An intermittent urinary catheter

Abstract

An intermittent urinary catheter (1) comprises an elongate main body (2) and a funnel (26). The elongate main body has an insertion end for insertion into a urethra and an outflow end. The funnel is provided at the outflow end of the elongate main body. The elongate main body further comprises an external flushing portion (7). The funnel comprises an inlet end (102) and an outlet end (101), and a bore (100) therebetween. The bore comprises an outlet portion (103) from which urine exits the catheter; a connection portion (105), where the elongate main body is connected to the funnel; and a urine collection portion (104), which, in use, collects urine flowing along the outer surface of the elongate main body. The urine collection portion comprises a converging portion (30) of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion.

Description

[0001] An Intermittent Urinary Catheter

[0002] Technical Field of the Invention

[0003] The present invention relates to an intermittent urinary catheter which is configured to aid flushing of the urethra in use. In particular, the present invention concerns the funnel of such a catheter.

[0004] Background to the Invention

[0005] Urinary catheters for draining urine from the bladder may be indwelling or intermittent and are used to drain urine from a bladder. Intermittent catheters are typically used by patients suffering from urinary incontinence or by disabled individuals several times a day to drain the bladder as required.

[0006] It is relatively common for users of intermittent catheters to develop urinary tract infections or other complications. In some cases, this is because intermittent catheters typically comprise a closed lumen which expels urine from the bladder without it contacting the urethra wall. As such, there can be a persistent build-up of bacteria and debris (e.g., skin cells or excretions) which would otherwise be flushed out by the urine.

[0007] WO2023156778, WO2023156776 and WO2023156777 all disclose at least some examples of intermittent urinary catheters comprising an elongate main body a funnel, in which the elongate main body has an insertion end for insertion into a urethra and an outflow end, the funnel being provided at the outflow end of the elongate main body. Each discloses that the elongate main body comprises an external flushing portion of some form extending along at least a portion of the elongate main body between the insertion end and the outflow end, to allow urine to flush the urethra.

[0008] In these disclosures, various embodiments are outlined with proposals for allowing urine to flow away from the outlet end. In practice, none of the proposed arrangements for allowing fluid to flow from the external surface of the catheter and away have proven satisfactory. Even where only part of the flow of urine is on the outside of the catheter and some flows through the centre, ensuring that all of the fluid re-enters an outlet section of the catheter, such as a funnel, is troublesome and pressure can build up outside the main body of the catheter, eventually bursting round the outside of the outlet portion or funnel.

[0009] Whilst prior art proposals are known in which the elongate main body (equivalent to a catheter tube in a conventional catheter assembly) and funnels are formed integrally, e.g. by moulding, in practice commercial considerations and material properties make it preferable, at least in some instances, for the funnel and the elongate main body to be manufactured separately and joined together (e.g. so that they can be made from different materials, each more suitable for its function, or so that the same funnels can be used with different types or sizes of catheter tubes / main bodies). In such an arrangement, the funnel and the elongate main body must be connected at a connection portion of the funnel, which may create a pinch-point in terms of space available for fluid flow. Thus in that case, the issue of urine escaping to the outside surface of the funnel can be even more problematic.

[0010] In another disclosure of an external flow catheters in WO2012 / 85124 the problem of forcing external flowing urine to flow back inside the catheter is circumvented by allowing the flow to exit the urethra still on the external surface of the elongate main body, with a handle provided rather than a funnel. This is quite different to what users are used to, and is considered unlikely to find traction in the market.

[0011] As such, the present invention seeks to provide an improved intermittent urinary catheter for flushing the urethra in use.

[0012] Summary of the Invention

[0013] The present disclosure provides an intermittent urinary catheter according to the appended claims.

[0014] The present disclosure provides, in a broad aspect, a catheter. The catheter may be a urinary catheter. The urinary catheter may be an intermittent urinary catheter. The intermittent urinary catheter may comprise an elongate main body and a funnel. The elongate main body may have an insertion end for insertion into a urethra. The elongate main body may have an outflow end. The funnel may be provided at the outflow end of the elongate main body. The elongate main body may comprise an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end. The funnel may comprise an inlet end and an outlet end, and a bore therebetween. The bore may comprise an outlet portion. In use urine may exit the catheter from the outlet portion. The bore may comprise a connection portion. The elongate main body may be connected to the funnel at the connection portion. The bore may comprise a urine collection portion. In use, the urine collection portion may collect urine flowing along the outer surface of the elongate main body. The urine collection portion may comprise a converging portion of the bore. In the converging portion of the bore the diameter of the bore may reduce from the inlet end towards the connection portion.

[0015] One broad aspect of the invention provides a catheter comprising a funnel, the funnel comprising an inlet end and an outlet end and a bore therebetween, the bore comprising a urine collection portion, and the urine collection portion comprising a converging portion of the bore.

[0016] Another broad aspect of the invention provides an intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion and a urine collection portion; wherein the urine collection portion comprises a converging portion of the bore

[0017] Another broad aspect of the invention provides an intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion; a connection portion; and a urine collection portion; wherein the urine collection portion comprises a converging portion of the bore. According to a first aspect of the invention, there is provided an intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion from which in use urine exits the catheter; a connection portion, where the elongate main body is connected to the funnel; and a urine collection portion, which, in use, collects urine flowing along the outer surface of the elongate main body; wherein the urine collection portion comprises a converging portion of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion.

[0018] By providing a converging portion in which the diameter of the bore reduces from the inlet end towards the connection portion, urine flowing on the external surface of the elongate main body is encouraged to flow into the funnel and not around it. The convergence may reduce turbidity / turbulence where the urine collection portion meets the connecting portion, thereby allowing a greater flow, and therefore a reduced pressure build up, and a reduced chance of urine bursting past the funnel rather than entering it.

[0019] The funnel and the elongate main body may be formed as separate parts and attached at the connection portion. The funnel and the elongate main body may be attached by adhesion or welding, for example, or may be attached by a push-fit, snap- fit or the like. This allows the use of different materials for the different parts. For example, the elongate main body may be provided with a hydrophilic surface, so that it may be lubricated by a wetting agent such as water, whilst the funnel may be provided in a different, more suitable or cheaper material (e.g. one without hydrophilic surface properties).

[0020] As noted above, with separate parts, the problem of urine bursting past the entrance to the funnel may be enhanced, thus the solution of the invention is particularly advantageous in such an arrangement. In a particularly preferred embodiment there is provided an intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion from which in use urine exits the catheter; a connection portion, where the elongate main body is connected to the funnel; and a urine collection portion, which, in use, collects urine flowing along the outer surface of the elongate main body; wherein the urine collection portion comprises a converging portion of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion, and wherein the funnel and elongate main body are attached by a push- fit.

[0021] In another particularly preferred embodiment, there is provided an intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion from which in use urine exits the catheter; a connection portion, where the elongate main body is connected to the funnel; and a urine collection portion, which, in use, collects urine flowing along the outer surface of the elongate main body; wherein the urine collection portion comprises a converging portion of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion, and wherein the funnel and elongate main body are formed from different materials.

[0022] The converging portion of the bore may have an opening (to receive urine). The outlet portion of the funnel may comprise an opening (through which urine exits the catheter). The opening of the converging portion may be larger than the opening of the outlet portion. The opening of the converging portion may have a maximum width (e.g. diameter for a circular-section funnel) of at least 6mm, at least 7mm, or at least 8mm. The opening of the outlet portion may have a maximum width of no more than 8mm, no more than 7mm or no more than 6.5 mm.

[0023] In a particularly preferred embodiment, there is provided an intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion from which in use urine exits the catheter; a connection portion, where the elongate main body is connected to the funnel; and a urine collection portion, which, in use, collects urine flowing along the outer surface of the elongate main body; wherein the urine collection portion comprises a converging portion of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion, wherein the converging portion of the bore has an opening to receive urine and the outlet portion of the funnel comprises an opening through which urine exits the catheter; and wherein the opening of the converging portion is larger than the opening of the outlet portion.

[0024] The opening of the converging portion of the bore may have a maximum width of no more than 15 mm, no more than 12mm, no more than 10mm, or no more than 9mm. For example it may be between 6mm and 12mm, or between 7mm and 9mm, such as about 8mm.

[0025] In a particularly preferred embodiment, there is provided an intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion from which in use urine exits the catheter; a connection portion, where the elongate main body is connected to the funnel; and a urine collection portion, which, in use, collects urine flowing along the outer surface of the elongate main body; wherein the urine collection portion comprises a converging portion of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion, wherein the converging portion of the bore has an opening to receive urine and the opening of the converging portion has a maximum width of at least 7mm.

[0026] In a particularly preferred embodiment, there is provided an intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion from which in use urine exits the catheter; a connection portion, where the elongate main body is connected to the funnel; and a urine collection portion, which, in use, collects urine flowing along the outer surface of the elongate main body; wherein the urine collection portion comprises a converging portion of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion, wherein the converging portion of the bore has an opening to receive urine and the opening of the converging portion of the bore has a maximum width of no more than 10mm.

[0027] The maximum width of the opening of the converging portion of the bore may be at least 20%, at least 30%, at least 40%, or at least 50% larger than the maximum width of the elongate main body at the same longitudinal position.

[0028] In a particularly preferred embodiment, there is provided an intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion from which in use urine exits the catheter; a connection portion, where the elongate main body is connected to the funnel; and a urine collection portion, which, in use, collects urine flowing along the outer surface of the elongate main body; wherein the urine collection portion comprises a converging portion of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion, wherein the converging portion of the bore has an opening to receive urine and the maximum width of the opening of the converging portion of the bore is at least at least 30% larger than the maximum width of the elongate main body at the same longitudinal position.

[0029] Provision of such a large opening (in both absolute and relative terms) is advantageous in terms of (a) ensuring a large enough opening to capture sufficient urine, and (b) exerting a pressure on the urethral opening sufficient to create a good seal therewith.

[0030] The converging portion may converge at an angle, i.e. an average angle along its length of at least 5 degrees, at least 10 degrees, at least 15 degrees or most preferably at least 20 degrees. It may converge at an angle of no more than 45 degrees, no more than 35 degrees or no more than 30 degrees. For example, the converging portion may converge at an angle of about 20 to 30 degrees, such as about 24-25 degrees.

[0031] The outlet portion of the bore may diverge, towards the outlet end. The converging portion of the bore may converge at a greater angle than the angle at which the outlet portion diverges, for example, at least 5 degrees, at least 10 degrees, at least 15 degrees or at least 20 degrees more than the angle by which the outlet portion diverges.

[0032] The converging portion of the bore may have a length of at least 3mm, at least 4mm, or at least 5 mm. The converging portion of the bore may have a length of no more than 10mm, no more than 8mm, or no more than 6mm. For example it may have a length of between 3mm and 9mm, between 4mm and 7mm, or between 5mm and 6mm, e.g. about 5.5mm.

[0033] In a particularly preferred embodiment, there is provided an intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion from which in use urine exits the catheter; a connection portion, where the elongate main body is connected to the funnel; and a urine collection portion, which, in use, collects urine flowing along the outer surface of the elongate main body; wherein the urine collection portion comprises a converging portion of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion and wherein the converging portion of the bore has a length of at least 4 mm.

[0034] This is an appropriate, but not excessive length to serve the purpose of collecting and directing urine.

[0035] The funnel may comprise a flared portion. The flared portion may corresponding with the urine collection portion of the bore. The flared portion may be tubular. The inner surface of the flared portion may be defined by the urine collection portion of the bore. The outer surface of the flared portion may be generally parallel with the inner surface of the flared portion.

[0036] The provision of a flared portion corresponding with the converging portion of the bore can further improve the seal between the funnel and the urethral opening, on account of the pressure applied to the urethral opening in the region of the flared portion. It is to be noted that typically, structures intended to enter or abut the urethra are tapered, with an outer surface diverging away from the point of entry, i.e. being thinnest at the tip, which enters first, so as to aid entry. This arrangement by contrast has a flare, with an outside surface converging away from the point of entry.

[0037] The outer surface of the flared portion may be provided with one or more ribs, for example two ribs. The or each rib may extend circumferentially. Each rib may project radially from the outer surface. In use, the flared portion will be arranged against the urethral opening of a user and the ribs may improve sealing performance against the urethra, improving resistance to urine flowing around the outside of the funnel. In a particularly preferred embodiment, there is provided an intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion from which in use urine exits the catheter; a connection portion, where the elongate main body is connected to the funnel; and a urine collection portion, which, in use, collects urine flowing along the outer surface of the elongate main body; wherein the urine collection portion comprises a converging portion of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion, wherein the funnel comprises a flared portion corresponding with the urine collection portion of the bore and wherein the outer surface of the flared portion is provided with one or more circumferentially extending ribs.

[0038] The converging portion of the bore may have a curved profile. The converging portion may have a concave curving profile. The converging portion of the bore may have a curved portion proximal the connection portion. The flared portion may have a curving profile. The external surface of the flared profile may have a concave curving portion. In this way, the internal and external profiles of the flared portion may correspond.

[0039] In a particularly preferred embodiment, there is provided an intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion from which in use urine exits the catheter; a connection portion, where the elongate main body is connected to the funnel; and a urine collection portion, which, in use, collects urine flowing along the outer surface of the elongate main body; wherein the urine collection portion comprises a converging portion of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion, and wherein the converging portion of the bore has a concave curved profile. Provision of a curve, particularly a concave curve and particularly in the region where the converging portion of the bore meets the connection portion may offer improved flow dynamics.

[0040] The converging portion of the bore may have a straight profile. The flared portion may have a straight profile. The external surface of the flared portion may have a straight profile. A straight profile may be easier to produce than a curved profile. A straight profile may in some circumstances offer improved flow dynamics.

[0041] The converging portion may have a stepped profile. The stepped profile may have at least two sections at different angles. The stepped profile may have at least three sections at different angles. None of the sections may have an angle of 0 degrees.

[0042] In a particularly preferred embodiment, there is provided an intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion from which in use urine exits the catheter; a connection portion, where the elongate main body is connected to the funnel; and a urine collection portion, which, in use, collects urine flowing along the outer surface of the elongate main body; wherein the urine collection portion comprises a converging portion of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion, and wherein the converging portion has a stepped profile.

[0043] In a particularly preferred embodiment, there is provided an intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion from which in use urine exits the catheter; a connection portion, where the elongate main body is connected to the funnel; and a urine collection portion, which, in use, collects urine flowing along the outer surface of the elongate main body; wherein the urine collection portion comprises a converging portion of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion, wherein the converging portion has a stepped profile wherein the stepped profile has at least two sections at different angles.

[0044] In a particularly preferred embodiment, there is provided an intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion from which in use urine exits the catheter; a connection portion, where the elongate main body is connected to the funnel; and a urine collection portion, which, in use, collects urine flowing along the outer surface of the elongate main body; wherein the urine collection portion comprises a converging portion of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion, wherein the converging portion has a stepped profile wherein the stepped profile has at least two sections at different angles wherein none of the sections has an angle of zero degrees.

[0045] In a particularly preferred embodiment, there is provided an intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion from which in use urine exits the catheter; a connection portion, where the elongate main body is connected to the funnel; and a urine collection portion, which, in use, collects urine flowing along the outer surface of the elongate main body; wherein the urine collection portion comprises a converging portion of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion, wherein the converging portion has a stepped profile wherein the stepped profile has at least three sections at different angles.

[0046] In a particularly preferred embodiment, there is provided an intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion from which in use urine exits the catheter; a connection portion, where the elongate main body is connected to the funnel; and a urine collection portion, which, in use, collects urine flowing along the outer surface of the elongate main body; wherein the urine collection portion comprises a converging portion of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion, wherein the converging portion has a stepped profile wherein the stepped profile has at least three sections at different angles wherein none of the sections has an angle of zero degrees.

[0047] One section of the stepped profile, preferably that nearest to the inlet end of the funnel may have an angle of about 0-5 degrees.

[0048] One section, preferably that furthest from the inlet end of the funnel may have a steeper angle than the section closest to the inlet end of the funnel may have an angle of at least 5 degrees, at least 10 degrees, at least 15 degrees or most preferably at least 20 degrees. It may converge at an angle of no more than 45 degrees, no more than 35 degrees or no more than 30 degrees. For example, the converging portion may converge at an angle of about 20 to 30 degrees, such as about 24-25 degrees. One section, preferably an intermediate section between the section closest to the inlet end of the funnel and the section furthest from the inlet end of the funnel may have a steepest angle, which may be of least 20 degrees, 30 degrees, 40 degrees or 45 degrees. It may converge at an angle of no more than 60 degrees, no more than 55 degrees or no more than 50 degrees.

[0049] For example, the converging portion comprise a section closest to the inlet end of the funnel with a lowest angle, an adjacent intermediate section with a highest angle and a section furthest from the end of the funnel with an intermediate opening. In this way, the converging portion may converge at an angle of about 20 to 30 degrees, such as about 24-25 degrees, but the part that abuts the urethral opening may not be angled, or only angled very slightly, with the overall angle achieved by the step, in particular the steepest section offsetting the least steep section.

[0050] The converging portion of the bore may be smooth, i.e. without any obstructions, such as projections or recesses.

[0051] The elongate main body may comprise one or more apertures arranged to receive urine collected by the urine collection portion of the bore. The or each aperture may be in fluid communication with the outlet portion of the bore. The or each aperture may extend to one or more lumen extending through the connection portion. In this way, the urine collection portion of the bore co-operates with the connection portion to aid fluid flow through the funnel.

[0052] The connecting portion may comprise a mechanical connecting feature, to cooperate with a corresponding mechanical connecting feature of the elongate main body. For example, the connecting portion may comprise a projection which corresponds to a recess on the elongate main body. Alternatively, the connecting portion may comprise an abutment area where the funnel and the elongate main body touch and are physically joined, e.g. by adhesion or welding.

[0053] The elongate main body may have a solid core. The elongate main body may have one or more elongate channels forming the external flushing portion. In such an arrangement, all of the flow of urine to the funnel may be along the external surface of the elongate main body. In such an arrangement the urine collection portion is required to collect all (or substantially all) of the urine flowing from the bladder and guide it through the funnel, making its effectiveness important.

[0054] The elongate main body may have a lumen. The lumen may extend between the insertion end and the outflow end. The elongate main body may further comprise at least one inlet aperture. The at least one inlet aperture may be proximal to the insertion end. The external flushing portion may extend along a portion of the elongate main body between the insertion end and the outflow end. The external flushing portion may comprise a plurality of elongate eyelets. The plurality of elongate eyelets may be formed through an external surface of the elongate main body.

[0055] Providing an external flushing portion comprising a plurality of elongate eyelets formed through the external surface of the elongate main body maintains the advantage of advantageous as it allows a flow of urine to contact the urethra during use. The flow of urine may act to flush the urethra and help reduce the possibility of infection. Furthermore, providing the external flushing portion with a plurality of elongate eyelets provides a relatively large amount of space through which urine may flow externally from the catheter to contact and flush the urethra in use whilst also providing a resilient structure capable of supporting and maintaining the urethra in an open state without warping or buckling under the pressures exerted by the wall of the urethra. Moreover, providing an intermittent urinary catheter with a plurality of elongate eyelets may be more appealing to users than providing alternative flushing features such as long channels, as eyelets are commonly found in intermittent urinary catheters (although hitherto, only as inlets), making such an intermittent urinary catheter more easily recognisable as a standard catheter. Therefore, users may not be as deterred by the eyelets and feel much more comfortable using such a catheter, whilst still receiving the benefits of flushing of the urethra.

[0056] There may be provided any suitable number of inlet apertures. There may be provided between one and four inlet apertures. In a preferred embodiment, the elongate main body may comprise two (and optionally only two) inlet apertures. The two inlet apertures may be circumferentially offset. For example, the two inlet apertures may be diametrically opposed. The two inlet apertures may be longitudinally offset. For example, the inlet apertures may be longitudinally offset and diametrically opposed. Providing the two inlet apertures diametrically opposed enables the bladder to be emptied from both sides of the catheter without compromising the structural integrity of the catheter. Furthermore, providing longitudinally offset inlet apertures enables the catheter to be inserted into the bladder by varying amounts without compromising or restricting flow of urine into the lumen.

[0057] The at least one inlet aperture may be configured to be fully inserted into the bladder. Additionally or alternatively, the at least one inlet portion may be configured to be partially inserted into the bladder. This configuration is particularly advantageous in ensuring full bladder emptying as the at least one inlet aperture overlaps both the urethra and bladder ensuring that any urine residing on the bottom of the bladder may be emptied via the at least one inlet aperture.

[0058] The at least one inlet aperture may comprise a means for directing flow. The at least one inlet aperture may comprise an open flow channel. The open flow channel may be provided in the external surface of the elongate main body. The open flow channel may extend over at least one quarter of the length of the at least one inlet aperture. The open flow channel may extend over at least one third of the length of the at least one inlet aperture. The open flow channel may extend over at least one half of the length of the at least one inlet aperture. The open flow channel may comprise a wall. The wall may be recessed from an external surface of the elongate main body.

[0059] Providing an inlet aperture having an open flow channel is particularly advantageous in directing urine from the bladder, through the at least one inlet aperture to the lumen such that the bladder may be efficiently emptied. The urine may then pass through the lumen and out of the catheter via the external flushing portion.

[0060] The open flow channel may comprise a base. The base may be substantially flat. Alternatively, the base may have a curved profile. Additionally or alternatively, the open flow channel may comprise a pair of side walls. The pair of side walls may be substantially flat. Additionally or alternatively, the pair of side walls may have a curved profile. The pair of side walls may be provided adjacent to the base. For example, one of the pair of side walls may extend along the left hand side of the base and the other side wall may extend along the right hand side of the base. The pair of side walls may be angled to form the open flow channel with a substantially “V” or “U” shaped cross section. The cross-sectional area of the open flow channel may be constant along a major portion of the length thereof. The cross-sectional area of the open flow channel may be constant along at least half of the length thereof. Providing an open flow channel having a cross section as described herein ensures a constant and efficient flow of urine through the open flow channel without being disturbed by irregularities within the cross section.

[0061] Additionally or alternatively, the open flow channel may further comprise an angled portion. The angled portion may be provided at the proximal end of the open flow channel. The angled portion may be configured to direct fluid from the bladder toward the lumen. There may be provided an insertion portion. The insertion portion may facilitate insertion of the catheter into and along the urethra. The insertion portion may be hollow. The insertion portion may comprise a rounded tip. The rounded tip may be provided at the insertion end. The rounded tip may aid insertion of the catheter into the bladder via the urethra. Providing a rounded tip improves comfort of the user, particularly during insertion of the catheter into the urethra. The insertion portion may comprise a hollow tubular wall. The hollow tubular wall may define the lumen. The at least one inlet aperture may be provided in the hollow tubular wall. The at least one open flow channel may be integrally formed with the hollow tubular wall. The base and / or pair of side walls may be integrally formed with the hollow tubular walls. The at least one inlet aperture may be in fluid communication with the lumen. The at least one inlet aperture may be in fluid communication with the external flushing portion via the lumen.

[0062] Providing at least one inlet aperture in fluid communication with the lumen allows for a more complete emptying of the bladder and flushing of the urethra via the external flushing portion.

[0063] The at least one inlet aperture may be rectangular. The at least one inlet aperture may be oval. In a preferred embodiment, the at least one inlet aperture may be stadium shaped. A stadium shaped inlet aperture is particularly advantageous as it does not comprise any pointed corners which may catch the walls of the urethra during insertion and removal of the catheter causing discomfort for the user. The at least one inlet aperture may comprise an angled edge, or ‘chamfer’ . The angled edge may extend partially or fully around the perimeter of the at least one inlet aperture. In a preferred embodiment, the angled edge may extend fully around the perimeter of the at least one inlet aperture. Providing an angled edge is particularly advantageous in increasing user comfort during insertion and use as it minimises the risk of sharp edges catching and cutting the users skin. The angled edge may be straight. The angled edge may be curved. The angled edge may be convex i.e. ‘radiused’. The angled edge may be concave.

[0064] The at least one inlet aperture may have a width in the range of 0.8 mm to 1.2 mm. The at least one inlet aperture may have a width in the range of 0.85 mm to 1.15 mm. The at least one inlet aperture may have a width in the range of 0.9 mm to 1.1 mm. The at least one inlet aperture may have a width in the range of 0.95 mm to 1.05 mm. In a preferred embodiment, the at least one inlet aperture may have a width of 1 mm.

[0065] The at least one inlet aperture may have a length in the range of 5 mm to 16 mm. The at least one inlet aperture may have a length in the range of 9 mm to 15.5 mm. The at least one inlet aperture may have a length in the range of 13 mm to 15 mm. In a preferred embodiment, the at least one inlet aperture may have a length of 14 mm.

[0066] The elongate main body may be straight (i.e., in the absence of bending forces, at rest, the elongate main body may be substantially straight).

[0067] The external surface of the elongate main body may form a hollow tubular wall. The hollow tubular wall may be substantially cylindrical. The hollow tubular wall may define the lumen. The lumen may be a hollow passageway. The lumen may extend from the insertion portion to the outflow end. The lumen may be in fluid communication with the plurality of elongate eyelets. The lumen may define a fluid flow path from the insertion portion to the outflow end. The lumen may comprise a first end and a second end. The first end may be in fluid communication with the at least one inlet aperture. The second end may be provided at the outflow end. Urine may exit the lumen and therefore the catheter at the second end. The lumen may have constant cross section along the length thereof. Alternatively, the lumen may have a constant cross section along a major portion of the length thereof. For example, the lumen may have a constant cross section along at least 70%, 80% or 90% of the length thereof. The external flushing portion may be configured, in use, to provide fluid communication between the catheter and the urethra via the plurality of elongate eyelets. Providing fluid communication between the catheter and the urethra via the plurality of elongate eyelets is particularly advantageous as it allows a flow of urine to contact the walls of the urethra during use, helping to reduce the possibility of infection.

[0068] The plurality of elongate eyelets may have a longitudinal axis. The longitudinal axis of the plurality of elongate eyelets may extend parallel to the longitudinal axis of the main body. The plurality of elongate eyelets may be spaced along the longitudinal axis of the elongate main body. The plurality of elongate eyelets may be spaced by a fixed distance along the longitudinal axis of the elongate main body. The plurality of elongate eyelets may be at least partially spaced along the longitudinal axis of the elongate main body. At least one of the plurality of elongate eyelets may be at least partially spaced along the longitudinal axis of the elongate main body. The plurality of elongate eyelets may be completely spaced along the longitudinal axis of the elongate main body. At least one of the plurality of elongate eyelets may be completely spaced along the longitudinal axis of the elongate main body. The plurality of elongate eyelets may be spaced by the length of at least one of the plurality of elongate eyelets. Providing the plurality of elongate eyelets completely spaced is particularly advantageous as it provides an improved fluid flow path for urine passing through the lumen having a more constant cross section which minimises turbulence of the flow passing through. Additionally or alternatively, at least one or each of the plurality of elongate eyelets may be spaced by the same distance along the longitudinal axis of the elongate main body. Additionally or alternatively, at least one or each of the plurality of elongate eyelets may be spaced by a different distance along the longitudinal axis of the elongate main body. Providing the plurality of elongate eyelets spaced along the longitudinal axis of the elongate main body is particularly advantageous as it ensures that the structural integrity of the catheter is maintained such that it may resist bending and buckling forces exerted during use whilst allowing flushing of the urethral wall which may prevent the build-up of bacteria. The spacing of the plurality of elongate eyelets provides flexibility which is particularly advantageous during insertion of the catheter as it enables the catheter to adapt to the shape of the urethra into which it is being inserted. At least one of the plurality of elongate eyelets may not directly oppose any other of the plurality of the elongate eyelets.

[0069] In alternative embodiments, at least one of the plurality of elongate eyelets may directly oppose another of the plurality of elongate eyelets. Additionally or alternatively, at least one of the plurality of elongate eyelets may partially oppose another of the plurality of elongate eyelets.

[0070] The plurality of elongate eyelets may be provided along a plane of the longitudinal axis of the elongate main body. A first series of elongate eyelets may be formed through a first side of the elongate main body. A second series of elongate eyelets may be formed through a second side of the elongate main body. Each series may comprise any suitable number of elongate eyelets. One or each series may comprise at least two elongate eyelets. One or each series may comprise at least three elongate eyelets. One or each series may comprise at least four elongate eyelets. One or each series may comprise at least five elongate eyelets. One or each series may comprise at least six elongate eyelets. One or each series may comprise at least seven elongate eyelets. One or each series may comprise at least eight elongate eyelets. One or each series may comprise at least nine elongate eyelets. One or each series may comprise at least ten elongate eyelets. Each of the first series and second series may comprise the same number of elongate eyelets. Each of the first series and second series may comprise a different number of elongate eyelets. In a preferred embodiment, each series may comprise three elongate eyelets. In a preferred embodiment, the first series of three elongate eyelets may be formed through the first side of the elongate main body and the second series of three elongate eyelets may be formed through the second side of the elongate main body. The first side of the elongate main body and the second side of the elongate main body may be diametrically opposed. The eyelets of the first series may be staggered with respect to the eyelets of the second series such that at least one eyelet of the first series opposes the space between eyelets of the second series. The pitch of the staggered eyelets may be such that no part of an eyelet of the first series directly opposes any part of an eyelet of the second series.

[0071] None of the elongate eyelets of the first series may directly oppose an elongate eyelet of the second series. Providing the series of elongate eyelets in this particular arrangement is particularly advantageous for manufacturing the catheters via injection moulding as the plurality of elongate eyelets do not extend through both a first side and diametrically opposing second side at the same point along the length of the elongate main body. This also helps to maintain rigidity and resistance to bending and / or buckling of the catheter during use.

[0072] In an alternative embodiment, the first series of elongate eyelets (e.g. the first series of three elongate eyelets) may be formed through the first side of the elongate main body and the second series of elongate eyelets (e.g. the second series of three elongate eyelets) may be formed through the second side of the elongate main body. The first series of elongate eyelets and the second series of elongate eyelets may be diametrically opposed. At least one of the elongate eyelets of the first series may directly oppose any of the elongate eyelets of the second series. Each of the elongate eyelets of the first series may directly oppose an elongate eyelet of the second series.

[0073] The plurality of elongate eyelets may have a substantially rectangular shape, for example, rectangular with rounded corners. The plurality of elongate eyelets may have an oval shape. In a preferred embodiment, the plurality of elongate eyelets may have a stadium shape. The plurality of elongate eyelets may comprise a pair of long sides. The long sides may be parallel. The long sides may extend longitudinally. The pair of long sides may be connected by a first short side and a second short side. At least one of the first and second short sides may be straight. At least one of the first and second short side may be curved. In a preferred embodiment, both the first and second short sides are curved. Providing at least one curved short side is particularly advantageous during insertion and withdrawal of the catheter into the urethra as it minimises the possibility of sharp edges catching and / or cutting the walls of the urethra.

[0074] At least one of the pair of long sides and / or the first short side and / or the second short side may comprise an angled edge, or ‘chamfer’. In a preferred embodiment all the sides comprise an angled edge, thereby minimising the presence of sharp edges cutting or catching the urethral wall. The angled edge may be straight. The angled edge may be curved. The angled edge may be convex i.e. ‘radiused’. The angled edge may be concave. At least one of the plurality of elongate eyelets may have a width of at least 0.7 mm. At least one of the plurality of elongate eyelets may have a width of at least 0.8 mm. At least one of the plurality of elongate eyelets may have a width of at least 0.85 mm. At least one of the plurality of elongate eyelets may have a width of at least 0.9 mm. At least one of the plurality of elongate eyelets may have a width of at least 0.95 mm. At least one of the plurality of elongate eyelets may have a width of at least 1 mm. At least one of the plurality of elongate eyelets may have a width of at least 1.05 mm. At least one of the plurality of elongate eyelets may have a width of at least 1.1 mm. At least one of the plurality of elongate eyelets may have a width of at least 1.15 mm. At least one of the plurality of elongate eyelets may have a width of at least 1.2 mm. At least one of the plurality of elongate eyelets may have a width of at least 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, or 2.5 mm. At least one of the plurality of elongate eyelets may have a width of no more than 2.5 mm, 2.4 mm, 3.3 mm, 2.2 mm, 2.1 mm, 2 mm, 1.9 mm, 1.8 mm, 1.7 mm, 1.6 mm, 1.5 mm, 1.4 mm, 1.3 mm, 1.2 mm, 1.1 mm, 1.15 mm, 1.1 mm, or 1.05 mm. At least one of the plurality of elongate eyelets may have a width in the range of 0.7 mm to 2.5 mm. At least one of the plurality of elongate eyelets may have a width in the range of 0.8 mm to 1.2 mm. At least one of the plurality of elongate eyelets may have a width in the range of 0.85 mm to 1.15 mm. At least one of the plurality of elongate eyelets may have a width in the range of 0.9 mm to 1.1 mm. At least one of the plurality of elongate eyelets may have a width in the range of 0.95 mm to 1.05 mm. In a preferred embodiment, at least one of the plurality of elongate eyelets may have a width of 1 mm.

[0075] At least one of the plurality of elongate eyelets may have a length of at least 2.5 mm. At least one of the plurality of elongate eyelets may have a length of at least 3 mm. At least one of the plurality of elongate eyelets may have a length of at least 3.5 mm. At least one of the plurality of elongate eyelets may have a length of at least 4 mm. At least one of the plurality of elongate eyelets may have a length of at least 4.5 mm. At least one of the plurality of elongate eyelets may have a length of at least 5 mm. At least one of the plurality of elongate eyelets may have a length of at least 5.5 mm. At least one of the plurality of elongate eyelets may have a length of at least 6 mm. At least one of the plurality of elongate eyelets may have a length of at least 6.5 mm. At least one of the plurality of elongate eyelets may have a length of at least 7 mm. At least one of the plurality of elongate eyelets may have a length of at least 7.5 mm. At least one of the plurality of elongate eyelets may have a length of at least 8 mm. At least one of the plurality of elongate eyelets may have a length of at least 8.5 mm, 9 mm, 9.5 mm, 10 mm, 10.5 mm, 11 mm, 11.5 mm, 12 mm, 12.5 mm, 13 mm, 13.5 mm, 14 mm, 14.5 mm, 15 mm, 15.5 mm, 16 mm, 16.5 mm, 17 mm, 17.5 mm, 18 mm, 18.5 mm, 19 mm, 19.5 mm, 20 mm, 20.5 mm, 21 mm, 21.5 mm, 22 mm, 22.5 mm, 23 mm, 23.5 mm, 24 mm, 24.5 mm, or 25 mm. At least one of the plurality of eyelets may have a length no more than 30 mm, 25 mm, 20 mm, 15 mm, 14 mm, 13 mm, 12 mm, 11 mm, 10 mm, 9 mm, 8 mm, or 7 mm. At least one of the plurality of elongate eyelets may have a length in the range of 2.5 mm to 25 mm. At least one of the plurality of elongate eyelets may have a length in the range of 2.5 mm to 8 mm. At least one of the plurality of elongate eyelets may have a length in the range of 4.5 mm to 7.75 mm. At least one of the plurality of elongate eyelets may have a length in the range of 6.5 to 7.5 mm. In a preferred embodiment, at least one of the plurality of elongate eyelets may have a length of 7 mm.

[0076] The external flushing portion may comprise at least 10% of the length of the catheter. The external flushing portion may comprise at least 20% of the length of the catheter. The external flushing portion may comprise at least 30% of the length of the catheter. The external flushing portion may comprise at least 40% of the length of the catheter. The external flushing portion may comprise at least 50% of the length of the catheter. The external flushing portion may comprise at least 60% of the length of the catheter. The external flushing portion may comprise at least 70% of the length of the catheter. The external flushing portion may comprise at least 80% of the length of the catheter. The external flushing portion may comprise at least 90% of the length of the catheter. The external flushing portion may comprise between 10% and 90% of the length of the catheter. The external flushing portion may comprise between 20% and 80% of the length of the catheter. The external flushing portion may comprise between 30% and 70% of the length of the catheter.

[0077] The elongate main body may have a constant outer diameter. The insertion portion and external flushing portion may have the same outer diameter. Providing the elongate main body with a constant outer diameter is particularly advantageous as it improves comfort for the user during insertion and withdrawal of the catheter.

[0078] The elongate main body may be formed via injection moulding. Alternatively, the elongate main body may be formed via extrusion. Additionally or alternatively, the plurality of elongate eyelets and the at least one inlet aperture may be formed by punching.

[0079] The outflow end of the elongate main body may be shaped for the attachment of a separate funnel. The outflow end may be configured for the attachment of separate funnel. The outflow end may be attached to the funnel.

[0080] Where the main body comprises a lumen, the outflow end may comprise the second end of the lumen.

[0081] The catheter may be a male catheter or a female catheter. In a preferred embodiment, the catheter is a female intermittent urinary catheter.

[0082] For a female catheter. The length of the catheter may be between 80 mm and 140 mm, preferably 100 mm. The length of the external flushing portion may be at least 60 mm, 70 mm, 80 mm, 90 mm, 100 mm, 110 mm or 120 mm. The length of the external flushing portion may be between 60 mm and 120 mm. In a preferred embodiment, the length of the external flushing portion may be 100 mm.

[0083] For a male catheter, the length of the catheter may be between 360 mm and 425 mm, preferably 405 mm. The length of the external flushing portion may be between 300 mm and 350 mm, preferably 325 mm.

[0084] The diameter of the insertion portion and the external flushing portion may be between 2mm and 6 mm depending on the size requirements of the intended user.

[0085] The depth of the at least one flushing channel may be between 0.5 mm and 2 mm, preferably 1mm.

[0086] The present disclosure provides, in a second aspect, a method of manufacturing an intermittent urinary catheter comprising the steps of: providing an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein bore comprises an outlet portion from which in use urine exits the catheter; a connection portion, where the elongate main body is connected to the funnel; and a urine collection portion, which, in use, collects urine flowing along the outer surface of the elongate main body; wherein the urine collection portion comprises a converging portion of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion; the method comprising attaching the elongate main body to the funnel.

[0087] The method may comprise adhering, welding, or push fitting the elongate main body to the funnel.

[0088] The elongate main body and funnel may have any of the optional features outlined above.

[0089] The present disclosure provides, in a third aspect, a method of catheterisation using a catheter according to the first aspect of the invention (or indeed any of the broad aspects of the invention), optionally including any optional features thereof. The method may comprise the steps of: (i) providing an intermittent urinary catheter of the first aspect (or any of the broad aspects), and (ii) inserting the catheter into the bladder via the urethra until the external flushing portion is in fluid communication with the bladder so that urine can drain from the bladder through the urethra to the outlet end via the plurality of elongate eyelets of the external flushing portion.

[0090] The person skilled in the art will appreciate that except where mutually exclusive, a feature described in relation to any one of the aspects, embodiments or examples described herein may be applied to any other aspect, embodiment or example. Furthermore, except where mutually exclusive, any feature described herein may be applied to any aspect and / or combined with any other feature described herein.

[0091] 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:

[0092] Figure 1 shows a side view of a first embodiment of a catheter according to the present disclosure;

[0093] Figure 2 shows a side view of the catheter of figure 1 at 90° to the view of figure

[0094] Figure 3 shows an enlarged side view of the inlet apertures and plurality of elongate eyelets of the catheter from the angle of figure 1 ;

[0095] Figure 4 shows a longitudinal sectional side view of the catheter from the same angle of figure 2;

[0096] Figure 5 shows an enlarged view of the catheter of figure 4 in the region of the funnel;

[0097] Figure 6 shows an isometric view of the funnel of a second embodiment of a catheter according to the present disclosure;

[0098] Figure 7 shows a longitudinal sectional side view of the funnel of figure 6;

[0099] Figure 8 shows side view of the funnel of figures 6 and 7 ;

[0100] Figure 9 shows a partial longitudinal sectional side view of a catheter of the second embodiment including the funnel of figures 6 to 8;

[0101] Figure 10 shows a longitudinal sectional side-view of a catheter according to a third embodiment;

[0102] Figure 11 shows a cut-away orthographic projection of the catheter of figure 10;

[0103] Figure 12 shows an end-view, along the longitudinal axis of the catheter of figures

[0104] 10 and 11, from the funnel end;

[0105] Figure 13 shows a perspective insertion-end- view of the funnel of a fourth embodiment of a catheter; and

[0106] Figure 14a-d shows side views of four options for main body portions of catheters according to the invention. In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of various embodiments and the inventive concept. However, those skilled in the art will understand that the present invention may be practised without these specific details or with known equivalents of these specific details, that the present invention is not limited to the described embodiments, and that the present invention may be practiced in a variety of alternative embodiments. It will also be appreciated that well known methods, procedures, components, and systems may have not been described in detail.

[0107] In the following description, reference to longitudinal should be taken to be in relation to the longitudinal axis of the catheter; the longitudinal axis being the axis extending between the insertion end and the outlet end. Reference to the “transverse cross-section”, or simply “cross-section”, should be taken to be the cross-section which is transverse to the longitudinal axis of the main body, unless otherwise stated. References to distal and proximal made herein should be taken to be in relation to the insertion end of the catheter.

[0108] The catheters described herein are primarily female intermittent urinary catheters. However, it will be appreciated that the inventive concepts and features described herein may be applied equally to male intermittent urinary catheters.

[0109] Referring to figures 1-4, a first embodiment of an intermittent urinary catheter 1 comprises an elongate main body 2 having a constant outer diameter. The elongate main body 2 has an insertion end 3 for insertion into a urethra and bladder, an outflow end 4 for the outflow of fluid e.g., urine from the catheter, and a lumen 5 extending between the insertion end 3 and the outflow end 4. The elongate main body 2 comprises at least one inlet aperture 6 provided proximal to the insertion end 3. The elongate main body 2 also comprises an external flushing portion 7 which extends between the insertion end 3 and the outlet end 4 and comprises a plurality of elongate eyelets 8 formed through an external surface of the elongate main body 2.

[0110] In other embodiments, the elongate main body may have a solid core, with no inlet aperture, nor inner lumen, and urine may flow along channels in the external surface, from the insertion end to the outflow end of the elongate main body. In this particular embodiment, the elongate main body 2 comprises two inlet apertures 6, each having a stadium shape. However, in alternative embodiments it will be understood that a different number of inlet apertures 6 may be provided, for example between one and four inlet apertures 6, and the inlet apertures 6 may be a different shape such as rectangular or oval. The two inlet apertures 6 are offset 180° about the circumference of the elongate main body 2 such that they are diametrically opposed. In this embodiment, the two inlet apertures 6 are not longitudinally offset. However, it will be understood that each inlet aperture 6 may be offset both longitudinally and circumferentially from another. Each inlet aperture 6 in this particular embodiment has a length of 14 mm and a width of 1 mm. However, it will be understood that in alternative embodiments, each inlet aperture 6 may have different lengths and / or widths. Each inlet aperture 6 in this embodiment comprises an angled i.e. chamfered, edge extending fully around the perimeter of the inlet aperture 6, specifically the edge is radiused, to increase comfort of the user during insertion and removal of the catheter 1.

[0111] Each inlet aperture 6 comprises a means for directing flow in the form of a separation wall 9 extending distally from the insertion tip 3, internally in the lumen 5, so as to form an open flow channel 9 at the proximal end of each inlet aperture 6. The open flow channel 9 is recessed into the external surface of the elongate main body 2, and in this embodiment has a width of 1 mm and a length of approximately 7 mm. The open flow channel 9 directs urine from the bladder entering through the at least one inlet aperture into the lumen 5 whereby the flow may pass through the lumen, via the external flushing portion 7, and out of the catheter 1. In this particular embodiment, the open flow channel 9 extends over approximately half of the length of the at least one inlet aperture 6. However, a person skilled in the art will understand that the open flow channel 9 may extend over a greater or lesser proportion of the length of the at least one inlet aperture.

[0112] The open flow channel 9 comprises a substantially flat base 10 and a pair of substantially flat side walls 11 adjacent to the base 10 seen best in figures 6 and 7. One of the pair of side walls 11 extends along the left hand side of the base and the other side wall 11 extends along the right hand side of the base 10, and both side walls 11 are angled such that the open flow channel 9 has a substantially “U” shaped cross section, shaped to guide a flow of urine from the bladder toward the distal end of the inlet aperture 6 and into the lumen 5. The cross-sectional area of the open flow channel 9 is constant along a major portion. However, toward the proximal end of the open flow channel 9, there is provided an angled portion 12 which assists in directing urine from the blader through the open flow channel 9 and toward the lumen 5.

[0113] The open flow channel 9 terminates at a point approximately halfway along the length of the at least one inlet aperture 6. The termination point 16 of the open flow channel has a concavely curved profile which defines the lower portion of the inlet aperture 6. The lower portion of the inlet aperture 6 has a stadium shaped profile defined at the proximal end by the termination point 16 of the open flow channel 9 and at the distal end, by the outline of the inlet aperture 6 formed through an external surface of the elongate main body 2. However, it will be understood that the termination point 16 of the open flow channel 9 may have various profiles such as straight or convexly curved, thereby adjusting the profile of the lower portion of the inlet aperture 6. The lower portion of the first inlet aperture aligns with the lower portion of the second inlet aperture such that the lower portion of the first and second inlet apertures 6 extend fully from a first side of the catheter to a second side of the catheter 1.

[0114] The catheter 1 is provided with an insertion portion 13 to facilitate insertion of the catheter 1 into and along the urethra. The insertion portion comprises a rounded tip 14 provided at the insertion end 3 to improve comfort for the user during insertion and a hollow tubular wall 15 in which the at least one inlet aperture 6 is provided. The hollow tubular wall 15 also defines the lumen 5 and comprises the integrally formed open flow channel 9 which is in fluid communication with the lumen 5.

[0115] In this particular embodiment, the insertion portion 13 and the at least one inlet aperture 6 are configured to be partially inserted into the bladder. The at least one inlet aperture 6 is configured to be inserted such that at least the open flow channel 9 is positioned in use within the bladder. This means that any urine on the bottom of the bladder may exit the bladder via the inlet aperture which overlaps a junction between the bladder and the urethra to ensure complete bladder emptying. The elongate main body 2 has a straight, substantially tubular form with an open outflow end 4, and a closed insertion end 3 by virtue of the rounded tip 14. The external surface of the elongate main body 2 forms a wall having a substantially cylindrical shape whose inner surface defines the lumen 5 (seen in figure 4). The lumen extends from a first end 17 of the insertion portion 13, specifically from the termination point 16 of the open flow channel 9, where the lumen 5 is in fluid communication with the inlet apertures 6, to a second end 18 provided at the outflow end 4 whereby urine may exit the lumen 5. The lumen 5 has a constant cross section, such that urine entering the at least one inlet aperture 6 passes through the entire length of the lumen 5 with a substantially undisturbed flow having a substantially regular flow rate.

[0116] The external flushing portion 7 is configured in use to provide fluid communication between the catheter 1 and the urethra via the plurality of elongate eyelets 8. The plurality of elongate eyelets 8 are formed through the external surface of the elongate main body such that each elongate eyelet 8 enables urine passing through the lumen 5 to contact and flush the walls of the urethra, assisting in reducing the bacteria present. In this particular embodiment there are six elongate eyelets 8, although it will be understood that in alternative embodiments a greater or lesser number of elongate eyelets 8 may be provided.

[0117] The plurality of elongate eyelets 8 each have a longitudinal axis 19 which extends parallel to the longitudinal axis of the elongate main body 2. The plurality of elongate eyelets are spaced / offset along the longitudinal axis 19 by the length of approximately one of the plurality of elongate eyelets 8, which in this particular embodiment is approximately 7 mm. Spacing the plurality of elongate eyelets 8 ensures that the structural integrity of the elongate main body 2 is maintained as the presence of the outer surface of the elongate main body 2 between each of the plurality of elongate eyelets 8 maintains the rigidity of the catheter 1 whilst allowing some flexibility enabling the catheter to conform to the shape of the users urethra. This means that the catheter can withstand the pressures exerted by the walls of the urethra during insertion and use without bending and / or buckling.

[0118] The plurality of elongate eyelets 8 each have a radial axis which each extend radially with respect to the radial axis of the elongate main body 2. In this embodiment, best seen in figure 2, none of the plurality of elongate eyelets 8 directly oppose another of the diametrically opposed plurality of elongate eyelets 8. A person looking through one of the plurality of elongate eyelets 8 would not be able to view another of the plurality of elongate eyelets 8 diametrically opposite and would instead see the internal surface of the elongate main body 2.

[0119] In this particular embodiment, the six elongate eyelets 8 are formed through the external surface of the elongate main body 2 along a plane of the longitudinal axis of the elongate main body which extends through the central axis of the elongate main body. The plane intersects the external surface of the elongate main body 2 on a first side of the elongate main body 21 and on a second side of the elongate main body 22 such that the first and second side are diametrically opposed.

[0120] With specific reference now to figures 2 and 4, a first series of three elongate eyelets 8 are provided along the first side of the elongate main body 2 at the point where the plane of the longitudinal axis intersects. Each of the three elongate eyelets 8 are the same length and width, and are stadium shaped. In this particular embodiment, each elongate eyelet has a length of 7 mm and a width of 1 mm. However, in alternative embodiments each elongate eyelet 8 may have a different length and / or width to this embodiment, and at least one elongate eyelet may have a different length and / or width to another of the plurality of elongate eyelets. The three elongate eyelets 8 are longitudinally spaced from one another by the approximate length of an elongate eyelet 8 such that there is a solid section of the elongate main body interspersed between the three elongate eyelets which helps to maintain the structural integrity of the catheter 1 whilst still providing some flexibility for the elongate main body 2 to bend. In this particular embodiment, the first inlet aperture 6 is also provided along the first side 21 of the elongate main body 2 at the point where the plane of the longitudinal axis intersects. The elongate eyelet 8 in the first series proximal to the insertion end is longitudinally spaced from the inlet aperture 6 by the approximate length of an elongate eyelet 8.

[0121] A second series of three elongate eyelets 8 are provided along the second side 22 of the elongate main body 2 at the point where the plane of the longitudinal axis intersects. The three eyelets of the second series are the same length, width and shape as the first series such that each of the plurality of elongate eyelets is identical. However, in other embodiments it will be understood that at least one of the plurality of elongate eyelets 8 may have a different shape and / or length and / or width to the other elongate eyelets 8. Each of the three eyelets 8 of the second series are longitudinally spaced from one another by the approximate length of an elongate eyelet 8. In this particular embodiment, the second inlet aperture 6 is also provided along the second side of the elongate main body 2 at the point where the plane of the longitudinal axis intersects. The elongate eyelet 8 in the second series proximal to the insertion end is longitudinally spaced from the inlet aperture by approximately 2.5 mm. The first series of elongate eyelets diametrically opposes the second series of elongate eyelets. However, as each series is spaced from the inlet aperture by a differing amount, the first series of elongate eyelets is staggered such that they do not directly oppose the second series; as such a person looking through an elongate eyelet of the first series would not be able to see an elongate eyelet of the second series directly opposite. Instead, such a person would see the internal surface of the elongate main body 2 of the space between the eyelets of the second series.

[0122] In this particular embodiment, the first series of elongate eyelets are perfectly longitudinally spaced from the second series of elongate eyelets such that an elongate eyelet is provided on the second side of the elongate main body 2 in the position directly opposing the portion between two elongate eyelets 8 of the first series.

[0123] The plurality of elongate eyelets 8 of this particular embodiment each have a pair of parallel long sides 23 connected by a first short side 24 and a second short side 25. The first short side 24 and second short side 25 in this embodiment are both curved to define the curved portions of the overall stadium shape of each elongate eyelet 8. However, it will be understood that in alternative embodiments, the plurality of elongate eyelets 8 may have an alternative shape and / or shapes and as such do not comprise a pair of parallel long sides and a first and second short side. Equally, in alternative embodiments, the first short side 24 and the second short side 25 may not be curved but may instead be straight for example to form a rectangular elongate eyelet 8. In this particular embodiment, the pair of long sides 23 and the first and second short sides have an angled edge / profile i.e. the edges are chamfered. The angled profile extends fully around the perimeter of each of the plurality of elongate eyelets such that there are no sharp edges and / or corners which may cut or catch a user’s skin during insertion and / or removal of the catheter 1.

[0124] With reference again to figures 1-4, and in particular figure 5, the outflow end 4 is arranged within, and attached to a funnel 26. The funnel 26 includes a bore 100 extending from its inlet end 102 to its outlet end 101. The bore 100 of the funnel 26 includes an outlet portion 103, in the form of a very slightly conical cavity which facilitates the outflow of urine from the catheter 1 via the outlet end 101 which is an opening in the end face of the funnel 26.

[0125] At its inlet end 102, the funnel 26 comprises a substantially tubular solid wall portion 28 with a diameter greater than that of the outlet end 4 and external flushing portion 7. Here, the bore defines a urine collection portion, 104 which, in use, collects urine flowing along the outer surface of the elongate main body 4. The urine collection portion 104 is a converging portion 30 of the bore in which the diameter of the bore reduces from the inlet end 102 towards a connection portion 105 of the bore 100. The connection portion 105 of the bore is where the elongate main body 4 is connected to the funnel 26.

[0126] The outlet portion 103 of the bore 100 and the converging portion 104 are conical cavities, with opposing cones, in the same arrangement as an hourglass. The connection portion 105 is shaped and configured for the insertion of the outflow end 4 of the elongate main body 2 therein with a tight fit. The elongate main body 2 and the funnel 26 may be bonded, e.g. adhered or welded together in the connection portion, which is the portion where the elongate main body 2 and the funnel 26 touch each other and are joined. When the funnel 26 is attached around the outflow end 4 of the elongate main body, a passageway from the external flushing portion 7 is defined by the outlet end 4 and funnel 26 to provide a fluid flow path for an exiting stream of urine from the bladder and urethra, when in use.

[0127] The outer surface of the funnel 26 comprises a pair of diametrically opposed grip surfaces 29 (see figures 1 and 2) provided at the distal end of the funnel 26 and having a substantially flat oval shaped surface. The pair of grip surfaces 29 encourages users to grip the catheter funnel with their thumb and forefinger, at the distal end of the funnel 26, thereby reducing the risk of bacteria from the user’s fingers entering the urethra and / or bladder during insertion and use of the catheter 1.

[0128] As outlined above, the proximal end of the funnel 26, in particular the urine collecting portion 104 is shaped to direct urine in the conical cavity to minimise the risk of urine leaking around the funnel 26 and contaminating the user’s hands. Any urine which has not re-entered the lumen 5 but has instead flowed along the outer surface of the elongate main body 2 is collected at the proximal end of the funnel via the converging portion 30 of the funnel and directed toward the conical cavity where it joins the urine which has flowed out of the outlet end 4 via the lumen 5. To achieve this, apertures (not shown) are provided through the elongate main body adjacent the narrowest part of the urine collection portion 104.

[0129] With reference to figures 6-9, a second embodiment of the present invention is shown.

[0130] Once again, the catheter 1 is a female intermittent urinary catheter, and once again it includes an elongate main body 2, shown in figure 9, and a funnel 26. The elongate main body has an insertion end (not shown) for insertion into a urethra and an outflow end 4. The funnel 26 is again provided at the outflow end 4 of the elongate main body 2, and of course, the elongate main body 2 further comprises an external flushing portion (not shown) extending along at least a portion of the elongate main body 2 between the insertion end and the outflow end 4.

[0131] The funnel 26 comprises an inlet end 102 and an outlet end 101, and a bore 100 therebetween. The bore 100 comprises an outlet portion 103 from which in use urine exits the catheter 1; a connection portion 105, where the elongate main body 2 is connected to the funnel 26; and a urine collection portion 104, which, in use, collects urine flowing along the outer surface of the elongate main body 2. The urine collection portion 104 is a converging portion of the bore 100 in which the diameter of the bore reduces from the inlet end 102 towards the connection portion 105.

[0132] The most notable difference between the first and second embodiments is perhaps the greater extent at which the converging portion 104 converges. In this second embodiment, the funnel 26 comprises a tubular flared portion 204, the inner surface of which defines (and is defined by) the urine collection portion 104 of the bore. The outer surface 205 of the flared portion is generally parallel with the inner surface of the flared portion 205 (i.e. the converging urine collection portion 104 of the bore 100. However, whereas the converging portion of the bore is smooth, with a straight profile to the walls of the bore, the outer surface 205 of the flared portion is provided with two circumferential, outwardly projecting ribs 207.

[0133] The provision of a flared portion 204 corresponding with the converging urine collection portion 104 of the bore 100 can further improve the seal between the funnel 26 and the urethra, on account of the pressure applied to the urethral opening in the region of the flared portion 204. This is further improved by the ribs 207, and particularly by the extent to which the converging portion converges, i.e. the angle at which it converges.

[0134] The diameter of the bore reduces more substantially from the inlet end towards the connection portion 105 than the first embodiment, and has a greater diameter of opening, to better encourage urine flowing on the external surface of the elongate main body 2 to flow into the funnel 26 and not around it. The convergence may reduce turbidity / turbulence where the urine collection portion 104 meets the connecting portion 105, thereby allowing a greater flow, and therefore a reduced pressure build up, and a reduced chance of urine bursting past the funnel rather than entering it.

[0135] The funnel 26 and the elongate main body 2 are again formed as separate parts and attached at the connection portion 105. In this embodiment, the funnel 26 and the elongate main body 2 are formed of different materials. For example, the elongate main body may be provided with a hydrophilic surface, so that it may be lubricated by a wetting agent such as water, whilst the funnel may be provided in a different, more suitable or cheaper material (e.g. one without hydrophilic surface properties).

[0136] In this example, the funnel is attached by a push-fit, snap-fit or the like. This allows the use of different materials for the different parts, without difficulties in attaching them.

[0137] The push fit is achieved by co-operating mechanical connecting features on the funnel 26 and the elongate main body 2. In particular, the connecting portion may comprises a circumferential projection 200, which extends radially inwardly and corresponds to a co-operating circumferential recess 201 on the elongate main body 2. In other embodiments, not shown the connecting portion may comprise an abutment area where the funnel and the elongate main body touch and are physically joined, e.g. by adhesion or welding.

[0138] In this embodiment, the elongate main body 2 has a lumen 202 in the region of the connecting portion, so that fluid can flow through the elongate main body 2. However, other embodiments are envisaged in which no lumen is present. In such embodiments, (or even where there is a lumen) the elongate main body may be provided with channels extending inwardly from its outer surface, and the recess in the outer surface of the elongate main body 2 may not be circumferential, such that there is a gap between the elongate main body 2 and the connecting portion, through which urine may flow to the outflow end of the elongate main body 2 and into the outlet portion 103 of the bore 100 through the funnel 26.

[0139] The converging portion 104 of the bore 100 has an opening 203 to receive urine at the terminal end of the urine collection portion 104. In the present embodiment, the opening is of approximately 8mm in diameter, and thus its maximum width is larger than the opening at the outlet portion of the funnel through which urine exits the catheter (which in this embodiment is of about 6mm in diameter).

[0140] As can be seen from figure 9, the maximum width of the opening 203 of the converging portion 104 of the bore 100 may be at least 20%, at least 30%, or at least 40% larger than the maximum width of the elongate main body at the same longitudinal position - in this embodiment the opening has a diameter which is about 140% of (i.e. 40% larger than) the main body at the same longitudinal position.

[0141] Provision of such a large opening is advantageous in terms of (a) ensuring a large enough opening to capture sufficient urine, and (b) exerting a pressure on the urethral opening sufficient to create a good seal.

[0142] The converging portion converges at an angle A (see figure 7) of about 20 to 30 degrees, in this embodiment about 24 degrees. This is substantially more than the angle B, by which the outlet portion 103 of the bore 100 diverges - the outlet portion is only very slightly conical, diverging towards the outlet end 101 at an angle of just over 1 degree. The converging portion of the bore 100, and the flared portion 204 in this particular embodiment have a length C of between 5mm and 6mm, e.g. about 5.5mm.

[0143] Returning to the elongate main body 2, of this embodiment, as seen in figure 9, the elongate main body may comprise apertures 208 arranged to receive urine collected by the urine collection portion 104 of the bore 100. In this example, there are four circumferentially spaced, equidistant, apertures 208, which are arranged to coincide with the opposite end of the urine collection portion 104 from the opening 203. The apertures 208 extend towards the opening 203 and are in fluid communication with the outlet portion 103 of the bore 100 via the lumen 202 that extends through the connecting portion 105 of the bore 100.

[0144] With reference to figures 10 to 12, a third embodiment of a catheter is shown. In this third embodiment, the funnel 26 is similar to the funnel of the second embodiment in terms of dimensions, for example, once again the length of the converging portion of the bore 100, and the flared portion in this particular embodiment have a length of between 5mm and 6mm, e.g. about 5.5mm, and, the opening 203 at the inlet end is of approximately 8mm in diameter, and thus its maximum width is larger than the opening at the outlet portion of the funnel through which urine exits the catheter (which in this embodiment is of about 6mm in diameter). Moreover, the converging portion converges at an average angle of about 20 to 30 degrees, in this embodiment about 24.5 degrees. This is substantially more than the angle, by which the outlet portion 103 of the bore 100 diverges - the outlet portion is only very slightly conical, diverging towards the outlet end 101 at an angle of just over 2 degrees in this embodiment.

[0145] The primary difference in relation to the funnel of the third embodiment of figures 10-12 lies in the shape of the converging portion 104, which, as best seen from figure 10 has a stepped profile, with three sections at different angles.

[0146] A first section 701 of the stepped profile nearest to the opening 203 at the inlet end of the funnel has an angle of convergence of 0 degrees, i.e. there is no convergence in this section. A second section 702 furthest from the opening 203 at the inlet end of the funnel 26 has a steeper angle than the section closest to the inlet end of the funnel 26, of about 24-25 degrees in this particular embodiment.

[0147] A third, intermediate section , 703 between the first section 701 and the second section 702 has the steepest angle, of about 45 degrees.

[0148] For example, the converging portion comprise a section closest to the inlet end of the funnel with a lowest angle, an adjacent intermediate section with a highest angle and a section furthest from the end of the funnel with an intermediate opening. In this way, the converging portion may converge at an angle of about 20 to 30 degrees, such as about 24-25 degrees, but the part that abuts the urethral opening may not be angled, or only angled very slightly, with the overall angle achieved by the step, in particular the steepest section offsetting the least steep section.

[0149] The converging portion of the bore may be smooth, i.e. without any obstructions, such as projections or recesses.

[0150] The ribs 707 in this embodiment are arranged on the flared portion on the section of its outside surface in the region of greatest diameter, i.e. the section closest to the opening 203 at the inlet end of the funnel, where the opening 203 can form a good seal against the urethral opening.

[0151] This funnel 26 is well suited to catheters in which a greater proportion of the flow enters the funnel 26 from outside the elongate main body, for example, catheters where the elongate main body has a solid core, and flow is entirely along the external surface.

[0152] Thus, the third embodiment includes such a solid-cored elongate main body 302, which unlike the first and second embodiments is not provided with apertures at the insertion end and an internal lumen through which urine flows from those apertures. Rather, the elongate main body 302 of the third embodiment has a series of elongate channels 300, recessed into the external surface of the elongate main body 302. In this embodiment there are four such channels 300, equidistantly spaced around the circumference of the elongate main body 302. Thus, in use, the catheter 1 is introduced into the urethra, such that the insertion end 303 enters the bladder, and all of the urine flows along the channels 300, flushing the urethra. To allow the urine to enter the funnel 26, each channel 300 is provided with an aperture 308 which, as in the second embodiment is arranged to coincide with the opposite end of the urine collection portion 104 from the opening 203 at the inlet end of the funnel 26. The apertures 308 extend towards the opening 203 and as in the second embodiment are in fluid communication with the outlet portion 103 of the bore 100 via the lumen 309 that is formed in a part of the elongate main body 302 that extends through the connecting portion 105 of the bore 100.

[0153] With reference to figure 13, a variation on the funnel 26 of the catheter of the first to third embodiments is shown. The funnel 26 is the same as those of the first to third embodiments in all respects other than the shape of the converging portion 404 that forms the urine collection portion of the funnel 26. Specifically, in this funnel, which with an elongate main body (not shown) attached represents a fourth embodiment, rather than having a straight edge or stepped profile, the profile of the converging portion 404 of the bore 100 is a concave curve. The dimensions of the funnel 26, including its length and the overall angle at which it converges are identical to those of the third embodiment.

[0154] With reference to figure 14a to figure 14d, four elongate main bodies are shown, each of which may be attached to any of the funnels 26 described in the first to fourth embodiments to form a female intermittent urinary catheter. Figure 14b shows the elongate main body 2 of the first embodiment of a urinary catheter 1 described at length above. Figure 14d shows the elongate main body 302 of the third embodiment.

[0155] Figure 14a shows an elongate main body 502 of a further embodiment. The elongate main body of figure 14a of course has an insertion end 503 and an opposite inflow end 504 which is the area with the most notable difference. Specifically, the embodiment of figure 14a includes two opposing elongate channels 500, which extend all the way to the insertion end 504. As such, there is no lumen in the catheter that would sit in the connection portion 105 of the bore 100 of the funnel. Rather, urine flow down the channels 500 continues down the channels 500 all the way to the outlet portion 103 of the funnel 26. The elongate main body 502 also lacks the mechanical features for connection to the funnel 26 and instead needs to be bonded (e.g. adhered) to the funnel, with the region where the elongate main body touches and is joined to the funnel defining a connection portion 105 of the bore 100. Figure 14c shows an embodiment of an alternative elongate main body 602 that is most similar to the elongate main body of the first and second embodiments. The sole difference is that instead of the three offset stadium- shaped flushing apertures on each side, the alternative elongate main body 602 includes ten diamond shaped flushing apertures 608 on each of two opposing sides of the elongate main body.

[0156] Naturally numerous alternative elongate main body portions with external flushing portions may be envisioned by those skilled in the art and would be applicable to the invention.

[0157] The catheters 1 of the embodiments are formed 3d printing. However, in alternative embodiments other suitable methods of manufacture may be used. For example, injection moulding would likely be more economical in large scale production. Or in another alternative, the elongate main body 2 may be extruded and the at least one inlet aperture and / or plurality of elongate eyelets 8 may subsequently be punched into an external surface thereof.

[0158] In use, the catheter 1 may be inserted by a user into the urethra until the inlet aperture 6 is at least partially inserted into the bladder, or in embodiments without such apertures (e.g. the embodiments of figures 10-12, 14a and 14d), until the external flow channels are partially inserted into the channel.

[0159] In the embodiments of figures 1-9, 14b and 14c, urine in the bladder may then flow from the bladder into the inlet aperture 6 via the open flow channel 9, and into the lumen 5. The urine flows through the lumen 5 to the outlet end 4 where it may be discharged into a suitable receptacle. As the urine flows through the lumen 5, flushing of the urethral walls is enabled by the plurality of elongate eyelets 8 or diamond shaped flushing apertures 608 which enable the urine to contact the urethral walls and flush away bacteria to minimise the risk of infection.

[0160] In the embodiments of figures 10-12, 14a and 14d, urine in the bladder may then flow from the bladder along the external flow channels 302, 502 enabling the urine to contact the urethral walls and flush away bacteria to minimise the risk of infection.

[0161] Urine outside the catheter (i.e. all urine released in the embodiments of figures 10-12, 14a and 14d, and any urine that has not re-entered the apertures 8, 608 in the embodiment of figures 1-9, 14b and 14c) is collected in the urine collection portion 104 of the bore 100 through the funnel 26, and guided through the connection portion 105 of the bore 100 to the outlet portion 105 of the bore 100, from which the urine may exit the catheter in a controlled fashion into a suitable receptacle, e.g. a toilet (or urine bag in the case of a closed system). When correctly used, urine passing to the outside surface of the funnel should be prevented, or at least minimised .

[0162] In some embodiments, the catheter is formed of a material of the group comprising: polyvinyl chloride, polytetrafluoroethylene, polyolefins, latex, silicones, synthetic rubbers, polyurethanes, polyesters, polyacrylates, polyamides, thermoplastic elastomeric materials, styrene block copolymers, poly ether block amide, thermoplastic vulcanizates, thermoplastic copolyesters, thermoplastic polyamides, and water disintegrable or enzymatically hydrolysable material, or combinations, blends or copolymers of any of the above materials.

[0163] In preferred embodiments, the catheter is formed of a material of the group comprising: polyolefins, polyesters, polyacrylates, polyamides, thermoplastic elastomeric material, polyether block amide, thermoplastic vulcanizates, thermoplastic copolyesters, thermoplastic polyamides, fluororubber, and water disintegrable or enzymatically hydrolysable material or combinations, blends or co-polymers of any of the above materials.

[0164] In some embodiments, said water disintegrable or enzymatically hydrolysable material comprises a material of teh group comprising: polyvinyl alcohol, extrudable polyvinyl alcohol, polyacrylic acids, polylactic acid, polyesters, polyglycolide, polyglycolic acid, poly lactic-co-glycolic acid, polylactide, amines, polyacrylamides, poly(N-(2-Hydroxypropyl) methacrylamide), starch, modified starches or derivatives, amylopectin, pectin, xanthan, scleroglucan, dextrin, chitosans, chitins, agar, alginate, carrageenans, laminarin, saccharides, polysaccharides, sucrose, polyethylene oxide, polypropylene oxide, acrylics, polyacrylic acid blends, poly(methacrylic acid), polystyrene sulfonate, polyethylene sulfonate, lignin sulfonate, polymethacrylamides, copolymers of aminoalkyl-acrylamides and methacrylamides, melamine-formaldehyde copolymers, vinyl alcohol copolymers, cellulose ethers, poly-ethers, polyethylene oxide, blends of polyethylene- polypropylene glycol, carboxymethyl cellulose, guar gum, locust bean gum, hydroxypropyl cellulose, vinylpyrrolidone polymers and copolymers, polyvinyl pyrrolidone-ethylene-vinyl acetate, polyvinyl pyrrolidone- carboxymethyl cellulose, carboxymethyl cellulose shellac, copolymers of vinylpyrrolidone with vinyl acetate, hydroxyethyl cellulose, gelatin, poly-caprolactone, poly(p-dioxanone), or combinations, blends or co-polymers of any of the above materials. In some preferred embodiments, the catheter is formed of a polyolefin material, especially polyethylene and / or polypropylene. In some preferred embodiments, the catheter is formed of a thermoplastic elastomeric material. In some preferred embodiments the catheter may be made from a polyolefin based synthetic thermoplastic polyolefin elastomer (TPE) containing a hydrophilic additive. In some preferred embodiments the catheter may be made from a polymer mixture comprising a first polymer and a second polymer, wherein the first polymer is a thermoplastic or thermo-curing polymer, and the second polymer is an amphiphilic block copolymer possessing both hydrophilic and lipophilic properties. A possible suitable polymer mixture is described and disclosed in EP2493521A1.

[0165] 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

CLAIMS1. An intermittent urinary catheter comprising: an elongate main body and a funnel; the elongate main body having an insertion end for insertion into a urethra and an outflow end; the funnel being provided at the outflow end of the elongate main body; the elongate main body further comprising an external flushing portion extending along at least a portion of the elongate main body between the insertion end and the outflow end; the funnel comprising an inlet end and an outlet end, and a bore therebetween; wherein the bore comprises an outlet portion from which in use urine exits the catheter; a connection portion, where the elongate main body is connected to the funnel; and a urine collection portion, which, in use, collects urine flowing along the outer surface of the elongate main body; wherein the urine collection portion comprises a converging portion of the bore in which the diameter of the bore reduces from the inlet end towards the connection portion.

2. An intermittent urinary catheter according to claim 1 wherein the funnel and the elongate main body are separate parts attached at the connection portion.

3. An intermittent urinary catheter according to claim 2 wherein the funnel and the elongate main body may be attached by adhesion or welding.

4. An intermittent urinary catheter according to claim 2 wherein the funnel and elongate main body are attached by a push- fit.

5. An intermittent urinary catheter according to any preceding claim wherein the funnel and elongate main body are formed from different materials.

6. An intermittent urinary catheter according to any preceding claim wherein the converging portion of the bore has an opening to receive urine and the outletportion of the funnel comprises an opening through which urine exits the catheter; wherein the opening of the converging portion is larger than the opening of the outlet portion.

7. An intermittent urinary catheter according to any preceding claim wherein the converging portion of the bore has an opening to receive urine and the opening of the converging portion has a maximum width of at least 7mm.

8. An intermittent urinary catheter according to claim 6 or 7 wherein the opening of the converging portion of the bore has a maximum width of no more than 10mm.

9. An intermittent urinary catheter according to any preceding claim wherein the converging portion of the bore has an opening to receive urine and the maximum width of the opening of the converging portion of the bore is at least at least 30% larger than the maximum width of the elongate main body at the same longitudinal position.

10. An intermittent urinary catheter according to any preceding claim wherein the converging portion converges at an angle of at least 20 degrees.

11. An intermittent urinary catheter according to any preceding claim wherein the converging portion converges at an angle of no more than 35 degrees.

12. An intermittent urinary catheter according to any preceding claim wherein the converging portion converges at an angle of 20 to 30 degrees.

13. An intermittent urinary catheter according to any preceding claim wherein the outlet portion of the bore diverges, towards the outlet end and the converging portion of the bore converges at a greater angle than the angle at which the outlet portion diverges.

14. An intermittent urinary catheter according to claim 13 wherein the converging portion converges at at least 15 degrees more than the angle by which the outlet portion diverges.

15. An intermittent urinary catheter according to any preceding claim wherein the converging portion of the bore may has a length of at least 4mm, and no more than 8mm16. An intermittent urinary catheter according to any preceding claim wherein the funnel may comprise a flared portion corresponding with the urine collection portion of the bore.

17. An intermittent urinary catheter according to claim 16 wherein the outer surface of the flared portion is provided with one or more circumferentially extending ribs.

18. An intermittent urinary catheter according to any preceding claim wherein the converging portion of the bore has a concave curved profile.

19. An intermittent urinary catheter according to claim 18 wherein the converging portion of the bore has a curved portion proximal the connection portion.

20. An intermittent urinary catheter according to any of claims 1 to 17 wherein the converging portion of the bore has a straight profile.

21. An intermittent urinary catheter according to any of claims 1 to 17 wherein the converging portion has a stepped profile.

22. An intermittent urinary catheter according to claim 21 wherein the stepped profile has at least two sections at different angles.

23. An intermittent urinary catheter according to claim 22 wherein the stepped profile has at least three sections at different angles.

24. An intermittent urinary catheter according to claim 22 wherein a section of the stepped profile, nearest to the inlet end of the funnel has an angle of about 0-5 degrees; a section furthest from the inlet end of the funnel has a steeper angle than the section closest to the inlet opening, about 20 to 30 degrees, and an intermediate section between the section closest to the inlet opening and the section furthest from the inlet opening has a steepest angle, at least 40 degrees.

25. An intermittent urinary catheter according to any preceding claim wherein the converging portion of the bore is smooth.

26. An intermittent urinary catheter according to any preceding claim wherein the elongate main body comprises one or more apertures arranged to receive urine collected by the urine collection portion of the bore, wherein the or each aperture is in fluid communication with the outlet portion of the bore and the or each aperture extends to one or more lumen extending through the connection portion.

27. An intermittent urinary catheter according to any preceding claim wherein the elongate main body has a solid core and one or more elongate channels forming the external flushing portion, wherein the urine collection portion collects all of the urine flowing from the bladder and guides it through the funnel.

28. An intermittent urinary catheter according to any of claims 1-26 wherein the elongate main body may has a lumen which extends between the insertion end and the outflow end; the elongate main body further comprising at least one inlet aperture proximal to the insertion end, wherein the external flushing portion may extends along a portion of the elongate main body between the insertion end and the outflow end and the external flushing portion comprises a plurality of elongate eyelets formed through an external surface of the elongate main body.

29. The intermittent urinary catheter of any preceding claim wherein the intermittent urinary catheter is a female intermittent urinary catheter.

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