WO2025248257A1

WO2025248257A1 - Urinary catheters

Info

Publication number: WO2025248257A1
Application number: PCT/GB2025/051181
Authority: WO
Inventors: Daniel Allen; Saskia BUCKLES; David Pollard; Nicola PILMER
Original assignee: Convatec Ltd
Current assignee: Convatec Ltd
Priority date: 2024-05-31
Filing date: 2025-05-30
Publication date: 2025-12-04
Anticipated expiration: 2026-11-30
Also published as: GB202408896D0

Abstract

There is provided a urinary catheter (51) comprising, a tip (55), a tubular portion (52) and a drainage end (57). The tubular portion comprising an inner lumen (59) which defines a portion of a drainage flow path. The tubular portion comprising at least one eyelet (58) and at least one small eyelet (61) configured to provide fluid communication between the inner lumen and an environment external to the tubular portion.

Description

Urinary Catheters

Technical Field of the Invention

The present invention relates to urinary catheters, in particular to intermittent urinary catheters.

Background to the Invention

A urinary catheter is a medical device comprising a hollow catheter tube designed for use for insertion into a user’s bladder via the urethra to drain the bladder. Typically, the catheter tube is provided with one or more eyelets - holes through the catheter tube to allow fluid communication between the bladder and an interior of the catheter tube, which allow the urine to be drained.

In use, these eyelets may become blocked by the bladder wall, the reduction in, or stoppage of, the flow may cause a negative pressure differential to occur within the catheter tube drawing the bladder wall into the eyelet.

Furthermore, depending upon the positioning of the catheter tube within the bladder an incomplete draining of the bladder may occur with the eyelets positioned above the urine such that the flow stops.

Stoppage of the flow can either lead the user to assume that the bladder is properly drained or require intervention to reposition the catheter and continue draining the bladder, neither of which is desirable.

In an attempt to address these issues, WO 2020/103996 Al describes a urinary catheter with a greater number (at least 12) of small eyelets (referred to as small drainage openings therein, but it will be readily understood by those skilled in the art that drainage openings and eyelets are synonymous) provided on the catheter tube.

However, in testing (as outlined in detail below) it has been found that small eyelets are more susceptible to blockage from sediment and mucus which can be found within the bladder, this blockage can be complete (that is the flow of urine stops completely) resulting in incomplete draining where the user incorrectly assumes the bladder has been emptied. It is an aim of an embodiment or embodiments of the invention to overcome or at least partially mitigate one or more problems with the prior art and/or provide an improved catheter tube.

Summary of the Invention

According to a broad aspect of the disclosure, there is provided a catheter, preferably a urinary catheter. The catheter may comprise a tip. The catheter may comprise a tubular portion. The catheter may comprise a drainage end. The tubular portion may comprise an inner lumen. The inner lumen may define a portion of a drainage flow path. The tubular portion may comprise at least one eyelet. The tubular portion may comprise at least one small eyelet. The at least one eyelet and/or one small eyelet may be configured to provide fluid communication between the inner lumen and an environment external to the tubular portion.

According to a first aspect of the disclosure, there is provided a urinary catheter comprising, a tip, a tubular portion and a drainage end, the tubular portion comprising an inner lumen which defines a portion of a drainage flow path, wherein the tubular portion comprises at least one eyelet and at least one small eyelet configured to provide fluid communication between the inner lumen and an environment external to the tubular portion.

Advantageously, the provision of a combination of eyelet and small eyelet provides improved drainage of the bladder, the eyelet clears sediment and mucus from the urine adjacent to the catheter whilst the small eyelet reduces the risk of large pressure differentials.

There may be a plurality of small eyelets. Some, or all, of the small eyelets may be provided in one or more arrays. The one, or more, or each array may be arranged at the same longitudinal position on the tubular portion as a corresponding eyelet. The one, or more, or each array may be arranged on an opposing side of the tubular portion to a corresponding eyelet. Where the tubular portion comprises a plurality of eyelets, the eyelets may be longitudinally separated. Where the tubular portion comprises a plurality of eyelets, the eyelets may be arranged on diametrically opposing sides of the tubular portion. An array may be provided diametrically opposite side of the tubular portion to one, or more, or each eyelet. That is to say directly opposite at the same longitudinal position.

Advantageously, the provision of small eyelets in arrays increases the drainage rate as more fluid can pass and the blockage of one small eyelet has a reduced effect on the overall drainage rate as the other small eyelets continue to drain the bladder. Furthermore, by arranging an array opposing an eyelet, in particular where more than one eyelet and array are provided, the eyelets on opposing sides of the tubular portion reduce the likelihood of all the eyelets being blocked.

There may be a plurality of eyelets. There may be at least two eyelets. There may be two eyelets. There may be no more than two eyelets. There may be at least three eyelets. There may be three eyelets. There may be no more than three eyelets. There may be at least four eyelets. There may be four eyelets. There may be no more than four eyelets.

The one, or more, or each eyelet may have a stadium shape. The longest axis of the one, or more, or each eyelet may extend longitudinally along the tubular portion. The one, or more, or each eyelet may have a length measured along the tubular portion. The one, or more, or each eyelet may have a length of at least 1 mm, preferably at least 1.5 mm, more preferably at least 2 mm, such as at least 3 nun. The one, or more, or each eyelet may have a length of between 0.5 and 6 mm, preferably between 1 and 5.5 mm, more preferably, between 2 and 5 mm, such as between 3.5 and 4.5 mm, for example 4.1 mm.

The one, or more, or each eyelet may have a width measured circumferentially around the tubular portion. The one, or more, or each eyelet may have a width of at least 0.5 mm, preferably at least 0.7 mm, more preferably at least 0.9 mm, for example at least 1 mm. The one, or more, or each eyelet may have a width of between 0.5 and 1.5 mm, preferably between 0.7 and 1.3 mm, more preferably between 0.9 and 1.1 mm, for example between 0.95 and 1.05 mm, such as 1 mm.

The one, or more, or each eyelet may have a circular shape. The one, or more, or each eyelet may have a diameter of at least 1 mm, preferably at least 1.2 mm, more preferably at least 1.4 mm. The one, or more, or each eyelet may have an oval shape. The tip may be closed. The tip may define a proximal end of the catheter. Where there is more than one eyelet, the eyelets may have a longitudinal displacement (as measured from a proximal end of one eyelet to a proximal end of another eyelet) of between 5 and 15 mm, preferably between 6 and 11 mm, more preferably between 7 and 8 mm, for example 7.5 mm.

The one, or more, or each eyelet may have a cross-sectional area of between 3 and 8 mm², preferably between 3.5 and 7 mm², more preferably between 4 and 5 mm², for example, between 4 and 54.5 mm², such as 4.3 mm².

The one, or more, or each eyelet may have a cross-sectional area of at least 2 nun², preferably at least 3 mm², more preferably at least 3.5 mm², for example at least 4 mm², such as at least 4.3 mm².

The eyelet proximate to the tip may be arranged between 5 and 15 mm from the tip, preferably between 7 and 13 mm, more preferably between 9 and 11 mm, for example 10 mm.

The small eyelets may have a stadium shape. The longest axis of the one, or more, or each small eyelet may extend longitudinally along the tubular portion. The length of the small eyelets may be measured along the longitudinal axis of the tubular portion. The one, or more, or each small eyelet may have a length of no more than 1.5 mm, preferably no more than 1.2 mm, more preferably no more than 1 mm. The one, or more, or each small eyelet may have a length of between 0.5 and 1.5 mm, preferably between 0.6 and 1.4 mm, more preferably, between 0.8 and 1.2 mm, such as between 0.9 and 1.1 mm, for example 1 mm.

The one, or more, or each small eyelet may have a width measured circumferentially around the tubular portion. The one, or more, or each small eyelet may have a width of no more than 1 mm, preferably no more than 0.9 mm, more preferably no more than 0.8 mm, for example no more than 0.6 mm. The one, or more, or each small eyelet may have a width of between 0.5 and 1.5 mm, preferably between 0.7 and 1.3 mm, more preferably between 0.9 and 1.1 nun, for example between 0.95 and 1.05 mm, such as 1 mm. The one, or more, or each small eyelet may have a cross-sectional area of between 0.2 and 0.8 mm², preferably between 0.25 and 0.7 mm², more preferably between 0.3 and 0.6 mm².

The one, or more, or each small eyelet may have a cross-sectional area of less than 1 mm², preferably less than 0.9 mm², more preferably less than 0.8 mm², for example less than 0.7 mm², such as less than 0.6 mm².

The small eyelets may have a circular shape. The small eyelets may have a diameter of no more than 1 mm, preferably no more than 0.8 mm, more preferably no more than 0.6 mm, for example no more than 0.5 mm. The small eyelets may have an oval shape.

The one, or more, or each array of small eyelets may comprise at least 2 rows of small eyelets. That is to say one or more small eyelets in a first row may be longitudinally displaced for one or more small eyelets in a second row. The array of small eyelets may comprise at least 3 rows, at least 4 rows, at least 5 rows, at least 10 rows, at least 15 rows.

The one, or more, or each row of the array may comprise at least 1 small eyelet, preferably at least 2 small eyelets, more preferably at least 3 small eyelets.

The one, or more, or each array may comprise at least 2 small eyelets, preferably at least 4 small eyelets, more preferably at least 6 small eyelets, for example at least 9 small eyelets, for example at least 12 small eyelets.

Within the one, or more, or each array, each small eyelet may be equally spaced from the adjacent small eyelets.

The one, or more, or each array may have a square shape (that is an equal number of small eyelets in each row as there are rows). The one, or mor, or each array may have a rectangular shape (that is the same number of small eyelets in each row, where that number is not equal to the number of rows). The one, or more, or each array may have a triangular shape (that is the number of small eyelets increasing in each respective row). The one, or more, or each array may have a diamond shape (that is the number of small eyelets increasing in each respective row to a middle row and decreasing in each respective row thereafter). The one, or more, or each array may have a circular shape. The one, or more, or each array may have a stadium shape. That is to say, a rectangular shape with a semicircles on a pair of opposing sides.

A plurality of small eyelets may be provided in one or more arrays. The one, or more, or each array may extend longitudinally along the tubular portion. The small eyelets may vary in cross-sectional area. The small eyelets proximate to the tip may have a smaller cross-sectional area than the small eyelets distal to the tip.

One, or more, or each row in an array of small eyelets may extend around the entire circumference of the tubular portion. One, or more, or each row in an array of small eyelets may comprise at least 3, at least 4, at least 5, at least 6, at least 7, at least 8 small eyelets.

The one, or more, or each array may extend over at least 10% of the length of the tubular portion, preferably at least 20% of the length, more preferably at least 30% of the length, more preferably still at least 40% of the length. The one, or more, or each array may have a length of at least 10 mm, preferably at least 15 mm, more preferably, at least 20 mm, more preferably still at least 25 mm, for example at least 30 mm, such as at least 35 mm.

In a preferred embodiment of the invention there is provided a urinary catheter comprising, a tip, a tubular portion and a drainage end, the tubular portion comprising an inner lumen which defines a portion of a drainage flow path, wherein the tubular portion comprises at least one eyelet and at least one small eyelet configured to provide fluid communication between the inner lumen and an environment external to the tubular portion, wherein a plurality of small eyelets are provided in one or more arrays, wherein the one, or more, or each array extends over at least 20% of the length of the tubular portion.

In a preferred embodiment of the invention there is provided a urinary catheter comprising, a tip, a tubular portion and a drainage end, the tubular portion comprising an inner lumen which defines a portion of a drainage flow path, wherein the tubular portion comprises at least one eyelet and at least one small eyelet configured to provide fluid communication between the inner lumen and an environment external to the tubular portion, wherein a plurality of small eyelets are provided in one or more arrays, wherein the one, or more, or each array has a length of at least 20 mm.

There may be one array. The array may comprise a plurality of rows. Each row may extend about an entire circumference of the tubular portion. The at least one eyelet may be arranged within the array. The at least one eyelet may extend between two adjacent rows.

In a preferred embodiment of the invention there is provided a urinary catheter comprising, a tip, a tubular portion and a drainage end, the tubular portion comprising an inner lumen which defines a portion of a drainage flow path, wherein the tubular portion comprises at least one eyelet and at least one small eyelet configured to provide fluid communication between the inner lumen and an environment external to the tubular portion, wherein a plurality of small eyelets are provided in an array, the array comprising a plurality of rows, each row extending about the entire circumference of the tubular portion, and wherein the array extends least 20% of the length of the tubular portion, wherein the at least one eyelet is arranged within the array extending between two adjacent rows.

One, more, or each eyelet may extend through the tubular portion from an external surface of the tubular portion to the inner lumen.

One, more, or each small eyelet may extend through the tubular portion from an external surface of the tubular portion to the inner lumen

The catheter tube may comprise or be coated in a hydrophilic material.

The urinary catheter may be an intermittent urinary catheter. The urinary catheter may be a female urinary catheter. The urinary catheter may be a male urinary catheter.

According to a second aspect of the invention there is provided a method of manufacturing a urinary catheter comprising, a tip, a tubular portion and a drainage end, the tubular portion comprising an inner lumen which defines a portion of a drainage flow path, wherein the tubular portion comprises at least one eyelet and at least one small eyelet configured to provide fluid communication between the inner lumen and an environment external to the tubular portion, the method comprising: providing a catheter tube, providing at least one eyelet and the at least one small eyelet.

The method may comprise removing portions of the tubular portion to provide the at least one eyelet and/or the at least one small eyelet.

The method may comprise moulding the at least one eyelet and/or at least one small eyelet into the tubular portion.

The urinary catheter of the second aspect may be the urinary catheter of the first aspect, optionally including any optional feature thereof.

According to a third aspect of the invention there is provided a method a draining a bladder, the method comprising providing a urinary catheter comprising, a tip, a tubular portion and a drainage end, the tubular portion comprising an inner lumen which defines a portion of a drainage flow path, wherein the tubular portion comprises at least one eyelet and at least one small eyelet, configured to provide fluid communication between the inner lumen and an environment external to the tubular portion, inserting the urinary catheter tip first into a user’ s urethra and draining the fluid in the bladder.

The method may comprise draining mucus and/or sediment and/or urine through the at least one eyelet. The method may comprise draining urine through the at least one small eyelet.

The method may comprise draining the bladder of a user with higher-than- average sediment and/or mucus in their urine.

The urinary catheter of the third aspect may be the urinary catheter of the first aspect, including any optional features thereof.

Detailed Description of the Invention

In order that the invention may be more clearly understood one or more embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, of which: Figure 1 shows a schematic view of a test apparatus for comparative testing of catheter draining characteristics;

Figure 2 shows a perspective view of a catheter tube according to the present invention;

Figure 3 shows a longitudinal cross-sectional view of the catheter tube of Figure 3;

Figure 4 shows a perspective view of a further catheter tube according to the present invention; and

Figure 5 shows a longitudinal cross-sectional view of the catheter tube of Figure 4.

With reference to Figure 1, a test apparatus 1 for running a test method to determining flow rates through a catheter and the results thereof is described. The test apparatus 1 is set up as outlined in ISO 20696:2018 “Sterile Urethral Catheters For Single Use” Annex E and comprises a l m hydrostatic head 2 connected to a bladder chamber 3. At the bottom of the bladder chamber 3 there is provided an approximately 2 cm thick layer of gelatin 4 to simulate the soft tissue of the bladder. A suitable sized rod (not shown) for example a 12 or 14 Charriere gauge is inserted through the gelatin 4 to create a simulated urethra with a urethral opening 5 to the bladder chamber 3.

In the presence of a number of conditions, in addition to urine in the bladder there can be an increased amount of mucus and sediment. Bladder sediment can be a result of infection, inflammation or contamination of the bladder, it comprises an increased concentration of cells (red blood cells, white blood cells), urinary casts and mineral debris. In order to simulate this mucus and sediment, egg whites and glass microbeads 6 are included in the test solution (hashed region).

In testing the test apparatus 1 is filled with 1.5 kg (approximately 1.5 L) of test solution, the test solution comprises:

95% w/w synthetic urine comprising 142 mmol sodium chloride and 2.5 mmol calcium chloride;

0.005% w/w dispersant;

5% w/w egg white to simulate mucus; and

10 cm³ 250-425 pm glass microbeads (not to scale) 6 to simulate sediment. The microbeads 6 settle to the bottom of the test apparatus and rest on top of the gelatin 4, whereas the egg whites more freely mix with the synthetic urine.

To test a catheter 7, it is inserted tip 8 first into the simulated urethra 5 until all eyelets 9 and/or small eyelets are within the bladder chamber 3, with the lowest most eyelet or small eyelet being aligned with the urethral opening 5a. Through subjective assessment observations the following parameters are assessed:

Flow rate - the volume of synthetic urine passing through the catheter 7 in a given time period.

Clearance of simulated mucus - an observation as to whether the simulated mucus is drawn into and through the catheter 7 and where this is the case, how much volume around the catheter 7 has a reduced) concentration (or is completely cleared) of simulated mucus.

Clearance of simulated sediment - an observation as to whether the simulated sediment is drawn into and through the catheter 7 and where this is the case, the distance from the catheter 7 which is clear of simulated sediment.

In one test under this regime the properties of a commercially available male catheter (which is understood to be made in accordance with the abovementioned WO 2020/103996 Al) were tested. During the test the small eyelets on the catheter were observed to become blocked by the simulated mucus such that the flow completely stopped before the completion of the test.

With reference to Figures 2 and 3 a first embodiment of a catheter tube 51 according to the present invention is described. In this embodiment that catheter tube 51 is a 14 Charrire (CH14) gauge catheter tube. The catheter tube 51 defines a longitudinal axis B-B and comprises a tubular portion 52 having a wall 53 defining an inner lumen 59. In this embodiment there is provided at an insertion end 54 of the catheter tube 51 a tip 55 having a hemispherical shape (referred to by those in the art as a “Nelaton tip”), the tip 55 defines a proximal end of the catheter tube 51. In other embodiments alternative tip geometries may be used, for example a Coude or Tiemann tip. At a distal end 56 of the catheter tube 51 there is provided a drain 57. In some embodiments the catheter tube 51 may be functionalised, for example it may comprise or be coated in a hydrophilic material.

Arranged on the tubular portion are two eyelets 58 which extend through the wall 53 of the tubular portion 52, providing a fluid connection between the inner lumen 59 and an exterior of the catheter tube 51. In addition to the eyelets 58, an array 60 of small eyelets 61 is provided on the tubular portion 52. In the present embodiment the array 60 comprises fifteen rows 62, each row 62, except those containing an eyelet 58 as elaborated upon below, comprises eight small eyelets 61 arranged circumferentially around the tubular portion 52 with even separation (i.e. with an angular separation of 45° between each small eyelet). Each row is longitudinally displaced from the adjacent rows such that the array 60 covers approximately 40% of the length (approximately 36 nun) of the tubular portion 52 from the tip 55. In alternative embodiments, there may be more, or fewer rows of small eyelets 61 and the number of small eyelets in each row may be greater or fewer.

As counted from the tip 55, the third 62a and fourth 62b rows comprise seven small eyelets 61, as these small eyelets 61 have the 45° angular separation there is a 90° angular separation between two small eyelets, between these two small eyelets 61 there is provided one of the two eyelets 58, a proximal eyelet 58a. Likewise, as counted from the tip 55, the seventh 62c and eighth 62d rows, comprise seven small eyelets 61, as these small eyelets 61 have the 45° angular separation there is a 90° angular separation between two small eyelets 61, between these two small eyelets 61 there is provided the other of the two eyelets 58, a distal eyelet 58b. Thus, in this embodiment the third 62a, fourth 62b, seventh 62c and eighth 62d rows each have 7 small eyelets 61 with the proximal eyelet 58a and distal eyelet 58b extending between the third 62a and fourth 62b, and seventh 62c and eighth 62d rows respectively. In alternative embodiments the relative positions of the eyelets 58 could vary, for example they could be provided at the same longitudinal position on the tubular portion 52, they could be arranged closer to the tip 55 or indeed further from it. In further alternative embodiments the number of eyelets 58 could also be varied, for example there may only be one eyelet, or there may be three, or four or more eyelets. The eyelets 58 are arranged on diametrically opposite sides of the tubular portion 52 and have an elongate stadium shaped outline (that is, a rectangle with semicircles on a pair of opposing edges). They have a length (measured longitudinally along the tubular portion 52) of 4.1 mm and a width (measured circumferentially around the tubular portion 52) of 1.1 mm, giving them a cross-sectional area (that is an area bounded by an edge of the eyelet 58 and perpendicular to the direction of flow as denoted by line C-C) 4.35.64 mm².

The small eyelets also have a stadium shaped outline, the size of the small eyelets 61 varies over the length (as measured along the longitudinal axis of the tubular portion) of the array 60. The small eyelets 61 have a constant length of 1 mm, but vary in width with the small eyelets 61 on the row closest to the tip 55 having a width of 0.4 nun which gradually increases over the rows such that the small eyelets 61 on the row distal to the tip 55 have a width of 0.8 mm. Thus, in this embodiment the small eyelets 61 have a cross-sectional area (measured in the same manner as the eyelets) of between 0.36 mm² and 0.56 mm².

When subjected to the test of flow rate set out above, it was observed that the eyelets 58 drew in the simulated mucus such that the nearby small eyelets 61 did not become blocked and the catheter tube 1 was able to completely drain the test apparatus. The eyelets 58 act to clear the volume adjacent to the catheter tube 1 of mucus, allowing the small eyelets to drain the simulated urine more effectively.

When used by a user, the catheter tube 51 is inserted tip 55 first into the user’s urethra until the eyelets 58 are within the bladder (which the user will note from the flow of urine starting). Advantageously, because the array 60 of small eyelets 61 extends below the distal eyelet 58b the catheter tube is less susceptible to over insertion into the bladder, the small eyelets will drain the urine from lower in the bladder. The urine flows along a flow path from the bladder through the eyelets 58 and small eyelets 61 into the inner lumen 59 and out via the drain 57. Advantageously, whilst the eyelets 58 and/or small eyelets 61 may become blocked by the walls of the bladder, mucus and/or sediment, the provision of more, and smaller eyelets results in reduced pressure differentials when this occurs. With reference to Figures 4 and 5 a second embodiment of a catheter tube 101 according to the present invention is described. The catheter tube 101 defines a longitudinal axis D-D and comprises a tubular portion 102 having a wall 103 defining an inner lumen 109. In this embodiment there is provided at an insertion end 104 of the catheter tube 101 a tip 105 having a hemispherical shape (referred to by those in the art as a “Nelaton” tip), the tip 105 defines a proximal end of the catheter tube 101. In other embodiments alternative tip geometries may be used, for example a Coude or Tiemann tip. At a distal end 106 of the catheter tube 101 there is provided a drain 107. In some embodiments the catheter tube 101 may be functionalised, for example it may comprise or be coated in a hydrophilic material.

Arranged on the tubular portion are two eyelets 108 which extend through the wall 103 of the tubular portion 102, providing a fluid connection between the inner lumen 109 and an exterior of the catheter tube 101.

The eyelets 108 are arranged on diametrically opposite sides of the tubular portion 102, a first, proximal, eyelet 108a is arranged approximately 9 mm from the tip 105, and a second, distal, eyelet 108b is arranged approximately 18 mm from the tip 105. The eyelets 108 have an elongate stadium shaped outline (that is, a rectangle with semicircles on a pair of opposing edges). The eyelets 108 have a length (measured longitudinally along the tubular portion 102) of 4.1 mm and a width (measured circumferentially around the tubular portion 102) of 1.1 mm, giving them a cross- sectional area (that is an area bounded by an edge of the eyelet 58 and perpendicular to the direction of flow as denoted by line E-E) 4.3 mm².

In addition to the eyelets 108 two arrays 110 of small eyelets 111 are provided on the tubular portion 102. In the present embodiment each array 110 comprises three rows 112, with each row comprising three evenly separated small eyelets 111. A first, proximal, array 110a is arranged diametrically opposite the proximal eyelet 105a and a second, distal, array 110b is arranged diametrically opposite the distal eyelet 105b.

The small eyelets 111 also have a stadium shaped outline, the small eyelets 111 have a length (as measured along the longitudinal axis of the tubular portion 102) of 1 nun and a width (as measured circumferentially around the tubular portion 102) of 0.4 mm. Thus, in this embodiment the small eyelets have a cross-sectional area (measured in the same manner as the eyelets 108) of approximately 0.56 mm².

In use the catheter tube 101 is inserted tip 105 first into the user’s urethra until the eyelets 108 are within the bladder (which the user will note from the flow of urine starting). Urine flows along a flow path from the bladder through the eyelets 108 and small eyelets 111 into the inner lumen and out of the drain 107. Advantageously, whilst the eyelets 108 and small eyelets 111 may become blocked by the walls of the bladder, the provision of a plurality of smaller small eyelets 111 results in reduced pressure differentials.

The combination of eyelets 108 and small eyelets 111 provides further advantageous effects. The provision of larger eyelets 108 provides an increased flow which draws sediment and mucus into the eyelets 58 thereby reducing or preventing blockage of the small eyelets 61 which can continue to drain urine.

As compared to the first embodiment, the reduction in the number of small eyelets increases the flow rate through each eyelet and small eyelet, this increases their ability to “draw in” and clear mucus and sediment.

The one or more embodiments are described above by way of example only. Many variations are possible without departing from the scope of protection afforded by the appended claims.

Claims

1. A urinary catheter comprising, a tip, a tubular portion and a drainage end, the tubular portion comprising an inner lumen which defines a portion of a drainage flow path, wherein the tubular portion comprises at least one eyelet and at least one small eyelet configured to provide fluid communication between the inner lumen and an environment external to the tubular portion.

2. A urinary catheter according to claim 1 wherein a plurality of small eyelets are provided in one or more arrays.

3. A urinary catheter according to claim 2 wherein there is one array, the array comprising a plurality of rows, each row extending about the entire circumference of the tubular portion, and wherein the array extends least 20% of the length of the tubular portion, wherein the at least one eyelet is arranged within the array extending between two adjacent rows.

4. A urinary catheter according to claim 3 wherein the tubular portion comprises a plurality of eyelets, wherein the eyelets are longitudinally separated and arranged on diametrically opposing sides of the tubular portion to adjacent eyelets.

5. A urinary catheter according to claim 2 wherein the or each array is arranged at the same longitudinal position on the tubular portion as a corresponding eyelet.

6. A urinary catheter according to claim 2 or 5 wherein the or each array is arranged on an opposing site of the tubular portion to a corresponding eyelet.

7. A urinary catheter according to claim 5 or 6 wherein the tubular portion comprises a plurality of eyelets, wherein the eyelets are longitudinally separated and arranged on diametrically opposing sides of the tubular portion, and an array is provided on a diametrically opposite side of the tubular portion to one, or more, or each eyelet.

8. A urinary catheter according to any of claims 5 to 7 wherein each array comprises at least 4 small eyelets.

9. A urinary catheter according to any of claims 5 to 8 wherein each array comprises at least 2 rows of small eyelets and each row comprises at least 2 small eyelets.

10. A urinary catheter according to any of claims 2 to 9 wherein each small eyelet is equally spaced from the adjacent small eyelets.

11. A urinary catheter according to any preceding claim wherein the urinary catheter comprises at least two eyelets.

12. A urinary catheter according to any of claims claim 2 to 11 wherein one or more or each array comprises at least 5 rows of small eyelets.

13. A urinary catheter according to claim 12 wherein one, or more, or each row comprises at least 6 small eyelets.

14. A urinary catheter according to any of claims 2 to 13 wherein the one, or more, or each array extends over at least 20% of the length of the tubular portion.

15. A urinary catheter according to any of claims 2 to 14 wherein the one, or more, or each array has a length of at least 20 mm.

16. A urinary catheter according to any preceding claim wherein the eyelets have a cross-sectional area of between 3 and 8 mm².

17. A urinary catheter according to any preceding claim wherein the small eyelets have a cross-sectional area of between 0.2 and 0.8 mm².

18. A urinary catheter according to any preceding claim wherein the catheter tube comprises or is coated in a hydrophilic material.

19. A urinary catheter according to any preceding claim wherein the catheter is an intermittent catheter.

20. A urinary catheter according to any preceding claim wherein the tip is a closed tip.