and includes the outlet opening 432. The fourth partition wall 454 connects and closes off the flow-path between the third partition wall 453 and the outer wall 450 (to the right in Figs. 10A-10B). In another example, the second and third partition walls 452, 453 can be dispensed with in the way that the first partition wall 451 and the fourth partition wall 454 are connected.Figure 10C illustrates a cross-sectional top view taken at the line indicated in figure 10A. An outlet opening 432 for letting urine out of the outlet portion is shown in figure 10C. This outlet is illustrated as an elliptical opening in the fourth partition wall 454; however, it might as well be square or rectangular or any other closed shape. Figure 10D illustrates an outlet portion seen from the distal end. In figure 10D, the first partition wall 451 is illustrated seen from the side and the second partition wall 452 is illustrated in crosssection. In dashed lines, the third partition wall 453, the fourth partition wall 454 and the outlet opening 432 are illustrated.

[0057] Embodiments, and features of the various exemplary embodiments described in this application, may be combined with each other (“mixed and matched”), unless specifically noted otherwise.

Claims

Claims1. A urinary catheter comprising- a tip portion in a proximal insertion portion of the urinary catheter,- a tubular portion extending from the tip portion and longitudinally to a distal end of the tubular portion, the tubular portion comprising a wall defining an exterior surface and an interior surface defining an interior lumen,- drainage openings provided in the tubular portion and traversing the wall providing fluid communication through the wall from the exterior surface to the interior lumen, each drainage opening being provided with an exterior edge at the exterior surface and an interior edge at the interior lumen and a drainage opening wall extending from the exterior edge to the interior edge, - wherein the urinary catheter further comprises pressure equalising means.

2. The urinary catheter as claimed in claim 1, wherein the pressure equalising means are configured for reducing a pressure differential in the interior lumen such that the difference between a first pressure at a proximal end of the catheter and a second pressure at a distal end of the catheter can be reduced at least 5 mBar.

3. The urinary catheter as claimed in claim 2, wherein the difference between a first pressure at a proximal end of the catheter and a second pressure at a distal end of the catheter can be reduced 10 mBar.

4. The urinary catheter as claimed in any of the preceding claims wherein the pressure equalising means comprises a vent tube extending from a proximal portion of the tubular portion of the catheter to, or beyond, a distal portion of the tubular portion of the catheter.

5. The urinary catheter as claimed in claim 4, wherein the vent tube is in fluid flow with a valve in either the proximal end or the distal end of the vent tube - or in both the proximal and distal end.

6. The urinary catheter as claimed in any of the preceding claims, wherein the pressure equalising means comprises a connector for a tubular portion of a catheter, the connector comprising a valve in fluid connection with a vent tube.

7. The urinary catheter as claimed in claim 6, wherein the vent tube extends proximally beyond the connector and wherein the vent tube has a length corresponding to the length of the tubular portion.

8. The urinary catheter as claimed in any of the preceding claims, wherein the pressure equalizing means comprises a flow channel with an outlet in the proximity of the drainage openings, and wherein the pressure equalizing means are configured for providing a counter-pressure at the outlet of the flow channel.

9. The urinary catheter as claimed in claim 8, wherein the counter-pressure is a result of fluid being fed through the flow channel to the outlet of the flow channel.

10. The urinary catheter as claimed in claim 9, wherein the fluid, which is entered into the flow channel is ambient air which has passed through a filtering or antibacterial process.

11. The urinary catheter as claimed in any of claims 8 to 10, wherein the pressure equalizing means further comprises a chamber configured for holding the fluid and where the distal end of the flow channel is in fluid flow with the chamber.

12. The urinary catheter as claimed in any of claim 8 to 10, wherein the pressure equalizing means further comprises a liquid reservoir.

13. The urinary catheter as claimed in any of the preceding claims, wherein the pressure equalising means comprises a valve configured to close off the urine drainage path in response to a pressure peak occurring in the interior lumen.

14. The urinary catheter as claimed in any of the preceding claims, wherein the pressure equalizing means further comprises an actuator, which comprises a pump, and at least one pressure sensor.

15. A connector for a urinary catheter comprising pressure equalising means comprising a valve.

16. The connector as claimed in claim 15, wherein the connector further comprises a vent tube in fluid communication with the valve.

17. The connector as claimed in any of claims 15 or 16, wherein the valve is configured to close off the urine drainage path in response to a pressure peak resulting from a blockage of the drainage openings.

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