catheter

Abstract

An intermittent hydrophilic urinary catheter defining a drainage conduit extending in a longitudinal direction from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for draining urine from the drainage conduit, the urinary catheter comprising a tube having a tubular wall made of a base material and defining an inner surface facing the drainage conduit and an opposite outer surface facing away from the drainage conduit, at least an insertable portion of the outer surface being covered by a layer of a hydrophilic material configured to change from a non-swollen state to a swollen state by contact with a swelling medium, the hydrophilic material defining a hydrophilic surface of the urinary catheter on the outer surface in a coating thickness, the urinary catheter comprising a plurality of drainage openings, each drainage opening being defined by a drainage opening wall extending between an outlet opening in the inner surface and an inlet opening in the outer surface, the drainage opening wall not being covered by the hydrophilic material.

Description

[0001] The present application is a divisional application of the application patent application with the title "Catheter", international application date 7 February 2020, international application number PCT / DK2020 / 050032, national application number 202080012934.0. TECHNICAL FIELD

[0002] The present disclosure relates to an intermittent hydrophilic catheter, a method of using such a catheter and a method of manufacturing such a catheter. BACKGROUND

[0003] Prior art catheters suffer from various problems, e.g. the drainage openings can be obstructed by bladder wall tissue, the bladder will not be completely emptied during catheterization. SUMMARY

[0004] The present invention provides an intermittent catheter, the intermittent hydrophilic catheter defining a drainage conduit extending in a longitudinal direction from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for draining urine from the drainage conduit, the catheter comprising a tube having a tubular wall made of a base material and defining an inner surface facing the drainage conduit and an opposite outer surface facing away from the drainage conduit, wherein at least an insertable portion of the outer surface is covered by a layer of a hydrophilic material configured to change from a non-swollen state to a swollen state by contact with a swelling medium, the hydrophilic material defining a hydrophilic surface of the catheter on the outer surface in a coating thickness, and wherein the catheter comprises a plurality of drainage openings, each drainage opening being defined by a drainage opening wall extending between an outlet opening in the inner surface and an inlet opening in the outer surface, wherein the drainage opening wall is not covered by the hydrophilic material. BRIEF DESCRIPTION OF DRAWINGS

[0005] The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute 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.

[0006] Figures 1-4 A problem that can occur with prior art intermittent catheters is illustrated.

[0007] Figure 5 An embodiment of an intermittent catheter with a plurality of small drainage openings is illustrated; the catheter is illustrated in a perspective view.

[0008] Figure 6 、 Figure 7 、 Figure 8 、 Figure 9A and Figure 9B shows the function of an embodiment of an intermittent urinary catheter.

[0009] Figure 10 shows a magnified view of a cross section of a portion of the catheter indicating the longitudinal direction along the center line CA.

[0010] Figures 11-12 shows a further magnified view at the discharge opening 5.

[0011] Figures 13-14 shows a protrusion around an opening in the outer surface.

[0012] Figure 15 、 Figure 16A and Figure 16B shows an embodiment of an intermittent urinary catheter.

[0013] Figures 17-19 shows the positioning of the laser emitter according to an embodiment of the method of manufacturing a catheter.

[0014] Figures 20-22 shows the positioning of the laser emitter according to an embodiment of the method of manufacturing a catheter.

[0015] Figures 23-25 shows the positioning of the laser emitter according to an embodiment of the method of manufacturing a catheter.

[0016] Figures 26-28 shows the size of the pressure pulse in an intermittent urinary catheter.

[0017] Figure 29A 、 Figure 29B 、 Figure 30 and Figure 31 shows the pressure pulse as a function of the size of the discharge opening.

[0018] Figures 32-34 shows a test device for determining the pressure pulse in an intermittent urinary catheter.

[0019] Figure 35 shows the flow rate curve as a function of the total inflow area. DETAILED DESCRIPTION

[0020] Embodiments of the present disclosure provide an intermittent hydrophilic urinary catheter defining a drainage conduit extending in a longitudinal direction from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for draining urine from the drainage conduit, the catheter comprising a tubular portion having a tubular wall made of a base material and defining an inner surface facing the drainage conduit and an opposite outer surface facing away from the drainage conduit, wherein at least an insertable portion of the outer surface is covered by a layer of a hydrophilic material configured to swell by contact with a swelling medium, the hydrophilic material defining a hydrophilic surface of the catheter on the outer surface in a coating thickness, and wherein the catheter comprises a plurality of drainage openings, each drainage opening being defined by a drainage opening wall extending between an inner opening in the inner surface and an outer opening in the outer surface, wherein the drainage openings are made by laser ablation of the hydrophilic material and the base material such that the drainage opening walls are not covered by the hydrophilic material.

[0021] As the drainage openings of these embodiments are made by laser ablation of the base material covered by the hydrophilic material, the base material as well as the hydrophilic material is removed at the drainage openings. Thus, there will be no residue of the hydrophilic material at the drainage opening walls. In other words, the drainage opening walls are free of the hydrophilic material. This has the effect that the drainage openings can have a very small size and are not blocked by the hydrophilic material when it swells.

[0022] Embodiments of the present disclosure provide an intermittent urinary catheter defining a drainage conduit extending along a central axis from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for draining urine from the drainage conduit, the catheter comprising a plurality of drainage openings, each drainage opening extending along a centerline from an inner opening into the drainage conduit to an outer opening in an outer surface, wherein at least two drainage openings have centerlines intersecting at an intersection point outside the drainage conduit.

[0023] These embodiments have the effect that a fluid flow from a single point in the bladder can flow linearly through more than one drainage opening into the drainage conduit. This can potentially provide improved flow characteristics and can also reduce the risk of blockage.

[0024] Embodiments of the present disclosure provide an intermittent urinary catheter defining a discharge conduit extending along a central axis from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for discharging urine from the discharge conduit, the catheter comprising a plurality of discharge openings each extending along a respective center line from an inner surface towards the discharge conduit to an outer surface facing away from the discharge conduit, wherein the discharge openings are formed in pairs such that a pair of discharge openings comprises a first discharge opening and a second discharge opening having the same center line.

[0025] The discharge openings are arranged on opposite sides of the central axis. This has the effect that if the first discharge opening of the pair of discharge openings is biased against the urinary canal wall, the likelihood of the second discharge opening not being in contact with the other side of the urinary canal increases, thus providing a freer flow of urine into the discharge conduit.

[0026] Embodiments of the present disclosure provide an intermittent hydrophilic urinary catheter defining a discharge conduit extending in a longitudinal direction from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for discharging urine from the discharge conduit, the catheter comprising a tubular portion having a tubular wall made of a base material and defining an inner surface facing towards the discharge conduit and an outer surface facing away from the discharge conduit, wherein at least an insertable portion of the outer surface is covered by a layer of a hydrophilic material configured to swell by contact with a swelling medium, the hydrophilic material defining a hydrophilic surface of the catheter at the outer surface at a coating thickness, and wherein the catheter comprises a plurality of discharge openings extending between an inner opening in the inner surface and an outer opening in the outer surface, and wherein the outer surface forms a protrusion surrounding the outer opening in the outer surface and extending above the hydrophilic surface when the hydrophilic material is in a non-swollen state.

[0027] The protrusions typically extend in a radial direction.

[0028] These embodiments have the effect that the risk of the hydrophilic material being displaced to a position where it covers the discharge openings is further limited as it has to pass over the protrusion.

[0029] During insertion of the urinary catheter, tissue in the urethra can collapse into the discharge opening. Providing a protrusion around the discharge opening can have the effect that during movement of the catheter in the urethra, the tissue is lifted over the discharge opening. Thus, the protrusion can reduce the risk of abrasions when the catheter slides along the tissue during insertion and removal.

[0030] The size of the protrusions and the thickness of the layer of hydrophilic material can be chosen such that the hydrophilic material extends over the protrusions when the hydrophilic material swells. As the hydrophilic material extends over the protrusions when the hydrophilic material swells, the tissue is protected by the hydrophilic material during catheter insertion and removal, and the risk of the tissue being scratched by the protrusions is reduced.

[0031] Embodiments of the present disclosure have the effect of providing an intermittent urinary catheter with significantly reduced risk of affecting the bladder wall and urethral tissue during intermittent catheterization. Furthermore, the catheterization procedure to empty the bladder will be easier, without the need to reposition the catheter, making it more likely that the bladder will be emptied to a satisfactory level at each catheterization.

[0032] During intermittent catheterization and emptying of the bladder, the bladder contracts and eventually the bladder wall will approach the catheter. The pressure difference between the bladder and the external environment causes urine to flow from the bladder through the catheter. If all the drainage openings in the intermittent urinary catheter are suddenly blocked by bladder wall tissue, a negative pressure pulse will be created in the catheter as the moving water column of urine in the catheter suddenly stops. This negative pressure will suddenly suck the tissue towards the drainage openings and, if this negative pressure remains, it can even be sucked into the inner lumen of the catheter. In the context of the present disclosure, this phenomenon will be referred to as occlusion. The suction can affect the bladder wall tissue. The size of the negative pressure depends, among other things, on the suddenness of the occlusion of the drainage openings and the flow rate. If the catheter is a prior art intermittent catheter, such as a catheter that is normally provided with two drainage openings, it is possible that one of the drainage openings is occluded by bladder wall tissue, which can only result in a limited negative pressure pulse, but if / when the second and last drainage opening is also occluded by bladder wall tissue, the flow of urine through the catheter is suddenly interrupted, resulting in a clear negative pressure pulse in the catheter. This results in the tissue in the vicinity of the drainage openings being sucked through the drainage openings into the inner lumen of the catheter. The occurrence of this negative pressure pulse sucking bladder tissue into the drainage openings can be the bladder compression feeling that some catheter users feel.

[0033] In contrast to these disadvantages of commonly available catheters, the present disclosure provides an intermittent urinary catheter that uses multiple drainage openings that prevent the possibility of all drainage openings closing abruptly at the same time, thereby eliminating the occurrence of a negative pressure pulse drawing bladder wall tissue towards and into the drainage openings. The multiple drainage openings described herein ensure that when contact between the bladder wall and the catheter occurs during urination, potential obstruction of the drainage openings occurs gradually. Additionally, if the drainage openings are small in size, there is the further advantage that when the last of all the drainage openings is obstructed by bladder wall tissue at the point of complete urination (no residual urine in the bladder), the reduced flow of urine through that last opening to be obstructed to the sudden closure of that last opening only causes a level of negative pressure pulse occurrence that is small.

[0034] During use of prior art intermittent catheters, it is possible for bladder wall tissue to obstruct the drainage openings, which can be caused by the suction flow into the drainage openings drawing bladder wall tissue towards the drainage openings, as described above. As demonstrated in the tests described below and illustrated in the accompanying drawings relating to prior art catheters, a large amount of bladder wall tissue can enter the inner lumen of the catheter and become trapped in the drainage openings due to the suction of the bladder tissue. It is thought that this is because the negative pressure pulse causes the drainage openings to become blocked as described above, and once the drainage openings are blocked, the pressure differential between the bladder wall and the inner lumen pressure gradually deforms the bladder wall so that it enters the drainage openings. If the blockage of the drainage openings significantly or completely reduces urine flow, the user can attempt to move the catheter up or down or rotate the catheter in order to reposition the drainage openings to regain flow. The user can also withdraw the catheter if it is believed that the bladder is empty because urine flow has stopped. The risk of bladder wall tissue being affected by movement of the catheter can be reduced by preventing bladder wall tissue from becoming trapped in the drainage openings.

[0035] As described above, contact between the bladder wall and the drainage openings of prior art catheters can cause bladder wall tissue to obstruct the drainage openings and thereby reduce or completely stop urine flow. Improper obstruction of the drainage openings of an intermittent catheter can cause the user to withdraw the catheter if it is believed that the bladder is empty because flow has stopped or has been significantly reduced. If the catheter user prematurely abandons the urination procedure for this reason, residual urine can remain in the bladder. The intermittent catheter with multiple small drainage openings according to the present disclosure prevents premature obstruction of the drainage openings, thereby ensuring urine flow until the bladder is empty. Thus, the intermittent catheter with multiple drainage openings as disclosed herein ensures that the catheter user is not falsely led to believe that the bladder is empty and therefore prematurely terminate the urination process, resulting in residual urine remaining in the bladder.

[0036] In the following, whenever the proximal end of an element of the disclosure is mentioned, it refers to the end that is adapted for insertion. Whenever the distal end of an element is mentioned, it refers to the end opposite the insertion end. In other words, the proximal end is the end that is closest to the user when the catheter is to be inserted, while the distal end is the opposite end, i.e. the end that is farthest from the user when the catheter is to be inserted.

[0037] The longitudinal direction is the direction from the distal end to the proximal end. The transversal direction is the direction perpendicular to the longitudinal direction, which direction corresponds to the direction across the catheter.

[0038] The intermittent urinary catheter according to the disclosure comprises a tubular portion extending from a tip portion in a proximal insertion end to a distal outlet end to a proximal end. The tubular portion can be cylindrical or conical. In embodiments, the tubular portion has an elliptical cross-section. The tubular portion is configured for providing urine flow through the intermittent catheter from the discharge portion to the distal end. A closed tip portion having a closed tip is positioned at the proximal end of the catheter and is provided as a rounded closed end of the tube constituting the main tubular portion of the catheter. The discharge portion of the tubular portion will typically be in a proximal portion of the tubular portion. In embodiments, the discharge portion comprises a plurality of discharge openings to provide for urine flow between the exterior of the catheter and the inner lumen of the tubular portion. In embodiments, the discharge portion is longer than the typical flow zone on prior art catheters, wherein the flow zone is defined as the length from the distal edge of the distal eyelet to the proximal edge of the proximal eyelet. In embodiments, the intermittent catheter comprises a connector at the distal end. In embodiments, the connector comprises a flared end of the catheter such that the diameter of the connector is increased relative to the tubular portion. In embodiments, the intermittent catheter comprises a handle at the distal end, the handle having a length allowing a user to manipulate the catheter.

[0039] Typically, the intermittent urinary catheter is from size 8 FR to size 18 FR. FR (or French size or Charriere (Ch)) is a standard gauge of catheters, which roughly corresponds to the outer circumference in mm. More precisely, the outer diameter of the catheter in mm corresponds to the FR divided by 3. Thus 8 FR corresponds to a catheter having an outer diameter of 2.7 mm and 18 FR corresponds to a catheter having an outer diameter of 6 mm.

[0040] The hydrophilic coating can be provided only on the insertable portion of the catheter. The hydrophilic surface coating is a type of surface coating that reduces friction on the surface area of the catheter intended to be inserted into the lower urinary tract of a user corresponding to the insertable portion of the catheter when hydration or swelling with a swelling medium is performed.

[0041] Intermittent hydrophilic catheters differ from indwelling catheters in that the hydrophilic surface coating of such catheters is not suitable for indwelling use, as the surface coating tends to stick inside the urethral mucosa if left in the body for a period of more than 5-20 minutes, due to the transition of the hydrophilic coating from a highly slippery when fully wet (95% by weight of water) to a sticky when the hydration level of the coating is reduced (<75% by weight of water).

[0042] The catheter can have a closed tip at the proximal insertion end, and in particular it can have a plurality of discharge openings distributed over a portion of the catheter located in the vicinity of the closed tip, e.g. constituting half or a third of the entire length of the catheter measured from the proximal end to the distal end.

[0043] The discharge openings described herein are sometimes referred to as eyelets or eyes in the art. These discharge openings have a closed loop perimeter, and can be circular, oval, square, triangular, and any other closed loop shape. Such closed loop shape defines an outer opening of the discharge opening. The inner opening of the discharge opening will also have a closed loop perimeter, and typically (but not necessarily) will have the same shape as the outer opening of the discharge opening.

[0044] The catheter can have at least 12 discharge openings, and the discharge openings can in particular be arranged in one or more groups, e.g. in straight rows extending in the longitudinal direction. The discharge openings can also be arranged in groups such that the density of discharge openings between groups is different.

[0045] Each discharge opening can be defined by a wall extending from an inner opening in an inner surface of the discharge conduit to an outer opening in an outer surface of the discharge conduit. The discharge opening wall can thus have a height corresponding to the distance between the inner surface and the outer surface of the tubular portion of the catheter. The discharge opening wall can in particular extend continuously between the inner surface and the outer surface. The inner opening can also be referred to as an outlet opening and the outer opening can also be referred to as an inlet opening.

[0046] The tubular wall of the tube can have a uniform wall thickness, thereby providing a uniform length of the discharge openings.

[0047] The tubular portion has a uniform outer surface, thereby enabling uniform bonding with the hydrophilic material. Furthermore, the risk of displacement of the hydrophilic material and thus potentially clogging of the discharge openings is minimized.

[0048] An embodiment relates to a catheter provided with a closed tip at the proximal insertion end. The closed tip can be formed as a Nelaton tip, a flexible tip, or generally as a known type of tip for a urinary catheter.

[0049] In the context of the present disclosure, the body lumen refers to the urethra.

[0050] The conduit can define a non-draining portion distal of the tip and a draining portion distal of the non-draining portion, the draining portion being provided with the plurality of draining openings. The non-draining portion may, for example, constitute less than 3 cm or less than 2 cm or less than 1 cm, and the draining portion can constitute less than 20 cm or less than 15 cm or less than 10 cm.

[0051] The inflow of urine through the plurality of draining openings depends on the sum of the cross-sectional areas of all draining openings (total inflow area) and the pressure gradient between the draining openings and the conduit outlet at the distal end, as explained above. The sum of the cross-sectional areas of the plurality of draining openings (total inflow area) must be sufficiently large to provide a sufficient inflow of urine, otherwise emptying the bladder will take a long time and thus be inconvenient for the user of the intermittent catheter. Each draining opening provides a certain resistance to the inflow of urine, which resistance depends, inter alia, on the cross-sectional area of the draining opening and the thickness of the conduit material at the draining opening, i.e. the extension of the draining opening wall from the inner opening to the outer opening.

[0052] Embodiments relate to the sum of the cross-sectional areas of the plurality of draining openings being larger than the cross-sectional area of the draining conduit of the catheter just distal of the draining openings. Just distal of the draining openings means within 5 mm in the longitudinal distal direction from the most distal draining opening.

[0053] Embodiments relate to the tubular portion defining a convex outer surface, and wherein the total inflow area of the draining openings in the convex outer surface of the tubular portion is larger than the cross-sectional area of the draining conduit of the catheter in a cross-section perpendicular to the longitudinal direction of the tubular portion at a location distal of the draining openings.

[0054] In embodiments, the sum of the cross-sectional areas of the plurality of draining openings (total inflow area) is more than twice the cross-sectional area of the inner lumen of the catheter just distal of the draining openings. The total inflow area of the draining openings is provided in the convex outer surface of the tubular portion. Providing such a large total inflow area ensures that the flow resistance at the draining openings will not impede the filling of the draining conduit of the catheter. Thus, the inflow through the draining openings into the draining conduit does not limit the flow through the intermittent catheter.

[0055] Further embodiments relate to the sum of the cross-sectional areas of the plurality of draining openings (total inflow area) being at least three times larger than the cross-sectional area of the draining conduit of the catheter.

[0056] Embodiments in which the total inflow area in the convex outer surface of the tubular portion is at least equal to or larger than the cross-sectional area of the discharge conduit of the tubular portion can relate to catheters having a cylindrical tubular portion. In this case, the cross-sectional area of the discharge conduit is constant over the length of the catheter. However, these embodiments can also relate to catheters having a conical tubular portion. In this case, the cross-sectional area increases along the length. In this case, the total inflow area should be compared to the cross-sectional area of the discharge conduit just distal of the most distal discharge opening, i.e. within 5 mm in the distal direction of the most distal discharge opening.

[0057] Embodiments relate to a number of discharge openings that is higher than the number required to fill the discharge conduit distal of said discharge openings. It will be understood that depending on the size of the individual discharge openings, a certain number of discharge openings is required to provide a total inflow area that corresponds to the cross-sectional area of the discharge conduit distal of the discharge openings. In the present disclosure, this number of discharge openings is referred to as a first predetermined discharge opening number. Embodiments thus relate to a number of discharge openings that is higher than the first predetermined discharge opening number.

[0058] Embodiments relate to a catheter as defined above and provided with a number of discharge openings configured for providing a total inflow area that exceeds the cross-sectional area of the discharge conduit in the catheter distal of the most distal discharge opening.

[0059] When the total inflow area exceeds the cross-sectional area of the discharge conduit of the catheter or the number of discharge openings is higher than the number required to fill the discharge conduit, then it is ensured that at least one discharge opening is always available to provide inflow. This is because the amount of inflow is less than the discharge opening is capable of discharging - thus, if another discharge opening is simultaneously obstructed by bladder tissue, at least one discharge opening will be able to provide further inflow. This means that the flow through the catheter will continue until the bladder is empty. Thus, the risk of residual urine being left in the bladder is greatly reduced.

[0060] In the context of the present disclosure, pressure refers to partial pressure, not absolute pressure. This means that pressure is always indicated as the pressure difference between the point of measurement and ambient pressure.

[0061] In embodiments, the maximum dimension of the individual discharge openings in the convex outer surface of the tubular portion is less than 1 mm. Maximum dimension refers to the diameter in the case of circular discharge openings, the major axis in the case of elliptical openings, the diagonal in the case of rectangular or square openings, etc. In other words, maximum dimension refers to the largest dimension across the opening between two oppositely located points on the perimeter of the opening at the convex outer surface of the tubular portion. In related embodiments, each discharge opening has a cross-sectional area of less than 0.8 mm 2 .

[0062] Thus, it is ensured that a negative pressure of no more than 50 mBar can occur when measuring at 10 cm H2O, thus significantly reducing the impact on the bladder wall tissue compared to prior art catheters having a small number, such as two, large drainage openings.

[0063] In embodiments, the largest dimension of any single drainage opening in the convex outer surface of the tubular portion is less than 0.7 mm. In related embodiments, the cross-sectional area of each single drainage opening is less than 0.4 mm 2 Thus, it is ensured that a negative pressure of no more than 40 mBar can occur when measuring at 10 cm H2O.

[0064] In embodiments, the largest dimension of any single drainage opening in the convex outer surface of the tubular portion is less than 0.5 mm. In related embodiments, the cross-sectional area of each single drainage opening is less than 0.2 mm 2 .

[0065] In embodiments, the number of drainage openings exceeds 20.

[0066] Thus, the likelihood of all drainage openings being clogged at the same time is significantly reduced.

[0067] In embodiments, the number of drainage openings can be significantly higher, for example exceeding 200 or even about 260 drainage openings. The number can also be around 100, 120 or 150, or close to 200, such as 180.

[0068] Embodiments relate to an intermittent urinary catheter, wherein the catheter is a CH10, the largest dimension of each drainage opening in the convex outer surface of the tubular portion is about 0.4 mm, and the number of drainage openings is greater than 32. Such a catheter provides sufficient inflow into the catheter lumen so that each drainage opening contributes to the drainage, but at least one drainage opening remains open at all times. About 0.4 mm means between 0.35 and 0.45 mm.

[0069] Other embodiments relate to an intermittent urinary catheter, wherein the catheter is a CH12, the largest dimension of each drainage opening in the convex outer surface of the tubular portion is about 0.7 mm, and the number of drainage openings is greater than 15. About 0.7 mm means between 0.65 and 0.75 mm.

[0070] Embodiments relate to an intermittent urinary catheter as claimed in any of the preceding claims, wherein each of the drainage openings extends transversely to the longitudinal direction of the catheter. Transversely extending means that the central axis of the drainage opening is substantially perpendicular to the longitudinal axis of the catheter, i.e. within 20 degrees in either direction.

[0071] In embodiments, the draining portion has a length in the longitudinal direction of the intermittent catheter of 4 cm. This provides a good emptying of the bladder. The draining portion is positioned distally of the closed tip portion, so if the closed tip portion is less than 2 cm in the longitudinal direction, the draining portion is within 6 cm of the most proximal of the catheter. This is a common insertion length of intermittent catheters in the bladder - so positioning the draining portion within the bladder provides for a large cross-sectional area of the plurality of draining openings to be located within the bladder, providing for a good and fast draining of the bladder. A draining portion of about 4 cm can be used for male catheters and female catheters. About 4 cm means between 35 mm and 45 mm, such as 40 mm, 37 mm or 42 mm.

[0072] In embodiments, the draining portion has a length in the longitudinal direction of the intermittent catheter of 10 cm. This provides an enhanced safety for emptying the bladder, as the draining openings will be positioned at the lower part of the bladder, at the bladder neck. Typically, an intermittent catheter will be inserted 5-6 cm into the urethra, so in these embodiments the draining portion will extend into a part of the urethra and be located in the bladder. A catheter with a draining portion of 10 cm or more is particularly useful for male catheters. Other embodiments relate to a length of the draining portion of about 8 cm, i.e. between 75 mm and 85 mm, such as 77 mm, 80 mm or 82 mm.

[0073] In embodiments, the draining portion has a length in the longitudinal direction of the intermittent catheter of 15 cm. This provides an enhanced safety for emptying the bladder. This is particularly beneficial for users who tend to insert their intermittent catheter too far into the bladder, which can be because they do not feel during insertion of the catheter.

[0074] Embodiments relate to a length of the draining portion of about 2 cm, i.e. between 15 mm and 25 mm. Such a short draining portion is particularly useful for female catheters, where the urethra is relatively short. The short draining portion reduces the risk of urine flowing out through the draining openings, in case some of the draining openings are located outside the urethra.

[0075] In embodiments, the draining openings are positioned in a dispersed manner along the longitudinal direction and around the circumference of the catheter.

[0076] In embodiments, the draining openings are positioned in four longitudinal rows, with 90 degrees between them around the circumference.

[0077] In embodiments, the draining openings are positioned in six longitudinal rows, with 60 degrees between them around the circumference.

[0078] In embodiments, the draining openings are positioned in eight longitudinal rows, with 45 degrees between them around the circumference.

[0079] In embodiments, the discharge openings are positioned in two longitudinal rows with 180 degrees between them around the circumference.

[0080] In embodiments, the discharge openings are positioned in two pairs of parallel rows with 180 degrees between the rows around the circumference.

[0081] In embodiments, the discharge openings are spirally spread out around the circumference.

[0082] The increased number of directions provides for better inflow and reduces the risk of the bladder tissue obstructing contact with all discharge openings.

[0083] In embodiments, the tip portion of the catheter is a nelaton tip, where the proximal end is simply closed to provide a hemispherical closed end.

[0084] The tip portion can be integrally formed with the main tubular portion (either as a 1 -piece or 2-piece formation), or can be provided as a separate element and then attached to the main tubular portion, e.g. by welding or adhesion.

[0085] In embodiments, the tip portion is a flex tip. In this type of embodiments, the catheter tip, starting from the distal end of the tip portion, comprises a discharge portion having discharge openings for urine to enter into the inner lumen of the catheter, an intermediate portion where the diameter of the catheter is reduced relative to the diameter of the rest of the catheter, and a proximal portion having a bulb with a diameter close to or exceeding the diameter of the tubular portion of the catheter. The bulb can also have a diameter slightly smaller than the diameter of the tubular portion of the catheter. The shape of the bulb can be close to spherical, or can be slightly elongated and shaped as an olive or a droplet. This type of tip portion can be useful for male users to guide the catheter around the bend in the urethra at the prostate.

[0086] The base material can be a polyurethane material (PU) or a polyvinyl chloride (PVC) or a polyolefin such as polyethylene (PE). Other materials can be silicone material, latex material, styrene block copolymer, TPS (TPE-s) (thermoplastic elastomer material), thermoplastic vulcanizate, TPV, thermoplastic copolyester, TPC (TPE-E), thermoplastic polyamide, TPA (TPE-A). The base material can also be referred to as the base material. The hydrophilic material can be polyvinylpyrrolidone (PVP) and copolymer.

[0087] The discharge openings can be formed in pairs, such that a pair of discharge openings comprises a first discharge opening and a second discharge opening having the same centre line.

[0088] Embodiments relate to the pair of discharge openings being positioned at an oblique angle relative to the longitudinal axis. Embodiments relate to the pair of discharge openings being positioned at an angle between 80 degrees and 87 degrees relative to the longitudinal axis, such as an angle between 85 degrees and 87 degrees.

[0089] The discharge openings can be shaped such that the walls of the first discharge opening converge in a direction from the outer opening to the inner opening, and the walls of the second discharge opening diverge in a direction from the outer opening to the inner opening.

[0090] Converging herein refers to the distance between the wall portions on opposite sides of the centerline decreasing in a direction from the outer surface to the inner surface. In other words, the area of the outer opening is larger than the area of the inner opening. Diverging herein refers to the distance between the wall portions on opposite sides of the centerline increasing in a direction from the outer surface to the inner surface. In other words, the area of the outer opening is smaller than the area of the inner opening.

[0091] If the discharge openings are circular, the discharge opening walls can have a truncated cone shape. In this context, the shape is referred to as truncated cone shaped to indicate that the cross-section of the discharge opening does not have to be circular.

[0092] The converging and diverging walls of the discharge openings provide different flow characteristics through the first and second discharge openings, and increase the likelihood that one of the two discharge openings opens up in case the other is blocked. The specific characteristic shape of the diverging and converging walls is such that for one of the discharge openings, the outer opening in the outer surface is larger than the inner opening in the inner surface, and for the other of the pair of discharge openings, the opposite is the case. Thus, preventing tissue from coming into contact with the relatively larger opening can not prevent flow through the relatively smaller opening, and vice versa.

[0093] The first and second discharge openings can have different dimensions. That is, the dimensions of the first discharge opening in a cross-section transverse to the centerline can be different from the dimensions of the second discharge opening, in particular when comparing the dimensions in a cross-section having the same distance to the inner and outer surfaces.

[0094] The coating thickness can decrease towards each of the inlet openings in the outer surface, thereby reducing the risk of blocking flow through the inlet openings when the hydrophilic material swells. This means that the coating in the area between the discharge openings is thicker than the coating in the area close to the discharge openings. Close to the discharge openings refers to within a distance of 0.5 mm from the edge of the discharge openings.

[0095] The tubular portion has a uniform outer surface, thereby enabling uniform bonding with the hydrophilic material, and further avoiding displacement of the hydrophilic material and thus potential blocking of the discharge openings.

[0096] The present disclosure provides manufacturing methods. For example, laser ablation can be performed using a CO2 laser.

[0097] The present disclosure provides a method of manufacturing a hydrophilic urinary catheter, the method comprising: providing a tube by extruding a base material through a die defining a tubular shape having an inner surface facing towards a drainage conduit and an opposite outer surface facing away from the drainage conduit; coating the outer surface with a hydrophilic material to define a hydrophilic surface; and providing a plurality of drainage openings from the outer surface to the inner surface by laser ablation of the hydrophilic material and the base material, such that drainage opening walls extending between the inner surface and the outer surface are uncoated. Thus, laser ablation is used not only to establish the drainage openings, but also to remove the hydrophilic material, thereby reducing the risk of the hydrophilic material obstructing the drainage openings.

[0098] The present disclosure further provides a method of manufacturing a hydrophilic urinary catheter. According to this method, a tube is provided by extruding a base material through a die defining a tubular shape having an inner surface facing towards a drainage conduit and an opposite outer surface facing away from the drainage conduit. The outer surface is coated with a hydrophilic material to define a hydrophilic surface, and subsequently, i.e. after coating the outer surface, a plurality of drainage openings are provided from the outer surface to the inner surface by laser ablation of the hydrophilic material and the base material, such that drainage opening walls extending between the inner surface and the outer surface are uncoated.

[0099] With this process, the hydrophilic material in the drainage openings is avoided without increasing manufacturing complexity, and thus the method provides a simple way of producing catheters with improved quality and potentially without increasing manufacturing costs.

[0100] Embodiments relate to a method of manufacturing an intermittent urinary catheter, the method comprising: providing a tube made of a base material and defining a tubular shape having an inner surface facing towards an internal drainage conduit and an opposite outer surface facing away from the internal drainage conduit; and providing a plurality of drainage openings extending between internal openings in the inner surface and external openings in the outer surface by laser ablation of the base material, wherein the laser ablation is performed with a laser emitted from an emitter point outside the drainage conduit at a certain emission angle, such that a first group of drainage openings is provided with a first emission angle and a second group of drainage openings is provided with a second emission angle.

[0101] The method can provide an efficient way of manufacturing allowing for manufacturing a plurality of drainage openings from one and the same origin, e.g. by laser ablation from a single emitter point.

[0102] The discharge openings can be provided in pairs as one discharge opening from the first group of discharge openings and one discharge opening from the second group of discharge openings, and wherein the emitter point is moved relative to the tubular portion between each pair of discharge openings.

[0103] When providing the discharge openings, the distance from the emitter point to the outer surface can be kept constant.

[0104] The discharge openings can be provided by ablation while the pressure in the discharge conduit is changed relative to the pressure outside the discharge conduit.

[0105] Embodiments relate to a method of manufacturing a hydrophilic urinary catheter, the method comprising: providing a tube made of a base material and defining a discharge conduit extending along a central axis from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for discharging urine from the discharge conduit; and providing a plurality of discharge openings extending between an inner opening in an inner surface facing the discharge conduit and an outer opening in an outer surface facing away from the discharge conduit, the discharge openings being made by laser ablation of the base material, wherein the laser ablation is performed to form a pair of discharge openings comprising a first discharge opening and a second discharge opening provided by ablating the base material simultaneously along a common center line on opposite sides of the central axis.

[0106] The laser can in particular be emitted from an emitter point outside the discharge conduit through the inner discharge conduit. The distance of the emitter point from the outer surface can correspond to at least 10 times the distance from the outer surface to the central axis, or to at least 15 or 20 times the distance from the outer surface to the central axis.

[0107] The discharge openings can be provided by ablation while the pressure in the discharge conduit is changed relative to the pressure outside the discharge conduit.

[0108] The laser can be emitted in at least two subsequent pulses, for example in 3, 4, 5, 6 or more subsequent pulses. The pulses can in particular be emitted at a frequency higher than 1 Hz, for example higher than 2, 3, 4, 5, 6 or even higher Hz.

[0109] The method can comprise determining a hole size for at least one of the first discharge opening and the second discharge opening. In this way, the laser ablation can be performed in a number of shots determined by the hole size. In one embodiment, a limit size is defined, and the number of shots is increased until the limit size of at least one of the first discharge opening and the second discharge opening is reached. In one embodiment, a limit size is defined for both the first discharge opening and the second discharge opening, and the number of shots is increased until both discharge openings have the required size.

[0110] In this document, the terms:

[0111] "continuous" defines that the surface in question extends continuously without sharp corners or edges or similar abrupt geometric changes, defining a radius of curvature of less than 3 mm.

[0112] "uniform outer surface" defines that the outer surface has the same surface texture, color and / or roughness or smoothness, except for the continuous surface.

[0113] "intermittent" defines that the catheter is not intended for indwelling use, and it does not include a balloon or other device for fixation in the bladder.

[0114] "hydrophilic" defines that the material swells to such an extent that the resulting hydrogel reduces surface friction and facilitates easier insertion of the proximal end into the user's body cavity.

[0115] Examples

[0116] A first test was performed to compare the pressure pulse level between a prior art catheter and a catheter with a small drainage opening with a maximum size of less than 1.2 mm. The purpose of these first tests was to simulate a situation in which one of the drainage openings is obstructed by bladder tissue, while the second (last) drainage opening is suddenly obstructed. A catheter with one small drainage opening (maximum size less than 1.2 mm) was used and compared to a standard prior art catheter provided with two standard size drainage openings. In the latter case, one of the drainage openings was obstructed by a piece of tape before the test. In all tests, the catheter was submerged in a water tank and drainage was started. The test setup is shown in Figures 32-34 and is referred to hereinafter. The pressure pulse in the lumen of the catheter was determined at the moment the second drainage opening was obstructed. This corresponds to the situation during catheter insertion in which the first of the two drainage openings in a prior art catheter is obstructed by bladder tissue or urethral tissue, and the suction through the catheter (caused by the flowing liquid) suddenly causes the second of the two drainage openings to also be obstructed by tissue.

[0117] Herein are listed the equipment used for the test:

[0118] • Water tank with holes and O-rings

[0119] • 25 L of water

[0120] • Catheter with one open drainage opening. If the catheter is provided with two drainage openings, one of the drainage openings is obstructed during the test.

[0121] • Waterproof pressure sensor attached to the needle

[0122] • Piece of pig bladder of 5 x 5 cm

[0123] • Latex gloves

[0124] The test was performed according to the following test protocol:

[0125] • A water tank was provided comprising a seal which was adapted to provide a liquid tight seal around the circumference of the catheter

[0126] • The catheter tip was inserted through the liquid tight seal into the water tank until one open drain opening was fully inside the water tank

[0127] • Water was allowed to start flowing out through the catheter

[0128] • The catheter was tapped to make sure there were no air bubbles in the catheter

[0129] • The sensor needle was inserted into the catheter lumen about 1 cm from one open drain opening

[0130] • It was made sure that there were no air bubbles in the catheter or the needle. This is important because even small water bubbles can mask the pressure reading

[0131] • When there were no air bubbles in the catheter or the needle, the position of the catheter in the water was adjusted to an immersion depth of 10 cm, which means that one open drain opening was about 10 cm below the water surface

[0132] • The part of the catheter positioned outside the water tank was adjusted so that the height difference between one open drain opening and the catheter connector was about 15-20 cm.

[0133] • Latex gloves were put on and porcine bladder tissue was taken

[0134] • The tissue was immersed in water

[0135] • The pressure recording was started and it was made sure that the sensor was tared, i.e. set to zero

[0136] • The porcine bladder tissue was slowly brought towards one open drain opening

[0137] • When the porcine bladder tissue encountered one open drain opening, a large (negative) pressure fluctuation occurred in the lumen of the catheter

[0138] • The size of this pressure fluctuation was noted

[0139] The noted pressure fluctuation corresponds to the pressure pulse in the catheter lumen. It will be noted as a (negative) peak in the pressure curve - see example in Figures 26-28

[0140] Some test results are shown in Table 1 below:

[0141] Table 1

[0142] ​ ID Max. size (mm) Suction pressure (mBar) 1.1 0.20 -1 1.2 0.46 -8 1.3 0.55 -15 1.4 0.65 -15 1.5 0.97 -44 1.6 3.90 -200

[0143] As can be seen from the above table, the suction pressure is significantly reduced when the maximum dimension of the drain opening is less than 1 mm (ID 1.1-1.5) compared to the prior art catheter with a maximum dimension of the drain opening of 3.9 mm (ID 1.6). The embodiments of the catheter according to the disclosure in ID 1.1-1.5 of table 1 all have a suction pressure below 50 mBar (below 44 mBar), whereas the suction pressure of the prior art catheter with a maximum dimension of the drain opening of 3.9 mm in ID 1.6 is 200 mBar. Thus, as described above in example 1, the threshold for the suction pressure in the lumen of the intermittent catheter according to the disclosure can be set to 50 mBar when tested at 10 cm H2O.

[0144] The test results are also shown in Figure 26 , Figure 29A , Figure 29B

[0145] The pressure inside a normally functioning bladder can reach about 400-500 mBar (40-50 cm H2O) before being emptied.

[0146] The second and third tests were performed in a similar manner, the only difference being that the catheter was submerged under 50 cm of H2O instead of 10 cm. Furthermore, male and female catheters were also tested. Male catheters were tested, where the height difference between the drain opening and the outlet (connector) was 25 cm, and female catheters were tested, where the height difference between the drain opening and the outlet (connector) was 6 cm.

[0147] The results are shown in the following tables 2 and 3:

[0148] Table 2

[0149]

[0150] Table 3

[0151]

[0152] The results are also shown in Figure 27 , Figure 28 , Figure 30 and Figure 31 ID 1.7-1.14 were tested for male catheters, and 1.15-1.22 were tested for female catheters.

[0153] The catheters that were tested as ID 1.7-1.13 and 1.15-1.21 are sold by Coloplast A / S under the trade name ​Polyurethane catheters of the catheter, while the prior art catheters tested (ID 1.14 and ID 1.22) are PVC grade catheters sold by Hollister Inc under the trade name Catheters. All types of catheters were in size CH12. In In the catheters (ID 1.7-1.13 and ID 1.15-1.22), only one drainage opening was made by laser cutting, and in the catheters of ID 1.14 and ID 1.22, one of the two existing drainage openings was blocked before the test, as described above.

[0154] The above is preferred if the suction pressure is always lower than the pressure reached inside the normally functioning bladder. And in particular, a suction pressure of about half the level of the prior art catheters is an improvement. Embodiments thus relate to an intermittent urinary catheter having a drainage opening and configured to provide a pressure pulse below a threshold of 350 mBar when subjected to the test as described in example 1, with the modification that the immersion depth is 50 cm and the height difference between the drainage opening and the outlet is 25 cm. Further embodiments relate to an intermittent urinary catheter having a drainage opening and configured to provide a pressure pulse below a threshold of 300 mBar when subjected to the test as described in example 1, with the modification that the immersion depth is 50 cm and the height difference between the drainage opening and the outlet is 6 cm. Related embodiments relate to an intermittent urinary catheter having a drainage opening and configured to provide a pressure pulse below a threshold of 200 mBar. Related embodiments relate to an intermittent urinary catheter having a drainage opening and configured to provide a pressure pulse below a threshold of 100 mBar.

[0155] Another test was performed to evaluate the number of drainage openings needed to provide the optimal flow rate through an intermittent catheter according to the disclosure. In this test, 108 prototype catheters were manufactured and the flow rate through each catheter was determined. The 108 catheters employed three CH sizes, namely CH10, CH12 and CH16. The catheters were provided with drainage openings of three sizes, 0.4 mm in diameter, 0.6 mm in diameter and 0.8 mm in diameter. The number of drainage openings varied between 15 and 240, and if the drainage openings were positioned in rows, between 3 and 6 rows.

[0156] The results are presented in Table 4 below and Figure 35 .

[0157] Table 4

[0158]

[0159] It is shown that when the sum of the cross-sectional areas of the discharge openings (total inflow area) reaches the level of the cross-sectional area of the inner lumen of the catheter, the flow rate through the catheter does not increase further. In other words, when the total inflow area reaches the level of the cross-sectional area of the inner lumen, the flow converges.

[0160] Detailed description of the drawings

[0161] Unless specifically stated otherwise, the embodiments described in this application and features of various exemplary embodiments can be combined with each other (“mixed and matched”).

[0162] Figures 1-4 Various problems of prior art catheters are demonstrated. Figure 1 A portion of a prior art catheter 100 inserted into the bladder 10 is shown, which catheter has two discharge openings 101, 102. During catheter insertion, one discharge opening 101 can be obstructed by bladder wall tissue, as shown, and then urine from the bladder is discharged entirely through the second discharge opening 102. This situation creates a high suction effect through the second discharge opening 102, which can cause bladder wall tissue to come into contact with this second discharge opening 102, as described above. Figure 2 A portion of a prior art catheter 100 is shown, which is located in the bladder 10. This figure demonstrates a situation in which the prior art catheter is located too high in the bladder 10, i.e. above the bladder neck 11, so that the bladder 10 will not be completely emptied during catheter insertion. Residual urine in the bladder can cause urinary tract infections. Figure 3 It is shown how the prior art catheter 100 then has to be moved both upwards and downwards in an attempt to alleviate the accumulation of residual urine. However, this upwards and downwards movement of the catheter can cause Figure 4 the situation shown, i.e. urethral tissue 21 from the bladder 10 or the upper urethra 20 enters into the discharge opening and is thus abraded during the upwards and downwards movement of the catheter.

[0163] Figure 5 An intermittent urinary catheter 1 as described herein is shown. The urinary catheter forms a discharge tube which extends in a longitudinal direction from a proximal insertion end to a distal outlet end. The catheter is provided with a tip 2 at the proximal end. In the shown embodiment, the tip is a Nelaton tip, but other tips can be applied. The tip 2 facilitates insertion into the bladder. Figure 5 The urinary catheter is further provided with a connection 3 at the distal end. The connection is configured for discharging urine from the discharge tube, e.g. into an extension tube, into a collection bag or into a toilet.

[0164] The urinary catheter is further provided with a connection 3 at the distal end. The connection is configured for discharging urine from the discharge tube, e.g. into an extension tube, into a collection bag or into a toilet.

[0165] The discharge openings 5 are positioned in the discharge portion 4. In this embodiment, the discharge openings 5 are positioned in four rows, positioned in pairs, with 180 degrees between the pairs. In this figure only two rows on the intermittent catheter side are visible.

[0166] The catheter is for intermittent catheterization and does not contain an inflatable balloon or similar device for long-term fixation in the bladder.

[0167] Figure 6 and Figure 7 An intermittent urinary catheter 1 as described herein is shown, positioned with the discharge portion extending into the bladder 10. In this embodiment, the tip 2 is a flex tip. In Figure 6 In the middle, the discharge openings 5 are positioned dispersed on the surface of the catheter. Figure 6 It is shown how the multiple discharge openings allow urine to flow in at multiple locations. Furthermore, having so many discharge openings reduces the likelihood of bladder tissue being sucked into a single discharge opening during catheterization, as described above. Figure 7 It is shown how the bladder 10 can be completely emptied by having so many discharge openings 5. This is because the likelihood of all discharge openings being blocked is very small; therefore, urine will continue to drain until the bladder 10 is completely emptied. Furthermore, the discharge portion 4 is long, thus allowing discharge openings 5 to be present at the bladder neck 11, thereby helping to ensure that the bladder 10 is emptied.

[0168] Figure 8 A part of an embodiment of an intermittent urinary catheter 1 as described herein positioned in the upper part of the urethra 20 is shown. The figure shows how the tissue 21 of the urethra will not enter through the discharge openings 5, thereby reducing the risk of affecting the urethral tissue 20.

[0169] Figure 9A and Figure 9B It is shown that the discharge portion 4 of a urinary catheter as described herein can be long, such that even if the catheter is inserted until the tip 2 is located at the top of the bladder Figure 9B ), the most distal of the discharge openings 5 is still located below the bladder neck, i.e. in the urethra.

[0170] Figure 10 An enlarged view of a cross-section of a part of the catheter is shown, indicating the longitudinal direction along the central axis CA. In this view, it is schematically shown that the catheter 1 comprises a tubular portion la made of a base material and defining an inner surface 6 facing the discharge conduit 7 and an opposite outer surface 8 facing away from the discharge conduit, which outer surface continuously extends from the proximal insertion end to the distal outlet.

[0171] The part of the outer surface that is considered for insertion into the body is covered by a layer of hydrophilic material 1 b forming a hydrophilic surface 9 of the catheter. The coating thickness Y defines the radial extent of the coating at the outer surface 8.

[0172] Figure 11 A further enlarged view of the discharge opening 5 is shown. Each discharge opening 5 is defined by a discharge opening wall 5a extending between an inner opening 5b in the inner surface and an outer opening 5c in the outer surface. In the shown embodiment, the outer opening 5c is larger than the inner opening, so that the discharge opening wall converges from the outer surface to the inner surface.

[0173] Since the discharge openings are made by laser ablation after the hydrophilic material is deposited on the outer surface, both the hydrophilic material and the base material are ablated, and thus the walls of the discharge openings are not covered by the hydrophilic material.

[0174] Figure 12 A further enlarged view of Figure 11 is shown, showing that the thickness of the layer of hydrophilic material 9 decreases towards each inlet opening 5c in the outer surface 8, and thereby forms a bevel angle 9a of the coating.

[0175] Figure 13 An embodiment of a catheter is shown that comprises protrusions 410 that surround the inlet openings 5c in the outer surface and extend above the hydrophilic surface 411 of the layer 9 when the hydrophilic material of the layer 9 is not swollen.

[0176] Figure 14 An embodiment of Figure 13 is shown when the hydrophilic material is swollen. In this state, the hydrophilic material extends above the protrusions 410.

[0177] Figure 15 A discharge portion of a catheter is shown as seen from above. In this view, it is shown that the discharge openings 5 are arranged in groups R1, R2, R3. The first group R1 comprises a plurality of discharge openings arranged along a first row and having non-circular outer openings 8a. The group R3 also has non-circular openings. The group R2 comprises a plurality of discharge openings having circular outer openings 8a.

[0178] Figure 16A A side view of an embodiment of an intermittent urinary catheter 1 is shown having discharge openings positioned in three groups 4a, 4b and 4c. In the first group 4a, the discharge openings are positioned in a dense configuration, in the second group 4b, the discharge openings are positioned in a less dense configuration, and in the third group 4c, the discharge openings are positioned even further apart.

[0179] Figure 16BA side view of an embodiment of an intermittent urinary catheter with a drainage portion 4 is shown, in which the drainage openings 5 are positioned in three rows. From the view, two rows are visible, but the third row is positioned at the back side of the catheter and is therefore shown in dashed lines.

[0180] Figure 17 An enlarged schematic view of a section of the catheter along the central axis CA is shown. In this view, it is shown that the catheter 1 forms a tubular wall lb, which defines an inner surface 6 facing the drainage channel 7 and an opposite outer surface 8 facing away from the drainage channel, which outer surface continuously extends from the proximal insertion end to the distal outlet. Both the proximal insertion end and the distal outlet are outside the boundaries of Figure 17

[0181] The catheter comprises a drainage portion which is considered for insertion into the body. The drainage portion comprises a plurality of drainage openings 5. Each drainage opening extends along a respective center line CL from an inner opening 6a into the drainage channel 7 to an outer opening 8a in the outer surface 8. The center lines of the drainage openings intersect at an intersection point P outside the drainage channel 7.

[0182] Figure 18 A perspective view of a portion of the drainage portion shown is shown. In this view, it is shown that the center lines CL of all drainage openings intersect at the intersection point P. Figure 15

[0183] A section along the section AA in Figure 19 is shown transverse to the central axis. Figure 15 The drainage openings form a first group Rl, a second group R2 and a third group R3 as mentioned and shown with respect to

[0184] . Each center line of the drainage openings of the first group intersects at least one center line of the drainage openings of the second group at the intersection point P outside the drainage channel 7 and well above the outer surface 8. Figure 15

[0185] In an alternative embodiment, for each drainage opening in one of the groups Rl, R2 or R3, a section of the type shown in Figure 19 is considered. In this alternative embodiment, the center lines of one group, i.e. Rl, R2 or R3, are parallel to the center lines of the same group of drainage openings in the other sections, while the center lines of one group of drainage openings still intersect at least one center line of the other group of drainage openings at the intersection point P outside the drainage channel 7.

[0186] Figure 20 ​​An enlarged schematic view of a section of the conduit along the central axis CA is shown. In this view, the conduit 1 is shown to form a tubular wall lb which defines an inner surface 6 facing the discharge duct 7 and an opposite outer surface 8 facing away from the discharge duct. The outer surface extends from a proximal insertion end to a distal outlet. Both the proximal insertion end and the distal outlet are outside the boundaries of Figure 20 .

[0187] The conduit comprises a discharge portion which is intended for insertion into the body. The discharge portion comprises a plurality of discharge openings 5. Each discharge opening extends along a respective centre line CL from an inner opening 6a into the discharge duct 7 to an outer opening 8a in the outer surface 8.

[0188] Each discharge opening extends along a respective centre line from an inner surface facing the discharge duct to an outer surface facing away from the discharge duct, wherein the discharge openings are formed in pairs such that a pair of discharge openings comprises a first discharge opening 5' and a second discharge opening 5" having the same centre line. Each pair of discharge openings comprises one discharge opening 5' on one side of the central axis and another discharge opening 5" on the opposite side of the central axis.

[0189] In the embodiment shown, the centre lines CL of the discharge openings intersect at a point of intersection P outside the discharge duct 7. Figure 20

[0190] In the embodiment shown, the discharge openings are shown to converge in the upper half of the figure, meaning that the inlet opening 8a is larger than the outlet opening 6a, while the discharge openings are shown to diverge in the lower half, meaning that the outlet opening 6a is larger than the inlet opening 8a. Figure 20

[0191] Figure 21 An alternative embodiment is shown in which the centre lines are parallel. In the embodiment shown, the discharge openings have perpendicular discharge opening walls, however, it is also conceivable that the discharge opening walls can be converging and diverging, respectively, as shown in Figure 20 .

[0192] Figure 22 A cross-sectional view along a section AA in Figure 15 transverse to the central axis CA is shown. Each centre line extends through two discharge openings 5' and 5". At least a middle pair of discharge openings is located on opposite sides of the central axis CA.

[0193] At least one centre line of the first group of discharge openings intersects with at least one centre line of the second group of discharge openings at a point of intersection P outside the discharge duct 7 and well above the outer surface 8. In an alternative embodiment, the centre lines are parallel, as shown in Figure 21 .

[0194] Figure 23 ​​An enlarged schematic view of a section of the conduit along the central axis CA is shown. In this view, it is shown that the conduit 1 forms a tubular wall lb which defines an inner surface 6 facing the discharge duct 7 and an opposite outer surface 8 facing away from the discharge duct. This outer surface extends from a proximal insertion end to a distal outlet. Both the proximal insertion end and the distal outlet are outside the boundaries of Figure 23

[0195] The conduit comprises a first discharge zone which is considered for insertion into the body. The first discharge zone comprises a plurality of discharge openings 5. Each discharge opening extends along a respective centre line CL from an inner opening 6a into the discharge duct 7 to an outer opening 8a in the outer surface 8.

[0196] Each discharge opening extends along a respective centre line from an inner surface facing the discharge duct to an outer surface facing away from the discharge duct, wherein the discharge openings are formed such that all discharge openings are displaced relative to each other, so that no discharge opening is positioned along the centre line of another discharge opening.

[0197] In the illustration of Figure 23 , the conduit comprises a first group of discharge openings 5' and a second group of discharge openings 5". Both groups are located on opposite sides of the central axis CA, but they are offset in the direction of the central axis CA such that no discharge opening is located at the centre line of another discharge opening.

[0198] In the embodiment shown in Figure 23 , the centre lines of the discharge openings intersect at a point of intersection P outside the discharge duct 7.

[0199] Figure 24 An alternative embodiment is shown in which the centre lines are parallel.

[0200] Figure 25 A cross-sectional view similar to the view in Figure 22 is shown, but it is based on a conduit portion as shown in Figure 24 . Each centre line extends through only one discharge opening 5' or 5" and never through two discharge openings.

[0201] The discharge openings 5' intersect at a point of intersection P outside the discharge duct 7.

[0202] Figures 5-25 A common feature of all the above-mentioned embodiments shown is that the discharge openings can be effectively manufactured by laser ablation, for example by a laser arranged at the point P.

[0203] Figure 26 ​This diagram schematically illustrates the pressure pulses that occur in an intermittent catheter during bladder emptying. The figure shows the pressure differential changing over time during a series of obstructions at the drain opening in the catheter. The pressure pulses occur as a sudden drop in pressure over a very short period (approximately 100 milliseconds or less), shown as a peak on the curve in the figure. As explained above, the pressure pulses occur because the movement of urine through the catheter abruptly stops due to tissue obstruction of the drain opening.

[0204] Figures 26-31 Demonstrated by using Figures 32-34 The test device in the middle is used to test various catheters and obtain the results. Figure 26 Results from tests on male catheters were presented with a discharge height of 15-20 cm and a water level of 10 cm H2O. Figure 26 Starting on the left, this graph shows the pressure pulses obtained within a prior art conduit of size CH16, which has two regular discharge openings with a maximum size of 5.6 mm. One of the discharge openings was closed before testing. Figure 26 As can be seen, the pressure pulse exceeds 200 mBar. Moving to the right of the graph, the next graph shows the pressure pulse obtained in a prior art catheter of size CH 12, which has two discharge openings with a maximum size of 3.9 mm. Such a catheter provides a pressure pulse of approximately 200 mBar. The third graph from the left shows the pressure pulse obtained on a prior art catheter of size CH10, which has a discharge opening with a maximum size of 3.4 mm. Here, the pressure pulse exceeds 100 mBar. The fourth graph from the left shows the pressure pulse obtained on an intermittent catheter as described herein, which has an open discharge opening with a maximum size of 1 mm. This graph shows that the pressure pulse only reaches about 40 mBar. The rightmost graph shows the pressure pulse of an intermittent catheter as described herein, which has an open discharge opening with a maximum size of approximately 0.4 mm. Here, the pressure is almost non-existent—the curve shows almost no peaks.

[0205] Figure 27 Results from tests on male catheters were presented with a discharge height of 25 cm and a water level of 50 cm H2O. Figure 27Starting from the left side, the graph shows the pressure pulses obtained in catheters with a single open discharge opening, which increases in size from left to right. The results are also reported in Table 2 below. It can be seen that for a discharge opening with a maximum size of 4 mm, the pressure pulse (under these test conditions) reaches 652 mBar, while towards the left, when the discharge opening is 0.19 mm, the pressure pulse (under these test conditions) is as low as 15 mBar. Levels of less than 100 mBar are obtained with discharge openings less than approximately 0.4 mm, less than 200 mBar with discharge openings less than approximately 0.6 mm, and less than 350 mBar with discharge openings less than approximately 1.00 mm.

[0206] Figure 28 Results from tests on female catheters were presented with a discharge height of 6 cm and a water level of 50 cm H2O. Figure 28 Starting on the left, the graph shows the pressure pulses obtained in catheters with a single open discharge opening, which increases in size from left to right. The results are also reported in Table 3 above. It can be seen that for a discharge opening with a maximum size of 4 mm, the pressure pulse (under these test conditions) reaches 639 mBar, while towards the left, when the discharge opening is 0.19 mm, the pressure pulse (under these test conditions) is as low as 12 mBar. Levels of less than 100 mBar are obtained with discharge openings less than approximately 0.5 mm, less than 200 mBar with discharge openings less than approximately 0.7 mm, and less than 350 mBar with discharge openings less than approximately 1.00 mm.

[0207] Figure 29A and Figure 29B Showing according to Figure 32 The test results are obtained from the test performed by the test device in the test. Figure 29BThe correlation between the amount of bladder wall or urethral tissue that enters the inner lumen through the discharge opening, the size of the discharge opening and the measured pressure pulse is shown for larger scales. From the results of the tests it should be understood that a pressure pulse below 40 mBar reduces the risk of bladder wall or urethral tissue entering the inner lumen through the small discharge opening in the intermittent catheter and reduces the risk of an impact on the tissue. In embodiments of the disclosure, an intermittent urinary catheter is realized in which no or very little tissue enters the inner lumen through the small discharge opening when the pressure pulse is below 40 mBar. A pressure pulse below 40 mBar is obtained when the maximum size of the discharge opening is less than 0.7 mm. Embodiments therefore relate to an intermittent urinary catheter configured for providing a pressure pulse below 40 mBar. Related embodiments are intermittent urinary catheters with a discharge opening having a maximum size of less than 0.7 mm.

[0208] Figure 30 and Figure 31 The test results of tests performed with the test device according to Figure 33 and Figure 34 are shown. Figure 30 The results in Figure 33 are used to test male catheters as shown in Figure 31 and Figure 34 The results in

[0209] In Figure 30 and Figure 31 the results of tests on discharge openings with a maximum size of 1 mm and below are shown. These curves show that if a discharge opening of less than 1 mm is used, the pressure pulse will be below 350 mBar for male catheters. For female catheters the pressure pulse will be below 300 mBar. If a discharge opening of 0.8 mm is used, the pressure pulse will be about 260 mbar for males and about 210 mBar for females. If a discharge opening of 0.4 mm is used, the pressure pulse will be about 90 mBar for male catheters and about 75 mBar for female catheters.

[0210] Embodiments

[0211] In the following, non-limiting examples of embodiments of intermittent hydrophilic urinary catheters, methods of use and methods of manufacture will be referred to.

[0212] 1. An intermittent hydrophilic urinary catheter defining a discharge conduit extending in a longitudinal direction from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for discharging urine from the discharge conduit, the catheter comprising a tube having a tubular wall made of a base material and defining an inner surface facing the discharge conduit and an opposite outer surface facing away from the discharge conduit, wherein at least an insertable portion of the outer surface is covered by a layer of a hydrophilic material configured to change from a non-swollen state to a swollen state by contact with a swelling medium, the hydrophilic material defining a hydrophilic surface of the catheter on the outer surface in a coating thickness, and wherein the catheter comprises a plurality of discharge openings, each discharge opening being defined by a discharge opening wall extending between an outlet opening in the inner surface and an inlet opening in the outer surface, wherein the discharge opening wall is not covered by the hydrophilic material.

[0213] 2. The catheter according to embodiment 1, wherein the discharge openings are made by laser ablation of the hydrophilic material and the base material, thereby ensuring that the discharge opening wall is not covered by the hydrophilic material.

[0214] 3. The catheter according to embodiment 1 or 2, wherein the discharge opening wall has a height corresponding to a distance between the inner surface and the outer surface.

[0215] 4. The catheter according to any one of the preceding embodiments, wherein the outer surface continuously extends from the proximal insertion end to the distal outlet end.

[0216] 5. The catheter according to any one of the preceding embodiments, wherein the coating thickness decreases towards each inlet opening in the outer surface.

[0217] 6. The catheter according to any one of the preceding embodiments, wherein the tubular wall of the tube has a uniform wall thickness.

[0218] 7. The catheter according to any one of the preceding embodiments, wherein the tube has a uniform outer surface.

[0219] 8. The catheter according to any one of the preceding embodiments, comprising a protrusion surrounding an inlet opening in the outer surface and extending above the hydrophilic surface when the hydrophilic material is in the non-swollen state.

[0220] 9. The catheter according to embodiment 8, wherein the hydrophilic material extends above the protrusion when the hydrophilic material is in the swollen state.

[0221] 10. The catheter of any of the preceding embodiments, wherein the discharge openings have a cross-sectional area of less than 0.4 mm 2 .

[0222] 11. The catheter of any of the preceding embodiments, wherein the proximal insertion end forms a closed tip.

[0223] 12. The catheter of embodiment 11, defining a non-discharge portion distal of the tip and a discharge portion distal of the non-discharge portion, the discharge portion being provided with the plurality of discharge openings.

[0224] 13. The catheter of any of the preceding embodiments, wherein the sum of the cross-sectional areas of the discharge openings is larger than the cross-sectional area of the discharge conduit.

[0225] 14. A method of manufacturing a hydrophilic urinary catheter, the method comprising: providing a tube made of a base material, the tube defining a tubular shape having an inner surface facing a discharge conduit and an opposite outer surface facing away from the discharge conduit; coating the outer surface with a hydrophilic material to define a hydrophilic surface; and providing a plurality of discharge openings from the outer surface to the inner surface by laser ablation of the hydrophilic material and the base material, such that a discharge opening wall extending between the inner surface and the outer surface is not coated.

[0226] 15. The method of embodiment 13, wherein the tube is provided by extruding the base material through a die.

[0227] 16. A method of reducing local peak suction pressure in a discharge opening in a bladder due to discharge opening obstruction by using an intermittent urinary catheter as defined in any of embodiments 1-12.

[0228] 17. An intermittent urinary catheter defining a discharge conduit extending along a central axis from a proximal insertion end configured for insertion into a body lumen to a distal outlet end configured for discharging urine from the discharge conduit, the catheter comprising a plurality of discharge openings each extending along a respective centerline from an internal opening into the discharge conduit to an external opening in an outer surface, wherein at least two discharge openings have centerlines intersecting at an intersection point outside the discharge conduit.

[0229] 18. The catheter of embodiment 17, wherein the centerlines of all discharge openings intersect at the intersection point.

[0230] 19. The catheter according to embodiment 17, comprising a first set of discharge openings and a second set of discharge openings, the centerlines of the first set of discharge openings being parallel, the centerlines of the second set of discharge openings being parallel, and each centerline of the first set of discharge openings intersecting at least one centerline of the second set of discharge openings at the intersection point.

[0231] 20. The catheter according to any one of embodiments 17 to 19, wherein the intersecting centerlines extend from the intersection point at an angle of 1-4 degrees.

[0232] 21. The catheter according to any one of embodiments 17-20, wherein the distance of the intersection point from the outer surface corresponds to at least 10 times the distance from the outer surface to the center axis.

[0233] 22. The catheter according to any one of embodiments 17 to 21, wherein the first set of outer openings are non-circular and the second set of outer openings are circular.

[0234] 23. The catheter according to embodiment 22, wherein the openings in the first set of outer openings extend along a first outer straight line parallel to the center axis.

[0235] 24. The catheter according to embodiment 22 or 23, wherein the openings in the second set of outer openings extend along a second outer straight line parallel to the center axis.

[0236] 25. The catheter according to any one of embodiments 17 to 24, wherein the discharge openings have a cross-sectional area of less than 0.4 mm2.

[0237] 26. The catheter according to any one of embodiments 17 to 25, wherein the proximal insertion end forms a closed tip.

[0238] 27. The catheter according to embodiment 26, defining a non-discharge portion distal of the tip and a discharge portion distal of the non-discharge portion, the discharge portion being provided with the plurality of discharge openings.

[0239] 28. The catheter according to any one of embodiments 17 to 27, wherein the sum of the cross-sectional areas of the discharge openings is larger than the cross-sectional area of the discharge conduit.

[0240] 29. A method of manufacturing an intermittent urinary catheter, the method comprising: providing a tube made of a base material and defining a tubular shape with an inner surface facing towards an internal drainage conduit and an opposite outer surface facing away from the internal drainage conduit; and providing a plurality of drainage openings extending between an internal opening in the inner surface and an external opening in the outer surface by laser ablation of the base material, wherein the laser ablation is performed with a laser emitted from an emitter point outside the drainage conduit at a certain emission angle, such that a first group of drainage openings is provided with a first emission angle and a second group of drainage openings is provided with a second emission angle.

[0241] 30. The method according to embodiment 29, wherein the drainage openings are provided in pairs from one drainage opening from the first group of drainage openings and one drainage opening from the second group of drainage openings, and wherein the emitter point moves relative to the tube between each pair of drainage openings.

[0242] 31. The method according to embodiment 29 or 30, wherein the distance from the emitter point to the outer surface is kept constant when providing the drainage openings.

[0243] 32. The method according to any one of embodiments 29-31, wherein the drainage openings are provided by ablation while a pressure in the drainage conduit is varied relative to a pressure outside the drainage conduit.

[0244] 33. The method according to any one of embodiments 29-32, wherein the outer surface is coated with a hydrophilic material prior to providing the drainage openings.

[0245] 34. A method of reducing local peak suction pressure in a drainage opening in a bladder due to obstruction of the drainage opening by using an intermittent urinary catheter according to any one of embodiments 17-28.

[0246] 35. An intermittent urinary catheter defining a drainage conduit extending along a central axis from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for draining urine from the drainage conduit, the catheter comprising a plurality of drainage openings each extending along a respective central line from an inner surface facing towards the drainage conduit to an outer surface facing away from the drainage conduit, wherein the drainage openings are formed in pairs such that a pair of drainage openings comprises a first drainage opening and a second drainage opening having the same central line.

[0247] 36. The catheter according to embodiment 35, wherein the first drainage opening and the second drainage opening are located on opposite sides of the central axis.

[0248] 37. The catheter of either of embodiments 35 or 36, wherein each drainage opening is defined by a wall extending from an inner surface facing the drainage conduit to an outer surface facing away from the drainage conduit, wherein the wall of the first drainage opening converges in a direction from the outer surface to the inner surface and the wall of the second drainage opening diverges in a direction from the outer surface to the inner surface.

[0249] 38. The catheter of any preceding embodiment 35 to 37, wherein the first drainage opening and the second drainage opening have different sizes.

[0250] 39. The catheter of any of embodiments 35 to 38, wherein the drainage openings have a cross-sectional area of less than 0.4 mm 2 .

[0251] 40. The catheter of any of embodiments 35 to 39, wherein the proximal insertion end forms a closed tip.

[0252] 41. The catheter of embodiment 40, defining a non-drainage portion distal of the tip and a drainage portion distal of the non-drainage portion, the drainage portion being provided with the plurality of drainage openings.

[0253] 42. The catheter of any of embodiments 35 to 41, wherein the sum of the cross-sectional areas of the drainage openings is larger than the cross-sectional area of the drainage conduit.

[0254] 43. A method of manufacturing an intermittent urinary catheter, the method comprising: providing a tube made of a base material and defining a drainage conduit extending along a central axis from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for draining urine from the drainage conduit; and providing a plurality of drainage openings extending between an inner opening in an inner surface facing the drainage conduit and an outer opening in an outer surface facing away from the drainage conduit, the drainage openings being made by laser ablation of the base material, wherein the laser ablation is performed to form a pair of drainage openings comprising a first drainage opening and a second drainage opening provided by simultaneously ablating the base material along a common center line on opposite sides of the central axis.

[0255] 44. The method of embodiment 43, wherein the laser is emitted through the inner drainage conduit from a transmitter point outside the drainage conduit.

[0256] 45. The method of either of embodiments 43 or 44, wherein the laser is emitted in at least two subsequent pulses.

[0257] 46. The method according to any one of embodiments 43 to 45, wherein a bore size of at least one of the first drainage opening and the second drainage opening is determined, and wherein the laser ablation is performed a number of times determined by the bore size.

[0258] 47. A method of reducing local peak pressure in a drainage opening in a bladder due to obstruction of the drainage opening by using an intermittent urinary catheter according to any one of embodiments 35 to 42.

Claims

1. An intermittent hydrophilic catheter defining a discharge conduit extending longitudinally from a proximal insertion end configured for insertion into a body cavity to a distal outlet end configured for discharging urine from the discharge conduit, the catheter comprising a tube having a tubular wall made of a base material and defining an inner surface facing the discharge conduit and an opposite outer surface facing away from the discharge conduit, wherein, At least the insertable portion of the outer surface is covered by a layer of hydrophilic material configured to change from a non-swellable state to a swellable state by contact with a swelling medium. The hydrophilic material defines a hydrophilic surface of the catheter on the outer surface by a coating thickness. The catheter includes a plurality of discharge openings, each defined by a discharge opening wall extending between an outlet opening in the inner surface and an inlet opening in the outer surface, wherein the discharge opening wall is not covered by the hydrophilic material.

2. The intermittent hydrophilic catheter according to claim 1, wherein, The discharge opening is made by laser ablation of the hydrophilic material and the substrate material, thereby ensuring that the wall of the discharge opening is not covered by the hydrophilic material.

3. The intermittent hydrophilic catheter according to claim 1 or 2, wherein, The discharge opening wall has a height corresponding to the distance between the inner surface and the outer surface.

4. The intermittent hydrophilic catheter according to claim 1, wherein, The outer surface extends continuously from the proximal insertion end to the distal exit end.

5. The intermittent hydrophilic catheter according to claim 1, wherein, The coating thickness decreases toward each inlet opening in the outer surface.

6. The intermittent hydrophilic catheter according to claim 1, wherein, The tubular wall of the tube has a uniform wall thickness.

7. The intermittent hydrophilic catheter according to claim 1, wherein, The tube has a uniform outer surface.

8. The intermittent hydrophilic catheter according to claim 1, wherein, The discharge opening has a diameter of less than 0.4 mm. 2 The cross-sectional area.

9. The intermittent hydrophilic catheter according to claim 1, wherein, The proximal insertion end forms a closed end.

10. The intermittent hydrophilic catheter of claim 9, wherein the intermittent hydrophilic catheter defines a non-discharge portion distal to the closed end and a discharge portion distal to the non-discharge portion, the discharge portion being provided with the plurality of discharge openings.

11. The intermittent hydrophilic catheter according to claim 1, wherein, The sum of the cross-sectional areas of the plurality of discharge openings is greater than the cross-sectional area of ​​the discharge pipe.

12. A method for manufacturing a hydrophilic urinary catheter, the method comprising: A tube made of a base material is provided, the tube defining a tubular shape having an inner surface facing the discharge pipe and an opposite outer surface facing away from the discharge pipe; The outer surface is coated with a hydrophilic material to define a hydrophilic surface; And by laser ablation of the hydrophilic material and the substrate material, a plurality of discharge openings are provided from the outer surface to the inner surface, such that the walls of the discharge openings extending between the inner surface and the outer surface are not coated.

13. The method according to claim 12, wherein, The tube is provided by extruding the base material via a die.

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