Technical Field of the Invention

The present invention provides a urinary catheter which is configured to aid flushing of the urethra in use.

Background to the Invention

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 patkients suffering from urinary incontinence or by disabled individuals several times a day to drain the bladder as required.

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. skins cells or excretions) which would otherwise be flushed out by the urine.

WO2012/85124 describes an intermittent urinary catheter comprising an elongate shaft with an insertion end, a handle connected to the elongate shaft at a distance from the aid insertion end, and a discharge end extending past the handle in a direction opposite the insertion end. The elongate shaft is provided with at least one discharge channel having an elongate opening extending along the elongate shaft. The discharge channel includes an opening against which a flow of urine can contact the urethra in use to aid with flushing of the urethra.

CN210992518U describes an indwelling catheter capable of flushing a urethra. The catheter includes a plurality of grooves formed along the length direction, and a plurality of small holes are formed at the bottom of each groove at intervals. During use, secretions in the urethra of a patkient enter the grooves and are discharged.

CN206239873 describes an indwelling make catheter having a wire mesh support structure which allows urine to contact the urethra.

The present invention seeks to provide an improved catheter for flushing urethra in use.

Summary of the Invention

The present invention provides a catheter according to the appended claims. The present disclosure provides, in a first aspect, a catheter comprising an elongate main body comprising an insertion portion at an insertion end and an outlet portion at an outlet end.

An external flushing portion may extend between the insertion portion and the outlet portion. The external flushing portion may comprise a tubular wall defining an internal passageway therein and a plurality of apertures distributed along the length thereof to provide fluid communication between the internal passageway and exterior of the main body.

Providing an internal passageway within a tubular wall having a plurality of apertures along its length allows a flow of urine to flow against the wall of urethra in use, thereby flushing the urethra in use.

The internal passageway may extend to an outlet at the outlet end.

The insertion portion may comprise an elongate open channel in an external surface thereof. The elongate channel may be in fluid communication with the internal passageway.

Providing an elongate open channel in an external surface at the insertion end of the catheter allows a flow of urine to flow against the urethra prior to entering the internal passageway. As such, the entire length of the urethra may be flushed regardless of the positioning of the catheter in relation to the bladder. Additionally, the elongate open channels, which may be referred to as inlet channels, generally make the insertion position of the catheter less critical (i.e., less sensitive to how far in the axial direction the catheter is inserted), as the elongate channels will function to receive a flow of urine in a range of insertion position.

The elongate open channel and apertures may be arranged to allow wetting of the urethra along the full length of the urethra. The outlet portion may comprise a solid walled tubular section in which there are no apertures and the flow path is contained within the walls of the catheter. In such instances, the catheter may be configured to flush between 95% and 75% of the length of the urethra, in use.

The apertures may comprise through-holes in the tubular wall to provide fluid communication therethrough. The elongate channel may terminate in one of the plurality of apertures. Accordingly one preferred embodiment provides a catheter comprising: an elongate main body comprising an insertion portion at an insertion end, an outlet portion at an outlet end and an external flushing portion extending between the insertion portion and the outlet portion, wherein the external flushing portion comprises a tubular wall defining an internal passageway therein and a plurality of apertures distributed along the length thereof to provide fluid communication between the internal passageway and exterior of the main body, wherein the internal passageway extends to an outlet at the outlet end, and wherein the insertion portion comprises an open elongate channel in an external surface thereof, the elongate channel being in fluid communication with the internal passageway, wherein the elongate channel terminates in one of the plurality of apertures.

The elongate channel may comprise an inlet aperture which passes through the tubular wall to provide a flow path between the elongate channel and the internal flow passage of the main body. The inlet aperture may be provided in a base of the elongate channel. The inlet aperture may be radially separated from an outermost surface of the catheter main body.

The elongate channel may extend to the external flushing portion. The elongate channel may open axially into the one of the plurality of apertures in which it terminates. The catheter may comprise a plurality of elongate channels, and at least one elongate channel may terminate in one of the plurality of apertures and at least one elongate channel may comprise an inlet aperture to provide fluid communication between the elongate channel and the internal passageway.

The tubular wall may comprise a plurality of elongate members. The elongate members may be spaced relative to one another to provide the plurality of apertures. The elongate members may extend longitudinally. The elongate members may extend circumferentially. The elongate members may comprise helical members.

The tubular wall may comprise one or more pairs of counter-rotating helical members. A pair of helical members may define therebetween the apertures.

The apertures may take any suitable shape and be any suitable size when viewed in radial plan. The apertures may be polygonal when viewed in radial plan. The polygonal apertures may be defined between adjacent helical members or adjacent turns of a helical member. The elongate open channels may extend longitudinally. The elongate open channels may extend parallel to the longitudinal axis of the main body. The elongate open channels may extend from a terminal end of the insertion portion and catheter, or may extend only partially along the length of the insertion portion. The insertion portion may be solid so as to not include the internal passageway.

The insertion portion may comprise a solid walled tubular section defining an inlet lumen. One or more eyelets may be formed through the solid tubular wall such that the one or more eyelets are in fluid communication with the internal passageway of the external flushing portion via the inlet lumen. There may be at least two eyelets. At least two eyelets may be formed on opposite sides respectively of the solid tubular wall. At least two eyelets may be longitudinally offset. At least two eyelets may be diametrically opposed.

Providing one or more eyelets extending through a solid tubular wall of the insertion portion and in fluid communication with the internal passageway of the external flushing portion via an inlet lumen allows urine to be efficiently drained from the bladder to the external flushing portion for wetting of the urethra.

The insertion portion may comprise an inlet lumen and one or more eyelets and one or more elongate open channels in an external surface thereof, all in fluid communication with the external flushing portion. With this combination, in use, multiple different flow paths may be provided, both through and along the outside of, the insertion portion from the bladder to the external flushing portion. Accordingly, such a combination may improve the flow rate of urine from the bladder through the catheter and reduce the likelihood of the flow of urine from the bladder becoming blocked when the catheter is in use.

The inlet lumen may comprise an outlet formed at a junction between the insertion portion and the external flushing portion to provide fluid communication therebetween.

There may be any suitable number of elongate channels. There may be between two and six elongate channels. There may be between three and five elongate channels. There may be at least four elongate channels.

The elongate channels may be distributed circumferentially around the insertion portion. The elongate channels may be evenly distributed and may extend parallel to one another. The elongate channels may be provided in diametrically opposing pairs.

The elongate channel may comprise an open recess in an external surface of the insertion portion. The open recess may comprise a radially inward base and at least one sidewall extending radially outwards from the base. The sidewall may be inclined away from a purely radial direction. The recess may comprise a through hole which provides a flow passage between the internal passageway and recess. The through hole may be referred to as an inlet aperture.

The plurality of apertures may be provided in a pattern which is desirable for flushing the wall of the urethra. In some embodiments, the plurality of apertures may be arranged in a plurality of circumferentially distributed longitudinal rows. There may be at least four longitudinal rows, optionally at least six or eight rows. Each of the rows may have a corresponding elongate channel circumferentially aligned therewith. At least one longitudinal row may comprise apertures that have a different size and/or shape than the apertures of at least one other longitudinal row. At least one longitudinal row may comprise apertures that are larger than the (smaller) apertures of at least one other longitudinal row. Each longitudinal row of larger apertures may have a corresponding elongate channel circumferentially aligned therewith.

The apertures of at least one longitudinal row, preferably a row of larger apertures, more preferably at least two longitudinal rows, and most preferably at least two diametrically opposed rows, may be diamond shaped. The apertures of at least one longitudinal row, preferably the row of larger apertures, more preferably at least two longitudinal rows, and most preferably at least two diametrically opposed rows, may have a long axis. The long axis of the or each row of larger apertures may be aligned with the longitudinal axis of the main body.

The apertures of at least one longitudinal row, preferably a row of smaller apertures, more preferably the (preferably smaller) apertures of at least two, three or four longitudinal rows, and most preferably the apertures of at least two opposing pairs of rows arranged between opposing rows of larger apertures may be triangular. The apertures of at least one longitudinal row, preferably a row of smaller apertures, more preferably the (preferably smaller) apertures of at least two, three or four longitudinal rows, and most preferably the apertures of at least two opposing pairs of rows arranged between opposing rows of larger apertures may have a long axis. The long axis of the or each row of smaller apertures may be aligned with the longitudinal axis of the main body.

The outlet may be provided at a terminal end of the main body. The outlet may be provided by an opening in an end face of the catheter. The size of the outlet may correspond to the internal passageway.

The outlet portion may comprise a solid tubular wall. Hence, the outlet portion may not comprise any apertures such that the flow of urine is contained within the outlet portion.

The outlet portion of the catheter may be shaped and configured for at least partial insertion into the urethra such that a junction and, hence, opening between the external flushing portion and the outlet portion is positioned fully within the urethra and a seal is formed at the urethral opening between the outlet portion and the urethral wall, in use.

The catheter may further comprise a formation extending from an external surface of the main body and arranged, in use, to abut the base of the urethra upon insertion of the catheter into the urethra. The formation may be a ring, e.g., an annular ring. The formation, e.g., annular ring, may have a convex surface. A proximal face of the formation, e.g., annular ring, may curve from the outlet portion away from the insertion end. The distance between the formation and the insertion end may be fixed and correspond to a maximum desired insertion depth of the catheter into the urethra. The formation may form a ridge extending around the main body.

The insertion end may have a non-circular cross-section. For example, the insertion end may have a square or cruciform cross section (especially where four inlet channels are provided), or a triangular cross section (for example if three inlet channels are provided, pentagonal cross section (for example if five inlet channels are provided). The number of sides of the cross section of the insertion end, may (or may not) correspond to the number of inlet channels provided.

The flushing portion may comprise between 20% and 80% of the length of the catheter. The length of the elongate channel may be between 10mm and 50mm, preferably 20mm.

The cross-sectional area of the elongate channel may be between 14mm ^A 2 and 22mm ^A 2, preferably 15mm ^A 2.

The pitch of the helical members may be between 5mm and 20mm, preferably 10mm.

The width of the helical members may be between 1mm and 3mm, preferably 2mm.

The apertures may have an area of between 15mm ^A 2 and 40mm ^A 2, preferably 25mm ^A 2.

The length of the insertion portion may be between 20mm and 50mm, preferably 30mm.

The length of the outlet portion may be between 10mm and 30mm, preferably 20mm.

The length of the catheter may be between 150mm and 420mm depending on whether the catheter is for a male or female anatomy. For a female catheter, the length may be between 150mm and 180mm, preferably 160mm. For a male catheter, the length of the catheter may be between 360mm and 420, preferably 405mm.

The diameter of the catheter may be between 2mm and 6mm depending on user requirements.

The present disclosure provides, in a second aspect, a method of catheterization using a catheter according to any aspect described herein. The method may comprise the steps of: (i) providing a catheter comprising an elongate main body having an insertion portion at an insertion end and an outlet portion at an outlet end, and an external flushing portion extending between the insertion portion and the outlet portion, wherein the external flushing portion comprises a tubular wall defining an internal passageway therein and a plurality of apertures distributed along the length thereof to provide fluid communication between the internal passageway and exterior of the main body, 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 portion. The outlet portion may be partially inserted into the urethra such that an opening to the outlet portion from the external flushing portion is fully located inside the urethra. The outlet portion of the catheter may be attached to a funnel. Where the catheter comprises an insertion depth guide extending from the outlet portion of the catheter, the catheter may be inserted into the urethra until the insertion depth guide abuts the base of the urethra.

The catheter may be an intermittent catheter. The catheter may be a urinary catheter. The catheter is preferably an intermittent urinary catheter. The catheter may be a male catheter (i.e. suitably sized for use by a man, with male anatomy), or a female catheter (i.e. suitably sided for use by a woman, with female anatomy). The catheter is preferably a male intermittent urinary catheter, or a female intermittent urinary catheter. The teachings herein are especially suited for intermittent urinary catheters.

The skilled person 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.

Brief Description of the Drawings

In order that the invention may be more clearly understood one or more embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, of which:

Figure 1 shows a schematic perspective view of a urinary catheter according to the present disclosure;

Figure 2 shows a partial longitudinal cross section of the outlet portion of the catheter shown in Figure 1 ;

Figure 3 shows a partial longitudinal cross section of the insertion portion of the catheter shown in Figure 1 ;

Figure 4 shows an inlet channel of the catheter shown in Figure 1;

Figure 5 shows an alternative inlet channel;

Figure 6 shows an alternative perspective view from the proximal end of a schematic representation of part of the catheter of Figure 1 ;

Figure 7 shows a first side view of the catheter of Figures 1 and 6; Figure 8 shows a cross section of a second side view of the catheter of Figures 1 and 6, wherein the second side view is circumferentially offset from the first side view by 90 degrees;

Figure 9 shows the insertion end of an alternative embodiment of a urinary catheter according to the present disclosure;

Figure 10 shows an alternative perspective view of the insertion end shown in Figure 9;

Figure 11 shows a first side view of the catheter of Figures 9 and 10;

Figure 12 shows a cross sectional side view of the catheter of Figures 9 and 10;

Figure 13 shows an enlarged perspective view of the outlet portion of the catheter shown in Figure 1 with an optional insertion depth guide extending therefrom;

Figure 14 shows a perspective view of a schematic representation of an alternative catheter according to the present disclosure with a funnel provided at the outlet end;

Figure 15 shows an enlarged perspective view of a junction between the external flushing portion and outlet portion of the catheter shown in Figure 14;

Figure 16 shows a cross sectional side view of the outlet portion and part of the external flushing portion of the catheter shown in Figure 14;

Figure 17 shows a side view of an alternative embodiment of a urinary catheter according to the present disclosure;

Figure 18 shows a cross sectional side view of the catheter shown in Figure 17 with the tip omitted;

Figure 19 shows a transverse cross sectional view of the insertion portion with inlet channels of the catheter shown in Figure 17; and,

Figure 20 shows a perspective view of a schematic representation of the catheter shown in Figure 17 with a funnel provided at the outlet end.

Detailed Description of 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 practiced 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.

In the following description, reference to longitudinal should be taken to be in relation to the longitudinal axis of the catheter, unless otherwise stated. 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.

The catheters described herein are primarily intermittent female catheters.

Figures 1 to 8 show various features, some optional, of a urinary catheter 1. The catheter 1 comprises an elongate main body 2 comprising an insertion portion 3 at an insertion end, an outlet portion 4 at an outlet end. An external flushing portion 5 extends between the insertion portion 3 and the outlet portion 4.

The external flushing portion 5 comprises a tubular wall defining an internal passageway 6 therein and a plurality of apertures 7 distributed along the length thereof to provide fluid communication between the internal passageway 6 and exterior of the main body 2 and urethra wall in use. The internal passageway 6 extends to an outlet 8 at the outlet end.

The flushing portion 5 may extend between the insertion portion 3 and outlet portion 4 and be defined by the presence of the plurality of apertures 7.

The insertion portion 3 may comprise a plurality of elongate open channels 9 in an external surface thereof. The elongate open channels 9 provide fluid communication between the exterior of the catheter 1 at the insertion end and the internal passageway 6.

The apertures 7 provide fluid communication between the internal passageway 6 and the exterior of the catheter 1 and may have any desirable size or shape and be provided in any desirable pattern as required. In the example shown in Figure 1, the apertures 7 have a polygonal form when viewed in radial plan. More specifically, the apertures 7 are diamond shaped with major axes extending longitudinally and circumferentially in relation to a central longitudinal axis 12 of the catheter 1. The apertures 7 comprise four sides of equal length arranged at approximately 90 degrees to one another. However, it will be appreciated that this configuration of aperture 7 is not a limitation and there may be fewer or more sides, the lengths of the sides may differ, and the angle between the sides may not be 90 degrees. For example, in some embodiments, the apertures 7 may be elongate in either the longitudinal or circumferential direction. In other embodiments, some of the apertures 7 may be elongate in the longitudinal direction and some other of the apertures 7 may be elongate in the circumferential direction. In other embodiments, the apertures 7 may be a round (e.g. circular, oval, racetrack-shaped, etc) triangular, rectangular, hexagonal, etc, or any combination of these.

The plurality of apertures 7 may have corresponding sizes and shapes and may be the same as one another. Alternatively, the plurality of apertures 7 may have different sizes and/or shapes. For example, in the embodiment shown in Figure 17, a first group of the plurality of apertures 207 may have corresponding sizes and shapes and may be the same as one another, and a second group of the plurality of apertures 207 may have corresponding sizes and shapes and may be the same as one another but different from the first group. The apertures 7 may be arranged in a tessellation with each aperture 7 separated by an elongate section of wall 10 to provide a suitably dense distribution of apertures 7, thereby allowing a large proportion of the urethra wall to come into fluid communication with the internal passageway 6.

The apertures 7 may be arranged to have a plurality of circumferentially distributed elongate rows. The apertures 7 of a first elongate row may have a different size and/or shape from the apertures 7 of a second elongate row of the circumferentially distributed elongate rows. In the embodiment shown in Figure 1 there are four rows, but this is not a limitation with, for example, the embodiment shown in Figures 9 to 12, comprising eight rows and the embodiment shown in Figures 17 to 20 comprising six rows.

When viewed collectively, the wall segments 10 which define the apertures 7 may form at least one pair of counter-rotating helical members. The pair of helical members may have a common pitch and may be provided in an anti-phasal relation such that the apertures are formed symmetrically about a centre line which is parallel to the central longitudinal axis 12. As such, the opposing counter-rotating helical members may start and/or terminate at a common circumferential and axial point.

The apertures 7 represent a through-hole in the tubular wall of the main body 2 and extend from the outer surface of the main body 2 to the inner surface of the main body 2 with a constant cross-sectional area when viewed in radial plan (discounting any rounding of the aperture edges at the outer or inner surface of the tubular member).

The size of the wall segments 10 may be any suitable size to provide the necessary structural strength to ensure that the catheter 1 remains sufficiently rigid when in use. Each wall segment 10 has a radial depth which extends from the outer surface to the inner surface which provides the internal passageway 6. The width of the wall segments 10 may be determined based on a required strength and/or to provide the required surface area for the apertures 7 and/or retention of the catheter in the urethra when in use.

The outlet portion 4 is shown in the partial longitudinal section of Figure 2 and in Figures 7 to 8. Here there is shown a solid tubular wall 11 extending from the distal end of the plurality of apertures 7 in the main body 2. The tubular wall 11 provides an extension to the internal passageway 6 which is centrally located on the central axis of the catheter 1. An outlet 8 is provided in the end face of the outlet portion 4 and provides a nozzle for an exiting flow of urine. In some embodiments the outlet portion may take a different form and may comprise one or more outlets which may or may not be provided in the external end face of the outlet portion, for example.

The insertion portion 3 extends from the proximal end of the apertures 7 to the terminal end of the catheter 1. The insertion portion 3 may be configured to aid insertion and may comprise one more features or formations to this end. In the embodiment shown in Figure 1, the insertion portion 3 is provided with a rounded terminal end 16 but this is not a limitation and the terminal end may be provided with a bulb or cone shaped member to aid insertion of the catheter 1.

The insertion portion 3 may comprise a plurality of inlets in the form of elongate open channels 9 which extend longitudinally parallel to the longitudinal axis 12 of the catheter 1. The elongate channels 9 may be referred to as inlet channels 9 herein. Although the inlet channels 9 are shown as having a purely longitudinal direction in Figure 1, this is not a limitation and the channels 9 may additionally extend circumferentially in some embodiments.

The inlet channels 9 are provided by troughs or elongate recesses provided in the outer surface of the catheter 1. As shown in Figure 3, the insertion portion 3 may comprise a solid body 15 such that the internal passageway 6 commences at the distal end of the insertion portion 3 but this is not a limitation and the insertion portion 3 may comprise a hollow body in some embodiments. Further, in some embodiments, the inlet channels 9 may penetrate the wall in the insertion portion 3 to provide a through-hole into the internal passageway 6. As such, the inlet channels 9 may be provided as elongate apertures similar to the plurality of apertures 7 provided in the main body 2.

In one example, the insertion portion 3 may comprise a solid tubular wall defining an inlet lumen (not shown) which is closed at the insertion end of the catheter 1 and open to the internal passageway 6 of the external flushing portion 5 at the junction between the insertion portion 3 and the external flushing portion 5. A pair of eyelets (not shown) may be formed through the tubular wall of the insertion portion 3 on opposite sides respectively and extend into the inlet lumen. The eyelets may be longitudinally offset such that one eyelet is closer to the terminal end of the catheter and the other eyelet is closer to the external flushing portion 5. Accordingly, a fluid flow path may be formed from the insertion portion 3 to the external flushing portion 5 via the eyelets and inlet lumen for the drainage of urine from the bladder.

The eyelets and inlet lumen may be provided in the insertion portion 3 in addition to the inlet channels 9 which may be formed along the outer surface of the solid tubular wall such that multiple different flow paths from the insertion portion 3 to the external flushing portion 5 are formed. Providing multiple different flow paths reduces the risk of a blockage occurring that prevents the drainage of urine from the bladder. Furthermore, the eyelets and inlet channels 9 may contribute to empty the bladder more fully and with a combined greater flow rate.

It will be appreciated that the number, shape, and position of the eyelets need not be limited as described above and that more, or less, eyelets may be formed through the solid tubular wall in different positions along the insertion portion 3. For example, the eyelets could be stadium shaped, rectangular, oval, square or circular and/or may be diametrically opposed at substantially the same longitudinal position. There could be just one eyelet, or more than two eyelets arranged at various locations about and/or along the solid tubular wall of the insertion portion 3.

The inlet channels 9 each comprise a base 13 with sidewalls 14 extending therefrom, with the sidewalls 14 terminating at the outer external surface of the insertion portion 3. The inlet channels 3 are configured to receive a flow of urine from the user’s bladder in use and channel that towards the internal passageway 6.

The elongate geometry of the inlet channels 9 means that the positioning of the catheter 1, in relation to the penetrating depth within the bladder, can be less precise and a range of penetrating depths is possible whilst still ensuring a reasonable flow inlet area is provided. As such, the catheter 1 can be inserted into the user’s urethra such that only the solid walled outlet portion 4 protrudes thereby allowing a greater amount of flushing contact with the urethra wall. Further, the elongate channels 9 provide the potential for a large inlet area when compared to other inlet apertures. Further still, the elongate inlet channels 9 allow the urethra wall to be in flushing contact with the urine flow as it exits the bladder and prior to entering the internal passageway 6, thereby aiding with the flushing of the urethra along a greater length.

The proximal end of the inlet channels 9 may terminate with a closed end, as shown, or may extend fully to the terminal end 16 of the catheter 1.

Figures 3 to 5 show options for the distal end of the inlet channels 9 and the provision of a fluid pathway between the respective inlet channels 9 and the internal passageway 6. Figure 3 shows a longitudinal cross-section of the catheter 1 showing two diametrically opposed inlet channels 9, with Figure 4 showing a perspective view of an inlet channel 9 to highlight an inlet aperture 17.

As described above, the inlet channels 9 comprise a base 13 and a sidewall 14 which is angled to provide the channel 9 with a V-shaped cross-section (which may be referred to as a wedge shape or tapered cross-section). At the distal end of the inlet channel 9, there is provided an inlet aperture 17 which fluidly connects the inlet channel 9 and the internal passageway 6. The inlet aperture 17 is provided in the base 13 of the inlet channel 9 and extends radially and axially through the thickness of the tubular wall of the main body to exit into the internal passageway 6 at a proximal end thereof. The size and shape of the inlet aperture 17 may be any suitable for providing a required fluid communication between the inlet channel 9 and internal passageway 6. Figure 5 shows an alternative arrangement, which is similar to that shown on the upper inlet channel of the catheter shown in Figure 1. Here, in place of having an inlet aperture 17 in the base 13 of the inlet channel 9, the inlet channel 9 terminates in one of the plurality of apertures 7 provided in the wall of main body 2. Hence, the distal end of the inlet channel 9 is open with no end wall. It will be appreciated that the catheter 1 may comprise both inlet apertures 17 and apertures 7 for providing fluid communication between the inlet channels 9 and the internal passageway 6. For example, a pair of diametrically opposed inlet channels 9 may each terminate in one of the plurality of apertures 7 provided in the wall of the main body 2, and the other pair of diametrically opposed inlet channels 9 may each terminate in an inlet aperture 17, as shown in Figures 7 and 8.

Figures 9 to 12 show an alternative arrangement in which there are eight rows of apertures 607 provided in a tessellation and four inlet channels 609. This arrangement provides a smaller flow contact area that than shown in Figure 1, as the apertures 607 are smaller and a greater percentage of the surface area of the main body 602 is taken up by the wall sections 610. However, the arrangement of Figures 9 to 12 is inherently stronger due to the inclusion of the larger number of wall segments 610. Each of the inlet channels 609 terminates in an inlet aperture as shown in Figures 3 and 4 or one of the plurality of apertures 607 as per Figure 5.

Referring to Figure 13, the outlet portion 4 may optionally include a formation 18 that provides an insertion depth guide which, in this embodiment, is a formation in the form of an annular ring. The annular ring 18 may have a convex outer surface 19 extending from the outlet wall 11 and fully around the circumference of the outlet portion 4. The annular ring 18 may be integrally formed with the outlet portion 4 and shaped such that the proximal face 20 curves from the wall 11 of the outlet portion 4 away from the insertion end. The annular ring 18 is spaced apart from the end face of the outlet portion 4 and positioned a distance from the insertion tip 16 of the catheter 1 that represents a maximum desired insertion depth of the catheter 1 into the urethra and, ultimately, the bladder. Accordingly, the annular ring 18 is shaped and configured to form a gentle ridge that is positioned, in use, to abut the base of the urethra and provide a non-intrusive, tactile and/or visual feedback to the user to indicate when the entrance from the external flushing portion 5 to the outlet portion 4 is appropriately positioned within the urethra and the catheter 1 has reached or is approaching its maximum desired insertion depth.

The annular ring 18 may also be arranged to form an abutment or depth guide for a separate funnel attachment (not shown) that may be inserted over the wall 11 of the outlet portion 4 from the end face thereof. The distance between the annular ring 18 and end face of the outlet portion 4 may therefore be equivalent to the maximum desired insertion distance for the funnel attachment over the wall 11 of the outlet portion 4 and assist a user in correctly positioning a funnel for the outflow of urine from the catheter 1 without leakage.

Whilst the outlet portion 4 may be shaped and configured for the attachment of a separate funnel at the terminal end thereof, it will be appreciated that a funnel may be incorporated into, and integrally formed with, the outlet portion 4. Referring to Figures 14 to 16, an alternative catheter 101 comprises an external flushing portion 105 having the same general form as that described above with wall segments 110 defining a plurality of apertures 107 in a tessellation. In this alternative embodiment, the outlet portion 104 comprises a funnel portion 121 forming an internal conical cavity 122 which expands toward an outlet 123 at the end face of the funnel portion 121 for the outflow of urine from the catheter 1.

The outlet portion 104 comprises a substantially tubular solid wall portion 111 with a diameter greater than that of the external flushing portion 105. The proximal side of the outlet portion 104 comprises an annular face 124 encircling the external flushing portion 105 and extending to an internal recessed portion 125 with a tapered inner wall 126. The recessed portion 125 is shaped to capture urine flowing between the external flushing portion 105 and the urethral wall and direct the urine toward the lower face of the recessed portion 125. An open-ended outlet lumen 127 is formed through the outlet portion 104 and extends along the central axis from the distal end of the external flushing portion 105 through to the conical cavity 122 of the funnel portion 121. A further two lumens or drainage channels 128 are formed through the outlet portion 104 on diametrically opposed sides of the central outlet lumen 127. The drainage channels 128 are likewise open at the junction between the external flushing portion 105 and the outlet portion 104 and extend through to the conical cavity 122 of the funnel portion 121. Accordingly, three flow channels are formed internally through the outlet portion 104 to the conical cavity 122 for the flow of urine from the external flushing portion

105 and out from the outlet 123 at the terminal end of the catheter 101.

The external flushing portion 105 is shaped and configured to be inserted into the urethra until the annular face 124 of the outlet portion 104 abuts the base of the urethra and encircles the urethra to capture urine flowing therefrom and direct it to the drainage channels 128. Accordingly, in the present embodiment, the outlet portion 104 is not shaped and configured to be partially inserted into the urethra and there is no requirement for a depth insertion guide extending from the outer wall 111 of the outlet portion 104. A flange 129 extends from the outlet portion 104 and is provided to facilitate handling and positioning of the catheter 101 by a user when being inserted into and removed from the urethra.

Referring to Figures 17 to 20, an alternative catheter 201 comprises an external flushing portion 205 having the same general form as that described above with wall segments 210 defining a plurality of apertures 207 in a tessellation. In this alternative embodiment, the tessellation of apertures 207 are arranged into six circumferentially distributed, longitudinal rows. Two of the rows of apertures 207 comprise larger, diamond shaped apertures 207a of substantially the same size that extend longitudinally. The two rows of diamond apertures 207a are arranged on opposite sides respectively of the flushing portion 205 to form a plurality of channels that extend transversely through the flushing portion 205.

The other four rows of apertures 207 comprise a plurality of smaller, triangular shaped apertures 207b of substantially the same size. Each row of triangular apertures 207b is arranged adjacent to a row of diamond apertures 207a such that two sides of a triangular aperture 207b are each parallel with a side of an adjacent diamond aperture 207a. In this arrangement, two rows of triangular apertures 207b are adjacent one another such that a side of each triangular aperture 207b of one row is parallel with a side of each triangular aperture 207b of the adjacent row. Accordingly, pairs of adjacent, triangular apertures 207b together form a plurality of channels extending transversely through the flushing portion 205. Advantageously, this tessellation pattern may facilitate manufacture by injection moulding without compromising the desired rigidity of the catheter 201. Additionally, unlike in the above-described embodiments, the insertion portion 203 comprises only two elongate inlet channels 209 that are arranged on opposite sides respectively of the catheter 201. Each inlet channel 209 is formed to be longitudinally aligned with a corresponding row of diamond apertures 207a such that the distal end of each inlet channel 209 fluidly connects the inlet channel 209 and the internal passageway via a diamond aperture 207a or partially formed (e.g., half) diamond aperture 207a of the correspondingly aligned row of diamond apertures 207a. Furthermore, with particular reference to Figure 19, the two inlet channels 209 are formed to provide a U-shaped cross-section rather than four V-shaped inlet channels as above described. Providing a reduced number of inlet channels 209 allows for deeper channels (e.g., 1.86mm instead of 0.93mm to 1.21mm) to be formed in the insertion portion 209 and this arrangement has been found to facilitate manufacture by injection moulding without adversely affecting the functionality or rigidity of the resulting catheter 201.

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, polyether 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.

In preferred embodiments, the catheter is formed of a material of the group comprising: polyolefins, polyesters, poly acrylates, 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.

In some embodiments, said water disintegrable or enzymatically hydrolysable material comprises a material of teh group comprising: polyvinyl alcohol, extrudable polyvinyl alcohol, poly aery lie 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 comprise a polymer mixture comprising a first polymer and a second polymer, wherein the first polymer is a thermoplastic or thermocuring 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.

The flushing portion may comprise between 20% and 80% of the length of the catheter. The length of the elongate channel may be between 10mm and 30mm, preferably 20mm. The cross-sectional area of the elongate channel may be between 14mm ^A 2 and 22mm ^A 2, preferably 17.5mm ^A 2. The pitch of the helical members may be between 7.5mm and 15mm, preferably 10mm. The width of the helical members may be between 1.5mm and 3.5mm, preferably 2.75mm. The apertures may have an area of between 15mm ^A 2 and 40mm ^A 2, preferably 25mm ^A 2. The length of the insertion portion may be between 20mm and 50mm, preferably 30mm. The length of the outlet portion may be between 10mm and 30mm, preferably 20mm. The length of the catheter may be between 420mm and 150mm depending on whether the catheter is intended for male or female anatomy. The diameter of the catheter may be between 2mm and 6mm depending on user requirements.

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.